Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue
Clinical narrative: fatigue for 3 days and it resolved then came back again; low backache for 3 days and it resolved then came back again; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) Via agency, based on information received by Pfizer from Labs (manufacturer control number US-MYLANLABS-2021M1073286), license party for epinephrine. This case is a split from AER # 202101360402 to capture event backache and fatigue to product COVID-19 VACCINE - MANUFACTURER UNKNOWN.  A 74 year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "fatigue for 3 days and it resolved then came back again"; BACK PAIN (non-serious), outcome "unknown", described as "low backache for 3 days and it resolved then came back again".  Additional Information: This non serious Post Market. Survey report was received from business partner, Pfizer (Reference number 202101360402) originated on 12-Oct-2021 and received by agency on 13-Oct-2021. This initial case, received from Other Health Professional, involved unknown age Female patient who reportedly experienced hot flush, tachycardia while receiving epinephrine. Medical history and concomitant medications were not reported. Current conditions included Skin lesion Unknown Date (In the late 70s or early 80s): The patient initiated epinephrine at an unknown dose and frequency via unknown route for unknown indication. Patient reported that she had a lesion removed from leg, they used epinephrine and whatever they use to numb the area. She experience tachycardia and her heart beat was 120 beats per minute. She could feel her heart pumping. She felt flush, warm. The outcome of events hot flush and tachycardia was unknown. Follow-up information was received by agency on 18-Oct-2021 which is non-significant. No new medically significant information added. Follow-up information was received by business partner Pfizer, on 25-Oct-2021 and received by agency on 26-Oct-2021 which is non-significant and follow-up information was received by business partner Pfizer,  on 26-Oct-2021 and received by agency on 26-Oct-2021 which is significant. Both follow up reports were processed together. The following information was added (new events syncope, back pain and fatigue added, medical history and company comment updated). Medical history included allergic reaction to excipient. 12-Oct-2021: The patient received her first covid vaccine and was concerned with the base component with the PPD. Unknown date: She had received a PPD, she was a health nurse, and she felt faint immediately. She was concerned with having an anaphylactic reaction to the covid vaccine. Consumer was able to go to a nurse clinic for her covid vaccine and had a low backache and fatigue for 3 days and it resolved then came back again. She was going to have her 2nd dose of the covid vaccine (on 2-Nov-2021). She reported that she had a dermatological procedure done and was given epinephrine and she had a reaction where she felt faint and another time with a dental procedure, so she was not to have epinephrine again. The outcome of the events back pain, fatigue and syncope was unknown. Action taken with epinephrine was unknown. Company Comment: Serious: Syncope, hot flush (non serious) and back pain (non serious) are unlisted events whereas tachycardia (non-serious) and fatigue (non serious) are listed events as per company RSI of epinephrine. Causality has been assessed as possible for events, as contributory role of suspect drug cannot be completely excluded considering the known safety profile of the drug.  Follow-up (14Dec2021): Follow-up attempts completed. No further information expected.