Sex: M
Vaccine: COVID19
Symptoms: Off label use, Pain in extremity, Product use issue, Tenderness
Clinical narrative: Pfizer Covid 19 booster: fatigue; Pfizer Covid 19 booster: headache; Pfizer Covid 19 booster: had the runs; Pfizer Covid 19 booster; Pfizer Covid 19 booster; severe case of chills/Stated that the night before when got up to go to bathroom that as soon as stepped in hallway that he started shaking uncontrollably/ he was so cold; he received Pfizer Covid 19 and the flu shot at the same time; minor pain to his left arm when he pressed on the area/Stated the Pfizer Covid 19 shot was to his left arm; Flu shot: tender to his right arm/tender to his left arm; This is a spontaneous report from a contactable consumer (patient himself). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via an unspecified route of administration in Left Arm on 24Sep2021 (Batch/Lot number and Expiry Date: Not reported) as Dose 3 (Booster), Single for Covid-19 immunization; influenza vaccine (FLU VACCINE VII), via an unspecified route of administration from 24Sep2021 (Batch/Lot number and Expiry Date: Not reported) to 24Sep2021, at Dose Number Unknown, Single for an unspecified indication. The patient was not related to any study or programme. The patient's medical history and concomitant medications were not provided. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date in 2021 as Dose 1, Single and via unspecified route of administration on an unspecified date in 2021 as Dose 2, Single both doses taken for Covid-19 immunization. The patient stated that he just had the booster last 24Sep2021 (Friday), stated his first two shots were fine other than where he got the shot, stated that when he got the booster that he had experienced that he had never had before, he had fatigue, headache, runs and a severe case of chills. He stated that the chills occurred that night when he had the shot. The patient stated that, the night before when woke up and gone to bathroom that as soon as stepped in hallway that he started shaking uncontrollably, he did all he wanted to do to get into bed because he was so cold; and after 15 minutes it subsided and the next day, he had no problems. The headache and fatigue started the next morning (25Sep2021); the fatigue grew during the day and the headache was minor. The patient further stated that with the first two shots that it was tender (on an unspecified date in 2021) but no pain unless he pressed on the area and then it was minor. The Pfizer Covid 19 shot was to his left arm. Stated that the right arm was where he got the flu shot and both arms felt the same (tender to his right arm/tender to his left arm). The patient asked if it was for the Pfizer Covid 19 and Pfizer Covid 19 booster. He stated that, he received Pfizer Covid 19 and the flu shot at the same time and was told that it was safe to take both. No Investigation assessment was provided. The outcome of the events chills/ shaking uncontrollably/ he was so cold was recovering, fatigue, headache and he had the runs was not recovered and the outcome of other events was unknown.  The lot number for the vaccine, BNT162B2 was not provided and will be requested during follow up.