Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Back pain, Chills, Diarrhoea, Exposure to SARS-CoV-2, Inappropriate schedule of product administration
Clinical narrative: fever; chills,; diarhea; throwing up; she also wanted to sleep; she got sick.; made herself late on the dupixent shot while being treated; The consumer mentioned coming in contact with the COVID-19 Delta variant on vacation twice; shingles three days after taking her first shingles vaccine; arm was also so sore and she could not even lift it,; arm was also so sore and she could not even lift it,; nervous,; many problems with her spine; lower back as the pain was killing her,; getting bruises at the injection site; the site also gets a little bit sore; Information has been received from a 61-year-old female patient via Sanofi, referring on herself. The patient's medical history, medical treatment(s), family history and concomitant therapies were not reported. As concurrent conditions were reported rheumatoid arthritis, carpal tunnel syndrome and hand deformity.  On an unknown date, the patient started taking dupilumab(DUPIXENT) solution for injection (strength: 300mg/2ml) at an unknown loading dose and frequency, followed by 300 mg maintenance dose every other week, subcutaneously (batch number and expiration date were unknown) for atopic dermatitis.   On an unknown date, the patient received the first dose of varicella zoster vaccine rge (cho)(SHINGRIX) (lot #, expiration date, administration route and anatomical location were not reported) and on 12-MAY-2021, the patient received the second dose of varicella zoster vaccine rge (cho)(SHINGRIX) (route; formulation; strength; batch number and expiry date were unknown). On the same date (on 12-May-2021), the patient also received a dose of diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid(TDAP) (route; formulation; strength; batch number and expiry date were unknown) and a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) ) (route; formulation; strength; batch number and expiry date were not reported) all the vaccines as prophylaxis. All the vaccines administered at the doctor's office. She said that she did not know that she was getting any of these shots.  On 13-MAY-2021, the patient got sick, developed fever (pyrexia), chills, diarrhea (diarrhoea), throwing up (vomiting) and she also wanted to sleep (somnolence). On unknown dates, the patient experienced herpes zoster(reported as "shingles three days after taking her first shingles vaccine"); arm was also so sore (pain in extremity) and she could not even lift it (mobility decreased), she was nervous (nervousness), presented many problems with her spine (spinal disorder), lower back pain (reported as the pain was killing her), bruises at the injection site (injection site bruising), the site also gets a little bit sore (injection site pain) and she got off her dupilumab(DUPIXENT), made herself late on the dupilumab(DUPIXENT) shot (inappropriate schedule of product administration).   The patient also had a magnetic resonance imaging (MRI) on 20-MAY-2021, but no results were provided. She stated that she forgot to inform the people who conducted the MRI that she was on dupilumab(DUPIXENT) and she was nervous.  On an unknown date, the patient also reported that she had to go to the pain center as she has so many problems with her spine. Trigger injections were done on her neck and lower back twice. The patient mentioned coming in contact with the COVID-19 Delta variant on vacation twice: once on her husband's birthday and one at a restaurant that she was at, where 5 employees got COVID. She went to get tested (no result was available).  The outcome of pyrexia, somnolence, vomiting, diarrhoea and chills was reported as resolved. The outcome of herpes zoster, exposure to sars-cov-2, illness, inappropriate schedule of product administration, injection site pain, injection site bruising, back pain, spinal disorder, nervousness, mobility decreased and pain in extremity was unknown.        The causality assessment between all the suspect products and the aforementioned events was not provided.