chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Myalgia, Nausea, Pyrexia
Clinical narrative: Headache, Myalgia, Fever, NauseaVomiting,  injection site pain, low grade fever
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Headache, Myalgia, Fever, NauseaVomiting,  injection site pain, low grade fever
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Headache, Injection site pain, Malaise
Clinical narrative: Headache, Fever, Diarrhea, Malaise and Pain at Injection Site, Abdominal Pain Narrative:
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache, Fever, Diarrhea, Malaise and Pain at Injection Site, Abdominal Pain Narrative:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Injection site pain, Pain
Clinical narrative: Headache EXTREME PAIN AT INJECTION SITE, CHILLS, JOINT PAIN, BODY ACHES EMPLOYEE STATES SHE IS IN MORE PAIN AFTER VACCINATION THAT SHE WAS WHEN SHE HAD COVID
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram thorax, Confusional state, Cough, Culture stool, Diarrhoea
Clinical narrative: Confusion, Dizziness, Myalgia, Tachypnea, CoughWheeze, Diarrhea &  HYPOtension Narrative:  severe diarrhea, sob, fatigue, cough feeling unwell, dizzy, hypotension, fainted- found to have pneumonia placed on antibiotics, stool cultures- lost many days from work- ct of chest pending - under PCP care  Other Relevant History:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Hypotension, Impaired work ability
Clinical narrative: Confusion, Dizziness, Myalgia, Tachypnea, CoughWheeze, Diarrhea &  HYPOtension Narrative:  severe diarrhea, sob, fatigue, cough feeling unwell, dizzy, hypotension, fainted- found to have pneumonia placed on antibiotics, stool cultures- lost many days from work- ct of chest pending - under PCP care  Other Relevant History:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Pneumonia, Syncope, Tachypnoea
Clinical narrative: Confusion, Dizziness, Myalgia, Tachypnea, CoughWheeze, Diarrhea &  HYPOtension Narrative:  severe diarrhea, sob, fatigue, cough feeling unwell, dizzy, hypotension, fainted- found to have pneumonia placed on antibiotics, stool cultures- lost many days from work- ct of chest pending - under PCP care  Other Relevant History:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Confusion, Dizziness, Myalgia, Tachypnea, CoughWheeze, Diarrhea &  HYPOtension Narrative:  severe diarrhea, sob, fatigue, cough feeling unwell, dizzy, hypotension, fainted- found to have pneumonia placed on antibiotics, stool cultures- lost many days from work- ct of chest pending - under PCP care  Other Relevant History:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pain in extremity
Clinical narrative: Headache, Myalgia CHILLS, SORE ARM
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Bone swelling, Chills, Dizziness, Eye swelling, Headache
Clinical narrative: BlurredVision, Dizziness, Headache, Fever, BODY ACHES, CHILLS, NAUSEA, SWOLLEN COLLARBONE, NECK AND EYE, RUNNY NOSE, NAUSEA Narrative:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Rhinorrhoea, Swelling
Clinical narrative: BlurredVision, Dizziness, Headache, Fever, BODY ACHES, CHILLS, NAUSEA, SWOLLEN COLLARBONE, NECK AND EYE, RUNNY NOSE, NAUSEA Narrative:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: BlurredVision, Dizziness, Headache, Fever, BODY ACHES, CHILLS, NAUSEA, SWOLLEN COLLARBONE, NECK AND EYE, RUNNY NOSE, NAUSEA Narrative:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Headache, Injection site pain, Myalgia
Clinical narrative: Dizziness, Headache, Myalgia, Fever, Diarrhea, NauseaVomiting injection site pain
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Dizziness, Headache, Myalgia, Fever, Diarrhea, NauseaVomiting injection site pain
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Oropharyngeal pain, Pain
Clinical narrative: Headache BODY ACHES, FATIGUE, CHILLS, SORE THROAT Narrative:  Other Relevant History:
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Chills, Dizziness, Headache, Heart rate increased
Clinical narrative: Dizziness, Headache, HYPERtension, INCREASED HEART RATE, CHILLS employee states: immediately following vaccination,he experienced tenderness at the injection site and then a few hours later chills. beginning on Friday he had dizziness and headache which increased during the day. By Saturday he also had increased heart rate. His BP began increasing as well. His readings were: BP 186/94 and HR 124. He left work and went to the ER at which time 9about 45 min later) his BP was 210/128. Was given saline bolus. at discharge his BP was still 178/108. He has continued to monitor his BP and it has remained higher than normal. States he has no history of high blood pressure. Sees his PC regularly, last seen 1/29/2021. He is still experiencing dizziness and is now on BP medication and f/up with PC.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Dizziness, Headache, HYPERtension, INCREASED HEART RATE, CHILLS employee states: immediately following vaccination,he experienced tenderness at the injection site and then a few hours later chills. beginning on Friday he had dizziness and headache which increased during the day. By Saturday he also had increased heart rate. His BP began increasing as well. His readings were: BP 186/94 and HR 124. He left work and went to the ER at which time 9about 45 min later) his BP was 210/128. Was given saline bolus. at discharge his BP was still 178/108. He has continued to monitor his BP and it has remained higher than normal. States he has no history of high blood pressure. Sees his PC regularly, last seen 1/29/2021. He is still experiencing dizziness and is now on BP medication and f/up with PC.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pyrexia
Clinical narrative: Arthralgia & Fever Narrative:  Other Relevant History:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Headache, Fever, FATIGUE
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Rash
Clinical narrative: Rash Narrative: Rash around injection site
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Chills, Headache, Hot flush
Clinical narrative: Headache CHILLS, CHEST PAIN THAT RADIATED TO BACK, JAW PAIN, CHILLS HOT FLASHES
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in jaw
Clinical narrative: Headache CHILLS, CHEST PAIN THAT RADIATED TO BACK, JAW PAIN, CHILLS HOT FLASHES
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Myalgia Narrative:  Other Relevant History:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pain, Pain in extremity
Clinical narrative: Fever CHILLS, NAUSEA, BODY ACHES ARM SORENESS, FATIGUE, ITCHY ARM
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia
Clinical narrative: Fever CHILLS, NAUSEA, BODY ACHES ARM SORENESS, FATIGUE, ITCHY ARM
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Headache, Fever, NauseaVomiting, BODY ACHES AND CHILLS Narrative:  Other Relevant History:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Headache, Fever, NauseaVomiting, BODY ACHES AND CHILLS Narrative:  Other Relevant History:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cough, Dyspnoea, Headache
Clinical narrative: Headache, Sedation, Myalgia, Arthralgia, Fever, CoughWheeze, Rash, Chills, dyspnea, Occipital headache extending down neck. Arms and legs felt heavy. Injection site with warmth, swelling and erythema.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Limb discomfort, Myalgia
Clinical narrative: Headache, Sedation, Myalgia, Arthralgia, Fever, CoughWheeze, Rash, Chills, dyspnea, Occipital headache extending down neck. Arms and legs felt heavy. Injection site with warmth, swelling and erythema.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pyrexia, Rash, Sedation, Wheezing
Clinical narrative: Headache, Sedation, Myalgia, Arthralgia, Fever, CoughWheeze, Rash, Chills, dyspnea, Occipital headache extending down neck. Arms and legs felt heavy. Injection site with warmth, swelling and erythema.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Breast feeding, Chills, Fatigue, Headache
Clinical narrative: Headache, Fever, NauseaVomiting, BODY ACHES, SORE ARM, FATIGUE, CHILLS, HOT FLASHES,  ABDOMINAL CRAMPING Narrative:  EMPLOYEE STATES EXPERIENCED SIMILAR SIDE EFFECTS TO FIRST AND SECOND VACCINE. ALSO STATES SHE WAS POSITIVE FOR COVIS AND CLEARED FROM QUARENTINE ON 1/8/21 (4 DAYS PRIOR TO FIRST DOSE) SHE IS ALSO 4 MONTHS POST-PARTUM AND CURRENTLY NURSING (BREAST FEEDING).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Headache, Fever, NauseaVomiting, BODY ACHES, SORE ARM, FATIGUE, CHILLS, HOT FLASHES,  ABDOMINAL CRAMPING Narrative:  EMPLOYEE STATES EXPERIENCED SIMILAR SIDE EFFECTS TO FIRST AND SECOND VACCINE. ALSO STATES SHE WAS POSITIVE FOR COVIS AND CLEARED FROM QUARENTINE ON 1/8/21 (4 DAYS PRIOR TO FIRST DOSE) SHE IS ALSO 4 MONTHS POST-PARTUM AND CURRENTLY NURSING (BREAST FEEDING).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Headache, Fever, NauseaVomiting, BODY ACHES, SORE ARM, FATIGUE, CHILLS, HOT FLASHES,  ABDOMINAL CRAMPING Narrative:  EMPLOYEE STATES EXPERIENCED SIMILAR SIDE EFFECTS TO FIRST AND SECOND VACCINE. ALSO STATES SHE WAS POSITIVE FOR COVIS AND CLEARED FROM QUARENTINE ON 1/8/21 (4 DAYS PRIOR TO FIRST DOSE) SHE IS ALSO 4 MONTHS POST-PARTUM AND CURRENTLY NURSING (BREAST FEEDING).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: CHILLS
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Myalgia Narrative:  Other Relevant History:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Headache, Myalgia, NauseaVomiting, fatigue sore arm chills 5 days
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vomiting
Clinical narrative: Headache, Myalgia, NauseaVomiting, fatigue sore arm chills 5 days
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Nausea
Clinical narrative: Headache, Sedation, Myalgia, Arthralgia, Fever, NauseaVomiting, Chills Narrative:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sedation, Vomiting
Clinical narrative: Headache, Sedation, Myalgia, Arthralgia, Fever, NauseaVomiting, Chills Narrative:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia, Rash
Clinical narrative: Headache, Myalgia, Arthralgia & Rash Narrative:  lasted a week  Other Relevant History:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Neck pain, Pyrexia
Clinical narrative: Myalgia, Arthralgia, Fever, fatigue, neck shoulder pain Narrative:  used flexeril at home  Other Relevant History:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Headache, Myalgia, Fever, injection site pain, chills, fatigue Narrative: use d otc meds
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache, Myalgia, Fever, injection site pain, chills, fatigue Narrative: use d otc meds
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Pain in extremity
Clinical narrative: injection site pain, fatigued Narrative:  Received 2 vaccine on 2/17/21, right arm had a lot of pain at injection site and felt very fatigued for rest of day. Woke up 2/18/21 feeling much better slight pain in arm. Advised to take soe otc acetaminophen for discomfort as needed or use an ice pack to arm.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Headache, Arthralgia, Fever, NauseaVomiting, arm pain, Narrative:
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Headache, Arthralgia, Fever, NauseaVomiting, arm pain, Narrative:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Depressed level of consciousness, Depressed mood, Fatigue, Headache
Clinical narrative: Headache, Sedation, Myalgia, Arthralgia, Fever, NauseaVomiting, Swollen glands Narrative:  "neck and spine pain. glands under chin were swollen and painful. vomiting was ""dry heaves"" fever was not a ""high"" fever. Headache radiated down neck and spine. injection was 0900 1/20/21, but I awoke at 1/21/21 at 0100 with a lot of pain, and the symptoms above. I could not return to sleep until 0700 (only after 220mg naprosyn and a long soak in my tub.) Rest of day was unhappy. I was tired for about two more days. Not as mentally alert as I should have been, either. Nasty!"  Other Relevant History:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Myalgia, Nausea, Neck pain
Clinical narrative: Headache, Sedation, Myalgia, Arthralgia, Fever, NauseaVomiting, Swollen glands Narrative:  "neck and spine pain. glands under chin were swollen and painful. vomiting was ""dry heaves"" fever was not a ""high"" fever. Headache radiated down neck and spine. injection was 0900 1/20/21, but I awoke at 1/21/21 at 0100 with a lot of pain, and the symptoms above. I could not return to sleep until 0700 (only after 220mg naprosyn and a long soak in my tub.) Rest of day was unhappy. I was tired for about two more days. Not as mentally alert as I should have been, either. Nasty!"  Other Relevant History:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Retching, Sedation, Sleep disorder
Clinical narrative: Headache, Sedation, Myalgia, Arthralgia, Fever, NauseaVomiting, Swollen glands Narrative:  "neck and spine pain. glands under chin were swollen and painful. vomiting was ""dry heaves"" fever was not a ""high"" fever. Headache radiated down neck and spine. injection was 0900 1/20/21, but I awoke at 1/21/21 at 0100 with a lot of pain, and the symptoms above. I could not return to sleep until 0700 (only after 220mg naprosyn and a long soak in my tub.) Rest of day was unhappy. I was tired for about two more days. Not as mentally alert as I should have been, either. Nasty!"  Other Relevant History:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Spinal pain, Vomiting
Clinical narrative: Headache, Sedation, Myalgia, Arthralgia, Fever, NauseaVomiting, Swollen glands Narrative:  "neck and spine pain. glands under chin were swollen and painful. vomiting was ""dry heaves"" fever was not a ""high"" fever. Headache radiated down neck and spine. injection was 0900 1/20/21, but I awoke at 1/21/21 at 0100 with a lot of pain, and the symptoms above. I could not return to sleep until 0700 (only after 220mg naprosyn and a long soak in my tub.) Rest of day was unhappy. I was tired for about two more days. Not as mentally alert as I should have been, either. Nasty!"  Other Relevant History:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Fever, chills, fatigue Narrative:
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Injection site pain, Myalgia
Clinical narrative: Headache, Sedation, Myalgia, Arthralgia, Fever,  Chills, pain at the injection site Narrative:  Other Relevant History:
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Sedation
Clinical narrative: Headache, Sedation, Myalgia, Arthralgia, Fever,  Chills, pain at the injection site Narrative:  Other Relevant History:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Pyrexia
Clinical narrative: Fever fatigue, axillary lymphadenopathy Narrative:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Chills, fatigue Narrative:  Other Relevant History:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: Headache, Fever, Sore Arm Narrative:  Other Relevant History:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Nausea
Clinical narrative: Headache, Sedation, Myalgia, Arthralgia, NauseaVomiting, Chills, night mares Narrative:   Other Relevant History:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Nightmare, Sedation, Vomiting
Clinical narrative: Headache, Sedation, Myalgia, Arthralgia, NauseaVomiting, Chills, night mares Narrative:   Other Relevant History:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia, Pyrexia, Sedation
Clinical narrative: Headache, Sedation, Myalgia, Arthralgia & Fever
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site erythema, Injection site pain, Myalgia, Sedation
Clinical narrative: Sedation, Myalgia, Chills, pain and redness at injection site Narrative:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Bronchiectasis, Chronic obstructive pulmonary disease, Condition aggravated
Clinical narrative: asthma Narrative:  asthma, copd, bronchiectasis exacerbation - meds: albuterol, advair, spiriva, qvar
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Headache, Myalgia, Fever, chills Narrative:
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: none Narrative:  1st dose was Pfizer manufacturer given on 1/22/21 at 16:09 hours. 2nd dose given by nurse was Moderna manufacturer on 2/17/21 at 15:45 hours. No reaction to date, only manufacturer difference.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, General symptom, Headache, Nausea
Clinical narrative: Headache, Fever, NauseaVomiting, General Symptoms:  Chills, fever, headaches, fatigue,  nausea, diarrhea. Narrative:  Other Relevant History:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Headache, Fever, NauseaVomiting, General Symptoms:  Chills, fever, headaches, fatigue,  nausea, diarrhea. Narrative:  Other Relevant History:
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Fatigue, Headache, Myalgia, Pain
Clinical narrative: Myalgia : headache, body aches "felt like bones were hurting", all around fatigue. Narrative:  Other Relevant History:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Lethargy, Myalgia, Pain
Clinical narrative: Headache, Sedation, Myalgia, Fever, First felt somewhat lethargic, then this morning chills,  body aches, headaches; some relief with Tylenol Narrative:  Other Relevant History:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Sedation
Clinical narrative: Headache, Sedation, Myalgia, Fever, First felt somewhat lethargic, then this morning chills,  body aches, headaches; some relief with Tylenol Narrative:  Other Relevant History:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Headache, Fever, fatigue, fever 100.1 Narrative:  Other Relevant History:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Laboratory test normal, Myalgia, Pyrexia, Rash
Clinical narrative: Rash Employee had erythema of her left arm that was approximately 50% of the circumference of her arm Narrative:  Rash covered >50% of her arm circumference-reported it was warm to the touch. She was evaluated by a primary care physician and labs were unremarkable. With the second dose, employee had severe myalgia, fever/chills. She did take ibuprofen/acetaminophen.  Other Relevant History:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: Rash Employee had erythema of her left arm that was approximately 50% of the circumference of her arm Narrative:  Rash covered >50% of her arm circumference-reported it was warm to the touch. She was evaluated by a primary care physician and labs were unremarkable. With the second dose, employee had severe myalgia, fever/chills. She did take ibuprofen/acetaminophen.  Other Relevant History:
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Mobility decreased, Myalgia, Pain, Pain in extremity, Vertigo
Clinical narrative: Difficulty raising arm; Vertigo; Muscle Pain; inability to sleep; Shooting pain in legs; injection site pain; This case was reported by a consumer via call center representative and described the occurrence of movement disorder in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on an unknown date refer case US2020AMR254584).   On 30th November 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 30th November 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On 4th December 2020, the patient experienced movement disorder, vertigo, muscle pain, sleeplessness and leg pain. On 7th December 2020, the outcome of the vertigo was recovered/resolved. On an unknown date, the outcome of the movement disorder and injection site pain were not recovered/not resolved and the outcome of the muscle pain, sleeplessness and leg pain were recovered/resolved.   It was unknown if the reporter considered the movement disorder, vertigo, muscle pain, sleeplessness, leg pain and injection site pain to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient received her second Shingrix vaccination.  About 4 days later, the patient began to experience difficulty raising her arm, vertigo, muscle pain, inability to sleep, and shooting pain in her legs.  She reported that all symptoms had resolved except for the difficulty raising her arm.  The patient also experienced injection site pain since that date that was still ongoing at the time of reporting. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR254584:same reporter US-GLAXOSMITHKLINE-US2020AMR254522:same reporter
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Movement disorder, Myalgia, Pain, Pain in extremity
Clinical narrative: Difficulty raising arm; Vertigo; Muscle Pain; inability to sleep; Shooting pain in legs; injection site pain; This case was reported by a consumer via call center representative and described the occurrence of movement disorder in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on an unknown date refer case US2020AMR254584).   On 30th November 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 30th November 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On 4th December 2020, the patient experienced movement disorder, vertigo, muscle pain, sleeplessness and leg pain. On 7th December 2020, the outcome of the vertigo was recovered/resolved. On an unknown date, the outcome of the movement disorder and injection site pain were not recovered/not resolved and the outcome of the muscle pain, sleeplessness and leg pain were recovered/resolved.   It was unknown if the reporter considered the movement disorder, vertigo, muscle pain, sleeplessness, leg pain and injection site pain to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient received her second Shingrix vaccination.  About 4 days later, the patient began to experience difficulty raising her arm, vertigo, muscle pain, inability to sleep, and shooting pain in her legs.  She reported that all symptoms had resolved except for the difficulty raising her arm.  The patient also experienced injection site pain since that date that was still ongoing at the time of reporting. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR254584:same reporter US-GLAXOSMITHKLINE-US2020AMR254522:same reporter
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Prophylaxis, Sleep disorder, Vertigo
Clinical narrative: Difficulty raising arm; Vertigo; Muscle Pain; inability to sleep; Shooting pain in legs; injection site pain; This case was reported by a consumer via call center representative and described the occurrence of movement disorder in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on an unknown date refer case US2020AMR254584).   On 30th November 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 30th November 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On 4th December 2020, the patient experienced movement disorder, vertigo, muscle pain, sleeplessness and leg pain. On 7th December 2020, the outcome of the vertigo was recovered/resolved. On an unknown date, the outcome of the movement disorder and injection site pain were not recovered/not resolved and the outcome of the muscle pain, sleeplessness and leg pain were recovered/resolved.   It was unknown if the reporter considered the movement disorder, vertigo, muscle pain, sleeplessness, leg pain and injection site pain to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient received her second Shingrix vaccination.  About 4 days later, the patient began to experience difficulty raising her arm, vertigo, muscle pain, inability to sleep, and shooting pain in her legs.  She reported that all symptoms had resolved except for the difficulty raising her arm.  The patient also experienced injection site pain since that date that was still ongoing at the time of reporting. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR254584:same reporter US-GLAXOSMITHKLINE-US2020AMR254522:same reporter
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Vaccination failure
Clinical narrative: in January 2020 / numbness /on the tip of her tongue; in January 2020 / tingling on the tip of her tongue; This case was reported by a consumer via call center representative and described the occurrence of numbness of tongue in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th November 2019, the patient received the 1st dose of Shingrix (intramuscular). In January 2020, between 1 and 3 months after receiving Shingrix, the patient experienced numbness of tongue and tingling tongue. On an unknown date, the outcome of the numbness of tongue and tingling tongue were not recovered/not resolved.   It was unknown if the reporter considered the numbness of tongue and tingling tongue to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient received the first dose of Shingrix vaccine and reported in January 2020 she developed a numbness and tingling on the tip of her tongue and this was ongoing at the time of reporting.  The patient did not have lot number or expiration date information to provide. The patient gave consent to follow up with HCP. For tolerance of 2nd dose please refer case US2020AMR255505.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR255505:same reporter, 1st dose
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Hypoaesthesia oral, Paraesthesia oral, Prophylaxis
Clinical narrative: in January 2020 / numbness /on the tip of her tongue; in January 2020 / tingling on the tip of her tongue; This case was reported by a consumer via call center representative and described the occurrence of numbness of tongue in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th November 2019, the patient received the 1st dose of Shingrix (intramuscular). In January 2020, between 1 and 3 months after receiving Shingrix, the patient experienced numbness of tongue and tingling tongue. On an unknown date, the outcome of the numbness of tongue and tingling tongue were not recovered/not resolved.   It was unknown if the reporter considered the numbness of tongue and tingling tongue to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient received the first dose of Shingrix vaccine and reported in January 2020 she developed a numbness and tingling on the tip of her tongue and this was ongoing at the time of reporting.  The patient did not have lot number or expiration date information to provide. The patient gave consent to follow up with HCP. For tolerance of 2nd dose please refer case US2020AMR255505.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR255505:same reporter, 1st dose
Age: 93.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sudden death
Clinical narrative: The patient died the day after receiving the vaccine. He died at the assisted living facility at which he was a resident.
Age: 93.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: The patient died the day after receiving the vaccine. He died at the assisted living facility at which he was a resident.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: first had a hard lump in the left arm.  7 days later began to have intensely itchy and painful hives on extremities, chest, and face with significant edema
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mass, Oedema, Pain, Pruritus, Urticaria
Clinical narrative: first had a hard lump in the left arm.  7 days later began to have intensely itchy and painful hives on extremities, chest, and face with significant edema
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Joint swelling, Peripheral swelling, Urticaria
Clinical narrative: Hives rash over joints, swelling of joints. Hives are itchy. No pain. Joints involved include elbows, hands, knees, toes.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein, Full blood count, Joint swelling, Metabolic function test, Pruritus
Clinical narrative: Hives rash over joints, swelling of joints. Hives are itchy. No pain. Joints involved include elbows, hands, knees, toes.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, Red blood cell sedimentation rate increased, Urticaria
Clinical narrative: Hives rash over joints, swelling of joints. Hives are itchy. No pain. Joints involved include elbows, hands, knees, toes.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Decreased appetite, Disorientation, Fatigue, Feeling abnormal, Full blood count normal
Clinical narrative: Dizziness, unsteadiness, fatigue, cognitive dysfunction
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Metabolic function test normal, Somnolence, Thinking abnormal
Clinical narrative: Dizziness, unsteadiness, fatigue, cognitive dysfunction
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Balance disorder, Cognitive disorder, Dizziness, Fatigue
Clinical narrative: Dizziness, unsteadiness, fatigue, cognitive dysfunction
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Full blood count normal, Magnetic resonance imaging normal, Metabolic function test normal, Psychotherapy
Clinical narrative: Dizziness, unsteadiness, fatigue, cognitive dysfunction
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Hypotension, Pruritus, Stridor, Throat tightness
Clinical narrative: Anaphylaxis
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cough, Dyspnoea, Eye swelling, Hypotension, Laboratory test
Clinical narrative: Anaphylaxis
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pruritus, Stridor, Swelling face
Clinical narrative: Anaphylaxis
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Joint stiffness, Sinus headache
Clinical narrative: Immediate BP spike to 180/110 within 15 min of injection of Pfizer vaccine; Continuous and Moderate Sinus Headaches for two weeks as of today; Ear pressure; dizziness; some difficulty in comprehension and formulating sentences; Slight burning sensation through arms and legs; vertigo; This is a spontaneous report from a contactable consumer (Patient). A 68-year-old male received second dose of bnt162b2 (COVID 19, Pfizer, Solution for injection, Lot number: EL1284), via unknown route of administration on Left arm on 21Jan2021 12: 30 at single dose for Covid-19 immunization. Age at vaccination was 68 Years. Medical history included Diverticulitis. Allergies to medications, food or other products included penicillin, codeine and iodine CT contrast. Concomitant medications received by the patient within 2 weeks of vaccination included olmesartan medoxomil (BENICAR), atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]), vitamin c [ascorbic acid], colecalciferol (D3), cinnamomum verum (CINNAMON), ubidecarenone (COQ10 [UBIDECARENONE]). The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took influenza vaccine on 23Nov2020 for influenza and experienced continuous and moderate sinus headaches, ear pressure, dizziness, some difficulty in comprehension and formulating sentences, slight burning sensation through arms and legs. Historical vaccine included first dose of BNT162B2 (COVID-19, Lot number: unknown) for Covid-19 immunization. On 21Jan2021 12: 45 the patient experienced immediate BP spike to 180/110 within 15 min of injection of Pfizer vaccine. Continuous and moderate sinus headaches for two weeks as of today. Ear pressure, dizziness, elevated BP now at 154/80, some difficulty in comprehension and formulating sentences and slight burning sensation through arms and legs experienced. Although unknown as to BP, had similar side effects to Influenza vaccine administered on 23Nov2020. First time receiving this vaccine. Additional symptoms were dizziness and vertigo. Seems to be some correlation between the reactions/side effects to both vaccines. The patient questioned about common element in both was PEG? The events resulted in doctor or other healthcare professional office/clinic visit. Cipro was received as treatment for the events, awaiting blood/urine testing results. The patient underwent lab tests and procedures which included blood pressure measurement: 180/110 on 21Jan2021 (Immediate BP spike to 180/110 within 15 min of injection of Pfizer vaccine) and 154/80 on Feb2021 (elevated BP). Outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Burning sensation, Dizziness, Ear discomfort, Hypertension
Clinical narrative: Immediate BP spike to 180/110 within 15 min of injection of Pfizer vaccine; Continuous and Moderate Sinus Headaches for two weeks as of today; Ear pressure; dizziness; some difficulty in comprehension and formulating sentences; Slight burning sensation through arms and legs; vertigo; This is a spontaneous report from a contactable consumer (Patient). A 68-year-old male received second dose of bnt162b2 (COVID 19, Pfizer, Solution for injection, Lot number: EL1284), via unknown route of administration on Left arm on 21Jan2021 12: 30 at single dose for Covid-19 immunization. Age at vaccination was 68 Years. Medical history included Diverticulitis. Allergies to medications, food or other products included penicillin, codeine and iodine CT contrast. Concomitant medications received by the patient within 2 weeks of vaccination included olmesartan medoxomil (BENICAR), atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]), vitamin c [ascorbic acid], colecalciferol (D3), cinnamomum verum (CINNAMON), ubidecarenone (COQ10 [UBIDECARENONE]). The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took influenza vaccine on 23Nov2020 for influenza and experienced continuous and moderate sinus headaches, ear pressure, dizziness, some difficulty in comprehension and formulating sentences, slight burning sensation through arms and legs. Historical vaccine included first dose of BNT162B2 (COVID-19, Lot number: unknown) for Covid-19 immunization. On 21Jan2021 12: 45 the patient experienced immediate BP spike to 180/110 within 15 min of injection of Pfizer vaccine. Continuous and moderate sinus headaches for two weeks as of today. Ear pressure, dizziness, elevated BP now at 154/80, some difficulty in comprehension and formulating sentences and slight burning sensation through arms and legs experienced. Although unknown as to BP, had similar side effects to Influenza vaccine administered on 23Nov2020. First time receiving this vaccine. Additional symptoms were dizziness and vertigo. Seems to be some correlation between the reactions/side effects to both vaccines. The patient questioned about common element in both was PEG? The events resulted in doctor or other healthcare professional office/clinic visit. Cipro was received as treatment for the events, awaiting blood/urine testing results. The patient underwent lab tests and procedures which included blood pressure measurement: 180/110 on 21Jan2021 (Immediate BP spike to 180/110 within 15 min of injection of Pfizer vaccine) and 154/80 on Feb2021 (elevated BP). Outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sinus headache, Speech disorder, Vertigo
Clinical narrative: Immediate BP spike to 180/110 within 15 min of injection of Pfizer vaccine; Continuous and Moderate Sinus Headaches for two weeks as of today; Ear pressure; dizziness; some difficulty in comprehension and formulating sentences; Slight burning sensation through arms and legs; vertigo; This is a spontaneous report from a contactable consumer (Patient). A 68-year-old male received second dose of bnt162b2 (COVID 19, Pfizer, Solution for injection, Lot number: EL1284), via unknown route of administration on Left arm on 21Jan2021 12: 30 at single dose for Covid-19 immunization. Age at vaccination was 68 Years. Medical history included Diverticulitis. Allergies to medications, food or other products included penicillin, codeine and iodine CT contrast. Concomitant medications received by the patient within 2 weeks of vaccination included olmesartan medoxomil (BENICAR), atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]), vitamin c [ascorbic acid], colecalciferol (D3), cinnamomum verum (CINNAMON), ubidecarenone (COQ10 [UBIDECARENONE]). The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took influenza vaccine on 23Nov2020 for influenza and experienced continuous and moderate sinus headaches, ear pressure, dizziness, some difficulty in comprehension and formulating sentences, slight burning sensation through arms and legs. Historical vaccine included first dose of BNT162B2 (COVID-19, Lot number: unknown) for Covid-19 immunization. On 21Jan2021 12: 45 the patient experienced immediate BP spike to 180/110 within 15 min of injection of Pfizer vaccine. Continuous and moderate sinus headaches for two weeks as of today. Ear pressure, dizziness, elevated BP now at 154/80, some difficulty in comprehension and formulating sentences and slight burning sensation through arms and legs experienced. Although unknown as to BP, had similar side effects to Influenza vaccine administered on 23Nov2020. First time receiving this vaccine. Additional symptoms were dizziness and vertigo. Seems to be some correlation between the reactions/side effects to both vaccines. The patient questioned about common element in both was PEG? The events resulted in doctor or other healthcare professional office/clinic visit. Cipro was received as treatment for the events, awaiting blood/urine testing results. The patient underwent lab tests and procedures which included blood pressure measurement: 180/110 on 21Jan2021 (Immediate BP spike to 180/110 within 15 min of injection of Pfizer vaccine) and 154/80 on Feb2021 (elevated BP). Outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Suture insertion, Syncope
Clinical narrative: A couple days after the vaccination I blacked out completely with no warnings signs or symtoms.  I had a head contusion and consuccion resulting in a few stitches in my head.  Several test were ran but all were normal.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Brain natriuretic peptide, Computerised tomogram, Concussion, Contusion, Electrocardiogram
Clinical narrative: A couple days after the vaccination I blacked out completely with no warnings signs or symtoms.  I had a head contusion and consuccion resulting in a few stitches in my head.  Several test were ran but all were normal.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count, Head injury, Loss of consciousness, Myocardial necrosis marker, Skin laceration
Clinical narrative: A couple days after the vaccination I blacked out completely with no warnings signs or symtoms.  I had a head contusion and consuccion resulting in a few stitches in my head.  Several test were ran but all were normal.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Atrial fibrillation, Chest X-ray, Condition aggravated, Electrocardiogram, Laboratory test
Clinical narrative: went into afib that required hospitalization X24 hours after receiving immunization.; This is a spontaneous report from a contactable nurse. A 70-year-old female patient received first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9265; expiry date: unknown) intramuscular in the right arm, on 29Jan2021 at 09:30, at a single dose, for immunization/COVID-19 immunisation. Medical history included atrial fibrillation (afib). It was unknown if the patient has allergies. Concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. Patient stated that she has a history of afib that has been well controlled for over 2 years. Patient has had 0 episodes during the past 2 years, but on 30Jan2021 at 14:00, she  went into afib that required hospitalization X24 hours after receiving immunization. Patient also stated that afib is usually able to be converted with cardiazem but it was not effective this time. Outcome of the event was recovered. It was unknown if the patient was tested for COVID after vaccination.; Sender's Comments: A causal relationship between the event "went into afib that required hospitalization X24 hours after receiving immunization" and suspect product bnt162b2 is possible based on the information provided, drug profile and a temporal association in this 70-year-old female patient with history of Atrial fibrillation. This case will be reassessed should additional information become 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Atrial fibrillation
Clinical narrative: went into afib that required hospitalization X24 hours after receiving immunization.; This is a spontaneous report from a contactable nurse. A 70-year-old female patient received first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9265; expiry date: unknown) intramuscular in the right arm, on 29Jan2021 at 09:30, at a single dose, for immunization/COVID-19 immunisation. Medical history included atrial fibrillation (afib). It was unknown if the patient has allergies. Concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. Patient stated that she has a history of afib that has been well controlled for over 2 years. Patient has had 0 episodes during the past 2 years, but on 30Jan2021 at 14:00, she  went into afib that required hospitalization X24 hours after receiving immunization. Patient also stated that afib is usually able to be converted with cardiazem but it was not effective this time. Outcome of the event was recovered. It was unknown if the patient was tested for COVID after vaccination.; Sender's Comments: A causal relationship between the event "went into afib that required hospitalization X24 hours after receiving immunization" and suspect product bnt162b2 is possible based on the information provided, drug profile and a temporal association in this 70-year-old female patient with history of Atrial fibrillation. This case will be reassessed should additional information become 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Atrial fibrillation, Condition aggravated
Clinical narrative: went into afib that required hospitalization X24 hours after receiving immunization.; This is a spontaneous report from a contactable nurse. A 70-year-old female patient received first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9265; expiry date: unknown) intramuscular in the right arm, on 29Jan2021 at 09:30, at a single dose, for immunization/COVID-19 immunisation. Medical history included atrial fibrillation (afib). It was unknown if the patient has allergies. Concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. Patient stated that she has a history of afib that has been well controlled for over 2 years. Patient has had 0 episodes during the past 2 years, but on 30Jan2021 at 14:00, she  went into afib that required hospitalization X24 hours after receiving immunization. Patient also stated that afib is usually able to be converted with cardiazem but it was not effective this time. Outcome of the event was recovered. It was unknown if the patient was tested for COVID after vaccination.; Sender's Comments: A causal relationship between the event "went into afib that required hospitalization X24 hours after receiving immunization" and suspect product bnt162b2 is possible based on the information provided, drug profile and a temporal association in this 70-year-old female patient with history of Atrial fibrillation. This case will be reassessed should additional information become 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Headache, Nasal congestion, Nausea
Clinical narrative: Patient general Malaise unknown cause . Onsite EMS was called vitals were taken BP 134/84  99% O2 room air HR 80. Patient refused evaluation/care. Left aginst medical advice.