Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood test, Diarrhoea, Nephrolithiasis, Off label use, Product use issue
Clinical narrative: After the vaccine she started having diarrhea; kidney stones; She took 1 Dulcolax Stool Softener after surgery on 16Jun2021 every day until 02Aug2021; She took 1 Dulcolax Stool Softener after surgery on 16Jun2021 every day until 02Aug2021; This is a spontaneous report from a non-contactable consumer (patient) based on the information received by Pfizer from Sanofi, (Mfr. Control No.: 2021SA276770). Initial information received on 18Aug2021 from United States regarding an unsolicited valid serious case received from a patient/non-hcp via call center. This case involves an unknown age female patient who experienced kidney stones, diarrhea pure liquids/loose stools again and she took 1 docusate sodium (DULCOLAX STOOL SOFTENER) after surgery on 16Jun2021 everyday until 20Aug2021 while being treated with docusate calcium (Dulcolax stool softener) and tozinameran (Pfizer biontech COVID-19 vaccine). The patient's past medical history included hand operation on 16Jun2021 (have to put plate and screws on her hand). The patient's past medical treatment(s) and family history were not provided. Concomitant medications included oxycodone hydrochloride, paracetamol (Percocet). In 2021, the patient started taking docusate calcium 1 DF (dosing frequency) QD (every day) (lot- 21B105, 31Jan2024) (formulation, route, strength: Unknown) for constipation. On 05Aug2021, the patient started taking tozinameran (with an unknown formulation, frequency, route, strength, dosage and batch number) for covid-19 vaccination. It was reported that patient had a hand surgery and they had to put plate and screws on her hand on 16Jun2021 and was advised to take oxycodone hydrochloride, paracetamol which could cause constipation and she was also advised to take docusate calcium. She took 1 docusate calcium after surgery every day until 02Aug2021 (Product use issue) (onset: unknown date in 2021, latency: unknown). She had her first Pfizer vaccine on 05Aug2021 and within 48hours after the vaccine she started having diarrhea (pure liquids) (Diarrhoea) (onset: unknow date in Aug2021, latency: unknown). She also mentioned she went to the emergency room to get hydrated again and was done stool samples, urine analysis and X-ray of her abdomen and blood work and found nothing that cause her diarrhea. She said she got better then, this morning she started having loose stools again. The diarrhea was now happening for 10 days. Patient also mentioned that she was scheduled for Eye surgery this coming Monday and was also informed by the doctor that she probably had kidney stones (Nephrolithiasis) (onset: unknown date in 2021 latency: unknown) (seriousness criteria: medically significant) but they would take care after her eye surgery. Action taken was not applicable. It was not reported if the patient receive idea corrective treatment for the events. At time of reporting, the outcome was not recovered I not resolved for diarrhoea and unknown for other two events. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance. With the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.