Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Insomnia, SARS-CoV-2 test
Clinical narrative: Paxlovid kept her awake at night with insomnia periodically; have taken 4 shots, still got Covid, had 2 Moderna and had 2 Pfizer (COVID-19 Vaccines); This spontaneous case was reported by a patient and describes the occurrence of INSOMNIA (Paxlovid kept her awake at night with insomnia periodically) and COVID-19 (have taken 4 shots, still got Covid, had 2 Moderna and had 2 Pfizer (COVID-19 Vaccines)) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 prophylaxis and NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19.    Previously administered products included for Cold: Nyquil (Had colds in the past and a little dose of Nyquil seems to help her sleep/rest.); for Product used for unknown indication: Tylenol (reaction : hot sweats) and Tylenol (reaction : heart flutters). Past adverse reactions to the above products included Heart fluttering with Tylenol; No adverse effect with Nyquil; and Sweaty with Tylenol. Concurrent medical conditions included Osteoporosis. Concomitant products included DENOSUMAB (PROLIA) for Osteoporosis.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form, dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form On an unknown date, received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. and NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient experienced INSOMNIA (Paxlovid kept her awake at night with insomnia periodically) and COVID-19 (have taken 4 shots, still got Covid, had 2 Moderna and had 2 Pfizer (COVID-19 Vaccines)). At the time of the report, INSOMNIA (Paxlovid kept her awake at night with insomnia periodically) outcome was unknown and COVID-19 (have taken 4 shots, still got Covid, had 2 Moderna and had 2 Pfizer (COVID-19 Vaccines)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2022, SARS-CoV-2 test: Positive.         The patient received 2 doses of Pfizer vaccine and 2 doses of Moderna vaccine.  Patient took the vaccine doses back in 2021 and 2022 and patient did not have the sore throat back then when vaccinated.  Patient had sore throat before starting Paxlovid therapy. The patient had a little bit of mild sore throat over the weekend and on 05-Dec-2022, the throat was extremely sore. The patient then tested positive for COVID-19.  The patient was prescribed Paxlovid by physician and took the Paxlovid medication as the patient had a severe sore throat and a cough. The patient asked about if taking Vicks Nyquil cold and flu medication could ease her condition. The patient was unaware that the ingredient of Nyquil, acetaminophen was Tylenol. The patient reported that her body did not work well with Tylenol, instead it does better with Advil and the patient's heart flutters when she takes Tylenol and it goes away after stopping therapy. Patient got hot sweat from Tylenol.  Patient experienced coughing a lot at night and could not sleep because of the constant dripping in throat and throat was extremely sore, and horribly sore at the beginning of this. Patient stated that taking the Paxlovid had helped. She still had swollen glands and she was still coughing, the worst was at night. She had to sleep sitting up because of dripping into throat and her back started aching.  Paxlovid kept her awake at night with insomnia periodically.  The patient thought that if the patient could take a little bit of Nyquil, it would smooth the condition down and the patient could sleep. The coughing wakes her up and she needed to get some rest. Paxlovid had helped to relieve the symptoms, as in the beginning she was sleeping at night and also during the day which was good for her because she needed her rest. On the previous day, the patient woke up early at 5 A.M and did not sleep all day to make sure she could sleep at night. When she went to bed on the previous night she could not sleep for some reason, and too wide awake and not feeling really exhausted and coughing more and more. She called at the pharmacy and the pharmacist said that they could not advise her about taking Nyquil. The pharmacist told her to call PMI at 8 A.M. The patient have had colds in the past and a little dose of Nyquil seemed to help the patient to sleep and rest. The patient reported that gargling did help and it was recommended to put salt in the water. The healthcare provider recommended her to use a teaspoon of salt and 8 oz of water, or something like that. The patient did the same and it burned her throat so badly. The patient used a little bit of salt water now and it helps.  Patient was not even sure if it was Pfizer vaccine that the patient received. The lot number of the first vaccine was 039TC20A and the second vaccine lot number was 006M20A.