Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood pressure measurement, Headache, Hyperkeratosis, Laboratory test, Pain in extremity
Clinical narrative: Skin callus; Headache; Callus On Bottom Of Feet Causing Pain; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 19K-163-2722008-00. FACILITATED COLLECT.  A 74 year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, TOZINAMERAN), intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1090269) as 40mg/0.8ml, subcutaneous (Lot number: 1121883), subcutaneous (Batch/Lot number: unknown) and subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. Relevant medical history included: high blood pressure for ten years (2011), one spot on lungs (2019) not verified if cancer, stroke (2010) and narrowing of the vein. On unknown dates, the patient experienced became unresponsive, brain condition that caused pain/spot on the brain that was inoperable, difficult to stand, lumps on arms, was forgetting things, cyst in mouth, button was pushed and received needle stick/it pierced skin and ran out/removed pen prior to 10 seconds/yellow or was observed after attempted injection/ partial injection received, pain all over body/pain left side, out of breath, sciatica pain, back pain, swelling in hands. In 2010, the experienced heart condition stroke. In 2016, the patient experienced lung issue/three spots on lung and hypertension. In 2019, the patient experienced seventy percent blockage on brain and three spot on lungs. In Dec2019, the patient experienced stent placed. In 2020, the patient experienced coughing and rheumatoid arthritis pain/pain in both legs straight to the ankle. In Jan2020, the patient experienced pain down leg. On an unknown date, cyst in mouth resolved. The patient was hospitalized in 2016 for hypertension and given wrong medication to which she became unresponsive. She had a heart condition. She had a spot on brain that was inoperable. Healthcare professional told that it was from the massive stroke she had years ago. She took pain medications for it. The patient was without HUMIRA due to a lapsed therapy and delays with refills. She had a 50 percent blockage on her brain om past medical history of stroke. She was not diagnosed with stroke nor verified cancer. She also had two additional spots in lungs during the therapy of HUMIRA in 2019 and used to forget things. Humira was held and experienced rheumatoid arthritis pain during the therapy hold. No-Tobacco Use. No alcohol use. No known allergies. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant medication(s) included: METHOTREXATE; ASPIRIN [ACETYLSALICYLIC ACID]; PROMETHAZINE. The following information was reported: Patient received COVID-19 vaccine, had headache from it, callus on bottom of feet causing pain and headache. The pain was from both legs straight to the ankle. She was feeling way better but she still had a cough. She had finished the Promethazine and the neurologist had not examined her for the brain blockage. She experienced calluses on bottom of feet causing pain. The patient was treated with NARCO and LYRICA. The patient underwent the following laboratory tests and procedures: blood pressure on 21Oct2019 with result 200/101; and unknown lab in 2019 with result two additional spots in lungs. The action taken for adalimumab was temporarily withdrawn. The outcome of Skin callus was not recovered and unknown for the other events. The reporter's causality for the event: Skin callus; Headache; Callus On Bottom Of Feet Causing Pain was No reasonable possibility.  Additional information: Solicited report from the USA by a consumer of a 74 year old female with events of seventy percent blockage on brain, became unresponsive, stent placed, lung issue/three spots on lung, heart condition/massive stroke, hypertension and three spot on lungs and non-serious brain condition that caused pain/spot on the brain that was inoperable, difficult to stand, lumps on arms, was forgetting things, cyst in mouth, button was pushed received needle stick/it pierced skin and ran out/removed pen prior to 10 seconds/yellow indicator was observed after attempted injection/ partial injection received, coughing, rheumatoid arthritis pain/pain in both legs straight to the ankle, pain all over body/pain left side, out of breath, pain down leg, sciatica pain, back  pain, swelling in hands, covid-19 vaccine, had headache from it, injection given and it pierced skin and ran out, callus on bottom of feet causing pain and headache with humira 40mg/0.8ml (adalimumab). the patient had a relevant medical history of high blood pressure, one spot on lungs, stroke and narrowing of the vein. on unknown dates, the patient experienced became unresponsive, brain condition that caused pain/spot on the brain that was inoperable, difficult to stand, lumps on arms, was forgetting things, cyst in mouth, button was pushed and received needle stick/it pierced skin and ran out/removed pen prior to 10 seconds/yellow or was observed after attempted injection/ partial injection received, pain all over body/pain left side, out of breath, sciatica pain, back pain, swelling in hands, received covid-19 vaccine, had headache from it, injection given and it pierced skin and ran out, callus on bottom of feet causing pain and headache. In 2010, the experienced heart condition stroke. In 2016, the patient experienced lung issue/three spots on lung and hypertension. In 2019, the patient experienced seventy percent blockage on brain and three spot on lungs. In Dec2019, the patient experienced stent placed. In 2020, the patient experienced coughing and rheumatoid arthritis pain/pain in both legs straight to the ankle. In Jan2020, the patient experienced pain down leg. On an unknown date, cyst in mouth resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. The patient was hospitalized in 2016 for hypertension and given wrong medi to which she became unresponsive. She had a heart condition. She had a spot on brain that was inoperable. Healthcare professional told that it was from the massive stroke she had years ago. She took pain medications for it. The patient was without HUMIRA due to a lapsed therapy and delays with refills. She had a 50rcent blockage on her brain om past medical history of stroke. She was not diagnosed with stroke nor verified cancer. She also had two additional spots in lungs during the therapy of HUMIRA in 2019 and used to forget things. She was beginning to get out of breath. The patient had strong headaches and her physician told that she had a blockage in the brain. She had cyst in her mouth for a while. On 24Jan2020, she viewed the window prior to the injection to be clear and colorless. Along with her nurse she administered the injection. Both caps were removed in the correct order without twisting. The skin was squeezed to raise the injection the pen was placed at a ninety-degree angle. The button was pushed and she received a needle stick. The pen was held with steady pressure against the skin while injecting. She stated that they saw medication on her skin and removed the pen prior to ten seconds only because they saw the medication. The yellow indicator was observed  attempted injection. Partial injection was received. On an unknown date in 2020, she experienced coughing. Humira was held and experienced rheumatoid arthritis pain during the therapy hold. The pain was from both legs straight to the ankle. She was feeling way better but she still had a cough. She had finished the Promethazine and the neurologist had not examined her for the brain blockage. She experienced calluses on bottom of feet causing pain. She had headache. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. She received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech and 2nd dose/Vaccine manufactured by Pfizer/BioNTech.  The patient was treated with NARCO and LYRICA. Causality for HUMIRA 40MG/0.8ML(ADALIM's causality for the event(s) of seventy percent blockage on brain, lung issue/three spots on lung, heart condition/massive stroke, brain condition that caused pain/spot on the brain that was inoperable, three spot on lungs, coughing, rheumatoid arthritis pain/pain in both legs straight to the ankle, pain down leg, swelling in hands, received covid-19 vaccine, had headache from it, callus on bottom of feet causing pain and headache with humira 40MG/0.8ML(ADALIMUMAB) was no reasonable possibility. The reporter&as causality for the event(s) of became unresponsive, stent placed, hypertension, difficult to stand, lumps on arms, was forgetting things, cyst in mouth, button was pushed and received needle stick/it pierced skin and ran out/removed pen prior to 10 seconds/yellow indicator was observed after attempted injection/ partial injection received unknown onset, button was pushed and received needle stick/it pierced skin and ran out/removed pen prior to 10 seconds/yellow indicator was observed after attempted injection/ partial injection received unknown onset, out of breath and injection given and it pierced skin and ran out was not prov's  causality for the event(s) of pain all over body/pain left side, sciatica pain and back pain with humira 40mg/0.8ml(adalimumab) was a reasonable possibility. opinion is that the events of seventy percent blockage on brain, lung issue/three spots on lung, heart condition/massive stroke, brain condition that caused pain/spot on the brain that was inoperable, lumps on arms, cyst in mouth, three spot on lungs, out of breath and headache are not assessable. abbvies opinion is that there is no reasonable possibility that the events of became unresponsive, stent placed, hypertension, difficult to stand, was forgetting things, button was pushed and received needle stick/it pierced skin and ran out/removed pen prior to 10 seconds/yellow indicator was observed after attempted injection/ partial injection received unknown onset, button was pushed and received needle stick/it pierced skin and ran out/removed pen prior to 10 seconds/yellow indicator was observed after attempted injection/ partial injection received unknown onset, rheumatoid arthritis pain/pain in both legs straight to the ankle, pain all over body/pain le pain down leg, sciatica pain, back pain, swelling in hands, received covid-19 vaccine, had headache from it, injection given and it pierced skin and ran out and callus on bottom of feet causing pain are related to HUMIRA 40MG/0.8M's opinion is that there is a reasonable possibility that the event of COUGHING is related to HUMIRA 40MG/0.8ML(ADALIMUMAB).   Change History On 16Jan2020, received updates to event information, reporter opinion of causality, company opinion of  causality, company alternative etiology, suspect drug information and narrative description. The events of  "DIFFICULT TO WALK", "DIFFICULT TO STAND" and "LUMPS ON ARMS" were added. On 29Jan2020, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. The events of "forget the things", "stent placed", "injection given and it pierced skin and ran out", "forgets things, cyst in mouth and "pain down leg" were added. the event of "50 70 percent blockage on brain" was amended to "seventy percent blockage on brain". On 04Feb2020, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. The event of button was pushed and received needle stick/removed pen prior to 10 seconds/the yellow indicator was observed after the attempted injection/ partial injection received" was added. On 03Apr2020, received updates to medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, concomitant drug information, laboratory/diagnostic procedures and narrative description. The events of "spot on lungs", "coughing and rheumatoid arthritis pain were added.  On 16Apr2020, received updates to company alternative etiology and narrative description.  On 23Nov2020, received updates to event information, reporter opinion of causality, company opinion of  causality, company alternative etiology, suspect drug information and narrative description. The even "brain condition that causes pain/spot on the brain that is inoperable" was amended to "brain condition that caused pain/spot on the brain that was inoperable". The event of "forgets things" was amended to "was forgetting things". The event of "rheumatoid arthritis pain" was amended to "rheumatoid arthritis, pain/pain in both legs straight to the ankle". The events of "forget the things" and "pain from rheumatoid arthritis" were removed. On 28Dec2020, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. The event of "swelling in hands" was added. The event of "pain all over body" was amended to "pain all over  body/pain left side". The event of "pain down leg" was amended pain down leg/pain in feet. The event of "pain left side" was removed.  On 13May2021, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. The event of "received covid-19 vaccine, had headache from it" was added.  On 13Jul2021, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology and narrative description. The event of "wrong medication given/became unresponsive" was amended to "became unresponsive". the event of "three spots on lung" was amended to "lung  issue/three spots on lung". the event of "lung issue/three spots on lungs is now considered serious. the event button was pushed and received needle stick/removed pen prior to 10 seconds/the yellow indicator was observed after the attempted injection/ partial injection" was amended to "button was pushed and received needle stick/it pierced skin and ran out/removed pen prior to 10 seconds/yellow indicator was observed after attempted injection/ partial injection received". the event of "spot on lungs" was amended to "three spot on lungs". the events of "difficult to walk" and "wrong medication given/became unresponsive"were removed.  On 15Sep2021, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. The event of "CALLUS ON BOTTOM OF FEET CAUSING PAIN" was added. On 14Oct2021, received updates to event information, suspect drug information, concomitant drug information, treatment drug information and narrative description. The event of "PAIN DOWN LEG/PAIN IN FEET AND F was amended PAIN DOWN.  On 15Nov2021, received updates to event information, reporter opinion of causality, company opinion of  causality, company alternative etiology and narrative description. The "HEADACHE" was added.  On 14Dec2021, received updates to event information, suspect drug information and narrative description.  Reaction Information Seq. No. : 1 Reaction :Cerebral artery occlusion (Cerebral artery occlusion) Start Date :2019 Seq. No. : 2 Reaction : Unresponsive to stimuli (Unresponsive to stimuli) Seq. No. : 3 Reaction : Stent placement (Stent placement) Start Date :Dec2019 Seq. No. : 4 Reaction : Lung disorder (Lung disorder) Start Date :2016 Seq. No. : Hypertension (Hypertension) Start Date :2016 Seq. No. : 7 Reaction : Brain disorder NOS  (Cerebral disorder) Seq. No. :8 Reaction : Difficulty in standing (Dysstasia) Seq. No. : 9 Reaction : Upper extremity mass (Limb mass) Seq. No. : 10 Reaction :Forgetfulness (Memory impairment)  Seq. No. :11 Reaction : Mouth cyst (Mouth cyst) Start Date :technique in drug usage process (Wrong technique in product usage process Seq. No. : 12 Reaction :Wrong technique in drug usage process (Wrong technique in product usage process)  Seq. No. : 13 Reaction : Incomplete dose administered (Incorrect dose administered) Seq. No. : 14 Reaction : Lung disorder  (Lung disorder) Start Date :2019 Seq. No. : 15 Reaction :Coughing (Cough) Start Date : 2020 Seq. No. :16 Reaction : Arthritic pains (Arthralgia) Seq. No. : 17 Reaction : General body pain (Pain) Start Date: Short of breath (Dyspnoea) Seq. No. : 19 Reaction : Leg pain  Start Date: Jan2020 Seq. No. : 20 Reaction : Sciatica(Sciatica) Seq. No. : 21 Reaction : Back pain(Back pain) Seq. No. : 22 Reaction : Swelling of hands (Peripheral swelling)  No. :23 Reaction : Headache (Headache) Seq. No. : 24 Reaction : Device issue (Device issue) Seq. No. : 25 Reaction : Skin callus (Hyperkeratosis) Seq. No. : 26 Reaction :Headache (Headache)  Suspect Drugs Information Suspect Drugs(include generic name): 1) HUMIRA 40MG/0.8ML(40 Milligram, Solution for injection in pre-filled pen)(ADALIMUMAB),1090269,1121883,UNK- Route of Administration: Subcutaneous Indication for Use: Moderate to severe rheumatoid arthritis Therapy dates: UNK - Disco Therapy Duration: 1 Years  Product-Reaction level Seq.No. :1 Drug: HUMIRA 40MG/0.8ML(40 Milligram, Solution for injection in pre-filled  pen)(ADALIMUMAB),1090269,1121883,UNKNOWN,NOT AVAILABLE Route of Admin : 1)Subcutaneous 2)Subcutaneous 3)Subcutaneous 4)Subcutaneous Therapy Dates/Duration :1) UNK - Discontinued 2) UNK - Discontinued  Suspect Drugs Information Suspect Drugs(include generic name): 2) PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN),UN-KNOWN,UNKNOWN Route of Administration: Intramuscular Indication for Use: Covid-19 Vaccination Therapy dates: UNK - Disco  Seq.No. : 2 Drug :PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN),UNKNOWN,UNKNOWN Route of Admin :  1)Intra-muscular 2)Intra-muscular Therapy Dates/Duration:1) UNK - Discontinued Causality for the events was not reported by the reporter.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be 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