chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia
Clinical narrative: PAIN IN FINGERS; FEVER; This spontaneous report received from a patient via other manufacturer (AbbVie) concerned a 58 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis, and other pre-existing medical conditions included: There was no reported medical history. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: unknown) dose was not reported, 1 total, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 58 years old. No concomitant medications were reported. The patient received non-company suspect drug: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis.  On an unspecified date in 2021, the patient experienced fever (covid vaccine issue low grade temperature) (dose number in series 1). On an unspecified date, the patient experienced pain in fingers (dose number in series 1). The patient received additional dose of non-company suspect vaccine: Moderna covid-19 vaccine (Elasomeran) (dose number in series 2) (form of admin unknown, intramuscular, batch number was not reported) dose was not reported, administered on 23-NOV-2021 for prophylactic vaccination.  On an unspecified date 2021, the patient experienced fever (covid vaccine issue low grade temperature) (dose number in series 2). On an unspecified date, the patient experienced pain in fingers (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab, and elasomeran was not reported. The patient was recovering from pain in fingers, and the outcome of fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Palpitations, Vaccination failure
Clinical narrative: COVID-19 PNEUMONIA; SUSPECTED CLINICAL VACCINATION FAILURE; HEART PALPITATIONS; This spontaneous report received from a patient via other manufacturer (Agency) through a company representative concerned an adult female of an unspecified age, race and ethnicity. The patient's height and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number and expiry were not reported) dose, start therapy date were not reported for covid-19 vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. It was reported that the patient started to have heart palpitations after she received Janssen Covid-19 vaccine and was under physician care. On an unspecified date, the patient had Covid and was off Humira for four weeks (suspected clinical vaccination failure). The patient also experienced fatigue and covid-19 pneumonia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart palpitations, suspected clinical vaccination failure and covid-19 pneumonia was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint and reference number has been requested.; Sender's Comments: V0: 20220553579-Covid-19 vaccine ad26.cov2.s-Covid-19 pneumonia . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.  20220553579-Covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood potassium, Blood potassium increased, Inappropriate schedule of product administration, Liver disorder, Off label use
Clinical narrative: LIVER DISORDER; POTASSIUM HIGH; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; BLOOD CLOT; This spontaneous report received from a patient concerned a 72 year old female of an unspecified race and ethnicity. 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, intramuscular, batch number: Unknow and expiry: Unknown) dose was not reported, 1 total, dose 1 (1 in 1 once) administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 8 decade old. The patient additionally received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknow and expiry: Unknown) dose was not reported, 1 total, dose 2 (1 in 1 once) administered on AUG-2021 for prophylactic vaccination which is off label use, and inappropriate schedule of vaccine administered.  The patient received non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) 40 mg, frequency, and therapy dates were not reported for psoriatic arthritis; and metformin ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported.  On 2021 (Date and month unspecified), the patient experienced blood clot. On MAR-2022, the patient experienced liver disorder, and potassium high. Laboratory data included: Potassium (NR: not provided) High (too high). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab, and metformin was not reported. The outcome of the liver disorder, potassium high, blood clot, off label use and inappropriate schedule of vaccine administered was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220553660- covid-19 vaccine ad26.cov2.s- blood clot. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: LIVER DISORDER; POTASSIUM HIGH; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; BLOOD CLOT; This spontaneous report received from a patient concerned a 72 year old female of an unspecified race and ethnicity. 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, intramuscular, batch number: Unknow and expiry: Unknown) dose was not reported, 1 total, dose 1 (1 in 1 once) administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 8 decade old. The patient additionally received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknow and expiry: Unknown) dose was not reported, 1 total, dose 2 (1 in 1 once) administered on AUG-2021 for prophylactic vaccination which is off label use, and inappropriate schedule of vaccine administered.  The patient received non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) 40 mg, frequency, and therapy dates were not reported for psoriatic arthritis; and metformin ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported.  On 2021 (Date and month unspecified), the patient experienced blood clot. On MAR-2022, the patient experienced liver disorder, and potassium high. Laboratory data included: Potassium (NR: not provided) High (too high). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab, and metformin was not reported. The outcome of the liver disorder, potassium high, blood clot, off label use and inappropriate schedule of vaccine administered was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220553660- covid-19 vaccine ad26.cov2.s- blood clot. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Platelet count, Platelet disorder
Clinical narrative: RED PLATELETS ON BACK AND LEFT LEG; This spontaneous report received from other manufacture AbbVie, and the patient was enrolled in non-Company sponsored solicited program Facilitated Collection and concerned an 8 decade old elderly female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe ulcerative colitis. The patient received covid-19 vaccine ad26.cov2.s  (dose number in series 1) (suspension for injection, intramuscular, batch number and expiry date was not reported) dose, 01 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe ulcerative colitis. No concomitant medications were reported.  On an unspecified date in 2022, the patient experienced red platelets on back and left leg (dose number in series 1). Laboratory data (dates unspecified) included: Platelet count (NR: not provided) abnormal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient had not recovered from red platelets on back and left leg. The patient received pfizer biontech covid-19 vaccine (tozinameran) (dose number in series 2), (form of admin: unknown, intramuscular, and batch number: unknown, expiry: unknown) dose was not reported, start therapy date were not reported 1 total for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with pfizer biontech covid-19 vaccine (tozinameran) (dose number in series 2). This report was non-serious.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT STORAGE OF VACCINE; ADMINISTRATION OF VACCINE WHICH WAS STORED OUTSIDE OF RECOMMENDED STORAGE CONDITIONS; This spontaneous report received from a health care professional concerned a 47 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: 1822809, expiry: 04-AUG-2022) dose was not reported, administered on 22-FEB-2022 for prophylactic vaccination.  Age at time of vaccination 47 years old. No concomitant medications were reported.  On 22-FEB-2022, the patient experienced administration of vaccine which was stored outside of recommended storage conditions. On an unspecified date, the patient experienced incorrect storage of vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine which was stored outside of recommended storage conditions and incorrect storage of vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20220558340, 20220558345, 20220558451, 20220558511, 20220558598, 20220558439, 20220558390 and 20220558823.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: ADMINISTRATION ERROR / VACCINE ADMINISTERED TO 16 YEAR OLD PATIENT; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 16 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: 1822809, and expiry: 04-AUG-2022) dose was not reported, administered on 09-NOV-2021 for prophylactic vaccination. Age at time of vaccination 16 years old. No concomitant medications were reported. On 09-NOV-2021, the patient experienced administration error / vaccine administered to 16 year old patient, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration error / vaccine administered to 16 year old patient and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20220558451, 20220558511, 20220558598, 20220558439, 20220558390, 20220558638 and 20220558823.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; VACCINE ADMINISTERED AFTER STORAGE OUTSIDE OF RECOMMENDED STORAGE CONDITIONS; This spontaneous report received from a health care professional concerned a 22 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: 1822809, and expiry: 04-AUG-2022) dose was not reported, administered on 18-JAN-2022 for prophylactic vaccination. Age at time of vaccination 22 years old. No concomitant medications were reported. On 18-JAN-2022, the patient experienced vaccine administered after storage outside of recommended storage conditions. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and vaccine administered after storage outside of recommended storage conditions was not reported. This report was non-serious. This case, from the same reporter is linked to 20220558451, 20220558511, 20220558598, 20220558439 and 20220558638.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: HEART ATTACK; This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. 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, and batch number and expiry date were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination.  The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced heart attack. Patient stated that, "I had my first heart attack after your vaccine, I doubt if I will be looking 25 years out". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart attack was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220558389-covid-19 vaccine ad26.cov2.s-Heart attack. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: PRODUCT STORAGE ERROR; VACCINE ADMINISTERED AFTER STORAGE OUTSIDE OF THE RECOMMENDED STORAGE CONDITIONS; 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: 1822809, and expiry: 04-AUG-2022) dose was not reported, administered on 25-FEB-2022 for prophylactic vaccination. Age at time of vaccination 40 years old. No concomitant medications were reported. On 25-FEB-2022, the patient experienced vaccine administered after storage outside of the recommended storage conditions. On an unspecified date, the patient experienced product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administered after storage outside of the recommended storage conditions and product storage error was not reported. This report was non-serious. This case, from the same reporter is linked to 20220558451, 20220558340, 20220558439, 20220558455, 20220558511, 20220558638, 20220558852, 20220558823, 20220558343, 20220558345, 20220558349, 20220558378, 20220558383 and 20220558598.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: PRODUCT STORAGE ERROR; ADMINISTRATION ERROR OF VACCINE STORED OUTSIDE OF THE RECOMMENDED STORAGE CONDITIONS; This spontaneous report received from a health care professional concerned a 38 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: 1822809, and expiry: 04-AUG-2022) dose was not reported, administered on 04-JAN-2022 for prophylactic vaccination. Age at time of vaccination 38 years old. No concomitant medications were reported. On 04-JAN-2022, the patient experienced administration error of vaccine stored outside of the recommended storage conditions. On an unspecified date, the patient experienced product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration error of vaccine stored outside of the recommended storage conditions and product storage error was not reported. This report was non-serious. This case, from the same reporter is linked to 20220558451, 20220558511, 20220558390, 20220558340, 20220558343, 20220558345, 20220558349, 20220558378, 20220558383, 20220558455, 20220558598, 20220558638, 20220558823 and 20220558852.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; ADMINISTRATION OF VACCINE THAT  WAS STORED OUTSIDE OF THE RECOMMENDED STORAGE CONDITIONS; This spontaneous report received from a health care professional concerned a 31 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: 1822809 expiry: 4-AUG-2022) dose was not reported, administered on 11-JAN-2022 for prophylactic vaccination. Age at time of vaccination 31 years old. No concomitant medications were reported.  On 11-JAN-2022, the patient experienced administration of vaccine that was stored outside of the recommended storage conditions. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine that was stored outside of the recommended storage conditions and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220558340, 20220558343, 20220558345, 20220558349, 20220558378, 20220558383, 20220558390, 20220558439, 20220558455, 20220558511, 20220558598, 20220558638 and 20220558852.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT STORAGE OF VACCINE; VACCINE ADMINISTERED AFTER STORAGE OUTSIDE OF RECOMMENDED STORAGE CONDITIONS; This spontaneous report received from a health care professional concerned a 31 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: 1822809 expiry: 04-AUG-2022) dose was not reported, administered on 11-JAN-2022 for prophylactic vaccination. Age at time of vaccination 31 years old. No concomitant medications were reported. On 11-JAN-2022, the patient experienced vaccine administered after storage outside of recommended storage conditions. On an unspecified date, the patient experienced incorrect storage of vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered after storage outside of recommended storage conditions and incorrect storage of vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20220558451, 20220558511, 20220558390, 20220558439, 20220558823 and 20220558598.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; ADMINISTRATION OF INCORRECTLY STORED VACCINE; This spontaneous report received from a physician concerned a 54 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: 211D21A, expiry: 08-SEP-2022) .5 ml, administered on 30-NOV-2021 for prophylactic vaccination. Age at time of vaccination 54 years old. No concomitant medications were reported. On 30-NOV-2021, the patient experienced administration of incorrectly stored vaccine. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of incorrectly stored vaccine and incorrect product storage was not reported. This report was non-serious. This report is associated with a product quality complaint: 90000233203. This case, from the same reporter is linked to 20220558497, 20220558479, 20220558436, 20220558475, 20220558482 and 20220558498.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Poor quality product administered, Product administered to patient of inappropriate age
Clinical narrative: VACCINE ADMINISTERED AFTER 6 HOURS OF VIAL PUNCTURE; OFF LABEL USE; INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; This spontaneous report received from a physician concerned a 13 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: 211D21A, expiry: 08-SEP-2022) .5 ml, administered on 25-MAR-2022 for prophylactic vaccination. Age at time of vaccination 13 years old. No concomitant medications were reported. On 25-MAR-2022, the patient experienced vaccine administered after 6 hours of vial puncture, off label use, and inappropriate age at vaccine administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered after 6 hours of vial puncture, off label use and inappropriate age at vaccine administration was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000233206. This case, from the same reporter is linked to 20220558436, 20220558469, 20220558475, 20220558479, 20220558482, 20220558498 and 20220558436.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; VACCINE ADMINISTERED AFTER STORAGE OUTSIDE OF RECOMMENDED STORAGE CONDITIONS; This spontaneous report received from a health care professional concerned a 42 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: 1822809, expiry: 4-AUG-2022) dose was not reported, administered on 17-FEB-2022 for prophylactic vaccination. Age at time of vaccination 42 years old. No concomitant medications were reported. On 17-FEB-2022, the patient experienced vaccine administered after storage outside of recommended storage conditions. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered after storage outside of recommended storage conditions and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220558451, 20220558340, 20220558343, 20220558345, 20220558349, 20220558378, 20220558383, 20220558439, 20220558455, 20220558390, 20220558823, 20220558852 and 20220558638.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; VACCINE ADMINISTERED AFTER STORAGE OUTSIDE OF THE RECOMMENDED STORAGE CONDITIONS; 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: 1822809, expiry: 4-AUG-2022) dose was not reported, administered on 03-MAR-2022 for prophylactic vaccination. Age at time of vaccination 51 years old. No concomitant medications were reported. On 03-MAR-2022, the patient experienced vaccine administered after storage outside of the recommended storage conditions. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered after storage outside of the recommended storage conditions and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220558343, 20220558345, 20220558349, 20220558378, 20220558383, 20220558451, 20220558439, 20220558823, 20220558455, 20220558511, 20220558638, 20220558852 and 20220558340.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; VACCINE ADMINISTERED AFTER STORAGE OUTSIDE OF RECOMMENDED STORAGE CONDITIONS; This spontaneous report received from a health care professional concerned a 19 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: 1822809, expiry: 4-AUG-2022) dose was not reported, administered on 17-FEB-2022 for prophylactic vaccination. Age at time of vaccination 19 years old. No concomitant medications were reported. On 17-FEB-2022, the patient experienced vaccine administered after storage outside of recommended storage conditions. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered after storage outside of recommended storage conditions and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220558390, 20220558439, 20220558451, 20220558455, 20220558511, 20220558598, 20220558638, 20220558340, 20220558343, 20220558345, 20220558349, 20220558378 and 20220558383.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; VACCINE ADMINISTERED AFTER STORAGE OUTSIDE OF RECOMMENDED STORAGE CONDITIONS; This spontaneous report received from a health care professional concerned a 37 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: 1822809 expiry: 04-AUG-2022) dose was not reported, administered on 21-JAN-2022 for prophylactic vaccination. Age at time of vaccination 37 years old. No concomitant medications were reported. On 21-JAN-2022, the patient experienced vaccine administered after storage outside of recommended storage conditions. On an unspecified date, the patient experienced incorrect product storage.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered after storage outside of recommended storage conditions and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220558390, 20220558451, 20220558511, 20220558598 and 20220558439.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Inappropriate schedule of product administration
Clinical narrative: unknown whether patient was immunocompromised, received booster for third dose/a 0.25 ml booster dose; unknown whether patient was immunocompromised, received booster for third dose/a 0.25 ml booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (unknown whether patient was immunocompromised, received booster for third dose/a 0.25 ml booster dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (unknown whether patient was immunocompromised, received booster for third dose/a 0.25 ml booster dose) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. In December 2021, the patient experienced ACCIDENTAL UNDERDOSE (unknown whether patient was immunocompromised, received booster for third dose/a 0.25 ml booster dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (unknown whether patient was immunocompromised, received booster for third dose/a 0.25 ml booster dose). At the time of the report, ACCIDENTAL UNDERDOSE (unknown whether patient was immunocompromised, received booster for third dose/a 0.25 ml booster dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (unknown whether patient was immunocompromised, received booster for third dose/a 0.25 ml booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter.  It was reported that it was 5 months after her first booster and she was immunocompromised. It was also reported that the patient was under 50 and needs a second booster.  No treatment medications were reported by the reporter.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 09-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. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Negative and positive (Positive) Positive. On 18-May-2022, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  The patient took the 5-day course of Paxlovid. His symptoms cleared after a few days, and he tested negative on a rapid test. Then around 10 days after his initial positive test, he developed symptoms and had been testing positive since 18 May 2022.  Company Comment: This is a spontaneous case concerning a 39-year-old male patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 13 months after receiving a dose of mRNA-1273 vaccine. The patient was treated with Nirmatrelvir/Ritonavir for 5 days, symptoms cleared and tested negative on rapid test. 10 days after the initial positive test, the patient developed symptoms and tested positive. The event had not resolved at the time of the report. 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 reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 13 months after receiving a dose of mRNA-1273 vaccine. The patient was treated with Nirmatrelvir/Ritonavir for 5 days, symptoms cleared and tested negative on rapid test. 10 days after the initial positive test, the patient developed symptoms and tested positive. The event had not resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 76-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 Rheumatoid arthritis, GERD, Penicillin allergy and Sulfonamide allergy. Concomitant products included ABATACEPT (ORENCIA) from 10-May-2022 to an unknown date and OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) from 01-Oct-2021 to an unknown date for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.            No concomitant medication information provided  The patient had past drug reaction allergy. The patient took other medications/products within 2 weeks of starting COVID-19 treatment.  The patient previously receives a COVID-19 Vaccine. Device date was reported as 23-May-2022. Reported Event: I finished the Paxlovid and felt better. Five days after finishing felt sick, low grade fever and cough. Five days later still feel about the same. Device Date : 23May2022  Company comment- This spontaneous case concerns a 76-year-old female patient with no relevant medical history, who experienced unexpected, non- serious adverse event of special interest Covid-19 which occurred at an unknown time with regards to the mRNA-1273 vaccination. The patient felt better after finishing her course of Paxlovid. However, five days after she felt sick, had low grade fever and cough with no relief. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 76-year-old female patient with no relevant medical history, who experienced unexpected, non- serious adverse event of special interest Covid-19 which occurred at an unknown time with regards to the mRNA-1273 vaccination. The patient felt better after finishing her course of Paxlovid. However, five days after she felt sick, had low grade fever and cough with no relief. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: retested positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (retested positive) in a 45-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 Drug allergy.   On 08-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (retested positive). At the time of the report, COVID-19 (retested positive) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant was reported by patient. Patient completed antiviral for 5 days, tested negative days 5-7. Patient still feeling unwell after 10 days, then progressively worse around what would be day 12 and retested positive.  Patient had taken 3 dose of Moderna vaccine on left arm. It was unknown if patient was taking any other medications or products within 2 weeks of starting COVID-19 treatment, patient previously receive a COVID-19 Vaccine. Patient reported Device Date as 20-May-2022. Treatment medication was not reported by patient.  Company comment- This spontaneous case concerns a 45-year-old male patient with no relevant medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 which occurred at an unknown time with regards to the mRNA-1273 vaccination. The patient completed the course of antiviral for 5 days and tested negative from days 5 to 7 but he still felt unwell after 10 days. His symptoms became worse on the 12th day, and he retested positive again. The outcome of the events was reported as not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 45-year-old male patient with no relevant medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 which occurred at an unknown time with regards to the mRNA-1273 vaccination. The patient completed the course of antiviral for 5 days and tested negative from days 5 to 7 but he still felt unwell after 10 days. His symptoms became worse on the 12th day, and he retested positive again. The outcome of the events was reported as not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Rebound infection with new positive testing, fever and symptoms two days after finishing paxlovid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Rebound infection with new positive testing, fever and symptoms two days after finishing paxlovid) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Hypothyroidism, Anxiety and Drug allergy (unknown drug). Concomitant products included LEVOTHYROXINE, FLUOXETINE, BUDESONIDE (PULMICORT) and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 30-Mar-2022 at 1:00 PM, 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 (Rebound infection with new positive testing, fever and symptoms two days after finishing paxlovid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 12-May-2022 to 17-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Rebound infection with new positive testing, fever and symptoms two days after finishing paxlovid) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: positive (Positive) Positive.         The patient used Paxlovid for treatment of COVID-19. On 20-MAY-2022, the patient had rebound infection with new positive testing, fever. The symptoms returned two days after finishing Paxlovid.  Company Comment: This is a spontaneous case concerning a 52-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately one and a half month after receiving a dose of mRNA-1273 vaccine. The patient was treated with Nirmatrelvir/Ritonavir for 5 days. 2 days after treatment, the patient had fever, symptoms and tested positive. The event had not resolved at the time of the report. It should be noted that the dose was received as fourth dose however, there were no information regarding the previous 3 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 52-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately one and a half month after receiving a dose of mRNA-1273 vaccine. The patient was treated with Nirmatrelvir/Ritonavir for 5 days. 2 days after treatment, the patient had fever, symptoms and tested positive. The event had not resolved at the time of the report. It should be noted that the dose was received as fourth dose however, there were no information regarding the previous 3 doses of COVID-19 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 8:52 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 8:52 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 77.16  No concomitant medications were reported.  Batch number 019B21A underwent temperature excursion on 31-Mar-2021 with temperature 32 degrees Fahrenheit at 8 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 31-Mar-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. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).