Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth, Headache, Lymph node pain, Odynophagia, Pain
Clinical narrative: hurts to swallow; horrible taste in back of tongue; headache; horrible pain in left foot; dry mouth; constantly thirsty; injection site pain in the right arm; severe aches and pains; glands under chin hurt; This is a spontaneous report received from contactable reporter(s) (Consumer or other non- HCP) from medical information team. The reporter is the patient.  A 45-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 14Aug2021 11:30 (Lot number: FA7485) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes", start date: Nov2007 (unspecified if ongoing); "Diabetic neuropathy" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN GA taken for diabetic neuropathy; LANTUS taken for diabetes mellitus, start date: Jun2021. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 16Aug2021, outcome "not recovered", described as "injection site pain in the right arm"; PAIN (non-serious) with onset 16Aug2021, outcome "not recovered", described as "severe aches and pains"; PAIN IN EXTREMITY (non-serious) with onset 17Aug2021, outcome "not recovered", described as "horrible pain in left foot"; DRY MOUTH (non-serious) with onset 16Aug2021, outcome "not recovered", described as "dry mouth"; THIRST (non-serious) with onset 16Aug2021, outcome "not recovered", described as "constantly thirsty"; TASTE DISORDER (non-serious) with onset 17Aug2021, outcome "not recovered", described as "horrible taste in back of tongue"; HEADACHE (non-serious) with onset 17Aug2021, outcome "recovering", described as "headache"; ODYNOPHAGIA (non-serious) with onset 18Aug2021, outcome "not recovered", described as "hurts to swallow"; LYMPH NODE PAIN (non-serious) with onset 16Aug2021, outcome "not recovered", described as "glands under chin hurt".  Additional information: Reporter Subtype: Patient. PQC Present: No.AE Present: Yes.PQC Details: Request Name: REQ-458084. Product: PFIZER-BIONTECH COVID-19 VACCINE. Question: Caller transferred from #. Caller is a consumer. Pfizer covid 19 vaccine confirmed. Caller received his first dose of the vaccine on 14Aug2021. He reports experiencing the following symptoms:  injection site pain in the right arm; severe aches and pains, horrible pain in left foot, dry mouth and constantly thirsty, horrible taste in back of tongue, headache, hurts to swallow, and glands under chin hurt. Caller would like to know if these symptoms are normal and if he should go to the hospital? E-transmitting to Agency for potential duplicate AE information. Caller is a 45 year old male. Response: Spoke to caller from the attached document providing that some of the symptoms he is experiencing are reported side effects of the vaccine but that there may be other side effects from the vaccine. Referred caller to HCP for medical evaluation for concerns over lasting symptoms. Survey offered. Request Name: Product: PFIZER-BIONTECH COVID-19 VACCINE. Question: Caller asked if he should get the second dose of the vaccine? Response: Provided contraindication clause from PI for caller. Referred to HCP for risks/benefits of receiving second dose. Is report related to a study or programme? No. Patient Ethnicity: withheld. Is the patient also the reporter? Yes. Reporter type: Consumer or other non- health professional. Specify Consumer or other non- health professional: self-Reporter telephone: withheld. Primary / Prescribing Healthcare Professional Info. HCP name: withheld. HCP Occupation/Specialty: Primary Care. HCP consent to contact: Yes. HCP postal address withheld. Reporter seriousness for Injection site pain on Right arm, severe aches and pains, Horrible pain in left foot, Dry mouth and constantly thirsty, Horrible taste in back of tongue, Headache, Hurts to swallow, Glands under chin hurt, Unspecified. Event: severe aches and pains and Dry mouth and constantly thirsty was reported as worsened. NDC number of Pfizer COVID 19 vaccine: Unknown. Expiry Date of Pfizer COVID 19 vaccine: Unknown. Why was the patient taking Pfizer COVID 19 vaccine (Verbatim): Mandated by job. Other Products: Yes. Additional Information for Concomitant Products Gabapentin: Taking for 3-4 years. Stop: Unspecified. He is still having adverse side effects all these days later.  He received his 1st shot on Saturday. Two days after shot, which was that Monday, is when he began having symptoms. He had a headache for 2 days and it did not go away, but today, it just does not hurt as bad.  It also hurtst to swallow.  He feels that much more today than yesterday. He said it will be mandated by his job that it will be needed by Nov 2021. He is taking his regular diabetic medication and his insulin, Lantus, is fairly new. He has only been taking it for about 2 months. For Only: Vaccination Facility Type: Pharmacy. Adverse Event (AE) Details: Provide the time of onset of AE(s): Injection site pain on right arm - 11:30.  It was immediate and never stopped hurting. Severe aches and pains - in the morning when he got up around 08:00. Horrible pain in left foot - in the middle of the night around 04:00. Dry mouth and constantly thirsty - In the morning when he got up around 08:00. Horrible taste in back of tongue - In the morning when he got up around 08:00. Headache - in the middle of the night on 17 Aug 2021. Hurts to swallow - In the morning when he got up around 08:00. Glands under chin hurt - Started at night because it was not going on in the morning and it hurt to touch and still does. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): none. Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity . Family Medical History Relevant to AE(s): none. Relevant Tests: None.List other relevant diagnostic and confirmatory test results for event(s), for example, from blood tests, cerebro-spinal fluid culture, pleural fluid culture, urine culture, diagnostic imaging, (e.g., chest X-ray, MRI). He would like to know if he should go to the hospital and if these symptoms are normal.   No follow-up attempts are possible. No further information is expected.