Age: 61.0
Sex: U
Vaccine: TD
Symptoms: Inflammation, Injection site cellulitis, Injection site mass, Injection site pain, Myalgia
Clinical narrative: Unable to function; Cellulities; Felt Awful; Dehydrated; Swelling; Numbness; Fatigue; Muscle Aches; Trigger finger; Intermittent pain in the lower right arm; Scabbiness; Initial Telephone Call, 14 Jun 2021 Pt. reported that was administered TDVAX (MassBiologics lot #A125A) in her left arm on 11 Apr 2021 for wound management after cutting her left ring finger on a can. On the same day, pt. was prescribed the antibiotic, amoxicillin, by her doctor for wound management. Pt. stated that the vaccine site was not appropriately cleaned prior to the injection and that she was unsure if the TDVAX was administered via an intramuscular injection. On 12 Apr 2021, she felt "awful", dehydrated and fatigued. She also reported muscle aches in her lower back, and noticed that cellulitis had started to develop at the injection site.   Pt. stated that over the couple of weeks post-vaccination she developed swelling in her feet and left hand.  Due to this, she could not exercise and felt tired all the time. Pt. stated that she has Epstin-Barr Virus and that could have played a role in her reaction to the vaccine.  During this call, she also mentioned that she still feels numbness in the left hand and pain at the wound site. In addition, she could feel little lump on the injection site which was painful if she applies pressure. She added that overall, her adverse reactions were getting better as of 6/14/2021 though she was not completely recovered.  Follow-up Telephone Call, 25 Jun 2021 During this call, pt. provided more information on the diagnosis of her cellulitis - A week after vaccination, her infectious disease doctor confirmed that she had cellulitis in her left arm and mentioned that the antibiotic which she is taking for the wound management would take care of the cellulitis as well. Therefore, Dr did not prescrib treatment to address the cellulitis.  However, Dr. prescribed Meloxicam to treat her inflammation and pain.  Pt. mentioned that she was feeling better; however, the AEs she reported were not fully recovered. She also mentioned that she had some numbness in her left hand and was feeling achy.  Further, pt. reported that she had recently developed a trigger finger (her right thumb) within the past week.  Follow-up Telephone Call, 15 Jul 2021 Pt. mentioned that the cellulitis in her left arm was no longer present but that numbness in her left hand, which she believes was the result of nerve damage, was worsening. She was planning to visit the neurologist for the numbness.  Further Follow-up After this call, MassBiologics attempted to reach out to pt. several times to check the status of the numbness of her left arm and to learn about her overall health but pt. did not answer calls on 10 Aug 2021, 18 Aug 2021, email on 31 Aug 2021. Thus, MassBiologics closed this case.; Sender's Comments: The adverse event reported in this case was assessed as follow: 1) Cellulitis, Generalised muscle aches, and Swelling was assesed as Non-serious and Labeled. 2) Rest of the AEs were assessed as Non-serious and Unexpected.