Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Lymphadenopathy, Pain in extremity
Clinical narrative: Sore right shoulder 11Hrs after first shot; aches in joints; chills,; low energy; Swollen lymph node under right arm; This is a spontaneous report from a contactable consumer or other non hcp (Patient).   A 55-years-old male patient received BNT162b2 (CONMINTARY, Solution for injection, Lot Number: EJ1685), via an unspecified route of administration, administered in Arm Right on 02Mar2021 08:30 as 1st dose, single for covid-19 immunisation (age at vaccination was 55 years). Medical history included ankylosing spondylitis from an unknown date and unknown if ongoing. Concomitant medication(s) included esomeprazole magnesium (ESOMEPRAZOLE MAGNESIUM) taken for an unspecified indication, start and stop date were not reported; atorvastatin (LIPITOR [ATORVASTATIN]) taken for an unspecified indication, start and stop date were not reported; adalimumab (HUMIRA) taken for an unspecified indication, start and stop date were not reported. The patient experienced sore right shoulder 11hrs after first shot, aches in joints, chills, low energy, swollen lymph node under right arm on 02Mar2021 07:00. Facility where the most recent COVID-19 vaccine was administered was workplace clinic. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No, treatment was received. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No, allergies to medications, food, or other products. Vaccine facility information available. Ethnicity information is available. Race information is available. Upon follow-up on 09Mar2021 is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of below mentioned query. The response included the Pfizer US Drug safety unit recently received the attached report submitted by you via please help to confirm the date that you became aware of the adverse events in this report as this effect regulatory reporting timelines. This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events. Response: To confirm, the adverse event start date is 02Mar2021. Outcome of the events was recovering.    Follow up(09Mar2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of below mentioned query. The response included the Pfizer US Drug safety unit recently received the attached report submitted by you via please help to confirm the date that you became aware of the adverse events in this report as this effect regulatory reporting timelines. This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events.  This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events.  Response: To confirm, the adverse event start date is 02Mar2021.  No follow-up attempts are needed. No further information is expected.