Age: 46.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site pain, Injection site rash, Insomnia, Loss of consciousness, Mobility decreased
Clinical narrative: A 46 yo woman received a dose of MassBiologics Td vaccine (Lot A041A) in the left upper arm on 1/23/12 at her health care provider's office as a routine booster vaccination.  She also had symptoms of hay fever at the time of the visit and was given a prescription for Claritin but she did not fill this prescription.  No other vaccinations were administered at that time and she was not taking any other concomitant medications.  The patient has a history of allergy to shellfish and believes she may also be allergic to aluminum and mercury.  She reports that she had a severe reaction to a vaccination containing tetanus, polio, and measles when she was very young and nearly died. The patient contacted MassBiologics on 4/11/16 to report adverse events experienced following administration of the dose of Td vaccine (Lot A041A) in January 2012.  She reports that at the time the Td vaccination was administered, the needle was pushed in so far that it punctured her subscapularis tendon.  She felt pain and felt like she would pass out, feeling disoriented, blurry, and "in shock."  She was not hospitalized.  Through approximately May/June 2012 (4.5 months post-Td administration), she continued to experience this pain, along with burning and erythema at the site of administration, which was severe enough to disrupt her sleep.  From May-July 2012 (4-6 months post-Td administration), she had numbness in her left arm, difficulty lifting the arm, burning and excruciating pain radiating from the site of administration down to her wrist.  From June 2012-December 2015 (4 months to 4 years post-Td administration) she experienced constant arthritis, which at the present time (2016) continues intermittently. In August 2012 (7 months post-Td administration), she experienced sudden sore throat and the feeling of facial swelling and numbness.  The following day she developed a rash which started in the left upper arm, spread to her left scapula, then abdomen and left back, and eventually to the right side of her body.  She also experienced shooting pain like electric shocks on the left side of her head/left temple, which also began to occur on the right side of her head after 1-2 days.  The rash persisted through December 2012 (11 months post-Td administration) and resolved after her doctor administered steroids in January 2013. In September 2012 (8 months post-Td administration), she experienced sudden numbness in her left arm.  Then in October 2012 (9 months post-Td administration), she experienced sudden numbness in her right arm followed by whole body numbness.  The numbness persisted until the summer of 2014 (2.5 years post-Td administration) then gradually resolved. In March 2013 (14 months post-Td administration), she experienced extreme fatigue and breathlessness to the point she could not walk.  This was followed later that day by searing pain in her left lower leg that caused her to collapse to the floor.  A few days later she experienced the same symptoms in the right lower leg. Also in 2013 (>1 year post-Td administration), she developed high blood pressure for which she was in the emergency room.  An EKG was performed in November 2013. In June-August 2013 and again in May 2014 (1.5-2.5 years post-Td administration), she reports experiencing multiple episodes of anaphylactic shock resulting in loss of consciousness.  She reports more detail on the May 2014 episode, noting she fractured her vertebrae and was referred to a specialist.  She had an MRI performed in June 2014 to evaluate for a possible concussion.  She was not hospitalized. Overall, the patient reports that in 2013 and 2014 (1-2 years post-Td administration), she felt crippled/could not move due to joint and muscle pain throughout her body.  She would pass out if she tried to get up, felt like she was gasping for air, was oversleeping, and was unable to drive a motor vehicle. At the time of the report of these events (4/2016, > 4 years post-Td administration), the patient reports that she currently experiences fogginess and arthritis pain. Sender's Comments: MassBiologics is working to obtain permission to discuss the reported symptoms with the patient's medical provider and review medical assessment and management of these symptoms that have occurred since administration of Td approximately 4.5 years ago. The medical evaluation of these symptoms given the nature and severity reported by the patient are needed to provide a more complete assessment.  A follow-up will also be performed with the patient to inquire about their recovery. This report will be updated with any additional information received.