Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Musculoskeletal stiffness, Myalgia, Pruritus
Clinical narrative: severe fatigue, she was so tired she had to sit down when take a shower; stiff neck; muscle pain; exaggerated joint pain; the intense itching that maybe it was serious anaphylactic shock; unable or unstable walking; did not sleep; poor appetite; severe itching mainly in the palms of both hands; itching spread onto both arms and legs; soreness at injection site; This is a spontaneous report from a contactable consumer. A 78-years-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on 21Aug2020 at single dose for pneumonia vaccination. Medical history included connective tissue disease from 2004 and ongoing, Graves' disease from 2004, ongoing slipped disc, back surgery for slipped disc in 2013, primary biliary cholangitis from 2004 and ongoing, ongoing rheumatoid arthritis. Concomitant medication included oxycodone from May2020 to 22Aug2020 for slipped disc, naproxen from 2006 to 21Aug2020 for connective tissue disease, ursodiol from 2004, methylprednisolone from 2004, hydroxychloroquine sulfate (PLAQUENIL) from 2004 , lisinopril from 2004, unknown vitamins, unknown influenza vaccine on 20Aug2020. This consumer reported a severe reaction starting 21Aug2020 to pneumococcal 13-val conj vac (dipht crm197 protein) administered 20Aug2020. Severe reaction: Further described as soreness at injection site and severe itching mainly in the palms of both hands; itching spread onto both arms and legs. Severe reaction was really bad on 22Aug2020 and 23Aug2020. She mentioned itching ongoing during this report; severe reaction reported as improving because she was taking Benadryl 50mg twice daily for itching. She was not able to leave the house. She further described event to include severe fatigue, she was so tired she had to sit down when take a shower; muscle pain and exaggerated joint pain; she had existing Rheumatoid arthritis (RA) but the muscle pain and exaggerated joint pain was different than that of her RA. She also experienced poor appetite, on 22Aug2020 all she ate was a cup of soup which was not normal for her. She was unable or unstable walking. At first she thought she was just itching because she was given Oxycodone but she was only taking 2-1/4 tablets of Oxycodoone and stopped Oxycodone in response but that was not the cause. She almost went to the Emergency Room on 22Aug2020 when event was so intense but there was no one to driver her there. She was scared because she was also having stiff neck at the time. She was scared so she did not sleep the whole day 22Aug2020 because she was scared she would not be able to wake up because of the intense itching that maybe it was serious anaphylactic shock. She mentioned this was the first time she knew she was administered this product (PREVNAR 13); but that she got a pneumonia vaccine every 5 years, last administered in 2015; the Nurse at the pharmacy that administered the Prevnar 13 warned her; she told the nurse she gets pneumonia vaccine every 5 years; and the nurse told her that Prevnar 13 is given only once in a lifetime. Outcome of event soreness at injection site was not recovered, severe itching mainly in the palms of both hands; itching spread onto both arms and legs was recovering. Information about Lot/batch number has been requested.