Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Fatigue, Headache, Illness, Influenza like illness
Clinical narrative: cellulitis; Fatigue; sickness; Pneumonia; Headache; Papular rash; Flu like symptoms; COVID-19; COVID-19; 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): 22K-163-4238403-00 (Agency).  Reaction information: Age years: Adult Sex: F Reaction onset: Jan2022  Seq. No.: 1 Reaction: Flu like symptoms (Influenza like illness) Start Date: Jan2022  Seq. No.: 2 Reaction: Headache (Headache) Start Date: 13Jan2022  Seq. No.: 3 Reaction: Fatigue (Fatigue)  Describe Reaction(s) (include relevant test/lab data): Flu like symptoms (Influenza like illness - Not recovered/not resolved Headache (Headache) - Not recovered/not resolved Fatigue (Fatigue) - Unknown  Solicited report by a consumer of a 50 year old female with events of non-serious flu like symptoms, headache and fatigue with humira (adalimumab). There was no reported medical history.  On an unknown date, the patient experienced fatigue. In Jan2022, the patient experienced flu like symptoms. On 13Jan2022, the patient experienced headache. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect.  It was unknown if patient was enrolled in a covid-19 vaccine trial. On 01Mar2021, patient received 1st dose covid-19 vaccine manufactured by pfizer. On 01Apr2021, patient received 2nd dose covid-19 vaccine manufactured by pfizer. On 12Jan2022, patient received 3rd dose covid-19 vaccine manufactured by pfizer.  Causality for Humira (Adalimumab) The reporter's causality for the event(s) of flu like symptoms, headache and fatigue was not provided.  Suspect drug(s) Information: Suspect drug(s): Humira (solution for injection in pre-filled pen) (Adalimumab), Unknown Daily dose: Citrate Free Route of administration: Sub-cutaneous Indications for use: moderate to severe hidradenitis suppurativa Therapy dates (From/To): Unk  Product-Reaction level: Seq.No.: 1 Drug: Humira (solution for injection in pre-filled pen) (Adalimumab), Unknown, Unknown  Causality:  Flu like symptoms (Influenza like illness) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A  Causality:  Headache (Headache) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A  Causality:  Fatigue (Fatigue) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A  Suspect drug(s): Pfizer biontech covid-19 vaccine(tozinameran)(tozinameran),unknown,unknown,unknown  Daily dose: First dose (1 i- Route of administration: Intra-muscular Indications for use: covid-19 vaccination Therapy dates (From/To): 01Mar2021  Product-Reaction level: Seq. No. 2 Drug: Pfizer biontech covid-19 vaccine(tozinameran)(injection)(tozinameran), unknown, unknown.  Daily dose:  1)1st dose (1 in 1 Once) 2)2nd dose (1 in 1 Once) 3)3rd dose Booster Dose (1 in 1 Once)  Route of administration:  1)Intra-muscular 2)Intra-muscular 3)Intra-muscular  Therapy Dates/Duration: 1) 01Mar2021 - 01Mar2021 2) 01Apr2021 - 01Apr2021 3) 12Jan2022 - 12Jan2022  Causality:  Flu like symptoms (Influenza like illness) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): possible Dechallenge: N/A  Causality:  Headache (Headache) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): possible Dechallenge: N/A  Causality:  Fatigue (Fatigue) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A  Did event abate after stopping drug? N/A Concomitant drugs and history: Concomitant drugs and dates of administration (exclude those used to treat event): Concomitant Drugs Not Reported Other relevant history: Not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow up (14Jun2022): This is a solicited follow-up report from a Non-interventional Study (MARKETING PROGRAM NAME NOT AVAILABLE) based on information received by Pfizer from Agency (MFR Control No.# 22K-163-4395029-00). A contactable 50-year-old female consumer (patient) reported for herself that:   Updated information includes: New events vaccination failure, Suspected covid-19, Pneumonia, Cellulitis, Illness. event onset date, outcome and sop add added. FACILITATED COLLECT removed from reference  Additional information: Describe reaction(s) (including relevant tests/lab data): COVID-19 (COVID-19) recovered/resolved COVID-19 (COVID-19) recovered/resolved COVID-19 (COVID-19) recovered/resolved Papular rash (Rash popular)- recovered/resolved Pneumonia (Pneumonia)- not recovered/not resolved sickness (illness) not recovered/not resolved Cellulitis (Cellulitis) Not recovered/not resolved  Solicited report by a consumer of an adult female with events of non-serious COVID, rash on chest with prickly pumps on the skin, pneumonia, sick and cellulitis with HUMIRA (ADALIMUMAB) .  There was no reported medical history .  On unknown dates, the patient experienced COVID, COVID, sick and cellulitis. In 2020, the patient experienced COVID . In 2022, the patient experienced rash on chest with prickly bumps on the skin. In May2022, the patient experienced pneumonia. In 2022, the COVID and Rash on chest with prickly bumps on the skin resolved. on unknown dates, COVID and COVID resolved. PFIZER BIONTECA COVID-19 VACCINE (TOZINAMERAN) was also considered suspect .  It was unknown if patient was enrol led In a COVID-19 Vaccine Trial.  Causality for HUMIRA(ADALIMUMAB)  The reporter's causality for the event (s) of COVID onset in 2020, COVID unknown onset, COVID unknown onset, rash on chest with prickly bumps on the skin and sick was not provided. The reporter' s causality for the event (s) of pneumonia and cellulitis with (ADALIMUMAB) was a reasonable possibility.    Change History  On 09 Jun 2022, received updates to event information reporter opinion of causality, suspect drug information, concomitant drug information and narrative description. The events of "pneumonia", "sick" and "cellulitis" were added.   Reaction information:  Seq. No.  : 1  Reaction : COVID-19 (COVID-19) Start date: 2020 Stop date: ??   Seq. No. : 2  Reaction : COVID-19 (COVID-19) Start date : ??  Stop date : ??   Seq. No.  : 3  Reaction  : COVID-19 (COVID-19) Start date: ??-??-2022 Stop date : ??   Seq. No. : 4  Reaction : Papular rash (Rash popular) Start date : ??-??-2022 Stop date : ??-??-2022  Seq. No. : 5  Reaction : Pneumonia (Pneumonia) Start date : ??-May-2022 Stop date : ??   Seq. No. : 6  Reaction : sickness (illness)  Seq. No. : 7  Reaction : Cellulitis (Cellulitis)  Suspect drug(s) information:  Suspect drug(s) (include generic name):  Humira (solution for injection in pre-filled pen) (Adalimumab), Unknown Daily dose: Citrate Free Route of administration: Sub-cutaneous Indications for use: moderate to severe hidradenitis suppurativa Therapy dates (From/To): Unk  Product-reaction level Seq.no.: 1 Drug: Humira (solution for injection in pre-filled pen) (Adalimumab), Unknown, Unknown  Causality 1) COVID-19 (COVID-19) Action(s) taken with drug: Unknown Causality as per reporter (drug/vaccine): Not reported Dechallenge: N/A  2) COVID-19 (COVID-19) Action(s) taken with drug: Unknown Causality as per reporter (drug/vaccine): Not reported Dechallenge: N/A  3) COVID-19 (COVID-19) Action(s) taken with drug: Unknown Causality as per reporter (drug/vaccine): Not reported Dechallenge: N/A  4) Papular rash (Rash popular) Action(s) taken with drug: Unknown Causality as per reporter (drug/vaccine): Not reported Dechallenge: N/A  5) Pneumonia (Pneumonia) Action(s) taken with drug: Unknown Causality as per reporter (drug/vaccine): Possible Dechallenge: N/A  6) sickness (illness) Action(s) taken with drug: Unknown Causality as per reporter (drug/vaccine): Not reported Dechallenge: N/A  7) Cellulitis (Cellulitis) Action(s) taken with drug: Unknown Causality as per reporter (drug/vaccine): Possible Dechallenge: N/A  Product-Reaction level: Seq. No. 2 Drug: Pfizer biontech covid-19 vaccine(tozinameran)(injection)(tozinameran), unknown, unknown.  Daily dose:  1)1st dose (1 in 1 Once) 2)2nd dose (1 in 1 Once) 3)3rd dose Booster Dose (1 in 1 Once)  Route of administration:  1)Intra-muscular 2)Intra-muscular 3)Intra-muscular  Therapy Dates/Duration: 1) 01Mar2021 - 01Mar2021 2) 01Apr2021 - 01Apr2021 3) 12Jan2022 - 12Jan2022  Causality 1) COVID-19 (COVID-19) Action(s) taken with drug: Unknown Causality as per reporter (drug/vaccine): Not reported Dechallenge: N/A  2) COVID-19 (COVID-19) Action(s) taken with drug: Unknown Causality as per reporter (drug/vaccine): Not reported Dechallenge: N/A   3) COVID-19 (COVID-19) Action(s) taken with drug: Unknown Causality as per reporter (drug/vaccine): Not reported Dechallenge: N/A  4) Papular rash (Rash popular) Action(s) taken with drug: Unknown Causality as per reporter (drug/vaccine): Not reported Dechallenge: N/A  5) Pneumonia (Pneumonia) Action(s) taken with drug: Unknown Causality as per reporter (drug/vaccine): Not reported Dechallenge: N/A  6) sickness (illness) Action(s) taken with drug: Unknown Causality as per reporter (drug/vaccine): Not reported Dechallenge: N/A  7) Cellulitis (Cellulitis) Action(s) taken with drug: Unknown Causality as per reporter (drug/vaccine): Not reported Dechallenge: N/A  Did event abate after stopping drug: NA  Concomitant drugs and history: concomitant  Concomitant drugs and history: Concomitant drugs not reported  Other relevant history: Not reported.; Sender's Comments: Based on the known safety profile and Limited information in the case report, a casual association between reported events and the suspect drug 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