Age: 66.0
Sex: F
Vaccine: TD
Symptoms: Musculoskeletal discomfort, Pain in extremity, Presyncope, Product administered at inappropriate site, Ultrasound scan abnormal
Clinical narrative: On 05/02/2018 this 66 year old woman received an injection of MassBiologics' Td vaccine (Lot #A110A) at an urgent care clinic in her left shoulder for wound prophylaxis. On 07/06/2018, 65 days post Td administration, she telephoned MassBiologics to report a set of adverse events consisting predominantly of injection site reactions and musculoskeletal complaints, summarized in this narrative. She considers the injection to have been administered too high in her arm. At the time of the telephone call, she was still experiencing aches and pain in her left arm and left shoulder as well as weakness in her left arm. She reported that she did not feel like herself.  Information regarding her past medical history and concomitant medications is limited but includes a back injury 4 years before her Td vaccination and ongoing asthma. Concomitant medications include Advair and inhaler. No other vaccines were administered with Td, nor within the 4 months prior to the visit.  During Td administration, she experienced intense pain at the administration site, presyncope, followed shortly by feeling her "head spinning".  On 05/03/2018, 1 day after Td administration, she experienced muscle tightness of her left bicep, weakness and severe pain in her left arm, and bilateral pain and aches in her arms and shoulders. She reported "not feeling like herself" and fearing death.  She had injection site redness, hardness, and a bump.  She visited her primary care practitioner who instructed her to ice her arm. She reported being housebound for 3 days due to the pain.  On 05/04/2018, 2 days after Td administration, a nurse examined her and indicated that the injection site was slightly high.  On 05/05/2018, 3 days after Td administration, she was examined by a doctor at the facility that had administered the vaccine.  She reported persistent swelling, redness, and induration at the injection site and that the physician noted that the injection site seemed high.  She also reported having problems getting dressed and with mobility.  On 05/08/2018, 6 days after Td administration, she returned to her primary health care facility and reported that "bloodwork" performed at that time was normal.  A stress test with normal findings was conducted 13 days after Td administration, (05/15/2018) and her cardiologist concluded that her heart was normal.  On 05/22/2018, 20 days after Td administration, she experienced intense pain in her right thigh, lasting approximately 2 days.  On 05/23/2018, 21 days post Td administration, x-rays of her arms and shoulders were normal.  Ultrasound examination of arms and shoulders on 05/24/2018, 22 days post Td administration, showed bone spurs in both shoulders.  At an unknown date after Td administration, examination by her "back doctor" concluded her current pain was not related to her back injury 4 years ago.; Sender's Comments: MassBiologics assessed adverse events in this case as both non-serious and serious, with both labeled and unexpected reactions.  Administration site reactions, swelling, musculoskeletal pain, myalgia, and pain in extremities are all listed in the package insert for Td.  Unexpected events reported include head spins, feeling abnormal, bone spurs, muscle tightness, muscular weakness, presyncope, fear of death, and impairment of daily activities.  The patient believes that the Td vaccine was given in an incorrect location.  While there are inconsistencies in the patient's report of events, the case as a whole is considered a serious event based on the overall impact on the patient's life, which resulted in a persistent incapacity and substantial disruption of the ability to conduct normal life functions.  As of 07/06/2018, 65 days post Td administration, the patient still experiences pain, achiness, and weakness in her left arm and left shoulder which causes difficulty lifting her arm and results in impairment of daily activities such as getting dressed and getting around.  MassBiologics contacted the patient on 07/12/2018 to request release of medical information from the facility where the Td vaccine was administered and is awaiting reply.