chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Nursing staff manager is calling to report a temperature excursion; No adverse event; There was only 1 person whom received the vaccine from this lot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Nursing staff manager is calling to report a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (There was only 1 person whom received the vaccine from this lot ) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Mar-2023, 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 23-Mar-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (There was only 1 person whom received the vaccine from this lot ). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Nursing staff manager is calling to report a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Nursing staff manager is calling to report a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (There was only 1 person whom received the vaccine from this lot ) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Nursing staff manager is calling to report a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (There was only 1 person whom received the vaccine from this lot ).    No concomitant drug information was provided.  Reporter reported that from a Bivalent - Lot no. AS7170B, unknown number of vials and doses- a temperature excursion was reported, time frame was for 2 hours and 12 minutes. Temperature dropped to 28-8-degree Fahrenheit - average temperature should be 39.6-degree Fahrenheit. It was reported that 4 Bivalent vials of Moderna COVID-19 vaccine experienced excursion in the refrigerator. On 23Mar2023, an adult patient received 1 Bivalent booster dose. At the time of excursion the vials were refrigerated and intact cartons. The vial size was 2.5 ml. Maximum temperature 42.2F and minimum temperatures 28 (Average: 39.6F) Excursion duration was reported as 2 hours and 12 minutes.  vial was moved from freezer to refrigerator on 28FEB2023. Upon the visual inspection, a vaccine state change was noted.   Treatment medication information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2023: Follow-up received, updated narrative.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine on 4APR2023 after the expiration date of 01APR2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine on 4APR2023 after the expiration date of 01APR2023) and NO ADVERSE EVENT (No adverse event) in a 22-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 044C22A) for COVID-19 prophylaxis.     Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 04-Apr-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Apr-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine on 4APR2023 after the expiration date of 01APR2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine on 4APR2023 after the expiration date of 01APR2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine on 4APR2023 after the expiration date of 01APR2023).    No concomitant medications was provided. No treatment medications was provided.  It was reported that, 4 patients, 3 of them received the 2nd dose of the primary series and 1 received a first dose. Information about patient number 2 listed in current case.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: Primary dose back in March of 2022 and She is requesting to get the second dose; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Primary dose back in March of 2022 and She is requesting to get the second dose) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    In March 2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Primary dose back in March of 2022 and She is requesting to get the second dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Primary dose back in March of 2022 and She is requesting to get the second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Primary dose back in March of 2022 and She is requesting to get the second dose).    No concomitant medications were provided. No treatment medication was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: Caller went 1 whole year without receiving 2nd primary dose; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Caller went 1 whole year without receiving 2nd primary dose) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Caller went 1 whole year without receiving 2nd primary dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Caller went 1 whole year without receiving 2nd primary dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Caller went 1 whole year without receiving 2nd primary dose).    No concomitant medication details was reported. No treatment medication details was reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Wrong product administered
Clinical narrative: No adverse event; Vaccine administered after manufacturer date of expiry; 06-month-old patient received 0.25 ml expired Moderna Monovalent 12+ for the first primary dose of Moderna COVID-19 vaccine on 06APR2023.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after manufacturer date of expiry), WRONG PRODUCT ADMINISTERED (06-month-old patient received 0.25 ml expired Moderna Monovalent 12+ for the first primary dose of Moderna COVID-19 vaccine on 06APR2023.) and NO ADVERSE EVENT (No adverse event) in an infant male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 063B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Apr-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after manufacturer date of expiry) and WRONG PRODUCT ADMINISTERED (06-month-old patient received 0.25 ml expired Moderna Monovalent 12+ for the first primary dose of Moderna COVID-19 vaccine on 06APR2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after manufacturer date of expiry), WRONG PRODUCT ADMINISTERED (06-month-old patient received 0.25 ml expired Moderna Monovalent 12+ for the first primary dose of Moderna COVID-19 vaccine on 06APR2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine administered after manufacturer date of expiry) and WRONG PRODUCT ADMINISTERED (06-month-old patient received 0.25 ml expired Moderna Monovalent 12+ for the first primary dose of Moderna COVID-19 vaccine on 06APR2023.).    Concomitant medication details not reported by the reporter. Vial size was reported as 5.5 ml. Vial was initially stored in refrigerator on 06-APR-23. Vial did not undergo any temperature excursion. Treatment details was not reported by the reporter.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Expired product administered, Interchange of vaccine products, No adverse event
Clinical narrative: No adverse event; Patient received expired Moderna Covid-19 vaccine for her second dose; First dose was Pfizer and second dose was Moderna; First dose was Pfizer and second dose was Moderna; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine for her second dose), INTERCHANGE OF VACCINE PRODUCTS (First dose was Pfizer and second dose was Moderna), COVID-19 IMMUNISATION (First dose was Pfizer and second dose was Moderna) and NO ADVERSE EVENT (No adverse event) in a 65-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 074B22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE on 05-Jul-2021, Prevnar vaccine on 27-Mar-2023 and Hepatitis A Vaccine on 27-Mar-2023. Past adverse reactions to the above products included No adverse event with Hepatitis A Vaccine, PFIZER BIONTECH COVID-19 VACCINE and Prevnar vaccine. Concurrent medical conditions included Psychiatric disorder NOS. Concomitant products included CLOZAPINE for Psychiatric disorder NOS.    On 05-Apr-2023, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 05-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine for her second dose), INTERCHANGE OF VACCINE PRODUCTS (First dose was Pfizer and second dose was Moderna) and COVID-19 IMMUNISATION (First dose was Pfizer and second dose was Moderna). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine for her second dose), INTERCHANGE OF VACCINE PRODUCTS (First dose was Pfizer and second dose was Moderna), COVID-19 IMMUNISATION (First dose was Pfizer and second dose was Moderna) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine for her second dose), INTERCHANGE OF VACCINE PRODUCTS (First dose was Pfizer and second dose was Moderna) and COVID-19 IMMUNISATION (First dose was Pfizer and second dose was Moderna).    It was more than 35 days between first and second primary series doses of Covid-19 Monovalent vaccine Pfizer and Moderna. Patient reported no other adverse reactions. No treatment information was provided.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 01-Mar-2023 and vaccine was administered on 04-Apr-2023; no adverse event; Staff gave an expired vaccine to a patient/Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Staff gave an expired vaccine to a patient/Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-Mar-2023 and vaccine was administered on 04-Apr-2023) and NO ADVERSE EVENT (no adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Apr-2023, 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 04-Apr-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Staff gave an expired vaccine to a patient/Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-Mar-2023 and vaccine was administered on 04-Apr-2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Staff gave an expired vaccine to a patient/Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-Mar-2023 and vaccine was administered on 04-Apr-2023) 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 EXPIRED PRODUCT ADMINISTERED (Staff gave an expired vaccine to a patient/Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-Mar-2023 and vaccine was administered on 04-Apr-2023).    No concomitant medications were reported.     The vial was initially stored in the refrigerator on 01-Mar-2023. The BUD  of Bivalent vail was reported as 01-Apr-2023.  No treatment medications were reported
Sex: U
Vaccine: COVID19-2
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: No adverse event; AE submitted for confusion of vaccine dose; This spontaneous case was reported by a pharmacist and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (AE submitted for confusion of vaccine dose) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE.    On 28-Sep-2022, 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 28-Sep-2022, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (AE submitted for confusion of vaccine dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (AE submitted for confusion of vaccine dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (AE submitted for confusion of vaccine dose).    Dosage text for suspect product was reported as additional booster.  Concomitant drugs were not reported.  It was reported that patient was administered with vaccine but reporter was not sure if patient received monovalent or bivalent. So far patient received 5 doses of vaccine. It was also reported that patient came for bivalent vaccine but suspected that patient already had it.  Treatment medications were not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: HCP stated they had a patient who received his 1st dose of Moderna and 1 year later he received a Bivalent booster instead of the 2nd dose of the primary series; No adverse event; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Apr-2023 and was forwarded to Moderna on 07-Apr-2023.    This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP stated they had a patient who received his 1st dose of Moderna and 1 year later he received a Bivalent booster instead of the 2nd dose of the primary series) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (HCP stated they had a patient who received his 1st dose of Moderna and 1 year later he received a Bivalent booster instead of the 2nd dose of the primary series) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP stated they had a patient who received his 1st dose of Moderna and 1 year later he received a Bivalent booster instead of the 2nd dose of the primary series) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (HCP stated they had a patient who received his 1st dose of Moderna and 1 year later he received a Bivalent booster instead of the 2nd dose of the primary series).    Patient had received 1st dose of Moderna vaccine one year before the Bivalent booster instead of the 2nd dose of the primary series.  No concomitant medications were reported. No treatment details were reported.   Reporter did not allow further contact
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted, Product availability issue
Clinical narrative: vaccine being unavailable; unable to get the second dose; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT AVAILABILITY ISSUE (vaccine being unavailable), PRODUCT ADMINISTRATION INTERRUPTED (unable to get the second dose) and NO ADVERSE EVENT (No adverse event) in a 36-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 047C22A) for COVID-19 prophylaxis.     Patient had no allergy or disease. Patient did not you receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 27-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT AVAILABILITY ISSUE (vaccine being unavailable), PRODUCT ADMINISTRATION INTERRUPTED (unable to get the second dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT AVAILABILITY ISSUE (vaccine being unavailable), PRODUCT ADMINISTRATION INTERRUPTED (unable to get the second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT AVAILABILITY ISSUE (vaccine being unavailable) and PRODUCT ADMINISTRATION INTERRUPTED (unable to get the second dose).    No concomitant medication were reported.  Patient was unable to get the second dose due to the vaccine being unavailable. No treatment information was provided by the reporter.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Atrial fibrillation, Chills, Erythema, Flushing
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Chills-Severe, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Tachycardia-Severe, Systemic: Weakness-Mild, Additional Details: PATIENT REPORTED HAVING SEVERE INCREASED HEART RATE WHICH TRIGGERED AFIB. SHE ALSO REPORTED SIGNIFICANT FACIAL FLUSHING AND REDNESS. SHE ALSO REPORTED JAW PAIN AND SIGNIFICANT ARM PAIN.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Heart rate increased, Hyperhidrosis, Injection site pain, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Chills-Severe, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Tachycardia-Severe, Systemic: Weakness-Mild, Additional Details: PATIENT REPORTED HAVING SEVERE INCREASED HEART RATE WHICH TRIGGERED AFIB. SHE ALSO REPORTED SIGNIFICANT FACIAL FLUSHING AND REDNESS. SHE ALSO REPORTED JAW PAIN AND SIGNIFICANT ARM PAIN.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in jaw, Pyrexia, Tachycardia
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Chills-Severe, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Tachycardia-Severe, Systemic: Weakness-Mild, Additional Details: PATIENT REPORTED HAVING SEVERE INCREASED HEART RATE WHICH TRIGGERED AFIB. SHE ALSO REPORTED SIGNIFICANT FACIAL FLUSHING AND REDNESS. SHE ALSO REPORTED JAW PAIN AND SIGNIFICANT ARM PAIN.
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect route of product administration
Clinical narrative: Error: Wrong Route (SC, IM, etc.)-
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case  All Moderna  dose 1 1/3/21  011L20A dose 2  1/31/21  011L20A dose 3  10/28/21  088D21A dose 4  4/21/22  002M21A
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Pfizer COVID-19 vaccine formulation for 5-11 years (orange cap)  was administered to a patient who was 4 years 6 mo and 14 days at time of vaccine administration.   No adverse reactions reported .
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Alanine aminotransferase increased, Aspartate aminotransferase increased, Asthenia, Bladder catheterisation
Clinical narrative: Patient is a 62-year-old male with history of diabetes on metformin, Hypothyroidism on Synthroid as well as a pituitary abnormality at birth on hydrocortisone 20 mg daily presenting to the emergency department via EMS from home for nausea, vomiting and generalized weakness.  Patient lives at home with mom, she states last night he felt nauseous and had multiple bouts of vomiting throughout the night.  She notes this morning he slept until approximately 10 AM, normally he gets up around 5 AM.  When he woke up he felt very weak and had no energy.  She states she tried to have him drink fluids, however he vomited them up, and he was too weak to pivot from the chair, so she called 911.  He has had no falls or injury.  He has not really eaten or drinking anything since yesterday.  Upon arrival to the ED, patient is somewhat slow to answer questions, however denies any pain, denies chest pain, abdominal pain or headache. Associated Symptoms: diarrhea, nausea, vomiting
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Blood bilirubin normal, Blood creatine phosphokinase MB, Blood creatine phosphokinase increased, Blood creatinine increased, Blood glucose normal
Clinical narrative: Patient is a 62-year-old male with history of diabetes on metformin, Hypothyroidism on Synthroid as well as a pituitary abnormality at birth on hydrocortisone 20 mg daily presenting to the emergency department via EMS from home for nausea, vomiting and generalized weakness.  Patient lives at home with mom, she states last night he felt nauseous and had multiple bouts of vomiting throughout the night.  She notes this morning he slept until approximately 10 AM, normally he gets up around 5 AM.  When he woke up he felt very weak and had no energy.  She states she tried to have him drink fluids, however he vomited them up, and he was too weak to pivot from the chair, so she called 911.  He has had no falls or injury.  He has not really eaten or drinking anything since yesterday.  Upon arrival to the ED, patient is somewhat slow to answer questions, however denies any pain, denies chest pain, abdominal pain or headache. Associated Symptoms: diarrhea, nausea, vomiting
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Blood lactic acid increased, Blood potassium normal, Blood sodium decreased, Blood test, Blood thyroid stimulating hormone decreased
Clinical narrative: Patient is a 62-year-old male with history of diabetes on metformin, Hypothyroidism on Synthroid as well as a pituitary abnormality at birth on hydrocortisone 20 mg daily presenting to the emergency department via EMS from home for nausea, vomiting and generalized weakness.  Patient lives at home with mom, she states last night he felt nauseous and had multiple bouts of vomiting throughout the night.  She notes this morning he slept until approximately 10 AM, normally he gets up around 5 AM.  When he woke up he felt very weak and had no energy.  She states she tried to have him drink fluids, however he vomited them up, and he was too weak to pivot from the chair, so she called 911.  He has had no falls or injury.  He has not really eaten or drinking anything since yesterday.  Upon arrival to the ED, patient is somewhat slow to answer questions, however denies any pain, denies chest pain, abdominal pain or headache. Associated Symptoms: diarrhea, nausea, vomiting
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Blood urea increased, COVID-19, Cardiac monitoring abnormal, Chest X-ray normal, Computerised tomogram abdomen normal
Clinical narrative: Patient is a 62-year-old male with history of diabetes on metformin, Hypothyroidism on Synthroid as well as a pituitary abnormality at birth on hydrocortisone 20 mg daily presenting to the emergency department via EMS from home for nausea, vomiting and generalized weakness.  Patient lives at home with mom, she states last night he felt nauseous and had multiple bouts of vomiting throughout the night.  She notes this morning he slept until approximately 10 AM, normally he gets up around 5 AM.  When he woke up he felt very weak and had no energy.  She states she tried to have him drink fluids, however he vomited them up, and he was too weak to pivot from the chair, so she called 911.  He has had no falls or injury.  He has not really eaten or drinking anything since yesterday.  Upon arrival to the ED, patient is somewhat slow to answer questions, however denies any pain, denies chest pain, abdominal pain or headache. Associated Symptoms: diarrhea, nausea, vomiting
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram head normal, Cough, Dehydration, Diarrhoea, Electrocardiogram
Clinical narrative: Patient is a 62-year-old male with history of diabetes on metformin, Hypothyroidism on Synthroid as well as a pituitary abnormality at birth on hydrocortisone 20 mg daily presenting to the emergency department via EMS from home for nausea, vomiting and generalized weakness.  Patient lives at home with mom, she states last night he felt nauseous and had multiple bouts of vomiting throughout the night.  She notes this morning he slept until approximately 10 AM, normally he gets up around 5 AM.  When he woke up he felt very weak and had no energy.  She states she tried to have him drink fluids, however he vomited them up, and he was too weak to pivot from the chair, so she called 911.  He has had no falls or injury.  He has not really eaten or drinking anything since yesterday.  Upon arrival to the ED, patient is somewhat slow to answer questions, however denies any pain, denies chest pain, abdominal pain or headache. Associated Symptoms: diarrhea, nausea, vomiting
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Haemoglobin normal, Hypoglycaemia, Hypophagia, Laboratory test, Lipase normal
Clinical narrative: Patient is a 62-year-old male with history of diabetes on metformin, Hypothyroidism on Synthroid as well as a pituitary abnormality at birth on hydrocortisone 20 mg daily presenting to the emergency department via EMS from home for nausea, vomiting and generalized weakness.  Patient lives at home with mom, she states last night he felt nauseous and had multiple bouts of vomiting throughout the night.  She notes this morning he slept until approximately 10 AM, normally he gets up around 5 AM.  When he woke up he felt very weak and had no energy.  She states she tried to have him drink fluids, however he vomited them up, and he was too weak to pivot from the chair, so she called 911.  He has had no falls or injury.  He has not really eaten or drinking anything since yesterday.  Upon arrival to the ED, patient is somewhat slow to answer questions, however denies any pain, denies chest pain, abdominal pain or headache. Associated Symptoms: diarrhea, nausea, vomiting
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Mental status changes, Metabolic function test normal, Nausea, Platelet count normal, SARS-CoV-2 test positive
Clinical narrative: Patient is a 62-year-old male with history of diabetes on metformin, Hypothyroidism on Synthroid as well as a pituitary abnormality at birth on hydrocortisone 20 mg daily presenting to the emergency department via EMS from home for nausea, vomiting and generalized weakness.  Patient lives at home with mom, she states last night he felt nauseous and had multiple bouts of vomiting throughout the night.  She notes this morning he slept until approximately 10 AM, normally he gets up around 5 AM.  When he woke up he felt very weak and had no energy.  She states she tried to have him drink fluids, however he vomited them up, and he was too weak to pivot from the chair, so she called 911.  He has had no falls or injury.  He has not really eaten or drinking anything since yesterday.  Upon arrival to the ED, patient is somewhat slow to answer questions, however denies any pain, denies chest pain, abdominal pain or headache. Associated Symptoms: diarrhea, nausea, vomiting
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Tachycardia, Thyroxine free normal, Troponin normal, Urine analysis normal, Vomiting
Clinical narrative: Patient is a 62-year-old male with history of diabetes on metformin, Hypothyroidism on Synthroid as well as a pituitary abnormality at birth on hydrocortisone 20 mg daily presenting to the emergency department via EMS from home for nausea, vomiting and generalized weakness.  Patient lives at home with mom, she states last night he felt nauseous and had multiple bouts of vomiting throughout the night.  She notes this morning he slept until approximately 10 AM, normally he gets up around 5 AM.  When he woke up he felt very weak and had no energy.  She states she tried to have him drink fluids, however he vomited them up, and he was too weak to pivot from the chair, so she called 911.  He has had no falls or injury.  He has not really eaten or drinking anything since yesterday.  Upon arrival to the ED, patient is somewhat slow to answer questions, however denies any pain, denies chest pain, abdominal pain or headache. Associated Symptoms: diarrhea, nausea, vomiting
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count increased
Clinical narrative: Patient is a 62-year-old male with history of diabetes on metformin, Hypothyroidism on Synthroid as well as a pituitary abnormality at birth on hydrocortisone 20 mg daily presenting to the emergency department via EMS from home for nausea, vomiting and generalized weakness.  Patient lives at home with mom, she states last night he felt nauseous and had multiple bouts of vomiting throughout the night.  She notes this morning he slept until approximately 10 AM, normally he gets up around 5 AM.  When he woke up he felt very weak and had no energy.  She states she tried to have him drink fluids, however he vomited them up, and he was too weak to pivot from the chair, so she called 911.  He has had no falls or injury.  He has not really eaten or drinking anything since yesterday.  Upon arrival to the ED, patient is somewhat slow to answer questions, however denies any pain, denies chest pain, abdominal pain or headache. Associated Symptoms: diarrhea, nausea, vomiting
Age: 0.33
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient given influenza vaccine at 4 months old, when the minimum age for first influenza vaccine is 6 months old. Patient came in for nurse visit with sibling for flu shots, and the age of the patient was overlooked. No side effects reported
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case
Age: 51.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Nasopharyngitis, Restlessness, SARS-CoV-2 test positive, Throat irritation
Clinical narrative: 3/23/2023 My throat started feeling a little scratchy, I assumed it was allergies.  I felt fine that next morning. That evening my throat began feeling scratchy again. I was very restless after going to bed.  It was the first cold symptoms I had in years, so I knew it was something.  On 3/25/23, I got up and tested positive with an At Home COVID test.  I had a telehealth appointment on 3/27/23 and was prescribed a medication that I never picked up because I was feeling better by then.  I tested negative on 3/31/23 with an at home COVID test.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Coronary arterial stent insertion, Myocardial infarction
Clinical narrative: I did not have an adverse event after receiving the vaccine. I had a heart attack on 03/15/2023. I do have a family history of cardiac disease on my mother's side of the family. I went to the emergency and admitted having three stents put into my heart. Today, I am feeling better.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Oropharyngeal pain, Pyrexia, Respiratory tract congestion
Clinical narrative: I had a breakthrough case of Covid-19 had a sore throat, cough, congestion and fever. It was a mild case and I was prescribed PAXLOVID and benzonatate, zinc and AIRBORNE.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: I had a breakthrough case of Covid-19 had a sore throat, cough, congestion and fever. It was a mild case and I was prescribed PAXLOVID and benzonatate, zinc and AIRBORNE.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Productive cough, Sputum discoloured
Clinical narrative: I had a very bad cough, a little yellow fluid. I am at home recovering.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cough, Fatigue, Feeling of body temperature change, Hyperhidrosis, Influenza like illness
Clinical narrative: In January I had a bad cough and flu like condition. I was hot and cold and sweating a lot. I felt run down. I went to the local clinic, and she felt it was either viral or bacterial. She prescribed me 5 days of antibiotics. She also prescribed another medication. I took those first then after a few days. I took the antibiotics then immediately felt a little better. I believe I had some type of pneumonia. I pretty much feel better, but I still have a cough.
Age: 53.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: Ageusia, Anosmia, Chills, Cough, Decreased appetite
Clinical narrative: 3/14/2023 that night I had a tickly and funny feeling in my throat. Throughout the night, I woke up with a very dry throat and stuffy. I woke up multiple times. I felt heart palpitations. I took FLONASE. This did not clean up my stuffy nose. The next afternoon, I had bad stomach problems. I took an at home COVID test and tested positive, 3/15/23. My nose started to run pretty bad that day and I had a dry cough. I started taking ibuprofen. On 3/16/23 I could not sleep at all, I was so congested and could only breathe through my mouth. I was not hungry. I had a high fever; I did not take my temperature. I felt very hot and had chills. My lips began to swell that evening and progressively got worse. My eyes were swollen. I took hydroxyzine and that brought the swelling down. On 3/17/23 I lost my sense of taste and smell. I still was very stuffy and breathing through my mouth. I checked my vitals. My blood pressure was a little high and my pulse was normal. I had a telehealth appointment and was prescribed PAXLOVID and began taking it that day. The next day, 3/18/23,the inside of my nostrils were burning. I was able to sleep fine. My saliva had a bitter taste. My nostrils were burning inside and I still had stuffiness. I feel asleep and when I woke up my oxygen level was 87. My blood pressure was elevated. I took another at home COVID test and it was positive. 3/19/23 A layer of skin fell of my top lip. My oxygen level was 92 and my heart rate was at 124. I had diarrhea and more stuffiness. On 3/19/23 My ears were clogged and was stuffy. I had a positive COVID test. On 3/20/23 I had a stuffy nose, headache and sweats. My stuffy nose was able to clear. 3/21/23 My vitals were better. The first day my smell was coming back. 3/22/23 the final day on PAXLOVID. Positive COVID test. 3/25/23 I still had congestion, sense of smell and taste still gone and I had a bad cough. Still testing positive for COVID. 3/26/23 I had more coughing fits and took albuterol. I am getting out of breath when moving. My heart rate jumps while sitting into the 100's. 3/29/23 I began to smell again, still coughing and out of breath. 4/1/23 I had uncontrollable cough. 4/2/23 I tested negative with an at home COVID test. I continued to cough and have heart palpitations. Sense of smell and taste returning. On 4/4/23 I called the doctor because I still had symptoms. I was prescribed cetirizine, azelastine and prednisone. I completed prednisone and are still taking the other two prescriptions.
Age: 53.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: Diarrhoea, Dry throat, Dysgeusia, Dyspnoea, Dyspnoea exertional
Clinical narrative: 3/14/2023 that night I had a tickly and funny feeling in my throat. Throughout the night, I woke up with a very dry throat and stuffy. I woke up multiple times. I felt heart palpitations. I took FLONASE. This did not clean up my stuffy nose. The next afternoon, I had bad stomach problems. I took an at home COVID test and tested positive, 3/15/23. My nose started to run pretty bad that day and I had a dry cough. I started taking ibuprofen. On 3/16/23 I could not sleep at all, I was so congested and could only breathe through my mouth. I was not hungry. I had a high fever; I did not take my temperature. I felt very hot and had chills. My lips began to swell that evening and progressively got worse. My eyes were swollen. I took hydroxyzine and that brought the swelling down. On 3/17/23 I lost my sense of taste and smell. I still was very stuffy and breathing through my mouth. I checked my vitals. My blood pressure was a little high and my pulse was normal. I had a telehealth appointment and was prescribed PAXLOVID and began taking it that day. The next day, 3/18/23,the inside of my nostrils were burning. I was able to sleep fine. My saliva had a bitter taste. My nostrils were burning inside and I still had stuffiness. I feel asleep and when I woke up my oxygen level was 87. My blood pressure was elevated. I took another at home COVID test and it was positive. 3/19/23 A layer of skin fell of my top lip. My oxygen level was 92 and my heart rate was at 124. I had diarrhea and more stuffiness. On 3/19/23 My ears were clogged and was stuffy. I had a positive COVID test. On 3/20/23 I had a stuffy nose, headache and sweats. My stuffy nose was able to clear. 3/21/23 My vitals were better. The first day my smell was coming back. 3/22/23 the final day on PAXLOVID. Positive COVID test. 3/25/23 I still had congestion, sense of smell and taste still gone and I had a bad cough. Still testing positive for COVID. 3/26/23 I had more coughing fits and took albuterol. I am getting out of breath when moving. My heart rate jumps while sitting into the 100's. 3/29/23 I began to smell again, still coughing and out of breath. 4/1/23 I had uncontrollable cough. 4/2/23 I tested negative with an at home COVID test. I continued to cough and have heart palpitations. Sense of smell and taste returning. On 4/4/23 I called the doctor because I still had symptoms. I was prescribed cetirizine, azelastine and prednisone. I completed prednisone and are still taking the other two prescriptions.
Age: 53.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: Ear discomfort, Eye swelling, Feeling hot, Headache, Heart rate increased
Clinical narrative: 3/14/2023 that night I had a tickly and funny feeling in my throat. Throughout the night, I woke up with a very dry throat and stuffy. I woke up multiple times. I felt heart palpitations. I took FLONASE. This did not clean up my stuffy nose. The next afternoon, I had bad stomach problems. I took an at home COVID test and tested positive, 3/15/23. My nose started to run pretty bad that day and I had a dry cough. I started taking ibuprofen. On 3/16/23 I could not sleep at all, I was so congested and could only breathe through my mouth. I was not hungry. I had a high fever; I did not take my temperature. I felt very hot and had chills. My lips began to swell that evening and progressively got worse. My eyes were swollen. I took hydroxyzine and that brought the swelling down. On 3/17/23 I lost my sense of taste and smell. I still was very stuffy and breathing through my mouth. I checked my vitals. My blood pressure was a little high and my pulse was normal. I had a telehealth appointment and was prescribed PAXLOVID and began taking it that day. The next day, 3/18/23,the inside of my nostrils were burning. I was able to sleep fine. My saliva had a bitter taste. My nostrils were burning inside and I still had stuffiness. I feel asleep and when I woke up my oxygen level was 87. My blood pressure was elevated. I took another at home COVID test and it was positive. 3/19/23 A layer of skin fell of my top lip. My oxygen level was 92 and my heart rate was at 124. I had diarrhea and more stuffiness. On 3/19/23 My ears were clogged and was stuffy. I had a positive COVID test. On 3/20/23 I had a stuffy nose, headache and sweats. My stuffy nose was able to clear. 3/21/23 My vitals were better. The first day my smell was coming back. 3/22/23 the final day on PAXLOVID. Positive COVID test. 3/25/23 I still had congestion, sense of smell and taste still gone and I had a bad cough. Still testing positive for COVID. 3/26/23 I had more coughing fits and took albuterol. I am getting out of breath when moving. My heart rate jumps while sitting into the 100's. 3/29/23 I began to smell again, still coughing and out of breath. 4/1/23 I had uncontrollable cough. 4/2/23 I tested negative with an at home COVID test. I continued to cough and have heart palpitations. Sense of smell and taste returning. On 4/4/23 I called the doctor because I still had symptoms. I was prescribed cetirizine, azelastine and prednisone. I completed prednisone and are still taking the other two prescriptions.
Age: 53.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: Hyperhidrosis, Hypertension, Lip exfoliation, Lip swelling, Nasal congestion
Clinical narrative: 3/14/2023 that night I had a tickly and funny feeling in my throat. Throughout the night, I woke up with a very dry throat and stuffy. I woke up multiple times. I felt heart palpitations. I took FLONASE. This did not clean up my stuffy nose. The next afternoon, I had bad stomach problems. I took an at home COVID test and tested positive, 3/15/23. My nose started to run pretty bad that day and I had a dry cough. I started taking ibuprofen. On 3/16/23 I could not sleep at all, I was so congested and could only breathe through my mouth. I was not hungry. I had a high fever; I did not take my temperature. I felt very hot and had chills. My lips began to swell that evening and progressively got worse. My eyes were swollen. I took hydroxyzine and that brought the swelling down. On 3/17/23 I lost my sense of taste and smell. I still was very stuffy and breathing through my mouth. I checked my vitals. My blood pressure was a little high and my pulse was normal. I had a telehealth appointment and was prescribed PAXLOVID and began taking it that day. The next day, 3/18/23,the inside of my nostrils were burning. I was able to sleep fine. My saliva had a bitter taste. My nostrils were burning inside and I still had stuffiness. I feel asleep and when I woke up my oxygen level was 87. My blood pressure was elevated. I took another at home COVID test and it was positive. 3/19/23 A layer of skin fell of my top lip. My oxygen level was 92 and my heart rate was at 124. I had diarrhea and more stuffiness. On 3/19/23 My ears were clogged and was stuffy. I had a positive COVID test. On 3/20/23 I had a stuffy nose, headache and sweats. My stuffy nose was able to clear. 3/21/23 My vitals were better. The first day my smell was coming back. 3/22/23 the final day on PAXLOVID. Positive COVID test. 3/25/23 I still had congestion, sense of smell and taste still gone and I had a bad cough. Still testing positive for COVID. 3/26/23 I had more coughing fits and took albuterol. I am getting out of breath when moving. My heart rate jumps while sitting into the 100's. 3/29/23 I began to smell again, still coughing and out of breath. 4/1/23 I had uncontrollable cough. 4/2/23 I tested negative with an at home COVID test. I continued to cough and have heart palpitations. Sense of smell and taste returning. On 4/4/23 I called the doctor because I still had symptoms. I was prescribed cetirizine, azelastine and prednisone. I completed prednisone and are still taking the other two prescriptions.