Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Vaccination failure
Clinical narrative: patient was tired; she didn't feel well; runny nose; Headaches; sick; suspected clinical  vaccination failure; suspected covid-19 infection; she passed out; face turned white; lips turned purple; Massive migraines; fell in chair; chills; Fever; she had bed with aches and pains; burning eyes; Felt like an elephant was on her; tearing eyes; flu like symptoms; couldn't move; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 20220112654(2.0) (Jansen).  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day as dose 1, single for covid-19 immunisation; janssen covid-19 vaccine (JANSSEN COVID-19 VACCINE), administered in deltoid left, administration date 04Jan2022 (Lot number: 211D21A, Expiration Date: 11Apr2022) as dose 2, single for immunisation. Relevant medical history included: "Interchange of Vaccine" (unspecified if ongoing); "medication allergy" (unspecified if ongoing); "Food allergy" (unspecified if ongoing); "allergy to vaccine" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tylenol, reaction(s): "patient had reaction with tylenol (paracetamol) in past". The following information was reported: VACCINATION FAILURE (medically significant) with onset 19Jan2022, outcome "unknown", described as "suspected clinical  vaccination failure"; COVID-19 (medically significant) with onset 04Jan2022, outcome "not recovered", described as "suspected covid-19 infection"; LOSS OF CONSCIOUSNESS (medically significant) with onset 04Jan2022, outcome "unknown", described as "she passed out"; SKIN DISCOLOURATION (medically significant) with onset 04Jan2022, outcome "not recovered", described as "face turned white"; LIP DISCOLOURATION (medically significant) with onset 04Jan2022, outcome "not recovered", described as "lips turned purple"; MIGRAINE (medically significant) with onset 04Jan2022, outcome "not recovered", described as "Massive migraines"; MOBILITY DECREASED (medically significant) with onset Jan2022, outcome "unknown", described as "couldn't move"; FALL (medically significant) with onset 04Jan2022, outcome "unknown", described as "fell in chair"; EYE IRRITATION (medically significant) with onset Jan2022, outcome "unknown", described as "burning eyes"; FEELING ABNORMAL (medically significant) with onset Jan2022, outcome "unknown", described as "Felt like an elephant was on her"; LACRIMATION INCREASED (medically significant) with onset Jan2022, outcome "unknown", described as "tearing eyes"; INFLUENZA LIKE ILLNESS (medically significant) with onset Jan2022, outcome "unknown", described as "flu like symptoms"; FATIGUE (medically significant), outcome "unknown", described as "patient was tired"; CHILLS (medically significant) with onset 04Jan2022, outcome "unknown", described as "chills"; PYREXIA (medically significant) with onset 04Jan2022, outcome "unknown", described as "Fever"; PAIN (medically significant) with onset 04Jan2022, outcome "unknown", described as "she had bed with aches and pains"; MALAISE (medically significant), outcome "unknown", described as "she didn't feel well"; RHINORRHOEA (medically significant), outcome "unknown", described as "runny nose"; HEADACHE (medically significant), outcome "unknown", described as "Headaches"; ILLNESS (medically significant), outcome "unknown", described as "sick". The patient underwent the following laboratory tests and procedures: body temperature: (Jan2022) 102 Fahrenheit; sars-cov-2 test: (19Jan2022) positive.  Clinical Course: Reporter stated that no medical, no hospitalization, no emergency room(ER) visits. Patient had cyanosis or history of cyanosis. No any trauma or injury post fall. No history of similar episode in the past. No history of other vaccine or product administration prior to events. Patient do not had hypertension and stroke. No any illness at the time of vaccination. She had no acute illness or hospitalization 30 days prior to vaccination. No risk factors and no family history of any disease (relevant to vaccination). She was not pregnant at time of vaccination and not currently breastfeeding. Reporter stated on 04Jan2021, following administration of covid-19 vaccine ad26.cov2.s, her face turned white, lips turned purple and just passed out did not lose consciousness. She sat down and fell in chair. Pharmacist gave her lollipop to suck but did not gave anything to drink,30 minutes later when they went home, she had massive migraines, chills and fever, she had bed with aches and pains (flu Iike symptoms) (dose number in series 2). covid-19 vaccine ad26.cov2.s vaccination failure. This event (s) is considered not related. The event (s) has a compatible/suggestive temporal relationship, is unlabeled and has unknown Scientific plausibility. There are other factors more likely to be associated with the event (s) than the drug. Covid-19 vaccine ad26.cov2.s she passed out. This event(s) is considered inaccessible. The event(s) has a compatible/suggestive temporal relationship is unlabeled and has unknown plausibility. There is no information on any other factors potentially associated with the event(s).  Reaction Information Seq. No.:1, Reaction: She passed out (Passed out, Loss of consciousness), Start date: 04Jan2022, Stop date: Unk, Duration: Unk, Seq. No.:2, Reaction: Suspected clinical vaccination failure (vaccination failure, Vaccination failure), Start date: 19Jan2022, Stop date: Unk, Duration: Unk, Seq. No.:3, Reaction: Face turned white (Skin discoloration, skin discoloration), Start date: 04Jan2022, Stop date: Unk, Duration: Unk, Seq. No.: 4, Reaction: Lips turned purple (Lip discoloration, lip discoloration), Start date: 04Jan2022, Stop date: Unk, Duration: Unk, Seq. No.: 5, Reaction: Massive Migraines (Migraine, Migraine), Start date: 04Jan2022, Stop date: Unk, Duration: Unk, Seq. No.: 6, Reaction: Suspected Covid-19 Infection (Suspected Covid-19, Suspected Covid-19), Start date: 04Jan2022, Stop date: Unk, Duration: Unk, Seq. No.: 7, Reaction: Could not move (Mobility decreased, Mobility decreased), Start date: Jan2022, Stop date: Unk, Duration: Unk, Seq. No.:8, Reaction: Fell in chair (Fall , Fall), Start date: 04Jan2022, Stop date: Unk, Duration: Unk, Seq. No.:9, Reaction: Burning Eyes (Burning eyes, Eye), Start date: Jan2022, Stop date: Unk, Duration: Unk, Seq. No.: 10, Reaction: Felt like an elephant was on her (Felling abnormal, Felling abnormal), Start date: Jan2022, Stop date: Unk, Duration: Unk, Seq. No.: 11, Reaction: Tearing eyes (Tearing eyes, Lacrimation increased), Start date: Jan2022, Stop date: Unk, Duration: Unk, Seq. No.: 12, Reaction: Flu like symptoms (Flu like symptoms), Start date: Jan2022, Stop date: Unk, Duration: Unk   Reactions include relevant test/lab data: She passed out (Passed out, Loss of consciousness)  Unknown, Protocol relatedness:, As per reporter: UNK, As per company: UNK, Suspected clinical vaccination failure (vaccination failure, Vaccination failure)  Unknown, Protocol relatedness:, As per reporter: UNK, As per company: UNK, Face turned white (Skin discoloration, skin discoloration) - Not recovered/not resolved , Protocol relatedness:, As per reporter: UNK, As per company: UNK, Lips turned purple (Lip discoloration, lip discoloration) - Not recovered/not resolved, Protocol relatedness:, As per reporter: UNK, As per company: UNK, Reaction: Massive Migraines (Migraine, Migraine) - Not recovered/not resolved, Protocol relatedness:, As per reporter: UNK, As per company: UNK, Suspected Covid-19 Infection (Suspected Covid-19, Suspected Covid-19) - Not recovered/not resolved, Protocol relatedness:, As per reporter: UNK, As per company: UNK, Could not move (Mobility decreased, Mobility decreased)  Unknown, Protocol relatedness:, As per reporter: UNK, As per company: UNK, Fell in chair (Fall , Fall)  Unknown, Protocol relatedness:, As per reporter: UNK, As per company: UNK, Burning Eyes (Burning eyes, Eye)  Unknown, Protocol relatedness:, As per reporter: UNK, As per company: UNK, Felt like an elephant was on her (Felling abnormal, Felling abnormal)  Unknown, Protocol relatedness:, As per reporter: UNK, As per company: UNK, Tearing eyes (Tearing eyes, Lacrimation increased)  Unknown, Protocol relatedness:, As per reporter: UNK, As per company: UNK, Flu like symptoms (Flu like symptoms, Influenza like illness)  Unknown, Protocol relatedness:, As per reporter: UNK, As per company: UNK   Causality for Drug Janssen Covid-19 Vaccine(Covid-19 Vaccine) (Suspension for injection) (Covid-19 Vaccine): 1) She passed out (Passed out, Loss of consciousness), Action(s) taken with drug: Not applicable, Causality as per reporter (Drug/Vaccine): Possible, Causality as per Mfr (Drug/Vaccine): Possible, Dechallenge: N/A, Rechallange: N/A, 2) Suspected clinical vaccination failure (vaccination failure, Vaccination failure), Action(s) taken with drug: Not applicable, Causality as per reporter (Drug/Vaccine): Possible, Causality as per Mfr (Drug/Vaccine): Possible, Dechallenge: N/A, Rechallange :N/A, 3) Face turned white (Skin discoloration, skin discoloration), Action(s) taken with drug: Not applicable, Causality as per reporter (Drug/Vaccine): Possible, Causality as per Mfr (Drug/Vaccine): Possible, Dechallenge: N/A, Rechallange :N/A, 4) Lips turned purple (Lip discoloration, lip discoloration), Action(s) taken with drug: Not applicable, Causality as per reporter (Drug/Vaccine): Possible, Causality as per Mfr (Drug/Vaccine): Possible, Dechallenge: N/A, Rechallange :N/A, 5) Massive Migraines (Migraine, Migraine), Action(s) taken with drug: Not applicable, Causality as per reporter (Drug/Vaccine): Possible, Causality as per Mfr (Drug/Vaccine): Possible, Dechallenge: N/A, Rechallange :N/A, 6) Suspected Covid-19 Infection (Suspected Covid-19, Suspected Covid-19), Action(s) taken with drug: Not applicable, Causality as per reporter (Drug/Vaccine): Possible, Causality as per Mfr (Drug/Vaccine): Possible, Dechallenge: N/A, Rechallange :N/A, 7) Could not move (Mobility decreased, Mobility decreased), Action(s) taken with drug: Not applicable, Causality as per reporter (Drug/Vaccine): Possible, Causality as per Mfr (Drug/Vaccine): Possible, Dechallenge: N/A, Rechallange :N/A, 8) Fell in chair (Fall , Fall), Action(s) taken with drug: Not applicable, Causality as per reporter (Drug/Vaccine): Possible, Causality as per Mfr (Drug/Vaccine): Possible, Dechallenge: N/A, Rechallange :N/A, 9) Burning Eyes (Burning eyes, Eye), Action(s) taken with drug: Not applicable, Causality as per reporter (Drug/Vaccine): Possible, Causality as per Mfr (Drug/Vaccine): Possible, Dechallenge: N/A, Rechallange :N/A, 10) Felt like an elephant was on her (Felling abnormal, Felling abnormal), Causality as per reporter (Drug/Vaccine): Possible, Causality as per Mfr (Drug/Vaccine): Possible, 11) Tearing eyes (Tearing eyes, Lacrimation increased), Causality as per reporter (Drug/Vaccine): Possible, Causality as per Mfr (Drug/Vaccine): Possible, 12) Flu like symptoms (Flu like symptoms), Causality as per reporter (Drug/Vaccine): Possible, Causality as per Mfr (Drug/Vaccine): Possible   Additional information was received from RA Department on 11Feb22. The following information was updated and incorporated into case narrative: product quality complaint number and batch Lot number added. (1805020) V2: This version updates: product quality complaint number and batch/lot number added (1805020) .Upon review following Information was amended: Reporter (Pfizer as contact) added and DD scheduled accordingly. This added information does not alter the previous causality assessment of reported events.   The lot number for bnt162b2 was not provided and will be requested during follow up.