Reporte zur Charge EN4199

Symptomtext

Arm became very heavy; Became lethargic; Became drowsy; My hands were shaking (could not hold glass); Fever: within 24 hours fever shot to 103.2; Extreme pain in my joints like my entire bone structure was about to collapse; unable to sleep due to pain; Headaches; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 65-years-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EN4199, expiration date: not reported), via an unspecified route of administration, administered in Arm Left on 17Mar2021 at 09:00 (at the age of 65 years) as dose 2, single for covid-19 immunization in hospital. Medical history included osteoporosis, osteoarthritis, Hashimoto thyroiditis and known allergies all from an unknown date and unknown if ongoing. Patient was not pregnant at the time of vaccination. Concomitant medications received within 2 weeks of vaccination included alendronate sodium (ALENDRONATE SODIUM) tablet and levothyroxine sodium (SYNTHROID) both were taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EN6201, expiration date: not reported), via an unspecified route of administration, administered in Arm Left on 23Feb2021 at 09:00 (at the age of 65 years) as dose 1, single for covid-19 immunization and experienced Pain and swelling for about 3days at injection location. After exactly one week she took Alendronate Sodium within the hour the injection location swelled up into a hard ball with intense itching. This lasted several days. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Mar2021, the patient experienced arm became very, became lethargic, became drowsy, my hands were shaking (could not hold glass), and on an unspecified date in Mar2021, the patient experienced fever, within 24 hours fever shot to 103.2, unable to sleep due to pain, headaches, extreme pain in my joints like my entire bone structure was about to collapse. It was reported that, after 3 hours of vaccination arm became very heavy, became lethargic and drowsy. By the evening my hands were shaking (could not hold glass), fever: within 24 hours fever shot to 103.2 - responded well to Tylenol. For 48 hours experienced extreme pain in my joints like her entire bone structure was about to collapse- unable to sleep due to pain, severe headaches etc. Patient was asking had anyone else reported interaction with Alendronate sodium (unspecified if she experienced). Having had this reaction when could I restart taking it safely? No treatment was received for the event. Clinical outcome of the events was reported as unknown. No follow-up attempts are needed. No further information is expected.