Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Fatigue, Loss of personal independence in daily activities, Malaise, Muscle spasms
Clinical narrative: Ear infection; Hearing loss; Intermittent cold feelings; Intermittent pain feelings; Cellulitis; Felt Unwell; Chronic Fatigue; Extreme Exhaustion; Muscle cramp in right foot; Unable to function; Hashimoto's Disease Exacerbated; Initial Telephone Call, 20 May 2021 Pt. reported that on 03 May 2021 she was administered TDVAX (MassBiologics lot #A125A) in her left arm for wound management after injury by a rusty nail. After vaccine administration, she started to feel unwell and continued to feel unwell. She was experiencing chronic fatigue and extreme exhaustion, keeping her from performing daily activities. Her fatigue was followed by muscle cramping in her right foot, treated with Diazepam.  She had received Tdap on 10APR2013 along with rabies, hepatitis and typhoid vaccines which lead to some unspecified reaction. The healthcare provider thought that it was related to the rubber stopper of the rabies vaccine and not to Tdap vaccine.   Pt. reported that she has Ehlers-Danlos Syndrome, Hashimoto Disease, and Fibromyalgia.   On 21 May 2021 Pt. called to inform MassBiologics that she had been in the emergency room (ER) three times in the last 24 hours after being stung by mud wasps. Within a day of having been stung, she developed cellulitis on her left ear (which she noted was at the same side as initial vaccination), and on her right elbow. Pt. was not sure if the cellulitis was related to vaccination.  She stated that she was consulting her doctor because she might be borderline anemic.  Follow-up Telephone Call, 24 May 2021 MassBiologics reached out to pt. to clarify the timeline of the wasp stings and ER visits. She stated that on 19 May 2021 she received multiple stings on both forearms and biceps, the right elbow and left ear. By 20 May 2021, she had developed cellulitis on the left ear and right elbow resulting in an ER visit on the same day. She was prescribed Benadryl and sent home. Her cellulitis continued to worsen, so she returned to the ER at 1:30 AM on 21 May 2021 where she was prescribed antibiotics. During this visit her labs were also taken and showed elevated TSH levels due to which she returned to the ER in the afternoon of 21 May 2021. Follow up lab results showed that TSH levels now has been dropped to its normal level. She stated that her endocrinologist was confused by these TSH results and thought that Td vaccine may have exacerbated her Hashimoto's Disease.   Further Follow-ups MassBiologics reached out to pt. several times to check her status but she did not answer calls on 4 Jun 2021, 7 June2021, 26 Jul 2021 or 28 Jul 2021. Pt. was contacted via email on 2 Aug 2021. On 6 Aug 2021, she contacted MassBiologics to follow up on the current status of the adverse events. She stated that she was "back to being herself" and that the originally reported events seemed to have resolved.   Upon being asked for more details on her ER visits and the medication prescribed, pt. explained that she was prescribed Cephalosporin during her visit to ER on 21 May 2021 and during the course of taking the Cephalosporin she began to experience a cold feeling, pain and some hearing loss in her left ear. She visited the ER on 16 June 2021 because the cold feeling and pain did not subside. She was diagnosed with a middle ear infection. She was prescribed, to the best of her recollection, ZPAK for duration of 10 days. Upon continuation of the cold feeling and ear pain, she followed up with her health care provider on 22 July 2021. During this examination, fluid was noted in her ear. She was prescribed Levaquin. As of 6 Aug 2021, pt. was still experiencing significant hearing loss, intermittently feeling cold and pain. During this call she expressed the intention to follow up with ENT specialist.   On 01 Oct 2021 MassBiologics contacted pt. to determine her current status.  She reported that her initially reported AEs had resolved and that she was feeling much better than a couple of months ago. She stated that her left ear no longer feels infected but that she was concerned that some hearing loss persisted.; Sender's Comments: The adverse event reported in this case was assessed as follow: 1) Chronic Fatigue,  was assesed as Non-serious and Labeled. 2) Rest of the AEs were assessed as Non-serious and Unexpected.