chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Hypoaesthesia, Pain, Pain in extremity
Clinical narrative: Urticarial, itchy, rash on both arms. She also has a large amount of swelling of left arm with pain from shoulder down arm and numbness/tingling  in fingers. Those symptoms are still present today 3/4/21. She also had headache and body aches on 3/2-3/3 but those have subsided. She is begin treated with decadron 10 mg IM, followed by prednisone taper starting at 60 mg tomorrow and continuing for total  of 9 days. Also claritin 10 mg daily and betamthasone cream 0.1% tid prn itching/rash. She is to recheck if not improved 3/5/21, and otherwise recheck 3/8/21.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral swelling, Pruritus, Rash, Rash pruritic
Clinical narrative: Urticarial, itchy, rash on both arms. She also has a large amount of swelling of left arm with pain from shoulder down arm and numbness/tingling  in fingers. Those symptoms are still present today 3/4/21. She also had headache and body aches on 3/2-3/3 but those have subsided. She is begin treated with decadron 10 mg IM, followed by prednisone taper starting at 60 mg tomorrow and continuing for total  of 9 days. Also claritin 10 mg daily and betamthasone cream 0.1% tid prn itching/rash. She is to recheck if not improved 3/5/21, and otherwise recheck 3/8/21.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Urticarial, itchy, rash on both arms. She also has a large amount of swelling of left arm with pain from shoulder down arm and numbness/tingling  in fingers. Those symptoms are still present today 3/4/21. She also had headache and body aches on 3/2-3/3 but those have subsided. She is begin treated with decadron 10 mg IM, followed by prednisone taper starting at 60 mg tomorrow and continuing for total  of 9 days. Also claritin 10 mg daily and betamthasone cream 0.1% tid prn itching/rash. She is to recheck if not improved 3/5/21, and otherwise recheck 3/8/21.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Limb injury, Pain, Product administered at inappropriate site, Sleep disorder
Clinical narrative: Pt came in today for her 2nd dox of Moderna COVID vaccine. States her first dose was given too high on her arm, injection felt very painful, believes she sustained shoulder injury from vaccination on 2/11/21. Pt said she had excruciating pain that night, she could not even lie down to sleep.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dysphagia, Erythema, Flushing, Paraesthesia oral
Clinical narrative: Approximately 2 minute after COVID-19 vaccination, the patient felt tingling and swelling of the tongue, followed by difficulty swallowing. Patient face and forehead was red and flushed about 15 minutes after vaccination. Some tightness and chest after the tongue swelling. Patient also felt some tightness of throat. About 40 minutes after vaccination patient received 25mg Benadryl and 40mg Pepcid. Patient feeling better 5-10 minutes after Benadryl/Pepcid. Tightness in throat much approved. No vomiting, diarrhea, fever. All symptoms resolved and patient discharge to home.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Throat tightness
Clinical narrative: Approximately 2 minute after COVID-19 vaccination, the patient felt tingling and swelling of the tongue, followed by difficulty swallowing. Patient face and forehead was red and flushed about 15 minutes after vaccination. Some tightness and chest after the tongue swelling. Patient also felt some tightness of throat. About 40 minutes after vaccination patient received 25mg Benadryl and 40mg Pepcid. Patient feeling better 5-10 minutes after Benadryl/Pepcid. Tightness in throat much approved. No vomiting, diarrhea, fever. All symptoms resolved and patient discharge to home.
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhage, Immediate post-injection reaction, Induration, Mass, Swelling
Clinical narrative: I vaccinated the patient with the Pfizer Covid-19 vaccine. Immediately afterwards, I noticed some bleeding and then a few seconds later I noticed a welt(swelling) start to form. It appeared to become slightly larger over the next couple minutes. It felt quite firm to the touch. However, the patient denied it being painful. The lump did not appear red or inflamed. I immediately applied a cotton ball and held gentle pressure; this was to stop the small amount of bleeding. After removing the cotton ball a few seconds later, I noticed the unusual swelling. I immediately notified the staff that I required a RN's assistance. I monitered the patient, and then asked my line leader (supervisor) to continue to moniter him as I had to continue vaccinating other patients. A couple minutes later, the RN came over and took over the situation. Patient's breathing was normal & did not appear to be in distress. Patient was then directed to drive to the Medical survellance outside.
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: I vaccinated the patient with the Pfizer Covid-19 vaccine. Immediately afterwards, I noticed some bleeding and then a few seconds later I noticed a welt(swelling) start to form. It appeared to become slightly larger over the next couple minutes. It felt quite firm to the touch. However, the patient denied it being painful. The lump did not appear red or inflamed. I immediately applied a cotton ball and held gentle pressure; this was to stop the small amount of bleeding. After removing the cotton ball a few seconds later, I noticed the unusual swelling. I immediately notified the staff that I required a RN's assistance. I monitered the patient, and then asked my line leader (supervisor) to continue to moniter him as I had to continue vaccinating other patients. A couple minutes later, the RN came over and took over the situation. Patient's breathing was normal & did not appear to be in distress. Patient was then directed to drive to the Medical survellance outside.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Paraesthesia oral, Product after taste, Tongue discolouration, Tongue disorder
Clinical narrative: Immediately after the shot I could taste it, then a few hrs later my tongue felt thick, patchy, funny...The next day my tongue still felt the same and I noticed a small white patch on it. The third day my tongue still felt the same and it was purple-ish. I brushed it and it started bleeding. The fourth day it was covered in white.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue haemorrhage
Clinical narrative: Immediately after the shot I could taste it, then a few hrs later my tongue felt thick, patchy, funny...The next day my tongue still felt the same and I noticed a small white patch on it. The third day my tongue still felt the same and it was purple-ish. I brushed it and it started bleeding. The fourth day it was covered in white.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pain
Clinical narrative: Localized pain at injection site (left deltoid) 2 wks after injection
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Throat tightness
Clinical narrative: anxiety, tight throat, upper chest tightness  Narrative:
Sex: U
Vaccine: COVID19
Symptoms: Apgar score, Foetal heart rate decreased, Foetal hypokinesia, Maternal exposure during pregnancy
Clinical narrative: decreased fetal movement; decreased fetal heart tones; 34 weeks pregnant; This is a spontaneous report from a contactable pharmacist. This pharmacist reported information for both mother and fetus. This is a fetus report. A fetus patient of an unspecified gender received the first dose of bnt162b2, transplacental on 16Mar2021 (Lot Number: Unknown) as single dose for covid-19 immunisation. The 31-year-old mother received this vaccine via Intramuscular. The patient medical history and concomitant medications were not reported. The mother presented to obstetrician office 2 weeks after covid vaccine with complaints of decreased fetal movement. Mother was taken to emergency c-section due to decreased fetal heart tones in the office. Baby was delivered with apgars of 0 and ultimately fetal demise. Mother was 34 weeks pregnant and had an otherwise uncomplicated pregnancy. The onset date of events decreased fetal movement and decreased fetal heart tones was 30Mar2021. The events were result in Doctor or other healthcare professional office/clinic visit and hospitalization for 3 days. The outcome of the events was fatal. The patient died on an unspecified date in 2021 due to events. It was not reported if an autopsy was performed.  Follow-up (14Apr2021): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: The reported events are likely due to an intercurrent condition and not related to   BNT162B2 .,Linked Report(s) : US-PFIZER INC-2021359597 Mother case; Reported Cause(s) of Death: 34 weeks pregnant; decreased fetal movement; decreased fetal heart tones
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Appendicectomy, Appendicitis, Blood test, Cardiac disorder
Clinical narrative: 1ST VACCINE- 1/11/2021 VERY SORE ARM, SAME DAY AS VACCINE . 1ST VACCINE.  SECOND VACCINE WAS GIVEN ON 2/01/2021 AND ARM WAS ALSO SORE SAME DAY, DAY TWO, HORRIBLE HEADACHE BEHIND MY RIGHT EYE, NAUSEA, WEAKNESS IN LIMBS.  ON 2/25/2021 HAD HORRIBLE STOMACH PAINS, THE NEXT MORING WENT TO ER. HAD ACCUTE APPENDICITIS. HAD APPENDIX REMOVED THE EVENING OF 2/26/2021. I NOW HAVE SOMETHING WRONG WITH MY LUNGS OR HEART. I AM CURRENTLY SEEKING TREATMENT AT the CARDIOLOGY department.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Computerised tomogram abdomen abnormal, Computerised tomogram thorax, Dyspnoea, Eye pain
Clinical narrative: 1ST VACCINE- 1/11/2021 VERY SORE ARM, SAME DAY AS VACCINE . 1ST VACCINE.  SECOND VACCINE WAS GIVEN ON 2/01/2021 AND ARM WAS ALSO SORE SAME DAY, DAY TWO, HORRIBLE HEADACHE BEHIND MY RIGHT EYE, NAUSEA, WEAKNESS IN LIMBS.  ON 2/25/2021 HAD HORRIBLE STOMACH PAINS, THE NEXT MORING WENT TO ER. HAD ACCUTE APPENDICITIS. HAD APPENDIX REMOVED THE EVENING OF 2/26/2021. I NOW HAVE SOMETHING WRONG WITH MY LUNGS OR HEART. I AM CURRENTLY SEEKING TREATMENT AT the CARDIOLOGY department.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Laboratory test, Lung disorder, Muscular weakness, Nausea
Clinical narrative: 1ST VACCINE- 1/11/2021 VERY SORE ARM, SAME DAY AS VACCINE . 1ST VACCINE.  SECOND VACCINE WAS GIVEN ON 2/01/2021 AND ARM WAS ALSO SORE SAME DAY, DAY TWO, HORRIBLE HEADACHE BEHIND MY RIGHT EYE, NAUSEA, WEAKNESS IN LIMBS.  ON 2/25/2021 HAD HORRIBLE STOMACH PAINS, THE NEXT MORING WENT TO ER. HAD ACCUTE APPENDICITIS. HAD APPENDIX REMOVED THE EVENING OF 2/26/2021. I NOW HAVE SOMETHING WRONG WITH MY LUNGS OR HEART. I AM CURRENTLY SEEKING TREATMENT AT the CARDIOLOGY department.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Scan with contrast, Scan with contrast abnormal
Clinical narrative: 1ST VACCINE- 1/11/2021 VERY SORE ARM, SAME DAY AS VACCINE . 1ST VACCINE.  SECOND VACCINE WAS GIVEN ON 2/01/2021 AND ARM WAS ALSO SORE SAME DAY, DAY TWO, HORRIBLE HEADACHE BEHIND MY RIGHT EYE, NAUSEA, WEAKNESS IN LIMBS.  ON 2/25/2021 HAD HORRIBLE STOMACH PAINS, THE NEXT MORING WENT TO ER. HAD ACCUTE APPENDICITIS. HAD APPENDIX REMOVED THE EVENING OF 2/26/2021. I NOW HAVE SOMETHING WRONG WITH MY LUNGS OR HEART. I AM CURRENTLY SEEKING TREATMENT AT the CARDIOLOGY department.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Nausea, Pyrexia
Clinical narrative: Arthralgia, Fever, NauseaVomitin, Fatigue, Chills Narrative: Symptoms started dat after injection, got better over several days
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Arthralgia, Fever, NauseaVomitin, Fatigue, Chills Narrative: Symptoms started dat after injection, got better over several days
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Headache, Influenza like illness, Injection site pain
Clinical narrative: Headache, Myalgia, Arthralgia, Fever, flu-like symptoms, sinus drainage, left arm pain at injections site, pressure in chest, cold, eyes are sensitive to light Narrative:
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nasopharyngitis, Paranasal sinus hypersecretion, Photophobia, Pyrexia
Clinical narrative: Headache, Myalgia, Arthralgia, Fever, flu-like symptoms, sinus drainage, left arm pain at injections site, pressure in chest, cold, eyes are sensitive to light Narrative:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Headache fatigue, nausea, neck ache, sore arm, chills Narrative: employee states: She experienced extreme fatigue beginning around 6pm same day as injection with nausea, sore arm at injection site, and restless sleeping. Friday 3/26/21: zero energy, headache, neck aches, nausea, mild chills, and sore at injection site Saturday 3/27/21: low energy, nausea, injection site tender Symptoms subsided late Saturday afternoon/early evening.  Other Relevant History:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Restlessness
Clinical narrative: Headache fatigue, nausea, neck ache, sore arm, chills Narrative: employee states: She experienced extreme fatigue beginning around 6pm same day as injection with nausea, sore arm at injection site, and restless sleeping. Friday 3/26/21: zero energy, headache, neck aches, nausea, mild chills, and sore at injection site Saturday 3/27/21: low energy, nausea, injection site tender Symptoms subsided late Saturday afternoon/early evening.  Other Relevant History:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Muscle spasms, Myalgia, Pyrexia
Clinical narrative: Dizziness, Headache, Myalgia, Fever, Leg Cramps Narrative: Symptoms started evening of injection, persisted for several days.  Other Relevant History:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Pyrexia
Clinical narrative: Myalgia, Arthralgia, Fever Fatigue Narrative:  Other Relevant History:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: Myalgia, Fever, sore throat Narrative:  Other Relevant History:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Insomnia, Pain in extremity, Pyrexia
Clinical narrative: Headache fever, chills, sore arm, insomnia  Narrative:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Pyrexia
Clinical narrative: Headache, Fever & Diarrhea Narrative:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Myalgia, Nausea
Clinical narrative: Myalgia, Arthralgia, Fever, NauseaVomiting, Fatigue,Chills Narrative:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Myalgia, Arthralgia, Fever, NauseaVomiting, Fatigue,Chills Narrative:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: Myalgia Chills Narrative:  Patient called to report symptoms the next day after initial dose. Took OTC Tylenol for muscle pain. Symptoms persisted for a few days before subsiding.  Other Relevant History:
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Myalgia, Pyrexia, Tenderness
Clinical narrative: Dizziness, Myalgia & Fever  Narrative: Felt dizzy and feverish (99.8), left arm tender, felt better after taking OTC Tylenol and Iburofen.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Headache, Myalgia, fatigue Narrative:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Myalgia, Nausea
Clinical narrative: Myalgia, Arthralgia, Fever, NauseaVomiting, Fatigue, Chills Narrative:  Other Relevant History:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Myalgia, Arthralgia, Fever, NauseaVomiting, Fatigue, Chills Narrative:  Other Relevant History:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Myalgia, NauseaVomiting, Chills Narrative: Felt fatigued that afternoon, nausea, headache, body aches started next day
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vomiting
Clinical narrative: Myalgia, NauseaVomiting, Chills Narrative: Felt fatigued that afternoon, nausea, headache, body aches started next day
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Myalgia
Clinical narrative: Myalgia, Arthralgia, Fatigue, Chills Narrative:  Other Relevant History:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Fatigue, Headache, Neck pain
Clinical narrative: Headache, Arthralgia, Fatigue Narrative:  Achy neck, back, and knees  Other Relevant History:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Myalgia
Clinical narrative: Dizziness, Myalgia, Arthralgia, Fatigue, Chills Narrative:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fever Fatigue Narrative:  Patient reported fatigue and fever 100.4 and going down  Other Relevant History:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Pyrexia
Clinical narrative: Arthralgia, Fever, Fatigue, Chills Narrative:  Other Relevant History:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Malaise, Nausea
Clinical narrative: NauseaVomiting malaise, fatigued, chills, and sweating (Staff member states,"No fever" Narrative:  Other Relevant History:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: NauseaVomiting malaise, fatigued, chills, and sweating (Staff member states,"No fever" Narrative:  Other Relevant History:
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fever Fatigue Narrative:  Fever 100.7  Other Relevant History:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Vomiting
Clinical narrative: NauseaVomiting Fatigue Narrative:  Other Relevant History:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Headache, Myalgia, Arthralgia, Fever & NauseaVomiting Narrative:  Symptoms started day after shot, subsiding the following day  Other Relevant History:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Headache, Myalgia, Arthralgia, Fever & NauseaVomiting Narrative:  Symptoms started day after shot, subsiding the following day  Other Relevant History:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness
Clinical narrative: Confusion & Dizziness Narrative:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever, NauseaVomiting, Fatigue Narrative:  Other Relevant History:
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Myalgia arm pain Narrative:  Other Relevant History:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Nausea, Pain, Vomiting
Clinical narrative: Headache, Arthralgia, Fever & NauseaVomiting Narrative:  Symptoms started night of injection. Nausea, headache, fever 99.4, body aches. Took Tylenol.  Other Relevant History:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: Narrative:  Patient developed high blood pressure for at least 5 days after receiving 2nd dose of pfizer vaccine, verified at unit visit. BPs are significantly elevated. Pt with no prior history of significant HTN.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Headache, Myalgia, Arthralgia, Fever, Chills Narrative: Symptoms started day after injection
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Myalgia, Rash
Clinical narrative: Headache, Myalgia & Rash Narrative:  Rash on left elbow and inner arm, 2 inch circles, they started appearing 2 hours after injection. Redness on chest, neck, forehead appeared next day. Used Epi-pen with no relief, took Tylenol.  Other Relevant History:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Headache, Fever, NauseaVomiting, Fatigue Narrative:  Symptoms started day after injection, persisted for several days  Other Relevant History:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: Myalgia, Fever, NauseaVomiting, Chills Narrative:  Other Relevant History:
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache Narrative:  Other Relevant History:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash Narrative:  Rash appeared 7 days post-injection, on back of neck extending to front  Other Relevant History:
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia, Nausea, Vomiting
Clinical narrative: Headache, Myalgia, Arthralgia & NauseaVomiting Narrative:  Other Relevant History:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: TONGUE SWELLING Narrative:  1307: Pt received her Pfizer Covid vaccine # 1. Pt states that she felt her tongue swelling within 5 minutes of receiving the shot bur reported after 15 minutes. She started to feel shaky, no shortness of breath nor chest pain. 1343: pT received epipen on R thigh. 1348: BP 127/78; HR 88; O2 Sat 95% 1350: Pt is transported from covid vaccine clinic to the treatment room via wheelchair. Pt awake, alert, coherent. Pt states that her tongue swelling has subsided. Pt still feels shaky, denies any SOB or chest pain. Pt is able to talk clearly, without any muffling. Dr. is notified and assessed the patient. 1353: BP 144/78; HR 75; O2 sat 96% Pt's brother is notified and brought him to the treatment room with the pt. He was notified of the incident. 1400: BP 135/75; HR 76; O2 Sat 96% Pt is alert and oriented x4, not in any kind of distress, in calm demeanor. Able to talk clearly. Denies toungue swelling, difficulty swallowing, or any chest pain. Noted no tongue swelling on oral Exam. 1405: BP 131/62; HR 75; O2 Sat 95% Pt is swallowing water without any difficulty. Pt remains calm and t alks without any problems. Pt states that she had worse reaction when she received her pneumonia shot years ago. She was also given epipen at that time. 1415: BP 120/76; HR 75; O2 Sat 96%; Temp: 36.4 C Dr reassessed patient, and patient was discharged home ambulatory and accompanied by brother. Educated patient on signs and symptoms of anaphylactic reaction. PCP advised pt not to receive her second covid vaccine. Note: Patient initially denied history of severe adverse reaction to previous vaccines, but later admitted to a history of reaction to Pneumococcal vaccine which required administration of epinephrine.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Myalgia Narrative:  Other Relevant History:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Headache, Myalgia, Arthralgia, Fever & NauseaVomiting Narrative:  Other Relevant History:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Headache, Myalgia, Arthralgia, Fever & NauseaVomiting Narrative:  Other Relevant History:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fever Fatigue Narrative:  Employee reported fatigue and fever 101  Other Relevant History:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dyspnoea
Clinical narrative: Narrative:  Patient received first dose Pfizer COVID-19 vaccine on 3/9/21. Reports having SOB and increased BP starting <30 mins after vaccine and lasting for 3 days. Resolved on it's own, was advised to go to ED but did not seek treatment. Patient reports previous allergy to flu vaccine and was given epi-pen at that time (self-reported, could not verify in chart).
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph node at left clavicle towards neck Narrative:  Other Relevant History:
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None reported on database Narrative: A 70yo male with history of CHR, DM and history of ESRD (on dialysis). Per nursing documentation of January 26, 2021, he received Covid-19 vaccine without complications and per policy and protocol, included advising the patient to stay on premise for 15 minutes. He was provided written information on side effects and how to report ADR
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema
Clinical narrative: Angioedema Narrative:  Other Relevant History:
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Headache, Myalgia fatigue Narrative:  Other Relevant History:
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Sensation of foreign body, Wheezing
Clinical narrative: sensation of an object in the back of his throat with swallowing Narrative: About five minutes after vaccine, he developed lightheadedness and the sensation of an object in the back of his throat with swallowing. He denied difficulty breathing. His initial vitals were 160/100, HR 100, O2 saturations 96%k. On examination, his tongue was not swollen and he had faint expiratory wheezing. He was given 12.5mg of liquid benadryl. He reported his symptoms slightly improved after five minutes of liquid benadryl. His vitals were measured again about 20 minutes after his first set of vitals and his vitals were 150/100, HR 105, O2 sats 95%. He was given a second dose of 12.5mg of liquid benadryl. After another 20 minutes, he reported that his symptoms were much improved. On examination, his tongue was not swollen and faint expiratory wheezing was heard. Last set of vitals were 140/95, HR 95, and O2 saturations 96%. He was informed to see his PCM and possibly be assessed by an allergist for clearance for second dose.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Lightheadedness Narrative:
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: Narrative:  He reports having developed 2-3 hours of nausea/diarrhea after the first vaccination. These adverse effects began about 2-3 hours after the vaccination. Both spontaneously resolved with rest. He denied other common adverse effects such as headache, fatigue, vomiting, abdominal cramping, and rash.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: Non reported Narrative: A 70yo male with history of HTN, DM, CAD with stent placements and ESRD (on Hemodialysis) Per nursing documentation, he received Covid-19 vaccine on January 23, 2021 at 8:45 and it was administered without complications per policy and protocol
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: None documented Narrative: An 88yo male with history of HTN, DM, Hyperlipidemia and GERD Per nursing immunization note he received his first Covid- 19 vaccine on January 13, 2021 and the second shot on February 3, 2021 and both times without complications, per Policy/protocol. He was advised to remain in the facility for 15 minutes post vaccination, was also provided information regarding side effects and how to report ADR
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Injection site discomfort, Injection site swelling
Clinical narrative: Headache Fingers start to get numb,Upper left arm felt tight and swelling. Narrative:  Other Relevant History:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: lip swelling Narrative:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None reported Narrative: A 69yo male with history of Arthritis, Joint pain (ankle and foot), Hyperlipidemia, Hypertension and Allergic Rhinitis Per nursing immunization note- received Covid- 19 vaccine on February 6, 2021 and the second shot on February 27, 2021 per Policy and protocol, without any complication. He was also advised to stay on facility for 15 minutes post vaccination, was provided information on side effects and how to report ADR
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue Narrative:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Pain
Clinical narrative: body aches, chills, injection site pain Narrative:  Pt had 2nd dose of Moderna Covid vaccine on 19FEB. She reports bodyaches, chills and pain at injection site starting on 20FEB. she states she took Tylenol 500mg and is feeling better. She has no SOB, no CP, no fever. She will report to sick call if symptoms worsens.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Myalgia, Nausea, Vomiting
Clinical narrative: Myalgia, Diarrhea & NauseaVomiting Narrative:  employee had chills, nausea, darrhea  Other Relevant History:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Catheterisation cardiac, Pyrexia, Troponin increased
Clinical narrative: NSTEMI, fever, elevated troponin Narrative:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, SARS-CoV-2 test positive
Clinical narrative: Headache Positive COVID-19 diagnosis on 3/31/2021 Narrative:  Other Relevant History:
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Pyrexia
Clinical narrative: Headache, Fever, Fatigue, Flu-like symptoms Narrative:
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Narrative: Pt with vomiting 1 day after 2nd COVID vaccine but nausea continued for 6 weeks to date.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness
Clinical narrative: Headache, Fatigue, Flu-like symptoms Narrative:
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Rash, Tachycardia
Clinical narrative: Headache, Myalgia, Tachypnea, Rash, NauseaVomiting & Tachycardia Narrative:
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Tachypnoea, Vomiting
Clinical narrative: Headache, Myalgia, Tachypnea, Rash, NauseaVomiting & Tachycardia Narrative:
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Impaired work ability, Myalgia, Pain, Pyrexia
Clinical narrative: Headache, Myalgia & Fever Narrative: employee had fever , body aches and headache, missed work 3/29 and 3/30.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Headache, Sedation, Myalgia, Fever, NauseaVomiting, chills Narrative:
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Headache, Sedation, Myalgia, Fever, NauseaVomiting, chills Narrative:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oedema peripheral
Clinical narrative: Swollen gland Narrative: Swelling in left armpit for one week.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site pain, Injection site reaction, Limb discomfort, Myalgia
Clinical narrative: Myalgia Narrative: Heavy left upper extremity with soreness days 1 & w after injection with numbness and tingling at tips of fingers, hands and feet continuing after2 weeks. States it is getting worse.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Myalgia Narrative: Heavy left upper extremity with soreness days 1 & w after injection with numbness and tingling at tips of fingers, hands and feet continuing after2 weeks. States it is getting worse.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: facial neuropathy Narrative:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Urticaria
Clinical narrative: Diffuse urticaria (no anaphylaxis), 27 hours after the shot: Prior to that fatigue and aches.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Limb discomfort, Pain, Pain in extremity
Clinical narrative: BAD pain in left arm.   Feels like I was punched HARD.   Sometimes it feels like it's being squeezed tight, other times like it's being twisted & knotted inside.   Sometimes it extends into back of shoulder.   Certain movements are so painful that I've been using right arm instead.   But, pain is not present 100% of the time.   I'd estimate about 75% of the time.  Has been going on since day after shot.   I thought it'd go away, but saw doctor  3/17/2021.   Recommended heating pad & P.T.   Bought a heating pad but it's nearly impossible to keep it on that part of arm.   First P.T., for evai, will be 4/3/21.   Second shot in right arm 1/26, no problem.  Will NOT get another!
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Contusion, Headache, Muscle spasms, Pruritus, Rash macular
Clinical narrative: c/o itching all over with intermittent red splotches all over body- intermittent bruising and cramping of thighs since recieving her 2nd covid vaccine. Also had Headache for 7days after each covid vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: patient lost consciousness after sitting in post vacc. Stated it has normal reaction to vaccines. lost consciousness again. EMS dispatched treated and released patient
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Facial paralysis, Stress
Clinical narrative: 4/1/21 Pt arrives to clinic for 2nd Moderna covid vaccinations. Pt states "my face isn't right" Pt takes off mask. O: R sided facial drooping; R Lip sided lips-unable to make smile; R eyelid drooping. Pt went to MD on 3/14; MD provided ABX and informed pt related to "stress" s/p #1 bells palsy- related to covid vaccination. Pt admits to h/p bells palsey x1 > 5 yrs.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Deafness neurosensory, Ear discomfort, Odynophagia, Tinnitus
Clinical narrative: Bilateral Sensorineural Hearing Loss; Bilateral Tinnitus; Right ear pain; Pressure on ears; This case was reported by a lawyer and described the occurrence of sensorineural hearing loss in a 56-year-old female patient who received Herpes zoster (Shingrix) for muscle pain.   The initial information was received on 31 March 2021 via medical record (case is now medically confirmed). The current condition includes Nonsmoker, Patient suffered with Bilateral Sensorineural Hearing Loss and Bilateral Tinnitus. The patient was used Shingrix 0.5 ml via Intramuscular route on 27 August 2020. According to MR patient had odynophagia (pain while swallowing) Patient was reported since August 25 had series of adverse effects includes loss hearing and tinnitus, later she experienced terrible pressure on her ear.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Peripheral swelling
Clinical narrative: tight facial drooping; numbness in right arm, neck and head; Right lower arm swelling; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 12Mar2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in right deltoid on 28Dec2020 09:12 (lot number: EH9899; Expiration Date: Mar2021) as single dose at the age of 35 years old as COVID vaccine. The patient's medical history and concomitant medications were not reported. On 28Dec2020 09:20, the patient experienced right lower arm swelling, numbness in right arm, neck and head. Eventually had tight facial drooping. The patient went to emergency department. The events numbness and facial drooping resulted in visit to physician office and emergency room. The patient was not admitted in the hospital. No treatment was received for the adverse events. The patient underwent CTA neck and CTA head; both on 29Dec2020 with negative results. The patient recovered from the events on unspecified date.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Angiogram cerebral, Facial paralysis, Hypoaesthesia, Peripheral swelling
Clinical narrative: tight facial drooping; numbness in right arm, neck and head; Right lower arm swelling; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 12Mar2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in right deltoid on 28Dec2020 09:12 (lot number: EH9899; Expiration Date: Mar2021) as single dose at the age of 35 years old as COVID vaccine. The patient's medical history and concomitant medications were not reported. On 28Dec2020 09:20, the patient experienced right lower arm swelling, numbness in right arm, neck and head. Eventually had tight facial drooping. The patient went to emergency department. The events numbness and facial drooping resulted in visit to physician office and emergency room. The patient was not admitted in the hospital. No treatment was received for the adverse events. The patient underwent CTA neck and CTA head; both on 29Dec2020 with negative results. The patient recovered from the events on unspecified date.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Flushing, Tachycardia, Urticaria
Clinical narrative: Patient reported hives on arms along with rednes @ 1215s. Diphenhydramine 50 mg PO was given to patient @ 1218. At 1225 patient reported facial swelling and redness with edema noted. Patient declined a rapid response team be called (to escort to emergency department) and declined IM epinephrine. She reported that she has had anaphylactic reactions and she knows that she needs steroids. Patient was escorted to the emergency department @ 1228. ED MD noted no hives on arms and no rash but several scatted hives on back. No symptoms consistent with anaphylaxis noted and patient improved with oral diphenhydramine and was ultimately discharged from the ED.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Blood pressure measurement, Body height, Body temperature, Electrocardiogram
Clinical narrative: Patient reported hives on arms along with rednes @ 1215s. Diphenhydramine 50 mg PO was given to patient @ 1218. At 1225 patient reported facial swelling and redness with edema noted. Patient declined a rapid response team be called (to escort to emergency department) and declined IM epinephrine. She reported that she has had anaphylactic reactions and she knows that she needs steroids. Patient was escorted to the emergency department @ 1228. ED MD noted no hives on arms and no rash but several scatted hives on back. No symptoms consistent with anaphylaxis noted and patient improved with oral diphenhydramine and was ultimately discharged from the ED.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Eye swelling, Heart rate, Investigation, Laboratory test, Oxygen saturation
Clinical narrative: Patient reported hives on arms along with rednes @ 1215s. Diphenhydramine 50 mg PO was given to patient @ 1218. At 1225 patient reported facial swelling and redness with edema noted. Patient declined a rapid response team be called (to escort to emergency department) and declined IM epinephrine. She reported that she has had anaphylactic reactions and she knows that she needs steroids. Patient was escorted to the emergency department @ 1228. ED MD noted no hives on arms and no rash but several scatted hives on back. No symptoms consistent with anaphylaxis noted and patient improved with oral diphenhydramine and was ultimately discharged from the ED.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pruritus, Respiratory rate, Scan, Urticaria, Weight
Clinical narrative: Patient reported hives on arms along with rednes @ 1215s. Diphenhydramine 50 mg PO was given to patient @ 1218. At 1225 patient reported facial swelling and redness with edema noted. Patient declined a rapid response team be called (to escort to emergency department) and declined IM epinephrine. She reported that she has had anaphylactic reactions and she knows that she needs steroids. Patient was escorted to the emergency department @ 1228. ED MD noted no hives on arms and no rash but several scatted hives on back. No symptoms consistent with anaphylaxis noted and patient improved with oral diphenhydramine and was ultimately discharged from the ED.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Drug hypersensitivity
Clinical narrative: Patient reported hives on arms along with rednes @ 1215s. Diphenhydramine 50 mg PO was given to patient @ 1218. At 1225 patient reported facial swelling and redness with edema noted. Patient declined a rapid response team be called (to escort to emergency department) and declined IM epinephrine. She reported that she has had anaphylactic reactions and she knows that she needs steroids. Patient was escorted to the emergency department @ 1228. ED MD noted no hives on arms and no rash but several scatted hives on back. No symptoms consistent with anaphylaxis noted and patient improved with oral diphenhydramine and was ultimately discharged from the ED.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Erythema, Oedema, Swelling face, Urticaria
Clinical narrative: Patient reported hives on arms along with rednes @ 1215s. Diphenhydramine 50 mg PO was given to patient @ 1218. At 1225 patient reported facial swelling and redness with edema noted. Patient declined a rapid response team be called (to escort to emergency department) and declined IM epinephrine. She reported that she has had anaphylactic reactions and she knows that she needs steroids. Patient was escorted to the emergency department @ 1228. ED MD noted no hives on arms and no rash but several scatted hives on back. No symptoms consistent with anaphylaxis noted and patient improved with oral diphenhydramine and was ultimately discharged from the ED.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Feeling cold, Immediate post-injection reaction, Paraesthesia oral, Rash
Clinical narrative: Tachycardia; Rash; This is a spontaneous report from a contactable healthcare professional. This is the second of two reports for the same patient with reoccurring events separated in time.  A 45-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose (Batch/Lot Number: UNKNOWN) via an unspecified route of administration on 26Jan2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The vaccination was received at the hospital. Medical history included asthma, clotting disorder and allergies. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included unspecified medications. It was reported that the patient had received other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 on 05Jan2021 for COVID-19 immunisation and experienced tachycardia, rash and presyncope. The patient developed tachycardia and rash which started approximately 2 weeks after the first vaccine and worsened after the second vaccine on 26Jan2021. The tachycardia and rash required a visit to the Emergency Room and Physician Office. Treatment included steroid injections, oral steroids and Diphenhydramine (BENADRYL). The patient was not admitted to the hospital. The outcome of event tachycardia was recovered on an unknown date. The outcome of event rash was recovering. The healthcare professional reported casual effect of the events  tachycardia and rash to the vaccine.  The lot number for the vaccine was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of  tachycardia and rash  due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is 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.,Linked Report(s) : US-PFIZER INC-2021092876 same patient/reporter, different vaccine dose and event.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash, Tachycardia
Clinical narrative: Tachycardia; Rash; This is a spontaneous report from a contactable healthcare professional. This is the second of two reports for the same patient with reoccurring events separated in time.  A 45-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose (Batch/Lot Number: UNKNOWN) via an unspecified route of administration on 26Jan2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The vaccination was received at the hospital. Medical history included asthma, clotting disorder and allergies. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included unspecified medications. It was reported that the patient had received other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 on 05Jan2021 for COVID-19 immunisation and experienced tachycardia, rash and presyncope. The patient developed tachycardia and rash which started approximately 2 weeks after the first vaccine and worsened after the second vaccine on 26Jan2021. The tachycardia and rash required a visit to the Emergency Room and Physician Office. Treatment included steroid injections, oral steroids and Diphenhydramine (BENADRYL). The patient was not admitted to the hospital. The outcome of event tachycardia was recovered on an unknown date. The outcome of event rash was recovering. The healthcare professional reported casual effect of the events  tachycardia and rash to the vaccine.  The lot number for the vaccine was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of  tachycardia and rash  due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is 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.,Linked Report(s) : US-PFIZER INC-2021092876 same patient/reporter, different vaccine dose and event.