chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No adverse event; received the wrong booster/received booster from incorrect vial; got the pediatric 6 to 11 year old formulation; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (received the wrong booster/received booster from incorrect vial), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (got the pediatric 6 to 11 year old formulation) and NO ADVERSE EVENT (No adverse event) in a 32-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR6965B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 06-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (received the wrong booster/received booster from incorrect vial) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (got the pediatric 6 to 11 year old formulation). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received the wrong booster/received booster from incorrect vial), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (got the pediatric 6 to 11 year old formulation) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (received the wrong booster/received booster from incorrect vial) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (got the pediatric 6 to 11 year old formulation).    No concomitant medications were reported. Patient got second Moderna booster. Patient was supposed to get a booster, but got the pediatric 6 to 11 year old formulation. The box said booster doses on the outside. The pharmacist explained that HCP grabbed a vial of the vaccine for 6 to 11 year olds and administered to 3 adult patients who were going for their booster shots.The pharmacist reported that it was confusing because the vial states Moderna COVID-19 Vaccine for booster doses only. There was a purple border on the carton, but not on the vial. It did not mention an age group on the carton at all.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-642004, US-MODERNATX, INC.-MOD-2022-642009 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-642004: US-MODERNATX, INC.-MOD-2022-642009:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Lack of efficacy; COVID-19; This spontaneous case was reported by an other health care professional and describes the occurrence of DRUG INEFFECTIVE (Lack of efficacy) and COVID-19 (COVID-19) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced DRUG INEFFECTIVE (Lack of efficacy) and COVID-19 (COVID-19). At the time of the report, DRUG INEFFECTIVE (Lack of efficacy) and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. COMPANY COMMENT: -This is an spontaneous case concerning an unknown-years-old male patient with no medical history reported who experienced the unexpected events of covid-19 (AESI) and drug ineffective unknown days after a  dose of  mRNA-1273 vaccine.  On an unknown date, SARS-CoV-2 test was Positive The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  Events seriousness was assessed based on medical judgement.; Sender's Comments: COMPANY COMMENT: -This is an spontaneous case concerning an unknown-years-old male patient with no medical history reported who experienced the unexpected events of covid-19 (AESI) and drug ineffective unknown days after a  dose of  mRNA-1273 vaccine.  On an unknown date, SARS-CoV-2 test was Positive The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  Events seriousness was assessed based on medical judgement.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Fatigue, Headache, Lethargy, Lumbar puncture
Clinical narrative: Headache , lethargy, muscle weakness, fatigue
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness
Clinical narrative: Headache , lethargy, muscle weakness, fatigue
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Death
Clinical narrative: My mom died the next morning after administration of the bivalent vaccine
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Admitted to hospital.
Age: 54.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Renal pain
Clinical narrative: My kidneys hurt a lot. Very painful.
Age: 54.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: My kidneys hurt a lot. Very painful.
Age: 54.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Pollakiuria, Renal pain
Clinical narrative: My kidneys hurt a lot. Very painful.
Age: 42.0
Sex: M
Vaccine: FLUR4
Symptoms: Blood test, Cough, Fatigue, Oropharyngeal pain, Pain
Clinical narrative: 0300 (20 hours post) runny nose, sore throat, coughing 0700 (22 hours post) sore throat, body aches, mild plegm in nose.  12:00pm body aches, no fever, tiredness , sneezing, nasal drip, sore throat   Did 2 Covid tests (BinaxNow) both negative Feels like the second Covid vaccine
Age: 42.0
Sex: M
Vaccine: FLUR4
Symptoms: Productive cough, Rhinorrhoea, SARS-CoV-2 test negative, Sneezing
Clinical narrative: 0300 (20 hours post) runny nose, sore throat, coughing 0700 (22 hours post) sore throat, body aches, mild plegm in nose.  12:00pm body aches, no fever, tiredness , sneezing, nasal drip, sore throat   Did 2 Covid tests (BinaxNow) both negative Feels like the second Covid vaccine
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Admitted to hospital.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; administered with 0.25ml of the bivalent booster dose instead of the 0.5ml dose; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (administered with 0.25ml of the bivalent booster dose instead of the 0.5ml dose) and NO ADVERSE EVENT (No adverse event) in a 69-year-old male patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Sep-2022, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 04-Sep-2022, the patient experienced UNDERDOSE (administered with 0.25ml of the bivalent booster dose instead of the 0.5ml dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (administered with 0.25ml of the bivalent booster dose instead of the 0.5ml dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (administered with 0.25ml of the bivalent booster dose instead of the 0.5ml dose).    Concomitant medication details were not reported by the reporter.  On 02-Mar-2021, patient received First dose of Moderna COVID-19 vaccine with batch number 002A21A.  On 30-Mar2021, patient received second dose  of Moderna COVID-19 vaccine with batch number 028A21A.  On 25-Oct-2021, patient received First booster  of Moderna COVID-19 vaccine dose with batch number 076C21A.  On 18-Apr-2022, patient received Second booster  of Moderna COVID-19 vaccine dose with batch number 001M21A.  The patient received the bivalent booster dose of the Moderna Covid-19 vaccine on 04-Sep-2022 and received 0.25ml instead of the 0.5ml dose. Vaccine provider called and informed patients that CDC recommended giving a full 0.5ml of the vaccine again instead of just 0.25.  Treatment details was not reported by the reporter.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site rash
Clinical narrative: 3 inch x 3 inch rash around the injection site. Area is red, slightly inflamed, and itchy. No tenderness. Itchiness is not completely controlled by OTC antihistamines.
Age: 35.0
Sex: F
Vaccine: COVID19-2, FLUR4
Symptoms: Exposure during pregnancy, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 21 weeks pregnant Red swollen warm bump at injection site
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Computerised tomogram, Echocardiogram, Facial paralysis, Laboratory test
Clinical narrative: TIA 1/21/22- sudden onset facial dropping.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Transient ischaemic attack, Ultrasound Doppler
Clinical narrative: TIA 1/21/22- sudden onset facial dropping.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Back pain, Chills, Fatigue, Hyperhidrosis
Clinical narrative: I had the first two COVID shots and the first booster, all made by Pfizer. I had ZERO symptoms from those shots. I decided to get the second booster and pharmacy told me to take the Moderna Bivalent.   In six hours I was feeling pain in my arm and back. It progressed down my spine and neck, both arm, and hips.  I could barely move, even my hands.  My legs could move, but I could not trun my body and it was agonizing.  I had a fever, chills, and was soaked in sweat.  I was literally thinking this was the end for me.  I am a strong person and kept telling myself this will pass. The pain lasted two days and today is the fouth day and the pain is completely gone, but I am exhausted as I did not sleep and could not move.    This was the worst suffering I ever had and will never take another vaccine.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Insomnia, Mobility decreased, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: I had the first two COVID shots and the first booster, all made by Pfizer. I had ZERO symptoms from those shots. I decided to get the second booster and pharmacy told me to take the Moderna Bivalent.   In six hours I was feeling pain in my arm and back. It progressed down my spine and neck, both arm, and hips.  I could barely move, even my hands.  My legs could move, but I could not trun my body and it was agonizing.  I had a fever, chills, and was soaked in sweat.  I was literally thinking this was the end for me.  I am a strong person and kept telling myself this will pass. The pain lasted two days and today is the fouth day and the pain is completely gone, but I am exhausted as I did not sleep and could not move.    This was the worst suffering I ever had and will never take another vaccine.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Spinal pain
Clinical narrative: I had the first two COVID shots and the first booster, all made by Pfizer. I had ZERO symptoms from those shots. I decided to get the second booster and pharmacy told me to take the Moderna Bivalent.   In six hours I was feeling pain in my arm and back. It progressed down my spine and neck, both arm, and hips.  I could barely move, even my hands.  My legs could move, but I could not trun my body and it was agonizing.  I had a fever, chills, and was soaked in sweat.  I was literally thinking this was the end for me.  I am a strong person and kept telling myself this will pass. The pain lasted two days and today is the fouth day and the pain is completely gone, but I am exhausted as I did not sleep and could not move.    This was the worst suffering I ever had and will never take another vaccine.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Breast mass, COVID-19, Cardiac discomfort, Chills, Choking sensation
Clinical narrative: In the morning of  12/22/2021 my body was itching and felt mild and slowly progressing choking sensation in my throat. I injected myself with EpiPen. Swollen lymph nodes in my neck both sides and left under arm. Lumps in both breasts more in the left side. Brain fog, chills start late afternoon, fatigue all day, dizziness, headache, fast heart beats and heart bubbling feeling and very occasional cough that doesn't bother me. Low BP between 12/22/21 - 12/30/21 (around 117/79). I was getting better from some symptoms after almost two weeks of side/adverse effects like chills, fatigue, dizziness and headache. On January 3rd, severe headache was constant and gets worst when I lay down. My stomach is not accepting food, drinks and medicines. Sometimes when I feel like vomiting, nothing comes out and the floor was already flooding with my urine. BP was 180/150 I don't look sick at all. Was Covid positive on January 5, 2022. Brain fog got worst, can no longer do my daily 10k steps straight per day perhaps for 5 months. Period lasted for weeks, uncontrolled urination, weak legs, electrical feeling, headache. I may have more symptoms, can't remember right now. I went to the ER on January 5. Consulted with my primary care physician on January 8. Please check my 2nd dose report.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Dizziness, Electric shock sensation, Exercise tolerance decreased
Clinical narrative: In the morning of  12/22/2021 my body was itching and felt mild and slowly progressing choking sensation in my throat. I injected myself with EpiPen. Swollen lymph nodes in my neck both sides and left under arm. Lumps in both breasts more in the left side. Brain fog, chills start late afternoon, fatigue all day, dizziness, headache, fast heart beats and heart bubbling feeling and very occasional cough that doesn't bother me. Low BP between 12/22/21 - 12/30/21 (around 117/79). I was getting better from some symptoms after almost two weeks of side/adverse effects like chills, fatigue, dizziness and headache. On January 3rd, severe headache was constant and gets worst when I lay down. My stomach is not accepting food, drinks and medicines. Sometimes when I feel like vomiting, nothing comes out and the floor was already flooding with my urine. BP was 180/150 I don't look sick at all. Was Covid positive on January 5, 2022. Brain fog got worst, can no longer do my daily 10k steps straight per day perhaps for 5 months. Period lasted for weeks, uncontrolled urination, weak legs, electrical feeling, headache. I may have more symptoms, can't remember right now. I went to the ER on January 5. Consulted with my primary care physician on January 8. Please check my 2nd dose report.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Fluid intake reduced, Headache, Heart rate increased
Clinical narrative: In the morning of  12/22/2021 my body was itching and felt mild and slowly progressing choking sensation in my throat. I injected myself with EpiPen. Swollen lymph nodes in my neck both sides and left under arm. Lumps in both breasts more in the left side. Brain fog, chills start late afternoon, fatigue all day, dizziness, headache, fast heart beats and heart bubbling feeling and very occasional cough that doesn't bother me. Low BP between 12/22/21 - 12/30/21 (around 117/79). I was getting better from some symptoms after almost two weeks of side/adverse effects like chills, fatigue, dizziness and headache. On January 3rd, severe headache was constant and gets worst when I lay down. My stomach is not accepting food, drinks and medicines. Sometimes when I feel like vomiting, nothing comes out and the floor was already flooding with my urine. BP was 180/150 I don't look sick at all. Was Covid positive on January 5, 2022. Brain fog got worst, can no longer do my daily 10k steps straight per day perhaps for 5 months. Period lasted for weeks, uncontrolled urination, weak legs, electrical feeling, headache. I may have more symptoms, can't remember right now. I went to the ER on January 5. Consulted with my primary care physician on January 8. Please check my 2nd dose report.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Hypotension, Lymphadenopathy, Magnetic resonance imaging head normal, Muscular weakness
Clinical narrative: In the morning of  12/22/2021 my body was itching and felt mild and slowly progressing choking sensation in my throat. I injected myself with EpiPen. Swollen lymph nodes in my neck both sides and left under arm. Lumps in both breasts more in the left side. Brain fog, chills start late afternoon, fatigue all day, dizziness, headache, fast heart beats and heart bubbling feeling and very occasional cough that doesn't bother me. Low BP between 12/22/21 - 12/30/21 (around 117/79). I was getting better from some symptoms after almost two weeks of side/adverse effects like chills, fatigue, dizziness and headache. On January 3rd, severe headache was constant and gets worst when I lay down. My stomach is not accepting food, drinks and medicines. Sometimes when I feel like vomiting, nothing comes out and the floor was already flooding with my urine. BP was 180/150 I don't look sick at all. Was Covid positive on January 5, 2022. Brain fog got worst, can no longer do my daily 10k steps straight per day perhaps for 5 months. Period lasted for weeks, uncontrolled urination, weak legs, electrical feeling, headache. I may have more symptoms, can't remember right now. I went to the ER on January 5. Consulted with my primary care physician on January 8. Please check my 2nd dose report.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, SARS-CoV-2 test positive, Urinary incontinence
Clinical narrative: In the morning of  12/22/2021 my body was itching and felt mild and slowly progressing choking sensation in my throat. I injected myself with EpiPen. Swollen lymph nodes in my neck both sides and left under arm. Lumps in both breasts more in the left side. Brain fog, chills start late afternoon, fatigue all day, dizziness, headache, fast heart beats and heart bubbling feeling and very occasional cough that doesn't bother me. Low BP between 12/22/21 - 12/30/21 (around 117/79). I was getting better from some symptoms after almost two weeks of side/adverse effects like chills, fatigue, dizziness and headache. On January 3rd, severe headache was constant and gets worst when I lay down. My stomach is not accepting food, drinks and medicines. Sometimes when I feel like vomiting, nothing comes out and the floor was already flooding with my urine. BP was 180/150 I don't look sick at all. Was Covid positive on January 5, 2022. Brain fog got worst, can no longer do my daily 10k steps straight per day perhaps for 5 months. Period lasted for weeks, uncontrolled urination, weak legs, electrical feeling, headache. I may have more symptoms, can't remember right now. I went to the ER on January 5. Consulted with my primary care physician on January 8. Please check my 2nd dose report.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Chills, Fatigue, Headache, Malaise
Clinical narrative: Very sore arm accompanied with weakness and what feels like a strain, massive headache, chills, malaise, bad fatigue, sore quad muscles (weird)
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Muscle strain, Myalgia, Pain in extremity, SARS-CoV-2 test negative
Clinical narrative: Very sore arm accompanied with weakness and what feels like a strain, massive headache, chills, malaise, bad fatigue, sore quad muscles (weird)
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Headache
Clinical narrative: Very sore arm accompanied with weakness and what feels like a strain, massive headache, chills, malaise, bad fatigue, sore quad muscles (weird)
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: VISION CHANGES (PT STATED ALL OF A SUDDEN SHE COULD SEE VERY FAR WHEREAS PREVIOUSLY NEEDED GLASSES, BUT HER NEARSIGHTEDNESS WAS WORSE - SENSITIVITY TO BRIGHT LIGHT), EAR RINGING, GENERAL FEELING OF SICKNESS, FATIGUE, HEADACHE, TROUBLE SLEEPING, INCREASED BATHROOM VISITS. PAIN, SWELLING, WARMTH IN INJECTION SITE.  PT HAD ICED ARM FOR PAIN/SWELLING. HADN'T TRIED ANYTHING YET FOR OTHER SYMPTOMS.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Malaise, Photophobia, Tinnitus, Visual impairment
Clinical narrative: VISION CHANGES (PT STATED ALL OF A SUDDEN SHE COULD SEE VERY FAR WHEREAS PREVIOUSLY NEEDED GLASSES, BUT HER NEARSIGHTEDNESS WAS WORSE - SENSITIVITY TO BRIGHT LIGHT), EAR RINGING, GENERAL FEELING OF SICKNESS, FATIGUE, HEADACHE, TROUBLE SLEEPING, INCREASED BATHROOM VISITS. PAIN, SWELLING, WARMTH IN INJECTION SITE.  PT HAD ICED ARM FOR PAIN/SWELLING. HADN'T TRIED ANYTHING YET FOR OTHER SYMPTOMS.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Headache, Impaired work ability, Injection site pain
Clinical narrative: Chills, aches, and pains began at approximately 10 p.m. the day of the vaccine.  Headache began at approximately 2 a.m. the following day, progressing to migraine-level headache with mild nausea and mild diarrhea.  Chills subsided quickly but headache persisted until approximately 4 p.m. the following day. Patient was unable to do regular activities such as work, prepare meals, etc.  Additionally, injection site arm pain appeared at approximately 3 p.m. the day of the vaccine but subsided approximately 15 minutes later to a mildly tender arm at site. Arm is still tender at time of reporting (9/17/2022, 11:00 a.m.)
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Migraine, Nausea, Pain
Clinical narrative: Chills, aches, and pains began at approximately 10 p.m. the day of the vaccine.  Headache began at approximately 2 a.m. the following day, progressing to migraine-level headache with mild nausea and mild diarrhea.  Chills subsided quickly but headache persisted until approximately 4 p.m. the following day. Patient was unable to do regular activities such as work, prepare meals, etc.  Additionally, injection site arm pain appeared at approximately 3 p.m. the day of the vaccine but subsided approximately 15 minutes later to a mildly tender arm at site. Arm is still tender at time of reporting (9/17/2022, 11:00 a.m.)
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: aches; fever; chills; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN (aches), PYREXIA (fever) and CHILLS (chills) in a 36-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Type 1 diabetes mellitus.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (aches), PYREXIA (fever) and CHILLS (chills). At the time of the report, PAIN (aches), PYREXIA (fever) and CHILLS (chills) had resolved.      No concomitant medications were reported. It was reported that after receiving the vaccine patient had experienced fever, chills, and aches that lasted for about 10-12 hours. No treatment medications were reported.   This case was linked to MOD-2022-642391 (Patient Link).
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event, Product availability issue
Clinical narrative: No adverse event; Patient received the monovalent booster instead of bivalent booster; received the monovalent booster, instead of the bivalent booster due to no availability of the bivalent on 2SEP2022; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT PRODUCT FORMULATION ADMINISTERED (Patient received the monovalent booster instead of bivalent booster), PRODUCT AVAILABILITY ISSUE (received the monovalent booster, instead of the bivalent booster due to no availability of the bivalent on 2SEP2022) and NO ADVERSE EVENT (No adverse event) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2022, the patient experienced INCORRECT PRODUCT FORMULATION ADMINISTERED (Patient received the monovalent booster instead of bivalent booster). 02-Sep-2022, the patient experienced PRODUCT AVAILABILITY ISSUE (received the monovalent booster, instead of the bivalent booster due to no availability of the bivalent on 2SEP2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT PRODUCT FORMULATION ADMINISTERED (Patient received the monovalent booster instead of bivalent booster), PRODUCT AVAILABILITY ISSUE (received the monovalent booster, instead of the bivalent booster due to no availability of the bivalent on 2SEP2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INCORRECT PRODUCT FORMULATION ADMINISTERED (Patient received the monovalent booster instead of bivalent booster) and PRODUCT AVAILABILITY ISSUE (received the monovalent booster, instead of the bivalent booster due to no availability of the bivalent on 2SEP2022).    Concomitant medication was not reported.  It was reported that no expired dose was given to the patient on 2SEP2022.  Patient was fine and did not experience any side effect.  Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2022: Significant information received. Patient details, event information updated.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Got covid with mild symptoms; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Got covid with mild symptoms) in a 71-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Concurrent medical conditions included MS and Living in nursing home.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Got covid with mild symptoms). At the time of the report, COVID-19 (Got covid with mild symptoms) had not resolved.            No concomitant medication information was provided. Events dyspnea and cough are subsumed under the event Covid19. Patient had coughed for a month and went away and had no cough after 3rd dose, now patient had long haul COVID.   Treatment information included patient on oxygen due to breathing problems.  Company Comment: This spontaneous case concerns a 71-year-old male patient, with relevant concurrent medical condition multiple sclerosis and living in a nursing home, who experienced unexpected, non-serious AESI Covid19, after receiving a second dose of mRNA-1273.  Onset latency of Covid19 from time of vaccination could not be determined due to limited information.  It was reported that after the second dose, he developed breathing problems and got Covid19 with mild symptoms.  He also had cough which lasted for a month.  It was further reported that after a third dose of vaccination, he now had long haul Covid19 with need for oxygen.  The ongoing Covid19 pandemic could be a contributory factor.  The patient's concurrent multiple sclerosis could also be a confounding factor.  The benefit risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-642170 (Patient Link).; Sender's Comments: This spontaneous case concerns a 71-year-old male patient, with relevant concurrent medical condition multiple sclerosis and living in a nursing home, who experienced unexpected, non-serious AESI Covid19, after receiving a second dose of mRNA-1273.  Onset latency of Covid19 from time of vaccination could not be determined due to limited information.  It was reported that after the second dose, he developed breathing problems and got Covid19 with mild symptoms.  He also had cough which lasted for a month.  It was further reported that after a third dose of vaccination, he now had long haul Covid19 with need for oxygen.  The ongoing Covid19 pandemic could be a contributory factor.  The patient's concurrent multiple sclerosis could also be a confounding factor.  The benefit risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Leukaemia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of LEUKAEMIA (leukemia) in a female patient of an unknown age who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced LEUKAEMIA (leukemia) (seriousness criterion medically significant) and FEELING ABNORMAL (changed them very much). At the time of the report, LEUKAEMIA (leukemia) and FEELING ABNORMAL (changed them very much) outcome was unknown. No concomitant medication was reported. The reporter stated that after the vaccination with the mRNA, it changed them very much. It was like not only mental and they were not as toxic and stuff but they had this now. They got them to take a booster. That's when everything really took a nose dive. Now it was really an urgent situation because the cutting edge type information that if it was caused by the vaccine, but the reporter thought it's leukemia because they were talked about chemo. It was stated that it might not be a good idea to use chemo and it might be a better idea to use since they know. The genes were inserted and not, that someone could possibly fix the leukemia with a gene. Company comment: This spontaneous case concerns a female patient of unspecified age with no medical history reported, who experienced the unexpected serious(medically significant) event of Leukaemia that occurred unknown days after receiving the third dose (booster ) of mRNA-1273.222 vaccination in COVID-19 vaccination series. No further details on risk factors, medical history, clinical course, additional vaccination details, concomitant medications and treatment details were provided. The outcome of the report was unknown at the time of report. The benefit-risk relationship of mRNA-1273.222 Vaccine is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2022-642151 (E2B Linked Report). Sender's Comments: This spontaneous case concerns a female patient of unspecified age with no medical history reported, who experienced the unexpected serious (medically significant) event of Leukaemia that occurred unknown days after receiving the third dose (booster ) of mRNA-1273.222 vaccination in COVID-19 vaccination series. No further details on risk factors, medical history, clinical course, additional vaccination details, concomitant medications and treatment details were provided. The outcome of the report was unknown at the time of report. The benefit-risk relationship of mRNA-1273.222 Vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-642151: parent case.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Post-acute COVID-19 syndrome
Clinical narrative: This spontaneous case was reported by a patient family member or friend and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (has long haul Covid) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included MS and Living in residential institution. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced POST-ACUTE COVID-19 SYNDROME (has long haul Covid) (seriousness criterion medically significant). The patient was treated with OXYGEN for Breathing difficult, at an unspecified dose and frequency. At the time of the report, POST-ACUTE COVID-19 SYNDROME (has long haul Covid) had not resolved. No Concomitant medications were provided. It was reported that patient had no cough after third dose. Patient was on oxygen due to breathing problems. Breathing difficult subsumed under Long Covid-19. Company Comment: This is a spontaneous case concerning a 71-year-old, male patient with medical history of multiple sclerosis living in a nursing home, who experienced the unexpected serious AESI of Post-acute COVID-19 syndrome. Patient experienced COVID-19 after the second dose of COVID-19 vaccination and developed long haul COVID-19 after the booster dose of mRNA-1273 vaccine. Patient is on oxygen due to breathing problems. Patient underlying condition is a risk factor for the requirement of supplemental oxygen. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. This case was linked to MOD-2022-642064 (Patient Link). Sender's Comments: This is a spontaneous case concerning a 71-year-old, male patient with medical history of multiple sclerosis living in a nursing home, who experienced the unexpected serious AESI of Post-acute COVID-19 syndrome. Patient experienced COVID-19 after the second dose of COVID-19 vaccination and developed long haul COVID-19 after the booster dose of mRNA-1273 vaccine. Patient is on oxygen due to breathing problems. Patient underlying condition is a risk factor for the requirement of supplemental oxygen. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, Mobility decreased, Pyrexia
Clinical narrative: overall malaise; could not lift arm beyond shoulder/couldn't take it from the down position; slight temperature; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (overall malaise), MOBILITY DECREASED (could not lift arm beyond shoulder/couldn't take it from the down position) and PYREXIA (slight temperature) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (overall malaise), MOBILITY DECREASED (could not lift arm beyond shoulder/couldn't take it from the down position) and PYREXIA (slight temperature). At the time of the report, MALAISE (overall malaise), MOBILITY DECREASED (could not lift arm beyond shoulder/couldn't take it from the down position) and PYREXIA (slight temperature) outcome was unknown.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.       No concomitant medications were reported. Patient states that his body was more used to the vaccine. No treatment medications were reported.   This case was linked to MOD-2022-642291, MOD-2022-642281 (Patient Link).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: overall malaise; could not lift arm beyond shoulder/couldn't take it from the down position; slight temperature; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (overall malaise), MOBILITY DECREASED (could not lift arm beyond shoulder/couldn't take it from the down position) and PYREXIA (slight temperature) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (overall malaise), MOBILITY DECREASED (could not lift arm beyond shoulder/couldn't take it from the down position) and PYREXIA (slight temperature). At the time of the report, MALAISE (overall malaise), MOBILITY DECREASED (could not lift arm beyond shoulder/couldn't take it from the down position) and PYREXIA (slight temperature) outcome was unknown.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.       No concomitant medications were reported. Patient states that his body was more used to the vaccine. No treatment medications were reported.   This case was linked to MOD-2022-642291, MOD-2022-642281 (Patient Link).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, Mobility decreased, Pyrexia
Clinical narrative: overall malaise; slight temperature; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (overall malaise) and PYREXIA (slight temperature) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (overall malaise) and PYREXIA (slight temperature). At the time of the report, MALAISE (overall malaise) and PYREXIA (slight temperature) outcome was unknown.            No concomitant medication were reported.  Patient stated that his body was more used to the vaccine.  No treatment medication were reported.   This case was linked to MOD-2022-642291, MOD-2022-642246 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: overall malaise; slight temperature; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (overall malaise) and PYREXIA (slight temperature) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (overall malaise) and PYREXIA (slight temperature). At the time of the report, MALAISE (overall malaise) and PYREXIA (slight temperature) outcome was unknown.            No concomitant medication were reported.  Patient stated that his body was more used to the vaccine.  No treatment medication were reported.   This case was linked to MOD-2022-642291, MOD-2022-642246 (Patient Link).   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis
Clinical narrative: Breathing problems, like bronchitis which occurred once a year, but not as severe as when she got the the 2nd shot; This spontaneous case was reported by a patient and describes the occurrence of BRONCHITIS (Breathing problems, like bronchitis which occurred once a year, but not as severe as when she got the the 2nd shot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B12A and 036A21A) for COVID-19 vaccination.     Patient not ever had COVID positive test or diagnosis. Patient did not received other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included Ex-smoker (but quit several years ago). Concurrent medical conditions included Drug allergy (no list.), Allergy to molds, Pollen allergy, Bronchitis (as a kid), Respiratory disorder (her whole life), Breathing difficult (not severe) and Coughing (once per year).   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced BRONCHITIS (Breathing problems, like bronchitis which occurred once a year, but not as severe as when she got the the 2nd shot). At the time of the report, BRONCHITIS (Breathing problems, like bronchitis which occurred once a year, but not as severe as when she got the the 2nd shot) was resolving.            No concomitant medications were reported.  Patient stated that she always had breathing problems, like bronchitis which occurred once a year, but not as severe as when she got the 2nd and 3 shot. 2nd dose set her off but cleared up a bit. Seen Pulmonologist and Cardiologist that monitors her heart. Not sure if doctors believe her.  No treatment information was reported.   This case was linked to MOD-2022-642383 (Patient Link).
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Aches; Fever; Chills; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN (Aches), PYREXIA (Fever) and CHILLS (Chills) in a 36-year-old male patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Type 1 diabetes mellitus (Type 1 diabetic).    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Aches), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PAIN (Aches), PYREXIA (Fever) and CHILLS (Chills) had resolved.            No concomitant medications were reported. No treatment medications were reported.  Patient had received 2 doses of the Moderna COVID-19 vaccine as well as 1 booster dose. Patient experienced fever, chills, and aches that lasted for about 10 to 12 hours after receiving all the doses.   This case was linked to MOD-2022-642058 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hypersensitivity
Clinical narrative: Patient had an allergic reaction to the first 3 Moderna COVID-19 shots. She had heat over her body.; Patient had an allergic reaction to the first 3 Moderna COVID-19 shots. She had severe rash and heat over her body.; This spontaneous case was reported by a patient and describes the occurrence of FEELING HOT (Patient had an allergic reaction to the first 3 Moderna COVID-19 shots. She had heat over her body.) and HYPERSENSITIVITY (Patient had an allergic reaction to the first 3 Moderna COVID-19 shots. She had severe rash and heat over her body.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 FEELING HOT (Patient had an allergic reaction to the first 3 Moderna COVID-19 shots. She had heat over her body.) and HYPERSENSITIVITY (Patient had an allergic reaction to the first 3 Moderna COVID-19 shots. She had severe rash and heat over her body.). At the time of the report, FEELING HOT (Patient had an allergic reaction to the first 3 Moderna COVID-19 shots. She had heat over her body.) and HYPERSENSITIVITY (Patient had an allergic reaction to the first 3 Moderna COVID-19 shots. She had severe rash and heat over her body.) outcome was unknown.            No concomitant medication was provided by reporter. No treatment medication was provided by reporter.   This case was linked to MOD-2022-642119 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; expired dose given; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose given) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 082B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Sep-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose given). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose given) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (expired dose given).    No Concomitant medication were reported. It was found out later that the vial Expired on. 04-Sep-2022 (From the time out of freezer to use). No treatment drug were reported.