chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: This spontaneous report received from a healthcare professional concerned a 54-year-old female. No medical history, weight, height, concomitant medications or concurrent conditions reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch/lot# 212A21A and expiry: May 20, 2022), dose not reported, administered Nov 18, 2021, for immunization. Age at time of vaccination: 54 years old.  On Nov 18, 2021, refrozen vaccine administered to patient. On an unspecified date, patient experienced vaccine refrozen. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome of the refrozen vaccine administered to patient and vaccine refrozen: not reported. This case, from the same reporter linked to 20220538379, 20220537688, 20220537683, 20220538480, 20220538149, 20220537341, 20220537444, 20220538292, 20220537548, 20220537356, 20220538411, 20220537356, 20220537532, 20220537532, 20220538428, 20220538425, 20220538210, 20220538238, 20220538573, 20220538666, 20220538693, 20220538146, 20220538297, 20220538758, 20220537507 and 20220539045.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: This spontaneous report received from a healthcare professional concerned a 51-year-old male. No medical history, weight, height, concomitant medications or concurrent conditions reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch/lot# 1821286 and expiry: Mar 20, 2022), dose not reported, on Nov 1, 2021, for immunization. Age at time of vaccination: 51 years old.  On Nov 1, 2021, administration of refrozen vaccine. On an unspecified date, patient experienced vaccine refrozen. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome of the vaccine refrozen and administration of refrozen vaccine: not reported. This case, from the same reporter linked to 20220538379, 20220537507, 20220538627, 20220537683, 20220537341, 20220538437, 20220538573, 20220537444, 20220538666, 20220538292, 20220537548, 20220538347, 20220538411, 20220539045, 20220537532, 20220538428, 20220538146, 20220538297, 20220538316, 20220538210, 20220538238, 20220538758, 20220537688, 20220537356, 20220538425, 20220538693 and 20220538149.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: This spontaneous report received from a patient concerned a 29-year-old male. No medical history, height, weight, concomitant medications or concurrent conditions reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin: not reported, batch/lot#: 204B21A and expiry: May 10, 2022), dose not reported, on Jul 13, 2021, for immunization. Age at time of vaccination: 29 years old. Jan 2022, patient acquired COVID-19 twice. Laboratory data included: COVID-19 rapid POC test (NR: not provided) positive. On Apr 12, 2022, laboratory data included: COVID-19 rapid POC test (NR: not provided) positive. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome of acquired COVID-19 twice: not reported.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: THE JANSSEN COVID 19 VACCINE WAS REFROZEN; ADMINISTERED REFROZEN VACCINE; This spontaneous report received from a health care professional concerned a 47 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26. cov2. S (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 20-MAR-2022) dose was not reported, 01 total, administered on 09-SEP-2021 for prophylactic vaccination. It was unknown whether patient had any adverse reactions following vaccination with covid-19 vaccine ad26.cov2.s. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 212A21A, expiry: 20-MAY-2022) dose was not reported, 01 total administered on 09-FEB-2022 for prophylactic vaccination in left arm. Age at time of vaccination 47 years old. No concomitant medications were reported. On 09-FEB-2022, the patient had been administered refrozen vaccine (Dose number in series 2). On an unspecified date, the janssen covid 19 vaccine was refrozen (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the janssen covid 19 vaccine was refrozen and administered refrozen vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20220538428, 20220538297, 20220538573, 20220538480, 20220538149, 20220538379, 20220538437, 20220537688, 20220537507, 20220538627, 20220537683, 20220537341, 20220537444, 20220538292, 20220537548, 20220538411, 20220537356, 20220539045, 20220538425, 20220538316, 20220538210, 20220538238, 20220538758 and 20220540524.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Oral pain
Clinical narrative: This spontaneous report received from a patient concerned a patient of unspecified age and gender. No medical history, height, weight, concomitant medications or concurrent conditions reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch/lot#: not reported), dose, start therapy date: not reported, for immunization. Per procedure, no follow-up requested for this case. On an unspecified date, patient's mouth was sore inside; neck sore and shoulder sore. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome of shoulder sore, mouth sore inside and neck sore: not reported.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE WAS REFROZEN; REFROZEN VACCINE WAS ADMINISTERED TO PATIENT; This spontaneous report received from a health care professional concerned a 63 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: 20-MAR-2022) dose was not reported, administered on 08-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced vaccine was refrozen, and refrozen vaccine was administered to patient. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was refrozen and refrozen vaccine was administered to patient was not reported. This report was non-serious. This case, from the same reporter is linked to 20220538292, 20220537341, 20220537356, 20220537444, 20220537507, 20220537548, 20220538146, 20220538210, 20220538297, 20220538379, 20220538480, 20220538890, 20220539045, 20220540324, 2005084289, 20220540611, 20220537688, 20220537683, 20220538238, 20220538316, 20220538425, 20220538428, 20220538437, 20220538573, 20220538627, 20220538666 and 20220538758.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE WAS  REFROZEN; REFROZEN VACCINE ADMINISTERED TO PATIENT; This spontaneous report received from a health care professional concerned a 40 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: 20-MAR-2022) dose was not reported, administered on 30-AUG-2021 for prophylactic vaccination. Age at time of vaccination 40 years old. No concomitant medications were reported.  On 30-AUG-2021, the patient experienced refrozen vaccine administered to patient. On an unspecified date, the patient experienced vaccine was refrozen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was refrozen and refrozen vaccine administered to patient was not reported. This report was non-serious.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE WAS REFROZEN; REFROZEN VACCINE WAS ADMINISTERED TO PATIENT; This spontaneous report received from a health care professional concerned a 51 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry date: 20-MAR-2022) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. Age at time of vaccination 51 years old. No concomitant medications were reported.  On 09-JUN-2021, the patient experienced refrozen vaccine was administered to patient. On an unspecified date, the patient experienced vaccine was refrozen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was refrozen and refrozen vaccine was administered to patient was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: got clots after 3rd full dose of a Covid-19 Vaccine of unknown manufacturer; This spontaneous case was reported by a nurse and describes the occurrence of THROMBOSIS (got clots after 3rd full dose of a Covid-19 Vaccine of unknown manufacturer) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (got clots after 3rd full dose of a Covid-19 Vaccine of unknown manufacturer) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (got clots after 3rd full dose of a Covid-19 Vaccine of unknown manufacturer) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported Nurse stated that she read a story on her iPhone from the clinic about the patient who got clots after 3rd full dose of covid-19 vaccine of unknown manufacturer.  Company comment- This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced unexpected, serious (medically significant) adverse event of special interest Thrombosis which occurred at an unknown time after vaccination with a third dose of mRNA-1273. A nurse stated that she read a story on her iPhone from the Clinic about someone who got clots after a 3rd dose of a Covid-19 Vaccine of unknown manufacturer. The outcome of the events was reported as unknown.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events' seriousness was assessed as per Regulatory Authority's report.   This case was linked to MOD-2022-569119; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced unexpected, serious (medically significant) adverse event of special interest Thrombosis which occurred at an unknown time after vaccination with a third dose of mRNA-1273. A nurse stated that she read a story on her iPhone from the Clinic about someone who got clots after a 3rd dose of a Covid-19 Vaccine of unknown manufacturer. The outcome of the events was reported as unknown.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events' seriousness was assessed as per Regulatory Authority's report.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity, Uveitis
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of uveitis flare-up in an elderly female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. Co-suspect product included Humira (adalimumab), solution for injection, for an unknown indication. No medical history reported. In 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. In 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. April 2022, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient took Humira (adalimumab), unknown route; at an unspecified dose. On an unknown date, patient experienced uveitis flare-up (medically significant), back pain and pain in extremity (pain in arm). At the time of the report, uveitis flare-up, back pain and pain in extremity (pain in arm) outcome: unknown. Unknown if patient was enrolled in COVID-19 vaccine trial. No concomitant medication or treatment information reported.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of COVID-19 (patient did a home test for COVID-19 (disease) on Friday, May 13, 2022; tested positive on Saturday, May 14, 2022 with a PCR test) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. December 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 14, 2022, patient experienced COVID-19 (patient did a home test for COVID-19 (disease) on Friday, May 13, 2022; tested positive on Saturday, May 14, 2022 with a PCR test). At the time of the report, COVID-19 (patient did a home test for COVID-19 (disease) on Friday, May 13, 2022; tested positive on Saturday, May 14, 2022 with a PCR test): resolving. Diagnostic results: On May 13, 2022, SARS-CoV-2 test: results not provided (inconclusive); Results not provided. On May 14, 2022, SARS-CoV-2 test: positive. No concomitant medications reported. Reportedly, patient was fully vaccinated with 2 primary doses and one booster dose of Moderna in Dec 2021, prior to getting COVID-19. He was prescribed Paxlovid. He has not picked up the prescription yet. He started not feeling well on Thursday, May 12, 2022. He did a home test for COVID-19 (disease) on Friday, May 13, 2022, and tested positive on Saturday, May 14, 2022, with a PCR test. On Saturday he felt worse, but started feeling better on Sunday, May 15, 2022; and "even better today." All doses were Moderna. Sender's comments: This is a spontaneous case concerning a 67-year-old male patient with no medical history reported, who experienced the unexpected adverse event of special interest COVID-19 confirmed by PCR test, which occurred approximately 5 months after receiving the third/booster dose of mRNA-1273 vaccine. Patient received 2 doses of mRNA-1273 vaccine, on unknown dates, prior to the third/booster dose. Initially, patient felt unwell and underwent COVID-19 PCR test with positive result. Patient prescribed Paxlovid, however has not picked up the prescription. It was not mentioned if patient took the medication. Patient reported he started feeling better the next day. The benefit-risk relationship of mRNA-1273 not affected by this report.
Sex: U
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Rebound covid. tested positive on 5/15/2022 after testing negative 3 times since completing the treatment; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Rebound covid. tested positive on 5/15/2022 after testing negative 3 times since completing the treatment) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032r21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19.    No Medical History information was reported.   On 19-Nov-2021 at 3:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 15-May-2022, the patient experienced COVID-19 (Rebound covid. tested positive on 5/15/2022 after testing negative 3 times since completing the treatment). At the time of the report, COVID-19 (Rebound covid. tested positive on 5/15/2022 after testing negative 3 times since completing the treatment) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-May-2022, SARS-CoV-2 test: positive (Positive) Positive. tested positive on 5/15/2022 after testing negative 3 times since completing the treatment.         No concomitant medication was reported. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. No treatment medication was reported. Company comment: This spontaneous case concerns a patient of an unknown age and gender, with no medical history reported, who experienced the non-serious unexpected AESI of COVID-19 (reported as Rebound covid) approximately 6 months after the third dose of mRNA-1273 vaccine. No details of previous doses were provided. As per narrative of the source document, he received Paxlovid (ritonavir) as COVID-19 treatment, and 10 days later he tested positive after testing negative 3 times since completing the treatment. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender, with no medical history reported, who experienced the non-serious unexpected AESI of COVID-19 (reported as Rebound covid) approximately 6 months after the third dose of mRNA-1273 vaccine. No details of previous doses were provided. As per narrative of the source document, he received Paxlovid (ritonavir) as COVID-19 treatment, and 10 days later he tested positive after testing negative 3 times since completing the treatment. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the mRNA-1273 is not affected by this report.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 11-Jan-2022 and administerd on 02-Mar-2022; Patient received expired dose after the 30 day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose after the 30 day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and administerd on 02-Mar-2022) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 044B21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose after the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and administerd on 02-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose after the 30 day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and administerd on 02-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient received expired booster 1 dose. It was reported that the staff were not dating the boxes of vaccine when placing them in the fridge for storage. The vial was initially stored in the refrigerator on 11-Jan-2022. The dose administered more than 30 days after 11-Jan-2022 was not in accordance with a Regulatory Authority. The vial did not undergo any temperature excursions. The patient had not reported adverse reaction to the HCP knowledge. No treatment information was reported.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered to the patient) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 11-Jan-2022 and administered on 01-Mar-2022) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination. Previously administered products included for Drug use for unknown indication: Pfizer (Dose 1 and Batch number as EL9265) on 28-Jan-2021; for Product used for unknown indication: Pfizer (Dose 2 and Batch number as EL9265) on 18-Feb-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. On 01-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered to the patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 11-Jan-2022 and administered on 01-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered to the patient) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 11-Jan-2022 and administered on 01-Mar-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. A pharmacist, the vaccine coordinator in their health care facility reported that they inadvertently administered expired dose of the Moderna COVID-19 vaccine. Date the vial was initially stored in the refrigerator was on 11-Jan-2022, which meant that all doses administered more than 30 days after 11-Jan-2022 were not in accordance with the EUA. The vial did not undergo any temperature excursions. They identified an additional issue that staff were not dating the boxes of vaccine when placing them in the fridge for storage. Patient received 1st booster dose on 01-Mar-2022 and not reported adverse reaction to the HCP's knowledge. No treatment medications were provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Mouth swelling, Swollen tongue, Trismus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MOUTH SWELLING (After I had taken 2.5 packs of the Paxlovid I had an adverse event in which my mouth swelled), SWOLLEN TONGUE (After I had taken 2.5 packs of the Paxlovid I had an adverse event in which my mouth swelled and tongue swelled) and TRISMUS (Felt like my mouth could not open far enough for me to be comfortable) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for an unknown indication. The patient had no allergy. Concomitant products included ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (BLISOVI 24 FE) for Birth control, FLUOXETINE HYDROCHLORIDE (PROZAC), BUSPIRONE and MONTELUKAST for an unknown indication. On 29-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 started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) 2.5 packs. On 12-May-2022, the patient experienced MOUTH SWELLING (After I had taken 2.5 packs of the Paxlovid I had an adverse event in which my mouth swelled), SWOLLEN TONGUE (After I had taken 2.5 packs of the Paxlovid I had an adverse event in which my mouth swelled and tongue swelled) and TRISMUS (Felt like my mouth could not open far enough for me to be comfortable). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) in May 2022 at a dose of 1 dosage form. On 12-May-2022, MOUTH SWELLING (After I had taken 2.5 packs of the Paxlovid I had an adverse event in which my mouth swelled), SWOLLEN TONGUE (After I had taken 2.5 packs of the Paxlovid I had an adverse event in which my mouth swelled and tongue swelled) and TRISMUS (Felt like my mouth could not open far enough for me to be comfortable) had resolved. An unknown drug was taken as COVID-19 treatment with start date on 10-MAY-2022 and end date on 12-May-2022. It was reported that after patient took 2.5 packs of the Paxlovid, patient had an adverse event on 12-May-2022 in which mouth swelled and tongue swelled. Patient felt like mouth could not be opened far enough to be comfortable. Patient needed to take Benadryl and contact the doctor for a care plan. The Device Date  was reported as 13-May-2022.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 16-Feb-2022; Dose administered after 30-day Use By Date/ inadvertently administered expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/ inadvertently administered expired dose of the Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 16-Feb-2022) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 008C21A and 044B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/ inadvertently administered expired dose of the Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 16-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/ inadvertently administered expired dose of the Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 16-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Date the vial was initially stored in the refrigerator was 11-Jan-2022. The vial did not undergo any temperature excursions. Patient did not reported any adverse reactions.  Treatment information was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) 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 IMMUNISATION REACTION (Vaccination adverse reaction) (seriousness criterion hospitalization). The patient was hospitalized for 7 days due to IMMUNISATION REACTION. At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       The concomitant medication was not reported.  The treatment medication was not provided. Patient was administered with Moderna COVID-19 vaccine and it put her in hospital for a week.  Company comment- This spontaneous case concerns a female of unknown age with no reported medical history, who experienced unexpected, serious (hospitalization) event of Immunisation reaction which occurred at an unknown time with regards to the mRNA-1273 vaccination. The patient was vaccinated with a dose of mRNA-1273 on an unknown date. No further information was provided. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events' seriousness was assessed as per Regulatory Authority's report.; Sender's Comments: This spontaneous case concerns a female of unknown age with no reported medical history, who experienced unexpected, serious (hospitalization) event of Immunisation reaction which occurred at an unknown time with regards to the mRNA-1273 vaccination. The patient was vaccinated with a dose of mRNA-1273 on an unknown date. No further information was provided. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events' seriousness was assessed as per Regulatory Authority's report.
Age: 39.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Runny nose and cold symptoms, testing positive again; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Runny nose and cold symptoms, testing positive again) in a 39-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 vaccination.    Concurrent medical conditions included Drug allergy (unknown drug).   On 26-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 14-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Runny nose and cold symptoms, testing positive again). At the time of the report, COVID-19 (Runny nose and cold symptoms, testing positive again) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2022, SARS-CoV-2 test: positive (Positive) positive. On an unknown date, SARS-CoV-2 test: negative (Negative) negative.         The patient race was given. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient had runny nose and cold symptoms. No treatment was received.  Company Comment: This is a spontaneous case concerning a 39-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 5 months after receiving a dose of mRNA-1273 vaccine. The patient reported runny nose and cold symptoms with positive test again for COVID after testing negative. Clinical course, other relevant diagnostic tests and treatment details were not provided in the case. The event had not resolved at the time of the report. It should be noted that the dose was reported as third dose however, there were no information regarding the previous 2 doses of COVID-19 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 39-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 5 months after receiving a dose of mRNA-1273 vaccine. The patient reported runny nose and cold symptoms with positive test again for COVID after testing negative. Clinical course, other relevant diagnostic tests and treatment details were not provided in the case. The event had not resolved at the time of the report. It should be noted that the dose was reported as third dose however, there were no information regarding the previous 2 doses of COVID-19 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 66.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Negative test on 5/9/22; symptoms gone. Symptoms returned 5/13/22; tested positive 5/14:22; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Negative test on 5/9/22; symptoms gone. Symptoms returned 5/13/22; tested positive 5/14:22) in a 66-year-old female 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.    The patient did not take any other medications/products within two weeks of starting COVID-19 treatment. The patient had previously received a COVID-19 Vaccine.  Concurrent medical conditions included Allergy.   On 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Oct-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 13-May-2022, the patient experienced COVID-19 (Negative test on 5/9/22; symptoms gone. Symptoms returned 5/13/22; tested positive 5/14:22). At the time of the report, COVID-19 (Negative test on 5/9/22; symptoms gone. Symptoms returned 5/13/22; tested positive 5/14:22) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 14-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported. No treatment medications were reported.  Company Comment: This spontaneous case concerns a 66-year-old female patient with no relevant medical history who experienced the unexpected non-serious AESI of COVID-19 which occurred 1 month 19 days after a dose mRNA-1273 vaccine (dose number not specified). Patient was administered with NIRMATRELVIR, RITONAVIR (Paxlovid) for 5 days as treatment for COVID-19 after the treatment he was tested negative for covid-19. 4 days later, symptoms returned and the next day she was tested positive for COVID-19. COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 66-year-old female patient with no relevant medical history who experienced the unexpected non-serious AESI of COVID-19 which occurred 1 month 19 days after a dose mRNA-1273 vaccine (dose number not specified). Patient was administered with NIRMATRELVIR, RITONAVIR (Paxlovid) for 5 days as treatment for COVID-19 after the treatment he was tested negative for covid-19. 4 days later, symptoms returned and the next day she was tested positive for COVID-19. COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 25.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Symptom recurrence
Clinical narrative: My symptoms rebounded after taking Paxlovid for COVID infection; This spontaneous case was reported by a patient and describes the occurrence of SYMPTOM RECURRENCE (My symptoms rebounded after taking Paxlovid for COVID infection) in a 25-year-old female 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 Multiple sclerosis and Allergy (Unknown historical drug).   On 08-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SYMPTOM RECURRENCE (My symptoms rebounded after taking Paxlovid for COVID infection). At the time of the report, SYMPTOM RECURRENCE (My symptoms rebounded after taking Paxlovid for COVID infection) was resolving.            Patient race was reported. No concomitant medication information was provided.  The patient was not taking any other medicationsproducts(unspecified) within 2 weeks of starting COVID-19 treatment.  No treatment medication were provided.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Dysphagia, Influenza
Clinical narrative: No appetite; tries to swallow food the food does not go all the way down; flu symptoms 7 hours after he received the booster dose.; This spontaneous case was reported by a patient and describes the occurrence of DECREASED APPETITE (No appetite), DYSPHAGIA (tries to swallow food the food does not go all the way down) and INFLUENZA (flu symptoms 7 hours after he received the booster dose.) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson and Johnson (The patient received Johnson and Johnson for his Primary Series and his first booster dose.). Past adverse reactions to the above products included No adverse event with Johnson and Johnson.    On 16-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced DECREASED APPETITE (No appetite), DYSPHAGIA (tries to swallow food the food does not go all the way down) and INFLUENZA (flu symptoms 7 hours after he received the booster dose.). At the time of the report, DECREASED APPETITE (No appetite), DYSPHAGIA (tries to swallow food the food does not go all the way down) and INFLUENZA (flu symptoms 7 hours after he received the booster dose.) outcome was unknown.            Patient took primary series and first booster of Johnson and Johnson vaccine and second Covid-19 vaccine booster dose as the Moderna vaccine. The patient had received second booster dose of Moderna vaccine on 16-May-2022. No concomitant information were reported by the reporter. No treatment information were reported by the reporter.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was first punctured on 17-May-2022 at 12 PM and administered on 18-May-2022 at 1 PM; Vaccine expired around 00:00 on 18-May-2022 and was administered on 18-May-2022 around 13:00; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expired around 00:00 on 18-May-2022 and was administered on 18-May-2022 around 13:00) and PRODUCT STORAGE ERROR (Vial was first punctured on 17-May-2022 at 12 PM and administered on 18-May-2022 at 1 PM) in a 51-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 025L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2022 at 1:00 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-May-2022 at 1:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired around 00:00 on 18-May-2022 and was administered on 18-May-2022 around 13:00). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 17-May-2022 at 12 PM and administered on 18-May-2022 at 1 PM). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine expired around 00:00 on 18-May-2022 and was administered on 18-May-2022 around 13:00) and PRODUCT STORAGE ERROR (Vial was first punctured on 17-May-2022 at 12 PM and administered on 18-May-2022 at 1 PM) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  The pharmacist found out that two patients in their hospital got expired Moderna COVID-19 vaccine on 18-May-2022 around 1 PM. The vials should have expired around 00:00 on 18-May-2022.   Date the vial was initially stored in the refrigerator on 27-Apr-2022. Date and time vial was first punctured on 17-May-2022 at 12 PM. Date and times of administration of vaccine was 18-May-2022 at 1 PM. The vial was stored in room temperature post puncture. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 to 25 C46 to 77 F) was 25 hours. No treatment medications were provided.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive on rapid & PCR on 5/3, took Paxlovid 5/3 to 5/8, tested negative on rapid 5/8, 5/9, 5/10 then tested positive on rapid 5/12, 5/13, 5/15, & 5/16; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive on rapid & PCR on 5/3, took Paxlovid 5/3 to 5/8, tested negative on rapid 5/8, 5/9, 5/10 then tested positive on rapid 5/12, 5/13, 5/15, & 5/16) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2022, the patient experienced COVID-19 (Tested positive on rapid & PCR on 5/3, took Paxlovid 5/3 to 5/8, tested negative on rapid 5/8, 5/9, 5/10 then tested positive on rapid 5/12, 5/13, 5/15, & 5/16). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 03-May-2022 to 08-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive on rapid & PCR on 5/3, took Paxlovid 5/3 to 5/8, tested negative on rapid 5/8, 5/9, 5/10 then tested positive on rapid 5/12, 5/13, 5/15, & 5/16) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 08-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 09-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 10-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 12-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 13-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 15-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 16-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.   No concomitant medications were reported.  It was unknown if the patient was taking any other medications or products within two weeks of starting COVID-19 treatment with Paxlovid. COMPANY COMMENT: This is an spontaneous case concerning a  53-years-old male patient with   no medical history who experienced the unexpected AESI event   of COVID-19 166 days after  receiving the  3rd  dose of  mRNA-1273 vaccine. The patient was treated with NIRMATRELVIR, RITONAVIR from 03-May-2022 to 08-May-2022 for COVID-19, at an unspecified dose and frequency The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning a  53-years-old male patient with   no medical history who experienced the unexpected AESI event   of COVID-19 166 days after  receiving the  3rd  dose of  mRNA-1273 vaccine. The patient was treated with NIRMATRELVIR, RITONAVIR from 03-May-2022 to 08-May-2022 for COVID-19, at an unspecified dose and frequency The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vial was first punctured on 17May2022 at 12 PM/stored at room temperature post puncture/ vial was exposed to room temperature for 25hrs; Patient got expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient got expired dose) and PRODUCT STORAGE ERROR (vial was first punctured on 17May2022 at 12 PM/stored at room temperature post puncture/ vial was exposed to room temperature for 25hrs) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2022 at 1:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2022 at 1:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient got expired dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was first punctured on 17May2022 at 12 PM/stored at room temperature post puncture/ vial was exposed to room temperature for 25hrs). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient got expired dose) and PRODUCT STORAGE ERROR (vial was first punctured on 17May2022 at 12 PM/stored at room temperature post puncture/ vial was exposed to room temperature for 25hrs) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  The pharmacist found out that two patients in their hospital got expired Moderna COVID-19 vaccine on 18-May-2022 around 1 PM. The vials should have expired around 00:00 on 18-May-2022. She wanted to make sure the vaccine still maintained potency and the patients did not need to be revaccinated.  Number of doses/vials included 2 doses.   Date the vial was initially stored in the refrigerator - 27-Apr-2022.  The vial did not undergo any temperature excursions.  Total amount of time the vial was exposed to room temperature range (8 to 25 C= 46 to 77 F): 25 hours  No treatment medications were provided.