chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Night sweats, Vaccination site pain
Clinical narrative: The patient had no other vaccine in 4 weeks and no other medications in 2 weeks. Patient was not covid tested post vaccination. The patient experienced muscle pain, fatigue, night sweats, sore arm on 31Jan2021.Therapeutic measures were not taken as a result of all events. The outcome of all event was recovered.  Follow-up attempts completed. No further information expected.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Condition aggravated, Death, Diabetes mellitus, Emphysema
Clinical narrative: Death:  4/22/2021 Causes of death listed on death certificate: 1) Respiratory failure  2) Emphysema  Other: Covid-19 pneumonia, diabetes
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Nucleic acid test, Polymerase chain reaction, Respiratory failure
Clinical narrative: Death:  4/22/2021 Causes of death listed on death certificate: 1) Respiratory failure  2) Emphysema  Other: Covid-19 pneumonia, diabetes
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Received his first Moderna vaccine on 2-17-21, got COVID infection on 3-5-21 and received BAM (monoclonal antibodies) on 3-5-21. Received his second Moderna vaccine on 3-17-21 (did not wait 90 days following the antibody infusion). Patient states he was informed that his 2nd vaccine was invalid and to return in 90 days for another COVID vaccine booster since he had his 2nd one too soon. Received 3rd Moderna vaccine on 6-22-21.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Herpes zoster, Pruritus, Skin lesion
Clinical narrative: The day after the shot, I woke up with shingles (Herpes Zoster) on the right side of my body. I had one lesion on the right side of my neck, two on my right breast, one the right of my abdomen, and many on my genitals. It lasted for 7 days.   After the seventh day, I woke up to COVID arm.  My entire upper left arm, had a red and itchy patch. The redness lasted 8 days, but the itchiness lasted 21 days.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Parosmia
Clinical narrative: Parosmia
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Vaccine injected was in syringe that had been drawn over 12 hours earlier
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Amyotrophic lateral sclerosis, COVID-19 pneumonia, Condition aggravated, Death
Clinical narrative: Death  4/29/2021 Causes of death listed on death certificate: 1) COVID 19 Pneumonia  2) Acute hypoxic respiratory failure  3) advanced amyotrophic lateral sclerosis
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nucleic acid test, SARS-CoV-2 test
Clinical narrative: Death  4/29/2021 Causes of death listed on death certificate: 1) COVID 19 Pneumonia  2) Acute hypoxic respiratory failure  3) advanced amyotrophic lateral sclerosis
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Gastrointestinal sounds abnormal, Nausea
Clinical narrative: nausea; at the end she felt the gurgling and distress of her lower intestines; at the end she felt the gurgling and distress of her lower intestines; she experienced diarrhea for 45 minutes; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history included allergic to MSG (monosodium glutamate), allergic to soy, and allergic to NSAIDs. Concomitant medications were not reported. It was reported that she received the first dose of the Covid vaccine and within 14 minutes of administration, on an unspecified date, she experienced diarrhea for 45 minutes. She reports that it was so intense, and she would also experience waves of nausea. It was reported that she had one of the side effects with the Covid vaccine. It's listed diarrhea as one of side effects. She wanted to know when that is usually seen because she had the first shot and stayed the 15 minutes like she was supposed to and at the end she felt the gurgling and distress of her lower intestines on an unspecified date. She made it home and made it to the bathroom and had 45 minutes of intense diarrhea, like you would get with a colonoscopy prep. Also had a case of nausea since she had the intense diarrhea. She asked if it was typically seen with this vaccine or due to her nerves of getting the vaccine and being enclosed in a building for the first time in over a year or was it being in a room in line with 40-50 other people. She wanted to know when do this side effect was seen and does it occur within 15 minutes of the shot. She asked was it a side effect and if it was safe for her to get the second shot. She asked if diarrhea occurs 15 minutes or hours after receiving the Covid vaccine. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Chest pain, Computerised tomogram abdomen, Death
Clinical narrative: On May 6, 2021, patients were relatively normal. On June 4th he started complaining of right sided abdominal pain along with increasing generalized weakness/fatigue. On June 10th CT Abdomen/Pelvis ordered by PCP, it was completed on 6/16/21. On 6/17/21 patient started c/o of right flank pain as well as ongoing right abdominal pain, U/A collected, normal results. On 6/22/21 patient contact PCP office c/o acute shortness of breath, chest pain and increased weakness. He was advised to call 9-1-1 and go to the ER. He was transported to local Medical Center and found to have extremely elevated platelet count as well as elevated liver enzymes. He was admitted to the ICU he ultimately succumbed to this acute illness on 6/25/21
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Flank pain, Full blood count, Hepatic enzyme increased
Clinical narrative: On May 6, 2021, patients were relatively normal. On June 4th he started complaining of right sided abdominal pain along with increasing generalized weakness/fatigue. On June 10th CT Abdomen/Pelvis ordered by PCP, it was completed on 6/16/21. On 6/17/21 patient started c/o of right flank pain as well as ongoing right abdominal pain, U/A collected, normal results. On 6/22/21 patient contact PCP office c/o acute shortness of breath, chest pain and increased weakness. He was advised to call 9-1-1 and go to the ER. He was transported to local Medical Center and found to have extremely elevated platelet count as well as elevated liver enzymes. He was admitted to the ICU he ultimately succumbed to this acute illness on 6/25/21
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Intensive care, Metabolic function test, Platelet count increased, Urine analysis normal
Clinical narrative: On May 6, 2021, patients were relatively normal. On June 4th he started complaining of right sided abdominal pain along with increasing generalized weakness/fatigue. On June 10th CT Abdomen/Pelvis ordered by PCP, it was completed on 6/16/21. On 6/17/21 patient started c/o of right flank pain as well as ongoing right abdominal pain, U/A collected, normal results. On 6/22/21 patient contact PCP office c/o acute shortness of breath, chest pain and increased weakness. He was advised to call 9-1-1 and go to the ER. He was transported to local Medical Center and found to have extremely elevated platelet count as well as elevated liver enzymes. He was admitted to the ICU he ultimately succumbed to this acute illness on 6/25/21
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac stress test, Computerised tomogram normal, Electrocardiogram normal, Fatigue, Heart rate increased
Clinical narrative: I was working at a university and that is why I got the shot there.  30 minutes after my 2nd shot, I was driving home and my heart started beating rapidly and it felt like I was having a asthma attack. I drove the apartment and laid down. I had the rapid heart beat and tiredness for several days. I had days where I was so exhausted I called in sick or worked from home. I still get tired easily , have rapid heart beats for up to an hour at a time and some days just take it easy.  I resigned from my job because I felt I could not function and I wanted to be closer to home where my doctors were located. I had only taken a day or two sick leave before my injection, but took many days after the shot.  I feel much better other than what I described above. I am reporting this because all news is talking about younger individuals. But I had/have the same symptoms and over 65.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability
Clinical narrative: I was working at a university and that is why I got the shot there.  30 minutes after my 2nd shot, I was driving home and my heart started beating rapidly and it felt like I was having a asthma attack. I drove the apartment and laid down. I had the rapid heart beat and tiredness for several days. I had days where I was so exhausted I called in sick or worked from home. I still get tired easily , have rapid heart beats for up to an hour at a time and some days just take it easy.  I resigned from my job because I felt I could not function and I wanted to be closer to home where my doctors were located. I had only taken a day or two sick leave before my injection, but took many days after the shot.  I feel much better other than what I described above. I am reporting this because all news is talking about younger individuals. But I had/have the same symptoms and over 65.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine injected was in syringe that had been drawn over 12 hours earlier
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine injected was in syringe that had been drawn over 12 hours earlier
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Condition aggravated, Death, SARS-CoV-2 test
Clinical narrative: Death:  5/2/2021 Causes of death listed on death certificate: Covid 19
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Feeling abnormal, Influenza, Oropharyngeal pain, Pain
Clinical narrative: My arm feels like it's on fire feels like an incision infected but worse on fire with 1st injection put in left 2nd in right arm. Excessive pain then normal  extremely then normal, horrible sore throat, fever this was with 2st injection im starting with 2nd already same. With 1st vaccine I was in bed 5 days. My memory since the 1st injection has been horrible I really have severe loss of memory. Nauseous. I know there is more since this is 1st full day of 2nd vaccine I will write down. I just feel like the flu but worse. I feel like I'm going to die it's horrible!!!!!!
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: My arm feels like it's on fire feels like an incision infected but worse on fire with 1st injection put in left 2nd in right arm. Excessive pain then normal  extremely then normal, horrible sore throat, fever this was with 2st injection im starting with 2nd already same. With 1st vaccine I was in bed 5 days. My memory since the 1st injection has been horrible I really have severe loss of memory. Nauseous. I know there is more since this is 1st full day of 2nd vaccine I will write down. I just feel like the flu but worse. I feel like I'm going to die it's horrible!!!!!!
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival bleeding, Taste disorder, Vaccine positive rechallenge
Clinical narrative: during the first shot I experienced a bad taste in my mouth approximately 30 minutes after, upon brushing my teeth my gums bleed.  Which I did not realize the connection at that time.   Second shot I experienced the same bad taste and rinsing my mouth when I returned home, noticing that my gums were bleeding.  They have continued to have a very slow rate of bleeding, however, it can be noticed when rinsing my mouth and taste remains.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein increased, Fibrin D dimer increased, Red blood cell sedimentation rate increased, Unevaluable event
Clinical narrative: None stated
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Random heart palpitations; This is a spontaneous report from a contactable consumer (patient). A 28-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EL8982,) via an unspecified route of administration in left arm on 22Jan2021 at 12:00 (at the age of 28-years-old) as first dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient did not receive any other vaccine received in four weeks. Patient had not been diagnosed with COVID prior to vaccination and had not been tested for COVID post the vaccination. On 25Jan2021, the patient reported that since receiving his vaccine, he noticed random heart palpitations. They have been less frequent as of recent but some of his coworkers have reported the same thing. They are non painful and happen irregular. Patient did not received the treatments. The outcome of the event was recovering.  Follow-up attempts completed. No further information expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Bursitis, Hypoacusis, Joint swelling
Clinical narrative: on her right arm she experienced Bursitis or swelling on her elbow/Olecranon bursitis/Popeye's Bursitis; on her right arm she experienced Bursitis or swelling on her elbow.; hard of hearing; This is a spontaneous report from a contactable consumer (patient). A 80-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EL9264; Expiration Date: 30May2021) via an unspecified route of administration, in right arm on 08Feb2021 (at the age of 80-year-old) as a single dose for covid-19 immunisation. The patient had no medical history and concomitant medications. Patient did not receive any other vaccines on the day of vaccination. On 08Feb2021, the patient got her first dose at her right arm and she experienced popeye's bursitis or olecranon bursitis/ Bursitis or swelling on her elbow. Patient stated that she was also hard of hearing on an unspecified date in 2021. Patient confirmed that the bursitis was located in her right arm. Patient was wondering if there was a connection, if the vaccine could have caused it as she had never had anything like that before. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: very, very sore arm; This is a spontaneous report from a contactable consumer (patient) via medical information team. An 80-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9261; Expiration Date: 31May2021), via an unspecified route of administration administered in left arm on 05Feb2021 at 10:40 (age at vaccination was 80 years) as 1st dose, single for COVID-19 immunization. The patient's medical history included high blood pressure, acid reflux, allergies to like cats and stuff like to tree if she got too close to them, she smoked for years 2 puffs every other morning, she had some beginning touches of COPD she thinks. She had a lot of problems or anything with COPD, she just got out of breath sometimes, but she was also getting old. Patient concomitant medication included amlodipine (AMLODIPINE) and hydrochlorothiazide, losartan potassium (LOSARTAN/HCTZ) both taken for high blood pressure been on this product for years and ongoing, omeprazole (OMEPRAZOLE) taken for acid reflux, tiotropium bromide (SPIRIVA) taken for chronic obstructive pulmonary disease from an unspecified start date and ongoing and atorvastatin (ATORVASTATIN) taken for an unspecified indication from an unspecified start date and ongoing. Patient was on no blood thinners. The patient's family history included one sister was dead, had asthma and allergic to everything. Her other sister had a heart attack and recovered very well but she was only 62 years old. One of her brothers died of brain cancer; and another brother died in his sleep of a heart attack. They have a lot of heart problems in the family. Her mother also had a heart attack and recovered but was no longer with us but also had emphysema. Her father died in 1968 of the Hong Kong Flu. The patient previously got the Flu shot on unspecified date in Sep2020 and had kind of punky/punchy/ugh; but nothing where it keeps her down in bed or anything like that. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no additional vaccines administered on same date of the Pfizer suspect. On 05Feb2021 around 12:00-13:00 the patient experienced very, very sore arm and it does not seem to be getting any better. The patient inquired if she could take Tylenol or Motrin for the very, very sore arm and if it will reduce the effect of the vaccine, as she was scheduled to had second dose on 26Feb2021. The outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Pain, X-ray
Clinical narrative: pain and soreness at the sight of his pacemaker just below his pacemaker on the left side and it became increasingly worse; This is a spontaneous report from a contactable consumer (patient). A 91-years-old male patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number and expiration date unknown), via an unspecified route of administration, administered in Arm Right on 05Feb2021 11:00 as DOSE 1, SINGLE for COVID-19 immunization. Medical history included blood pressure, prostate issues and tremor. The patient slipped and fell and cracked his head and broke his back about a year ago (but they repaired his back on an unknown date). The patient's concomitant medications included blood pressure medication from an unknown date at twice daily by mouth, Prostate medication from an unknown date and dose, tremor medication from an unknown date (from past 3-4 years) at 125mg taken once daily and ongoing. On 05Feb2021, the patient experienced pain and soreness at the sight of his pacemaker just below his pacemaker on the left side and it became increasingly worse and so severe he was taken to the ER. The patient was examined a blood work was done and an X-ray was taken, and they could not find anything wrong. Patient stated the pain was really heavy and took more than 48 hours for it to subside and patient continued to have some pain today. The patient was concerned he might be having a heart attack. He went to the hospital ER, they checked him out and everything was fine. He was sent home, but the pain has just gotten worse. The doctor pushed down just below the pacemaker and he thought he would go through the ceiling. The outcome of the events was reported as recovering at the time of report.  Follow-up attempts completed. No further information expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Body temperature, Headache, Pyrexia
Clinical narrative: headache; low temperature, temperature was 97 degrees and went up 101 at one point; stomach cramps; bad backache; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot number: EN5318, expiration date and NDC number was unknown), via an unspecified route of administration, administered in left arm on 22Jan2021 at 16:00-16:30 hours as dose 1, single dose (at the age of 79-years-old) for COVID-19 immunisation. The patient had no medical history and relevant family medical history. There were no concomitant medications or other products used by the patient. Patient had no other vaccinations within four weeks prior to the first administration date of the vaccine. On 24Jan2021 at 07:30 hours, patient had bad backache, stomach cramps and low grade temperature. Patient stated that she was in bed for three days with a bad backache, stomach cramps and low temperature, temperature was 97 degrees and went up 101 at one point. Patient stated that on the information sheet paperwork that it stated that if she had a reaction with that one that she should not get the second vaccine, so patient wanted to know what to do. On 26Jan2021, at 10:00 hours, patient had a headache the last day. Patient took Tylenol, as treatment. Patient had no emergency room and physician office visit. No relevant lab tests were performed. The outcome of all the events was resolved on 26Jan2021.  Lot/batch number was not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Hypertension, Vision blurred
Clinical narrative: I checked my blood pressure and it was 190/104; my vision was off, reading bothered; horrendous headache/had this tremendous headache and banger of a headache; This is a spontaneous report from a non-contactable Nurse (patient self, reported). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 04Feb2021, as a single dose for COVID-19 immunization. The patient's medical history included high blood pressure (that was controlled with medication). Concomitant medications were not reported. The patient reported that she had 1st dose of the Pfizer vaccine on Thursday, On 05Feb2021, Friday morning she started with, woke up with horrendous headache, took Motrin, didn't touch it, had it all afternoon, her vision was off, reading bothered. She checked her blood pressure, and it was 190/104. That was why she had this tremendous headache and banger of a headache. Because of her background, she knew what to do. She took her medications early and took additional medications that she knew was safe, and within an hour and a half the headache started to subside, she has been fine since. She was concerned about the second dose and would like some information and because of her adverse reaction, she was hesitant to get the second vaccine. Outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: My hand and fingers were swollen and, unable to stretch fingers; Fingers were very stiff; My hand and fingers were swollen and, unable to stretch fingers; Fingers were very stiff; Mild headache at back of neck; swollen lymph nodes; This is a spontaneous report from a contactable other-health care professional (patient). A 60-year-old non-pregnant female patient (not pregnant at the time of vacciantion) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN5318), via intramuscular route of administration in right arm on 04Feb2021 at 10:00 AM (at the age of 60 year old) as single for covid-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EK4176), via intramuscular route of administration in right arm on 14Jan2021 at 10:00 AM (at the age of 60 year old) for covid-19 immunisation. Medical history included high blood pressure, high cholesterol, seizures from an unknown date and unknown if ongoing. Patient had no known allergies. Concomitant medications included vitamin c [ascorbic acid]; colecalciferol (D); zinc; elderberry [sambucus nigra]; paracetamol (TYLENOL), high blood pressure med, seizure meds, high cholesterol med. The patient had no other vaccine in four weeks. Since the vaccination, the patient hasn't been tested for COVID-19. On 05Feb2021 at 02:30 AM, patient experienced hand and fingers were swollen and, unable to stretch fingers; fingers were very stiff; mild headache at back of neck and swollen lymph nodes. The patient did not received treatment due to the events. The outcome of events was recovered on an unspecified date in 2021.   Follow-up (11MAY2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Heart rate, Heart rate increased, Hyperhidrosis
Clinical narrative: She experienced sweats and chills; She experienced sweats and chills; She states she began having a racing heart moments after the injection.; it continued with chest soreness; This is a spontaneous report received from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 03Feb2021 1st Dose, Single for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had the first dose of the Pfizer Covid 19 vaccine (last Wednesday) on 03Feb2021.  On the same date, the patient began having a racing heart moments after the injection, it continued with chest soreness. On 04Feb2021, she experienced sweats and chills. The patient went back to work and it continued with chest soreness. She experienced sweats and chills the next morning on 04Feb2021 and the racing heart continued the next day. On 05Feb2021 (Friday) it was a little better but continued. Later she felt more normal and herself. She did not know what kind of reaction it was. "She asked how many people in the clinical trial reported a fast heartbeat". The patient underwent lab tests and procedures which included heart rate: racing on 03Feb2021. The outcome of the events was resolving.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness
Clinical narrative: diarrhea; lightheadedness; dizziness; This is a spontaneous report from a contactable consumer(patient). A 93-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN9581), via an unspecified route of administration, administered in Arm Left on 04Feb2021 at 09:45 (at the age of 93 years old) as first dose, single for covid-19 immunisation at School  Health Clinic. Medical history included hypertension, hyperthyroidism, osteoarthritis from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Allergy to paper and Dairy products from an unknown date and unknown if ongoing. Concomitant medications included amlodipine (AMLODIPINE), telmisartan (MICARDIS) and levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. Patient was not received any other vaccine prior four weeks of vaccination. Patient received Amlodipine -10mg; Micardis 120mg; Synthroid 50m within two weeks of vaccination. Pfizer vaccine taken on Thursday 04Feb2021 at 09:45 and by Friday on 05Feb2021 at 14:15 afternoon had dizziness. Sunday on 07Feb2021 afternoon experienced lightheaded ness and on Monday 08Feb21 afternoon experienced dizziness and diarrhoea. Therapeutic measures were taken as a result of the events with Peptide Bismal. The outcome of the event was reported as not recovered.   Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus; This is a spontaneous report from a contactable or other health care professional (patient). A 60-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3249), via an unspecified route of administration, administered in arm left on 27Jan2021 13:00 as dose 2, single (age at vaccination 60-years) for COVID-19 immunization. The patient's medical history included allergy to thimerasol. Concomitant medications included acetylsalicylic acid (ASPIRIN) taken for an unspecified indication. The patient did not have covid prior vaccination and was not tested covid for post vaccination. The patient did not receive any other vaccine within four weeks. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. On 29Jan2021, the patient stated that approximately 48 hours after second dose experienced constant tinnitus. Has not stopped at all for over 2 weeks. The treatment was not received for the event. The outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Electrocardiogram, Eye disorder, Fatigue, Gait disturbance
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non hcp. A 78-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EM9809) via intramuscular route of administration in left arm on 05Feb2021 at 09:45 (age at vaccination 78 years old) as single dose for COVID-19 immunization. Medical history included cardiac disorder from an unknown date and unknown if ongoing Mother had heart issues, but she is passed away, ongoing panic attack the caller said that she has only had like 2 panic attacks in her life. She said that on 30Dec2021 she had a panic attack on the day of the vaccine, she had a light one on the way to get the injection, she said that she had COVID-19 previously and was diagnosed 05Jan2021 and was cleared so she took the vaccine, ongoing fatigue She said that her tiredness started during when she had COVID-19, but stated that she understands it was a symptom post COVID-19, ongoing gait disturbance She said that she may have been wobbly on her feet since she had COVID-19, but has gotten worse since the injection. There were no concomitant medications. On 05Feb2021 the patient experienced panic attack, her heart was racing/heart was racing to 132, unstable and wobbly on her feet, extremely tired and on unspecified date in February 2021 she said she feels like her eyesight has gotten worse, unstable and wobbly on her feet was reported as worsened/extremely tired was reported as worsened/she said she feels like her eyesight has gotten worse/and got very worse after vaccination. with outcome of unknown. The patient underwent lab tests and procedures which included electrocardiogram fine in 2021. The clinical outcome of the event panic attack, her heart was racing/heart was racing to 132 were recovered and unstable and wobbly on her feet, extremely tired were not recovered other events were unknown. Follow-up attempts are completed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Panic attack
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non hcp. A 78-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EM9809) via intramuscular route of administration in left arm on 05Feb2021 at 09:45 (age at vaccination 78 years old) as single dose for COVID-19 immunization. Medical history included cardiac disorder from an unknown date and unknown if ongoing Mother had heart issues, but she is passed away, ongoing panic attack the caller said that she has only had like 2 panic attacks in her life. She said that on 30Dec2021 she had a panic attack on the day of the vaccine, she had a light one on the way to get the injection, she said that she had COVID-19 previously and was diagnosed 05Jan2021 and was cleared so she took the vaccine, ongoing fatigue She said that her tiredness started during when she had COVID-19, but stated that she understands it was a symptom post COVID-19, ongoing gait disturbance She said that she may have been wobbly on her feet since she had COVID-19, but has gotten worse since the injection. There were no concomitant medications. On 05Feb2021 the patient experienced panic attack, her heart was racing/heart was racing to 132, unstable and wobbly on her feet, extremely tired and on unspecified date in February 2021 she said she feels like her eyesight has gotten worse, unstable and wobbly on her feet was reported as worsened/extremely tired was reported as worsened/she said she feels like her eyesight has gotten worse/and got very worse after vaccination. with outcome of unknown. The patient underwent lab tests and procedures which included electrocardiogram fine in 2021. The clinical outcome of the event panic attack, her heart was racing/heart was racing to 132 were recovered and unstable and wobbly on her feet, extremely tired were not recovered other events were unknown. Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: experienced injection site pain, pain at the site of injection; a mild headache; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 10Jan2021 as single dose and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 01Feb2021 as single dose for covid-19 immunization. The patient's medical history was not reported. The concomitant medications included acetaminophen for his back and cosmetic fillers. After both doses of the vaccines he experienced injection site pain, pain at the site of injection and a mild headache the next morning on 11Jan2021. He wanted to know if this was related to the vaccine and if this meant the vaccine worked. The patient had read that he should not take acetaminophen before the vaccine, but he takes a dose every morning. He wanted to know if that affected the vaccine. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Nausea, Pain
Clinical narrative: nausea; stomach pain; diarrhea; body aches; headache; This is a spontaneous report from a contactable consumer (nurse).    A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on 28Jan2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 29Jan2021 02:00 She reports waking up 8 hours later at 2am the patient experienced nausea, stomach pain, diarrhea, body aches and headache. Patient wanted to know After the second dose, do people have more or less side effects than the first dose. The patient received treatment of a tylenol and gasx and went back to bed. At the time of reporting, the outcome of the events were unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cough, Dry throat, Dyspnoea
Clinical narrative: Felt weak; Dry throat; States she has noticed she has been burping a lot and coughing harder.; States she has noticed she has been burping a lot and coughing harder.; She has a dry cough and when she coughs hard she gags until almost vomiting/ she has had some coughing where she coughs until she feels like she has to throw up; she has been having shortness of breath that started when she got the first dose of the Pfizer COVID vaccine on 27Jan2021; Chills; she just felt tired was all; pain at the injection site in her right arm so she took Tylenol that morning; This is a spontaneous report from a contactable nurse (patient). A 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9265) dose 1 via intramuscular route of administration in Arm Right on 27Jan2021 at 13:30(at the age of 80 years old) as single for COVID-19 immunisation. Medical history was none. There were no concomitant medications. Patient had no other vaccines on the same day as the COVID vaccine. The patient experienced as, she has been having shortness of breath that started when she got the first dose of the pfizer covid vaccine, chills, she just felt tired was all, pain at the injection site in her right arm so she took tylenol that morning on 27Jan2021, felt weak on 07Feb2021, she has noticed she has been burping a lot and coughing harder, she has a dry cough and when she coughs hard she gags until almost vomiting/ she has had some coughing where she coughs until she feels like she has to throw up, and dry throat on an unspecified date on Feb2021. Therapeutic measures were taken as a result of she just felt tired was all and pain at the injection site in her right arm so she took tylenol that morning. The patient underwent lab tests and procedures which included weight: 145-147 on an unspecified date. Therapeutic measures were taken as a result of she just felt tired was all and pain at the injection site in her right arm so she took tylenol that morning. Outcome of the event shortness of breath and chills were recovered and unknown for rest events.  Information about batch/lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Eructation, Fatigue, Vaccination site pain, Weight
Clinical narrative: Felt weak; Dry throat; States she has noticed she has been burping a lot and coughing harder.; States she has noticed she has been burping a lot and coughing harder.; She has a dry cough and when she coughs hard she gags until almost vomiting/ she has had some coughing where she coughs until she feels like she has to throw up; she has been having shortness of breath that started when she got the first dose of the Pfizer COVID vaccine on 27Jan2021; Chills; she just felt tired was all; pain at the injection site in her right arm so she took Tylenol that morning; This is a spontaneous report from a contactable nurse (patient). A 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9265) dose 1 via intramuscular route of administration in Arm Right on 27Jan2021 at 13:30(at the age of 80 years old) as single for COVID-19 immunisation. Medical history was none. There were no concomitant medications. Patient had no other vaccines on the same day as the COVID vaccine. The patient experienced as, she has been having shortness of breath that started when she got the first dose of the pfizer covid vaccine, chills, she just felt tired was all, pain at the injection site in her right arm so she took tylenol that morning on 27Jan2021, felt weak on 07Feb2021, she has noticed she has been burping a lot and coughing harder, she has a dry cough and when she coughs hard she gags until almost vomiting/ she has had some coughing where she coughs until she feels like she has to throw up, and dry throat on an unspecified date on Feb2021. Therapeutic measures were taken as a result of she just felt tired was all and pain at the injection site in her right arm so she took tylenol that morning. The patient underwent lab tests and procedures which included weight: 145-147 on an unspecified date. Therapeutic measures were taken as a result of she just felt tired was all and pain at the injection site in her right arm so she took tylenol that morning. Outcome of the event shortness of breath and chills were recovered and unknown for rest events.  Information about batch/lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy
Clinical narrative: Fatigued; Lymph nodes swollen under arm pit; This is a spontaneous report received from a contactable other health care professional. A 43-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 01Feb2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (Lot: unknown) on 11Jan2020 in the Left arm for COVID-19 immunisation. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. The patient experienced extremely fatigued and lymph nodes swollen under arm pit. No treatment was received for the events. The outcome of the events was reported as recovering.  Information about lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Dysphonia, Nasopharyngitis, Oropharyngeal discomfort, Sinus disorder
Clinical narrative: some symptoms of a throat condition that he has often; Cold like symptoms; sinus problem; throat hoarseness; This is a spontaneous report from a contactable consumer reporting for her husband. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247, Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced some symptoms of a throat condition that he has often, cold like symptoms, sinus problem, throat hoarseness reporter asking if her husband can receive his second covid vaccine dose if about 1 week ago he started to develop some symptoms of a throat condition that he has often due for their second vaccination tomorrow, but she wonders if he will get denied. She reports that he does not have a fever but asks if there are any symptoms that would disqualify him from getting the second dose. He has had a cold which is not what she would consider a symptom. It could just be a sinus problem. She has looked at every source of information and does not see any information about preventing one from getting a second dose with this and wanted to know if it would be contraindicated. He did not get the symptom after he got the first dose. He has had this a lot of times. He has throat hoarseness occasionally. It is the same type thing. The outcome of events was unknown.   Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Headache, Hypertension, Pyrexia
Clinical narrative: high blood pressure; fever of 101F; headache; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 01Feb2021 as single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller got the first dose of the Pfizer vaccine on 01Feb2021. Her second dose was scheduled on 19Feb2021 which was only 18 days after. She would like to know whether there be a problem. Caller said she also experienced high blood pressure, fever of 101 F, headache from her first dose. She said that she had already reported this in DSU (possible duplicate AE). Caller was worried about her second shot of the vaccine since she had adverse events with the first shot. She wanted to know what to do. Outcome of the events was unknown.  Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chromaturia, Dehydration, Dizziness, Fluid intake reduced, Obesity
Clinical narrative: Felt dizzy; Not been drinking enough water recently; Might be dehydrated; Stated she has been drinking water and her urine went to clear from yellow; Severely obese; This is a spontaneous report from a contactable consumer (patient herself) via a medical information team. A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration in left arm on 05Feb2021 (Friday) at 09:48 (at the age of 68-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included ongoing blood pressure, dehydration, hospitalization. Mentioned in the past she had a hospitalization for dehydration. Concomitant medication included felodipine, orally from an unspecified date (taking for years) and ongoing at 5 mg once a day (5 mg take once daily by mouth) for blood pressure. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). Patient's medical history (including any illness at time of vaccination) was none. Family medical history was none. It was reported that, patient did not experience any immediate adverse event, however, today (08Feb2021) she felt dizzy, asked if: There are reports of other patients feeling dizzy days after vaccination, dizziness was usually followed by other side effects. Patient acknowledged she has not been drinking enough water recently (08Feb2021), considered the dizziness experienced may be a result of that and probably not an adverse event associated to the COVID-19 vaccine. She didn't have any side effects for three days and then she began to feel dizzy. Adds that it was not too bad as she was able to work but it was persisting. Mentioned she read that dizziness could be a severe side effect and she was asking could it come on three days later. Adds that she might be dehydrated on 08Feb2021 and stated she has been drinking water and her urine went to clear from yellow on 08Feb2021. Mentioned she didn't drink enough water on Saturday or Sunday, so she was trying to make that up today. Also asking would she have other side effects along with the dizziness if this was a side effect. Mentioned in the past she had a hospitalization for dehydration. Asking to have any of you girls heard anything about this. Mentioned that she was severely obese on an unspecified date in 2021. Adds she was scheduled to receive the second dose of the vaccine on 26Feb2021. The adverse events did not require a visit to physician or emergency room. No relevant test. No investigation assessment. The events were considered as non-serious by the consumer. The outcome of the event felt dizzy was not resolved and unknown for the other events.  Follow-up attempts completed. No further information expected.