chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Date the vial was initially stored was on 31 Jan 2022 and patient administered vaccine on 31 Mar 2022; Patient administered vaccine on 31 Mar 2022 and thaw expiration date was on 02 Mar 2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 31 Mar 2022 and thaw expiration date was on 02 Mar 2022) and PRODUCT STORAGE ERROR (Date the vial was initially stored was on 31 Jan 2022 and patient administered vaccine on 31 Mar 2022) in a 37-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022 at 10:18 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Mar-2022 at 10:18 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 31 Mar 2022 and thaw expiration date was on 02 Mar 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored was on 31 Jan 2022 and patient administered vaccine on 31 Mar 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 31 Mar 2022 and thaw expiration date was on 02 Mar 2022) and PRODUCT STORAGE ERROR (Date the vial was initially stored was on 31 Jan 2022 and patient administered vaccine on 31 Mar 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 patient received doses after the beyond use date.Date vials were  initially stored in refrigerator was reported as  31 Jan 2022.  It was reported that the thaw expiration date was on 02 Mar 2022, and the total doses given were 20 doses of 15 vials used.  It was reported that the vials had not undergone any temperature excursion.  No treatment medication were reported.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Skin discolouration
Clinical narrative: He started to notice his dark blue skin marks or discoloration at the four places in his body under his armpits, hip joints area, groin; He only noticed about it when those places started to get itchy; This spontaneous case was reported by a patient and describes the occurrence of SKIN DISCOLOURATION (He started to notice his dark blue skin marks or discoloration at the four places in his body under his armpits, hip joints area, groin) and PRURITUS (He only noticed about it when those places started to get itchy) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 001B21A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN DISCOLOURATION (He started to notice his dark blue skin marks or discoloration at the four places in his body under his armpits, hip joints area, groin) and PRURITUS (He only noticed about it when those places started to get itchy). The patient was treated with TRIAMCINOLONE at a dose of 0.025 and TACROLIMUS at a dose of 0.1%. At the time of the report, SKIN DISCOLOURATION (He started to notice his dark blue skin marks or discoloration at the four places in his body under his armpits, hip joints area, groin) and PRURITUS (He only noticed about it when those places started to get itchy) had not resolved.            No concomitant product use was provided.  First dose was taken on 8 or 21-Feb-2021.  Two and half to three weeks after receiving the booster shot, the patient started to notice his dark blue skin marks or discoloration at the four places in his body under his armpits, hip joints area, groin. He only noticed about it when those places started to get itchy.  Patient seek for medical help from his internists, and two dermatologists.  Patient was prescribed and using 0.025 Triamcinolone ointment and cream and shifted to 0.1% Tacrolimus.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Receiving doses after the beyond use date/ Thaw expiration date was 3/2/2022, date administered was on 10-May-2022 11:43 AM; Receiving doses after the beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Receiving doses after the beyond use date) and PRODUCT STORAGE ERROR (Receiving doses after the beyond use date/ Thaw expiration date was 3/2/2022, date administered was on 10-May-2022 11:43 AM) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-2022 at 11:43 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 10-May-2022 at 11:43 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Receiving doses after the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Receiving doses after the beyond use date/ Thaw expiration date was 3/2/2022, date administered was on 10-May-2022 11:43 AM). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Receiving doses after the beyond use date) and PRODUCT STORAGE ERROR (Receiving doses after the beyond use date/ Thaw expiration date was 3/2/2022, date administered was on 10-May-2022 11:43 AM) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the HCP administered the vaccine after the beyond use date, as the HCP didn't know that the vials shouldn't be used past 30 days from thawing the vials. Vials were initially stored on 31-Jan-2022. Thaw expiration date was 02-Mar-2022. The vial did not undergo any temperature excursion.  No treatment medications were reported..
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial initially stored on 31-JAN-2022 and then administered on 12-May-2022; receiving doses after the beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving doses after the beyond use date) and PRODUCT STORAGE ERROR (Vial initially stored on 31-JAN-2022 and then administered on 12-May-2022) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-May-2022 at 12:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving doses after the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored on 31-JAN-2022 and then administered on 12-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving doses after the beyond use date) and PRODUCT STORAGE ERROR (Vial initially stored on 31-JAN-2022 and then administered on 12-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant were reported. The vials initially stored on 31-Jan-2022. Thaw expiration date was 02-Mar-2022. It was reported that 15 vials were used. No treatment were reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for an unknown indication.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 20-May-2022 to 25-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative- for 2 days. and positive (Positive) Positive.         It was reported that the patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Paxlovid relapse. Tested negative for 2 days, then started having symptoms again and tested positive again.  On 29-May-2022, the patient had COVID- 19 relapse after Paxlovid treatment. Device Date was reported as 01-Jun-2022.  Company comment: This spontaneous case concerns a patient (age and gender unspecified) with no medical history reported, who experienced the unexpected non-serious AESI of Covid-19, on an unspecified date after receiving mRNA-1273 vaccine as 3rd dose. The patient had received a course of Paxlovid (Nirmatrelvir + Ritonavir) for five days and tested negative for two days after this. The symptoms recurred and the patient was tested positive again. The outcome was reported as resolving. Details of symptoms, start date, clinical course, further investigation reports and treatment were not provided. Details of previous Covid-19 vaccines was not provided. The current pandemic situation of Covid-19 could be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient (age and gender unspecified) with no medical history reported, who experienced the unexpected non-serious AESI of Covid-19, on an unspecified date after receiving mRNA-1273 vaccine as 3rd dose. The patient had received a course of Paxlovid (Nirmatrelvir + Ritonavir) for five days and tested negative for two days after this. The symptoms recurred and the patient was tested positive again. The outcome was reported as resolving. Details of symptoms, start date, clinical course, further investigation reports and treatment were not provided. Details of previous Covid-19 vaccines was not provided. The current pandemic situation of Covid-19 could be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial initially stored on 31-JAN-2022 and then administered on 26-May-2022; The patient received dose after the beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received dose after the beyond use date) and PRODUCT STORAGE ERROR (Vial initially stored on 31-JAN-2022 and then administered on 26-May-2022) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-May-2022 at 12:30 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-May-2022 at 12:30 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received dose after the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored on 31-JAN-2022 and then administered on 26-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received dose after the beyond use date) and PRODUCT STORAGE ERROR (Vial initially stored on 31-JAN-2022 and then administered on 26-May-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.  Patient had received 1 booster dose.  It was reported that the HCP administered the vaccine after the beyond use date, as the HCP didn't know that the vials shouldn't be used past 30 days from thawing the vials. Vials were initially stored on 31-Jan-2022. Thaw expiration date was 02-Mar-2022. The vial did not undergo any temperature excursion.  No treatment medications were reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: the vial was initially stored on 31-Jan-2022 and the vaccine was administered on 15-Mar-2022; dose of the Moderna COVID-19 vaccine was administered after the beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose of the Moderna COVID-19 vaccine was administered after the beyond use date) and PRODUCT STORAGE ERROR (the vial was initially stored on 31-Jan-2022 and the vaccine was administered on 15-Mar-2022) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2022 at 1:10 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Mar-2022 at 1:10 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose of the Moderna COVID-19 vaccine was administered after the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored on 31-Jan-2022 and the vaccine was administered on 15-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose of the Moderna COVID-19 vaccine was administered after the beyond use date) and PRODUCT STORAGE ERROR (the vial was initially stored on 31-Jan-2022 and the vaccine was administered on 15-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Thaw expiration date was reported as 02-Mar-2022. It was reported that the HCP did not know that the vial should not be used past 30 days from thawing the vial. The vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-583132 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance
Clinical narrative: slowly started to walk very slow,like her right leg was not  responding,now she is going like someone that is going into rehab for a stroke, after their first booster; This spontaneous case was reported by a patient family member or friend and describes the occurrence of GAIT DISTURBANCE (slowly started to walk very slow,like her right leg was not  responding,now she is going like someone that is going into rehab for a stroke, after their first booster) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient had no allergies to medication, food and other products. The patient had not diagnosed or tested positive for COVID-19.  The patient's past medical history included Hemorrhage brain in 2013. Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot. Concomitant products included WARFARIN, ESTRADIOL, MECLIZINE [MECLOZINE], FAMOTIDINE, SODIUM LACTATE (LACTAT), AMITRIPTYLINE, SIMVASTATIN and LORAZEPAM for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Oct-2021, received 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 GAIT DISTURBANCE (slowly started to walk very slow,like her right leg was not  responding,now she is going like someone that is going into rehab for a stroke, after their first booster). The patient was treated with Rehabilitation therapy for Gait disturbance. At the time of the report, GAIT DISTURBANCE (slowly started to walk very slow,like her right leg was not  responding,now she is going like someone that is going into rehab for a stroke, after their first booster) had not resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received blood thinner as concomitant medication.  The patient had no adverse event and both acute and chronic illnesses at the time of vaccination. It was reported that, the patient had this reaction a couple of week later. The patient had back in 2013 a brain bleed and the hospital cauterized the vain to stop the bleed. The patient was in rehab to control her right leg and was susceptible for covid.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Date the vial was initially stored : 31-Jan-2022., Date(s) of administration of vaccine :17-MAY-2022; patients received expired Moderna COVID-19 vaccine beyond the 30 day refrigerator shelf life; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received expired Moderna COVID-19 vaccine beyond the 30 day refrigerator shelf life) and PRODUCT STORAGE ERROR (Date the vial was initially stored : 31-Jan-2022., Date(s) of administration of vaccine :17-MAY-2022) in a 21-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2022 at 5:37 AM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 17-May-2022 at 5:37 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received expired Moderna COVID-19 vaccine beyond the 30 day refrigerator shelf life). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored : 31-Jan-2022., Date(s) of administration of vaccine :17-MAY-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients received expired Moderna COVID-19 vaccine beyond the 30 day refrigerator shelf life) and PRODUCT STORAGE ERROR (Date the vial was initially stored : 31-Jan-2022., Date(s) of administration of vaccine :17-MAY-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. The vial was initially stored on 31-Jan-2022. It was reported that vial did not undergo temperature excursion. Thaw expiration date was reported as 02-Mar-2022. It was reported that HCP did not know that vails should not be used past 30 days from thawing the vials. Total Doses given: 20 doses, 15 vials have been used. No treatment drug was reported.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vials initially stored on 31-JAN-2022, thawed expiration date was 2-MAR-2022 and vaccine was administered on 10-MAY-2022; provided doses of Moderna COVID-19 vaccine after the beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (provided doses of Moderna COVID-19 vaccine after the beyond use date) and PRODUCT STORAGE ERROR (The vials initially stored on 31-JAN-2022, thawed expiration date was 2-MAR-2022 and vaccine was administered on 10-MAY-2022) in a 26-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-2022 at 7:30 AM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 19-May-2022 at 7:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (provided doses of Moderna COVID-19 vaccine after the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vials initially stored on 31-JAN-2022, thawed expiration date was 2-MAR-2022 and vaccine was administered on 10-MAY-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (provided doses of Moderna COVID-19 vaccine after the beyond use date) and PRODUCT STORAGE ERROR (The vials initially stored on 31-JAN-2022, thawed expiration date was 2-MAR-2022 and vaccine was administered on 10-MAY-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  The vials initially stored on 31 Jan 2022, and thawed expiration date was 2 Mar 2022. The vial did not undergo any temperature excursions.           No treatment medication was reported.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: the vial was initially stored on 31-Jan-2022 and the vaccine was administered on 26-MAY-2022; Dose of the Moderna COVID-19 vaccine was administered after the beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose of the Moderna COVID-19 vaccine was administered after the beyond use date) and PRODUCT STORAGE ERROR (the vial was initially stored on 31-Jan-2022 and the vaccine was administered on 26-MAY-2022) in a 63-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-May-2022 at 1:00 AM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 26-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose of the Moderna COVID-19 vaccine was administered after the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored on 31-Jan-2022 and the vaccine was administered on 26-MAY-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose of the Moderna COVID-19 vaccine was administered after the beyond use date) and PRODUCT STORAGE ERROR (the vial was initially stored on 31-Jan-2022 and the vaccine was administered on 26-MAY-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.    The vial did not undergo any temperature excursions.  No treatment information was reported.   This case was linked to MOD-2022-583132 (Patient Link).
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Receiving doses after the beyond use date/ Thaw expiration date was 3/2/2022, date administrered was on 5/5/2022 8:16 PM; Receiving doses after the beyond use date/ Thaw expiration date was 3/2/2022, date administrered was on 5/5/2022 8:16 PM; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Receiving doses after the beyond use date/ Thaw expiration date was 3/2/2022, date administrered was on 5/5/2022 8:16 PM) and PRODUCT STORAGE ERROR (Receiving doses after the beyond use date/ Thaw expiration date was 3/2/2022, date administrered was on 5/5/2022 8:16 PM) in a 24-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2022 at 8:16 PM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 05-May-2022 at 8:16 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Receiving doses after the beyond use date/ Thaw expiration date was 3/2/2022, date administrered was on 5/5/2022 8:16 PM). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Receiving doses after the beyond use date/ Thaw expiration date was 3/2/2022, date administrered was on 5/5/2022 8:16 PM). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Receiving doses after the beyond use date/ Thaw expiration date was 3/2/2022, date administrered was on 5/5/2022 8:16 PM) and PRODUCT STORAGE ERROR (Receiving doses after the beyond use date/ Thaw expiration date was 3/2/2022, date administrered was on 5/5/2022 8:16 PM) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the HCP administered the vaccine after the beyond use date, as the HCP didn't know that the vials shouldn't be used past 30 days from thawing the vials. Vials were initially stored on 31-Jan-2022. Thaw expiration date was 02-Mar-2022. The vial did not undergo any temperature excursion. No treatment medications were reported.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Date the vial was initially stored was on 31 Jan 2022 and patient administered vaccine on 07 Apr 2022; Patient administered vaccine on 07 Apr 2022 and thaw expiration date was on 02 Mar 2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 07 Apr 2022 and thaw expiration date was on 02 Mar 2022) and PRODUCT STORAGE ERROR (Date the vial was initially stored was on 31 Jan 2022 and patient administered vaccine on 07 Apr 2022) in a 31-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 045L21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 07-Apr-2022 at 9:16 AM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Apr-2022 at 9:16 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 07 Apr 2022 and thaw expiration date was on 02 Mar 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored was on 31 Jan 2022 and patient administered vaccine on 07 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 07 Apr 2022 and thaw expiration date was on 02 Mar 2022) and PRODUCT STORAGE ERROR (Date the vial was initially stored was on 31 Jan 2022 and patient administered vaccine on 07 Apr 2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported that patient received doses after the beyond use date.Date vials were  initially stored in refrigerator was reported as  31 Jan 2022.  It was reported that the thaw expiration date was on 02 Mar 2022, and the total doses given were 20 doses of 15 vials used.  It was reported that the vials had not undergone any temperature excursion.  No treatment medication were reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid-19 prior to Paxlovid treatment.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19 prior to Paxlovid treatment.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient do not have any allergies. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  Concurrent medical conditions included Drug allergy (Unspecified drug). Concomitant products included IBUPROFEN for an unknown indication.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19 prior to Paxlovid treatment.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 16-May-2022 to 20-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid-19 prior to Paxlovid treatment.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: positive (Positive) Covid starting immediately after 5 days of Paxlovid..         Patient previously receive a COVID-19 Vaccine. Patient stated that Rebound COVID started immediately after 5 days of Paxlovid. Lasting another week. Still have shortness of breath and intermittent cough & sneezing. Device Date : 05Jun2022  Company Comment: This spontaneous case concerns a patient (age and gender not specified) with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving the third dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 16 th to 20 th May 2022 for Covid-19 and had a rebound covid 5 days after the Paxlovid which lasted a week with shortness of breath and intermittent cough & sneezing. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a patient (age and gender not specified) with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving the third dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 16 th to 20 th May 2022 for Covid-19 and had a rebound covid 5 days after the Paxlovid which lasted a week with shortness of breath and intermittent cough & sneezing. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a  patient of an unknown age and gender 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 COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jun-2022, SARS-CoV-2 test: positive Positive- 6 days after finishing the medications.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was provided.  It was reported that an unspecified drug was administered with start date 22-May-2022 and stop date 27-May-2022, with the indication treatment of COVID-19. Device date was reported as 02-Jun-2022.  Company comment: This spontaneous case concerns a patient (age and gender unspecified) with no medical history reported, who experienced the unexpected non-serious AESI of Covid-19, on an unspecified date after receiving a dose of mRNA-1273 vaccine. The patient had taken a course of Paxlovid (Nirmatrelvir + Ritonavir) for five days for Covid-19. Six days after the treatment, the patient had recurrence of symptoms and tested positive for SARS-CoV-2 test. The outcome was reported as resolving. Details of symptoms, start date, clinical course, further investigation reports and treatment were not provided. Details of previous Covid-19 vaccines was not provided. The current pandemic situation of Covid-19 could be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient (age and gender unspecified) with no medical history reported, who experienced the unexpected non-serious AESI of Covid-19, on an unspecified date after receiving a dose of mRNA-1273 vaccine. The patient had taken a course of Paxlovid (Nirmatrelvir + Ritonavir) for five days for Covid-19. Six days after the treatment, the patient had recurrence of symptoms and tested positive for SARS-CoV-2 test. The outcome was reported as resolving. Details of symptoms, start date, clinical course, further investigation reports and treatment were not provided. Details of previous Covid-19 vaccines was not provided. The current pandemic situation of Covid-19 could be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: EN6204), on 05Apr2021 as dose 2, single (Lot number: ER8734) and on 15Oct2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 41 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 19Apr2022 at 12:30 as dose 4 (booster), single (Lot number: 002M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative Colitis" (unspecified if ongoing); "Known allergies: PCN" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA, start date: May2012, stop date: 02Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" (Jun2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (28May2022) Negative; (29May2022) Negative; (31May2022) Negative; (02Jun2022) Positive; (02Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE) cannot be ruled out.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: EN6204), on 05Apr2021 as dose 2, single (Lot number: ER8734) and on 15Oct2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 41 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 19Apr2022 at 12:30 as dose 4 (booster), single (Lot number: 002M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative Colitis" (unspecified if ongoing); "Known allergies: PCN" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA, start date: May2012, stop date: 02Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" (Jun2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (28May2022) Negative; (29May2022) Negative; (31May2022) Negative; (02Jun2022) Positive; (02Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE) cannot be ruled out.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: administered with vaccine which underwent temperature excursion; administered with vaccine which underwent temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine which underwent temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine which underwent temperature excursion) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005M21A, 065f21A, 038A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine which underwent temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine which underwent temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine which underwent temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine which underwent temperature excursion) 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 reporter stated that they had a temperature excursion involving 14 Moderna Covid-19 vials. She mentioned that they had 4 thermometers but only the data logger recorded a temperature excursion on 02-May-2022- plus 5.11 F which occurred for 7minutes; thermometer in the freezer and the other 2 data loggers did not record any. This was just found out when they had an inspection with the state department, and they were advised to call Moderna to determine the viability of these vaccines. 4 doses were administered to patients from one vial and the dates of administration were 12-May-2022 (1 dose), 18-May-2022 (1 dose) and 25-May-2022 (2doses). Storage condition at the time of the excursion: frozen storage / refrigerated storage / ambient room temperature: freezer The vials were stored as quarantined in the freezer now. Vaccine was still frozen; frozen at that time the temperature excursion happened. 14 vials were impacted but one vial had been used to administer 4 doses to patients. The vials were not punctured and no previous excursions with the impacted vials.  No treatment information was reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I took anti viral felt better now 4 days after I feel worse than initially getting Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (I took anti viral felt better now 4 days after I feel worse than initially getting Covid) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Unspecified drug). Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) from 23-May-2022 to 25-May-2022, PARACETAMOL (TYLENOL) from 23-May-2022 to 25-May-2022 and GUAIFENESIN (MUCINEX) from 23-May-2022 to 25-May-2022 for an unknown indication.    On 04-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (I took anti viral felt better now 4 days after I feel worse than initially getting Covid). At the time of the report, COVID-19 (I took anti viral felt better now 4 days after I feel worse than initially getting Covid) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient took other medications or products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine.   Patient took Pfizer product (Unspecified drug) as a COVID-19 Treatment from 23-May-2022 to 27-May-2002.  Device Date : 02Jun2022  Company comment: This is a spontaneous case concerning a 58-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious AESI event of Covid-19. The event occurred approximately 1 year after the unknown dose number of mRNA-1273 vaccine administration. It was reported that the patient received Ibuprofen (Advil), Paracetamol (Tylenol), Guaifenesin (Mucinex), unspecified antiviral and unspecified medication by Pfizer for Covid-19 treatment. No other information surrounding the event was reported. The outcome of the event was reported as not resolved. The current Covid-19 pandemic remain confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 58-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious AESI event of Covid-19. The event occurred approximately 1 year after the unknown dose number of mRNA-1273 vaccine administration. It was reported that the patient received Ibuprofen (Advil), Paracetamol (Tylenol), Guaifenesin (Mucinex), unspecified antiviral and unspecified medication by Pfizer for Covid-19 treatment. No other information surrounding the event was reported. The outcome of the event was reported as not resolved. The current Covid-19 pandemic remain confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient received an expired vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received an expired vaccine) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033k21-2a, 029A21a and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jun-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received an expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications reported. It was reported that the number of dose per vial was unknown. The date vial was initially stored in the refrigerator was unknown. Vial did not undergo any temperature excursions. Patient did not have any allergies. COVID test or diagnosis with patient was unknown. Patient did not have any medical history . Patient did not seek medical care like office visit, Urgent care, ER, hospitalized. Patient did not experience similar event in the past. Patient did not have any symptoms.  Other vaccines given within 1 month prior to Moderna COVID-19 vaccine like type, brand, lot, route, dose Zoster vaccine 3Jun2022 with lot number ms5hc.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Initial COVID-19 infection prior to COVID-19 treatment; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Initial COVID-19 infection prior to COVID-19 treatment) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O28K21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Drug allergy (Prednisone). Concomitant products included APIXABAN (ELIQUIS) from 25-Feb-2022 to an unknown date for an unknown indication.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Initial COVID-19 infection prior to COVID-19 treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 16-May-2021 to 21-May-2021 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Initial COVID-19 infection prior to COVID-19 treatment) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-May-2022, SARS-CoV-2 test: positive (Positive) Tested positive for Covid one week after stopping Paxlovid..         It was reported that patient had tested positive for Covid one week after stopping Paxlovid on 28 May 2022, no hospitalization Prolonged.  Company comment: This spontaneous case concerns a 75-year-old male patient with no relevant medical history, who experienced the unexpected non-serious AESI of Covid-19, approximately 4months after receiving the 3rd dose of mRNA-1273 vaccine. She had taken a course of Paxlovid (Nirmatrelvir + Ritonavir) for five days. Following this she tested positive for a week after completion of the treatment. The outcome was reported as unknown. Details of symptoms, start date, clinical course, further investigation reports and treatment were not provided. Details of prior Covid-19 vaccination was not provided. The current pandemic situation of Covid-19 could be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 75-year-old male patient with no relevant medical history, who experienced the unexpected non-serious AESI of Covid-19, approximately 4months after receiving the 3rd dose of mRNA-1273 vaccine. She had taken a course of Paxlovid (Nirmatrelvir + Ritonavir) for five days. Following this she tested positive for a week after completion of the treatment. The outcome was reported as unknown. Details of symptoms, start date, clinical course, further investigation reports and treatment were not provided. Details of prior Covid-19 vaccination was not provided. The current pandemic situation of Covid-19 could be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.