chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Mediastinal mass, Rib fracture
Clinical narrative: I have 3 masses in the anterior mediastinal; broke a rib; This spontaneous case was reported by a patient and describes the occurrence of MEDIASTINAL MASS (I have 3 masses in the anterior mediastinal) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A and 014B22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 30-May-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MEDIASTINAL MASS (I have 3 masses in the anterior mediastinal) (seriousness criterion medically significant) and RIB FRACTURE (broke a rib). At the time of the report, MEDIASTINAL MASS (I have 3 masses in the anterior mediastinal) and RIB FRACTURE (broke a rib) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: 3 masses in the anterior mediastinal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient had 3 masses in the anterior mediastinal. One was large next to the heart the other two by the thyroid. Patient never had this problem and had no medical problems until now. She knows now because her rib had broken, and the X-ray showed these masses in her chest X-ray. CT with contrast done. Thoracic surgeon ordered 6 blood tests, results not yet received. It was unknown if the patient experienced any additional symptoms/events.  Patient also received Moderna vaccine on 24-NOV-2023.  No treatment medications were reported.  Company comment:  This spontaneous case concerns a 60  year  old female patient, with no medical history reported, who received two doses with Moderna COVID-19 Vaccine (mRNA  1273) and experienced the unexpected, serious (medically significant) event of mediastinal mass. Latency cannot be properly assessed since exact onset date was not provided. The report stated that the patient broke a rib and the X-ray showed 3 masses in the anterior mediastinal. One was large next to the heart and the other two by the thyroid. The patient had a computed tomography with contrast, blood tests, a positron emission tomography scan, and biopsy; however, results were not provided. No further clinical details were provided for medical reviewing. The causality of rib fracture was assessed as not related to Moderna COVID-19 vaccine due to lack of biological plausibility and since it could be more likely related to mediastinal masses. By the moment of reporting, the event mediastinal mass was assessed as not related to Moderna COVID-19 vaccine due to lack of biological plausibility. The benefit-risk relationship of Moderna COVID-19 vaccine (mRNA  1273) is not affected by this report.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Injection site rash, Vaccination site pain
Clinical narrative: General weakness/Lack of energy; Rash on injection arm began within 20 min of injection; pain in injection arm; Pain in chest around heart; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Pain in chest around heart), ASTHENIA (General weakness/Lack of energy), INJECTION SITE RASH (Rash on injection arm began within 20 min of injection) and VACCINATION SITE PAIN (pain in injection arm) in a 66-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In November 2023, the patient experienced CHEST PAIN (Pain in chest around heart). On 24-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced ASTHENIA (General weakness/Lack of energy), INJECTION SITE RASH (Rash on injection arm began within 20 min of injection) and VACCINATION SITE PAIN (pain in injection arm). At the time of the report, CHEST PAIN (Pain in chest around heart) and ASTHENIA (General weakness/Lack of energy) had not resolved and INJECTION SITE RASH (Rash on injection arm began within 20 min of injection) and VACCINATION SITE PAIN (pain in injection arm) was resolving.            Concomitant product use was not provided by the reporter. Treatment information was not provided.   Patient had pain in injection arm, pain in chest around heart, general weakness, lack of energy, rash on injection arm began within 20 min of injection, 1st day after, pain has lessened but still feel weak and pain in chest, heart.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Delusional perception, Dysmenorrhoea
Clinical narrative: chills; was delusional; vaginal bleeding; feeling extremely ill; She feels her legs are heavy; weak; menstrual cramps; This spontaneous case was reported by a patient and describes the occurrence of DELUSIONAL PERCEPTION (was delusional), VAGINAL HAEMORRHAGE (vaginal bleeding), MALAISE (feeling extremely ill), LIMB DISCOMFORT (She feels her legs are heavy) and ASTHENIA (weak) in a 70-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (hospitalized for 7 weeks in 2022 before receiving any covid-19 vaccines.) in 2022 and Menopausal. Previously administered products included for Product used for unknown indication: Pfizer COVID-19 vaccine on 02-May-2022, Pfizer COVID-19 vaccine on 23-May-2022 and Pfizer COVID-19 vaccine on 29-Sep-2022. Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine, Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine. Concurrent medical conditions included Menstrual cramps. Concomitant products included IBUPROFEN for Menstrual cramps.    On 07-Nov-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 07-Nov-2023 at 5:00 AM,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced CHILLS (chills). In November 2023, the patient experienced DELUSIONAL PERCEPTION (was delusional), VAGINAL HAEMORRHAGE (vaginal bleeding), MALAISE (feeling extremely ill), LIMB DISCOMFORT (She feels her legs are heavy), ASTHENIA (weak) and DYSMENORRHOEA (menstrual cramps). At the time of the report, DELUSIONAL PERCEPTION (was delusional), VAGINAL HAEMORRHAGE (vaginal bleeding), MALAISE (feeling extremely ill), LIMB DISCOMFORT (She feels her legs are heavy), ASTHENIA (weak), DYSMENORRHOEA (menstrual cramps) and CHILLS (chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2023, Body temperature: 101.4 AF.         Patient had 10 years post-menopausal and has a history of sever uterine thyroids. No treatment information was reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Malaise, Vaginal haemorrhage
Clinical narrative: chills; was delusional; vaginal bleeding; feeling extremely ill; She feels her legs are heavy; weak; menstrual cramps; This spontaneous case was reported by a patient and describes the occurrence of DELUSIONAL PERCEPTION (was delusional), VAGINAL HAEMORRHAGE (vaginal bleeding), MALAISE (feeling extremely ill), LIMB DISCOMFORT (She feels her legs are heavy) and ASTHENIA (weak) in a 70-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (hospitalized for 7 weeks in 2022 before receiving any covid-19 vaccines.) in 2022 and Menopausal. Previously administered products included for Product used for unknown indication: Pfizer COVID-19 vaccine on 02-May-2022, Pfizer COVID-19 vaccine on 23-May-2022 and Pfizer COVID-19 vaccine on 29-Sep-2022. Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine, Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine. Concurrent medical conditions included Menstrual cramps. Concomitant products included IBUPROFEN for Menstrual cramps.    On 07-Nov-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 07-Nov-2023 at 5:00 AM,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced CHILLS (chills). In November 2023, the patient experienced DELUSIONAL PERCEPTION (was delusional), VAGINAL HAEMORRHAGE (vaginal bleeding), MALAISE (feeling extremely ill), LIMB DISCOMFORT (She feels her legs are heavy), ASTHENIA (weak) and DYSMENORRHOEA (menstrual cramps). At the time of the report, DELUSIONAL PERCEPTION (was delusional), VAGINAL HAEMORRHAGE (vaginal bleeding), MALAISE (feeling extremely ill), LIMB DISCOMFORT (She feels her legs are heavy), ASTHENIA (weak), DYSMENORRHOEA (menstrual cramps) and CHILLS (chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2023, Body temperature: 101.4 AF.         Patient had 10 years post-menopausal and has a history of sever uterine thyroids. No treatment information was reported.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose abnormal, Chills, Pain, Pyrexia, Urine ketone body present
Clinical narrative: joint aches; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (joint aches), PYREXIA (fever) and CHILLS (chills) in a 35-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 23-Nov-2023, the patient experienced PAIN (joint aches), PYREXIA (fever) and CHILLS (chills). At the time of the report, PAIN (joint aches), PYREXIA (fever) and CHILLS (chills) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose abnormal: Inconclusive. On an unknown date, Urine ketone body present: Inconclusive.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.       No concomitant and treatment medication were reported.
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: She tested positive a week ago for covid and had no symptoms except for a cough.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (She tested positive a week ago for covid and had no symptoms except for a cough.) in an 83-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Lot-025L20A) on 11-Jan-2021, Moderna COVID-19 Vaccine (Lot-010M20A) on 08-Feb-2021 and Moderna COVID-19 Vaccine (Lot-939904) on 24-Oct-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 25-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In November 2023, the patient experienced COVID-19 (She tested positive a week ago for covid and had no symptoms except for a cough.). At the time of the report, COVID-19 (She tested positive a week ago for covid and had no symptoms except for a cough.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2023, SARS-CoV-2 test: Positive. On 25-Nov-2023, SARS-CoV-2 test: Negative.         The concomitant medication was not reported by reporter. Patient mentioned that she had all Moderna vaccines and has had no reactions to them. The treatment medication was not reported by reporter.
Age: 86.0
Sex: F
Vaccine: COVID19-2, RSV
Symptoms: Arthralgia, Discomfort, Injection site pain
Clinical narrative: Spoke with patient on 11/27/2023. Patient complained of pain in injection arm since being vaccinated on 10/31/2023. Patient can not rest comfortably due to shoulder pain. Advised patient to take tylenol, do stretches, and alternate heat and ice at injection site. Advised patient that if pain did not resolve, they should schedule appointment with physician.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Feeling abnormal, Headache
Clinical narrative: feeling bad; headache; stomach is upset; every joint hurts; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (feeling bad), ABDOMINAL DISCOMFORT (stomach is upset), ARTHRALGIA (every joint hurts) and HEADACHE (headache) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Nov-2023, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In November 2023, the patient experienced ABDOMINAL DISCOMFORT (stomach is upset) and ARTHRALGIA (every joint hurts). On 23-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced FEELING ABNORMAL (feeling bad) and HEADACHE (headache). At the time of the report, FEELING ABNORMAL (feeling bad) and HEADACHE (headache) had not resolved and ABDOMINAL DISCOMFORT (stomach is upset) and ARTHRALGIA (every joint hurts) outcome was unknown.            No concomitant medication was reported.  No treatment information was reported.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Atrial fibrillation, Condition aggravated, Dizziness, Feeling abnormal
Clinical narrative: I woke up with super ventricular tachycardia with HR of 154-158. I then got up and went to the bathroom and then went back to bed where I noticed irregular heart beat.  I am a cardiac and pediatric anesthesiologist so I can recognize these things. I Waited 5 minutes and tried to get up and had atrial fibrillation again for 39 minutes. I didn't do anything stressing but I had tachycardia and AFIB throughout the day. I stayed in bed. I was dizzy and very weak.   The following day I had 1 episodes of AFIB and tachycardia.  The 3rd day I was not feeling great but only had 1 episode of super ventricular tachycardia. I was ok by 10/30.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate irregular, Supraventricular tachycardia, Tachycardia
Clinical narrative: I woke up with super ventricular tachycardia with HR of 154-158. I then got up and went to the bathroom and then went back to bed where I noticed irregular heart beat.  I am a cardiac and pediatric anesthesiologist so I can recognize these things. I Waited 5 minutes and tried to get up and had atrial fibrillation again for 39 minutes. I didn't do anything stressing but I had tachycardia and AFIB throughout the day. I stayed in bed. I was dizzy and very weak.   The following day I had 1 episodes of AFIB and tachycardia.  The 3rd day I was not feeling great but only had 1 episode of super ventricular tachycardia. I was ok by 10/30.
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash
Clinical narrative: patient experienced itching and rash
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received second dose 44 days after first dose (8/14/23) rather than the 2 to 6 month window. No side effects reported by patient up to this date.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was ordered 10/11/2023 and was received 10/16/2023. Upon receiving vaccine, it was stored in the medication fridge (not freezer). Vaccine was given to patient on 11/27/2023 after the 30 days Beyond Use Date of thawed medication.
Age: 66.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Injection site bruising, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Patient called in the morning (11/29/23) and came in at around 11:30am to the pharmacy for me to look at her arm. She had a bruise on her Left arm at where the vaccine was given. There was redness and is swollen from below the  vaccine site to her near her elbow. Warm to touch.  Patient said the Immunizer (Pharmacist) told her that Fluad given on the left arm, but on consent form said the right arm. I will ask the Pharmacist who gave the shots on his next shift to clarify.  Therefore, there's a possibility that Comirnaty was given on her left arm because she got one shot in each arm.  I advised the patient to go to Urgent Care or see PCP to stop the reaction.
Age: 74.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: Patient states 24 hours receiving both vaccines her arms began to swell with redness/tenderness.  Both arms had swelling (approximately 2 inches).  Patient had no breathing issues and no reaction anywhere else on her body that she is aware of.   Patient states swelling and tenderness began to improve now (48 hours after).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: With her COVID-19 she had upper chest congestion, a plugged nose, and a headache. Had a slight fever.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (With her COVID-19 she had upper chest congestion, a plugged nose, and a headache. Had a slight fever.) in a 71-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058628) for COVID-19 prophylaxis.     It was reported that patient did not  received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine on 25-Feb-2021, Moderna COVID-19 vaccine on 25-Mar-2021, Moderna COVID-19 vaccine on 18-Nov-2021, Moderna COVID-19 vaccine on 27-Mar-2022, MODERNA COVID-19 VACCINE and BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) on 25-Sep-2022. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5), Moderna COVID-19 vaccine, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine and Moderna COVID-19 vaccine.    On 13-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In November 2023, the patient experienced COVID-19 (With her COVID-19 she had upper chest congestion, a plugged nose, and a headache. Had a slight fever.). The patient was treated with GUAIFENESIN (MUCINEX) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COVID-19 (With her COVID-19 she had upper chest congestion, a plugged nose, and a headache. Had a slight fever.) was resolving.            No concomitant medication was reported. It was reported that with her COVID-19 she had upper chest congestion, a plugged nose, and a headache. Had a slight fever. Had been taking Mucinex and Tylenol. She had no underlying conditions. She believes her vaccine was not effective because of improper storage and handling of the product at the facility.   This case was linked to MOD-2021-064154, MOD-2022-654596 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pruritus, Pyrexia
Clinical narrative: Itching all over almost immediately; Fever of 100 the next day.; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching all over almost immediately), PYREXIA (Fever of 100 the next day.) and FATIGUE (Fatigue) in a 60-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058876) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 on 21-Dec-2022 and Obesity. Concurrent medical conditions included Asthma.    On 25-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 25-Nov-2023, the patient experienced PRURITUS (Itching all over almost immediately), PYREXIA (Fever of 100 the next day.) and FATIGUE (Fatigue). On 26-Nov-2023, PRURITUS (Itching all over almost immediately), PYREXIA (Fever of 100 the next day.) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2023, Body temperature: 100.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Patient took 0.3 milliliter Spikevax and had itched all over almost immediately. It subsided within an hour. Fever of 100 the next day. Patient had fatigue. The patient did not experience any additional symptoms or events.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Overdose
Clinical narrative: overdose - used full .5mL vial; irregular patchy redness surrounding band aid-shaped hypopigmented area on right posterior biceps; This spontaneous case was reported by an other health care professional and describes the occurrence of ERYTHEMA (irregular patchy redness surrounding band aid-shaped hypopigmented area on right posterior biceps) and OVERDOSE (overdose - used full .5mL vial) in a 3-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 milliliter. On 24-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced ERYTHEMA (irregular patchy redness surrounding band aid-shaped hypopigmented area on right posterior biceps). On an unknown date, the patient experienced OVERDOSE (overdose - used full .5mL vial). At the time of the report, ERYTHEMA (irregular patchy redness surrounding band aid-shaped hypopigmented area on right posterior biceps) had resolved and OVERDOSE (overdose - used full .5mL vial) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  Patient had irregular patchy redness surrounding band aid-shaped hypopigmented area on right posterior biceps, not crossing elbow. . It was unknown if the patient experienced any additional symptoms/events.  No Treatment information was reported.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pancreatitis acute
Clinical narrative: acute pancreatitis; This spontaneous case was reported by a patient and describes the occurrence of PANCREATITIS ACUTE (acute pancreatitis) in a 53-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032089) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 07-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced PANCREATITIS ACUTE (acute pancreatitis) (seriousness criterion medically significant). At the time of the report, PANCREATITIS ACUTE (acute pancreatitis) had not resolved.            No concomitant medications were reported.  It was unknown if the patient experienced any additional symptoms/events.  No treatment medications were reported.  Company Comment:  This spontaneous case concerns a 53-year-old male patient with no medical history reported who experienced the seriousness criterion medically significant unexpected AESI of pancreatitis acute the following day after a dose of mRNA-1273.815 vaccine. At the time of the report, the event had not resolved. Concomitant medication details nor Treatment details were reported The benefit-risk relationship of mRNA-1273.815 vaccine is not affected by this report.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Erythema, Nausea
Clinical narrative: swelling and it hing on injection site; Fever of 104 that evening of; chills; nausea; weakness; redness; swelling and it hing on injection site; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (weakness), ERYTHEMA (redness), VACCINATION SITE PRURITUS (swelling and it hing on injection site), VACCINATION SITE SWELLING (swelling and it hing on injection site) and CHILLS (chills) in a 45-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058877) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergic reaction. Concomitant products included SALBUTAMOL (ALBUTEROL HFA) for Asthma, PARACETAMOL (TYLENOL) for Fever.    On 25-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 25-Nov-2023, the patient experienced ASTHENIA (weakness), ERYTHEMA (redness), VACCINATION SITE PRURITUS (swelling and it hing on injection site), CHILLS (chills) and NAUSEA (nausea). On an unknown date, the patient experienced VACCINATION SITE SWELLING (swelling and it hing on injection site) and PYREXIA (Fever of 104 that evening of). At the time of the report, ASTHENIA (weakness), ERYTHEMA (redness), VACCINATION SITE PRURITUS (swelling and it hing on injection site), VACCINATION SITE SWELLING (swelling and it hing on injection site), CHILLS (chills), NAUSEA (nausea) and PYREXIA (Fever of 104 that evening of) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: Fever of 104.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Lab data/results: Negative lab results It was unknown if there were additional lab data/results available.  No treatment medication was reported.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: swelling and it hing on injection site; Fever of 104 that evening of; chills; nausea; weakness; redness; swelling and it hing on injection site; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (weakness), ERYTHEMA (redness), VACCINATION SITE PRURITUS (swelling and it hing on injection site), VACCINATION SITE SWELLING (swelling and it hing on injection site) and CHILLS (chills) in a 45-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058877) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergic reaction. Concomitant products included SALBUTAMOL (ALBUTEROL HFA) for Asthma, PARACETAMOL (TYLENOL) for Fever.    On 25-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 25-Nov-2023, the patient experienced ASTHENIA (weakness), ERYTHEMA (redness), VACCINATION SITE PRURITUS (swelling and it hing on injection site), CHILLS (chills) and NAUSEA (nausea). On an unknown date, the patient experienced VACCINATION SITE SWELLING (swelling and it hing on injection site) and PYREXIA (Fever of 104 that evening of). At the time of the report, ASTHENIA (weakness), ERYTHEMA (redness), VACCINATION SITE PRURITUS (swelling and it hing on injection site), VACCINATION SITE SWELLING (swelling and it hing on injection site), CHILLS (chills), NAUSEA (nausea) and PYREXIA (Fever of 104 that evening of) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: Fever of 104.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Lab data/results: Negative lab results It was unknown if there were additional lab data/results available.  No treatment medication was reported.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Blister, Hyperkeratosis
Clinical narrative: feeling anxious; Patient stated both of his thumbs has callus; Underneath each callus he has blisters; This spontaneous case was reported by a patient and describes the occurrence of ANXIETY (feeling anxious), HYPERKERATOSIS (Patient stated both of his thumbs has callus) and BLISTER (Underneath each callus he has blisters) in a 79-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Patient stated he never tested positive for COVID-19.  Previously administered products included for Product used for unknown indication: Pfizer (Dose 1, lot number EL0142) on 24-Jan-2021, Pfizer (Dose 2, lot number EL9261) on 11-Feb-2021, Pfizer (Dose 3, lot number EL9261) on 30-Mar-2021, Pfizer (Dose 4, lot number FK9893) on 11-Apr-2021, Pfizer (Dose 5, lot number TH9694) on 15-Sep-2022 and Flu on 15-Sep-2023. Past adverse reactions to the above products included No adverse event with Flu, Pfizer, Pfizer, Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Diabetes (Patient has been diabetic for 40 years).    On 27-Sep-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANXIETY (feeling anxious), HYPERKERATOSIS (Patient stated both of his thumbs has callus) and BLISTER (Underneath each callus he has blisters). At the time of the report, ANXIETY (feeling anxious) had not resolved and HYPERKERATOSIS (Patient stated both of his thumbs has callus) and BLISTER (Underneath each callus he has blisters) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. Dosage text was reported as unknown. The treatment medication was not reported by reporter.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Diarrhoea
Clinical narrative: Patient experienced uncontrollable diarrhea the evening after receiving the RSV vaccine, and has so far attempted over the counter Loperamide as well as a light diet. Patient is still experiencing intermittent bouts of diarrhea
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray normal, Cough, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: Fever, sore throat, cough, very thick sputum and nasal discharge.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Sputum abnormal
Clinical narrative: Fever, sore throat, cough, very thick sputum and nasal discharge.
Age: 5.0
Sex: M
Vaccine: UNK
Symptoms: Circumstance or information capable of leading to medication error, Vomiting
Clinical narrative: My son was given 6 vaccines. This was for his 5 year WCC/kindergarten physical.   The nurse only documented 5 vaccines. I and my mother witnessed the 6 shots being administered (3 in each leg) and I have pictures of the bandaids and the injection sites. I notified the facility and was told that their vaccine counts were correct and that she documented 5 vaccines.  I explained how very concerned I was and they told me their system was effective and there was nothing missing. As a nurse myself, this terrifies me that there are errors happening that aren?t being caught or worse are being covered. I now have no idea what he has received. I pray that they didn?t mix up my son and 6 month old daughter?s shots. My son also had a very large emesis the morning after the vaccines.
Age: 45.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Fatigue, Headache, Pain
Clinical narrative: Chills Body aches Headache Low back pain Fatigue
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose decreased, Blood pressure decreased, Confusional state, Cyanosis, Generalised tonic-clonic seizure
Clinical narrative: 11/22 shot administered 11/23 headache begins in evening 11/24 severe headache, confusion 11/25 unresponsive then tonic-clonic (grand mal) seizure.  Loss of consciousness, turned blue, loss bladder control, etc. 11/26 incoherent and in terrible pain including headache
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Incoherent, Loss of consciousness, Pain
Clinical narrative: 11/22 shot administered 11/23 headache begins in evening 11/24 severe headache, confusion 11/25 unresponsive then tonic-clonic (grand mal) seizure.  Loss of consciousness, turned blue, loss bladder control, etc. 11/26 incoherent and in terrible pain including headache
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli, Urinary incontinence
Clinical narrative: 11/22 shot administered 11/23 headache begins in evening 11/24 severe headache, confusion 11/25 unresponsive then tonic-clonic (grand mal) seizure.  Loss of consciousness, turned blue, loss bladder control, etc. 11/26 incoherent and in terrible pain including headache
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Feeling abnormal, Hypertension, Pain, Vomiting
Clinical narrative: A few hours after receiving the vaccine i was have sever body aches (which have continue for another 24 hours) Very mild fever (99) has accompanied the body aches SO FAR I HAVE NOT SOUGHT MEDICAL TREATMENT FOR THE ADVERSE REACTIONS - not sure what to do - may call my Doctor tomorrow morning if overnight I don't improve My hypertension is WELL CONTAINED on medication however, all day today I have had systolic pressure (home measurement) about 20 to 30 points higher than normal Overall I have a significant feel of unease and have even vomitted twice
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Pain
Clinical narrative: pt had severe erythema on injection arm which spread from the shoulder to the elbow. Pt also stated he felt like he got "hit by a bus" the following 2 days after being vaccinated. he said he had no previous reactions to any other covid vaccines.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Trigger finger, X-ray
Clinical narrative: Arthritic-like condition of hands and knees. Trigger finger of little finger on right hand.
Age: 65.0
Sex: M
Vaccine: UNK
Symptoms: Eosinophil count normal, Urticaria
Clinical narrative: Chronic hives
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Fall, Syncope
Clinical narrative: Patient fainted and fell in the bathroom at home 12 hours after receiving both his Covid & Flu vaccines on the same day at the same time.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness, Hypoaesthesia, Loss of consciousness, Pallor, Tonic convulsion
Clinical narrative: Within 15 minutes of receiving vaccines, Patient developed right upper extremity numbness, dizziness, Pallor, blurry vision and subsequently lost consciousness.  Had a tonic seizure lasting about 2 minutes before regaining consciousness. EMT Services Called to Clinic and Patient transferred to ER.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Vision blurred
Clinical narrative: Within 15 minutes of receiving vaccines, Patient developed right upper extremity numbness, dizziness, Pallor, blurry vision and subsequently lost consciousness.  Had a tonic seizure lasting about 2 minutes before regaining consciousness. EMT Services Called to Clinic and Patient transferred to ER.
Age: 87.0
Sex: F
Vaccine: RSV
Symptoms: Cough, Decreased appetite, Fatigue, Laboratory test, Pyrexia
Clinical narrative: Coughing, runny nose, tired, no appetite, fever.
Age: 87.0
Sex: F
Vaccine: RSV
Symptoms: Rhinorrhoea
Clinical narrative: Coughing, runny nose, tired, no appetite, fever.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Headache, Incorrect route of product administration, Injection site erythema
Clinical narrative: On 11/8/23, patient called medical office to report adverse reaction. She complained of headache, nausea, muscle ache, fatigue.  Injection site warm/red approx 5-6mm in size. Patient declined office appointment. 11/10/23 - redness/swelling Improved               Patient stated arm Was still sore. Patient was advised to call office if symptoms persisted.  11/12/23 - Patient was in contact with office staff. No complaints/concerns relating to vaccine reaction or symptoms following vaccine. Vaccine was administered subcutaneously in error. Outdated vaccine information updated in clinical area to prevent future error.    Vaccinator educated on proper route for Shingrix administration.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Myalgia, Nausea, Pain in extremity, Swelling
Clinical narrative: On 11/8/23, patient called medical office to report adverse reaction. She complained of headache, nausea, muscle ache, fatigue.  Injection site warm/red approx 5-6mm in size. Patient declined office appointment. 11/10/23 - redness/swelling Improved               Patient stated arm Was still sore. Patient was advised to call office if symptoms persisted.  11/12/23 - Patient was in contact with office staff. No complaints/concerns relating to vaccine reaction or symptoms following vaccine. Vaccine was administered subcutaneously in error. Outdated vaccine information updated in clinical area to prevent future error.    Vaccinator educated on proper route for Shingrix administration.
Sex: M
Vaccine: DTAPHEPBIP, HEP, HIBV, PNC20, RV5
Symptoms: Infant irritability, Injection site erythema
Clinical narrative: Patient was fussy & had mild injection site redness on the date of administration only. No other signs, symptoms, or treatments reported.
Age: 44.0
Sex: F
Vaccine: FLU4, FLUC4
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site pain, Pain, Pain in extremity
Clinical narrative: Immediate pain in shoulder + radiating down (R) arm + numbness in hand  Ongoing symptoms since injection
Age: 44.0
Sex: F
Vaccine: FLU4, FLUC4
Symptoms: Ultrasound scan
Clinical narrative: Immediate pain in shoulder + radiating down (R) arm + numbness in hand  Ongoing symptoms since injection
Age: 44.0
Sex: F
Vaccine: FLU4, FLUC4
Symptoms: Arthralgia, Immediate post-injection reaction, Magnetic resonance imaging, Pain, Pain in extremity
Clinical narrative: Immediate pain in shoulder + radiating down (R) arm + numbness in hand  Ongoing symptoms since injection
Age: 44.0
Sex: F
Vaccine: FLU4, FLUC4
Symptoms: Ultrasound scan, X-ray limb
Clinical narrative: Immediate pain in shoulder + radiating down (R) arm + numbness in hand  Ongoing symptoms since injection
Sex: F
Vaccine: COVID19, RSV
Symptoms: Pulmonary embolism, Thrombectomy
Clinical narrative: large Pulmonary embolism requiring thrombectomy. Good outcome following treatment; Patient has history of breast cancer in remission for > 5 years. Will be getting malignancy work up
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Heart rate, Heart rate increased, Heart rate variability decreased, Heart rate variability test
Clinical narrative: Post menopausal Menstrual bleeding
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Postmenopausal haemorrhage
Clinical narrative: Post menopausal Menstrual bleeding
Age: 1.25
Sex: F
Vaccine: HEPA, PNC20, HEPA, PNC20
Symptoms: Extra dose administered, Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: Patient received an extra dose of Hep A vaccine and PCV vaccine at 15 months. Her previous doses of Hep A and PCV were given on  08/30/2023.
Age: 1.25
Sex: F
Vaccine: HEPA, PNC20, HEPA, PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient received an extra dose of Hep A vaccine and PCV vaccine at 15 months. Her previous doses of Hep A and PCV were given on  08/30/2023.
Sex: U
Vaccine: PPV, PPV
Symptoms: Expired product administered
Clinical narrative: No additional AE; Caller is a nurse who reports PNEUMOVAX 23 (pfs) that expired 9/30/2023 was administered to a patient today, 11/27/2023. Product had not experienced TE through the date of administration. No additional AE details. No additional AE. No PQC.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 27-NOV-2023, the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (lot #W019533 waa valid for formulation pre-filled syringe, expiration date 30-SEP-2023, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Expired vaccine used). Product had not experienced temperature excursion (TE) through the date of administration. No additional adverse event (AE) details. No additional AE (No adverse event). No product quality complaint (PQC).
Sex: U
Vaccine: PPV, PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Caller is a nurse who reports PNEUMOVAX 23 (pfs) that expired 9/30/2023 was administered to a patient today, 11/27/2023. Product had not experienced TE through the date of administration. No additional AE details. No additional AE. No PQC.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 27-NOV-2023, the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (lot #W019533 waa valid for formulation pre-filled syringe, expiration date 30-SEP-2023, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Expired vaccine used). Product had not experienced temperature excursion (TE) through the date of administration. No additional adverse event (AE) details. No additional AE (No adverse event). No product quality complaint (PQC).
Age: 72.0
Sex: F
Vaccine: RSV, VARZOS, VARZOS
Symptoms: Erythema, Injection site pallor, Pain, Pruritus, Swelling
Clinical narrative: Pt reported to VAERs herself incorrectly as Abrysvo but it was the Shingrix in the left arm.  She reported fever, pain/redness/swelling at injection site.
Age: 72.0
Sex: F
Vaccine: RSV, VARZOS, VARZOS
Symptoms: Tenderness
Clinical narrative: Pt reported to VAERs herself incorrectly as Abrysvo but it was the Shingrix in the left arm.  She reported fever, pain/redness/swelling at injection site.
Age: 72.0
Sex: F
Vaccine: RSV, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Pt reported to VAERs herself incorrectly as Abrysvo but it was the Shingrix in the left arm.  She reported fever, pain/redness/swelling at injection site.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Immediate post-injection reaction, Vomiting
Clinical narrative: HBP reporting a 2 month old patient vomited about 30 seconds after the administration of ROTATEQ; This spontaneous report was received from a medical assistant (also reported as health business professional), referring to a 2-month-old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies, or concomitant therapies were not reported.  On 30-OCT-2023, the patient received the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1947642 with expiration date on 26-MAY-2024, administered orally, for prophylaxis (dose was not reported).  According to the reporter, the patient vomited about 30 seconds after rotavirus vaccine, live, oral, pentavalent (ROTATEQ) administration. No additional details were provided.  By the time of the report, the outcome of the event was unknown.  The reporter's causality assessment between vomiting and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not provided.  Lot number 1947642 has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent.
Age: 1.58
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no symptomatic adverse events were reported due to administration of VAQTA./No additional AE/PQC reported.; temperature excursion/patient who was administered VAQTA that was stored improperly; This spontaneous report was received from a medical assistant referring to a 19-month-old patient of unspecified gender. Information regarding medical history, concurrent conditions and concomitant therapies was not reported.  On 27-OCT-2023, the patient was vaccinated with an improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) 0.5 ml once (route of administration and anatomical site of vaccination were not reported; lot number X010374 has been verified to be valid, expiration date reported and established as 13-NOV-2024) for prophylaxis.  The vaccine was exposed to a temperature excursion of 47.14 degrees Fahrenheit during a time frame of 45 minutes. There was a previous temperature excursion of 46.6 degrees Fahrenheit for 20 minutes, and 47.59 degrees Fahrenheit for 30 minutes (product storage error). No adverse event was reported (no adverse event).
Age: 75.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient has not reported any symptoms; Medical assistant reported that the pediatric formulation of RECOMBIVAX HB was inadvertently administered to an adult patient on 11/2/2023.; This spontaneous report was received from a medical assistant referring to a 75-year-old patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 02-NOV-2023, the patient was inadvertently vaccinated with a pediatric dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot number W002452, expiration date 26-FEB-2024, 0.5 milliliter (route of administration not provided) for prophylaxis (incorrect dose administered). No adverse event was reported.
Sex: U
Vaccine: HPV4
Symptoms: Poor quality product administered
Clinical narrative: Side effects; Poor quality vaccine administered; Information has been received from a consumer regarding a case in litigation, regarding to a patient (pt) of unknown age and gender. The pt's medical history, concurrent conditions, and concomitant medications were not provided. On an unspecified date, the pt was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) injection as prophylaxis (strength, dose, vaccination scheme, route of administration, anatomical site of injection were not reported). On an unspecified date, the pt developed side effects (Immunisation reaction) from taking Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (also reported as defective drug (Poor quality vaccine administered)). Additionally, it was reported, that the pt, would like to be a part of district court litigation and would be seeking damages. The outcome of adverse event was not provided. The adverse event considered to be related to suspect therapy.