Sex: F
Vaccine: RAB
Symptoms: Pain, Paraesthesia, Pyrexia, Vision blurred
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of blindness in a 75-year-old female patient who received RABAVERT (batch number 6270118, expiry date March 2020). Co-suspect products included IMOVAX and RABAVERT. Concurrent medical conditions included knee injury (2 years ago fell on her left side). On 8th September 2017, the patient received the 3rd dose of RABAVERT (subcutaneous). On 7th August 2017, the patient received the 2nd dose of IMOVAX. On 3rd August 2017, the patient received the 1st dose of RABAVERT. On 7th August 2017, not applicable after receiving RABAVERT and unknown after receiving RABAVERT, the patient experienced interchange of vaccine products. On 12th August 2017, the patient experienced pain, rib pain, muscle weakness and fever. On 23rd August 2017, the patient experienced blindness (serious criteria GSK medically significant), dehydration and tingling. On 8th September 2017, the patient experienced pain in elbow, shoulder pain and intramuscular formulation administered by other route. On 9th September 2017, the patient experienced injection site bruising. On 10th September 2017, the patient experienced injection site hematoma. On an unknown date, the patient experienced blurred vision. On an unknown date, the outcome of the blindness was recovered/resolved and the outcome of the pain, rib pain, muscle weakness, dehydration, fever, tingling, pain in elbow, injection site hematoma, injection site bruising, shoulder pain, interchange of vaccine products and intramuscular formulation administered by other route were unknown and the outcome of the blurred vision was not recovered/not resolved. It was unknown if the reporter considered the blindness, pain, rib pain, muscle weakness, dehydration, fever, tingling, blurred vision, pain in elbow, injection site hematoma, injection site bruising, shoulder pain and intramuscular formulation administered by other route to be related to RABAVERT. It was unknown if the reporter considered the blindness, pain, rib pain, muscle weakness, dehydration, fever, tingling, blurred vision, pain in elbow, injection site hematoma, injection site bruising, shoulder pain and interchange of vaccine products to be related to RABAVERT. Additional details were reported as follows: The post exposure occurred on 8th July 2017. The reporter stated that the patient did not receive 1st dose of RABAVERT until 3rd August 2017 at an emergency room. The patient received 2nd dose at an urgent care and was given IMOVAX, which led to interchange of products. The patient received 3rd dose of RABAVERT subcutaneously in the left arm, which led to inappropriate route of vaccination. She stated that the nurse held the needle at a 45 degree angle and the site was below the deltoid muscle. The patient stated the 3rd dose was also delayed till 8th September 2017 in her left arm because she had fever with body temperature of 100.3 with muscle weakness, pain in her side, ribs and elbow on 12th August 2017. She also developed severe dehydration, tingling and left eye blindness that resolved after she increased her water intake on 23rd August 2017. The caller was encouraged to contact the Center of Disease Control (CDC) and discuss all these issues with her physician. The patient stated the blindness gradually resolved but she still had blurred vision in her left eye. She had not completed the series of rabies vaccine at this time and never received any Human rabies immunoglobulin, this was her 1st post exposure to rabies event. She stated they were not sure if she was actually exposed, and that was also the reason for the 3 week delay in treatment. She also noted a titer was drawn after the second dose and she was told she didn't show protection. The patient noted after her 3rd shot she experienced pain in shoulder, and elbow within an hour after vaccination. On Saturday, 9th September 2017, the patient experienced a bruise and Sunday, 10th September 2017, hematoma at the site.