chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine had been given after being stored in a fridge for over 30 days) and PRODUCT STORAGE ERROR (Vaccine had been stored in fridge for over 30 days prior to administration) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 vaccination. It was unknown if the patient had any acute illnesses at the time of vaccination and up to one month before.     On 29-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine had been given after being stored in a fridge for over 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine had been stored in fridge for over 30 days prior to administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine had been given after being stored in a fridge for over 30 days) and PRODUCT STORAGE ERROR (Vaccine had been stored in fridge for over 30 days prior to administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was unknown if the patient was taking any prescriptions, over-the-counter medications, dietary supplements, or herbal remedies at time of vaccination and/or at the time of the adverse event.  The vaccine was given in the deltoid (anatomical location).  Number of doses/vials were reported as 2 - not positive; not full vial was administered. The vial was initially stored in the refrigerator was on 27-May-2022. The vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.   This case was linked to MODERNATX, INC.-MOD-2022-600655 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-600655:Master case
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was stored in fridge longer than 30 days prior to administration; Vaccine was stored in fridge longer than 30 days prior to administration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in fridge longer than 30 days prior to administration) and PRODUCT STORAGE ERROR (Vaccine was stored in fridge longer than 30 days prior to administration) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 30-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in fridge longer than 30 days prior to administration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in fridge longer than 30 days prior to administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in fridge longer than 30 days prior to administration) and PRODUCT STORAGE ERROR (Vaccine was stored in fridge longer than 30 days prior to administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. The vial was initially stored in the refrigerator on 27 May 2022. The vial did not undergo any temperature excursions.  It was reported that Route and Body site was deltoid. Treatment medication was not provided by the reporter.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was stored and administered beyond 30 days use by date; Vaccine was stored and administered beyond 30 days use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was stored and administered beyond 30 days use by date) and PRODUCT STORAGE ERROR (Vaccine was stored and administered beyond 30 days use by date) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 vaccination.     It was unknown whether patient has diagnosed/tested positive for COVID-19.  Acute illness at the time of vaccination and up to one month before and chronic or long-standing health conditions were unknown.     On 30-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 30-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was stored and administered beyond 30 days use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored and administered beyond 30 days use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was stored and administered beyond 30 days use by date) and PRODUCT STORAGE ERROR (Vaccine was stored and administered beyond 30 days use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  The vial was initially stored in the refrigerator on 27-May-2022. Date of administration of vaccine on 29th or 30th of Jun 2022. The vial did not undergo any temperature excursions.  It was reported that Route and Body site was deltoid.  Treatment medication was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-600655 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-600655:Master case
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine stored in refrigerator longer than 30 days prior to administration and administered beyond 30 day use by date; Vaccine was stored in refrigerator and administered beyond 30 day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator and administered beyond 30 day use by date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator longer than 30 days prior to administration and administered beyond 30 day use by date) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 30-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator and administered beyond 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator longer than 30 days prior to administration and administered beyond 30 day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator and administered beyond 30 day use by date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator longer than 30 days prior to administration and administered beyond 30 day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The vial was initially stored in the refrigerator on 27-May-2022. Date of administration of vaccine on 29th or 30th of Jun 2022. The vial did not undergo any temperature excursions.  It was reported that Route and Body site was deltoid.  No treatment medication was reporter.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was stored in refrigerator on 27-May-2022 and administered on 30-Jun-2022; possible administration of vaccine stored beyond the 30 use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (possible administration of vaccine stored beyond the 30 use by date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 27-May-2022 and administered on 30-Jun-2022) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 30-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (possible administration of vaccine stored beyond the 30 use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 27-May-2022 and administered on 30-Jun-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (possible administration of vaccine stored beyond the 30 use by date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 27-May-2022 and administered on 30-Jun-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported.  Route and body site was reported as deltoid. It was unknown if the patient had any COVID-19 test or diagnosis previously. Acute illness or the chronic conditions at the time of vaccination was also unknown.  Product was initially stored in refrigerator on 27-May-2022. Vaccine was stored in fridge longer than 30 days prior to administration. It was confirmed that the vial had not undergone any temperature excursion issue.  No treatment drug information was provided.   This case was linked to MOD-2022-613779, MOD-2022-613779 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine stored in refrigerator longer than 30 days prior to administration and administered beyond 30 day use by date; Vaccine was stored in refrigerator and administered beyond 30 day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator and administered beyond 30 day use by date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator longer than 30 days prior to administration and administered beyond 30 day use by date) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Jun-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 30-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator and administered beyond 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator longer than 30 days prior to administration and administered beyond 30 day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator and administered beyond 30 day use by date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator longer than 30 days prior to administration and administered beyond 30 day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vial was initially stored in the refrigerator on 27-May-2022 and had been stored in the refrigerator since then and stored longer than 30 days prior to administration.  The vial did not undergo any temperature excursions.  Full vial was not administered.  It was reported that site of administration of the vaccine was deltoid.  No treatment medication information was provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was stored in fridge longer than 30 days prior to administration; Vaccine was stored in fridge longer than 30 days prior to administration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in fridge longer than 30 days prior to administration) and PRODUCT STORAGE ERROR (Vaccine was stored in fridge longer than 30 days prior to administration) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 30-Jun-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 30-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in fridge longer than 30 days prior to administration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in fridge longer than 30 days prior to administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in fridge longer than 30 days prior to administration) and PRODUCT STORAGE ERROR (Vaccine was stored in fridge longer than 30 days prior to administration) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Suspect route of administration and body site was reported as deltoid.  Concomitant product use was not provided by the reporter.  Unknown if the patient has ever been diagnosed with or tested positive for COVID-19.  Unknown if the patient had acute illnesses at the time of vaccination and up to one month before.  Unknown if the patient had chronic or long-standing health conditions.  The vial was initially stored in the refrigerator on 27-May-2022.  The vial didn't undergo any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-600655 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-600655:Master Case
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation
Clinical narrative: Chronic Constipation; This spontaneous case was reported by an other health care professional and describes the occurrence of CONSTIPATION (Chronic Constipation) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038c21A and 038c21A) for COVID-19 prophylaxis.     It was unknown if patient had ever been diagnosed positive with Covid-19.  It was unknown if patient had any acute illness at the time of vaccination or up to one month before.  Concurrent medical conditions included Drug allergy (lexapro allergy), Anxiety disorder (no recent changes) since 28-Jan-2021 and Mixed hyperlipidemia (no recent changes) since 27-Jul-2019. Concomitant products included DOCUSATE SODIUM from 06-Dec-2021 to an unknown date, PAROXETINE from 28-Jan-2021 to an unknown date and ROSUVASTATIN from 27-Jul-2019 to an unknown date for an unknown indication.   On 09-Jun-2021 at 4:28 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jul-2021 at 2:36 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 06-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CONSTIPATION (Chronic Constipation). At the time of the report, CONSTIPATION (Chronic Constipation) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not experience similar event in the past.  It was reported, patient did not have any adverse event including signs symptoms, clinical course or treatment with dates/timelines.   Patient did not experience, any symptoms during the temperature excursion.  Patient did not seek medical care due to the adverse event.  There were no potential causes to the adverse event.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-503423 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Migraine
Clinical narrative: Migraine; Received first dose on 01-Feb-2022 and second dose on 22-Mar-2022 which was more than 25-35 days; This spontaneous case was reported by an other health care professional and describes the occurrence of MIGRAINE (Migraine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose on 01-Feb-2022 and second dose on 22-Mar-2022 which was more than 25-35 days) in a 40-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 084J21A and 084J21A) for COVID-19 prophylaxis.     The patient had no known drug allergies.  The patient's past medical history included Migraine (no recent changes in condition status) on 01-Mar-2018 and Migraine (no recent changes in condition status) on 29-Oct-2021. Concomitant products included FAMOTIDINE, IBUPROFEN (DUEXIS) from 29-Oct-2021 to an unknown date, IBUPROFEN from 01-Mar-2018 to an unknown date and FAMOTIDINE from 18-Mar-2022 to an unknown date for an unknown indication.   On 01-Feb-2022 at 12:47 PM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 22-Mar-2022 at 10:25 AM, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On 22-Mar-2022 at 10:25 AM,  after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose on 01-Feb-2022 and second dose on 22-Mar-2022 which was more than 25-35 days). On 18-May-2022, the patient experienced MIGRAINE (Migraine). At the time of the report, MIGRAINE (Migraine) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose on 01-Feb-2022 and second dose on 22-Mar-2022 which was more than 25-35 days) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Patient weight was reported as 180. No treatment medications were reported.   This case was linked to MOD-2022-503443 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Dysmenorrhoea, Heavy menstrual bleeding, Menstrual disorder, Swelling
Clinical narrative: After the vaccine my armpit on left side.very swollen and painful. A couple months later I noticed change in my period. I went from being very regular to irregular and much heavier flow amd menstrual pain.  Now I will bleed for a couple days, it stops for a day (bleeding stops but cramping does not) then bleeding returns.  Period used to last 4 to 5 days now it persists for 2 weeks.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Moderna 2/12/21, 3/12/21, 11/16/21, 6/15/22. Positive on 7/27/22
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Mastication disorder, Pain in jaw, Toothache
Clinical narrative: Systemic: tooth pain on right, lower jaw-Medium, Additional Details: Patient described tooth pain on the right, lower jaw. She set up an appointment to be seen by her dentist, no updates on outcomes of that visit. Says she could not chew on that side of her mouth without extreme discomfort.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Flushing, Haemorrhage, Hyperhidrosis
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe, Additional Details: I accidentally hit a vein and blood squired out, applied pressure to stop bleeding and applied cold pack to reduce swelling, pt felt very faint, profusely sweating, pale in color, pt has high anxiety when getting a shot, talked to pt and kept him alert, supported him so he wouldn't fall and called ambulance asap and by time ambulance arrived, pt had started to stop sweating, color returned to his face and he was feeling better but they still checked all his vital signs and all were good
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site swelling, Pallor, Swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe, Additional Details: I accidentally hit a vein and blood squired out, applied pressure to stop bleeding and applied cold pack to reduce swelling, pt felt very faint, profusely sweating, pale in color, pt has high anxiety when getting a shot, talked to pt and kept him alert, supported him so he wouldn't fall and called ambulance asap and by time ambulance arrived, pt had started to stop sweating, color returned to his face and he was feeling better but they still checked all his vital signs and all were good
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Eye movement disorder, Feeling abnormal, Flushing
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: pt's eyes rolled back in head, went limp, fainted-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Medium, Additional Details: Pt is very phobic concerning shorts, high anxiety, I accidentally hit a vein when giving shot, applied pressure to stop bleeding & applied cold pack for swelling - hematoma at site of inj. when pt started to feel worse, called ambulance and when pt fainted, layed her on floor and put feet up and pillow under head, by time ambulance arrived, pt coming around, talking, squeezed my hand, they checked all vitals and all good
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Haemorrhage, Hyperhidrosis, Injection site bruising, Injection site haematoma
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: pt's eyes rolled back in head, went limp, fainted-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Medium, Additional Details: Pt is very phobic concerning shorts, high anxiety, I accidentally hit a vein when giving shot, applied pressure to stop bleeding & applied cold pack for swelling - hematoma at site of inj. when pt started to feel worse, called ambulance and when pt fainted, layed her on floor and put feet up and pillow under head, by time ambulance arrived, pt coming around, talking, squeezed my hand, they checked all vitals and all good
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Nausea, Product administered at inappropriate site, Syncope, Unresponsive to stimuli
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: pt's eyes rolled back in head, went limp, fainted-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Medium, Additional Details: Pt is very phobic concerning shorts, high anxiety, I accidentally hit a vein when giving shot, applied pressure to stop bleeding & applied cold pack for swelling - hematoma at site of inj. when pt started to feel worse, called ambulance and when pt fainted, layed her on floor and put feet up and pillow under head, by time ambulance arrived, pt coming around, talking, squeezed my hand, they checked all vitals and all good
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Presyncope, Visual impairment
Clinical narrative: Systemic: Vasovagal reaction-Mild, Additional Details: ~5 minutes following vaccination pt told his father he started seeing "black spots" and fell. Denied headstrike. Returned to clinic where I gave the pt water, monitored BP and pt status for ~15 minutes. Pt left in stable condition, no longer experiencing any symptoms.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case. Moderna 2/15/21 031L20A, 3/15/21 030A21A,  boosted 11/4/21 076C21A,  6/8/22 058A22-2A
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case. Moderna 3/16/21 002B21A, 4/13/21 025B21A and boosted Moderna 048B21A, Pfizer FK9894
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Discomfort, Fatigue, Insomnia, Pain in extremity
Clinical narrative: Patient had arm soreness without swelling that started the evening she received the 4th dose.  Entire arm was sore for about 5 days.  Patient was fatigued and no energy for 5 days.  No fever.  Pt called doctor, and she took a COVID test, and tested negative.  She was unable to sleep the first night due to soreness, and discomfort.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Patient had arm soreness without swelling that started the evening she received the 4th dose.  Entire arm was sore for about 5 days.  Patient was fatigued and no energy for 5 days.  No fever.  Pt called doctor, and she took a COVID test, and tested negative.  She was unable to sleep the first night due to soreness, and discomfort.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, FLUR4
Symptoms: COVID-19, Nasopharyngitis, SARS-CoV-2 test positive
Clinical narrative: * PT TESTED POSITIVE ON 9/1/2021...MILD COLD SYMPTOMS...BUT SHOULD HAVE BEEN ASKED AND NOT RECEIVE A BOOSTER W/I 90 DAYS OF POSITIVE DIAGNOSIS...PATIENT WAS NOT ASKED...ADMINISTERED AT HEALTH DEPT WHO RECEIVES ALL POSITIVE RESULTS.  * PT= 82 YEARS OLD BUT WALKED 2 MILES/DAY AND PERFORMED ON STAGE 34- NIGHTS A WEEK UNTIL 11/16/2021  * HE HAS ALWAYS HAD SUPER QUAD FLU SHOT WITHOUT INCIDENT...  * CALL DAUGHTER WITH QUESTIONS
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalization of fully vaccinated with 1 booster covid positive pt
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Unilateral axillary lymphadenopathy still present nine months after vaccination.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Breakthrough COVID case
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalization of covid pt who was fully vaccinated with one booster
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Chest X-ray, Computerised tomogram, Cough
Clinical narrative: Approximately 2 months after receiving vaccine I developed a breakthrough case of COVID-19. Tested positive on July 10. Symptoms fever, cough, brain fog, headache, nausea, vomiting, diarrhea,  fatigue, dizziness, and congestion.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Feeling abnormal, Headache
Clinical narrative: Approximately 2 months after receiving vaccine I developed a breakthrough case of COVID-19. Tested positive on July 10. Symptoms fever, cough, brain fog, headache, nausea, vomiting, diarrhea,  fatigue, dizziness, and congestion.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive, Scan with contrast
Clinical narrative: Approximately 2 months after receiving vaccine I developed a breakthrough case of COVID-19. Tested positive on July 10. Symptoms fever, cough, brain fog, headache, nausea, vomiting, diarrhea,  fatigue, dizziness, and congestion.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis, Vaccine breakthrough infection, Vomiting
Clinical narrative: Approximately 2 months after receiving vaccine I developed a breakthrough case of COVID-19. Tested positive on July 10. Symptoms fever, cough, brain fog, headache, nausea, vomiting, diarrhea,  fatigue, dizziness, and congestion.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient COVID vaccinated and got COVID disease.
Age: 1.08
Sex: F
Vaccine: COVID19, UNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received Moderna 6m-5 year vaccine 6 days too soon.
Age: 8.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Administered vaccination (7/27/22) 2 days past expiration date (7/25/22), no adverse events were reported by client.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Breakthrough COVID
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Breakthrough COVID
Age: 7.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: Administered a vaccination (7/27/22) that was 2 days expired (7/25/22), no s/e reported.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Biopsy, Skin exfoliation, Skin lesion, Stomatitis, Wound
Clinical narrative: Began with mouth soars for 8 months than spread to body mass with skin peeling when scratched and then open soars that didn't heal quickly.  As if 6/26 Prednisone 5 mg on 7/27 Doctor adjusted dosage to 10mg
Age: 1.92
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 4 days of fever averaging 100-101° without medication, given Tylenol or Motrin with it just coming right back.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Speech disorder
Clinical narrative: Since vaccination which was April 16th , the patient has had dizziness, gait disturbance and speech disturbance.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Death on 07/14/2022
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Muscle twitching, Paraesthesia, Pyrexia
Clinical narrative: fever started 5 hours after vaccine.  She then had facial tingling and muscle twitch.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: Swollen and sore at injection site, chills, body aches, headache and tired
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Swollen and sore at injection site, chills, body aches, headache and tired
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Severe pain in the left deltoid area that has lasted for months. Was seen by Urgent Care, doctor and Physical Therapy.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered an expired vaccine. There was a different Beyond Use Date and and expiration date which was that of 9/10/22. Instructions were not clear on what date to use therefore , instructed  to go by the expiration date  9/10 instead of Beyond Use Date of 7/13.  Vaccine was administered.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Arthralgia, Erythema, Eye pain, Fatigue
Clinical narrative: Left arm redness and rash, (same as first 2 doses)  Extreme fatigue slept over 13 hours, fever 103.6, severe headache, eye pain, nausea, intense dreams, severe bilateral foot pain , inflammation of hand and feet, joints body aches. Both feet have been sore and inflammed since last dose x 5 months. Arthritis stated bilaterally in both feet  continual extreme daily fatigue and body aches brain fog
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Hypersomnia, Inflammation, Nausea
Clinical narrative: Left arm redness and rash, (same as first 2 doses)  Extreme fatigue slept over 13 hours, fever 103.6, severe headache, eye pain, nausea, intense dreams, severe bilateral foot pain , inflammation of hand and feet, joints body aches. Both feet have been sore and inflammed since last dose x 5 months. Arthritis stated bilaterally in both feet  continual extreme daily fatigue and body aches brain fog
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Osteoarthritis, Pain, Pain in extremity, Pyrexia, Rash
Clinical narrative: Left arm redness and rash, (same as first 2 doses)  Extreme fatigue slept over 13 hours, fever 103.6, severe headache, eye pain, nausea, intense dreams, severe bilateral foot pain , inflammation of hand and feet, joints body aches. Both feet have been sore and inflammed since last dose x 5 months. Arthritis stated bilaterally in both feet  continual extreme daily fatigue and body aches brain fog
Sex: U
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: Moderna Vaccine lot #005C21A was affected due to out of temperature range. No adverse reactions from patients.
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Moderna Vaccine lot #005M21A was affected due to out of temperature range. No adverse reactions from patients.  3 patient's affected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram abdomen, Computerised tomogram thorax abnormal, Fatigue, Hepatic lesion, Liver disorder
Clinical narrative: Lesions on Liver.  Extreme fatigue for 2 weeks after shot going to generalized fatigue.  Liver issues discovered during chest CT jan 22
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Scan with contrast
Clinical narrative: Lesions on Liver.  Extreme fatigue for 2 weeks after shot going to generalized fatigue.  Liver issues discovered during chest CT jan 22
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Moderna Vaccine lot #006C21A was affected due to out of temperature range. No adverse reactions from patients.  94 patient's affected.
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Moderna Vaccine lot #012H21B was affected due to out of temperature range. No adverse reactions from patients.  102 patient's affected.
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Moderna Vaccine lot # 035C21A was affected due to out of temperature range. No adverse reactions from patients.  2 patient's affected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered an expired vaccine. There was a different Beyond Use Date and and expiration date which was that of 9/10/22. Instructions were not clear on what date to use therefore , instructed  to go by the expiration date  9/10 instead of Beyond Use Date of 7/13.  Vaccine was administered.
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Moderna Vaccine lot #037C21A was affected due to out of temperature range. No adverse reactions from patients.  947 patient's affected.
Age: 11.0
Sex: M
Vaccine: COVID19, MMR, COVID19, MMR
Symptoms: Product preparation error
Clinical narrative: On 7/6/22, Pfizer 5-11 orange cap was administered to patient without dilution.  On 7/27/22, this was realized when patient came in for 2nd dose. Pfizer was contacted, no recommendation given for 2nd dose. Patient and parent were notified. Patients Medical Provider notified.
Age: 11.0
Sex: M
Vaccine: COVID19, MMR, COVID19, MMR
Symptoms: Overdose, Product preparation error, Somnolence
Clinical narrative: On 7/6/22, Pfizer 5-11 orange cap was administered to patient without dilution.  On 7/27/22, this was realized when patient came in for 2nd dose. Pfizer was contacted, no recommendation given for 2nd dose. Patient and parent were notified. Patients Medical Provider notified.
Age: 11.0
Sex: M
Vaccine: COVID19, MMR, COVID19, MMR
Symptoms: Unevaluable event
Clinical narrative: On 7/6/22, Pfizer 5-11 orange cap was administered to patient without dilution.  On 7/27/22, this was realized when patient came in for 2nd dose. Pfizer was contacted, no recommendation given for 2nd dose. Patient and parent were notified. Patients Medical Provider notified.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Upon entering information into system It was noted that the patient received her second booster earlier then schedule released by CDC.  Vaccine series is as follows: Pfizer 3/31/21, Pfizer 4/21/21, Pfizer 4/27/22  and Pfizer 7/27/22.   I attempted to contact patient at phone number listed on consent form to advise her of the information  and obtain additional information, but have been unable to speak with her as of yet.
Sex: U
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: Moderna Vaccine lot #060H21A was affected due to out of temperature range. No adverse reactions from patients.  17 patient's affected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Bile duct stone, COVID-19, Cough, Pyrexia
Clinical narrative: Patient seen in the ED on 7/1 for abdominal pain, along with fever and cough. While in the ED, he tested PCR positive for COVID-19. Patient was admitted from 7/1-7/7 for sepsis and choledocholithiasis. This meets criteria for vaccine breakthrough case review.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Sepsis
Clinical narrative: Patient seen in the ED on 7/1 for abdominal pain, along with fever and cough. While in the ED, he tested PCR positive for COVID-19. Patient was admitted from 7/1-7/7 for sepsis and choledocholithiasis. This meets criteria for vaccine breakthrough case review.
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Pfizer vaccine lot #FK9729 was affected due to out of temperature range. No adverse reactions from patients.  3 patient's affected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test
Clinical narrative: I experienced a breakthrough case of COVID-19, fatigue, congestion and fever.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: I experienced a breakthrough case of COVID-19, fatigue, congestion and fever.
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Pfizer Vaccine lot #30135BA was affected due to out of temperature range. No adverse reactions from patients.  132 patient's affected.
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Pfizer Vaccine lot #FC3183 was affected due to out of temperature range. No adverse reactions from patients.  51 patient's affected.
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Pfizer Vaccine lot #FE3594 was affected due to out of temperature range. No adverse reactions from patients.  7 patient's affected.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pt received a vaccine that was past the 30 day use date. No adverse affects noted at time of administration or following administration. No treatment was necessary after administration of vaccine.  Moderna was contacted, case #CEA-2944. Lot analysis completed and they determined that the vaccine maintained the activity necessary to protect againt the SARS-Cov-2 virus.
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Pfizer Vaccine lot #FF8841 was affected due to out of temperature range. No adverse reactions from patients.  194 patient's affected.
Sex: U
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: Pfizer Vaccine lot #FJ1611 was affected due to out of temperature range. No adverse reactions from patients.  43 patient's affected.
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Pfizer Vaccine lot #FJ1620 was affected due to out of temperature range. No adverse reactions from patients.  2 patient's affected.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Death on 07/24/2022
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered an expired vaccine. There was a different BUD and and expiration date which was that of 9/10/22. Instructions were not clear on what date to use therefore , instructed  to go by the expiration date  9/10 instead of BUD of 7/13.  Vaccine was administered by attending RN.
Age: 70.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient is experiencing redness, itching, and heat at injection site . Patient was instructed to use cortizone cream , ice and benadryl . If no relief to go to an urgent/ walk-in clinic for further treatment.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered an expired vaccine. There was a different BUD and and expiration date which was that of 9/10/22. Instructions were not clear on what date to use therefore , instructed  to go by the expiration date  9/10 instead of BUD of 7/13.  Vaccine was administered by attending RN.
Age: 49.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Ageusia, Bell's palsy, Blood test normal, Corneal abrasion, Eye irritation
Clinical narrative: Post injection- severe headache, body aches, and fever.   2 days out from injection, partial loss of tase.  7 days out severe headache.  8 Days out eye irritation and development of Bells Palsy in left side of face which led to severe corneal abrasion..  Treatment with Prednisone and Valacyclovir, for eye... Erythromycin and Moxiflooxin  Bells Palsy is ongoing
Age: 49.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Laboratory test normal, Pain, Pyrexia
Clinical narrative: Post injection- severe headache, body aches, and fever.   2 days out from injection, partial loss of tase.  7 days out severe headache.  8 Days out eye irritation and development of Bells Palsy in left side of face which led to severe corneal abrasion..  Treatment with Prednisone and Valacyclovir, for eye... Erythromycin and Moxiflooxin  Bells Palsy is ongoing
Age: 49.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Ageusia, Bell's palsy, Eye disorder, Eye irritation, Mobility decreased
Clinical narrative: Post injection- severe headache, body aches, and fever.   2 days out from injection, partial loss of tase.  7 days out severe headache.  8 Days out eye irritation and development of Bells Palsy in left side of face which led to severe corneal abrasion..  Treatment with Prednisone and Valacyclovir, for eye... Erythromycin and Moxiflooxin  Bells Palsy is ongoing
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dysphonia, Vaccine positive rechallenge
Clinical narrative: Patient experienced voice hoarseness and slight chest tightness about 15 minutes after receiving vaccination (history of experiencing following previous doses as well that was relieved with prednisone/Benadryl). Patient took a 100mg dose of Benadryl and remained in the pharmacy for a total of 45 minutes after vaccination. Symptoms subsided and patient went home. Followed up with patient 3 days later and stated no adverse reactions occurred.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, COVID-19, Cardiac failure, Condition aggravated, Conjunctivitis
Clinical narrative: recipient of vaccine reports decline in health starting end of January 2022 lasting for eight weeks. Recipient was diagnosed with COVID 19 in January after receiving vaccine in April 2021. recipient reports onset of upper respiratory infections, heart failure, exacerbation of arthritis, diverticulitis, strep related infections, conjunctivitis, hallucinations and nightmares
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Diverticulitis, General physical health deterioration, Hallucination, Nightmare, Pharyngitis streptococcal
Clinical narrative: recipient of vaccine reports decline in health starting end of January 2022 lasting for eight weeks. Recipient was diagnosed with COVID 19 in January after receiving vaccine in April 2021. recipient reports onset of upper respiratory infections, heart failure, exacerbation of arthritis, diverticulitis, strep related infections, conjunctivitis, hallucinations and nightmares
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Upper respiratory tract infection
Clinical narrative: recipient of vaccine reports decline in health starting end of January 2022 lasting for eight weeks. Recipient was diagnosed with COVID 19 in January after receiving vaccine in April 2021. recipient reports onset of upper respiratory infections, heart failure, exacerbation of arthritis, diverticulitis, strep related infections, conjunctivitis, hallucinations and nightmares
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, SARS-CoV-2 test positive
Clinical narrative: I was out of the country and took many different types of public transportation and was exposed to a lot of people in a short amount of time. I had been suffering an intermittent cough for a few months due to a medication I was taking at the time, but I noticed the coughing had increased that week and by the time my plane landed home on Friday evening 07/15/2022, the cough was at its worst. Monday morning, I went to my doctor's office who confirmed that I had COVID-19. He suggested initially that I just "ride it out" unless my symptoms worsened. My symptoms did get worse, so he prescribed LAGEVRIO and a steroid for 5 days. After beginning the medication, my symptoms got worse for another day, but after that they began to improve.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Cardio-respiratory arrest, Death, Heart rate decreased
Clinical narrative: patient was admitted on 7/22/2022 to the LTACH with covid pneumonia on 7/22/2022, tested positive for COVID 19 on 7/19/2022, 7/24/2022 pt was on 4L NC for o2 needs, during toileting patient began to show a decrease in oxygen levels and Heart rate, and became unresponsive. code blue initiated and patient expired.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, SARS-CoV-2 test positive, Unresponsive to stimuli
Clinical narrative: patient was admitted on 7/22/2022 to the LTACH with covid pneumonia on 7/22/2022, tested positive for COVID 19 on 7/19/2022, 7/24/2022 pt was on 4L NC for o2 needs, during toileting patient began to show a decrease in oxygen levels and Heart rate, and became unresponsive. code blue initiated and patient expired.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Electroencephalogram, Epilepsy, Generalised tonic-clonic seizure, Magnetic resonance imaging
Clinical narrative: August 31st had a tonic-clonic seizure at 5:00 am, had another one on November 10th 4:30am. Due to having a second one I was diagnosed with epilepsy
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Ear infection, Influenza virus test negative, Nasopharyngitis, Productive cough, Pyrexia
Clinical narrative: He had exhibiting a runny nose with a wet cough and had a brief fever that was 10 minutes in duration. We did a at home COVID-19 test which was negative and we took him to the night clinic and they administered a flu test COVID-19 test, Strep test and all were negative. He was diagnosed with a common cold along with an ear infection. Treatment that was provided was only amoxicillin antibiotic.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: He had exhibiting a runny nose with a wet cough and had a brief fever that was 10 minutes in duration. We did a at home COVID-19 test which was negative and we took him to the night clinic and they administered a flu test COVID-19 test, Strep test and all were negative. He was diagnosed with a common cold along with an ear infection. Treatment that was provided was only amoxicillin antibiotic.