chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient received the Moderna COVID-19 Vaccine Bivalent booster after a temperature excursion; Facility had a temperature excursion in the freezer; No Adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Bivalent booster after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Facility had a temperature excursion in the freezer) and NO ADVERSE EVENT (No Adverse Event) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 vaccination.     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 POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Bivalent booster after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Facility had a temperature excursion in the freezer) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Bivalent booster after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Facility had a temperature excursion in the freezer) 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 assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Bivalent booster after a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Facility had a temperature excursion in the freezer).    No concomitant medications were reported.   The facility had a temperature excursion in the freezer. They had an inspection and saw that their DDL was not recording the temperatures.  At the time of the excursion, the vaccine was in frozen storage. The vaccines were in broken cartons with vial size of 2.5 ml and 5.5 ml.  Because only manual recording was done twice a day, the maximum and minimum temperatures reached by the vials were unknown.  The excursion duration was unknown. The vaccine was returned to the freezer.   The visual inspection showed the vaccine state as still frozen.  The vial underwent temperature excursion for the first time.  No treatment information was provided by the reporter.
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients received the vaccination after a temperature excursion; had a temperature excursion in the freezer; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (had a temperature excursion in the freezer) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 vaccination.     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 POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (had a temperature excursion in the freezer) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (had a temperature excursion in the freezer) 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 assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (had a temperature excursion in the freezer).    Concomitant drugs were not reported. It was reported that the unbroken cartons of bivalent vaccine of both 2.5ml and 5.5ml size was stored in frozen storage at the time of excursion and was returned to freezer and was still frozen. The duration of excursion and the maximum and minimum temperature reached at the time of excursion was unknown and only had manual twice a day recording. It was also reported that it was first time that patients were involved. Treatment medications were not provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Refridgeration excursions identified; No adverse event; Patient was administered vaccine which had undergone several temperature excursions; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-2022 at 11:55 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 26-Sep-2022 at 11:55 AM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified).    No concomitant medications were reported.  The patient received previous 3 doses of Moderna vaccine as intramuscular injection in deltoid. Patient received the fourth dose of vaccine in deltoid muscle.  On 07-Sep-2022, the vials were initially moved from freezer to refrigerator.  The nurse reported that, Moderna Monovalent and Bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back in Aug-2022. It was reported that, refrigeration excursions were identified, and state vaccines were housed in these units. The manufactures were notified, and the state department made aware of the situation. The storage condition of vial at the time of excursion was in refrigerator. The vials were not visually inspected.  No adverse reactions had been reported for the patient as per the reporter's knowledge.  No treatment medications were reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccines stored in the refrigerator underwent several temperature excursions; No adverse event; Vaccines stored in the refrigerator underwent several temperature excursions and may have; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccines stored in the refrigerator underwent several temperature excursions and may have), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines stored in the refrigerator underwent several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 51-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     It was unknown if the patient ever been diagnosed with/ tested positive for COVID-19.     On 22-Sep-2022 at 3:20 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 22-Sep-2022 at 3:20 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccines stored in the refrigerator underwent several temperature excursions and may have). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines stored in the refrigerator underwent several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccines stored in the refrigerator underwent several temperature excursions and may have), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines stored in the refrigerator underwent several temperature excursions) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vaccines stored in the refrigerator underwent several temperature excursions and may have) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines stored in the refrigerator underwent several temperature excursions).    No concomitant medication was provided.  On an unknown date, patient received dose 1, dose 2, dose 3 of Moderna vaccine, intramuscularly in the deltoid muscle. Patient received dose 4 in the deltoid muscle.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation. The reporter stated that the clinic she was assisting, underwent several temperature excursions with vaccines stored in the refrigerator going back to Aug-2022.   No treatment products reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-654537 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654537:same reporter
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Bivalent vaccines have undergone several temperature excursions; No adverse event; Bivalent vaccines have undergone several temperature excursions and have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions ) and NO ADVERSE EVENT (No adverse event) in a 31-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     It was unknown if patient had ever been diagnosed or tested positive for COVID-19.     On 23-Sep-2022 at 5:43 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 23-Sep-2022 at 5:43 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions ) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions ) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions ).    No concomitant product reported by the reporter.  Patient had received previous 3 doses of vaccine, intramuscular with anatomical site as deltoid. Dose 4 anatomical site was also reported as deltoid. Bivalent vaccines stored in the refrigerator that underwent several temperature excursions in August 2022.Refrigeration excursions were identified, state vaccine was housed in the units. There were excursions noted. Manufactures were notified and the state department was made aware of the situation.  No adverse reactions were reported for any of the patients at the time of the report.  No treatment medication reported by the reporter.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Refridgeration excursions identified; No adverse event; Bivalent vaccines have undergone several temperature excursions and may have been administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Sep-2022 at 3:45 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 23-Sep-2022 at 3:45 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and may have been administered to patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and may have been administered to patients).    No concomitant products reported.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation. The Nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. Date vial moved from freezer to refrigerator was 07 Sep 2022. The vial underwent temperature excursion. The body site was mentioned as deltoid.  No adverse reactions reported for the patient.  No treatment products reported.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Bivalent vaccines have undergone several temperature excursions; No adverse event; Bivalent vaccines have undergone several temperature excursions and may have; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and may have), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 78-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     It was unknown if the patient ever been diagnosed with/ tested positive for COVID-19.     On 15-Sep-2022 at 4:32 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 15-Sep-2022 at 4:32 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and may have). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and may have), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and may have) and PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions).    No concomitant product reported by the reporter.  Patient received vaccine in deltoid.It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation. The Nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. No adverse reactions reported for the patient.Date vial moved from freezer to refrigerator was 07 Sep 2022. The vial underwent temperature excursion. The patient had previous doses intramuscularly and the location was reported as deltoid.  No treatment medication reported by the reporter.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654537:Master case
Age: 45.0
Sex: M
Vaccine: COVID19, FLUX, MEN
Symptoms: Adverse drug reaction
Clinical narrative: reacted to the Covid vaccine; received Flu and Meningitis vaccines prior to reported event; Initial information received from  on 03-Nov-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 45 year old male patient who reacted to the covid vaccine; received flu and meningitis vaccines prior to reported event while receiving vaccines COVID-19 VACCINE, INFLUENZA VACCINE and MENINGOCOCCAL VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect MENINGOCOCCAL VACCINE for Immunization and INFLUENZA VACCINE for Prophylaxis produced by unknown manufacturer (lot number, dose, formulation, expiry date and strength not reported) via unknown route in unknown administration site.  On an unknown date, the patient received suspect COVID-19 VACCINE not produced by Sanofi Pasteur (lot number, dose, formulation, expiry date and strength not reported) via unknown route in unknown administration site.  On an unknown date the patient reacted to the covid vaccine; received flu and meningitis vaccines prior to reported event (adverse drug reaction) (unknown latency) following the administration of MENINGOCOCCAL VACCINE, INFLUENZA VACCINE and COVID-19 VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event. ; Sender's Comments:  01351636:
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site bruising, Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: Patient send swelling to baseball size, with pain and discoloaration. Counsel if it get worse in pain, swelling, color, and it start spreading to seek medical attention
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash pruritic
Clinical narrative: Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: patient stated that about 1 day following administration of both vaccines, she developed a bilateral itchy rash that started on trunk/hip area and spread across back and parts of legs. patient self-treated with benadryl to help with the itch. patient reports that the rash has improved and seemed to be clearing up after about 1 week post-administration.
Age: 6.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Chills, Injection site erythema, Injection site pruritus, Myalgia
Clinical narrative: Redness and itching at injection site, muscle pain, chills
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal menstrual clots, Dysmenorrhoea, Heavy menstrual bleeding, Smear cervix
Clinical narrative: I had normal/regular periods and after receiving the vaccine, my periods became extremely heavy with excessive bleeding and clotting that never returned to normal.  The bleeding is uncontrollable with painful cramping and clotting and lasts days longer with little change in flow from onset to end.
Age: 85.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Swelling at Injection Site-Medium
Age: 82.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 21.0
Sex: M
Vaccine: COVID19-2
Symptoms: Syncope, Unresponsive to stimuli, Visual impairment
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Visual Changes/Disturbances-Mild
Age: 22.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pruritus, Rash
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Mild
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dizziness, Dyspnoea, Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient had what seemed to be a coughing fit immediately afterwards, but after 5 minutes it had resolved. No signs of anaphylaxis, patient was able to verbally communicate that she could breathe fine.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Dehydration, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient had received Pfizer bivalent booster shot in left arm. Patient then received the Flulaval shot in right arm. They shortly passed out for a few seconds before regaining consciousness. Incident is most likely due to dehydration.
Age: 25.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium
Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Inflammatory marker increased, Injected limb mobility decreased, Laboratory test abnormal, Loss of personal independence in daily activities
Clinical narrative: Crippling/Severe Pain starting from my shoulders down to my knees (both sides).  Could not raise my arms or use them to dress completely, severe pain when getting into and out of bed, lifting blankets off of me, walking was the easiest to do, standing up and down from a sitting position.  The worse time was bedtime and in the morning.  It was less severe during the day.  I was prescribed Prednisone.
Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: Pain, X-ray abnormal, X-ray limb, X-ray of pelvis and hip abnormal
Clinical narrative: Crippling/Severe Pain starting from my shoulders down to my knees (both sides).  Could not raise my arms or use them to dress completely, severe pain when getting into and out of bed, lifting blankets off of me, walking was the easiest to do, standing up and down from a sitting position.  The worse time was bedtime and in the morning.  It was less severe during the day.  I was prescribed Prednisone.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Systemic: Diarrhea-Medium, Additional Details: pt has not been to the doctor or discussed with him, takes electrolytes
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: advised patient to use ice pack and take tylenol. and to follow up with a doctor if symptoms do not improve or persists
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case  dose 1 Pfizer 2/25/21 EN6198 dose 2 Pfizer 3/18/21 EN6205 dose 3 Pfizer 10/24/21 FH8020
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Chills, Pain, Pyrexia
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Fever-Medium, Systemic: Joint Pain-Mild
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 96.0
Sex: M
Vaccine: COVID19
Symptoms: Agitation, COVID-19, Condition aggravated, Confusional state, Cough
Clinical narrative: Discharge Provider:  DO Primary Care Provider:  MD Admission Date: 11/4/2022 Discharge Date: 11/10/2022  Covid Positive Date: 11/4/2022 Clinical Narrative: This is a 96-year-old gentleman with dementia who is cared for at home by h his daughter.  Patient had not been feeling well and had cough and chest congestion, and the daughter her tested him for COVID which was positive, and followed his pulse oximetry at home and had intermittent mild hypoxemia noted.  His brought to the emergency room where his workup revealed pulse oximetry revealed variable episodes measurements of pulse oximetry less than 90%., and there were no pulmonary infiltrates.  He was started on dexamethasone and remdesivir.  He subsequently developed increased agitation and confusion thought to be secondary to the corticosteroids versus sundowners delirium.  This led to discontinuation of the dexamethasone, which improved but did not resolve the restlessness.  He also developed severe urinary frequency urinating about every 15 minutes.  He had variable  postvoid residuals, but not greater than 160 mL.  Dr. was consulted and recommended against the bladder antispasmodics and alpha blockers due to his age and dementia.  Subsequent urine analysis and culture demonstrated Enterococcus urinary tract infection turn culture positive on 11 10 which was the day of discharge.  He received 1 dose of amoxicillin prior to discharge.  Another measure that was taken to decrease the urinary frequency was a reduction in his Bumex dose from 1 mg daily to 0.5 mg daily for his chronic congestive heart failure.  Due to his restlessness and tendency toward agitation, he was started on Seroquel which he will be discharged on.   Patient will return home under the care of his daughter, with home health care.
Age: 96.0
Sex: M
Vaccine: COVID19
Symptoms: Culture urine positive, Delirium, Hypoxia, Malaise, Oxygen saturation decreased
Clinical narrative: Discharge Provider:  DO Primary Care Provider:  MD Admission Date: 11/4/2022 Discharge Date: 11/10/2022  Covid Positive Date: 11/4/2022 Clinical Narrative: This is a 96-year-old gentleman with dementia who is cared for at home by h his daughter.  Patient had not been feeling well and had cough and chest congestion, and the daughter her tested him for COVID which was positive, and followed his pulse oximetry at home and had intermittent mild hypoxemia noted.  His brought to the emergency room where his workup revealed pulse oximetry revealed variable episodes measurements of pulse oximetry less than 90%., and there were no pulmonary infiltrates.  He was started on dexamethasone and remdesivir.  He subsequently developed increased agitation and confusion thought to be secondary to the corticosteroids versus sundowners delirium.  This led to discontinuation of the dexamethasone, which improved but did not resolve the restlessness.  He also developed severe urinary frequency urinating about every 15 minutes.  He had variable  postvoid residuals, but not greater than 160 mL.  Dr. was consulted and recommended against the bladder antispasmodics and alpha blockers due to his age and dementia.  Subsequent urine analysis and culture demonstrated Enterococcus urinary tract infection turn culture positive on 11 10 which was the day of discharge.  He received 1 dose of amoxicillin prior to discharge.  Another measure that was taken to decrease the urinary frequency was a reduction in his Bumex dose from 1 mg daily to 0.5 mg daily for his chronic congestive heart failure.  Due to his restlessness and tendency toward agitation, he was started on Seroquel which he will be discharged on.   Patient will return home under the care of his daughter, with home health care.
Age: 96.0
Sex: M
Vaccine: COVID19
Symptoms: Pollakiuria, Pulmonary congestion, Restlessness, SARS-CoV-2 test positive, Urinary tract infection enterococcal
Clinical narrative: Discharge Provider:  DO Primary Care Provider:  MD Admission Date: 11/4/2022 Discharge Date: 11/10/2022  Covid Positive Date: 11/4/2022 Clinical Narrative: This is a 96-year-old gentleman with dementia who is cared for at home by h his daughter.  Patient had not been feeling well and had cough and chest congestion, and the daughter her tested him for COVID which was positive, and followed his pulse oximetry at home and had intermittent mild hypoxemia noted.  His brought to the emergency room where his workup revealed pulse oximetry revealed variable episodes measurements of pulse oximetry less than 90%., and there were no pulmonary infiltrates.  He was started on dexamethasone and remdesivir.  He subsequently developed increased agitation and confusion thought to be secondary to the corticosteroids versus sundowners delirium.  This led to discontinuation of the dexamethasone, which improved but did not resolve the restlessness.  He also developed severe urinary frequency urinating about every 15 minutes.  He had variable  postvoid residuals, but not greater than 160 mL.  Dr. was consulted and recommended against the bladder antispasmodics and alpha blockers due to his age and dementia.  Subsequent urine analysis and culture demonstrated Enterococcus urinary tract infection turn culture positive on 11 10 which was the day of discharge.  He received 1 dose of amoxicillin prior to discharge.  Another measure that was taken to decrease the urinary frequency was a reduction in his Bumex dose from 1 mg daily to 0.5 mg daily for his chronic congestive heart failure.  Due to his restlessness and tendency toward agitation, he was started on Seroquel which he will be discharged on.   Patient will return home under the care of his daughter, with home health care.
Age: 96.0
Sex: M
Vaccine: COVID19
Symptoms: Urine analysis abnormal
Clinical narrative: Discharge Provider:  DO Primary Care Provider:  MD Admission Date: 11/4/2022 Discharge Date: 11/10/2022  Covid Positive Date: 11/4/2022 Clinical Narrative: This is a 96-year-old gentleman with dementia who is cared for at home by h his daughter.  Patient had not been feeling well and had cough and chest congestion, and the daughter her tested him for COVID which was positive, and followed his pulse oximetry at home and had intermittent mild hypoxemia noted.  His brought to the emergency room where his workup revealed pulse oximetry revealed variable episodes measurements of pulse oximetry less than 90%., and there were no pulmonary infiltrates.  He was started on dexamethasone and remdesivir.  He subsequently developed increased agitation and confusion thought to be secondary to the corticosteroids versus sundowners delirium.  This led to discontinuation of the dexamethasone, which improved but did not resolve the restlessness.  He also developed severe urinary frequency urinating about every 15 minutes.  He had variable  postvoid residuals, but not greater than 160 mL.  Dr. was consulted and recommended against the bladder antispasmodics and alpha blockers due to his age and dementia.  Subsequent urine analysis and culture demonstrated Enterococcus urinary tract infection turn culture positive on 11 10 which was the day of discharge.  He received 1 dose of amoxicillin prior to discharge.  Another measure that was taken to decrease the urinary frequency was a reduction in his Bumex dose from 1 mg daily to 0.5 mg daily for his chronic congestive heart failure.  Due to his restlessness and tendency toward agitation, he was started on Seroquel which he will be discharged on.   Patient will return home under the care of his daughter, with home health care.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case. Moderna 3/8/21 012A21A, 4/6/21 017B21A and boosted 12/8/21 067F (lot number stated).
Age: 39.0
Sex: F
Vaccine: COVID19-2, PNC20
Symptoms: Breast swelling, Dermatitis, Dizziness, Electrocardiogram normal, Epistaxis
Clinical narrative: On the right upper arm it became very swollen and hot. I work at a doctor's office and so I got vitals at the end of my shift with a BP of 174/112, HR 113, temp 99.1 that climbed to 99.5  by the time I got home. I was hot, feverish, dizzy, nauseous (without vomiting), fatigued. The swelling and extreme heat at site persisted through four days. I got the vaccine Sunday morning and it is Friday morning. My arm is markedly swollen (won't entirely fit in my uniform sleeve) with collateral swelling through shoulder, right side of neck, right breast, right underarm, right scapula area. Flushed cheeks and inflamed facial skin spreading down to neck and upper chest, more towards right side. Persistent through day five. Elevating extremity provided no relief. Tylenol and Ibuprofen taken to not much effect other than bringing down the fever a bit, did not reduce pain, redness, or swelling. Ice packs helped to reduce heat but at no point did the site become cold under persistent icing. Would melt solid ice packs in less than 45 minutes with little relief. Right sinus began bleeding with blood clots after persistent right sinus headache and eye socket pain for 2 hours. Resolved in 20 minutes after starting. Over the course of the week experienced general myalgia.
Age: 39.0
Sex: F
Vaccine: COVID19-2, PNC20
Symptoms: Eye pain, Fatigue, Feeling hot, Flushing, Influenza virus test negative
Clinical narrative: On the right upper arm it became very swollen and hot. I work at a doctor's office and so I got vitals at the end of my shift with a BP of 174/112, HR 113, temp 99.1 that climbed to 99.5  by the time I got home. I was hot, feverish, dizzy, nauseous (without vomiting), fatigued. The swelling and extreme heat at site persisted through four days. I got the vaccine Sunday morning and it is Friday morning. My arm is markedly swollen (won't entirely fit in my uniform sleeve) with collateral swelling through shoulder, right side of neck, right breast, right underarm, right scapula area. Flushed cheeks and inflamed facial skin spreading down to neck and upper chest, more towards right side. Persistent through day five. Elevating extremity provided no relief. Tylenol and Ibuprofen taken to not much effect other than bringing down the fever a bit, did not reduce pain, redness, or swelling. Ice packs helped to reduce heat but at no point did the site become cold under persistent icing. Would melt solid ice packs in less than 45 minutes with little relief. Right sinus began bleeding with blood clots after persistent right sinus headache and eye socket pain for 2 hours. Resolved in 20 minutes after starting. Over the course of the week experienced general myalgia.
Age: 39.0
Sex: F
Vaccine: COVID19-2, PNC20
Symptoms: Injection site swelling, Injection site warmth, Joint swelling, Myalgia, Nausea
Clinical narrative: On the right upper arm it became very swollen and hot. I work at a doctor's office and so I got vitals at the end of my shift with a BP of 174/112, HR 113, temp 99.1 that climbed to 99.5  by the time I got home. I was hot, feverish, dizzy, nauseous (without vomiting), fatigued. The swelling and extreme heat at site persisted through four days. I got the vaccine Sunday morning and it is Friday morning. My arm is markedly swollen (won't entirely fit in my uniform sleeve) with collateral swelling through shoulder, right side of neck, right breast, right underarm, right scapula area. Flushed cheeks and inflamed facial skin spreading down to neck and upper chest, more towards right side. Persistent through day five. Elevating extremity provided no relief. Tylenol and Ibuprofen taken to not much effect other than bringing down the fever a bit, did not reduce pain, redness, or swelling. Ice packs helped to reduce heat but at no point did the site become cold under persistent icing. Would melt solid ice packs in less than 45 minutes with little relief. Right sinus began bleeding with blood clots after persistent right sinus headache and eye socket pain for 2 hours. Resolved in 20 minutes after starting. Over the course of the week experienced general myalgia.
Age: 39.0
Sex: F
Vaccine: COVID19-2, PNC20
Symptoms: Pain, Paranasal sinus haemorrhage, Pyrexia, SARS-CoV-2 test negative, Sinus headache
Clinical narrative: On the right upper arm it became very swollen and hot. I work at a doctor's office and so I got vitals at the end of my shift with a BP of 174/112, HR 113, temp 99.1 that climbed to 99.5  by the time I got home. I was hot, feverish, dizzy, nauseous (without vomiting), fatigued. The swelling and extreme heat at site persisted through four days. I got the vaccine Sunday morning and it is Friday morning. My arm is markedly swollen (won't entirely fit in my uniform sleeve) with collateral swelling through shoulder, right side of neck, right breast, right underarm, right scapula area. Flushed cheeks and inflamed facial skin spreading down to neck and upper chest, more towards right side. Persistent through day five. Elevating extremity provided no relief. Tylenol and Ibuprofen taken to not much effect other than bringing down the fever a bit, did not reduce pain, redness, or swelling. Ice packs helped to reduce heat but at no point did the site become cold under persistent icing. Would melt solid ice packs in less than 45 minutes with little relief. Right sinus began bleeding with blood clots after persistent right sinus headache and eye socket pain for 2 hours. Resolved in 20 minutes after starting. Over the course of the week experienced general myalgia.
Age: 39.0
Sex: F
Vaccine: COVID19-2, PNC20
Symptoms: Swelling
Clinical narrative: On the right upper arm it became very swollen and hot. I work at a doctor's office and so I got vitals at the end of my shift with a BP of 174/112, HR 113, temp 99.1 that climbed to 99.5  by the time I got home. I was hot, feverish, dizzy, nauseous (without vomiting), fatigued. The swelling and extreme heat at site persisted through four days. I got the vaccine Sunday morning and it is Friday morning. My arm is markedly swollen (won't entirely fit in my uniform sleeve) with collateral swelling through shoulder, right side of neck, right breast, right underarm, right scapula area. Flushed cheeks and inflamed facial skin spreading down to neck and upper chest, more towards right side. Persistent through day five. Elevating extremity provided no relief. Tylenol and Ibuprofen taken to not much effect other than bringing down the fever a bit, did not reduce pain, redness, or swelling. Ice packs helped to reduce heat but at no point did the site become cold under persistent icing. Would melt solid ice packs in less than 45 minutes with little relief. Right sinus began bleeding with blood clots after persistent right sinus headache and eye socket pain for 2 hours. Resolved in 20 minutes after starting. Over the course of the week experienced general myalgia.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID Vaccine breakthrough case. Pfizer 01/30/2021 EN5318, 2/20/21 EN6201 and boosted 10/23/21 PAA166261
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Received the Bivalent Pfizer on 10/6/22 and again on 10/10/22 by another healthcare facility . No reaction.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chest discomfort, Dyspnoea, Eye swelling
Clinical narrative: Difficulty breathing, heavy chest, swollen left eye
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling abnormal, Hypersensitivity, Loss of personal independence in daily activities, Pain
Clinical narrative: red  painful dangling feeling went swimming and allergic reaction
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dyspnoea, Pruritus, Rash, Skin reaction, Swelling face
Clinical narrative: Approximately 11 days after the vaccine, I started developing massive itchiness to my entire back.  I had no changes in diet, medication, or environmental contact.  I took a zyrtec that night slept fine and woke up the next morning with continued massive itching and hives throughout entire body with face swelling and minimally hard time breathing (felt as though I could not get a good breath in).  I was able to get an appointment with my dermatologist who recommended first line antihistamines prior to starting steroids.  After the visit, on that Wednesday morning, I took two claritins.  The massive itch continued throughout the day with rash and hives throughout entire body.  That night I took a benadryl, slept well again.  Woke up with continued extreme massive itching and hives throughout body.  At this time, my face was no longer swollen and breathing felt fine.  I was able to get an appointment with my allergist on Thursday afternoon.  From there, I have been started on prednisone and instructed to take two zyrtecs once in the morning and again at night.  Currently it is Friday, I took my first dose of 40mg prednisone yesterday.  I still am itchy but nothing as severe as before.  The hives have also decreased.
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Urticaria
Clinical narrative: Approximately 11 days after the vaccine, I started developing massive itchiness to my entire back.  I had no changes in diet, medication, or environmental contact.  I took a zyrtec that night slept fine and woke up the next morning with continued massive itching and hives throughout entire body with face swelling and minimally hard time breathing (felt as though I could not get a good breath in).  I was able to get an appointment with my dermatologist who recommended first line antihistamines prior to starting steroids.  After the visit, on that Wednesday morning, I took two claritins.  The massive itch continued throughout the day with rash and hives throughout entire body.  That night I took a benadryl, slept well again.  Woke up with continued extreme massive itching and hives throughout body.  At this time, my face was no longer swollen and breathing felt fine.  I was able to get an appointment with my allergist on Thursday afternoon.  From there, I have been started on prednisone and instructed to take two zyrtecs once in the morning and again at night.  Currently it is Friday, I took my first dose of 40mg prednisone yesterday.  I still am itchy but nothing as severe as before.  The hives have also decreased.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVOID vaccine breakthrough case. Moderna 4/24/21 016B21A, 5/22/21 033C21A, and boosted 12/2/21 013F21A
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Client was given a Pediatric dose of Hep B instead of an Adult dose of Hep B. Client schedule 11/30/22 for Heplisav series of 2 to get fully up to date on Hep B and Hep A instead of choosing to correct and complete Hepatitis B only series.
Age: 12.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: The patient is 12 years old and received a 5-11 Pfizer Covid Bivalent
Age: 6.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product preparation error
Clinical narrative: administered a non-diluted dose of Pfizer 5?11-year-old bivalent to the patient prior to realizing the vaccine had not been diluted properly