chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Epstein-Barr virus antibody, Fatigue, Feeling abnormal, Fibrin D dimer, Full blood count
Clinical narrative: nosebleed; palpitations; extreme fatigue; my resting heart rate was 99BPM in the urgent care; Almost faint; This is a spontaneous report from a contactable other hcp (patient). A 47-year-old non-pregnant female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER2613), via an unspecified route of administration on 26Mar2021 11:00 (Friday) as single dose for COVID-19 immunization. Medical history included diagnosed with ongoing MCAS (mast cell activation syndrome) 2 weeks ago. Concomitant medications included zinc, probiotics, ergocalciferol (VIT D), turmeric [curcuma longa rhizome], bacillus coagulans, bifidobacterium lactis, fructooligosaccharides, herbal nos, lactobacillus acidophilus, lactobacillus reuteri, minerals nos, vitamins nos (GUNDRY MD VITAL REDS); all taken for an unspecified indication, start and stop date were not reported. Patient had known allergy to pseudoephedrine, previously took pseudoephedrine and experienced rash. Patient reported she had no preexisting conditions, very healthy and active. 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. On 26Mar2021, within 1 minute after vaccination, patient felt like almost faint. 24 hours later on 27Mar2021 12:00, patient had a nose bleed, palpitations, and extreme fatigue etc. Resting heart rate was 99BPM in the urgent care on 27Mar2021. The patient underwent lab tests and procedures which included heart rate: 99 beats per minute on 27Mar2021, sars-cov-2 test (Nasal swab): negative on 07May2021 and 27Mar2021. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of events with Antihistamines, supplements, Low Dose Naltrexone. Since the vaccination, patient not tested positive for Covid-19 . The outcome of heart rate was 99BPM was unknown and patient was recovering from rest all of the events.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Galectin-3 test, HIV test, Insulin-like growth factor, Laboratory test, Malaise
Clinical narrative: nosebleed; palpitations; extreme fatigue; my resting heart rate was 99BPM in the urgent care; Almost faint; This is a spontaneous report from a contactable other hcp (patient). A 47-year-old non-pregnant female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER2613), via an unspecified route of administration on 26Mar2021 11:00 (Friday) as single dose for COVID-19 immunization. Medical history included diagnosed with ongoing MCAS (mast cell activation syndrome) 2 weeks ago. Concomitant medications included zinc, probiotics, ergocalciferol (VIT D), turmeric [curcuma longa rhizome], bacillus coagulans, bifidobacterium lactis, fructooligosaccharides, herbal nos, lactobacillus acidophilus, lactobacillus reuteri, minerals nos, vitamins nos (GUNDRY MD VITAL REDS); all taken for an unspecified indication, start and stop date were not reported. Patient had known allergy to pseudoephedrine, previously took pseudoephedrine and experienced rash. Patient reported she had no preexisting conditions, very healthy and active. 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. On 26Mar2021, within 1 minute after vaccination, patient felt like almost faint. 24 hours later on 27Mar2021 12:00, patient had a nose bleed, palpitations, and extreme fatigue etc. Resting heart rate was 99BPM in the urgent care on 27Mar2021. The patient underwent lab tests and procedures which included heart rate: 99 beats per minute on 27Mar2021, sars-cov-2 test (Nasal swab): negative on 07May2021 and 27Mar2021. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of events with Antihistamines, supplements, Low Dose Naltrexone. Since the vaccination, patient not tested positive for Covid-19 . The outcome of heart rate was 99BPM was unknown and patient was recovering from rest all of the events.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test, Palpitations, Paraesthesia, Prothrombin time, Rash
Clinical narrative: nosebleed; palpitations; extreme fatigue; my resting heart rate was 99BPM in the urgent care; Almost faint; This is a spontaneous report from a contactable other hcp (patient). A 47-year-old non-pregnant female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER2613), via an unspecified route of administration on 26Mar2021 11:00 (Friday) as single dose for COVID-19 immunization. Medical history included diagnosed with ongoing MCAS (mast cell activation syndrome) 2 weeks ago. Concomitant medications included zinc, probiotics, ergocalciferol (VIT D), turmeric [curcuma longa rhizome], bacillus coagulans, bifidobacterium lactis, fructooligosaccharides, herbal nos, lactobacillus acidophilus, lactobacillus reuteri, minerals nos, vitamins nos (GUNDRY MD VITAL REDS); all taken for an unspecified indication, start and stop date were not reported. Patient had known allergy to pseudoephedrine, previously took pseudoephedrine and experienced rash. Patient reported she had no preexisting conditions, very healthy and active. 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. On 26Mar2021, within 1 minute after vaccination, patient felt like almost faint. 24 hours later on 27Mar2021 12:00, patient had a nose bleed, palpitations, and extreme fatigue etc. Resting heart rate was 99BPM in the urgent care on 27Mar2021. The patient underwent lab tests and procedures which included heart rate: 99 beats per minute on 27Mar2021, sars-cov-2 test (Nasal swab): negative on 07May2021 and 27Mar2021. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of events with Antihistamines, supplements, Low Dose Naltrexone. Since the vaccination, patient not tested positive for Covid-19 . The outcome of heart rate was 99BPM was unknown and patient was recovering from rest all of the events.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sleep disorder, Thyroxine, Treponema test, Troponin I, Ultrasound pelvis
Clinical narrative: nosebleed; palpitations; extreme fatigue; my resting heart rate was 99BPM in the urgent care; Almost faint; This is a spontaneous report from a contactable other hcp (patient). A 47-year-old non-pregnant female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER2613), via an unspecified route of administration on 26Mar2021 11:00 (Friday) as single dose for COVID-19 immunization. Medical history included diagnosed with ongoing MCAS (mast cell activation syndrome) 2 weeks ago. Concomitant medications included zinc, probiotics, ergocalciferol (VIT D), turmeric [curcuma longa rhizome], bacillus coagulans, bifidobacterium lactis, fructooligosaccharides, herbal nos, lactobacillus acidophilus, lactobacillus reuteri, minerals nos, vitamins nos (GUNDRY MD VITAL REDS); all taken for an unspecified indication, start and stop date were not reported. Patient had known allergy to pseudoephedrine, previously took pseudoephedrine and experienced rash. Patient reported she had no preexisting conditions, very healthy and active. 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. On 26Mar2021, within 1 minute after vaccination, patient felt like almost faint. 24 hours later on 27Mar2021 12:00, patient had a nose bleed, palpitations, and extreme fatigue etc. Resting heart rate was 99BPM in the urgent care on 27Mar2021. The patient underwent lab tests and procedures which included heart rate: 99 beats per minute on 27Mar2021, sars-cov-2 test (Nasal swab): negative on 07May2021 and 27Mar2021. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of events with Antihistamines, supplements, Low Dose Naltrexone. Since the vaccination, patient not tested positive for Covid-19 . The outcome of heart rate was 99BPM was unknown and patient was recovering from rest all of the events.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urine analysis
Clinical narrative: nosebleed; palpitations; extreme fatigue; my resting heart rate was 99BPM in the urgent care; Almost faint; This is a spontaneous report from a contactable other hcp (patient). A 47-year-old non-pregnant female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER2613), via an unspecified route of administration on 26Mar2021 11:00 (Friday) as single dose for COVID-19 immunization. Medical history included diagnosed with ongoing MCAS (mast cell activation syndrome) 2 weeks ago. Concomitant medications included zinc, probiotics, ergocalciferol (VIT D), turmeric [curcuma longa rhizome], bacillus coagulans, bifidobacterium lactis, fructooligosaccharides, herbal nos, lactobacillus acidophilus, lactobacillus reuteri, minerals nos, vitamins nos (GUNDRY MD VITAL REDS); all taken for an unspecified indication, start and stop date were not reported. Patient had known allergy to pseudoephedrine, previously took pseudoephedrine and experienced rash. Patient reported she had no preexisting conditions, very healthy and active. 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. On 26Mar2021, within 1 minute after vaccination, patient felt like almost faint. 24 hours later on 27Mar2021 12:00, patient had a nose bleed, palpitations, and extreme fatigue etc. Resting heart rate was 99BPM in the urgent care on 27Mar2021. The patient underwent lab tests and procedures which included heart rate: 99 beats per minute on 27Mar2021, sars-cov-2 test (Nasal swab): negative on 07May2021 and 27Mar2021. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of events with Antihistamines, supplements, Low Dose Naltrexone. Since the vaccination, patient not tested positive for Covid-19 . The outcome of heart rate was 99BPM was unknown and patient was recovering from rest all of the events.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: tingling and numbness in right foot developed in evening following vaccination; this has happened previously 4 years ago after an international flight; tingling and numbness in right foot developed in evening following vaccination; this has happened previously 4 years ago after an international flight; This is a spontaneous report from a contactable pharmacist. This pharmacist reported for a patient (family member) a 30-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: ER2613; Expiration date: unknown) via intramuscularly, administered in Arm Left on 30Mar2021 17:15 (at the age of 30-years-old) as first dose, single for COVID-19 immunization at Workplace clinic. The patient medical history and concomitant medications were not reported. Patient had not any allergies to medications, food, or other products. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. On 30Mar2021, patient had tingling and numbness in right foot developed in evening following vaccination and this has happened previously 4 years ago after an international flight. Patient had not received any treatment for the adverse events. Patient was not diagnosed with COVID-19 prior and since the vaccination. Seriousness was reported as No. The outcome of events was recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow up report is being submitted to amend previously reported information: (To update the patient information.)
Sex: F
Vaccine: COVID19
Symptoms: Herpes virus infection
Clinical narrative: flare up of the herpes virus; This is a spontaneous report from a non-contactable consumer. This female consumer reported for herself.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 18Mar2021 as 1ST dose, single for COVID-19 immunization. Medical history included ongoing herpes virus infection. The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient stated that she had side effects from the first dose of the Pfizer vaccine which she received on 18Mar2021. Two weeks later she had a flare up of the herpes virus. She has not had any additional stress and was not been working. She wore her masks so she could only conclude the flare up (which she hasn't had in many years) occurred due to the vaccine. Her 2nd vaccine is scheduled for 09Apr2021. Treatment medication included an unknown antiviral and ongoing with it. Outcome of the event was reported as Unknown.    No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Cognitive disorder, Disturbance in attention, Feeling abnormal, Lethargy
Clinical narrative: About two weeks after the vaccine I woke up with a brain fog that will not go away. It's been over a week and the brain fog still remains. Focusing, holding a conversation, and multitasking have turned into very difficult tasks. My body is fine but my brain fog makes me constantly feel lethargic even when I know I have energy.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Fatigue, Pyrexia
Clinical narrative: I had really bad chills and  fever I lost my taste and smell and  started feeling extremely  fatigued. I could not get out of bed. I went got 2 covid test, I got a rapid and a send off both came back negative. I stayed in bed for a week.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: I had really bad chills and  fever I lost my taste and smell and  started feeling extremely  fatigued. I could not get out of bed. I went got 2 covid test, I got a rapid and a send off both came back negative. I stayed in bed for a week.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Feeling hot, Headache, Hyperhidrosis
Clinical narrative: Immediately after shot was administered, my entire left arm started tingling down to my left pinky finger. I become overheated and had to sit down and fan myself from fainting. After 20 minutes, I was able to drive home. That evening, I wasn't able to sleep. My entire body was in severe pain, had a bad headache, and sweated through the sheets. The following day at work, I ran a low grade fever, was pale and felt like I didn't sleep for weeks. Ran a low grade fever all day. The following day, I took off work and tried to rest. On Friday morning, experienced chest pains. Took Ibuprofen and it subsided. Still have pain in left arm.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Pain, Pain in extremity, Pallor, Paraesthesia
Clinical narrative: Immediately after shot was administered, my entire left arm started tingling down to my left pinky finger. I become overheated and had to sit down and fan myself from fainting. After 20 minutes, I was able to drive home. That evening, I wasn't able to sleep. My entire body was in severe pain, had a bad headache, and sweated through the sheets. The following day at work, I ran a low grade fever, was pale and felt like I didn't sleep for weeks. Ran a low grade fever all day. The following day, I took off work and tried to rest. On Friday morning, experienced chest pains. Took Ibuprofen and it subsided. Still have pain in left arm.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: Immediately after shot was administered, my entire left arm started tingling down to my left pinky finger. I become overheated and had to sit down and fan myself from fainting. After 20 minutes, I was able to drive home. That evening, I wasn't able to sleep. My entire body was in severe pain, had a bad headache, and sweated through the sheets. The following day at work, I ran a low grade fever, was pale and felt like I didn't sleep for weeks. Ran a low grade fever all day. The following day, I took off work and tried to rest. On Friday morning, experienced chest pains. Took Ibuprofen and it subsided. Still have pain in left arm.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Myalgia
Clinical narrative: My left arm injection site has never stopped hurting.  It occasionally itches.  It is sore in the muscle.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Presyncope
Clinical narrative: Patient had vasovagal response to receiving the vaccine, became light-headed and briefly lost consciousness. We called Dr.  in the attached office and his intern over to make sure Pt. was okay. Gave the pt water and he felt fine after sitting for ~15 minutes
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Fatigue
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Dizziness /Lightheadedness-Mild, Systemic: Exhaustion/Lethargy-Medium, Systemic: Fever-Mild, Systemic: burning sensation in skin-Mild, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extremities)-Medium, Systemic: Weakness-Mild, Additional Details: numbness and tingling in arm, back and spine. Patient states symptoms felt like shingles. Loss of feeling from mid-spine up. Burning sensation on upper, left shoulder.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site pain, Injection site swelling, Lethargy, Pain
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Dizziness /Lightheadedness-Mild, Systemic: Exhaustion/Lethargy-Medium, Systemic: Fever-Mild, Systemic: burning sensation in skin-Mild, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extremities)-Medium, Systemic: Weakness-Mild, Additional Details: numbness and tingling in arm, back and spine. Patient states symptoms felt like shingles. Loss of feeling from mid-spine up. Burning sensation on upper, left shoulder.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia, Skin burning sensation
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Dizziness /Lightheadedness-Mild, Systemic: Exhaustion/Lethargy-Medium, Systemic: Fever-Mild, Systemic: burning sensation in skin-Mild, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extremities)-Medium, Systemic: Weakness-Mild, Additional Details: numbness and tingling in arm, back and spine. Patient states symptoms felt like shingles. Loss of feeling from mid-spine up. Burning sensation on upper, left shoulder.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Dizziness, Headache, Hyperhidrosis
Clinical narrative: A-Team member stated they didn't feel good this morning and last night after taking the J&J vaccine. Around 8 am looked for the employee health nurse to get medication for nausea and headache. She was then making tea and was noted not to be feeling well and fainted.  Another employee found her on the floor, and her heart rate was 115, and BP was 112/64 with a 100-degree temp Fahrenheit. A couple of hours prior, her temp was 97 degrees Fahrenheit.  She looked diaphoretic, hypoglycemic, and was too weak to get off the floor, there was a maxi lift used to transfer to a wheelchair, and she was very dizzy. The only medicine taken was Pepto Bismol for nausea.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoglycaemia, Malaise, Nausea, Syncope
Clinical narrative: A-Team member stated they didn't feel good this morning and last night after taking the J&J vaccine. Around 8 am looked for the employee health nurse to get medication for nausea and headache. She was then making tea and was noted not to be feeling well and fainted.  Another employee found her on the floor, and her heart rate was 115, and BP was 112/64 with a 100-degree temp Fahrenheit. A couple of hours prior, her temp was 97 degrees Fahrenheit.  She looked diaphoretic, hypoglycemic, and was too weak to get off the floor, there was a maxi lift used to transfer to a wheelchair, and she was very dizzy. The only medicine taken was Pepto Bismol for nausea.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Dyspnoea, Dyspnoea exertional, Fatigue
Clinical narrative: Within 6 hours of getting his last COVID vaccine, he stated he knew he was in trouble. For 4 days he could not even function. He couldn't even use the phone to call for help. He stated his temperature was 104. Stated he continues to have shortness of breath all the time. He can't even walk the full length of his house without getting winded. He has no energy and feels tired all the time. He wakes up in the morning feeling tired. He feels like it is slowly getting a little better, but it has been over 2 months already. He denies having any further headaches. He still gets floaters in his left eye but feels like the flashes of light are getting less. This report 6/15/2021.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Photopsia, Vitreous floaters
Clinical narrative: Within 6 hours of getting his last COVID vaccine, he stated he knew he was in trouble. For 4 days he could not even function. He couldn't even use the phone to call for help. He stated his temperature was 104. Stated he continues to have shortness of breath all the time. He can't even walk the full length of his house without getting winded. He has no energy and feels tired all the time. He wakes up in the morning feeling tired. He feels like it is slowly getting a little better, but it has been over 2 months already. He denies having any further headaches. He still gets floaters in his left eye but feels like the flashes of light are getting less. This report 6/15/2021.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received the dose after manufacturer recommended freezer storage duration.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Fatigue, Headache, Intermenstrual bleeding
Clinical narrative: Menstrual spotting; bloody nose; headache; fatigue; This is a spontaneous report received from a non-contactable consumer, the patient. A 34-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number unknown) via an unspecified route of administration in Arm Right on 07Apr2021 15:00 (age at vaccination 34years old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included Ehlers Danlos syndrome from an unknown date and unknown if ongoing. Concomitant medication included naltrexone (NALTREXONE) taken for an unspecified indication, start and stop date were not reported. The patient had no allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested positive for COVID-19. Timeframe between vaccination and starting of symptoms was reported as 5Hours. On 07Apr2021 20:00, the patient experienced menstrual spotting, bloody nose, headache and fatigue. It was unknown if patient received any treatment for the adverse events. The clinical outcome of the events was reported as unknown.  Information on the lot/batch number has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: Extreme soreness after first injection. After second injection, soreness moved to left shoulder which has been compromised as to motion. Unable to move shoulder as before injections.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node in arm pit; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER- BIONTECH COVID-19 m RNA vaccine; Lot number: Ew0151), via an unspecified route of administration to the left arm on 07Apr2021 at 1130 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history included Hashimotos. The patient had an allergy to Penicillin. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. Concomitant medication included thyroid medications. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced swollen lymph node in the arm pit on 08Apr2021, the size of a golf ball. Since the vaccination, the patient had not tested positive for COVID-19. The patient did not receive any treatment for the adverse event. The clinical outcome of the event of swollen lymph node was not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: 2 weeks after getting the vaccine I had swollen lymph nodes in the top of my neck. I discussed it with the physician on 3/17/2021 and we decided to just continue to watch it without any treatment for now. I'm having blood work in about a month.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received the dose after manufacturer recommended freezer storage duration.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Nausea, Vomiting
Clinical narrative: Systemic: Abdominal Pain-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: patient vomiting within minutes of receiving injection
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 40-years-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number: ER8734) via an unspecified route of administration in the left arm on 08Apr2021 at 08:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included palindromic rheumatism and sulfonamide allergy. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number; ER8727) via an unspecified route of administration in the left arm on 18Mar2021 at 08:15 (at the age of 40-years-old) as a single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient was not tested for COVID-19. The patient experienced swelling in ankles and in feet most severe on left side on 08Apr2021 at 17:00. The patient did not receive any treatment for the events. The clinical outcome for events swelling in ankles and in feet was resolved on unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperthermia, Lethargy, Pain
Clinical narrative: Moderate lethargy, soreness, achyness, suspected mild hyperthermia
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received the dose after manufacturer recommended freezer storage duration.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Approxiamately 5 minutes after the vaccine the patient felt light headed and dizzy. She then fainted forward and her mom lifted her back and at that point she appeared to shake (2 jerking motions) and then became alert. The patient was instructed to lay down. Her blood pressure was taken and was normal. The ambulance was called due to the shaking motion which appeared to be a possible seizure. The patient and her mom did not wish to be taken to the hospital.  Follow-up call not answered
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Bursitis, X-ray
Clinical narrative: I went to hospital on 06/04/2021.  They x-rayed it and wrapped it.  I followed up with my rheumatologist.   She put a drain in it but it came back that night.  They diagnosed it as olecranon bursitis.  All I have on now is a compression wrap.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received the dose after manufacturer recommended freezer storage duration.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: patient said she had numbness occure 2 hours after first shot. numbness in left neck,left chest,left arm,left shoulder
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Diarrhoea haemorrhagic, Discomfort
Clinical narrative: Sudden pain in the left lower part of of the abdomen, it started the next day at noon after the vaccine, it wasn't a continuous pain but more or less constant and suddenly and it kept me from doing what I was doing. Bloody diarrhea that's started 20 minutes after the initial stomach pain. I had about 6 bloody bowel movements during that day, the pain disappeared that same day during the evening, the bloody diarrhea stopped during the night and I had two more bloody bowel movements  between 7 and 9am on the 10th of June.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Retching
Clinical narrative: fever>101.2 and dry heaving (unable to vomit due to lack of eating)
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Hypersomnia, Oropharyngeal pain
Clinical narrative: Extreme fatigue, headache, sore throat, and high fever. The high fever ran for a few days. I had no appetite. I slept a lot.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Extreme fatigue, headache, sore throat, and high fever. The high fever ran for a few days. I had no appetite. I slept a lot.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Borrelia test negative, Condition aggravated, Depression, Fatigue
Clinical narrative: Patient has been feeling extremely fatigue, joints sore (knees, wrists), more depressed and has passed out twice since the 2nd Moderna vaccine. The patient has been seen by his PCP and has been tested for lyme as had a tick bite last year, but the bloodwork came back negative.  Pt also feels his normal pain medication (oxycodone 5mg) is not working as well for his back pain.  He said he will do yard work that he normally does, like mowing the lawn, and is extremely tired. No change in medication or health status other than noticing these symptoms.  The patient passed out once while raking leaves and another time on the porch and stood up and passed out.  The patient feels these symptoms are getting progressively worse and not getting any better.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Patient has been feeling extremely fatigue, joints sore (knees, wrists), more depressed and has passed out twice since the 2nd Moderna vaccine. The patient has been seen by his PCP and has been tested for lyme as had a tick bite last year, but the bloodwork came back negative.  Pt also feels his normal pain medication (oxycodone 5mg) is not working as well for his back pain.  He said he will do yard work that he normally does, like mowing the lawn, and is extremely tired. No change in medication or health status other than noticing these symptoms.  The patient passed out once while raking leaves and another time on the porch and stood up and passed out.  The patient feels these symptoms are getting progressively worse and not getting any better.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received the dose after manufacturer recommended freezer storage duration.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Additional Details: patietn said dizziness occurred  within the 15 minutes while she was waiting post vaccine
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure, COVID-19 pneumonia
Clinical narrative: COVID-19 PNEUMONIA, ACUTE RESPIRATORY FAILURE WITH HYPOXIC
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Mobility decreased, Myalgia, Nausea
Clinical narrative: Severe nausea Severe headache Severe chills Severe muscle aches  Severe side effects lasted 6 hrs. Worse than the flu which I?ve had twice. After that in bed 2 more days but not severe
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nodule
Clinical narrative: Lump on the lower left breast
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray normal, No adverse event
Clinical narrative: Asymptomatic.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: Systemic: Weakness-Severe
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Electrocardiogram normal, Headache, Paraesthesia
Clinical narrative: Chest pressure, headache, joint pain and tingling sensation that lasted from June 16th until today June 25.  Visited urgent care on the 20th and was prescribed a high dosage of ibuprofen. EKG came normal. As of June 25, the side effects are slowly wearing off.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Chest pressure, headache, joint pain and tingling sensation that lasted from June 16th until today June 25.  Visited urgent care on the 20th and was prescribed a high dosage of ibuprofen. EKG came normal. As of June 25, the side effects are slowly wearing off.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Laboratory test, Night sweats, Pyrexia
Clinical narrative: Pt states night of the 2nd vaccinations fever, chills lasted several  days. Violent loose stool, vomiting, night sweats . Dr. visit 05/26/2021 - 06/16/2021. Gastro 06/22/2021, still waiting for results. Symptoms still continuing
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: Pt states night of the 2nd vaccinations fever, chills lasted several  days. Violent loose stool, vomiting, night sweats . Dr. visit 05/26/2021 - 06/16/2021. Gastro 06/22/2021, still waiting for results. Symptoms still continuing
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: About a half hour after my vaccination I experienced twitching in my arm, stomach, legs. Thought it would go away. Had extreme twitching in legs like electricity was running throughout every muscle. Lasted about 4 weeks. It was in every muscle of my body. Stomach, legs, arms rear end. Constant all day all night. Never experienced anything like that before. Very uncomfortable and thought I was the only one but have multiple friends who said they experienced the same thing just thought it was low electrolytes. I tried everything to get rid of it. Electrolyte drink, magnesium, potassium, rest. Nothing made it go away. Went to the doctors because of it
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling around cheek bones area/mild tingling around cheek bones area; This is a spontaneous report from a non-contactable consumer (patient) reported in response to non-HCP letter sent in cross-referenced case. A 71-years-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) intramuscular, administered in left arm on 17Mar2021 at 10:50 am (age at vaccination was 71 years) as 2nd dose, single for COVID-19 immunization. The patient did not have any medical history. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) intramuscular, administered in right arm on 24Feb2021 at 10:55 am (age at vaccination was 71 years) as 1st dose, single for COVID-19 immunization. On 24Feb2021 at 11:10 am, after the 1st dose, the patient experienced mild allergic reaction to the first shot, tingling hand & face and hips turned numb. Duration of symptoms was 3.5 hrs. The facility where the most recent COVID-19 vaccine was administered was other. The vaccine was not administered at  Facility. The patient did not receive any prior vaccinations. On 17Mar2021 at 11:35 am, after the 2nd shot, the patient experienced mild tingling around cheek bones area. No treatment was received for the adverse event. The patient did not have any relevant tests. The seriousness criteria was reported as Important medical event. The outcome of the event was resolved on an unknown date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Foetal disorder
Clinical narrative: My baby stopped developing 3 days after the vaccine.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received the dose after manufacturer recommended freezer storage duration.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Blood count, Chills, Computerised tomogram, Influenza virus test, Nausea
Clinical narrative: A few weeks later I started having nausea and vomiting. I had chills, fever, and body ache. I've lost a lot of weight
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test, Ultrasound scan, Vomiting
Clinical narrative: A few weeks later I started having nausea and vomiting. I had chills, fever, and body ache. I've lost a lot of weight
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: A few weeks later I started having nausea and vomiting. I had chills, fever, and body ache. I've lost a lot of weight
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Employee contracted COVID-19
Age: 28.0
Sex: U
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: INHALE ONE PUFF BY MOUTH EVERY FOUR HOURS AS NEEDED
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Systemic: swelling and pain in opposite arm-Medium, Additional Details: patient is having pain and swelling in right arm, not the left where the injection was. went to the hospital on june 21st and received hydrocodone for pain. went to doctor on june 24th with swelling in arm. received medrol dosepak
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Blood glucose increased, Blood pressure decreased, Brain natriuretic peptide, C-reactive protein increased
Clinical narrative: I actually tested positive for Covid 10 days after my first dose of the vaccine and ended up having numerous issues and was referred to the long term Covid clinic. Balance issues, wheezing, cough, palpitations, headaches, shortness of breath, extreme fatigue, high blood sugars, blood pressure dropped
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cardiac stress test, Catheterisation cardiac, Computerised tomogram normal, Cough
Clinical narrative: I actually tested positive for Covid 10 days after my first dose of the vaccine and ended up having numerous issues and was referred to the long term Covid clinic. Balance issues, wheezing, cough, palpitations, headaches, shortness of breath, extreme fatigue, high blood sugars, blood pressure dropped
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram normal, Electrocardiogram abnormal, Electrocardiogram ambulatory normal, Fatigue
Clinical narrative: I actually tested positive for Covid 10 days after my first dose of the vaccine and ended up having numerous issues and was referred to the long term Covid clinic. Balance issues, wheezing, cough, palpitations, headaches, shortness of breath, extreme fatigue, high blood sugars, blood pressure dropped
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer increased, Headache, Palpitations, Pulmonary function test normal, Stent placement
Clinical narrative: I actually tested positive for Covid 10 days after my first dose of the vaccine and ended up having numerous issues and was referred to the long term Covid clinic. Balance issues, wheezing, cough, palpitations, headaches, shortness of breath, extreme fatigue, high blood sugars, blood pressure dropped
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: I actually tested positive for Covid 10 days after my first dose of the vaccine and ended up having numerous issues and was referred to the long term Covid clinic. Balance issues, wheezing, cough, palpitations, headaches, shortness of breath, extreme fatigue, high blood sugars, blood pressure dropped
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Pfizer-BioNTech COVID-10 Vaccine EUA. After receiving the first dose of Pfizer vaccine, patient experienced lightheadedness. This occurred within a couple minutes after administration of vaccine. Vital signs include BP 116/63, P 84, O2 100%. Cetirizine 10mg PO administered at 15:35. Patient felt comfortable with no additional or worsening symptoms upon leaving clinic.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received the dose after manufacturer recommended freezer storage duration.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: INHALE ONE PUFF BY MOUTH EVERY FOUR HOURS AS NEEDED
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Throat tightness
Clinical narrative: Pt reports feeling "throat tight" like when she "reacts to ibprofen.  25 mg of benadryl given.  Pt with "coughing" clearing throat sound.  Some improvement.  Pt returned for 2nd dose on 4/23 no reaction
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Localised infection, Pain in extremity
Clinical narrative: Left arm pain after vaccine administered and got infection in arm was hospitalized
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: INHALE ONE PUFF BY MOUTH EVERY FOUR HOURS AS NEEDED
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Pain in extremity
Clinical narrative: her arm was sore; felt fatigued; This is a spontaneous report from a Pfizer Sponsored Program from a contactable other hcp. A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation; tofacitinib citrate (XELJANZ), oral from 15Feb2021 (Batch/Lot Number: DK6867) to an unspecified date, twice a day for an unspecified indication. Medical history included benign tumour excision from an unknown date and unknown if ongoing She had a surgery due to benign tumor in her right ear, sulfa allergy from an unknown date and unknown if ongoing , surgery from an unknown date and unknown if ongoing, facial paralysis from an unknown date and unknown if ongoing. Patient indicated that previous to beginning tofacitinib citrate she had surgery due to a benign tumor in her right ear. Patient reported that during surgery "They hit a nerve and the right side of my face is paralyzed". Concomitant medications included hydroxyzine HCL for an unspecified indication, start and stop date were not reported; duloxetine HCL for an unspecified indication, start and stop date were not reported; folic acid for an unspecified indication, start and stop date were not reported; trazodone HCL for an unspecified indication, start and stop date were not reported; hydroxychloroquine sulfate for an unspecified indication, start and stop date were not reported. The patient received her first dose of the COVID-19 vaccine and reported that her arm was sore and she felt fatigued. She denied missing doses (of tofacitinib citrate). The action taken with tofacitinib citrate in response to the events was dose not changed. The outcome of the events, arm was sore and fatigued was unknown.   No further follow-up needed. No further information expected
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Skin exfoliation
Clinical narrative: PATIENT REPORTED SKIN ON FEET AND LEGS STARTED TO PEEL 2-3 WEEKS AFTER INITIAL VACCINE. SHE JUST GOT THE 2ND VACCINE  A FEW DAYS AGO SO IT IS TOO EARLY TO TELL IF IT WILL HAPPEN AGAIN. BUT SHE REPORTS THAT WHEN SHE TOOK OFF THE BANDAID THIS TIME, THE SKIN WAS PEELING
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Chest pain, Chills, Dysphagia
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Additional Details: anxiety  1:56pm - BP(120/70mmHG), HR(88bpm),O2sat(100%)
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Throat tightness, Tremor
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Additional Details: anxiety  1:56pm - BP(120/70mmHG), HR(88bpm),O2sat(100%)
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Janssen COVID-19 Vaccine EUA I began developing a severe headache around 2:00 pm and took naproxen. The headache continued and I went to bed early. When I woke in the middle of the night, I felt more sick than I have ever felt. I was sweating, also felt chilled, was nauseous, and my head pounded. I experienced these symptoms for most of the following day and had to stay in bed. After that, I felt weak and worn out, but did not need to stay in bed.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Mobility decreased, Nausea, Sleep disorder
Clinical narrative: Janssen COVID-19 Vaccine EUA I began developing a severe headache around 2:00 pm and took naproxen. The headache continued and I went to bed early. When I woke in the middle of the night, I felt more sick than I have ever felt. I was sweating, also felt chilled, was nauseous, and my head pounded. I experienced these symptoms for most of the following day and had to stay in bed. After that, I felt weak and worn out, but did not need to stay in bed.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Patient reported mild tingling in her leg and face, which lasted for a few minutes (unknown time course). Denied any swelling of the face, swelling of the tongue, rash, itching, cough, shortness of breath or chest tightness.