chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; 24 year old male patient who never received a primary series with monovalent formulation was given bivalent booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (24 year old male patient who never received a primary series with monovalent formulation was given bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in a 24-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Feb-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Feb-2023, the patient experienced WRONG PRODUCT ADMINISTERED (24 year old male patient who never received a primary series with monovalent formulation was given bivalent booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (24 year old male patient who never received a primary series with monovalent formulation was given bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (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 WRONG PRODUCT ADMINISTERED (24 year old male patient who never received a primary series with monovalent formulation was given bivalent booster dose).    Concomitant medication of the patient was not reported.  The patient never received a primary series with monovalent formulation and was given bivalent booster dose.  Treatment information was not provided by the reporter.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, Eosinophil count, Headache, SARS-CoV-2 test
Clinical narrative: He took the Moderna COVID vaccine all 5 doses and the only side effect was headache; He had COVID on Dec 29; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (He had COVID on Dec 29) and HEADACHE (He took the Moderna COVID vaccine all 5 doses and the only side effect was headache) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Asthma and Nasal polyps.    The patient's past medical history included Stent placement (2 Stents implanted). Concurrent medical conditions included Rhinitis, Heart attack (2 Stents implanted) since 2016, Pulmonary embolism since 2019, Asthma, Nasal polyps, Blood pressure high (Controlled, recovering.), Factor V Leiden mutation, Difficulty breathing (Issues with breathing) and Condition aggravated (Last couple of years, he had increased flare ups). Concomitant products included RIVAROXABAN (XARELTO) for Factor V Leiden mutation.   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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and DUPILUMAB (DUPIXENT) (unknown route) 1 dosage form. On 29-Dec-2022, the patient experienced COVID-19 (He had COVID on Dec 29). On an unknown date, the patient experienced HEADACHE (He took the Moderna COVID vaccine all 5 doses and the only side effect was headache). At the time of the report, COVID-19 (He had COVID on Dec 29) and HEADACHE (He took the Moderna COVID vaccine all 5 doses and the only side effect was headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2022, SARS-CoV-2 test: Positive. On an unknown date, Blood pressure measurement: High. On an unknown date, Eosinophil count: Several points higher than normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had bouts of good and bad with the conditions. He was vaccinated and did well with COVID-19 in Dec-2022.   Treatment information was not reported.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Maternal exposure before pregnancy, Pregnancy test, SARS-CoV-2 test, Ultrasound scan
Clinical narrative: Maternal exposure before pregnancy; SARS-CoV-2 infection; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of COVID-19 (SARS-CoV-2 infection) and MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal exposure before pregnancy) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension (worsening) since 01-Jan-2007. Concomitant products included LABETALOL and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 19-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. The patient's last menstrual period was on 31-Dec-2021 and the estimated date of delivery was 30-Sep-2022. On 22-May-2022, the patient experienced COVID-19 (SARS-CoV-2 infection). On an unknown date, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal exposure before pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. The cesarean delivery occurred on 24-Sep-2022, which was reported as Full-term. For neonate 1, The outcome was reported as Delivered NOS. At the time of the report, COVID-19 (SARS-CoV-2 infection) outcome was unknown and MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal exposure before pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jan-2022, Pregnancy test: Positive. On 22-May-2022, SARS-CoV-2 test: Positive. In 2022, Ultrasound scan: No abnormalities.         Treatment medications were not provided. Company Comment: This is a spontaneous case of Maternal exposure before pregnancy, concerning a 37-year-old female patient with no relevant medical history, who experienced the non-serious unexpected, event of COVID-19, which occurred approximately 6 months after a dose of mRNA-1273 vaccine, received as the second dose for COVID-19 vaccination. Patient was vaccinated with mRNA-1273 vaccine approximately one month and 10 days before last menstrual period date. The cesarean delivery was reported as Full-term. The outcome for neonate was reported as Delivered. The outcome of event COVID-19 was unknown. No further information was disclosed.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.    This case was linked to US-MODERNATX, INC.-MOD-2022-646081 (Patient Link).
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vaccine got expired on 12-Mar-2023 and was intially stored in the refrigerator on 13-Mar-2023; No adverse event; Moderna COVID-19 monovalent vaccine was administered to 2 patients after the expiration date.; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 monovalent vaccine was administered to 2 patients after the expiration date.), PRODUCT STORAGE ERROR (The vaccine got expired on 12-Mar-2023 and was intially stored in the refrigerator on 13-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 44-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 071B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 monovalent vaccine was administered to 2 patients after the expiration date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine got expired on 12-Mar-2023 and was intially stored in the refrigerator on 13-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 monovalent vaccine was administered to 2 patients after the expiration date.), PRODUCT STORAGE ERROR (The vaccine got expired on 12-Mar-2023 and was intially stored in the refrigerator on 13-Mar-2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 monovalent vaccine was administered to 2 patients after the expiration date.) and PRODUCT STORAGE ERROR (The vaccine got expired on 12-Mar-2023 and was intially stored in the refrigerator on 13-Mar-2023).    No concomitant medications was reported. HCP stated that a dose of the Moderna COVID-19 monovalent vaccine was administered to 2 patients after the expiration date. No adverse reactions have been reported by any patients for this invalid dose. It was unknown whether its Individual vials or intact cartons.  The size of vial was 5.5 ml which was initially stored in the refrigerator on 13-Mar-2023.  The vial did not undergo any temperature excursions. No treatment drug details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-715335 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715335:other patient, same reporter
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient had first dose of Moderna COVID-19 vaccine primary series on 06-Jul-2021 and second dose on 13-Mar-2023; Vaccine was administered on 13-Mar-2023 with expiration on 12-Mar-2023; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had first dose of Moderna COVID-19 vaccine primary series on 06-Jul-2021 and second dose on 13-Mar-2023), EXPIRED PRODUCT ADMINISTERED (Vaccine was administered on 13-Mar-2023 with expiration on 12-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 23-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071B22A and 041C21A) for COVID-19 prophylaxis.     Reporter had no medical history information on the patient. It was unknown if patient had any other vaccines in the 4 weeks prior to COVID-19 vaccine.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2023, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2023, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had first dose of Moderna COVID-19 vaccine primary series on 06-Jul-2021 and second dose on 13-Mar-2023) and EXPIRED PRODUCT ADMINISTERED (Vaccine was administered on 13-Mar-2023 with expiration on 12-Mar-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had first dose of Moderna COVID-19 vaccine primary series on 06-Jul-2021 and second dose on 13-Mar-2023), EXPIRED PRODUCT ADMINISTERED (Vaccine was administered on 13-Mar-2023 with expiration on 12-Mar-2023) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had first dose of Moderna COVID-19 vaccine primary series on 06-Jul-2021 and second dose on 13-Mar-2023) and EXPIRED PRODUCT ADMINISTERED (Vaccine was administered on 13-Mar-2023 with expiration on 12-Mar-2023).    Concomitant drugs were not reported.  It was reported that patient had no adverse reaction to dose 1 and dose 2.  Treatment medications were not provided.
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: had COVID-19 after getting the vaccines; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (had COVID-19 after getting the vaccines) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (had COVID-19 after getting the vaccines). At the time of the report, COVID-19 (had COVID-19 after getting the vaccines) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided. No treatment medications was provided.   Reporter did not allow further contact
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: HCP states they provided patient with Moderna Covid19 Bivalent as primary series instead of Monovalent Moderna Covid 19 vaccine.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP states they provided patient with Moderna Covid19 Bivalent as primary series instead of Monovalent Moderna Covid 19 vaccine.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (HCP states they provided patient with Moderna Covid19 Bivalent as primary series instead of Monovalent Moderna Covid 19 vaccine.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP states they provided patient with Moderna Covid19 Bivalent as primary series instead of Monovalent Moderna Covid 19 vaccine.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (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 WRONG PRODUCT ADMINISTERED (HCP states they provided patient with Moderna Covid19 Bivalent as primary series instead of Monovalent Moderna Covid 19 vaccine.).    Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Breast mass, Headache
Clinical narrative: I did not have a reaction to the vaccine. In 11/2022, I developed recurring headaches and happening more frequently. In 01/2023, I had a lump in my left breast. It was determined they didn't see anything concerning with the lump, so we are monitoring.
Age: 62.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: Started with a dry cough, body ache, bad headache, and just felt tired. I felt like I did an intense workout and had a hangover at the same time. I tested and tested positive for COVID. I called my doctor to get PAXLOVID and the request was put it and I took it for about a week and went through the whole regime and I felt better. A couple of days later it rebounded and all the symptoms came back. My whole household also got it from me and we are all vaccinated. It was all mild cases, like a strong cold. I feel that even though I am fully recovered now, I feel like I still get out of breath easier now even 3 months after. My daughter also in her 20s suffers the same thing and we are the only ones who also take anxiety medication so not sure if that is why. But that is about it, nothing to severe. After the rebound it lasted about another week without taking any medication.
Age: 62.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hangover, Headache, Nasopharyngitis, Pain, SARS-CoV-2 test positive
Clinical narrative: Started with a dry cough, body ache, bad headache, and just felt tired. I felt like I did an intense workout and had a hangover at the same time. I tested and tested positive for COVID. I called my doctor to get PAXLOVID and the request was put it and I took it for about a week and went through the whole regime and I felt better. A couple of days later it rebounded and all the symptoms came back. My whole household also got it from me and we are all vaccinated. It was all mild cases, like a strong cold. I feel that even though I am fully recovered now, I feel like I still get out of breath easier now even 3 months after. My daughter also in her 20s suffers the same thing and we are the only ones who also take anxiety medication so not sure if that is why. But that is about it, nothing to severe. After the rebound it lasted about another week without taking any medication.
Age: 62.0
Sex: M
Vaccine: COVID19-2
Symptoms: Symptom recurrence
Clinical narrative: Started with a dry cough, body ache, bad headache, and just felt tired. I felt like I did an intense workout and had a hangover at the same time. I tested and tested positive for COVID. I called my doctor to get PAXLOVID and the request was put it and I took it for about a week and went through the whole regime and I felt better. A couple of days later it rebounded and all the symptoms came back. My whole household also got it from me and we are all vaccinated. It was all mild cases, like a strong cold. I feel that even though I am fully recovered now, I feel like I still get out of breath easier now even 3 months after. My daughter also in her 20s suffers the same thing and we are the only ones who also take anxiety medication so not sure if that is why. But that is about it, nothing to severe. After the rebound it lasted about another week without taking any medication.
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dysstasia, Vertigo
Clinical narrative: I experienced vertigo, I could not stand up because the room was spinning.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Laryngitis, Malaise, SARS-CoV-2 test positive, Sick relative
Clinical narrative: My daughter who lives in another country arrived home 16DEC2022 mon 18DEC2022 and became symptomatic on 19DEC2022 I became symptomatic 19DEC2022 and tested positive on a home test and on 20DEC2022 tested positive with a PCR test. I started with laryngitis on the morning of 20DEC2022. I developed malaise and other symptoms and was relatively well by 21DEC2022.
Age: 79.0
Sex: M
Vaccine: UNK
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: +covid-vaccinated
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: hospitalized after found down in assisted living apt.  Requiring 2L O2.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Chills, Fatigue, Myalgia, Respiratory tract congestion
Clinical narrative: I had some chills, congestion, runny nose, and tiredness/muscle aches. I decided to take a COVID-19 test on 03/03/2023; later it came back positive so I knew to call my doctor. I spoke to a physician assistant who spoke with my doctor; I was prescribed PAXLOVID for treatment and recovery. Since then, other than having a residual runny nose, I've made a pretty well recovery. I haven't retested to confirm I'm negative since they say you can test positive for some months, but I'm feeling better.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: I had some chills, congestion, runny nose, and tiredness/muscle aches. I decided to take a COVID-19 test on 03/03/2023; later it came back positive so I knew to call my doctor. I spoke to a physician assistant who spoke with my doctor; I was prescribed PAXLOVID for treatment and recovery. Since then, other than having a residual runny nose, I've made a pretty well recovery. I haven't retested to confirm I'm negative since they say you can test positive for some months, but I'm feeling better.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Respiratory tract congestion
Clinical narrative: Patient brought to the ED with worsening weakness and congestion.  Patient admitted to the hospital with Covid and treated with remdesivir.
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Eye irritation, Eye swelling, Hordeolum, Ocular hyperaemia, Tenderness
Clinical narrative: I developed a Stye in my left eye and it kept getting worse. It was very red, tender, swelling, and my eye itself was very red and irritated. I went to the walk-in clinic and was prescribed Polymyxin B Sulfate Trimethoprim Ophthalmic Solution.  I used the medication and the Stye is gone now.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Pfizer-BioNTech Bivalent COVID-19 Vaccine EUA: case resulting in invalid dose given  Patient has previously received Moderna Vaccines on 3/4/2021, 4/1/2021, and 1/28/2022. Patient received Pfizer-BioNTech Bivalent vaccine on 3/13/2023 at 08:45AM. Pt inadvertently received vaccine from vial opened on 03/10/2023 since 15:30PM. Error was found while documenting on 3/13/2023. No harm came to patient. Patient has been contacted, is doing well, and will return for revaccination per Pfizer and CDC recommendations.
Age: 1.25
Sex: M
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: 15 month old healthy child seen for well visit in clinic. They were due for a booster dose of COVID-19 vaccine and the chart flagged in record as being due for a booster. Pfizer bivalent vaccine for 6mo-4y old children was ordered and given. After it was given, the team realized that the child had received the Moderna primary series of two doses at an outside facility. Because of this, they should have been given the Moderna bivalent booster and not the Pfizer booster.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Abdominal pain, Haematochezia, Laboratory test normal
Clinical narrative: Patient developed specks of blood in her stools along with what appeared to be abdominal pain. starting on 03/10/2023 and was seen in the office again. It persisted through 03/13/23 where she was referred to be evaluated in the ER.  Her parents reported she had a  normal work up and her symptoms resolved on 03/14/23.
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Anosmia, COVID-19, Dry mouth, Influenza virus test negative, SARS-CoV-2 test positive
Clinical narrative: I started with very dry mouth. I checked my temperature to see if I was sick, but my temperature was normal. I had no headache or sore throat or anything. My mother told me to still go to urgent care to get tested to make sure I wasn't sick and infect her. I went to urgent care on 12/14/2022, and I was tested for COVID-19 and influenza. I was called and told I tested positive for COVID-19 and was prescribed Nirmatrelvir/ritonavir for treatment. I started taking it immediately the same day; the next day, I noticed reduced dryness in my mouth, but I started losing a slight sense of smell. When I finished the treatment, I was fine. By day 14, I retested and was finally negative.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt presented in the clinic requesting required vaccines for school attendance. Pt did not have immunization records from previous residence and first dose of HEP A was given 9/19/2022.  HEP A was given at a too short interval.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Dysphonia, Fatigue, Oropharyngeal pain
Clinical narrative: I was positive for COVID-19 on 03MAR2023, I was feeling tired, sore throat, mild cough an a runny nose. I was also congested, my voice was rough and for one day I had a mild fever. I was prescribed paxlovid, I started to feel better the next day after taking the medication.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: I was positive for COVID-19 on 03MAR2023, I was feeling tired, sore throat, mild cough an a runny nose. I was also congested, my voice was rough and for one day I had a mild fever. I was prescribed paxlovid, I started to feel better the next day after taking the medication.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: death
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient accidentally administered Moderna COVID-19 Vaccine Bivalent BUD; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient accidentally administered Moderna COVID-19 Vaccine Bivalent BUD) and NO ADVERSE EVENT (No adverse event) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 044H22A) for COVID-19 prophylaxis.     It was unknown if the patient had medical history/conditions, allergy, concomitant diseases and risk factor.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient accidentally administered Moderna COVID-19 Vaccine Bivalent BUD) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient accidentally administered Moderna COVID-19 Vaccine Bivalent BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (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 EXPIRED PRODUCT ADMINISTERED (Patient accidentally administered Moderna COVID-19 Vaccine Bivalent BUD).    No concomitant medications were reported.  The healthcare professional (HCP) mentioned 2 doses were given on 19-Feb-2023, 1 dose on 20-Feb-2023, and 1 dose on 10-Mar-2023. Caller did not specified which date corresponded to patient 1 but HCP stated patient 1 did not reported any AEs.  No treatment medications were reported.  This case was linked to US-MODERNATX, INC.-MOD-2023-715321, US-MODERNATX, INC.-MOD-2023-715348, US-MODERNATX, INC.-MOD-2023-715325 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715321: US-MODERNATX, INC.-MOD-2023-715348:Patient 1 case US-MODERNATX, INC.-MOD-2023-715325:Patient 1 case
Age: 33.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Muscle disorder, Myalgia, Nodule, Skin discolouration
Clinical narrative: Patient has experienced excessive soreness, redness, discoloration, and knot in the muscle since receiving her shingrix vaccine
Age: 72.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Blister, Blood test abnormal, Herpes zoster, Insomnia, Pruritus
Clinical narrative: On 03/03/23 I noticed a red rash with blister. I was away from home and talked a doctor at the health care facility there. He examined me and determined that I had a shingles outbreak. He prescribed an antibiotic, antiviral, and topical cream to help deal with the itching. Although the first night was hard to sleep, it is getting better.
Age: 72.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Rash erythematous
Clinical narrative: On 03/03/23 I noticed a red rash with blister. I was away from home and talked a doctor at the health care facility there. He examined me and determined that I had a shingles outbreak. He prescribed an antibiotic, antiviral, and topical cream to help deal with the itching. Although the first night was hard to sleep, it is getting better.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abnormal faeces, Crying, Hyperhidrosis, Irritability, Mucous stools
Clinical narrative: Vaccines were given on 03/07/2023.  Patient presented to our office on 03/10/2023, having intermittent crying spells accompanied by sweating, seemed to be cramping. No blood in the stool, but was passing some mucous in her stool, but has had a history of mucous in the stool prior to that.  Stools were thicker than usual along with smaller in size.  She has improved with her symptoms as of 03/14/23, much less fussy, and a small amount of mucous in the stool.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Muscle spasms
Clinical narrative: Vaccines were given on 03/07/2023.  Patient presented to our office on 03/10/2023, having intermittent crying spells accompanied by sweating, seemed to be cramping. No blood in the stool, but was passing some mucous in her stool, but has had a history of mucous in the stool prior to that.  Stools were thicker than usual along with smaller in size.  She has improved with her symptoms as of 03/14/23, much less fussy, and a small amount of mucous in the stool.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Chest pain, Cough, Dysgeusia, Fatigue
Clinical narrative: On 02/01/2023, I woke up with a little tickle in the back of my throat. I normally wouldn't think much of it, but we have been super healthy these past few years and my husband was preparing for a hip surgery. I continued to feel worse over the next twelve hours. When I woke up on 02/03/2023, I took a COVID-19 test and was positive. I developed a fever and a cough. I called my clinic to inform them of my positive test. They prescribed PAXLOVID, which I took for 5 days. During that time, I felt like I had a pocket full of dirty coins in my mouth. It was a horrible taste. My symptoms didn't really improve during the 5 days. My coughing was really horrible, and I had chest pain. My fever was around 100 to 101. My husband tested positive a few days later and our symptoms gradually improved over the next few weeks. Since 02/02/2023, the fatigue really hit us hard, but I think we are back to where we were.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, SARS-CoV-2 test positive, Throat irritation
Clinical narrative: On 02/01/2023, I woke up with a little tickle in the back of my throat. I normally wouldn't think much of it, but we have been super healthy these past few years and my husband was preparing for a hip surgery. I continued to feel worse over the next twelve hours. When I woke up on 02/03/2023, I took a COVID-19 test and was positive. I developed a fever and a cough. I called my clinic to inform them of my positive test. They prescribed PAXLOVID, which I took for 5 days. During that time, I felt like I had a pocket full of dirty coins in my mouth. It was a horrible taste. My symptoms didn't really improve during the 5 days. My coughing was really horrible, and I had chest pain. My fever was around 100 to 101. My husband tested positive a few days later and our symptoms gradually improved over the next few weeks. Since 02/02/2023, the fatigue really hit us hard, but I think we are back to where we were.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal discomfort, Abdominal distension, Anxiety, Blood test normal, Decreased appetite
Clinical narrative: I started feeling nausea a few weeks prior to the event and took ZOFRAN, on 10FEB2023 I started a double dose of lansoprazole my symptoms were lack of appetite stomach discomfort complete fullness feeling I was not able to eat and trying to keep fluids and basic nutrition. I tried to get an appointment with my Gastro 10March2023 was the first available. 15FEB2023 and 16FEB2023 I was feeling lightheaded and winded I couldn't tell if it was reflux or whatever 13FEB2023 and on 17FEB2023 I passed out my husband caught me he called EMS they came and I came to right away I was taken to the ER concerned of heart attack or anxiety. By 17FEB2023 I was released on Saturday around five PM. I was told the conditions were a perfect storm and they described vasovagal episode, stress and anxiety. I was told to follow up with PCP. On 21FEB2023 I saw my Primary care and she got to the Gastro and they scheduled an Endoscopy on 02MAR2023. I have gastritis and stress.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Dyspnoea, Electrocardiogram, Feeding disorder, Gastritis
Clinical narrative: I started feeling nausea a few weeks prior to the event and took ZOFRAN, on 10FEB2023 I started a double dose of lansoprazole my symptoms were lack of appetite stomach discomfort complete fullness feeling I was not able to eat and trying to keep fluids and basic nutrition. I tried to get an appointment with my Gastro 10March2023 was the first available. 15FEB2023 and 16FEB2023 I was feeling lightheaded and winded I couldn't tell if it was reflux or whatever 13FEB2023 and on 17FEB2023 I passed out my husband caught me he called EMS they came and I came to right away I was taken to the ER concerned of heart attack or anxiety. By 17FEB2023 I was released on Saturday around five PM. I was told the conditions were a perfect storm and they described vasovagal episode, stress and anxiety. I was told to follow up with PCP. On 21FEB2023 I saw my Primary care and she got to the Gastro and they scheduled an Endoscopy on 02MAR2023. I have gastritis and stress.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Loss of consciousness, Nausea, Presyncope, Stress
Clinical narrative: I started feeling nausea a few weeks prior to the event and took ZOFRAN, on 10FEB2023 I started a double dose of lansoprazole my symptoms were lack of appetite stomach discomfort complete fullness feeling I was not able to eat and trying to keep fluids and basic nutrition. I tried to get an appointment with my Gastro 10March2023 was the first available. 15FEB2023 and 16FEB2023 I was feeling lightheaded and winded I couldn't tell if it was reflux or whatever 13FEB2023 and on 17FEB2023 I passed out my husband caught me he called EMS they came and I came to right away I was taken to the ER concerned of heart attack or anxiety. By 17FEB2023 I was released on Saturday around five PM. I was told the conditions were a perfect storm and they described vasovagal episode, stress and anxiety. I was told to follow up with PCP. On 21FEB2023 I saw my Primary care and she got to the Gastro and they scheduled an Endoscopy on 02MAR2023. I have gastritis and stress.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect route of product administration
Clinical narrative: Patient received MRV intramuscularly instead of subcutaneously.
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19 pneumonia
Clinical narrative: Patient vaccinated against then hospitalized for COVID-19 pneumonia
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Autoimmune disorder, Fatigue, Pain, Pyrexia
Clinical narrative: I had a fever, aches and fatigue after the vaccine for about 48 hours. I developed arthritis in my feet and hands in 05/2022 and it was diagnosed in 08/2022. It was diagnosed as an autoimmune disease in 02/2023. I am undergoing test to determine what disease I have.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Myalgia, Nausea, Neuralgia, Pain
Clinical narrative: I had the usual sore arm, muscle aches, nausea, weakness for a couple of days that went away in 3 or 4 days. However, I also developed shooting nerve pains in various areas of my body that moved around and persisted for about 2 plus months. It was almost debilitating depending on where the nerve pain moved to.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: I had the usual sore arm, muscle aches, nausea, weakness for a couple of days that went away in 3 or 4 days. However, I also developed shooting nerve pains in various areas of my body that moved around and persisted for about 2 plus months. It was almost debilitating depending on where the nerve pain moved to.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Atrial fibrillation, Blood test, Cardiac stress test, Cardioversion, Heart rate irregular
Clinical narrative: I experienced fainting, EMT arrived and found irregular heart beat. I went to the local hospital and I was in over night. I was diagnosed with Atrial fibrillation, I was placed on new prescriptions. then I went to cardio version to shot the heart to normal rythum.  Since then I have been in normal rhythm.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Syncope
Clinical narrative: I experienced fainting, EMT arrived and found irregular heart beat. I went to the local hospital and I was in over night. I was diagnosed with Atrial fibrillation, I was placed on new prescriptions. then I went to cardio version to shot the heart to normal rythum.  Since then I have been in normal rhythm.
Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Headache, Nasal congestion, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: On February 27, I had a sore throat, nasal congestion, slight headache It was in the evening, and I went to bed. The next morning the symptoms were more so I took the at home COVID-19 test and I was positive. I called the PCP and they did a video call and then prescribed PAXLOVID and I started that afternoon. By the following day I was greatly improved my symptoms were just about gone. The next day which is day three I had no more symptoms. The next day I was clear, and I had been in isolation and day 10 all my symptoms came back. They all lasted for about three days. I then isolated for 5 days, and I had symptoms for 3 of them days. I was still testing positive 13 days out with no symptoms at all.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Influenza like illness, Mobility decreased, Pain
Clinical narrative: I was fine until around five or three or five hours later and I was in bed like with the flu and aches all over my body and I had stay in bed, this lasted for two full days on the third day I felt better.
Age: 66.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Colectomy, Colonoscopy abnormal, Large intestine anastomosis, Large intestine polyp
Clinical narrative: I had a routine colonoscopy on 12/7/2022. They found a polyp. I needed to have it removed. I had surgery on 12/28/2022, it was a Colectomy Partial Anastomosis. I feel great now, I needed no radiation or chemo.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Basal cell carcinoma, Immediate post-injection reaction, Injection site inflammation, Skin neoplasm excision
Clinical narrative: I received the Pfizer doses of the vaccine.  The two entry points on my right shoulder immediately started becoming inflamed, and never healed.  2 years after the incident, the site of the shots had turned into Basil Cell Carcinoma.  At which point he had the entire site removed at a $1,000 cost.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Ear discomfort, Ear irrigation, Ear pain, Eustachian tube obstruction, Respiratory tract congestion
Clinical narrative: 1/20/23 I started getting congested, mostly in the head. It was not loose and did not involve the lungs. At some point my right ear became blocked and I felt pain and pressure. I went to the doctor on 2/06/23 and saw the physician assistant and had my ear cleaned out. This did not solve the problem after continuing to clean my ear. I went to see the doctor around 2/23/23 and he diagnosed it as a blocked eustachian tube and had me take MUCINEX and pseudoephedrine. I was then prescribed prednisone a week later because the medications were not helping. The prednisone also did not work. My congestion eventually went away, but my ear continued to be blocked. I saw an ENT specialist on 3/8/23. She prescribed FLONASE. I am still taking this trying to clear this issue up. I am through the virus, but I still have the eustachian tube blocked.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Ultrasound head abnormal, Viral infection
Clinical narrative: 1/20/23 I started getting congested, mostly in the head. It was not loose and did not involve the lungs. At some point my right ear became blocked and I felt pain and pressure. I went to the doctor on 2/06/23 and saw the physician assistant and had my ear cleaned out. This did not solve the problem after continuing to clean my ear. I went to see the doctor around 2/23/23 and he diagnosed it as a blocked eustachian tube and had me take MUCINEX and pseudoephedrine. I was then prescribed prednisone a week later because the medications were not helping. The prednisone also did not work. My congestion eventually went away, but my ear continued to be blocked. I saw an ENT specialist on 3/8/23. She prescribed FLONASE. I am still taking this trying to clear this issue up. I am through the virus, but I still have the eustachian tube blocked.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; A dose of Moderna Covid-19 vaccine (Monovalent) that was expired was given on 12Mar2023. It actually expired on 11Mar2023.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine (Monovalent) that was expired was given on 12Mar2023. It actually expired on 11Mar2023.) and NO ADVERSE EVENT (No Adverse Event) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 074B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Mar-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine (Monovalent) that was expired was given on 12Mar2023. It actually expired on 11Mar2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine (Monovalent) that was expired was given on 12Mar2023. It actually expired on 11Mar2023.) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine (Monovalent) that was expired was given on 12Mar2023. It actually expired on 11Mar2023.).    No concomitant medications was provided. No treatment medications was provided.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood creatine phosphokinase increased, Burning sensation, Myalgia
Clinical narrative: On 09/08/2022 I received my Covid-19 vaccine. 02/08/2023 I started experiencing muscle pain and burning throughout both legs. Symptoms lasted about a week.
Age: 13.0
Sex: F
Vaccine: COVID19-2, FLU4, HPV9
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient received a Pfizer Bivalent vaccine instead of a Pfizer Monovalent vaccine for their 2nd primary Covid-19 vaccine. No known adverse events occurred.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Feeling cold, Influenza like illness, Myalgia, Nasal congestion
Clinical narrative: It was on 02/28/2023. I started with a little sore throat and on that day, it progressed into flu like symptoms. I was very cold, had a fever and felt achy. Muscular aches and pains. I had nasal congestion. I think that's about it symptom wise. I took an at home COVID-19 test that day. It was positive. I called that day for a telehealth visit and had that the next day 03/01/2023. He did prescribe Paxlovid and so I filled that prescription and started taking that medication. I started that on 03/01/2023. On the 2nd day of taking the medication, I started feeling itchy all over. I took the medication for one more day and the itching began to get worse and there was a rash on my torso. I called the doctor from the telehealth visit and he said to stop taking it. It sounded like I was having an allergic reaction to it so he mentioned to start taking Benadryl. After the first day, I felt better and better each successive day during the infection. Eventually after 6 days, I felt like my symptoms had all subsided.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Oropharyngeal pain, Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: It was on 02/28/2023. I started with a little sore throat and on that day, it progressed into flu like symptoms. I was very cold, had a fever and felt achy. Muscular aches and pains. I had nasal congestion. I think that's about it symptom wise. I took an at home COVID-19 test that day. It was positive. I called that day for a telehealth visit and had that the next day 03/01/2023. He did prescribe Paxlovid and so I filled that prescription and started taking that medication. I started that on 03/01/2023. On the 2nd day of taking the medication, I started feeling itchy all over. I took the medication for one more day and the itching began to get worse and there was a rash on my torso. I called the doctor from the telehealth visit and he said to stop taking it. It sounded like I was having an allergic reaction to it so he mentioned to start taking Benadryl. After the first day, I felt better and better each successive day during the infection. Eventually after 6 days, I felt like my symptoms had all subsided.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Fatigue
Clinical narrative: I noticed a lingering sore throat that seemed to not go away. It was persistent for several days. After 3 or 4 days I completed an at home COVID-19 home test on Monday January 09, 2023. By this time, I had developed fever, achiness in feet, cough, and tiredness. I chose not to take the recommended medications. I treated my symptoms with acetaminophen. At night I took NYQUIL for stuffiness. I started to feel improvement 3 or 4 days later. I also lost my taste and smell. This symptom took the longest to return. There are still sometimes when it returns but for the most part it is gone.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Nasal congestion, Oropharyngeal pain, Pain in extremity, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I noticed a lingering sore throat that seemed to not go away. It was persistent for several days. After 3 or 4 days I completed an at home COVID-19 home test on Monday January 09, 2023. By this time, I had developed fever, achiness in feet, cough, and tiredness. I chose not to take the recommended medications. I treated my symptoms with acetaminophen. At night I took NYQUIL for stuffiness. I started to feel improvement 3 or 4 days later. I also lost my taste and smell. This symptom took the longest to return. There are still sometimes when it returns but for the most part it is gone.