Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein increased, Chills, Crying, Fatigue, Grunting
Clinical narrative: Swollen lymph nodes; blood pressure was 90/50; Chills; body aches; Fatigue; Joint pain; Bone pain; Headache; Swelling, pain, redness and soreness at the injection site; Swelling, pain, redness and soreness at the injection site; Swelling, pain, redness and soreness at the injection site; Tachycardia / heart rate was 144-152; painful to breath and she was grunting; also said that the injection site itched a little bit.; Fever; First dose on 17Dec2020, second does on 04Jan2021; This is a spontaneous report from a contactable nurse reporting for herself.   A 35-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) ( (lot number was unknown) intramuscularly on 17Dec2020 at 0.3ml, and the second single dose (lot number EJ1685) intramuscularly on 04Jan2021 07:45 at 0.3ml, for COVID-19 prophylaxis.  Medical history included ongoing diabetes. Her diabetes was diagnosed about 6 months ago (reported on 06Jan2021) and was well controlled. Her glucose was at 140 at the ER (emergency room) even after drinking a drink that had sugar in it. The patient's concomitant medications were not reported.  The patient received the second dose on 04Jan2021 at 07:45 and experienced a severe reaction hours after she received it, and she ended up having to go the ER and that they were baffled about what happened.   She reported her symptoms were: fatigue, joint pain mainly in her knees, bone pain that did not feel like muscle pain, headache, swollen lymph nodes in the left axilla, and swelling, redness, pain, and soreness in the left arm at the injection site and also said that the injection site itched a little bit.   Her symptoms started about 9-10 at night on 04Jan2021. She said that she felt like with the second dose she noticed the soreness and pain and redness at injection site after about 2 hours after receiving the second dose, which was sooner than with the first injection. The fever started with the chills and body aches. The chills and body aches started at 22:00 on 04Jan2021. She took acetaminophen and melatonin to try and sleep it off. Fever was after that at around midnight 04Jan2021 and she was burning in fever and her temperature was 104. She stated she started taking layers off and got out from under her covers. She had a sweater on when she took her temperature and her axillary temperature was 105. She said that she got into a hot shower because that was the only thing that provided comfort to her chills. She had not had any chills in about the last 12 hours though (as reported on 06Jan2021). She said that the body aches were so severe that she just sat in her bed and cried. She had tachycardia and she was grunting in pain. She was rotating ibuprofen and acetaminophen and then her fever was not as high. She stated that if her fever came back it was lower each time, and if she did not take the medications though, the bone pain was excruciating. She said that with the bone pain it was like no-one can hold her hand or hug her. Fatigue started at around midnight 04Jan2021. Her headache was at midnight. She felt like she had a headband on and was radiating down the back of her neck. She noticed the lymph nodes were swollen after she went to the ER at around 07:00-08:00 05Jan2021. She was walking with pillow under her arm, and if she moved or lifted her arm it hurt.  She went to the ER at 01:00 05Jan2021. Her blood pressure was 90/50, her heart rate was 144-152 at rest, temperature was 102.8, O2 saturation was 95-96. She said that it was painful to breath and she was grunting, but did not have any breathing issues. The nurse thought she was septic and notified the doctor. The nurse and the doctor did not think it was the vaccine and thought that she was COVID-19 positive. But after they tested her, she was negative for flu and COVID and they were baffled. They were unclear on what happened and did not think it was from the vaccine. They bolused her 1 liter of Normal Saline and gave her a dose of Fentanyl that minimally helped with the bone pain. She was also given 30mg of ketorolac (TORADOL) IV (intravenous) and that significantly improved her pain. She was there a total of 3 hours. She was admitted to the back area of the ER. She said that they drew labs and everything was within normal limits. Her CRP (C-reactive protein) was 30 and her lactate was at 1.5. She said that they told her that  she was most likely having an immune response to the vaccine. Her heart rate and blood pressure came to a more normal range and everything returned to baseline. Her heart rate was 109. She was told to rotate paracetamol (TYLENOL) and ibuprofen for at least the next 24 hours and hydrate.  The events fever, chills, fatigue, joint pain, bone pain, headache, swollen lymph nodes, and swelling, pain, redness and soreness at the injection site were serious due to hospitalization from 05Jan2021 to 05Jan2021. The patient was recovering from fever, chills, joint pain, headache, heart rate and blood pressure, not recovered from fatigue, bone pain, swollen lymph nodes and swelling, pain, redness and soreness at the injection site. The event swollen lymph nodes worsened. The outcome of "injection site itched a little bit" was unknown.   The reporter considered the events fever, chills, fatigue, joint pain, bone pain, headache, swollen lymph nodes, and swelling, pain, redness and soreness at the injection site were all related to the vaccine; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events pyrexia, chills, fatigue, pain, arthralgia, bone pain, headache, lymphadenopathy, vaccination site erythema, vaccination site swelling, vaccination site pain, blood pressure decreased, tachycardia, grunting and vaccination site pruritus cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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.