Age: 39.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Chills, Headache, Hypoaesthesia, Injection site erythema, Nausea
Clinical narrative: numbness in arm/Arm feels asleep; Injection site redness; Headache; Chills with Fever; Chills with Fever; nausea without vomiting; Felt chest racing; swelling and numbness in arm.; This is a spontaneous report from a contactable pharmacist.  A 39-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13; lot number CD0208; expiration date Jan2022) via an unspecified route of administration on 17Jan2020 at 0.5 ml single for immunisation. Relevant medical history included tobacco user. The patient was receiving unspecified concomitant medications. On 17Jan2020, the patient experienced swelling and numbness in arm, injection site redness, headache, chills with fever, nausea without vomiting and felt chest racing and on 21Jan2020 she experienced also numbness in arm/arm feels asleep. The reporting pharmacist stated that she has a patient that was given pneumococcal 13-val conj vac (dipht crm197 protein) injection and developed some adverse events with the injection. Her arm was numb and has swelling. She only used the first injection out of a box of 10. She gave the injection on Friday and the patient entered the ER over the weekend and that was all the information that he has. She wanted a replacement for the ones that she has left because she didn't feel comfortable using them. The pharmacist stated that the doctor ordered the patient to have a pneumonia shot because the patient was a smoker. Regarding all adverse events except her "arm feels asleep" patient went to the Emergency Room. She went to the Emergency Room on the night of 17Jan2020 and then again on Sunday, 19Jan2020. The pharmacist referred the patient to her physician or emergency room for "arm feels asleep". Treatment: she was given a prescription for an antibiotic but the pharmacist was not sure if the patient had filled it yet. The swelling and redness were the size of a tennis ball. She didn't believe there was a bump protruding from the skin the size of a tennis, but that it was the diameter of a tennis ball. All the events were considered serious as medically significant. The patient had not recovered from the swelling and numbness in arm and from the injection site redness; the patient recovered from the felt chest racing on an unspecified date; the outcome of the other events was unknown.; Sender's Comments: There is a reasonable possibility that the events injection site redness, headache, pyrexia, chills, and nausea were related to pneumococcal 13-valent conjugate vaccine based on known drug safety profile. The association between the other events with pneumococcal 13-valent conjugate vaccine can not be excluded based on close temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.