chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Dry skin, Erythema, Inflammation, Oral mucosal blistering
Clinical narrative: Patient started to have a rash develop on her face after 4 days of receiving the vaccine. This rash is very similar to shingles and has occurred for a month with Valtrex treatment. Patient states face is extremely taut, dry, and has red/inflammed pustules/blisters. Upon presentation, patients has extremely dry face and visible redness from previous blisters.  At one point, patient stated blisters developed within her mouth and on the tongue. Patient has tried multiple products over-the-counter products to cure the dryness. Valtrex 1g three times a day was prescribed and patient finished a full month of this prescription without full resolution. Patient was also given prednisone for 1 week. This medication cured the rash, however promptly represented after completion. Patient is continuing treatment, but is unable to get help from a dermatologist due to limited appointments available. Patient has been to an urgent care, hospital, and regular PCP without resolution of issue.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Pustule, Rash, Tongue blistering
Clinical narrative: Patient started to have a rash develop on her face after 4 days of receiving the vaccine. This rash is very similar to shingles and has occurred for a month with Valtrex treatment. Patient states face is extremely taut, dry, and has red/inflammed pustules/blisters. Upon presentation, patients has extremely dry face and visible redness from previous blisters.  At one point, patient stated blisters developed within her mouth and on the tongue. Patient has tried multiple products over-the-counter products to cure the dryness. Valtrex 1g three times a day was prescribed and patient finished a full month of this prescription without full resolution. Patient was also given prednisone for 1 week. This medication cured the rash, however promptly represented after completion. Patient is continuing treatment, but is unable to get help from a dermatologist due to limited appointments available. Patient has been to an urgent care, hospital, and regular PCP without resolution of issue.
Age: 3.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: There is a possibility patient may have received 0.25 ml of vaccine rather than the recommended 0.2 ml of the Moderna Bivalent presentation for 6 months to 5 years. A staff member was not aware of the correct dosing of the bivalent vaccine. The system in place for drawing up vaccine and administering vaccine may have allowed for staff member to have drawn up 0.25 ml and another staff member to give the vaccine. It cannot be determined fi the correct or incorrect amount was drawn up or given. There has been no reported adverse reaction from the parents to date.
Age: 10.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: Patient was given undiluted Pfizer Omicron Bivalent 5yrs-11yrs vaccine resulting in a higher dose. Patient's parent has been notified of the vaccine administration error.  Mom states patient did not have any adverse reactions.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: redness, swelling, itching
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No adverse event, wrong  dose given . Was given Moderna Bi-Valent .25
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: Patient was given undiluted Pfizer Omicron Bivalent 5yrs-11yrs vaccine resulting in a higher dose. Patient's parent has been notified of the vaccine administration error.  Mom states patient did not have any adverse reactions.
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: This patient received the monovalent Pfizer COVID-19 (6 months-4 years) vaccine for doses 1 and 2 on 8/7/22 and 11/30/22 when he was 4 years old. He was scheduled for dose 3 at the injection center on 1/25/23 and was 5 year old at the time.  CDC recommends that patients who turn 4 years to 5 years and start the primary series with Pfizer?s 6 months-4 years formulation should complete it with the 6 month-4 years formulation even though they turn 5 years old.  Based on this, the patient should receive the bivalent Pfizer COVID-19 (6 months-4 years) vaccine as the 3rd dose to complete the primary series, however the patient was incidentally given the 5-11 year formulation.   Patient's parent and provider was informed of the error.  No adverse event reported yet by patient's parent following vaccination.
Age: 26.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received Moderna Bivalent instead of Primary dose. Per CDC Patient needs to be communicated no harm done but patient will need to return to receive a Pfizer full primary dose to have it count for primary. Intervals for second dose will change to scheduling 8 weeks after invalid dose.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Acne, Pruritus, Rash
Clinical narrative: Pt presents today at Minuteclinic stated that he got a small pimple on his right hand 2 days after the second shot pfizer monovalent. He received the vaccine at Pharmacy.  The pimple was very itchy at that time, and then started to become rash on right hand. The rash is getting progressively worse, which covers his back, chest and most all extremities. He denies having this rash before and claims to be healthy otherwise. He took OTC cream and benadryl for the past 2 weeks but with minimal relief. Denies SOB, fever, or angioedema.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: pt received moderna bivalent booster instead of moderna first dose, no adverse events, pt went to another pharmacy for 2nd dose and cdc was called and pharmacy was told the bivalent can count as primary dose, pt recieved second dose 1/27/23, no adverse events noted
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram cerebral normal, Arteriogram carotid normal, Blood test normal, Cardiac imaging procedure normal, Cardiac stress test normal
Clinical narrative: Cryptogenic - Acute Ischemic Stroke 15 days after booster.  Have had every scan/test under the sun, and docs can't find anything wrong with me.   Brain, heart, and full body MRI's, blood work, stress tests.....
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram abdomen normal, Computerised tomogram thorax normal, Factor VIII activity normal, Gene mutation identification test negative, Ischaemic stroke
Clinical narrative: Cryptogenic - Acute Ischemic Stroke 15 days after booster.  Have had every scan/test under the sun, and docs can't find anything wrong with me.   Brain, heart, and full body MRI's, blood work, stress tests.....
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test normal, Magnetic resonance imaging head normal, Magnetic resonance imaging whole body, Scan with contrast normal, Ultrasound Doppler
Clinical narrative: Cryptogenic - Acute Ischemic Stroke 15 days after booster.  Have had every scan/test under the sun, and docs can't find anything wrong with me.   Brain, heart, and full body MRI's, blood work, stress tests.....
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pt scheduled for Pfizer (12+) bivalent covid vaccine, but received Pfizer (12+) monovalent covid vaccine. Pt left clinic in stable condition, no distress noted. Called and informed pt about the error and advised to wait at least 2 months before receiving Pfizer bivalent vaccine.  Pt verbalized understanding. Pt states she will speak with her PCP.
Age: 69.0
Sex: F
Vaccine: HEPAB, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: same day had some itching, two days later injection site red, hot and swollen
Age: 9.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient registered for Booster dose and has not yet completed the primary series
Age: 12.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: A dose of the bivalent booster was administered without the patient completing the primary series.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Client received Moderna Bivalent 0.5 mL IM route, today 01/31/2023 at 1100. Client was already given the Moderna Bivalent booster on 10/07/2022.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Pelvic pain, Postmenopausal haemorrhage
Clinical narrative: I got vaccined  for the first time on January the 12th of 2023 at supermarket Pharmacy.  On January the 30th of 2023  (18 days later) I started bleeding (as a regular period).  However, I had early menopause when I was 42 years old, so I?m not having my period for 5 YEARS ( I?m 47 years old now).  Today January 31st of 2023, I still bleeding, felling cramps and pelvic pain.   Ps.: I got Covid -Omicron on December 2022 , with almost no  symptoms, I recovered pretty well and NO SIDE EFFECTS at all !!
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Cardiac arrest, Central venous catheterisation, Chest X-ray
Clinical narrative: Patient became ill, chest tight, harder to breathe. Tested + for COVID 1/19/21. Had Regeneron on Fri. Started running 104-105 fevers several hours later. Entered ER Wed night was held in ER. IV infusions of antibiotic started & we were informed his kidneys were shutting down & he had the COVID  white lung. Patient went to the floor in am. After no food for 8 hrs on floor, no meds for 10hr or so he was now in a bad way.  Started high flow oxygen that evening.At some point they intubated him without notifying me. On Fri I believe care startled him & he was losing me ration. Staff sedated him & didn?t even begin to discuss tube feedings until sun after I refused a pic line when he had a central line. Patient had CPR performed on him but heart never responded.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Endotracheal intubation, Immunisation reaction, Malaise
Clinical narrative: Patient became ill, chest tight, harder to breathe. Tested + for COVID 1/19/21. Had Regeneron on Fri. Started running 104-105 fevers several hours later. Entered ER Wed night was held in ER. IV infusions of antibiotic started & we were informed his kidneys were shutting down & he had the COVID  white lung. Patient went to the floor in am. After no food for 8 hrs on floor, no meds for 10hr or so he was now in a bad way.  Started high flow oxygen that evening.At some point they intubated him without notifying me. On Fri I believe care startled him & he was losing me ration. Staff sedated him & didn?t even begin to discuss tube feedings until sun after I refused a pic line when he had a central line. Patient had CPR performed on him but heart never responded.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Renal impairment, Resuscitation, SARS-CoV-2 test positive, Urine analysis
Clinical narrative: Patient became ill, chest tight, harder to breathe. Tested + for COVID 1/19/21. Had Regeneron on Fri. Started running 104-105 fevers several hours later. Entered ER Wed night was held in ER. IV infusions of antibiotic started & we were informed his kidneys were shutting down & he had the COVID  white lung. Patient went to the floor in am. After no food for 8 hrs on floor, no meds for 10hr or so he was now in a bad way.  Started high flow oxygen that evening.At some point they intubated him without notifying me. On Fri I believe care startled him & he was losing me ration. Staff sedated him & didn?t even begin to discuss tube feedings until sun after I refused a pic line when he had a central line. Patient had CPR performed on him but heart never responded.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: The patient had already received an influenza vaccine on 1/10/2023.  Duplicate vaccine within the same season.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypoaesthesia, Incorrect route of product administration, Mobility decreased, Pain in extremity
Clinical narrative: Vaccine appeared to be given slightly lower than deltoid muscle on arm. The injection itself did not cause pain but about 24 hours after receiving the vaccination patient reported that her hand became painful and numb. Patient reported she lost control of her hand for about a day or two. After a few days the pain subsided, and she regained control of her hand.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Urticaria
Clinical narrative: INJECTED 1-23-23; PT SAID FULL BODY HIVES STARTED 1-26-23, BY 1-29-23, PT STATED THAT SHINGLES BLISTERS BEGAN TO APPEAR UNDER THE PRIVATE MALE AREA
Age: 75.0
Sex: F
Vaccine: COVID19-2, VARZOS
Symptoms: Death, Hypoxia
Clinical narrative: Resident became hypoxic and possibly aspiration transported to the ER. Resident passed away on the 1/16/2023
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest discomfort, Dizziness, Intensive care, Ischaemic stroke, Laboratory test abnormal
Clinical narrative: I flew on 9/23/22 and was shopping with my son on 9/25 when I felt light headed.  Upon sitting down I began to feel tightness in my left chest and down my arm. I thought I was having a heart attack.  My son drove me to emergency room which was about 10 minutes away.  They admitted me immediately  after some tests told me I had a mild ischemic stroke.  I was given the stroke medication and went to ICU for 24 hr. monitoring.  I then was transported to Hospital for further tests and monitoring.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Limb discomfort
Clinical narrative: I flew on 9/23/22 and was shopping with my son on 9/25 when I felt light headed.  Upon sitting down I began to feel tightness in my left chest and down my arm. I thought I was having a heart attack.  My son drove me to emergency room which was about 10 minutes away.  They admitted me immediately  after some tests told me I had a mild ischemic stroke.  I was given the stroke medication and went to ICU for 24 hr. monitoring.  I then was transported to Hospital for further tests and monitoring.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient came in for the second dose of the primary series pfizer covid vaccine on 01-30-23.  it was noted after administration that the vaccine had the 10 week expiration date of 01-26-23.  patient did not experience any side effects at the time of the event or on 01-31-23 when the patient was contacted regarding the situation.
Age: 95.0
Sex: F
Vaccine: VARZOS
Symptoms: Electrocardiogram, Hypotension, Unresponsive to stimuli
Clinical narrative: PATIENT APPEARED TO BE UNRESPONSIVE ABOUT 5 MIN AFTER SHINGRIX VACCINE. LOWERED PATIENT TO THE FLOOR, THEN SHE STARTED TO BE RESPONSIVE, TOOK BLOOD PRESSURE WHICH WAS LOW 58/32 HR 65 AND SHORTLY THERE AFTER PARAMEDICS ARRIVED. PLACED PATENT BACK IN CHAIR AND THEY OBTAINED A 12 LEAD EKG AND LEFT WITH THE PATIENT
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram normal, Diplegia, Electrocardiogram normal, Electromyogram normal, Generalised tonic-clonic seizure
Clinical narrative: First Paralysis legs 09/15/22, 12 hrs, function returned to legs Grand mal seizure 1 hr at home, grand mal seizure in ambulance 10/31/22 Second Paralysis legs, 12 hrs in hospital, kept in hospital for test
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test normal, Magnetic resonance imaging normal, Neurological examination
Clinical narrative: First Paralysis legs 09/15/22, 12 hrs, function returned to legs Grand mal seizure 1 hr at home, grand mal seizure in ambulance 10/31/22 Second Paralysis legs, 12 hrs in hospital, kept in hospital for test
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Malaise
Clinical narrative: I got the vaccine and then less than a week later I started having symptoms. Then today I found out I had covid. So the vaccine actually gave me covid.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Dysphagia, Dyspnoea, Laboratory test, Pharyngeal swelling
Clinical narrative: Throat swollen, difficulty speaking, swallowing and breathing Still continues to have swollen throat, difficulty speaking. Skin broken out on legs and feet. Has been prescribed several medications.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Speech disorder
Clinical narrative: Throat swollen, difficulty speaking, swallowing and breathing Still continues to have swollen throat, difficulty speaking. Skin broken out on legs and feet. Has been prescribed several medications.
Age: 66.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Patient has been under the services of hospice care since4-7-22. He tested positive COVID positive on 1-23-23 and expired in house 1-30-23
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site nodule, Injection site pain, Injection site pruritus
Clinical narrative: I received the injection Friday morning. A firm painful nodule occurred at the injection site by Saturday morning but it was not too bad and is resolving. Itching at the injection site occurred Saturday evening but not too bad (tolerable) and is not yet resolving.
Age: 1.5
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered
Clinical narrative: Nursing manager was informed of incident. She in turn contacted Patients mother and explained to parent and reassured her of no harm to extra dose. Patient will need to return for Pentacel (18 month immunization
Age: 54.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine used; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 54-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 052D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Nov-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 25-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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 EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant and treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live Significant follow up received: Patient information and vaccination details updated. On 24-Jan-2023: Live Non-significant follow up: Vaccine details updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master Case
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse event; A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No Adverse event) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022).    No concomitant product reported by reporter. Pharmacy staff reported that they inadvertently administered 51 doses of the monovalent vaccines. Lot number 004M21A, expiration date 13Jul2022 Date(s) of administration of vaccine were 26Jul2022 (40 doses), 04Aug2022 (1 dose), 19Aug2022 (1 dose), 30Sep2022 (1 dose). No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:Master case
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022) and NO ADVERSE EVENT (No adverse event) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 069H21A, 048C21A and 021C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022).    No concomitant product reported by reporter. Pharmacy staff reported that they inadvertently administered 51 doses of the monovalent vaccines. Lot number 004M21A, expiration date 13Jul2022 Date(s) of administration of vaccine were 26Jul2022 (40 doses), 04Aug2022 (1 dose), 19Aug2022 (1 dose), 30Sep2022 (1 dose). No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:Master Case
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse event; Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No Adverse event) in a 98-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 014F21A, 030L20A and 025L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant product reported by reporter. Pharmacy staff reported that they inadvertently administered 51 doses of the monovalent vaccines. Lot number 004M21A, expiration date 13Jul2022 Date(s) of administration of vaccine were 26Jul2022 (40 doses), 04Aug2022 (1 dose), 19Aug2022 (1 dose), 30Sep2022 (1 dose). No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:Master case
Age: 101.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No adverse event) in a 101-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 014F21A, 030L20A and 025L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022).    No concomitant product reported by reporter. Pharmacy staff reported that they inadvertently administered 51 doses of the monovalent vaccines. Lot number 004M21A, expiration date 13Jul2022 Date(s) of administration of vaccine were 26Jul2022 (40 doses), 04Aug2022 (1 dose), 19Aug2022 (1 dose), 30Sep2022 (1 dose). No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:Master Case
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022) and NO ADVERSE EVENT (No adverse event) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 069H21A, 030L20A and 025L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022).    No concomitant product reported by reporter. Pharmacy staff reported that they inadvertently administered 51 doses of the monovalent vaccines. Lot number 004M21A, expiration date 13Jul2022 Date(s) of administration of vaccine were 26Jul2022 (40 doses), 04Aug2022 (1 dose), 19Aug2022 (1 dose), 30Sep2022 (1 dose). No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:Master Case
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse event; A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No Adverse event) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 014F21A, 030L20A and 025L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022).    No concomitant product reported by reporter. Pharmacy staff reported that they inadvertently administered 51 doses of the monovalent vaccines. Lot number 004M21A, expiration date 13Jul2022 Date(s) of administration of vaccine were 26Jul2022 (40 doses), 04Aug2022 (1 dose), 19Aug2022 (1 dose), 30Sep2022 (1 dose). No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:Master case
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022) and NO ADVERSE EVENT (No adverse event) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, FF8839 and EW0186) for COVID-19 prophylaxis.     No Medical History information was reported.   On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022).    No concomitant product reported by reporter. Pharmacy staff reported that they inadvertently administered 51 doses of the monovalent vaccines. Lot number 004M21A, expiration date 13Jul2022 Date(s) of administration of vaccine were 26Jul2022 (40 doses), 04Aug2022 (1 dose), 19Aug2022 (1 dose), 30Sep2022 (1 dose). No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260, US-MODERNATX, INC.-MOD-2023-704260 ( Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:(Master case) US-MODERNATX, INC.-MOD-2023-704260:
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No adverse event) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 027A21A, 027B21A and 014F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022).    No concomitant medication was provided by reporter. A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines. They want to know what their next step would be for these patients.  No treatment medication was provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:(Master case)
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No adverse event) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 016M20A, 027A21A and 037C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022).    No concomitant medication was provided by reporter. A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines. They want to know what their next step would be for these patients. Lot number 004M21A, expiration date 13Jul2022 Date(s) of administration of vaccine were - 26Jul2022 (40 doses), 04Aug2022 (1 dose), 19Aug2022 (1 dose), 30Sep2022 (1 dose).  No treatment medication was provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260, US-MODERNATX, INC.-MOD-2023-704260 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:MAster case US-MODERNATX, INC.-MOD-2023-704260:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse event; Reported that they inadvertently administered 51 doses of the monovalent vaccines expiration date 13Jul2022 Date(s) of administration of vaccine were 26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Reported that they inadvertently administered 51 doses of the monovalent vaccines expiration date 13Jul2022 Date(s) of administration of vaccine were 26Jul2022) and NO ADVERSE EVENT (No Adverse event) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 025L20A, 030L20A and 014F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Reported that they inadvertently administered 51 doses of the monovalent vaccines expiration date 13Jul2022 Date(s) of administration of vaccine were 26Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Reported that they inadvertently administered 51 doses of the monovalent vaccines expiration date 13Jul2022 Date(s) of administration of vaccine were 26Jul2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Reported that they inadvertently administered 51 doses of the monovalent vaccines expiration date 13Jul2022 Date(s) of administration of vaccine were 26Jul2022).    No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:Master case