Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Gastrointestinal disorder, Guillain-Barre syndrome
Clinical narrative: DEATH; ANAPHYLAXIS; SEIZURES; STROKE/CEREBROVASCULAR ACCIDENT; BLOOD CLOTS; MENTAL IMPAIRMENT; BELL'S PALSY; SYNCOPE; GUILLAIN-BARRE SYNDROME; DVT; PULMONARY EMBOLISM; GASTROINTESTINAL SYMPTOMS; CHANGE IN BLOOD PRESSURE; ABNORMAL BEHAVIOR/MOOD CHANGES; VISION CHANGES BLURRED; OTHER PAIN; TACHYCARDIA; SOB/DIFFICULTY BREATHING; BODY ACHE; OTHER; SWELLING NON-INJECTION SITE; INJECTION-SITE SEVERE; DIZZINESS; SHINGLES; VERTIGO; VISION CHANGES IMPAIRED; INJECTION-SITE NON-SEVERE; BRAIN FOG; PALPITATIONS; RASH NON-INJECTION SITE; JOINT PAIN; CHILLS; HEADACHE; HIVES NON-INJECTION SITE; FATIGUE; FEVER; PARESTHESIA/TINGLING; TINNITUS; NUMBNESS; MYALGIA; This spontaneous report was received. An observational of adverse drug reactions to COVID-19 vaccines reported to the poison center hotline. CLINICAL TOXICOLOGY. 2022 Dec 02; 177-83. This report concerned multiple adult patients (median age 56) (38 female, 17 male and 1 unspecified sex). The aim of this study was to evaluated adverse reactions reported to a statewide hotline after the administration of a coronavirus disease-2019 (COVID-19) vaccine. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 11-MAR-2020, from hotline patients reported any adverse drug reaction experienced after covid-19 vaccine. The network that operated the covid-19 hotline during this study included the statewide poison center for general Covid-19 questions, a managed care nurse line for covid-19 symptom-related questions, and an epidemiologist line primarily dedicated to answering questions from healthcare providers. Callers dialed a common line, then a single-digit extension number, based on their needs. Each phone line received calls reporting ADRs after vaccine administration, and all partners took a summary of the case and forwarded it to the pharmacist at the poison center, who conducted follow up calls using a standard question list to gather ADR details and counsel on treatments. The the pharmacists documented all the cases and used translators when needed. Resolution of ADR or failure to reach patients after at least three attempts was the requirement for closing a case. All cases were included in the data analysis. The inclusion criteria were adrs reported after the first shot of all three vaccines and second shot of both pfizer and moderna, between 01-DEC-2020 through 31-AUG-2021 in individuals 12 years of age and older. For each case we recorded: demographic information (age, sex, race, ethnicity), history of prior COVID-19 infection, pregnancy status for females, vaccine brand, lot number, dose number, date and time of vaccine administration, allergy history, chronic medical problems, ADR nature and symptoms, onset time, treatment issued (if any), resolution time, and outcome severity. Exclusion criteria were calls with vaccine administered outside of state and children under the age of 12 years. A 638 ADR cases were recorded. The majority were female (70.8 percent) and the overall median age was 56. Out of 638 cases, 56 percent were received covid-19 vaccine ad26.cov2.s vaccine of which 38 were female, 17 were male and 1 was unspecified sex. The most common onset time for an ADR was within 12 to 24 hour after vaccination and time to recovery fell between less than 1 week (21.0 percent), less than 1 month (23.32 percent) and more than 1 month (21.5 percent). On an unspecified date, the patients experienced death, anaphylaxis, seizures, stroke/cerebrovascular accident, blood clots, mental impairment, syncope, bell's palsy, guillain-barre syndrome, dvt, pulmonary embolism, gastrointestinal symptoms, change in blood pressure, abnormal behavior/mood changes, vision changes blurred, other pain, tachycardia, sob/difficulty breathing, body ache, other, swelling non-injection site, injection-site severe, dizziness, shingles, vertigo, vision changes impaired, injection-site non-severe, brain fog, palpitations, rash non-injection site, joint pain, chills, headache, hives non-injection site, fatigue, fever, paresthesia/tingling, tinnitus, numbness, and myalgia. On an unspecified date, the patients died from unknown cause of death. It was unknown whether an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patients died of death on an unspecified date, and the outcome of headache, gastrointestinal symptoms, fatigue, fever, syncope, anaphylaxis, seizures, change in blood pressure, bell's palsy, paresthesia/tingling, stroke/cerebrovascular accident, blood clots, abnormal behavior/mood changes, tinnitus, vision changes blurred, other pain, mental impairment, tachycardia, joint pain, sob/difficulty breathing, numbness, myalgia, body ache, chills, other, hives non-injection site, swelling non-injection site, rash non-injection site, injection-site severe, dizziness, vertigo, shingles, guillain-barre syndrome, dvt, pulmonary embolism, vision changes impaired, brain fog, palpitations and injection-site non-severe was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0-20230337007- Death-Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.  V0-20230337007- Anaphylaxis, Guillain-barre syndrome, Bells palsy, DVT, Pulmonary embolism- The event has an unknown/unclear temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.  V0-20230337007- Blood clots- The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.  V0-20230337007- Seizures, stroke/cerebrovascular accident, mental impairment, syncope- The event 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. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH