Received Mar 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | — | — |
dysautonomia; POTS syndrome; activation of underlying Ehlos Danlos Syndrome; This is a spontaneous report received from a Physician. A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidaemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amitza, reaction(s): "allergies: Amitza". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: AUTONOMIC NERVOUS SYSTEM IMBALANCE (disability), outcome "not recovered", described as "dysautonomia"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (disability), outcome "not recovered", described as "POTS syndrome"; EHLERS-DANLOS SYNDROME (disability), outcome "not recovered", described as "activation of underlying Ehlos Danlos Syndrome". Expert at a hospital stated she had seen this a lot with her patients. Therapeutic measures were taken as a result of autonomic nervous system imbalance, postural orthostatic tachycardia syndrome, ehlers-danlos syndrome and included treatment with midodrine and naloxone. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Based on available information, the reported events autonomic nervous system imbalance, postural orthostatic tachycardia syndrome and Ehlers-Danlos syndrome are considered likely intercurrent conditions and assessed as not related to suspect BNT162b2. 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.
Medical History/Concurrent Conditions: Hyperlipidemia