chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Lymphadenopathy
Clinical narrative: swollen supraclavicular lymph node; headache; chills; soreness to injection site for 2 days; This is a spontaneous report from a contactable nurse, reporting for a patient.  A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE),  lot number: EJ1685, via intramuscular on 22Dec2020 at 14:45 (at the age of 47 years old) as a single dose in the left arm for COVID-19 vaccination.  Medical history included asthma, celiacs, and hypertension from an unknown date. The patient had known allergies to shellfish, latex, sulfa, Levaquin, Morphine. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included hydrochlorothiazide, zyrtec, dicyclomine, ibuprofen, benadryl, all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 23Dec2020, the patient experienced soreness to injection site for 2 days (23Dec2020 and 24Dec2020). On 26Dec2020 at 16:00, she started having chills and headache. On 27Dec2020 chills were to the point where she couldn't get warm. Shivering chills. She remained afebrile just bad chills for 2 days. On 28Dec2020, she noticed swollen supraclavicular lymph node to left clavicle area which  was painful to touch and approximately quarter in size. It was not as painful today and swelling was starting to subside. The patient did not receive treatment for the events. The clinical outcome of soreness to injection site for 2 days was recovered on 25Dec2020. The clinical outcome for headache, chills, and swollen supraclavicular lymph node was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Fatigue, Headache, Muscular weakness, Palpitations
Clinical narrative: severe dizziness, chest palpitations, extreme muscle weakness, projectile vomiting- all x15 minutes, followed by fever of 101.1 after tylenol. general fatigue, headaches for rest of day
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Vomiting projectile
Clinical narrative: severe dizziness, chest palpitations, extreme muscle weakness, projectile vomiting- all x15 minutes, followed by fever of 101.1 after tylenol. general fatigue, headaches for rest of day
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Dizziness, Fatigue, Headache, Muscular weakness
Clinical narrative: severe dizziness, chest palpitations, extreme muscle weakness, projectile vomiting- all x15 minutes, followed by fever of 101.1 after tylenol. general fatigue, headaches for rest of day
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Palpitations, Pyrexia, Vomiting projectile
Clinical narrative: severe dizziness, chest palpitations, extreme muscle weakness, projectile vomiting- all x15 minutes, followed by fever of 101.1 after tylenol. general fatigue, headaches for rest of day
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Ear discomfort, Headache, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: approximately 15 minutes after the vaccine was administered I developed numbness in my tongue, metallic taste in mouth, and headache and a fullness feeling in ears.  1 and 1/2 hours later I developed neck pain and numbness in the left side of my face that lasted for 48 hours.  Benadryl was taking for 2 days to help with the reaction.  Day 3 after the vaccine symptoms seemed to resolve except for a slight feeling of numbness in left cheek but much better than first 2 days and almost gone completely.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: approximately 15 minutes after the vaccine was administered I developed numbness in my tongue, metallic taste in mouth, and headache and a fullness feeling in ears.  1 and 1/2 hours later I developed neck pain and numbness in the left side of my face that lasted for 48 hours.  Benadryl was taking for 2 days to help with the reaction.  Day 3 after the vaccine symptoms seemed to resolve except for a slight feeling of numbness in left cheek but much better than first 2 days and almost gone completely.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Dyspnoea, Flushing, Headache, Impaired work ability
Clinical narrative: Got 1st shot at 1430 1/4/21. Was sent back to my unit (OR). At 1455 got full body flush followed by tingling lips, tight throat, trouble swallowing and SOB. No obvious signs of swelling of the lips. Used inhaler for SOB which helped marginally. After 1.5 hrs tingling in lips and flushed skin went away. Throat tightness and SOB still remained but weren't progressing so went home after my shift. Later that night around 2100 took 1 25mg  Benadryl. Tightness in throat and SOB improved. The next morning 1/5/21, I reported to work for my shift. Tightness and SOB was manageable at this point. At 0800 the tightness in my throat, trouble swallowing and SOB got significantly worse. I was scrubbed into a surgery and had to call for a replacement so I could take Benadryl. I took 1 25mg tablet and 2 puffs of my inhaler and went back to my case. After the Benadryl and inhaler, the tightness in my throat and SOB became slightly more manageable. At 1240 the symptoms came back and I took another Benadryl and 2 puffs of my inhaler with slight relief of symptoms. Stayed the rest of my shift continuing my inhaler as needed and a Benadryl every 4 hrs. At 1600 I developed a headache at the front of my head above my eyes like a weight was sitting there. The next day when I woke up 1/6/21, the tightness in my throat, SOB and headache were worse so I had to call into work. The headache that morning had progressed to 7 out of 10 pain and the pain then included my neck where it attaches to the skull. At 0830 I called employee health and they advised my to go to an urgent care. I was checked over by a PA and was prescribed prednisone 40 mg for 5 days along with Benadryl every 4 hrs and inhaler as needed. I was also nasal swabbed for Covid. After taking the steroid, the headache and neck pain, tightness in throat went away. The SOB also improved. Currently taking the steroid, Benadryl (every 4 hrs) and inhaler 2 puffs as needed. Symptoms are mostly controlled. 1/7/21 tried to cut back the Benadryl to every 6 hrs. Noticed a huge difference in my breathing and had an increase in SOB so went back to every 4 hrs. 1/8/21 still taking steroid and Benadryl every 4 hrs and inhaler. SOB is worse today even with taking Benadryl. Have an appointment with my PCP to talk about getting the 2nd shot.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neck pain, Paraesthesia oral, SARS-CoV-2 test negative, Throat tightness
Clinical narrative: Got 1st shot at 1430 1/4/21. Was sent back to my unit (OR). At 1455 got full body flush followed by tingling lips, tight throat, trouble swallowing and SOB. No obvious signs of swelling of the lips. Used inhaler for SOB which helped marginally. After 1.5 hrs tingling in lips and flushed skin went away. Throat tightness and SOB still remained but weren't progressing so went home after my shift. Later that night around 2100 took 1 25mg  Benadryl. Tightness in throat and SOB improved. The next morning 1/5/21, I reported to work for my shift. Tightness and SOB was manageable at this point. At 0800 the tightness in my throat, trouble swallowing and SOB got significantly worse. I was scrubbed into a surgery and had to call for a replacement so I could take Benadryl. I took 1 25mg tablet and 2 puffs of my inhaler and went back to my case. After the Benadryl and inhaler, the tightness in my throat and SOB became slightly more manageable. At 1240 the symptoms came back and I took another Benadryl and 2 puffs of my inhaler with slight relief of symptoms. Stayed the rest of my shift continuing my inhaler as needed and a Benadryl every 4 hrs. At 1600 I developed a headache at the front of my head above my eyes like a weight was sitting there. The next day when I woke up 1/6/21, the tightness in my throat, SOB and headache were worse so I had to call into work. The headache that morning had progressed to 7 out of 10 pain and the pain then included my neck where it attaches to the skull. At 0830 I called employee health and they advised my to go to an urgent care. I was checked over by a PA and was prescribed prednisone 40 mg for 5 days along with Benadryl every 4 hrs and inhaler as needed. I was also nasal swabbed for Covid. After taking the steroid, the headache and neck pain, tightness in throat went away. The SOB also improved. Currently taking the steroid, Benadryl (every 4 hrs) and inhaler 2 puffs as needed. Symptoms are mostly controlled. 1/7/21 tried to cut back the Benadryl to every 6 hrs. Noticed a huge difference in my breathing and had an increase in SOB so went back to every 4 hrs. 1/8/21 still taking steroid and Benadryl every 4 hrs and inhaler. SOB is worse today even with taking Benadryl. Have an appointment with my PCP to talk about getting the 2nd shot.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Got 1st shot at 1430 1/4/21. Was sent back to my unit (OR). At 1455 got full body flush followed by tingling lips, tight throat, trouble swallowing and SOB. No obvious signs of swelling of the lips. Used inhaler for SOB which helped marginally. After 1.5 hrs tingling in lips and flushed skin went away. Throat tightness and SOB still remained but weren't progressing so went home after my shift. Later that night around 2100 took 1 25mg  Benadryl. Tightness in throat and SOB improved. The next morning 1/5/21, I reported to work for my shift. Tightness and SOB was manageable at this point. At 0800 the tightness in my throat, trouble swallowing and SOB got significantly worse. I was scrubbed into a surgery and had to call for a replacement so I could take Benadryl. I took 1 25mg tablet and 2 puffs of my inhaler and went back to my case. After the Benadryl and inhaler, the tightness in my throat and SOB became slightly more manageable. At 1240 the symptoms came back and I took another Benadryl and 2 puffs of my inhaler with slight relief of symptoms. Stayed the rest of my shift continuing my inhaler as needed and a Benadryl every 4 hrs. At 1600 I developed a headache at the front of my head above my eyes like a weight was sitting there. The next day when I woke up 1/6/21, the tightness in my throat, SOB and headache were worse so I had to call into work. The headache that morning had progressed to 7 out of 10 pain and the pain then included my neck where it attaches to the skull. At 0830 I called employee health and they advised my to go to an urgent care. I was checked over by a PA and was prescribed prednisone 40 mg for 5 days along with Benadryl every 4 hrs and inhaler as needed. I was also nasal swabbed for Covid. After taking the steroid, the headache and neck pain, tightness in throat went away. The SOB also improved. Currently taking the steroid, Benadryl (every 4 hrs) and inhaler 2 puffs as needed. Symptoms are mostly controlled. 1/7/21 tried to cut back the Benadryl to every 6 hrs. Noticed a huge difference in my breathing and had an increase in SOB so went back to every 4 hrs. 1/8/21 still taking steroid and Benadryl every 4 hrs and inhaler. SOB is worse today even with taking Benadryl. Have an appointment with my PCP to talk about getting the 2nd shot.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Cough, Dysgeusia
Clinical narrative: Severe bodyache with joint pain severe (Knee pain and upper back), chills, headache but more pain in  right side headache with right ear tinnitus, sometimes cough, runny nose and metal taste in mouth.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Rhinorrhoea, Tinnitus
Clinical narrative: Severe bodyache with joint pain severe (Knee pain and upper back), chills, headache but more pain in  right side headache with right ear tinnitus, sometimes cough, runny nose and metal taste in mouth.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: I woke up 6 hours after the vaccine with significant swelling in my face; This is a spontaneous report from a contactable nurse, the patient.  A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL0140, via an unspecified route of administration on 29Dec2020 at 07:30 (at the age of 54 years old) as a single dose in the left arm for COVID-19 vaccination.  Medical history included allergies to azithromycin and compazine.  The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 29Dec2020, the patient stated she woke up 6 hours after the vaccine with significant swelling in her face. It did not affect her breathing. She took 50 mg Benadryl . The swelling was gone 4 hours later. The clinical outcome of swelling in her face was recovered on 29Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: patient presented with  delayed localized reaction one week post reaction - redness, warmth, and pain to the touch. she did not report reaction after initial injection but this was a delayed reaction she is now experiencing.  she  did not take any medications to treat symptoms.  she was advised to seek medical evalauation in the emergency room for this reaction.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Injection site pain; sore arm; muscle aches; fatigue; fever; headache; This is a spontaneous report from a contactable consumer (patient herself). A 25-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: EK9231, expiration date: unknown), via an unspecified route of administration on the left arm on 31Dec2020 at 15:45 at a single dose for COVID-19 immunization administered at the hospital. The patient had no medical history. The patient had no known allergies; no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Jan2021, the patient experienced injection site pain, sore arm, muscle aches, fatigue, fever, and headache. The reporter assessed the events as non-serious. The patient did not receive any treatment for the events. The patient was recovering from all the events.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain; sore arm; muscle aches; fatigue; fever; headache; This is a spontaneous report from a contactable consumer (patient herself). A 25-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: EK9231, expiration date: unknown), via an unspecified route of administration on the left arm on 31Dec2020 at 15:45 at a single dose for COVID-19 immunization administered at the hospital. The patient had no medical history. The patient had no known allergies; no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Jan2021, the patient experienced injection site pain, sore arm, muscle aches, fatigue, fever, and headache. The reporter assessed the events as non-serious. The patient did not receive any treatment for the events. The patient was recovering from all the events.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Stomatitis
Clinical narrative: Mouth sores; This is a spontaneous report from a contactable other healthcare professional, the patient.  A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot Number: Er9231, via an unspecified route of administration on 30Dec2020 at 09:00 (at the age of 28 years old) as a single dose in the left arm for COVID-19 vaccination.  Medical history included herpes simplex virus 1 from an unknown date, and known allergies to some fruits and vegetables (mild itching), and Neosporin.  The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included Benzoyl peroxide and tretinoin face cream, and vitamin D, all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 31Dec2020, the patient experienced mouth sores. Treatment was not received for the event. It was also reported that since the vaccination, the patient has been tested for COVID-19 using a nasal swab on 31Dec2020, with results of negative. The clinical outcome of mouth sores was recovering.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea
Clinical narrative: Symptoms: Chills, headache, nausea, fatigue.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Lymphadenopathy, Pain in extremity
Clinical narrative: She also complained of all the COVID signs and symptoms; She also complained of all the COVID signs and symptoms; left cervical, axillary, clavicular and periscapular lymphadenopathy; left arm and shoulder pain; left arm and shoulder pain; This is a spontaneous report from a contactable physician. An adult female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection, lot number was unknown, intramuscular in the left arm on 28Dec2020 at a single dose for COVID-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient is not pregnant. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that after receiving the Pfizer COVID-19 vaccine in the left deltoid, the patient experienced left cervical, axillary, clavicular and periscapular lymphadenopathy in Dec2020 with outcome of not recovered. She also complained of left arm and shoulder pain and all the COVID signs and symptoms in Dec2020 with outcome of not recovered. The onset was within a day of immunization. She has a history of COVID-19, she had Covid prior vaccination. It was unknown if the patient tested for Covid post vaccination. The onset date of the events was reported as Dec2020. The events was reported as non-serious and it was unknown if the patient received treatment for the events.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the suspected LOE, COVID 19 and other reported events due to temporal relationship.  Of note, it is reported that the patient had a history of COVID-19, and she was diagnosed with  COVID 19 infection prior to the  vaccination.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics , 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.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Rash and pain at injection site
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Nausea, Pain in extremity
Clinical narrative: Moderna COVID-19 Vaccine EUA- fever, chills, sweats, headache, nausea, pain in arm
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Moderna COVID-19 Vaccine EUA- fever, chills, sweats, headache, nausea, pain in arm
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Enlarged uvula, Hypogeusia, Oropharyngeal pain, Pharyngeal erythema
Clinical narrative: Have a sore, reddened throat with significant uvula swelling.  Diminished sense of taste.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Osteoarthritis
Clinical narrative: muscular and arthrosis pain over 3 days, occasionally severe pain
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Diarrhoea, Fatigue, Nausea
Clinical narrative: a slight sore throat and cough with a slight fatigue; a slight sore throat and cough with a slight fatigue; body aches; chills; fatigue; mild fever; diarrhea; nausea; This a spontaneous report from a contactable nurse (patient).  A 26-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number EJI685, unspecified route of administration on 30Dec2020 15:45 (at the age of 26-years-old) as 1 single dose in the right arm  for COVID-19 immunization.  Medical history included Polycystic ovarian syndrome (PCOS) and anxiety. Concomitant medication included ascorbic acid (VITAMIN C) colecalciferol (VITAMIN D), zinc and birth control. The patient was allergic to sulfamethoxazole and trimethoprim (BACTRIM) antibiotics. The most recent COVID-19 vaccine was administered in the hospital. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.The next morning after receiving the vaccine the patient had full body aches, chills, fatigue, mild fever, diarrhea, and nausea. These all resolved within 24 hours as the next day (2nd day after vaccination). The patient felt much better, and only had a slight sore throat and cough with very slight fatigue.The full body aches, chills, fatigue, mild fever, diarrhea, nausea, a slight sore throat and cough with a slight fatigue did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events full body aches, chills, fatigue, mild fever, diarrhea, nausea, a slight sore throat and cough with a slight fatigue. Outcome of the events full body aches, chills, fatigue, mild fever, diarrhea, and nausea was recovered. Outcome of the events a slight sore throat and cough with a slight fatigue was recovering. Since the vaccination, the patient has not been tested for COVID-19.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: a slight sore throat and cough with a slight fatigue; a slight sore throat and cough with a slight fatigue; body aches; chills; fatigue; mild fever; diarrhea; nausea; This a spontaneous report from a contactable nurse (patient).  A 26-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number EJI685, unspecified route of administration on 30Dec2020 15:45 (at the age of 26-years-old) as 1 single dose in the right arm  for COVID-19 immunization.  Medical history included Polycystic ovarian syndrome (PCOS) and anxiety. Concomitant medication included ascorbic acid (VITAMIN C) colecalciferol (VITAMIN D), zinc and birth control. The patient was allergic to sulfamethoxazole and trimethoprim (BACTRIM) antibiotics. The most recent COVID-19 vaccine was administered in the hospital. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.The next morning after receiving the vaccine the patient had full body aches, chills, fatigue, mild fever, diarrhea, and nausea. These all resolved within 24 hours as the next day (2nd day after vaccination). The patient felt much better, and only had a slight sore throat and cough with very slight fatigue.The full body aches, chills, fatigue, mild fever, diarrhea, nausea, a slight sore throat and cough with a slight fatigue did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events full body aches, chills, fatigue, mild fever, diarrhea, nausea, a slight sore throat and cough with a slight fatigue. Outcome of the events full body aches, chills, fatigue, mild fever, diarrhea, and nausea was recovered. Outcome of the events a slight sore throat and cough with a slight fatigue was recovering. Since the vaccination, the patient has not been tested for COVID-19.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Clavicular lymphadenophathy on the same side as the injection
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Heart rate, Tachycardia
Clinical narrative: Tachycardia/HR going up to 140 /minute; Blood pressure went up to 157/94; This is a spontaneous report from a contactable physician (patient himself). A 59-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) via an unspecified route of administration (left arm), on 21Dec2020 at 16:30, at a single dose, for COVID-19 immunization. Relevant medical history included coronary artery disease (CAD) prior percutaneous coronary intervention (PCI) in 2004. The patient has no known allergies. Concomitant medications in two weeks included aspirin, ramipril, ezetimibe, simvastatin (VYTORIN), vitamin D3, and diclofenac. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. The vaccine was administered in the hospital. On 21Dec2020, within 3 minutes of receiving the vaccine (at 16:45), the patient developed tachycardia with heart rate (HR) going up to 140 /minute and blood pressure went up to 157/94. Heart rate returned to 90s within few minutes while his blood pressure slowly returned to baseline 134/84 after 2 hours. The patient did not receive treatment for the events. The patient recovered from the events on the same day (21Dec2020). Since vaccination, the patient has not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at injection site; This is a spontaneous report from a contactable nurse (patient).  A 24-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL1284, intramuscularly on 30Dec2020 (at the age of 24-years-old) as a 1 single dose in the left arm for COVID-19 immunization. Medical history included type one diabetic and celiac disease. The patient had a medical history of allergies to iodine, shellfish, seafood and fish. Concomitant medications was unknown. The most recent COVID-19 vaccine was administered in the hospital.  The patient was not pregnant at the time of vaccination.   Prior to vaccination, the patient was not diagnosed with COVID-19.  On unspecified date, the patient experienced soreness at injection site.   The soreness at injection site did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect.  No treatment was received for the event.  Outcome of the event Soreness at injection site was recovered. Since the vaccination, the patient has not been tested for COVID-19.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Pain
Clinical narrative: Chills with goose bumps, headache, severe aches, weakness/fatigue which began ~ 7 hours after injection and progressively worsened over 24 hours, ~40 hours after injection symptoms were gone.      -took advil, increase fluids and went to bed to sleep ~ 7 hours
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Piloerection
Clinical narrative: Chills with goose bumps, headache, severe aches, weakness/fatigue which began ~ 7 hours after injection and progressively worsened over 24 hours, ~40 hours after injection symptoms were gone.      -took advil, increase fluids and went to bed to sleep ~ 7 hours
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Anxiety, Asthenia, Chills
Clinical narrative: tested positive for Covid test; tested positive for Covid test; difficulty breathing; chills; fluctuating fever; nausea; weakness; weakness/extreme fatigue; loss of taste and smell; loss of taste and smell; muscle pain; cough; sore throat; nasal drip; dizziness; fast heartbeat; injection site pain; anxiety; crying; This is a spontaneous report from a contactable healthcare professional. This 21-year-old female patient reported for herself that she received BNT162B2 1st dose on 31Dec2020 10:00 AM intramuscular at left arm for COVID-19 immunisation. Medical history included known allergies: Penicillin and Covid-19. Concomitant therapy included BC as reported. The patient experienced difficulty breathing, chills, fluctuating fever, nausea, dizziness, weakness, fast heartbeat, tiredness, loss of taste and smell, muscle pain, injection site pain, anxiety, cough, sore throat, nasal drip, crying, extreme fatigue, Etc on 31Dec2020 at 06:00 PM. The events resulted in doctor or other healthcare professional office/clinic visit, emergency. The patient was hospitalized for 1 day and received treatment included blood thinner rivaroxaban (XARELTO) and had 2 weeks quarantine. The patient had Covid prior to vaccination and tested positive for Covid test post vaccination on 01Jan2021. The outcome of the events was not resolved.  Information on Lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the suspected LOE, SARS-CoV-2 test positive and the other reported events due to temporal relationship.  Of note, it is reported that the patient had history of COVID 19 infection prior to the vaccination.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, 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.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Crying, Dizziness, Dyspnoea, Fatigue
Clinical narrative: tested positive for Covid test; tested positive for Covid test; difficulty breathing; chills; fluctuating fever; nausea; weakness; weakness/extreme fatigue; loss of taste and smell; loss of taste and smell; muscle pain; cough; sore throat; nasal drip; dizziness; fast heartbeat; injection site pain; anxiety; crying; This is a spontaneous report from a contactable healthcare professional. This 21-year-old female patient reported for herself that she received BNT162B2 1st dose on 31Dec2020 10:00 AM intramuscular at left arm for COVID-19 immunisation. Medical history included known allergies: Penicillin and Covid-19. Concomitant therapy included BC as reported. The patient experienced difficulty breathing, chills, fluctuating fever, nausea, dizziness, weakness, fast heartbeat, tiredness, loss of taste and smell, muscle pain, injection site pain, anxiety, cough, sore throat, nasal drip, crying, extreme fatigue, Etc on 31Dec2020 at 06:00 PM. The events resulted in doctor or other healthcare professional office/clinic visit, emergency. The patient was hospitalized for 1 day and received treatment included blood thinner rivaroxaban (XARELTO) and had 2 weeks quarantine. The patient had Covid prior to vaccination and tested positive for Covid test post vaccination on 01Jan2021. The outcome of the events was not resolved.  Information on Lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the suspected LOE, SARS-CoV-2 test positive and the other reported events due to temporal relationship.  Of note, it is reported that the patient had history of COVID 19 infection prior to the vaccination.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, 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.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Injection site pain, Myalgia, Nausea, Oropharyngeal pain
Clinical narrative: tested positive for Covid test; tested positive for Covid test; difficulty breathing; chills; fluctuating fever; nausea; weakness; weakness/extreme fatigue; loss of taste and smell; loss of taste and smell; muscle pain; cough; sore throat; nasal drip; dizziness; fast heartbeat; injection site pain; anxiety; crying; This is a spontaneous report from a contactable healthcare professional. This 21-year-old female patient reported for herself that she received BNT162B2 1st dose on 31Dec2020 10:00 AM intramuscular at left arm for COVID-19 immunisation. Medical history included known allergies: Penicillin and Covid-19. Concomitant therapy included BC as reported. The patient experienced difficulty breathing, chills, fluctuating fever, nausea, dizziness, weakness, fast heartbeat, tiredness, loss of taste and smell, muscle pain, injection site pain, anxiety, cough, sore throat, nasal drip, crying, extreme fatigue, Etc on 31Dec2020 at 06:00 PM. The events resulted in doctor or other healthcare professional office/clinic visit, emergency. The patient was hospitalized for 1 day and received treatment included blood thinner rivaroxaban (XARELTO) and had 2 weeks quarantine. The patient had Covid prior to vaccination and tested positive for Covid test post vaccination on 01Jan2021. The outcome of the events was not resolved.  Information on Lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the suspected LOE, SARS-CoV-2 test positive and the other reported events due to temporal relationship.  Of note, it is reported that the patient had history of COVID 19 infection prior to the vaccination.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, 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.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid test; tested positive for Covid test; difficulty breathing; chills; fluctuating fever; nausea; weakness; weakness/extreme fatigue; loss of taste and smell; loss of taste and smell; muscle pain; cough; sore throat; nasal drip; dizziness; fast heartbeat; injection site pain; anxiety; crying; This is a spontaneous report from a contactable healthcare professional. This 21-year-old female patient reported for herself that she received BNT162B2 1st dose on 31Dec2020 10:00 AM intramuscular at left arm for COVID-19 immunisation. Medical history included known allergies: Penicillin and Covid-19. Concomitant therapy included BC as reported. The patient experienced difficulty breathing, chills, fluctuating fever, nausea, dizziness, weakness, fast heartbeat, tiredness, loss of taste and smell, muscle pain, injection site pain, anxiety, cough, sore throat, nasal drip, crying, extreme fatigue, Etc on 31Dec2020 at 06:00 PM. The events resulted in doctor or other healthcare professional office/clinic visit, emergency. The patient was hospitalized for 1 day and received treatment included blood thinner rivaroxaban (XARELTO) and had 2 weeks quarantine. The patient had Covid prior to vaccination and tested positive for Covid test post vaccination on 01Jan2021. The outcome of the events was not resolved.  Information on Lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the suspected LOE, SARS-CoV-2 test positive and the other reported events due to temporal relationship.  Of note, it is reported that the patient had history of COVID 19 infection prior to the vaccination.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, 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.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Severe myalgia for one week
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Dizziness, Dyspnoea, Fatigue, Hot flush
Clinical narrative: typical flu body aches; also had terrible fatigue. I couldn't do normal activity; my arm was getting so sore I couldn't lift it; Within a few hrs I lost the ability to move it at all for a few hrs; overwhelmed with fatigue; Every bone hurt and my ribs were so sore I couldn't take deep breaths; Every bone hurt and my ribs were so sore I couldn't take deep breaths; Every bone hurt and my ribs were so sore I couldn't take deep breaths; nauseous; dizzy; No fever but I felt hot & flushed.; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: Ek9231), via an unspecified route of administration on the right arm on 31Dec2020 09:00 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included lupus.The patient also had allergies to penicillin (PCN). It was also mentioned that the patient COVID twice (Mar2020 until 2020&Nov2020 until 2020). Concomitant medications included lisdexamfetamine mesilate (VYVANSE) and bupropion hydrochloride (WELLBUTRIN). It was reported that the patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient reported that she had a very slight reaction after administration & took diphenhydramine (BENADRYL). She described that approximately at the 11-hour mark (31Dec2020 20:00), her arm was getting so sore and she couldn't lift it. Within a few hours, she lost the ability to move it at all. Also, she was getting overwhelmed with fatigue & she had a feeling that can best be described as the feeling of death entering my bones. Every bone hurt and her ribs were so sore she couldn't take deep breaths. The patient would wake up crying in pain & her pain tolerance was very high. She felt nauseous & dizzy and was the worst night of her life. She took acetaminophen (APAP) 1000mg & meloxicam 15mg that night with no relief. She narrated that she had COVID twice (Mar & Nov) & that night that she experienced; she would rather have COVID 1000 more times than ever have this pain she was in. It was also mentioned that she had no fever, but she felt hot & flushed. At the 23hour mark (01Jan2020 20:00), her symptoms became typical flu body aches which was 100% manageable & was a relief after what she had. It was mentioned that she still had terrible fatigue and couldn't do normal activity (in Jan2021). The patient was not sure if she will take the 2nd shot after this. Outcome of the event of fatigue was not recovered; unknown for "couldn't do normal activity" and recovering for the remaining events.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Musculoskeletal chest pain, Nausea, Pain, Vaccination site movement impairment
Clinical narrative: typical flu body aches; also had terrible fatigue. I couldn't do normal activity; my arm was getting so sore I couldn't lift it; Within a few hrs I lost the ability to move it at all for a few hrs; overwhelmed with fatigue; Every bone hurt and my ribs were so sore I couldn't take deep breaths; Every bone hurt and my ribs were so sore I couldn't take deep breaths; Every bone hurt and my ribs were so sore I couldn't take deep breaths; nauseous; dizzy; No fever but I felt hot & flushed.; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: Ek9231), via an unspecified route of administration on the right arm on 31Dec2020 09:00 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included lupus.The patient also had allergies to penicillin (PCN). It was also mentioned that the patient COVID twice (Mar2020 until 2020&Nov2020 until 2020). Concomitant medications included lisdexamfetamine mesilate (VYVANSE) and bupropion hydrochloride (WELLBUTRIN). It was reported that the patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient reported that she had a very slight reaction after administration & took diphenhydramine (BENADRYL). She described that approximately at the 11-hour mark (31Dec2020 20:00), her arm was getting so sore and she couldn't lift it. Within a few hours, she lost the ability to move it at all. Also, she was getting overwhelmed with fatigue & she had a feeling that can best be described as the feeling of death entering my bones. Every bone hurt and her ribs were so sore she couldn't take deep breaths. The patient would wake up crying in pain & her pain tolerance was very high. She felt nauseous & dizzy and was the worst night of her life. She took acetaminophen (APAP) 1000mg & meloxicam 15mg that night with no relief. She narrated that she had COVID twice (Mar & Nov) & that night that she experienced; she would rather have COVID 1000 more times than ever have this pain she was in. It was also mentioned that she had no fever, but she felt hot & flushed. At the 23hour mark (01Jan2020 20:00), her symptoms became typical flu body aches which was 100% manageable & was a relief after what she had. It was mentioned that she still had terrible fatigue and couldn't do normal activity (in Jan2021). The patient was not sure if she will take the 2nd shot after this. Outcome of the event of fatigue was not recovered; unknown for "couldn't do normal activity" and recovering for the remaining events.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: typical flu body aches; also had terrible fatigue. I couldn't do normal activity; my arm was getting so sore I couldn't lift it; Within a few hrs I lost the ability to move it at all for a few hrs; overwhelmed with fatigue; Every bone hurt and my ribs were so sore I couldn't take deep breaths; Every bone hurt and my ribs were so sore I couldn't take deep breaths; Every bone hurt and my ribs were so sore I couldn't take deep breaths; nauseous; dizzy; No fever but I felt hot & flushed.; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: Ek9231), via an unspecified route of administration on the right arm on 31Dec2020 09:00 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included lupus.The patient also had allergies to penicillin (PCN). It was also mentioned that the patient COVID twice (Mar2020 until 2020&Nov2020 until 2020). Concomitant medications included lisdexamfetamine mesilate (VYVANSE) and bupropion hydrochloride (WELLBUTRIN). It was reported that the patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient reported that she had a very slight reaction after administration & took diphenhydramine (BENADRYL). She described that approximately at the 11-hour mark (31Dec2020 20:00), her arm was getting so sore and she couldn't lift it. Within a few hours, she lost the ability to move it at all. Also, she was getting overwhelmed with fatigue & she had a feeling that can best be described as the feeling of death entering my bones. Every bone hurt and her ribs were so sore she couldn't take deep breaths. The patient would wake up crying in pain & her pain tolerance was very high. She felt nauseous & dizzy and was the worst night of her life. She took acetaminophen (APAP) 1000mg & meloxicam 15mg that night with no relief. She narrated that she had COVID twice (Mar & Nov) & that night that she experienced; she would rather have COVID 1000 more times than ever have this pain she was in. It was also mentioned that she had no fever, but she felt hot & flushed. At the 23hour mark (01Jan2020 20:00), her symptoms became typical flu body aches which was 100% manageable & was a relief after what she had. It was mentioned that she still had terrible fatigue and couldn't do normal activity (in Jan2021). The patient was not sure if she will take the 2nd shot after this. Outcome of the event of fatigue was not recovered; unknown for "couldn't do normal activity" and recovering for the remaining events.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye irritation, Feeling cold, Myalgia
Clinical narrative: 10 hrs. after receiving the vaccine, I started getting chills followed by muscle pain. My eyes were burning. I went to bed under 3 blankets and couldn't get warm. 5 hours later, the chills went away, but the pain persisted. 3 hours later, I took tylenol for the pain and felt much better 1 hour later.