Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Sinus disorder, Vaccination site pain
Clinical narrative: sore arm; Covid-19; Covid-19; sinus issue; numbness; coughing; Fatigue; Headache;   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): 21K-163-4130777-00.  A 65 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous (Lot number: 1152121) and second regimen subcutaneous (Lot number: 1154443) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2 of BNT162B2, Route of administration: Intramuscular, Total knee replacement - Recovering/resolving), administration date: 22Apr2021, when the patient was 64 years old, for Covid-19 immunization, reaction(s): "right knee replaced"; Bnt162b2 (Dose 1 of BNT162B2, Route of administration: Intramuscular), administration date: 01Apr2021, when the patient was 64 years old, for Covid-19 immunization; Covid-19 vaccine moderna (Dose 2 of COVID-19 VACCINE MODERNA, Route of administration: Intramuscular, Heaviness in arm - Recovered/resolved), for Covid-19 vaccination, reaction(s): "arm felt heavy and stiff"; Covid-19 vaccine moderna (Dose 2 of COVID-19 VACCINE MODERNA, Route of administration: Intramuscular, Limbs stiffness - Recovered/resolved), for Covid-19 vaccination, reaction(s): "arm felt heavy and stiff"; Covid-19 vaccine moderna (Dose 2 of COVID-19 VACCINE MODERNA, Route of administration: Intramuscular, Total knee replacement - Recovering/resolving), for Covid-19 vaccination, reaction(s): "right knee replaced"; Covid-19 vaccine moderna (Dose 1 of COVID-19 VACCINE MODERNA, Route of administration: Intramuscular), for Covid-19 vaccination. The following information was reported: FATIGUE (medically significant) with onset 2021, outcome "recovered" (2021), described as "Fatigue"; HEADACHE (medically significant) with onset 2021, outcome "recovered" (2021), described as "Headache"; VACCINATION SITE PAIN (medically significant), outcome "recovered", described as "sore arm"; COVID-19 (medically significant), outcome "recovered", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Covid-19"; SINUS DISORDER (medically significant), outcome "not recovered", described as "sinus issue"; HYPOAESTHESIA (medically significant), outcome "not recovered", described as "numbness"; COUGH (medically significant), outcome "not recovered", described as "coughing". The action taken for adalimumab was unknown.  Additional information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of right knee replaced, arm felt heavy and stiff unknown onset, arm felt heavy and stiff unknown onset, fatigue and mild headache was not provided.  opinion is that there is no reasonable possibility that the events of right knee replaced, arm felt heavy and stiff unknown onset, arm felt heavy and stiff unknown onset, fatigue and mild headache are related to Humira (Adalimumab).  PFIZER BIONTECH COVID-19 VACCINE: Fatigue: Causality as per reporter (Drug/Vaccine): Possible Headache: Causality as per reporter (Drug/Vaccine): Possible  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up(19Jan2022): This is a solicited follow-up report based on the information received by Pfizer from (Mfr. Control No. : 21K-163-4130777-00). A contactable 65-year-old female consumer reported outcome of the reports.  Solicited report from the USA by a consumer of an adult female with events of RIGHT KNEE REPLACED and non-serious SECOND DOSE OF MODERNA MADE ARM FELT HEAVY AND STIFF, BOOSTER PFIZER COVID-19 VACCINE CAUSED SORE ARM AND FATIGUED, FATIGUE, MILD HEADACHE, COVID-19, SINUS ISSUE, HEADACHE, NUMBNESS and COUGHING with HUMIRA (ADALIMUMAB). There was no reported medical history. On unknown dates, the patient experienced RIGHT KNEE REPLACED, SECOND DOSE OF MODERNA MADE ARM FELT HEAVY AND STIFF, BOOSTER PFIZER COVID-19 VACCINE CAUSED SORE ARM AND FATIGUED, COVID-19, SINUS ISSUE, HEADACHE, NUMBNESS and COUGHING. In 2021, the patient experienced FATIGUE and MILD HEADACHE. In 2021, the FATIGUE and MILD  HEADACHE resolved. On unknown dates, SECOND DOSE OF MODERNA MADE ARM FELT HEAVY AND STIFF, BOOSTER PFIZER  COVID-19 VACCINE CAUSED SORE ARM AND FATIGUED and COVID-19 resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) and COVID-19 VACCINE MODERNA (ELASOMERAN) were also considered suspect. The patient had right knee replaced and was off HUMIRA for a week. Second dose of Moderna made her arm felt  heavy and stiff. Booster shot caused fatigue and mild headache. She started feeling sick two weeks ago had  sinus, headache, numbness, and coughing previously had Covid and thought she had it again. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On an unknown date, patient received 1st dose COVID-19 Vaccine manufactured by Moderna. On an unknown date, patient received 2nd dose COVID-19 Vaccine manufactured by Moderna. On 01Apr2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 22Apr2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On19Dec2021, patient received booster dose of COVID-19 Vaccine manufactured by Pfizer/BioNTech.   Causality for HUMIRA(ADALIMUMAB)The reporter's causality for the event(s) of RIGHT KNEE REPLACED, SECOND DOSE OF MODERNA MADE ARM FELT HEAVY AND STIFF unknown onset, SECOND DOSE OF MODERNA MADE ARM FELT HEAVY AND STIFF unknown onset, BOOSTER PFIZER COVID-19 VACCINE CAUSED SORE ARM AND FATIGUED unknown onset, BOOSTER PFIZER COVID-19 VACCINE CAUSED SORE ARM AND FATIGUED unknown onset, FATIGUE, MILD HEADACHE, COVID-19, SINUS ISSUE, HEADACHE, NUMBNESS and COUGHING was not provided.  opinion is that there is no reasonable possibility that the events of RIGHT KNEE REPLACED, SECOND DOSEOF MODERNA MADE ARM FELT HEAVY AND STIFF unknown onset, SECOND DOSE OF MODERNA MADE ARM FELT HEAVY AND STIFF unknown onset, BOOSTER PFIZER COVID-19 VACCINE CAUSED SORE ARM AND FATIGUED unknown onset, BOOSTER PFIZER COVID-19 VACCINE CAUSED SORE ARM AND FATIGUED unknown onset, FATIGUE, MILD HEADACHE, COVID-19, SINUS ISSUE, HEADACHE, NUMBNESS and COUGHING are related to HUMIRA(ADALIMUMAB).   Change History On 20Dec2021, 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 "FATIGUE" and "MILD HEADACHE" were added.   On 17Jan2022, 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  "BOOSTER PFIZER COVID-19 VACCINE CAUSED SORE ARM AND FATIGUED", "COVID-19", "SINUS ISSUE", "HEADACHE", "NUMBNESS" and "COUGHING" were added. The event of "ARM FELT HEAVY AND STIFF" was amended to "SECOND DOSE OF MODERNA MADE ARM FELT HEAVY AND STIFF".  Reaction Information  Seq. No. : 1 Reaction : Total knee replacement Knee arthroplasty Start Date : ?? Stop Date : ??  Seq. No. : 2 Reaction : Heaviness in arm Limb discomfort  Start Date : ?? Stop Date : ??  Seq. No. : 3 Reaction : Limbs stiffness Musculoskeletal stiffness  Start Date : ?? Stop Date : ??  Seq. No.: 4 Reaction : Vaccination site pain  Start Date : ?? Stop Date : ??  Seq. No. : 5 Reaction : Fatigue  Start Date : ?? Stop Date : ??  Seq. No. : 6 Reaction : Fatigue   Start Date : ??-??-2021 Stop Date : ??-??-2021  Seq. No. : 7 Reaction : Headache  Start Date : ??-??-2021 Stop Date : ??-??-2021  Seq. No. : 8 Reaction : COVID-19   Start Date : ?? Stop Date : ??  Seq. No. : 9 Reaction : Sinus disorder  Start Date :?? Stop Date : ??  Seq. No. : 10 Reaction : Headache  Start Date : ?? Stop Date : ??  Seq. No. : 11 Reaction : Numbness  Start Date : ?? Stop Date : ??  Seq. No. : 12 Reaction : Coughing  Start Date : ?? Stop Date : ??  Check all appropriate to Adverse reaction: Other medically important condition Did event abate after stopping drug: Yes  Suspect Drugs  Product-Reaction level Seq.No. 1 Drug : HUMIRA(Solution for injection in pre-filled pen)(ADALIMUMAB) Route of Admin : 1)Subcutaneous  Therapy Dates/Duration : 1) UNK - Discontinued Causality 1)Total knee replacement (Knee arthroplasty Action(s) taken with drug :  Drug discontinued Causality as per reporter (Drug/Vaccine) :  Not Reported Causality as per Mfr.(Drug/Vaccine):  No reasonable possibility Dechallenge :  Yes 2)Heaviness in arm  (Limb discomfort   Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Not Reported Causality as per Mfr.(Drug/Vaccine) :  No reasonable possibility Dechallenge : N/A 3)Limbs stiffness  (Musculoskeletal stiffness Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Not Reported Causality as per Mfr.(Drug/Vaccine) :  No reasonable possibility Dechallenge : N/A 4)Vaccination site pain  (Vaccination site pain  Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Not Reported Causality as per Mfr.(Drug/Vaccine) :  No reasonable possibility Dechallenge :  N/A 5)Fatigue  (Fatigue Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Not Reported Causality as per Mfr.(Drug/Vaccine) :  No reasonable possibility Dechallenge :  N/A 6)Fatigue  (Fatigue Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Not Reported Causality as per Mfr.(Drug/Vaccine) :  No reasonable possibility Dechallenge :  N/A 7)Headache  (Headache  Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Not Reported Causality as per Mfr.(Drug/Vaccine) :  No reasonable possibility Dechallenge :  N/A 8)COVID-19  (COVID-19  Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Not Reported Causality as per Mfr.(Drug/Vaccine) :  No reasonable possibility Dechallenge :  N/A 9)Sinus disorder  (Sinus disorder Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Not Reported Causality as per Mfr.(Drug/Vaccine) :  No reasonable possibility Dechallenge :  N/A 10)Headache  (Headache  Action(s) taken with drug : Unknown Causality as per reporter (Drug/Vaccine) :  Not Reported Causality as per Mfr.(Drug/Vaccine) :  No reasonable possibility Dechallenge :  N/A 11)Numbness  (Hypoaesthesia  Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Not Reported Causality as per Mfr.(Drug/Vaccine) :  No reasonable possibility Dechallenge :  N/A 12)Coughing  (Cough  Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Not Reported Causality as per Mfr.(Drug/Vaccine) : No reasonable possibility Dechallenge :  N/A  Seq.No. : 2 Drug : PFIZER BIONTECH COVID-19  VACCINE(TOZINAMERAN)(Injection)(TOZINAMERAN),UNKNOWN,UNKNOWN,UNKNOWN Daily Dose : 2) (1 in 1 Once) 3)booster shot (1 in 1 Once) Route of Admin : 1)Intra-muscular 2)Intra-muscular 3)IIntra-muscular Therapy Dates/Duration :1) 01-APR-2021 - 01-APR-2021 2) 22-APR-2021 - 22-APR-2021 3) 19-DEC-2021 - 19-DEC-2021  Causality 1)Total knee replacement  (Knee arthroplasty  Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Not Reported Dechallenge :  N/A 2)Heaviness in arm  (Limb discomfort  Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Not Reported Dechalleng :  N/A 3)Limbs stiffness  (Musculoskeletal stiffness  Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Not Reported Dechallenge : N/A 4)Vaccination site pain (Vaccination site pain  Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Possible Dechallenge :  N/A 5)Fatigue  (Fatigue  Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Possible Dechallenge :  N/A 6)Fatigue  (Fatigue  Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Possible Dechallenge :  N/A 7)Headache  (Headache  Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Possible  Dechallenge :  N/A 8)COVID-19  (COVID-19 Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Not Reported Dechallenge :  N/A 9)Sinus disorder (Sinus disorder  Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Not Reported Dechallenge :  N/A 10)Headache  (Headache Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine):  Not Reported Dechallenge :  N/A 11)Numbness  (Hypoaesthesia  Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Not Reported Dechallenge :  N/A 12)Coughing  (Cough  Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Not Reported Dechallenge :  N/A Drug : COVID-19 VACCINE MODERNA(ELASOMERAN)(Injection)(ELASOMERAN),UNKNOWN,UNKNOWN Daily Dose :1)1st dose (1 in 1 Once) 2)2nd dose (1 in 1 Once) Route of Admin : 1)Intramuscular 2)Intramuscular Indication for use : 1)COVID-19 VACCINATION Causality 1)Total knee replacement  (Knee arthroplasty  Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Not Reported Dechallenge :  N/A 2)Heaviness in arm  (Limb discomfort  Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Not Related Dechallenge :  N/A 3)Limbs stiffness  (Musculoskeletal stiffness  Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Not Related Dechallenge :  N/A 4)Vaccination site pain  (Vaccination site pain  Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Not Reported Dechallenge :  N/A 5)Fatigue  (Fatigue  Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Not Reported Dechallenge :  N/A 6)Fatigue  (Fatigue Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Not Reported Dechallenge :  N/A 7)Headache  (Headache  Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Not Reported Dechallenge :  N/A 8)COVID-19  (COVID-19  Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Not Reported Dechallenge :  N/A 9)Sinus disorder  (Sinus disorder  Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Not Reported Dechallenge :  N/A 10)Headache  (Headache  Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Not Reported Dechallenge : N/A 11)Numbnes (Hypoaesthesia  Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Not Reported Dechallenge :  N/A 12)Coughing  (Cough  Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Not Reported Dechallenge : N/A  Concomitant Drugs Not Reported Other relevant history: Not reported  - The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.; Sender's Comments: Based temporal relationship there is reasonable possibility of causal association between the reported events and the suspect drug BNT162B2.