Sex: F
Vaccine: COVID19
Symptoms: Chronic fatigue syndrome, Feeling abnormal, Headache
Clinical narrative: TEMPORAL LOBE FELT AS IF SOMEONE IS PIERCING A GUN OR KNIFE; DEBILITATING CHRONIC FATIGUE SYNDROME; BRAIN FOG; This spontaneous report was received from a parent via company representatives and concerned a 42 year-old female patient of unspecified race and ethnicity. Initial information was received via an email from the parent on 11-AUG-2021 and was processed together with information received following a telephone call to the parent on the same day. The patient's height and weight were not reported. The patient was reported to have had a mild case of COVID-19 infection approximately six months ago. The father was not aware of any other significant past medical history and no concurrent conditions were reported. The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, route of administration batch number and expiry date not reported), dose not reported, once in total, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included unspecified multivitamins. On 07-APR-2021, the patient called her father whilst driving and reported that their 'temporal lobe feels as if someone is piercing a gun or knife' (coded to temporal headache). The patient and her father recited seven-syllable charka vibrational mantras for 12 minutes. The parent then asked the patient how they felt, and 30 seconds later, the patient reported that the feeling was gone. Her father also reported that the patient was suffering from brain fog and debilitating chronic fatigue syndrome. The father reported that chronic fatigue syndrome was 'reoccurring....life-changing and devastating...and had ruined the life of my lovely daughter'.  He also reported that she experienced no other symptoms than the fatigue and headache. The patient went to the emergency room on an unspecified date for the symptoms, but was released the same day. The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The patient had recovered from temporal lobe felt as if someone is piercing a gun or knife on 07-APR-2021. The father reported that when he last spoke to his daughter 'a few days ago', she was doing better and was not that fatigued (outcome entered as recovering for debilitating chronic fatigue syndrome and brain fog). This report was serious (other medically important condition).; Sender's Comments: V0: This spontaneous report received from the parent of the patient concerns a 42 year-old female of unspecified race/ethnicity who experienced a piercing feeling in her "temporal lobe", "debilitating chronic fatigue syndrome", and "brain fog" 6 days after receiving the Janssen Covid-19 vaccine. Medical history included a mild case of Covid-19 infection 6 months prior. The reporter was unaware of other medical conditions. Concomitant medications included multivitamins. Six days post-vaccination, the patient experienced a feeling that her "temporal lobe" was being pierced by a gun or a knife while driving. She called her parent (the reporter) and together they recited vibrational mantras for 12 minutes, after which the feeling resolved. The parent also reported that his daughter has been experiencing "brain fog" and "debilitating chronic fatigue syndrome". The patient went to the emergency room for the symptoms on an unspecified date and was released the same day; information regarding diagnostic tests or corrective treatments was not provided. As of a "few" days ago when the parent reporter spoke to the patient, she was feeling better and was "not that fatigued". Headache has been commonly observed following vaccination and based on the scientific plausibility along with the temporal relationship, the temporal lobe headache is considered consistent with a causal association to vaccine. The "debilitating chronic fatigue syndrome" and "brain fog" lack sufficient information for assessment (e.g. clarification of symptoms) and thus their relationships to vaccination are considered unclassifiable. Additional information will be requested.