chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Culture negative, Dyspnoea, Laboratory test abnormal, Leukocytosis
Clinical narrative: Presented to ED with covid like symptoms for the past 8 days including cough, fever, and dyspnea.  Requiring HFNC 60% FIO2, given 1 dose of Decadron, along with 1 L IVF's.  Initial labs significant for leukocytosis, marked elevation of CRP, and procalcitonin.  Concern for bacterial superinfection in the setting of Covid PNA, started on Azithromycin and ceftaz.  Started on dexamethasone.  On 8/19/21 worsening respiratory effort and oxygenation, repeat chest CT demonstrated moderate bilateral pulmonary emboli, and placed on heparin infusion, Vancomycin restarted d/t concern for possible post viral staphylococcal PNA.  Patient requested to be DNR/DNI and transition to comfort measures and transitioned to inpatient hospice.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Procalcitonin increased, Pulmonary embolism, Pyrexia, Renal mass
Clinical narrative: Presented to ED with covid like symptoms for the past 8 days including cough, fever, and dyspnea.  Requiring HFNC 60% FIO2, given 1 dose of Decadron, along with 1 L IVF's.  Initial labs significant for leukocytosis, marked elevation of CRP, and procalcitonin.  Concern for bacterial superinfection in the setting of Covid PNA, started on Azithromycin and ceftaz.  Started on dexamethasone.  On 8/19/21 worsening respiratory effort and oxygenation, repeat chest CT demonstrated moderate bilateral pulmonary emboli, and placed on heparin infusion, Vancomycin restarted d/t concern for possible post viral staphylococcal PNA.  Patient requested to be DNR/DNI and transition to comfort measures and transitioned to inpatient hospice.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Cardiac flutter, Chest discomfort, Fatigue, Palpitations
Clinical narrative: chest pain,  SOB, inability to exercise, exercise intolerance, Pericarditis by echocardiogram blue extremities
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Cyanosis, Dyspnoea, Echocardiogram abnormal, Exercise tolerance decreased
Clinical narrative: chest pain,  SOB, inability to exercise, exercise intolerance, Pericarditis by echocardiogram blue extremities
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pericarditis
Clinical narrative: chest pain,  SOB, inability to exercise, exercise intolerance, Pericarditis by echocardiogram blue extremities
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alopecia areata, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Hi, patient got her 2nd COVID 19 Pfizer vaccine on 05Nov2021. Patient started losing noticeable hair from December but then in January, I noticed  an approximate  3x3 bald spot on her right side on her head. We got an appointment with her pediatrician and she diagnosed it as Alopecia Areata. We had started her on Steroid injection treatments since March 2022 but the bald spot is coming on new sites on her scalp. Patient has lost approximately 30% of her hair. She is continuing to loss her hair. No one in my or my husbands family has history of hair loss or hair thinning.  All her blood work is done & her results are within normal range including hormone levels.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alopecia, Alopecia areata, Blood test normal
Clinical narrative: Hi, patient got her 2nd COVID 19 Pfizer vaccine on 05Nov2021. Patient started losing noticeable hair from December but then in January, I noticed  an approximate  3x3 bald spot on her right side on her head. We got an appointment with her pediatrician and she diagnosed it as Alopecia Areata. We had started her on Steroid injection treatments since March 2022 but the bald spot is coming on new sites on her scalp. Patient has lost approximately 30% of her hair. She is continuing to loss her hair. No one in my or my husbands family has history of hair loss or hair thinning.  All her blood work is done & her results are within normal range including hormone levels.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Chest pain, Exposure to SARS-CoV-2, Nausea, SARS-CoV-2 test positive
Clinical narrative: 04/22/22 presents to EC ED for "shortness of breath, cough, and chest pain". PMHx of "CAD status post stenting, hypertension, and hyperlipidemia"
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: 04/22/22 presents to EC ED for "shortness of breath, cough, and chest pain". PMHx of "CAD status post stenting, hypertension, and hyperlipidemia"
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Chest pain, Cough, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: 04/22/22 presents to EC ED for "shortness of breath, cough, and chest pain". PMHx of "CAD status post stenting, hypertension, and hyperlipidemia"
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC, RV5
Symptoms: Generalised tonic-clonic seizure, Laboratory test normal, Ultrasound head normal
Clinical narrative: Generalized Convulsive Seizure x 45 seconds on 4/21/22 @8pm
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC, RV5
Symptoms: Blood glucose normal, Metabolic function test normal, Seizure, Ultrasound head normal
Clinical narrative: Generalized Convulsive Seizure x 45 seconds on 4/21/22 @8pm
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Blood test, Rhinorrhoea, SARS-CoV-2 test negative, Urine analysis normal
Clinical narrative: Started to lose hair after getting first dose of the vaccine.; Runny nose after getting the first dose of vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Started to lose hair after getting first dose of the vaccine.) and RHINORRHOEA (Runny nose after getting the first dose of vaccine.) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H271A) for COVID-19 vaccination.     The patient's past medical history included Carpal tunnel syndrome in January 2022 and Surgery in January 2022. Concurrent medical conditions included Penicillin allergy (Patient is allergic since she was a kid.), Allergy to NSAIDs (Patient is allergic since she was a kid.) and Heartbeats irregular (Since patient was a kid.). Concomitant products included VITAMIN D NOS for Carpal tunnel syndrome, METOPROLOL for Heartbeats irregular.    On 23-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced ALOPECIA (Started to lose hair after getting first dose of the vaccine.) and RHINORRHOEA (Runny nose after getting the first dose of vaccine.). On 23-Dec-2021, RHINORRHOEA (Runny nose after getting the first dose of vaccine.) had resolved. At the time of the report, ALOPECIA (Started to lose hair after getting first dose of the vaccine.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Blood test: normal (normal) Normal. In January 2022, SARS-CoV-2 test negative: negative (Negative) Negative. In January 2022, Urine analysis normal: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. No vaccine received 1 month prior to Moderna Covid-19 Vaccine. Patient did not experienced similar events in the past. Patient mentioned that they do not have any family history of hair loss.   This case was linked to MOD-2022-553114 (Patient Link).
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: A medical assistant called to determine the valiidity of the dose of PROQUAD given to 14 year old; No additional AE's; This spontaneous report was received from a certified medical assistant and refers to a 14-year-old patient of unknown gender. The patient's medical history, concomitant medications, concurrent conditions and drug reactions/ allergies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (product administered to patient of inappropriate age) (dose, lot number, expiration date, route of administration and injection site were not reported) for prophylaxis. The reporter called to determine the validity of this vaccination. No additional adverse events were reported.  This is one of 2 reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA005604:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Nurse reporting patient was administered VAQTA after labeled expiration date.; This spontaneous report was received from a Licensed Practical Nurse, referring to a patient of unspecified age and gender as reporter refuse to provide information. The patient's concurrent conditions, concomitant medications, pertinent medical history, past drug reactions or allergies were not provided.  On 20-APR-2022, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) 50 units per milliliter (50U/1.0 ML) injection at a dose of 1 milliliter administer once (1 mL/once) (vaccination scheme frequency, route of administration and anatomical site of application were not reported; lot number T040581 that was verified to be a valid lot number for syringe formulation with an expiration date reported and established as 28-MAR-2022) for prophylaxis (expired product administered).  No additional adverse event was reported (no adverse event). No product quality complaints (PQC) reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Product storage error; Administering past the date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administering past the date) and PRODUCT STORAGE ERROR (Product storage error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administering past the date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administering past the date) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. No treatment medication reported by reporter. expiration date was 19-Mar-2022.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Storing Moderna vaccine in their refrigerator and administered vaccine on 18-Jan-2022  past the date 01-Nov-2021; Patient administered vaccine on 18-Jan-2022 past the date 01-Nov-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 18-Jan-2022 past the date 01-Nov-2021) and PRODUCT STORAGE ERROR (Storing Moderna vaccine in their refrigerator and administered vaccine on 18-Jan-2022  past the date 01-Nov-2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 18-Jan-2022 past the date 01-Nov-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Storing Moderna vaccine in their refrigerator and administered vaccine on 18-Jan-2022  past the date 01-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 18-Jan-2022 past the date 01-Nov-2021) and PRODUCT STORAGE ERROR (Storing Moderna vaccine in their refrigerator and administered vaccine on 18-Jan-2022  past the date 01-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information reported. No treatment information reported. reported as 01-Nov-2021.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Refreezed- the vial stored post puncture (ambient room temperature or refrigerator) refrigerator; 3 Moderna COVID-19 Booster Shots were given to patients greater than 12 hours post-puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 Moderna COVID-19 Booster Shots were given to patients greater than 12 hours post-puncture) and PRODUCT STORAGE ERROR (Refreezed- the vial stored post puncture (ambient room temperature or refrigerator) refrigerator) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2022 at 3:30 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2022 at 3:30 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 Moderna COVID-19 Booster Shots were given to patients greater than 12 hours post-puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Refreezed- the vial stored post puncture (ambient room temperature or refrigerator) refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 Moderna COVID-19 Booster Shots were given to patients greater than 12 hours post-puncture) and PRODUCT STORAGE ERROR (Refreezed- the vial stored post puncture (ambient room temperature or refrigerator) refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported Patient received Second Booster dose. Number of doses/vials: 3 booster doses / 1 vial (15.5 ml) Red Cap Date the vial was initially stored in the refrigerator: 22 APRIL 2022 Date and time vial was first punctured: 22 APRIL 2022 at 9:55AM vial was stored in the Refrigerator post puncture. The vial did not undergone any temperature excursions Total amount of time the vial was exposed to room temperature range 8° to 25°C= 46° to 77°F on 22-APR-2022 for 2 hours, 25-APR-2022 for 1 hour and 26-APR-2022 for 1.5 hours at room temperature.  The rest of the time the vial was in the refrigerator No treatment medications were reported   This case was linked to MOD-2022-551983, MOD-2022-551984.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2022: Live Significant follow up-Event added (Product storage error) Dosage information received On 28-Apr-2022: Live follow up - reporter contact number was added.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was stored in refrigerator on 01 Apr 2022 and was expired on 17 Apr 2022 and administered on 20 Apr 2022; Expired vaccine that expired on 17April2022 and they think it was administer to 6 people; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine that expired on 17April2022 and they think it was administer to 6 people) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 01 Apr 2022 and was expired on 17 Apr 2022 and administered on 20 Apr 2022) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine that expired on 17April2022 and they think it was administer to 6 people). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 01 Apr 2022 and was expired on 17 Apr 2022 and administered on 20 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine that expired on 17April2022 and they think it was administer to 6 people) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 01 Apr 2022 and was expired on 17 Apr 2022 and administered on 20 Apr 2022) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided.  Vial did not undergo any temperature excursions.  No treatment medications was not reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna COVID-19 Vaccine that was left at room temperature during 27 hours; Dose administered after exposure to room temperature during 27 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature during 27 hours) and PRODUCT STORAGE ERROR (Moderna COVID-19 Vaccine that was left at room temperature during 27 hours ) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056A22A and 004F21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sulfa drugs), Thyroid disorder (Thyroid issues) and Arthritis. Concomitant products included LEVOTHYROXINE, MELOXICAM and TOPIRAMATE for an unknown indication.   On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature during 27 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna COVID-19 Vaccine that was left at room temperature during 27 hours ). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature during 27 hours) and PRODUCT STORAGE ERROR (Moderna COVID-19 Vaccine that was left at room temperature during 27 hours ) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator was 14-Apr-2022. Maximum or minimum temperatures reached was 73°F Temperature excursion: yes. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 27 hours Caller did not know if patient experienced any Adverse events or if any treatment was given after getting the vaccine.  Treatment medication was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: potentially given a vaccine which expired 3 days before; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (potentially given a vaccine which expired 3 days before) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 007J21) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (potentially given a vaccine which expired 3 days before). At the time of the report, EXPIRED PRODUCT ADMINISTERED (potentially given a vaccine which expired 3 days before) outcome was unknown.            It was reported that Lot number 007J21 - written on the vaccination card. Agent tried to enter lot numbers as 007J21A and 007J21B) but it said the lot number does not exist. Patient enquired what would happen if he was given an expired vaccine and which was expired 3 days before. Patient read some information in the form that he was given by the vaccine provider that said 0.25 ml/0.5 ml VIS 01221 and OXP Apr 19. No concomitant medications information was reported. No treatment medications information was reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Had lip swelling from the Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Had lip swelling from the Moderna Covid-19 vaccine) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIP SWELLING (Had lip swelling from the Moderna Covid-19 vaccine). At the time of the report, LIP SWELLING (Had lip swelling from the Moderna Covid-19 vaccine) outcome was unknown.      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 vaccination.     Patients pre-existing conditions and allergy are unknown.     On 26-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported  No Treatment medication was reported. HCP reports on Apr-26-2022 3 patients received expired vaccine. Administrations included 2 second booster and 1 first booster of Moderna covid-19 vaccine.HCP reports no side effects regarding the individuals. patients pre-existing conditions and allergy are unknown. Patient administer 1st booster dose.   This case was linked to MOD-2022-553198 (Patient Link).
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 04-Apr-2022; Expired vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 04-Apr-2022) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 04-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 04-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the refrigerator on 04-Apr-2022. The vial did not undergo any temperature excursions. It was reported that pharmacist thought that the vaccine expired in Jun-2022, however it was expired in 01-Apr-2022. No temperature excursions.  No treatment information was reported.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired vaccine administered to patient; date of expiry 01APR2022, Store in refrigeration on 4APR2022, Date of administration 5Apr2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) and PRODUCT STORAGE ERROR (date of expiry 01APR2022, Store in refrigeration on 4APR2022, Date of administration 5Apr2022) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Apr-2022, the patient experienced PRODUCT STORAGE ERROR (date of expiry 01APR2022, Store in refrigeration on 4APR2022, Date of administration 5Apr2022). On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) and PRODUCT STORAGE ERROR (date of expiry 01APR2022, Store in refrigeration on 4APR2022, Date of administration 5Apr2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The Pharmacist was calling to verify an expiration date for lot number 026L21B. The pharmacist said that when his Pharmacy received this vaccine on 23FEB2022 that a Pharmacy staff member looked up the expiration date and came up with an expiration date of June 2022. However another Pharmacy Staff member looked up the expiration date of the Moderna Covid-19 vaccine in question and the expiration date is 01APR2022. Number of doses/vials: 80 doses administered. The vial did not undergo any temperature excursions. Caller mentioned 155 patients where vaccinated with expired doses from 2Apr2022 to 19Apr2022. The Pharmacist did not have any other information on the patients at this time.  Treatment medications were not reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: patients were vaccinated with expired vaccine doses; vaccine expired on 01-Apr-2022 and it was initially stored in the refrigerator 04-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients were vaccinated with expired vaccine doses) and PRODUCT STORAGE ERROR (vaccine expired on 01-Apr-2022 and it was initially stored in the refrigerator 04-Apr-2022) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients were vaccinated with expired vaccine doses) and PRODUCT STORAGE ERROR (vaccine expired on 01-Apr-2022 and it was initially stored in the refrigerator 04-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients were vaccinated with expired vaccine doses) and PRODUCT STORAGE ERROR (vaccine expired on 01-Apr-2022 and it was initially stored in the refrigerator 04-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported that the pharmacist thought that the expiry date of the vaccine was JUNE 2022, However the vaccine expired on 01-Apr-2022.  It was confirmed that the vial didn't undergo temperature excursion issue.  Vaccine was placed in refrigerator on 4-Apr-2022.  No treatment medication were reported.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired vaccine administered to patient; Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 04-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 04-Apr-2022) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 04-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 04-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications information was reported.  The vial did not undergo any temperature excursion.  The vial was initially stored in the refrigerator on 04-Apr-22.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered to 155 patients; WARNING: THE STUDY CONFIGURATION IS MISSING THE STUDY PHASE. PLEASE UPDATE THE STUDY PHASE AND RE-GENERATE THE NARRATIVE AGAIN.    This     The subject received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B). The report describes a case of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients).     No Medical History information was reported.  On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter.  No treatment medication reported by reporter.   This case was linked to MOD-2022-551714.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered to 155 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment medication information provided. On 04-Apr-2022 vial was initially stored in the refrigerator.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 04-Apr-2022; patients where vaccinated with expired doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients where vaccinated with expired doses) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 04-Apr-2022) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients where vaccinated with expired doses). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 04-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients where vaccinated with expired doses) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 04-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported. It was reported that the pharmacist thought that the expiry date of the vaccine was JUNE 2022, however the vaccine expired on 01-Apr-2022. It was confirmed that the vial didn't undergo temperature excursion issue. Vaccine was stored in the refrigerator on 4-Apr-2022. No treatment drug information was provided.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Infection, Laboratory test abnormal, Peripheral swelling, Pruritus
Clinical narrative: Unable to read lot and exp number on card. Symptoms started 2 weeks later. Woke up early morning to my legs and head being itchy.  Not sure if I was scratching but my feet and hands were swollen. Took Benadryl and eventually fell back asleep. Next morning hives kept closing and going all over my body. I had welts and was itchy. Went to urgent care that evening and when I went it felt like it was my head. My throat was scratchy my ears were swollen. They gave me a steroid injection and medrol dose pack and said to continue taking benadryl
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Urticaria
Clinical narrative: Unable to read lot and exp number on card. Symptoms started 2 weeks later. Woke up early morning to my legs and head being itchy.  Not sure if I was scratching but my feet and hands were swollen. Took Benadryl and eventually fell back asleep. Next morning hives kept closing and going all over my body. I had welts and was itchy. Went to urgent care that evening and when I went it felt like it was my head. My throat was scratchy my ears were swollen. They gave me a steroid injection and medrol dose pack and said to continue taking benadryl
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Infertility female, Infertility tests
Clinical narrative: Infertility
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Pruritus, Rash erythematous, Rash papular, Scratch
Clinical narrative: Since 11 December he has complained of recurrent episodes of generalized itching and rashes described as raised, red, itchy whelts which can occur anywhere on his body, especially at sites of pressure or where his skin is scraped or scratched. Lesions last less than 24 hours, affected his palms and soles, and resolve without post-inflammatory changes. Symptoms led him to present to the ER on 12 December where he was treated with oral corticosteroids without clear benefit. He reports having some intermittent laryngeal swelling which he localizes to the base of his neck and causes him to have difficulty taking a breath and inspiratory wheezing; he reports using Albuterol with benefit 3-4 times per week. Symptoms occur at rest; he denies nocturnal and exercise symptoms. No activity limitations. He denies cough and chest tightness. He denies dysphagia, GI, neurologic, and cardiovascular symptoms with these episodes. Episodes not associated with heat, exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, known infections, or insect bites/stings. He received his Moderna COVID-19 vaccine booster dose on 3 December, 8 days prior to onset of symptoms. He has used oral antihistamines with benefit. He denies constitutional symptoms. UCT score today is 8 (0, 2, 1, 1, 2, 1, 1, 0). No history of adverse reactions to prior vaccines.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Urticaria, Wheezing
Clinical narrative: Since 11 December he has complained of recurrent episodes of generalized itching and rashes described as raised, red, itchy whelts which can occur anywhere on his body, especially at sites of pressure or where his skin is scraped or scratched. Lesions last less than 24 hours, affected his palms and soles, and resolve without post-inflammatory changes. Symptoms led him to present to the ER on 12 December where he was treated with oral corticosteroids without clear benefit. He reports having some intermittent laryngeal swelling which he localizes to the base of his neck and causes him to have difficulty taking a breath and inspiratory wheezing; he reports using Albuterol with benefit 3-4 times per week. Symptoms occur at rest; he denies nocturnal and exercise symptoms. No activity limitations. He denies cough and chest tightness. He denies dysphagia, GI, neurologic, and cardiovascular symptoms with these episodes. Episodes not associated with heat, exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, known infections, or insect bites/stings. He received his Moderna COVID-19 vaccine booster dose on 3 December, 8 days prior to onset of symptoms. He has used oral antihistamines with benefit. He denies constitutional symptoms. UCT score today is 8 (0, 2, 1, 1, 2, 1, 1, 0). No history of adverse reactions to prior vaccines.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: subsequent cva
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient administered booster dose of the Moderna vaccination after the expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient administered booster dose of the Moderna vaccination after the expiration date) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022J21A, 077C21B, 001C21A and 003B21A) for COVID-19 vaccination.     The patient had not tested/diagnosed with COVID-19. The patient had no acute illnesses at the time of vaccination and up to one month before. The patient had no chronic or long-standing health conditions and it was unknown if the patient had prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination. The details of allergies to medications, food, and other products were not reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 25-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 25-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient administered booster dose of the Moderna vaccination after the expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient administered booster dose of the Moderna vaccination after the expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient had no adverse reaction  after receiving the vaccine and after 15 minutes of standard post-vaccination observation.  The vial was initially stored in refrigerator on 18-Apr-2022. The vial did not undergo any temperature excursion. Number was doses/vials was 2. The frequency was reported as times per.  No treatment medications were reported.   This case was linked to MOD-2022-553183 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2022: Follow-up document received includes significant information; patient's demographics, medical history, dose details of suspect vaccine was added and I-narrative was updated.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: contracted COVID-19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (contracted COVID-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (contracted COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (contracted COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Patient contracted COVID-19.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   They are now eligible for a second booster dose per the prescribing criteria.  Company Comment: This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who experienced the unexpected non-serious AESI of COVID-19 (contracted COVID-19) which occurred unknown number of days after receiving the booster dose of mRNA-1273 Vaccine. The patient was also given the first two doses of mRNA-1273, dates of administration not provided. He qualified for and took Paxlovid. There was also no information regarding clinical course. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who experienced the unexpected non-serious AESI of COVID-19 (contracted COVID-19) which occurred unknown number of days after receiving the booster dose of mRNA-1273 Vaccine. The patient was also given the first two doses of mRNA-1273, dates of administration not provided. He qualified for and took Paxlovid under the EUA. There was also no information regarding clinical course. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Nauseated; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nauseated) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2022, the patient experienced NAUSEA (Nauseated) and HEADACHE (Headache). At the time of the report, NAUSEA (Nauseated) and HEADACHE (Headache) had not resolved.            No concomitant medications was reported. Patient received booster dose on 25-Apr-2022. Patient had mammogram scheduled on 26 Apr 2022 at a hospital. No treatment information was reported.   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Burning sensation, Muscular weakness
Clinical narrative: patient felt a very bad burning on her whole left side,patient felt a very bad burning from her back to the ankle; weakness on the left leg; Patient felt weak on her left side; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Patient felt weak on her left side), BURNING SENSATION (patient felt a very bad burning on her whole left side,patient felt a very bad burning from her back to the ankle) and MUSCULAR WEAKNESS (weakness on the left leg) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A, 030M20A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to chemicals, Diabetes (No recent change in status such as improvement or worsening.) since 1993 and Kidney disorder (No recent change in status such as improvement or worsening.). Concomitant products included DULAGLUTIDE (TRULICITY), INSULIN DETEMIR (LEVEMIR), GLIPIZIDE, METOPROLOL, LOSARTAN, FAMOTIDINE, ASPIRIN [ACETYLSALICYLIC ACID] and ROSUVASTATIN for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ASTHENIA (Patient felt weak on her left side). On 30-Sep-2021, the patient experienced BURNING SENSATION (patient felt a very bad burning on her whole left side,patient felt a very bad burning from her back to the ankle) and MUSCULAR WEAKNESS (weakness on the left leg). The patient was treated with GABAPENTIN for Adverse event, at a dose of 100mg 3 a day. On 30-Sep-2021, ASTHENIA (Patient felt weak on her left side) had resolved. At the time of the report, BURNING SENSATION (patient felt a very bad burning on her whole left side,patient felt a very bad burning from her back to the ankle) and MUSCULAR WEAKNESS (weakness on the left leg) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient height was reported as 5'2. Patient did not ever had COVID positive test or diagnosis. The patient did not have any other vaccines within 1 month prior to Moderna COVID-19 vaccine. It was also reported that patient did not experience a similar event in the past. The patient seeks the medical care and visits the physician office. Further it was reported that the symptoms were worsened.   This case was linked to MOD-2022-552512, MOD-2022-552517 (Patient Link).