Age: 44.0
Sex: F
Vaccine: COVID19, PPV, TDAP, UNK, UNK, UNK, UNK
Symptoms: Urticaria
Clinical narrative: rash on back; face was very red; eyes almost shut; Swelling in face/ face was stretched to limit; facial hives; rash on eyelids; face was stretched to limit and really hurt; burning face; severely  uncomfortable; 104 temp; This case was reported by a consumer via other manufacturer and described the occurrence of facial swelling in a 44-year-old female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis, TOZINAMERAN (COVID 19 VACCINE PFIZER) (batch number FK9894, expiry date unknown) for prophylaxis, levetiracetam (Keppra) unknown for product used for unknown indication, pregabalin unknown for product used for unknown indication, estradiol unknown for product used for unknown indication and adalimumab (Humira) unknown for product used for unknown indication.   Previously administered products included COVID 19 VACCINE PFIZER (1st dose received on 15th March 2022 at 03.15 pm with batch number EA6207 in left arm), COVID 19 VACCINE PFIZER (2nd dose received on 5th April 2021 at 01.15 pm with batch number EW0151 in right arm), LEVOFLOXACIN with an associated reaction of hypersensitivity, ZOSTER VACCINE RECOMBINANT, ADJUVANTED with an associated reaction of hypersensitivity, FUROSEMIDE with an associated reaction of hypersensitivity, DILTIAZEM with an associated reaction of hypersensitivity and SHINGLES VACCINE (TRADE NAME UNKNOWN) with an associated reaction of hypersensitivity (on an unknown date received shingles vaccine and also experienced hives and facial swelling, refer case US2022AMR091014). Concurrent medical conditions included ankylosis, spondylitis, epilepsy, rheumatoid arthritis, gastroesophageal reflux disease, restless legs and cystitis interstitial.   On 29th April 2022 11:30, the patient received the 1st dose of Tdap Vaccine and the 1st dose of PNEUMONIA VACCINE. On 29th April 2022, the patient received the 3rd dose of COVID 19 VACCINE PFIZER. On an unknown date, the patient started Keppra at an unknown dose and frequency, pregabalin at an unknown dose and frequency and estradiol at an unknown dose and frequency. In May 2022, the patient started Humira at an unknown dose and frequency. On 30th April 2022, 1 days after receiving Tdap Vaccine and less than a week after starting Keppra, the patient experienced high temperature. On 5th May 2022, the patient experienced facial swelling, hives, eyelid rash, facial pain, burning sensation in face and facial discomfort. On an unknown date, the patient experienced rash, red face and eyelid function disorder. The patient was treated with cetirizine (Claritin (Cetirizine)), steroids nos (Steroids) and cetirizine hydrochloride (Zyrtec). The action taken with Keppra was unknown. The action taken with pregabalin was unknown. The action taken with estradiol was unknown. The action taken with Humira was unknown. On an unknown date, the outcome of the facial swelling, hives, eyelid rash, facial pain, burning sensation in face, facial discomfort, rash, eyelid function disorder and high temperature were recovering/resolving and the outcome of the red face was not recovered/not resolved.   It was unknown if the reporter considered the facial swelling, hives, eyelid rash, facial pain, burning sensation in face, facial discomfort, rash, red face, eyelid function disorder and high temperature to be related to Tdap Vaccine and Keppra.     Linked case(s) involving the same patient:  US2022AMR091014   Additional Information: Agency Receipt Date: 07-June-2022 Reporter's Comments: The patient self-reported this case. The patient did not receive the other vaccines within 4 weeks prior to the COVID vaccine. The patient received dose of Tdap vaccine into left arm and the Pneumonia vaccine and the Covid 19 vaccine Pfizer on right arm. The Covid 19 vaccine was administered at doctor's office. The patient also started Humira 5 days after shot. The patient received other medications within 2 weeks of vaccination as Pregabalin, Estradiol, Keppra, Pota, Plaquene and experienced swelling in face and facial hives or rash on eyelids. Face was stretched to limit and really hurt and burned where the patient was severely uncomfortable. It starting to occur the next week but got worse on week 2 of shot.  The patient had 104 temperature the next day of shot.  The Steroids did not respond to the shot. The patient started steroid pills on Monday June 16 (unspecified) and was worse Wednesday (unspecified) morning with eyes almost shut.  The patient visited to allergist office and the allergist gave the shot and put on 2 Zyrtec and 2 Claritin and 4 tagments day. Still there was no response. The patient was getting better about four weeks. Had some rash on back. It was a burning sensation on face and face was very red and still red. Rheumatologist said it was not thing related to the patient's RA or Ankylosis Spondylitis.  The patient was allergic to the shingles shot severely Hives and facial swelling but different than this. The patient visited doctor office but did not had any adverse events till May 16 (unspecified). The patient was not diagnosed with Covid 19 and since the vaccination the patient not tested for Covid 19. On 30th April 2022, 1 days after receiving Pneumonia vaccine and the Covid 19 vaccine Pfizer and less than a week after starting Pregabalin, estradiol and Humira, the patient experienced high temperature. On 5th May 2022, 6 days after receiving Pneumonia vaccine and the Covid 19 vaccine Pfizer, the patient experienced facial swelling, hives, eyelid rash, facial pain, burning sensation in face, facial discomfort. The time to onset for the events rash, red face and Eyelid function disorder was less than 2 months with respect to Tdap Vaccine, Pneumonia vaccine and the Covid 19 vaccine Pfizer. Less than a week after starting Pregabalin, estradiol and Humira, the patient experienced facial swelling, hives, eyelid rash, facial pain, burning sensation in face, facial discomfort, rash, red face, high temperature and eyelid function disorder. It was unknown if the reporter considered the facial swelling, hives, eyelid rash, facial pain, burning sensation in face, facial discomfort, rash, red face, high temperature and eyelid function disorder to be related to Pneumonia vaccine, the Covid 19 vaccine Pfizer, Pregabalin, estradiol and Humira. The reporter gave permission to contact her and healthcare provider about this report. Additional supportive information: The suspects Pota and plaquene were not captured as they are not available. The vaccination date for the 2nd dose of Covid 19 vaccine Pfizer was reported as 5th April 2021. However, the correct date expected upon follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR091014:Same Reporter