Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Overdose, Oxygen saturation, Swelling
Clinical narrative: Period was off; Pain in every joint in her body and back pain; Pain in every joint in her body and back pain; Left arm pain at injection site; Pounding headache; Swelling in roof of mouth and glands; Severe Left arm muscle weakness; Received 0.45ml; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200283629 (Pfizer).  A 32 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 31Dec2020 10:42 (Lot number: EJ1685) at the age of 32 years as dose 1, 0.45ml single for covid-19 immunisation. Relevant medical history included: "diagnosed allergies" (unspecified if ongoing); "compromised immune status" (unspecified if ongoing); "respiratory illness" (unspecified if ongoing); "genetic/chromosomal abnormalities" (unspecified if ongoing), notes: genetic/chromosomal abnormalities; "endocrine abnormalities" (unspecified if ongoing), notes: endocrine abnormalities (including diabetes); "diabetes" (unspecified if ongoing), notes: endocrine abnormalities (including diabetes); "obesity" (unspecified if ongoing); "Asthma" (ongoing); "shellfish allergies" (ongoing), notes: She has certain shellfish allergies, like crab, lobster.; "ADHD" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "Achiness" (unspecified if ongoing); "panic attacks" (unspecified if ongoing). Concomitant medication(s) included: FLUARIX taken for influenza immunisation, administration date 20Dec2020; ADDERALL taken for attention deficit hyperactivity disorder, start date: 2008; ATIVAN taken for post-traumatic stress disorder, panic attack, start date: 2018; TYLENOL taken for pain, start date: 02Jan2021. The following information was reported: OVERDOSE (medically significant) with onset 31Dec2020 10:42, outcome "recovered with sequelae", described as "Received 0.45ml"; HEADACHE (medically significant) with onset 31Dec2020 12:45, outcome "not recovered", described as "Pounding headache"; MENSTRUAL DISORDER (medically significant) with onset 02Feb2021, outcome "recovering", described as "Period was off"; SWELLING (non-serious) with onset 31Dec2020 10:45, outcome "recovering", described as "Swelling in roof of mouth and glands"; ASTHENIA (non-serious) with onset 31Dec2020 10:45, outcome "unknown", described as "Severe Left arm muscle weakness"; INJECTION SITE PAIN (non-serious) with onset 01Jan2021 23:00, outcome "recovering", described as "Left arm pain at injection site"; ARTHRALGIA (non-serious), BACK PAIN (non-serious) all with onset 02Jan2021 16:00, outcome "recovering" and all described as "Pain in every joint in her body and back pain". The patient underwent the following laboratory tests and procedures: oxygen saturation: 99 %.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event cannot be totally excluded.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators,as appropriate