Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Ear discomfort, Electrocardiogram, Fatigue
Clinical narrative: intermittent pulsations in her right ear; intermittent palpitations; tachycardiac; heart rate of 113bpm; the patient has been complaining of chest pain; Fatigue; Chills; body aches; 35-year old female patient received the whole vial without diluent of Pfizer-BioNTech Covid19 Vaccine (Purple cap) on 09Dec2021 for the 1st dose; Also patient did have a dose of J&J Covid Vaccine on 09June2021.; The vial was not diluted. It was kept out to be at room temperature with the cap on. Someone came and opened it and drew the whole vial thinking it was ready.; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 35-year-old female patient received bnt162b2 (BNT162B2), administration date 09Dec2021 (Lot number: FJ1620, Expiration Date: 28Feb2022) at the age of 35 years as dose 2 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LOSARTAN taken for blood pressure measurement; VITAMIN D 2000; OMEGA 3 [FISH OIL; TOCOPHEROL]. Vaccination history included: Covid-19 vaccine (Patient did have a dose of J&J Covid Vaccine on 09June2021., LOT: 203A21A), administration date: 09Jun2021, for Covid-19 Immunization. The following information was reported: OVERDOSE (non-serious) with onset 09Dec2021, outcome "unknown", described as "35-year old female patient received the whole vial without diluent of Pfizer-BioNTech Covid19 Vaccine (Purple cap) on 09Dec2021 for the 1st dose"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 09Jun2021, outcome "unknown", described as "Also patient did have a dose of J&J Covid Vaccine on 09June2021."; PRODUCT PREPARATION ISSUE (non-serious), outcome "unknown", described as "The vial was not diluted. It was kept out to be at room temperature with the cap on. Someone came and opened it and drew the whole vial thinking it was ready."; CHEST PAIN (non-serious) with onset Feb2022, outcome "recovered", described as "the patient has been complaining of chest pain"; PALPITATIONS (non-serious) with onset 07Feb2022, outcome "unknown", described as "intermittent palpitations"; TACHYCARDIA (non-serious) with onset 07Feb2022, outcome "unknown", described as "tachycardiac"; HEART RATE INCREASED (non-serious) with onset 07Feb2022, outcome "unknown", described as "heart rate of 113bpm"; FATIGUE (non-serious) with onset 10Dec2021, outcome "unknown", described as "Fatigue"; CHILLS (non-serious) with onset 10Dec2021, outcome "unknown", described as "Chills"; PAIN (non-serious) with onset 10Dec2021, outcome "unknown", described as "body aches"; EAR DISCOMFORT (non-serious), outcome "unknown", described as "intermittent pulsations in her right ear". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of fatigue, chills, pain, ear discomfort.  Additional Information: Per HCP, a 35-year-old female patient received the whole vial without diluent of Pfizer-BioNTech Covid19 Vaccine (Purple cap) on 09Dec2021 for the 1st dose. Ever since 07Feb2022, the patient has been complaining of chest pain and intermittent palpitations. Patient reported the chest pain a week prior and it went away. On 07Feb2022 when the patient came into the clinic, the patient was tachycardiac with a heart rate of 113bpm. Also, patient did have a dose of J&J Covid Vaccine on 09June2021. HCP Questioned what the Pfizer's recommendation regarding the symptoms of the patient after are having the higher dose of the Pfizer Covid19 vaccine. The reporter stated she was from a community clinic, regarding the Pfizer vaccine, purple cap. She states that the patient received the first Pfizer vaccine 09Dec2021 and had received the whole purple vail without any diluent. The reporter clarified that she was referring to the Pfizer Covid vaccine, purple cap and that the patient received it 9Dec2021. The reporter stated that the patient was still complaining of chest pain and palpitations that are intermittent and not very often. The patient does get tachycardic and has been s having symptoms of palpitations. The reporter stated that the patient has also received J and J on 09Jun2021. Clarified that the patient had received the Johnson and Johnson Covid vaccine, 09Jun2021(LOT: 203A21A). Regarding the chest pain and palpitations, it was clarified that the provider states the patient complained of this as a new issue. The reporter stated states that the chest pain, palpitations, and tachycardia occurred after the vaccine. She states that she talked to the provider, who had said that the palpations are intermittent and are not really every day. She stated that the patient came to see the provider 07Feb2022 and the patient had stated that one week prior to that visit, she had the chest pain and it had went away. The patient does feel the palpitations intermittently, every now and then. At the clinic that day, 07Feb2022, the patient's heart rate was up to 113. The reporter stated that the first week when the incident happened, of the patient receiving the undiluted dose of the Covid vaccine on 09Dec2021, they called the patient to make sure she was ok and she came for another visit, 10Dec2021. At that time, she was fine, and they checked everything.  Clarified that the visit the patient had on 07Feb2022 was a follow up.  Further clarified that when the patient came for a visit 10Dec2021, she did present with possible side effects from the vaccine of fatigue, chills, body aches, regular vaccine side effects. The patient was also having intermittent pulsations in her right ear. The patient had taken Tylenol for that. Clarified that the intermittent pulsations were only in her right ear. Treatment: The reporter stated the patient has been taking her blood pressure medication and Vitamin D, and Omega 3, as prescribed. She stated that the patient has been taking Losartan for blood pressure. Clarified that this is a medication the patient had been taking before. The type of medication error was overdose. The stage of medication error was preparation and administration. The contributing factor for the medication error was the vial was not diluted. It was kept out to be at room temperature with the cap on. Someone came and opened it and drew the whole vial thinking it was ready. Patient had complained of chest pain and palpitations, as reported initially. It is intermittent and not resolved. They did an EKG that day the overdose occurred, and it was normal. Patient came back to the doctor's office on 10Dec2021 for the other side effects already reported.    No follow-up attempts are possible. No further information is expected.