Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, Insomnia, Loss of personal independence in daily activities, Movement disorder, Pain in extremity
Clinical narrative: scared; injection site pain; fatigue.; she could only feel the 1st bend on her fingers; inability to move her arm; swelling and burning of her fingers/ her hand is still swollen/swelling in arm and fingers; swelling and burning of her fingers/heat in arm and fingers; her shoulder starting hurting; She took another acetaminophen (TYLENOL) as pain medication, but it did not work; heat in their arm and fingers; Patient reported first received pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) on 12-AUG-2011, the second dose on 28-SEP-2015; tingling in arm and fingers; she did not sleep well; could not move in bed; lost control/function of their arms and fingers (They could not shower during that time due to not having function of their arm. Patient stated it was very painful and traumatic.); only slept for 2 hours; her hand is still swollen and sore/ her arm is still sore; This spontaneous report has been received from a female patient of unknown age, who was reporting on herself. The patient had no pertinent medical history. The patient's concurrent conditions included multiple unspecified allergies to unspecified pain medications (she could take only acetaminophen (TYLENOL)). In 2012 (reported as "3 years ago"), the patient was vaccinated with an unspecified pneumococcal vaccine and she was advised that an updated version of the pneumococcal vaccine was required.  On 28-SEP-2015 at 12:00, the patient was vaccinated intramuscularly in the arm with an unknown dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, lot# and expiry date were not reported) for prophylaxis. Concomitant therapies included influenza virus vaccine (unspecified), also administered on 28-SEP-2015 at 12:00, in the other arm, and acetaminophen (TYLENOL) (considered as suspect drug), which the patient took as premedication thirty minutes before and post vaccination.  On 28-SEP-2015 at 18:00, 6 hours after vaccination, the patient experienced swelling and burning of her fingers and her shoulder started hurting. She took another acetaminophen (TYLENOL) as pain medication, but it did not work (drug ineffective). On 28-SEP-2015 at 20:00, 8 hours after vaccination, the patient was not able to move her arm. She tried using a cold pack on her arm, which helped, but her hand was still swollen. In the night of 28-SEP-2015, she did not sleep well, and "could not move in bed". She also used alternating "cold water bottles and hot", but only slept for 2 hours. On 29-SEP-2015, when she woke up, she could only feel the first bend on her fingers, and her hand was still swollen and sore. On 29-SEP-2015 at 14:00, 26 hours post vaccination, she can lift her arm, but it was still sore, "but getting better". The patient did not seek medical attention, because she considered that the physician would tell her to go to the emergency room and she did not want to pay so much money, because her arm seemed to be getting better. No lab diagnostics studies were performed. The patient reported that inability to move her arm lasted for 24 hours (resolved on approximately 29-SEP-2015 at 20:00). At the time of report, the patient was recovering from the events of swelling and burning of her fingers, hurting shoulder, sleeping unwell, movement disorder, sleep decreased, hypoaesthesia of fingers, hand swollen and sore. The outcome of drug ineffective was not reported.   The relatedness between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.  Additional information is not expected as no contact details were provided and the reporter did not wish contact the physician.  Follow up information was received from the patient (consumer) on 17-AUG-2022. The patient currently age was 65-year-old. She had eight autoimmune diseases. It was confirmed that no known allergies to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) components. Patient reported first received pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) on 12-AUG-2011 (also reported as "3 years ago" in the previous version) for prophylaxis of pneumococcal (strength, dose, route, lot# and expiry date were not reported). She had a normal reaction, some injection site pain and fatigue on an unknown date. It was recommended she got revaccinated later due to being a caregiver and having eight autoimmune diseases. On 28-SEP-2015, she received another and the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine for prophylaxis of pneumococcal (inappropriate schedule of product administration). On that day, patient stated the reactions were extremely severe: patient stated she had tingling, heat and swelling in the arm and fingers, they lost control/function of arms and fingers, and the reaction did not subside for 4 days, she could not shower during that time due to not having function of the arm (it was very painful and traumatic). The doctor stated the reaction could have come from receiving the same vaccine twice. Patient was needing to get another pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine due to being 65-year-old and high-risk, but she was scared due to reported adverse events from 2015. The outcome of scared was not reported. The outcome of the other events reported on this version was resolved. The causality was not reported.; Sender's Comments: , MERCK1509USA015117:Mfr number