Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Pain, Pyrexia
Clinical narrative: My fever continued to increase up to 102.3 at 8:40 am; Shaking really bad; Freezing; Neck swollen; Body aches; 101.4 fever; Heart rate 120; Dose 1: Janssen COVID-19 vaccine and Dose 2 (Booster): Pfizer COVID-19 vaccine; Dose 1: Janssen COVID-19 vaccine and Dose 2 (Booster): Pfizer COVID-19 vaccine; Dose number 2 (Booster); This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Dec2021 at 14:00 (Lot number: 33025BD) at the age of 45 years as dose 2 (booster), single for COVID-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Gastroparesis" (unspecified if ongoing), "Thyroid function decreased" (unspecified if ongoing), notes: Under active thyroid and "Lupus erythematosus" (unspecified if ongoing), notes: Lupus. Concomitant medications were not reported. Past drug history included: Effexor, reaction: "Drug allergy", notes: Known allergies: Effexor and Reglan, reaction: "Drug allergy", notes: Known allergies: Reglan. Vaccination history included: Janssen covid-19 vaccine (johnson &Johnson) (DOSE 1, SINGLE; Lot Number: 1808980; Anatomical site: Right arm), administration date: 21May2021, when the patient was 45 years old, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 30Dec2021 at 14:00, outcome "unknown", and all described as "Dose 1: Janssen COVID-19 vaccine and Dose 2 (Booster): Pfizer COVID-19 vaccine"; IMMUNISATION (non-serious) with onset 30Dec2021 at 14:00, outcome "unknown", described as "Dose number 2 (Booster)"; TREMOR (non-serious) with onset 31Dec2021 at 06:30, outcome "recovering", described as "Shaking really bad"; FEELING COLD (non-serious) with onset 31Dec2021 at 06:30, outcome "recovering", described as "Freezing"; SWELLING (non-serious) with onset 31Dec2021 at 06:30, outcome "recovering", described as "Neck swollen"; PAIN (non-serious) with onset 31Dec2021 at 06:30, outcome "recovering", described as "Body aches"; PYREXIA (non-serious) with onset 31Dec2021 at 06:30, outcome "recovering", described as "101.4 fever"; HEART RATE INCREASED (non-serious) with onset 31Dec2021 at 06:30, outcome "recovering", described as "Heart rate 120"; BODY TEMPERATURE INCREASED (non-serious) with onset 31Dec2021 at 08:40, outcome "recovering", described as "My fever continued to increase up to 102.3 at 8:40 am". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tremor, feeling cold, swelling, pain, pyrexia, heart rate increased and body temperature increased. Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient had vaccine on 30Dec2021 at 14:00. Woke up on 31Dec2021 at 06:30 due to shaking really bad, freezing, neck swollen, body aches, and 101.4 fever and heart rate 120. Patient fever continued to increase up to 102.3 at 08:40. Fever started to break around 14:40. Body aches were still present at 17:00 (at the time of this report). Patient did not go to emergency room and if her fever had not broken, she would have gone. Currently temperature was staying around 100. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.