Sex: U
Vaccine: COVID19, FLUX
Symptoms: Dysphagia, Ear infection, Feeding disorder, Feeling abnormal, Illness
Clinical narrative: chronic sore throat; Ear infection; Throat infection; couldn't talk; couldn't swallow/still having swallowing issues/barely drank; couldn't eat; wished for months I would die; so ill now; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (chronic sore throat), EAR INFECTION (Ear infection), PHARYNGITIS (Throat infection), SPEECH DISORDER (couldn't talk), DYSPHAGIA (couldn't swallow/still having swallowing issues/barely drank), FEEDING DISORDER (couldn't eat), FEELING ABNORMAL (wished for months I would die) and ILLNESS (so ill now) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (chronic sore throat) (seriousness criterion hospitalization), EAR INFECTION (Ear infection) (seriousness criterion hospitalization), PHARYNGITIS (Throat infection) (seriousness criterion hospitalization), SPEECH DISORDER (couldn't talk) (seriousness criterion hospitalization), DYSPHAGIA (couldn't swallow/still having swallowing issues/barely drank) (seriousness criterion hospitalization), FEEDING DISORDER (couldn't eat) (seriousness criterion hospitalization), FEELING ABNORMAL (wished for months I would die) (seriousness criterion hospitalization) and ILLNESS (so ill now) (seriousness criterion hospitalization). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (chronic sore throat), EAR INFECTION (Ear infection), PHARYNGITIS (Throat infection), SPEECH DISORDER (couldn't talk), FEEDING DISORDER (couldn't eat) and FEELING ABNORMAL (wished for months I would die) outcome was unknown and DYSPHAGIA (couldn't swallow/still having swallowing issues/barely drank) and ILLNESS (so ill now) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  Patient had two doses of Modena covid vaccine and had an appointment scheduled for booster and patient also received flu shot.  It was reported that patient had the vaccine and reports winded up to addict Tylenol. Patient had put in the hospital and wished for months to die. Patient was so ill now and was still having swallowing issues.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This spontaneous case concerns a patient, of unknown age and gender, with history of co-suspect administration of Influenza vaccine, who experienced the unexpected, serious (hospitalization) events of oropharyngeal pain, ear infection, pharyngitis, speech disorder, dysphagia, feeding disorder, feeling abnormal and illness. The events occurred unknown number of days after receiving the second dose of the mRNA-1273 vaccine and unknown number of days after receiving the Influenza vaccine. Of note, the vaccination dates and the event onset dates were not provided, hence, the onset latency could not be assessed. It was reported that the patient experienced chronic sore throat, ear infection, throat infection, could not talk and could not swallow, and could not eat and barely drank. The patient was in the hospital and wished death for months. At the time of the report, patient was so ill and was still having swallowing issues. No further clinical information (including details about hospitalization) was available for medical review. However, it was reported that the patient 'wound up addict' to Tylenol (paracetamol). The co-suspect administration of Influenza vaccine remains a confounder for the events oropharyngeal pain and pharyngitis which are common side effects of the vaccine. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a patient, of unknown age and gender, with history of co-suspect administration of Influenza vaccine, who experienced the unexpected, serious (hospitalization) events of oropharyngeal pain, ear infection, pharyngitis, speech disorder, dysphagia, feeding disorder, feeling abnormal and illness. The events occurred unknown number of days after receiving the second dose of the mRNA-1273 vaccine and unknown number of days after receiving the Influenza vaccine. Of note, the vaccination dates and the event onset dates were not provided, hence, the onset latency could not be assessed. It was reported that the patient experienced chronic sore throat, ear infection, throat infection, could not talk and could not swallow, and could not eat and barely drank. The patient was in the hospital and wished death for months. At the time of the report, patient was so ill and was still having swallowing issues. No further clinical information (including details about hospitalization) was available for medical review. However, it was reported that the patient 'wound up addict' to Tylenol (paracetamol). The co-suspect administration of Influenza vaccine remains a confounder for the events oropharyngeal pain and pharyngitis which are common side effects of the vaccine. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.