chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 1:17 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 1:23 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  On 28-Mar-2021, Excursion time was 10 AM, temperature was 35, total doses given for the day was 150, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 15 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021.  On 28-Feb-2021, Excursion time was 09 AM and 1PM, temperature was 27 and 26, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021.   On 28-Feb-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 27, 10 AM: 40, 11 AM: 44, 12 AM: 46, 1PM: 26, 2 PM: 37, 3 PM: 43 and 4 PM: 45.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug tolerance increased, Liver function test, Liver function test increased, Peripheral swelling, Therapeutic product effect decreased
Clinical narrative: Humaria stopped working and became immune; arm to swell with a giant ball; Humaria stopped working and became immune; Liver function test increased; This spontaneous case was reported by a consumer and describes the occurrence of LIVER FUNCTION TEST INCREASED (Liver function test increased), DRUG TOLERANCE INCREASED (Humaria stopped working and became immune), PERIPHERAL SWELLING (arm to swell with a giant ball) and THERAPEUTIC PRODUCT EFFECT DECREASED (Humaria stopped working and became immune) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Plaque psoriasis.    There was no reported medical history.  Concurrent medical conditions included Plaque psoriasis.   On 16-Jun-2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In August 2021, the patient experienced LIVER FUNCTION TEST INCREASED (Liver function test increased). On an unknown date, the patient experienced DRUG TOLERANCE INCREASED (Humaria stopped working and became immune), PERIPHERAL SWELLING (arm to swell with a giant ball) and THERAPEUTIC PRODUCT EFFECT DECREASED (Humaria stopped working and became immune). At the time of the report, LIVER FUNCTION TEST INCREASED (Liver function test increased), DRUG TOLERANCE INCREASED (Humaria stopped working and became immune) and THERAPEUTIC PRODUCT EFFECT DECREASED (Humaria stopped working and became immune) had not resolved and PERIPHERAL SWELLING (arm to swell with a giant ball) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Liver function test: increased increased.         Concomitant drugs were not reported. No treatment medication information reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 immunisation.     No Medical History information was reported.  On 11-Jan-2021 at 3:50 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 3:50 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 57.54.  Concomitant products were not provided.  On 11-Jan-2021, Excursion time was 02 PM, temperature was 35, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 08-Jan-2021, vial was moved to clinic on 11-Jan-2021. 9 vials were sent to clinic. Vaccine BUD date was 07-Feb-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine administered on 20-may-2022 and freezed on 25-may-2022; patient received an expired Moderna booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received an expired Moderna booster dose) and PRODUCT STORAGE ERROR (Vaccine administered on 20-may-2022 and freezed on 25-may-2022) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2022 at 10:17 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2022 at 10:17 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received an expired Moderna booster dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered on 20-may-2022 and freezed on 25-may-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received an expired Moderna booster dose) and PRODUCT STORAGE ERROR (Vaccine administered on 20-may-2022 and freezed on 25-may-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.  It was reported that the vial was stored in refrigerator on 25-May-2022 and was pulled straight out of freezer and thawed out. The vial did not undergo any temperature excursion.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID -19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID -19) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), ATORVASTATIN CALCIUM (LIPITOR), ESCITALOPRAM OXALATE (LEXAPRO), MELATONIN and TELMISARTAN for an unknown indication.    On 07-Apr-2022, the patient received fourth 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 12-May-2022 to 16-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID -19) had not resolved.            Patient didn't had any allergies. The patient taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine.  On 22-May-2022 relapse of COVID symptoms occurred 5-6 days after taking Paxlovid.  Relapse of COVID symptoms 5-6 days after taking Paxlovid. Device Date : 23May2022.  Company Comment: This spontaneous case concerns a 52-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving fourth dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 12-May-2022 to 16-May-2022 and had a relapse of COVID symptoms 5-6 days after taking Paxlovid. 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.; Sender's Comments: This spontaneous case concerns a 52-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving fourth dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 12-May-2022 to 16-May-2022 and had a relapse of COVID symptoms 5-6 days after taking Paxlovid. 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.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: My COVID came back 7 days after I stopped medication.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (My COVID came back 7 days after I stopped medication.) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 014c21a and 036b21h) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Allergy. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and LISINOPRIL for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (My COVID came back 7 days after I stopped medication.). At the time of the report, COVID-19 (My COVID came back 7 days after I stopped medication.) had not resolved.            The patient reported that his COVID came back 7 days after he stopped medication.  The patient took COVID 19 treatment with unknown drug with batch number FY5656 from 12-May-2022 till 16-May-2022.  Company comment: This is a spontaneous case concerning a 47-years-old male patient with no relevant medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (COVID-19) which occurred 5 months 19 days after receiving the third dose of mRNA-1273 vaccine. The event COVID was reported as;My COVID came back 7 days after I stopped medication. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 04-May-2022 to 08-May-2022 for COVID-19, at an unspecified dose and frequency. SARS-CoV-2 test was positive as on 13-May-2022. Ongoing Covid 19 pandemia could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This is a spontaneous case concerning a 47-years-old male patient with no relevant medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (COVID-19) which occurred 5 months 19 days after receiving the third dose of mRNA-1273 vaccine. The event COVID was reported as;My COVID came back 7 days after I stopped medication. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 04-May-2022 to 08-May-2022 for COVID-19, at an unspecified dose and frequency. SARS-CoV-2 test was positive as on 13-May-2022. Ongoing Covid 19 pandemia could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pemphigoid
Clinical narrative: Bullous pemphigoid; This literature-non-study case was reported in a literature article and describes the occurrence of PEMPHIGOID (Bullous pemphigoid) in a 73-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.       No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PEMPHIGOID (Bullous pemphigoid) (seriousness criterion medically significant). At the time of the report, PEMPHIGOID (Bullous pemphigoid) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered PEMPHIGOID (Bullous pemphigoid) to be related.    No concomitant and treatment medications were reported. Company comment:  This literature-non-study case concerns a 73-year-old female patient, with no reported medical history, who experienced the unexpected serious (medically significant) event of PEMPHIGOID (reported as Bullous pemphigoid), which occurred after receiving the second dose of mRNA-1273 vaccine. Latency cannot be assessed, as vaccination date was not reported. No further information was disclosed to this date. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This literature-non-study case concerns a 73-year-old female patient, with no reported medical history, who experienced the unexpected serious (medically significant) event of PEMPHIGOID (reported as Bullous pemphigoid), which occurred after receiving the second dose of mRNA-1273 vaccine. Latency cannot be assessed, as vaccination date was not reported. No further information was disclosed to this date. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 53.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Cough, Dyspnoea, Headache, Sinus congestion
Clinical narrative: Dry cough; sinus congestion; shortness of breath; headaches; This spontaneous case was reported by a patient and describes the occurrence of COUGH (Dry cough), SINUS CONGESTION (sinus congestion), DYSPNOEA (shortness of breath) and HEADACHE (headaches) in a 53-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Allergy were reported as none.    On 01-Apr-2022 at 3:00 PM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 17-May-2022, the patient experienced COUGH (Dry cough), SINUS CONGESTION (sinus congestion), DYSPNOEA (shortness of breath) and HEADACHE (headaches). The patient was treated with FLUTICASONE PROPIONATE (FLOVENT) at an unspecified dose and frequency. At the time of the report, COUGH (Dry cough), SINUS CONGESTION (sinus congestion), DYSPNOEA (shortness of breath) and HEADACHE (headaches) had not resolved.            No concomitant medication were reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Caught Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Caught Covid) in a female 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 COVID-19 (Caught Covid). At the time of the report, COVID-19 (Caught Covid) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medications were not reported.  Treatment information was not reported.  Company comment: This is a spontaneous case concerning a unspecified age female patient with no medical history reported, who experienced unexpected non-serious  event of covid-19, which occurred unspecified days after a dose (dose number not specified) of mRNA-1273 vaccine. Current ongoing pandemic remains as a confounder. The benefit-risk relationship of mRNA-1273 is not affected.   This case was linked to MOD-2022-576695 (Patient Link).  Sender's Comments: This is a spontaneous case concerning a unspecified age female patient with no medical history reported, who experienced unexpected non-serious  event of covid-19, which occurred unspecified days after a dose (dose number not specified) of mRNA-1273 vaccine. Current ongoing pandemic remains as a confounder. The benefit-risk relationship of mRNA-1273 is not affected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: the freezer went too low two weeks ago; expired doses given to two patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses given to two patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (the freezer went too low two weeks ago) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses given to two patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (the freezer went too low two weeks ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired doses given to two patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (the freezer went too low two weeks ago) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 18-May-2022. Reporter was told to record second booster shots that reporter gave on 24-May-2022, but reporter realized that the Moderna vaccines expired on 18-May-2022. Reporter explained that they ordered Moderna in Nov-2021, and the box said frozen. They didn't have a freezer then and found out they could be unfrozen for a month. Then they got a freezer and ordered another supply, which came in on 09-Dec-2021. The HCP called the state department, who referred to Moderna to check if the doses were viable. The HCP connected the doctor on the line to see if could provide information on previous excursions. The doctor stated that there were fluctuations in the freezer two weeks ago. The freezer went too low.  No concomitant medications was reported. No treatment medications was reported.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid infection) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051FZ1A) for COVID-19 vaccination.     Patient had no known allergy.  Concurrent medical conditions included Diabetes mellitus (Diabetic under control). Concomitant products included SIMVASTATIN (ZOCOR) from an unknown date to 10-May-2022 and METFORMIN HYDROCHLORIDE (GLUCOPHAGE) from an unknown date to 10-May-2022 for an unknown indication.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2022, the patient experienced COVID-19 (Covid infection). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 10-May-2022 to 15-May-2022 for COVID-19 treatment, at a dose of 1 dosage form. On 16-May-2022, COVID-19 (Covid infection) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 17-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 23-May-2022, SARS-CoV-2 test: positive (Positive) positive: faint line appeared..         On the third day of COVID infection the patient started Paxlovid and became negative on day 9 and day 10. Then on day 16 was tested again positive using Rapid test kit.  Device date : 23-May-2022  Company comment: This spontaneous case concerns a 72-year-old male patient with medical history of diabetes mellitus, who experienced the unexpected non-serious of Covid-19, 6 months after receiving the 3rd dose of mRNA-1273 vaccine. The patient was treated with Paxlovid (Nirmatrelvir + Ritonavir) for five days. A day after the completion of course the SARS-CoV-2 test was negative. A week later, the patient was tested positive again. The outcome of the event was reported as resolved and recurrent test positive was reported as resolving. Details of previous two doses were 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 72-year-old male patient with medical history of diabetes mellitus, who experienced the unexpected non-serious of Covid-19, 6 months after receiving the 3rd dose of mRNA-1273 vaccine. The patient was treated with Paxlovid (Nirmatrelvir + Ritonavir) for five days. A day after the completion of course the SARS-CoV-2 test was negative. A week later, the patient was tested positive again. The outcome of the event was reported as resolved and recurrent test positive was reported as resolving. Details of previous two doses were 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: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: the freezer went too low two weeks ago; expired doses given to two patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses given to two patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (the freezer went too low two weeks ago) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-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 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses given to two patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (the freezer went too low two weeks ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired doses given to two patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (the freezer went too low two weeks ago) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 18-May-2022. Reporter was told to record second booster shots that reporter gave on 24-May-2022, but reporter realized that the Moderna vaccines expired on 18-May-2022. Reporter explains that they ordered Moderna in Nov-2021, and the box said frozen. They didn't have a freezer then and found out they can be unfrozen for a month. Then they got a freezer and ordered another supply, which came in on 09-Dec-2021. The HCP called the state department, who referred her to Moderna to check if the doses were viable. The HCP connected the doctor on the line to see if he can provide information on previous excursions. The doctor states that there were fluctuations in the freezer two weeks ago. The freezer went too low.  No concomitant medications was reported. No treatment medications was reported.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: three days after vaccinated with moderna, Got her period. But it lasted for 7 weeks before she called for help; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (three days after vaccinated with moderna, Got her period. But it lasted for 7 weeks before she called for help) in a female 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 HEAVY MENSTRUAL BLEEDING (three days after vaccinated with moderna, Got her period. But it lasted for 7 weeks before she called for help). At the time of the report, HEAVY MENSTRUAL BLEEDING (three days after vaccinated with moderna, Got her period. But it lasted for 7 weeks before she called for help) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  It was classified by ER team as adverse event after vaccination.  No treatment medications were provided by the reporter
Age: 69.0
Sex: M
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 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Hyperlipidemia, Hypertension and Allergy NOS. Concomitant products included ATORVASTATIN for an unknown indication.    On 18-Apr-2022, the patient received fourth 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 09-May-2022 to 13-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (covid-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not provided by the reporter.  Company Comment: This spontaneous case concerns a 69-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving fourth dose of mRNA-1273 vaccine. It was reported that patient started with Paxlovid On 09-May-2022.  and Covid symptoms returned and tested positive on antigen test 8 days after starting with Paxlovid. 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.; Sender's Comments: This spontaneous case concerns a 69-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving fourth dose of mRNA-1273 vaccine. It was reported that patient started with Paxlovid On 09-May-2022.  and Covid symptoms returned and tested positive on antigen test 8 days after starting with Paxlovid. 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.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: the vial undergo temperature excursions; Vaccine initially stored in the refrigerator on 20 Jan 2022, Administered on 29 Mar 2022; 13 patients received  an expired vaccine for a booster dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (13 patients received  an expired vaccine for a booster dose), PRODUCT TEMPERATURE EXCURSION ISSUE (the vial undergo temperature excursions) and PRODUCT STORAGE ERROR (Vaccine initially stored in the refrigerator on 20 Jan 2022, Administered on 29 Mar 2022) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     The patient had no allergies. It was unknown whether the patient was ever had COVID-19 test or diagnosis.     On 29-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (13 patients received  an expired vaccine for a booster dose). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (the vial undergo temperature excursions) and PRODUCT STORAGE ERROR (Vaccine initially stored in the refrigerator on 20 Jan 2022, Administered on 29 Mar 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (13 patients received  an expired vaccine for a booster dose), PRODUCT TEMPERATURE EXCURSION ISSUE (the vial undergo temperature excursions) and PRODUCT STORAGE ERROR (Vaccine initially stored in the refrigerator on 20 Jan 2022, Administered on 29 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.   The height of the patient is 172.72 cm.             They administered vaccine from 23-Feb-2022 until the 12-may-2022 to 13 patients, all booster dosages, after vaccines were expired. The vial was moved from freezer and was initially stored in the refrigerator on 20-Jan-2022. The vial underwent temperature excursions for 3 months. The vial was in refrigerated storage condition at the time of the excursion. Maximum or minimum temperatures reached were Maximum 44.6°F and minimum 38.8°F. The Visual inspection did not note any vaccine state change and they were in seal boxes.  No treatment information was provided by the reporter.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 1:52 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 1:52 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 48.19.  Concomitant products were not provided.  On 03-Apr-2021, excursion time was 09 AM and temperature was 34 respectively, total doses given for the day was 210, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vial was moved to clinic on 03-Apr-2021. Vaccine BUD date was 29-Apr-2021.  Vial was stored on cooler 1 , on 27-Oct-2021, Excursion duration At 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM : 41, 2 PM : 41, 3 PM: 40, 4 PM: 40 and 5 PM : 41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Age: 46.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Symptoms returned 2 days later and testing positive again.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Symptoms returned 2 days later and testing positive again.) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Shellfish allergy, Blood pressure high and Asthma.   On 21-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 21-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Symptoms returned 2 days later and testing positive again.). At the time of the report, COVID-19 (Symptoms returned 2 days later and testing positive again.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative and positive (Positive) Positive.         It was reported that the Device Date  is 23-May-2022 Patient had Negative test the day after completing Paxlovid No concomitant medications were provided by the reporter No treatment medications were provided by the reporter Company comment: This spontaneous case concerns a 46-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest COVID-19 (with a positive SARS-CoV-2 test). The event occurred 181 days after administration of third dose of mRNA-1273. There was no information provided regarding the initial two doses. The patient started treatment regimen with Paxlovid on May 12, 2022, it has been reported that patient had a negative SARS-CoV-2 test after the treatment regimen, however the symptoms recurred after two days and again was positive on SARS-CoV-2 test. Outcome of the events was unknown at the time of this report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 46-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest COVID-19 (with a positive SARS-CoV-2 test). The event occurred 181 days after administration of third dose of mRNA-1273. There was no information provided regarding the initial two doses. The patient started treatment regimen with Paxlovid on May 12, 2022, it has been reported that patient had a negative SARS-CoV-2 test after the treatment regimen, however the symptoms recurred after two days and again was positive on SARS-CoV-2 test. Outcome of the events was unknown at the time of this report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: the vial underwent temperature excursions; vial was moved from freezer to refrigerator and expired on 20-Jan-2022; received  an expired vaccine for a booster dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received  an expired vaccine for a booster dose), PRODUCT TEMPERATURE EXCURSION ISSUE (the vial underwent temperature excursions) and PRODUCT STORAGE ERROR (vial was moved from freezer to refrigerator and expired on 20-Jan-2022) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer and Pfizer. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 22-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received  an expired vaccine for a booster dose). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (the vial underwent temperature excursions) and PRODUCT STORAGE ERROR (vial was moved from freezer to refrigerator and expired on 20-Jan-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received  an expired vaccine for a booster dose), PRODUCT TEMPERATURE EXCURSION ISSUE (the vial underwent temperature excursions) and PRODUCT STORAGE ERROR (vial was moved from freezer to refrigerator and expired on 20-Jan-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. Patient received first booster on 22-Apr-2022. The date the vial was initially stored in the refrigerator on 20-Jan-2022 Storage condition at the time of the excursion: refrigerated storage Maximum or minimum temperatures reached, as applicable : Maximum 44.6°F minimum 38.8°F Excursion duration was reported as 3 months  No treatment drug details was reported.   This case was linked to MOD-2022-572778 (Patient Link).
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 2:10 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 2:10 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 20.08  Concomitant products were not provided.  15-Apr-2021Excursion time was reported at 9am with temperature as 34 degrees Fahrenheit respectively , total doses given for the day was 188 ,condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Return of symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Return of symptoms) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046L21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Thyroid cancer.   On 24-Mar-2022 at 5:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 09-May-2022 at 7:00 PM, the patient experienced COVID-19 (Return of symptoms). At the time of the report, COVID-19 (Return of symptoms) was resolving.            Concomitant medications were not reported. The patient did not took any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine. On 09May2022 Return of symptoms. Patient treated with antibiotic and device date was 24May2022.  Company comment: This spontaneous case concerns a 43 year old female patient, with relevant medical history of micropapillary thyroid cancer, who experienced the unexpected non serious AESI of COVID-19, unknown days after receiving the fourth dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient took Paxlovid for COVID-19 for 5 days. However, symptoms returned after about 9 days. The event was resolving. No further details on the previous doses of vaccination and COVID-19 test dates before and after Paxlovid treatment were available in the report. Medical history of micropapillary thyroid cancer and the ongoing COVID-19 pandemic could be risk factors for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 43 year old female patient, with relevant medical history of micropapillary thyroid cancer, who experienced the unexpected non serious AESI of COVID-19, unknown days after receiving the fourth dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient took Paxlovid for COVID-19 for 5 days. However, symptoms returned after about 9 days. The event was resolving. No further details on the previous doses of vaccination and COVID-19 test dates before and after Paxlovid treatment were available in the report. Medical history of micropapillary thyroid cancer and the ongoing COVID-19 pandemic could be risk factors for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.