Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Chills, Fatigue, Inappropriate schedule of product administration, Muscle spasms
Clinical narrative: VOMITING; GOT THE TREMFYA INJECTION LATE; SORENESS/BODY ACHES/ACHES; SPASMS; CHILLS; MUSCLE ACHES; FATIGUE; FEVER; REALLY BAD REACTION; This spontaneous report received from a patient concerned a 74 year old female of an unspecified race and ethnicity. The patient's weight was 135 pounds, and height was 160 centimeters. The patient's past medical history included: aneurysm (recovered), and concurrent conditions included: blood pressure (controlled), non-alcohol user, non-smoker, and plaque arthritis, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug use. The patient had no known drug or non-drug allergies. The patient was not pregnant at the time of the report. The patient previously received dose 1 with covid-19 vaccine ad26.cov2.s (unspecified manufacturer), (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s, (unspecified manufacturer), (Dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered on an unspecified date in FEB-2022 for covid-19 prophylaxis. Age at time of vaccination 74 years old. The batch number was not reported and has been requested. No concomitant medications were reported. The patient received guselkumab (solution for injection, route of admin, batch number and expiry date were not reported) dose, frequency, and therapy dates were not reported for plaque arthritis. The drug was associated with Medication error. The batch number was not reported and has been requested. It was reported that while on guselkumab the patient had a bad reaction on two separate occasions. First occasion was on an unspecified date in FEB-2022, around the time the patient received her Covid-19 vaccine (Dose number in series 2). The second occasion was in on an unspecified date in FEB-2023. The patient believed that they got the guselkumab injection late. The physician said that the vaccine and guselkumab would not have made her sick. On the second occasion, when the patient had an injection, patient had muscle aches and fatigue, vomiting and chills and fever (Dose number in series 2). The patient was on therapy now for a month for aches and spasms. The patient couldn't stop throwing up and was brought to the hospital and stayed in for 2 days. The hospitalization date and discharge date was unknown. It was excruciating. The patient had therapy to get rid of soreness and aches out of the body. The patient was doing physical therapy to get back to normal activities. (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; action taken with guselkumab for got the tremfya injection late was not reported; and treatment with guselkumab was withdrawn for muscle aches, fatigue, vomiting, chills and fever, really bad reaction spasms and soreness. The outcome of the got the tremfya injection late, muscle aches, fatigue, vomiting, chills, spasms, soreness/body aches/aches, fever and really bad reaction was not reported. This report was serious (Hospitalization Caused / Prolonged). This case is a duplicate of 20230458622.  It was determined that deletion was required for Manufacturer Report Number 20230458622 as it was duplicate of Manufacturer Case Number 20230446117. All relevant information regarding Manufacturer Report Number 20230458622 will be submitted under Manufacturer Case Number 20230446117.; Sender's Comments: V0: 20230446117- covid-19 vaccine ad26.cov2.s -vomiting. The event shows an incompatible temporal relationship. Therefore, this event is considered inconsistent with vaccine administration. 20230446117- guselkumab -vomiting. 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.