Sex: U
Vaccine: COVID19
Symptoms: Dehydration, Dizziness, Injection site pain, Laboratory test, Stridor
Clinical narrative: DEHYDRATED; DIZZINESS; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; STRIDOR; FELT LIKE SUFFOCATING; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: unknown) dose was not reported, 1 total administered on 03-SEP-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 03-SEP-2021, the patient experienced injection site pain. On 08-JAN-2022, patient started with food and was not able to taste (100%) and loss of smell (85%) on and off for 2 days. Patient had these spine chills down to patient's back and went to sleep early. On 09-Jan-2022 patient experienced low-grade fever, headache, very sore throat, dizziness, malaise. The patient experienced suspected covid-19 infection which led to suspected clinical vaccination failure. On an unknown date in JAN-2022, the patient had a stridor (loud breathing) and felt like broken glass. Patient completely lost voice as well, and if patient coughed, it caused severe pain, but nothing would come up. That lasted for 3 days. Patient felt very dehydrated. Patient ended up with steroids, Mucinex. On 11-JAN-2022 patient had telephonic appointment in which patient was prescribed prednisone, guaifenesin. On JAN-2022, lab test was performed and result was received on 12-JAN-2022 (unknown) and on 13-JAN-2022 amoxicillin sodium; clavulanic acid (Augmentin) was prescribed. The patient had worst days on 15-JAN-2022, 16-JAN-2022 and 17-JAN-2022. Patient got scared because patient was coughing up bright green mucus. Patient had appointment on 17-JAN-2022. On an unknown date in JAN-2022, the patient felt like suffocating and put on oral and inhaled steroids. Patient was on ivermectin, montelukast sodium (Singulair), budesonide for 10 days. Patient was on rescue breathing treatments. Patient never had any breathing issues prior. Patient was on doxycycline for 2 weeks, famotidine, acetylsalicylic acid twice a day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected clinical vaccination failure, suspected covid-19 infection, and dizziness, and the outcome of injection site pain, dehydrated, stridor and felt like suffocating was not reported.  This report was serious (Other Medically Important Condition). This report associated with product quality complaint: 90000219228.; Sender's Comments: V0: 20220256505-  covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. The event(s) has a compatible/suggestive 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.