Received Jul 3, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER LIVE (ZOSTAVAX) | MERCK & CO. INC. | UNK | — | OT |
she was given "stuff" to try that didn't work; Wet macular degeneration; tremendous eye staph infection after a injection; combination of ZOSTAVAX and previously having chickenpox caused a "super virus"; IGG and IGM test as done in February 2026 which showed it was high; IGG and IGM test as done in February 2026 which showed it was high; she is "Incapacitated''; reduced blood flow to the legs and decreased circulation/legs started getting cramps at night; her legs started getting cramps at night; Zoster sine Herpete shingles without the rash; no blood flow to her nippes/started to experience Nipple pain/ both nipples became erect and hypersensitive; it could be Renaurd's Syndrome; chronic pain; believes the shingles has activated her sympathetic nervous system; This spontaneous report was received from an approximately 68-year-old female patient referring to herself. The patient's medical histories included cataract surgery and chicken pox. The patient's concurrent conditions included macular degeneration, lumbar stenosis, drug reactions or allergies to penicillin, a dust mite and outside mold. The patient's historical drugs included penicillin. The patient's concomitant medications were reported as none. In 2010, when the patient turned 60-year-old, she was vaccinated with zoster vaccine live (ZOSTAVAX) injection (strength, dose, route of administration, lot # and expiration date were not reported) to prevent shingles. The vaccine was reconstituted with sterile diluent (lot # and expiration date were not provided). In 2019, side effects began: the patient experienced severe zoster sine herpete shingles without the rash (internal shingles) (Zoster sine herpete) from zoster vaccine live (ZOSTAVAX). She said she had been to 7 doctors. She went to a breast surgeon who diagnosed no blood flow to her nipples (Vascular insufficiency). The breast surgeon initially thought it could be Renaurd's Syndrome. The customer said she was given "stuff" (unspecified medications; dose, frequency, route of administration, lot # and expiration date not reported) to try that didn't work (Drug ineffective). She then went to neurologist who diagnosed the issue being from shingles. The neurologist did an electromyography (EMG) scan, and a computed tomography (CT) scan (Results not provided). She tried a cream botulinum toxin type a (BOTOX), that didn't help; tried cannabidiol (CBD), that didn't help. The patient said the zoster sine was still active in her body. She was still suffering from the zoster sine herpete without the rash (outcome was not recovered). She said it was getting worse. The patient thought it had been a nightmare. At the time of reporting, the outcome of vascular insufficiency and Raynaud's phenomenon was unknown. The action taken with suspect vaccine with the reconstituted sterile diluent was not applicable. The patient considered the event zoster sine herpete (severe) to be related to suspect vaccine with the reconstituted sterile diluent; the causality between the events of vascular insufficiency, Raynaud's phenomenon and suspect vaccine with the reconstituted sterile diluent was not reported. Lot # is being requested and will be submitted if received. Follow-up information was received from the consumer on 24-Jun-2026. Caller states that since 2019, she has had chronic pain (pain) and believes the shingles activated her sympathetic nervous system (nervous system disorder) and has been horrible since then. Consumer reported that she started to experience nipple pain and both nipples became erect and hypersensitive and nothing has helped at all (vascular insufficiency) and several doctors had told her that there was nothing they could do and they had not seen anything like that before. From there, she went to a neurologist who said the side effects were from shingles, however the neurologist did not know what to do or how to treat her. An electromyography (EMG) test was done and showed automatic nervous system was fine. Caller then mentioned her legs started getting cramps at night (muscle spasms). Therefore, she went to an acupuncturist for consultation, where they said she had reduced blood flow to the legs and decreased circulation (poor peripheral circulation). Then, she went to another primary doctor to get complete blood work as well and where everything looked fine. Caller states she received gabapentin from the primary doctor and also went to pain management doctor and none of that worked. On 12-Aug-2025, the patient had imaging and a computerized tomography (CT) scan on upper and lower back (results not provided). On 06-Feb-2026, magnetic resonance imaging (MRI) was done in thoracic region and lab work, and blood work was done again (results not provided). Immunoglobulin G and M tests were performed in February 2026 which showed they were high (blood immunoglobulin G increased and blood immunoglobulin M increased). The patient mentioned that currently she is incapacitated (disability) and stated the vaccine activated her sympathetic nervous system and was limiting blood flow. The consumer then claimed that combination of zoster vaccine live (ZOSTAVAX) and previously having chickenpox caused a super virus that is causing her problems (superinfection viral). Also, the consumer mentioned that she also had wet macular degeneration (Neovascular age-related macular degeneration) that requires injections but states it is hereditary. Caller states she had a tremendous eye staph infection after an injection (eye infection staphylococcal) and believed it was also connected to her sympathetic nervous system not working well. The reporter considered the events of nervous system disorder and poor peripheral circulation to be related to the vaccine. For the remaining events, the causal relationship was not provided. Upon internal review, the events of superinfection viral and neovascular age-related macular degeneration were considered medically significant. Also seriousness criteria of incapacitated is diasability.
Allergy to molds; House dust mite allergy; Lumbar spinal stenosis; Macular degeneration; Penicillin allergy
Medical History/Concurrent Conditions: Cataract operation; Chickenpox
sterile diluent
Test Date: 202602; Test Name: IGG test; Result Unstructured Data: High; Test Date: 202602; Test Name: IGM test; Result Unstructured Data: high