Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lipase, Lymphadenopathy, Lymphocyte count, Mean cell haemoglobin concentration, Mean platelet volume
Clinical narrative: does not feel her immune system is the same; hasn't had a voice/ hasn't been able to talk with her regular voice; wheezing; cough stuff up; couldn't breathe; her blood sugar is elevated; a lot of stomach pain; Headache; Chest pressure; D Dimer test that was high/ some sort of an infection maybe; Respiratory infection; Enlarged Lymph nodes; pain/ like it was burning, throbbing/ in different locations of her body; cold sweats; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received the second dose of bnt162b2 (COMIRNATY, Lot Number: EW0169), via an unspecified route of administration, administered in right arm on 30Aug2021 (45-year-old at time of vaccination) as single dose for COVID-19 immunization. Medical history included tachycardia, insomnia, depression, obesity, "sleep". Concomitant medications included amitriptyline (AMITRIPTYLINE) taken for sleep (she was already prescribed amitriptyline prior to receiving the vaccines as needed for sleep, but she doesn't like to take medicine she rarely took that); propranolol (PROPRANOLOL) taken for tachycardia. The patient previously received levofloxacin (LEVAQUIN) and experienced drug allergy; previously received doxycycline (DOXYCYCLINE) and experienced drug allergy. The patient previously received the first dose of bnt162b2 (COMIRNATY, Lot Number: EW0169), via an unspecified route of administration, administered in right arm on 09Aug2021 (45-year-old at time of vaccination) as single dose for COVID-19 immunisation and experienced "lymph nodes are enlarged on her neck and armpit area" and pain in the neck. Narrative: Patient states that both first and second dose of the Pfizer covid vaccine have the same Lot Number EW0169. She got both doses on the dominant arm, on her right arm. She received first vaccination dose on 09Aug2021, after she has been having issues with her lymph nodes. On the right side the lymph nodes are enlarged on her neck and armpit area. She got an ultrasound done with labs. Her HCP still recommended her to get the 2nd Pfizer vaccine. She got the second dose on 30Aug2021 ever since then she has had a headache (later clarified as "started 3 days after the second dose"). She has a neurologist appointment coming up. The first night after the second dose (30Aug2021) she had cold sweats, the next day (31Aug2021) she woke up with excruciating pain, it was different type of pain, like it was burning, throbbing, and she feels the pain at the same time in different locations of her body. Her pain was bad that she could not be touched. She called the doctor the next day (01Sep2021) because she was chest pressure, the pain is still there but not as excruciating. She went to urgent care and they did labs, a D Dimer test that was high (0.58 on 02Sep2021), they did an emergency CT Scan with contrast of the chest, and the doctor said that was negative. The doctor said that she felt like D Dimer test indicated she had some sort of an infection maybe. Patient states that she was back to her doctor because the pain was random, it was like ice picks would stab in random parts of body. She can't get rid the of headache. They ran more tests, she has started to feel better with exception of the headache. She is on medication that she was not on before. She has a follow up with neurology. Two and half weeks ago (Sep2021) she got a respiratory infection, she tested negative for flu (Sep2021) and COVID-19 (22Sep2021). They put her on an inhaler, steroids, and antibiotics, and she is still sick. She does not feel her immune system is the same. She hasn't had a voice in 2.5 weeks. They gave her another round of antibiotics, she still needed an inhaler because she developed wheezing. She has never had this before, all of this is ongoing since the second vaccination. Event details: Enlarged Lymph nodes: It started about 2 days after the first dose, it started off with pain in the neck, she did not have a sore throat but when moving the neck she could feel it pull, she then physically felt the enlargement by feeling it with touch. It had subsided after a week and a half. Then after the second vaccination it came back, however it wasn't until 2.5 weeks after the second dose it enlarged again. The second time around it subsided about a week later (Sep2021) and ended beginning of Oct2021. Headache: It started 3 days after the second dose. She is on medication for it now, for the headache. Outcome: some days are better than others, she still feels the tight band around the head. Treatment for headaches: She takes amitriptyline every night because it helps with the headache, she was already on propranolol, she was also given a migraine medication, a new one that she cant remember the name of. She is schedule for a MRI on 28Oct2021. Pain: It started the day after the second dose (31Aug2021), it's random pain that she didn't have before. It feels like ice picks now, like she will have nerve pain on cuticle of the toe. It's weird spots it comes up. The severity comes on fast, on a pain scale her pain is between 7-8 out of 10. When it comes it doesn't last long. Chest Pressure: It started on 01Sep2021, the day before she went to urgent care, she called the doctor and she actually wanted her to call 911 the day before but she didn't. She went to urgent care on 02Sep2021. Outcome: Her Chest still feels tight however she does not know if it's the respiratory infection. Patient clarified she did not go to an emergency room in a hospital, she went to an urgent care facility that was attached to the big organization and so they were able to send her to different places within the facility for tests. Respiratory infection: She happens to love her Nurse practitioner but she is tired of seeing her. When she goes for her yearly exams she is overweight but not unhealthy. She saw the Nurse practitioner on 16Sep2021 because she couldn't breathe. Outcome: She is on the second round of antibiotics, it's got better from where it was before. She is now actually able to cough stuff up but she still has wheezing, She hasn't been able to talk with her regular voice since this started. Treatment: The 1st antibiotic she was given was a Z-Pak and the steroid is prednisone 20mg twice a day. The Second antibiotic is Augmentin twice a day, the doctor gave her steroids because she is still tight but not wheezing as much, the doctor told her to try not to take the steroids if she can help it, since her blood sugar is elevated (on 02Sep2021). She was also given an albuterol inhaler. She has not Lot numbers to provide for Amitriptyline, Migraine Medication with unknown name, Propranolol, Z-Pak, Augmentin, or Prednisone, they are not physically with her at this moment. Patient states that the Antibiotic was taken twice a day. Investigation: Before she only had yearly checks up and that's it. Patient states that she has had a lot of lab work done starting on 18Aug2021. 20Aug2021: She has an ultrasound of soft neck tissue with the result of a nonspecific anterior neck lymph nodes with first one having measurements of 1.0cm by 0.9cm by 0.4cm and the other one being 1.2cm by 1.3cm by 0.3cm. 02Sep2021: She had many tests. Her BMP for the most part was good, the glucose was elevated. She had a CBC in which the White Blood Cells was fine, Red Blood Cells was fine, the Hemoglobin was fine, her MCHC was 31.4, and the MPV 11.2, She has 59% neutrophils, 27% lymphocytes, 8% monocytes, 5% eosinophils, and 1% basophils. She has an Abdominal Ultrasound that was normal, an Abdominal obstruction Series that was normal, she clarified that she was also having a lot of stomach pain (on 02Sep2021). She has a CT of the Chest to rule out a PE, it was normal, she had a 12 lead EKG that showed sinus rhythm. 22Sep2021: On this day she went back to doctor, and they drew a CBC which had abnormal hematocrit 43.2, her neutrophil was 69%, lymphocytes was 23%, monocytes 5%, eosinophils 3%, and the basophil was back to normal at 0%. Her CMP (comprehensive metabolic panel) showed her glucose was still elevated but she is on steroids. 13Oct2021: She went to the doctor because they wanted to listen to lungs a second time. She is allergic to Levaquin and Doxycycline. Patient would also like to add her upcoming appointments She see's Neurology on 21Oct2021 for the headaches. She has an Ultrasound schedule for 20Oct2021 at 3:10PM. She has a MRI schedule 27Oct2021. Other test data: On 18Aug2021: Mono: Negative; comprehensive metabolic panel: Normal; Strep Group A: Negative. On 02Sep2021: ANA: normal; CK: normal; Chest X-ray: fine; C-reactive protein: Elevated 0.82; BNP, Test for Heart Failure: 27, Normal; Lipase: 17, Normal; Liver Panel: Bilirubin on 02Sep202: 0.1, low; Urine analysis: normal. On 22Sep2021: Sediment: 17; Rheumatoid factor: Normal; Uric acid: normal; CT Scan without Contrast: normal. On 13Oct2021: TSH: normal; Hemoglobin A1C: normal. The case was reported as non-serious. The outcome of enlarged lymph nodes was recovered in Oct2021; headache and "pain/ like it was burning, throbbing/ in different locations of her body" were not recovered; respiratory infection was recovering; outcome of other events was unknown.; Sender's Comments: Based on the temporal relationship, the association between the event respiratory infection with COMIRNATY use can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.