chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Facial discomfort, Facial paralysis, SARS-CoV-2 test
Clinical narrative: facial paralysis/facial drooping/facial palsy/eyes started drooping and then mouth started drooping; strange feelings in face; This is a spontaneous report received from a Pfizer sponsored program.This contactable consumer patient himself and a contactable physician psychologist, (parent of patient reported) that a 33-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, administered in left arm on 21Mar2021 16:15 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination.  On 21Mar2021 at 07:30 PM, after receiving his first dose, he began noticing facial drooping, which began to intensify, on the right side. He was advised by a medical professional to immediately call an ambulance and he was then taken to an emergency room where received a CT scan and full bloodwork on Mar2021. Luckily, the facial palsy began to subside and he was able to return home after the test results came back and a stroke was ruled out - it was stated that this was some kind of immuno-reaction to the vaccine. He still felt as though his face was still not 100% back to normal and still felt a bit droopy (noticeable in the mirror) yet it does feel better than on 21Mar2021 evening. Patient had a nasal swab on 22Mar2021 with negative result. One of the reporters is a psychologist and reported that her son received Pfizer-BioNTech COVID-19 Vaccine. Psychologist asking about risk of Bell's palsy, incidence, and outcomes and if these patients received their second dose of the Pfizer-BioNTech COVID-19 Vaccine. She read about 7 cases of Bell's palsy in a Dec2020 article in the [Redacted], 4 of them on the Pfizer vaccine. The reporter further clarified and described that at 6pm (2 hours after dose), patient reported he felt fine and was happy he got the vaccine; but then sometime after that, he reported "strange feelings in face" and then eyes started drooping and then mouth started drooping, all on right side of face. They called the university clinic and was instructed to go to ER. Brain scans and blood work were done; they ruled out stroke and said it was a possible reaction to the vaccine. He was discharged at midnight and by then, paralysis was 80-85% resolved. He is an otherwise very healthy young man. The psychologist wanted to know the efficacy after just one dose and stated that a friend suggested to perhaps not get second dose and consider getting a dose of the non mRNA vaccine like Johnson and Johnson.  The outcome of the event was recovering.   Information on Lot/Batch number has been requested.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral thrombosis, Thrombocytopenia
Clinical narrative: Thrombocytopenia; Blood clots in brain; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) solution for injection, dose 1 via an unspecified route of administration, administered in left arm on 29Mar2021 13:00 (Batch/Lot Number: EN6206) as single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 30Mar2021, patient developed thrombocytopenia and was brought to emergency room/department or urgent care leading to admission, surgery was performed (mechanical thrombectomy) on 30Mar2021 at 10am to address blood clots in the brain. Patient was currently in ICU until he fully recovered. Patient was hospitalized in Mar2021 for 2 days. The events were reported as life-threatening and have caused disability. Outcome of the events was unknown.  Information on lot/batch number has been available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested Positive for COVID19 through a PCR test; This is a spontaneous report from a contactable consumer (patient). This 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 22MAR2021 at single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included Bamlanivimab. The patient mentioned that he received the 1st dose of the Pfizer Covid19 vaccine 10 days ago but tested Positive for COVID19 through a PCR test 2 days ago. He mentioned that he was already infused with Bamlanivimab, a monoclonal antibody product. He may have been exposed to the virus even though they have been doing the same thing for 12 months. He is high risk with comorbidities and would like to know any general information with his situation on taking the 2nd dose of the vaccine. The outcome of the event was unknown.  Information on Lot/Batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction, SARS-CoV-2 test
Clinical narrative: I had heart attack about 2 weeks after the 1st dose. I was almost lost my life. Doctor still could not diagnose the cause because I am a healthy women; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208), dose 1 via an unspecified route of administration at the age of 38-years, administered in arm left on 14Mar2021 15:15 as single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient had heart attack about 2 weeks after the 1st dose (25Mar2021 09:00). I was almost lost my life. Doctor still could not diagnose the cause because I am a healthy women. I will provide more detail if you need them for research. The patient did not receive other vaccine in four weeks, did not receive other medications in twoweeks, she received treatment (Emergency room, hospitalized, cardiac procedure) for the event. The patient did not received Covid prior vaccination, she tested Covid post vaccination (Covid-19 PCR test) via Nasal Swab on 28Mar2021, Covid test result was negative. There is no known allergies. The outcome of the event was unknown.
Age: 0.17
Sex: U
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: two month old baby received FLUZONE QUADRIVALENT vaccine/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist (Reference number- 00523288) and transmitted to company on 17-Mar-2021.  This case involves a 2-months-old patient to whom nurse practitioner accidentally gave INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (batch number, expiry date, route and site of administration not reported) (product administered to patient of inappropriate age) on 17-Mar-2021 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration (latency: same day).  The caller is asking what can happen as a result of this. The caller had no information as to if anything happened as a result of this or any of the company adverse event questionnaire questions or smart script questions.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Disorientation, Fatigue, Rhinorrhoea
Clinical narrative: Disorientation; Extreme fatigue; runny nose; shoulder pain; This is a spontaneous report from a contactable Other HCP. This 52-year-old (at the time of vaccination) female Other HCP (patient) reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number; EN6200) via an unspecified route of administration on 21Feb2021 at 01:00 pm at single dose on left arm for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Vaccine was administered at hospital facility. Medical history included anxiety (dates unspecified), known allergies; no. Concomitant medications included citalopram 100 mg one time a day. Other vaccine was not administered in four weeks. Patient experienced extreme fatigue, disorientation, runny nose, shoulder pain on 21Feb2021 at 1:30 pm. Treatment for adverse events was not given. Patient did not have covid prior vaccination and covid was not tested post vaccination. The outcome of events was not recovered.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site bruising, Vaccination site haemorrhage
Clinical narrative: When I was given the shot, blood burst out.; bruise; slight pain; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 19Feb2021 15:45 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included asthma. Concomitant medication(s) included (in two weeks) thyroid (ARMOUR THYROID) taken for thyroid disorder. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Treatment was not received for the adverse event. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Known allergies: No. The patient experienced when I was given the shot, blood burst out, bruise, slight pain; all (non-serious) on 19Feb2021 15:45. Adverse event: When I was given the shot, blood burst out. The nurse held a pad over it, and said she wanted to make sure none of the dose came out with the blood, she wanted to make sure I got the full dose. Now I have a bruise and slight pain 4 days later. Mainly, I just want to know if it's possible I didn't get a full dose. Facility type vaccine other: Clinic. The outcome of events was not recovered.  Information for lo/batch number has been requested
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate abnormal
Clinical narrative: Within an hour I experienced a rapid heartbeat; This is a spontaneous report from a contactable consumer, the patient. A 60-years-old non-pregnant female patient received first dose of bnt162b2 (Solution for injection, Lot Number: EM9810), via an unspecified route of administration in left arm on 06Feb2021 11:15 as single dose for covid-19 immunisation. Medical history included covid-19 from beginning of Nov2020. There were no concomitant medications. On 06Feb2021 12:15, the patient experienced within an hour I experienced a rapid heartbeat. The patient did not receive any treatment for the events. The clinical outcome of the within an hour I experienced a rapid heartbeat was recovering. No follow-up attempts are possible.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: Upper body soreness (chest, left and right arms), consistent fever (101.2), chills, stomach pains.   Upper body soreness and fever presented 30 minutes after vaccination and continues as of filing this report. Chills and stomach pains subsided after two days of vaccination.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Axillary pain, Balance disorder, Fatigue, Injection site pain
Clinical narrative: About 12 hours after the injection the following started...fever, severe body aches, severe body weakness, unsteadiness/shakiness, legs felt as though they were going to give out, fatigue, nausea. VERY sore, swollen and somewhat itchy left armpit (I am assuming this is the lymph node -also same arm shot was given). The injection site is sore, hot, swollen and itchy (can?t tell if it?s red because I have a very large tattoo that covers this area).   It?s been a little over 48 hours and everything has subsided except the nausea and the armpit/lymph node is extremely sore, swollen and itchy. Slightly still shaky but its getting better.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Lymphadenopathy, Muscular weakness
Clinical narrative: About 12 hours after the injection the following started...fever, severe body aches, severe body weakness, unsteadiness/shakiness, legs felt as though they were going to give out, fatigue, nausea. VERY sore, swollen and somewhat itchy left armpit (I am assuming this is the lymph node -also same arm shot was given). The injection site is sore, hot, swollen and itchy (can?t tell if it?s red because I have a very large tattoo that covers this area).   It?s been a little over 48 hours and everything has subsided except the nausea and the armpit/lymph node is extremely sore, swollen and itchy. Slightly still shaky but its getting better.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Tremor
Clinical narrative: About 12 hours after the injection the following started...fever, severe body aches, severe body weakness, unsteadiness/shakiness, legs felt as though they were going to give out, fatigue, nausea. VERY sore, swollen and somewhat itchy left armpit (I am assuming this is the lymph node -also same arm shot was given). The injection site is sore, hot, swollen and itchy (can?t tell if it?s red because I have a very large tattoo that covers this area).   It?s been a little over 48 hours and everything has subsided except the nausea and the armpit/lymph node is extremely sore, swollen and itchy. Slightly still shaky but its getting better.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: 5:05pm feeling tired and dizzy after vaccination and because he has hypertension said he wanted to get checked out.  EMS on scene:  BP 142/90, HR 70, T 95. 5:20pm Left observation w/out futher complaints.  Wife driving.  Advised to seek medical attention if symptoms reappear.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity, Vomiting
Clinical narrative: Arm was sore during Saturday directly after the shot. Tiredness was felt Sunday morning and arm was still sore. Chills started Sunday evening during sleep. Vomiting occurred around 4:00 am Monday.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Depressed mood, Diarrhoea, Headache
Clinical narrative: Headache - severe Tinnitus  Diarrhea Fever 102 Joint pain - hips Muscle pain - whole body Shaking Chills Feeling of dread/hopelessness
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Tinnitus, Tremor
Clinical narrative: Headache - severe Tinnitus  Diarrhea Fever 102 Joint pain - hips Muscle pain - whole body Shaking Chills Feeling of dread/hopelessness
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema
Clinical narrative: Dark pink oval patch (2X3 inches) at the sight of the vaccine 8 days after vaccine. No fever, no pain just tickes
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Fatigue, Headache, Pain
Clinical narrative: Temperature over 100 degrees, headache, body aches, tiredness.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness
Clinical narrative: equilibrium affected....felt fairly dizzy for a few days happened with first shot, not with second
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Tinnitus
Clinical narrative: As I was walking out of the vaccine sight on 3/10 after receiving my second COVID vaccine, after my required 15 min wait, I noticed my ears starting to get clogged (similar to being in an an airplane ascending) and they started ringing. I didn't think much of it right at the moment because it was warm and windy thought it might be the storm and pressure change (I've never had an issue with storms/pressure in the past though). The clogged feeling lasted approximately 45-60 minutes and then just stopped. The ringing has been pretty consistent since. It is a lot less noticeable in the day but at night when it's really quiet it's much more noticeable and loud.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Pallor, Syncope
Clinical narrative: Flush, faint, sweaty and pale
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hypotension
Clinical narrative: Hypotension/dizziness
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Insomnia, Pain, Pyrexia
Clinical narrative: Chills, fever, extreme head ache, insomnia, body aches
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Feeling hot, Headache
Clinical narrative: First shot (administered on 5 Mar 21, Pfizer Lot# EN6198) only had injection site tenderness (appeared next day) and arm pain which lasted for 2 days.  Second shot reaction, in order of symptom appearance; Injection site pain - within minutes of the injection Arm pain when lifting above shoulder level - within approx. 2 hours Exhaustion - started approx. 3pm Headache - started approx. 5pm and varied in intensity throughout symptoms. Chills (to the degree that a warm bath was required to heat extremities) - started approx. 7:30pm, interfered with sleep before soaking in hot water at approx. midnight. Diminished after soaking although chills did alternate with being overheated throughout the night. Mild joint pain - started approx. 7:30pm. Was worse in fingers/wrist and ankles where there are pre-existing joint issues. Nausea - started approx. 11pm. Did not advance to vomiting. Fever - temperature was elevated, 99.5F, around 12:45am and increased to 101.9F at 0345, at which point Tylenol was taken.   Temperature bounced around between 99.0 and 100.5 until the morning of the 28th. Other symptoms decreased (except fatigue) and were pretty much gone by approx. 5pm on 27 Mar 21.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: First shot (administered on 5 Mar 21, Pfizer Lot# EN6198) only had injection site tenderness (appeared next day) and arm pain which lasted for 2 days.  Second shot reaction, in order of symptom appearance; Injection site pain - within minutes of the injection Arm pain when lifting above shoulder level - within approx. 2 hours Exhaustion - started approx. 3pm Headache - started approx. 5pm and varied in intensity throughout symptoms. Chills (to the degree that a warm bath was required to heat extremities) - started approx. 7:30pm, interfered with sleep before soaking in hot water at approx. midnight. Diminished after soaking although chills did alternate with being overheated throughout the night. Mild joint pain - started approx. 7:30pm. Was worse in fingers/wrist and ankles where there are pre-existing joint issues. Nausea - started approx. 11pm. Did not advance to vomiting. Fever - temperature was elevated, 99.5F, around 12:45am and increased to 101.9F at 0345, at which point Tylenol was taken.   Temperature bounced around between 99.0 and 100.5 until the morning of the 28th. Other symptoms decreased (except fatigue) and were pretty much gone by approx. 5pm on 27 Mar 21.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: First shot (administered on 5 Mar 21, Pfizer Lot# EN6198) only had injection site tenderness (appeared next day) and arm pain which lasted for 2 days.  Second shot reaction, in order of symptom appearance; Injection site pain - within minutes of the injection Arm pain when lifting above shoulder level - within approx. 2 hours Exhaustion - started approx. 3pm Headache - started approx. 5pm and varied in intensity throughout symptoms. Chills (to the degree that a warm bath was required to heat extremities) - started approx. 7:30pm, interfered with sleep before soaking in hot water at approx. midnight. Diminished after soaking although chills did alternate with being overheated throughout the night. Mild joint pain - started approx. 7:30pm. Was worse in fingers/wrist and ankles where there are pre-existing joint issues. Nausea - started approx. 11pm. Did not advance to vomiting. Fever - temperature was elevated, 99.5F, around 12:45am and increased to 101.9F at 0345, at which point Tylenol was taken.   Temperature bounced around between 99.0 and 100.5 until the morning of the 28th. Other symptoms decreased (except fatigue) and were pretty much gone by approx. 5pm on 27 Mar 21.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: So called ?covid arm?, swelling and hardness at injection site. It began about an hour after I received the injection, and has only grown in size and pain since then. I have not sought treatment as of now.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise, Pain, Pyrexia
Clinical narrative: Fever, malaise, fatigue, shivering, aches
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Blood test, Dyspnoea, Electrocardiogram, Heart rate increased
Clinical narrative: Shortness of breath, rapid heart arrhythmia, tinitus
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Shortness of breath, rapid heart arrhythmia, tinitus
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Impaired driving ability, Malaise, Mydriasis, Pallor
Clinical narrative: About 5 minutes after vaccine was administered, patient became to appear pale and reported feeling unwell to me.  She commented that her vision was "getting black" I noted that her pupils were dilated and that her heart rate was 50 beats per minute. She was quite diaphoretic. No loss of consciousness.  She noted that she had not eaten for several hours prior to vaccine administration.  Patient was given water to drink and a bottle of fruit flavored tea.  After consuming fluids, she began to regain her usual skin tone and reported "feeling better, but not quite right".  She was observed for an additional 20 minutes and offered crackers to eat.  She called a friend to come pick her up and drive her home.  She left the clinic ambulatory accompanied by friend.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Visual impairment
Clinical narrative: About 5 minutes after vaccine was administered, patient became to appear pale and reported feeling unwell to me.  She commented that her vision was "getting black" I noted that her pupils were dilated and that her heart rate was 50 beats per minute. She was quite diaphoretic. No loss of consciousness.  She noted that she had not eaten for several hours prior to vaccine administration.  Patient was given water to drink and a bottle of fruit flavored tea.  After consuming fluids, she began to regain her usual skin tone and reported "feeling better, but not quite right".  She was observed for an additional 20 minutes and offered crackers to eat.  She called a friend to come pick her up and drive her home.  She left the clinic ambulatory accompanied by friend.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Malaise, Mydriasis, Pallor, Vitreous floaters
Clinical narrative: About 5 minutes after vaccine was administered, patient became to appear pale and reported feeling unwell to me.  She commented that her vision was "getting black" I noted that her pupils were dilated and that her heart rate was 50 beats per minute. She was quite diaphoretic. No loss of consciousness.  She noted that she had not eaten for several hours prior to vaccine administration.  Patient was given water to drink and a bottle of fruit flavored tea.  After consuming fluids, she began to regain her usual skin tone and reported "feeling better, but not quite right".  She was observed for an additional 20 minutes and offered crackers to eat.  She called a friend to come pick her up and drive her home.  She left the clinic ambulatory accompanied by friend.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pyrexia, Vomiting
Clinical narrative: chills, fever, nausea, vomiting, fatigue
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Pruritus
Clinical narrative: Headache, Itchy hands and arms
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dizziness, Headache, Pruritus, Urticaria
Clinical narrative: Headache, Itchy hands and arms
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient fainted after getting his pfizer shot. he was sweating.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus - ongoing
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Rash
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Medium, Additional Details: Patient contacted pharmacy 4/7/21 at 8pm to seek advice on a rash that has covered his entire upper torso.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Vision blurred
Clinical narrative: Sweating Blurry vision
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Flushing, Nausea, Syncope
Clinical narrative: Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Medium, Systemic: Shakiness-Medium
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Medium, Systemic: Shakiness-Medium
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Feeling hot
Clinical narrative: Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Medium, Systemic: Shakiness-Medium
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Angioedema, Full blood count, Laboratory test, Metabolic function test, Tryptase
Clinical narrative: acute angioedema of right side of tongue
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Lethargy, Pain, Syncope
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadedness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadedness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood test, Chest X-ray
Clinical narrative: Atrial fibrillation.  Treated in the hospital with diltiazem fir approximately 4 hours. Sent Home one heart rate was below 100. A Fib resolved approximately two hours later
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dysphagia, Dyspnoea, Eye swelling, Mouth swelling
Clinical narrative: Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Swollen tongue, Throat tightness
Clinical narrative: Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Pain in extremity
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA  pain in the arm,  strongest on the second day, gone by the third day. lump in the armpit (similar during past flu shots).
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: light headed, fainted after 5-10mins received vaccine-Mild, Additional Details: After received vaccine 5-10mins, he started feeling light headed, fainted. RN notified him to floor leftside, cold water to back of neck and forehead. BP: 91/66 -90/70, HR 91-85 when left side lying, BP 123/87, Hr 100 when sitting on floor. BP 122/85- 117/83, HR 99-95 when sitting in chair. He went home acoompanied by his mother when feeling better. He has fainted in past with shots and blood draws
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Rash
Clinical narrative: flu like symptoms; little rash; This case was reported by a consumer via other manufacturer and described the occurrence of influenza-like symptoms in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms and rash. On an unknown date, the outcome of the influenza-like symptoms and rash were unknown.   It was unknown if the reporter considered the influenza-like symptoms and rash to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced little rash and flu like symptoms.
Age: 0.33
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: was administrated with Kinrix instead of Pediarix; was administrated with Kinrix instead of Pediarix; This case was reported by a physician via call center representative and described the occurrence of wrong vaccine administered in a 4-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: No information about patient's identifiers, lot number, expiration date and vaccination date was provided. The patient received Kinrix instead of Pediarix which led to wrong vaccine administered at the age of 4 months which led to inappropriate age at vaccine administration. No adverse event was reported. The reporter consented to follow up.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested postive for COVID -19; This is a spontaneous report from a contactable consumer reporting on herself. An 81-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was Not available/provided), via an unspecified route of administration on 18Feb2021 14:30 as SINGLE DOSE for COVID-19 immunization. The patient medical history was not reported. The patient had no previous allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines in four weeks or any other medications in two weeks. The patient tested with positive for COVID -19 (sars-cov-2 test positive) on 22Feb2021. The event resulted in Emergency room/department or urgent care. The patient did not receive any treatment for the event. The patient underwent lab tests and procedures which included Nasal Swab and Rapid PCR with positive result on 22Feb2021. The outcome of the event was unknown.  Information on the batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Hypotension, Loss of consciousness, Visual impairment
Clinical narrative: Systemic: Chills-Medium, Systemic: Hypotension-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: During observation period, patient reported visual changes (seeing spots) and light headness. she temporary loss consciousness, therefore 911 was activated. While waiting for EMS to arrived, immunization pharmacist & technician checked patient's pulse and temperature. When EMS arrived, patient was coherent and EMS continued to provided care. I called patient earlier (around 8:15pm) to check on her status, patient reported feeling better. She received fluid & discharged from the hospital at 6pm
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vitreous floaters
Clinical narrative: Systemic: Chills-Medium, Systemic: Hypotension-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: During observation period, patient reported visual changes (seeing spots) and light headness. she temporary loss consciousness, therefore 911 was activated. While waiting for EMS to arrived, immunization pharmacist & technician checked patient's pulse and temperature. When EMS arrived, patient was coherent and EMS continued to provided care. I called patient earlier (around 8:15pm) to check on her status, patient reported feeling better. She received fluid & discharged from the hospital at 6pm
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood culture, Dysstasia, Hypotension, Loss of consciousness, Mobility decreased
Clinical narrative: Systemic: Chills-Medium, Systemic: Hypotension-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: During observation period, patient reported visual changes (seeing spots) and light headness. she temporary loss consciousness, therefore 911 was activated. While waiting for EMS to arrived, immunization pharmacist & technician checked patient's pulse and temperature. When EMS arrived, patient was coherent and EMS continued to provided care. I called patient earlier (around 8:15pm) to check on her status, patient reported feeling better. She received fluid & discharged from the hospital at 6pm
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Sensory disturbance, Urine analysis normal
Clinical narrative: Systemic: Chills-Medium, Systemic: Hypotension-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: During observation period, patient reported visual changes (seeing spots) and light headness. she temporary loss consciousness, therefore 911 was activated. While waiting for EMS to arrived, immunization pharmacist & technician checked patient's pulse and temperature. When EMS arrived, patient was coherent and EMS continued to provided care. I called patient earlier (around 8:15pm) to check on her status, patient reported feeling better. She received fluid & discharged from the hospital at 6pm
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Shortly after receiving my first injection of the Moderna vaccine, I started having ringing in my ears.  I spoke with the health department concerning this.  They did not hear of anyone having this issue.  The ringing still continues as of today and I can think of nothing else that might have brought this on.  Prior to the injection I did not have this issue.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Fatigue, Lethargy, Syncope
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Syncope, light head, blurry vision.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Throat tightness, Unresponsive to stimuli, Vision blurred
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Syncope, light head, blurry vision.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling cold, Feeling hot, Headache, Injection site pain
Clinical narrative: Fever as high as 103.7, normal fever in 100-101.5 range, hot and cold flashes, sore arm and swelling in left hand, diarrhea, head aches
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site swelling, Peripheral swelling, Pyrexia
Clinical narrative: Fever as high as 103.7, normal fever in 100-101.5 range, hot and cold flashes, sore arm and swelling in left hand, diarrhea, head aches
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Tremor
Clinical narrative: Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Additional Details: uncontrolable shaking. patient stated that benadryl has helped her in the past with this type of reaction. gave benadryl. patient has a history of having reactions to vaccines. 911 was called and brought her to the hospital.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Nausea, Pyrexia
Clinical narrative: Severe headache, fever, chills, nausea, diarrhea
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Lip swollen
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Fatigue, Injection site pain, Mobility decreased
Clinical narrative: Fatigue on 4/1/21 that became very noticeable around 2:45 pm. General muscle soreness/aches on 4/1/21 and a bit on 4/2/21. Left shoulder sore and uncomfortable to move through full range of movement from 4/1/21 afternoon until afternoon of 4/3/21. Soreness did noticeable die down as time passed.  Discomfort/muscle tightness starting around 3:00 pm 4/6/21 in the left axillary region. No swelling/redness/rash visible on surface. Discomfort most noticeable when stretching arm forwards/backwards or squeezing upper arm against side. Squeezing arm to side results in a feeling similar to if someone were trying to hold a marble in their armpit.   4/8/21 woke up still with arm pit discomfort and a return of the discomfort in the out shoulder muscle where the vaccine was administered.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Myalgia, Pain
Clinical narrative: Fatigue on 4/1/21 that became very noticeable around 2:45 pm. General muscle soreness/aches on 4/1/21 and a bit on 4/2/21. Left shoulder sore and uncomfortable to move through full range of movement from 4/1/21 afternoon until afternoon of 4/3/21. Soreness did noticeable die down as time passed.  Discomfort/muscle tightness starting around 3:00 pm 4/6/21 in the left axillary region. No swelling/redness/rash visible on surface. Discomfort most noticeable when stretching arm forwards/backwards or squeezing upper arm against side. Squeezing arm to side results in a feeling similar to if someone were trying to hold a marble in their armpit.   4/8/21 woke up still with arm pit discomfort and a return of the discomfort in the out shoulder muscle where the vaccine was administered.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Flushing, Hyperhidrosis, Injection site bruising
Clinical narrative: Site: Bruising at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Severe, Additional Details: vasovagel reaction pt layed down on floor with legs elevated for 30 min felt better and coloring came back to skin and he was released, tried to call at 5 pm after clinic to follow up to see how feeling no answer on above phone number
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pallor, Presyncope
Clinical narrative: Site: Bruising at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Severe, Additional Details: vasovagel reaction pt layed down on floor with legs elevated for 30 min felt better and coloring came back to skin and he was released, tried to call at 5 pm after clinic to follow up to see how feeling no answer on above phone number
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Chills, Headache, Heart rate increased, Pain in extremity
Clinical narrative: About 3hrs after shot I had elevated heart rate sitting in my chair it was 124 bpm with bp of 124 over 107 I usually have normal bp .this lasted several hours then in the morning I had chills and head acke arm was sore bp normal hand heart rate was 71bpm
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Influenza like illness, Myalgia
Clinical narrative: Less than 24 hours after injection I am experiencing flu like symptoms including a fever(101,) chills, vomiting, headache, diarrhea, and muscle aches.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Less than 24 hours after injection I am experiencing flu like symptoms including a fever(101,) chills, vomiting, headache, diarrhea, and muscle aches.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clots in right leg and left lung
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Panic attack
Clinical narrative: Systemic: panic attack-Mild, Additional Details: Patient had a panic attack about 5 min after injection.  she stayed in the pharmacy under observation for 35 min.  a friend drove her home
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Nausea, Palpitations
Clinical narrative: less than ten minutes after administration of JJ vaccine, patient started to complain of nausea, palpitations, and a "warm flush feeling", but the patient did not exhibit any signs of visible color change.  All of the stated symptoms appeared with rapid onset together over a period of 1 to 2 minutes, then started to reside.  Patient was given 25mg diphenhydramine and stabilized.  Patient instructed to wait additional 30 minutes in pharmacy and had no additional symptoms and stated she felt ok prior to leaving.  Follow up phone call 4/7/2021 and patient stated she experienced no additional or subsequent events/symptoms.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Tinnitus
Clinical narrative: Tinititus and hearing loss right ear
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Fatigue, Hyperhidrosis, Injection site discolouration
Clinical narrative: Shortly  after midnight on 03/27/2021, I was feeling tired w/chills.  When I got up somewhere between 5-7 a.m. I had a migraine-like headache.  Felt very tired.  Body ached all over.  Temperature went from 99.1 to 103.4.  After I took Tylenol the temp went back down to 99s.  Chills and perspiration after the Tylenol.   Left arm was warm to touch and hard at the injection site with redness; approximate 3 inch diameter redness.   The arm remained the same for another 10 days.  Leaving a discoloration where the redness was, but no hardness.   Sunday, 03/27/2021 only a very mild headache.  Monday no symptoms at all.  None since then.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Migraine, Pain
Clinical narrative: Shortly  after midnight on 03/27/2021, I was feeling tired w/chills.  When I got up somewhere between 5-7 a.m. I had a migraine-like headache.  Felt very tired.  Body ached all over.  Temperature went from 99.1 to 103.4.  After I took Tylenol the temp went back down to 99s.  Chills and perspiration after the Tylenol.   Left arm was warm to touch and hard at the injection site with redness; approximate 3 inch diameter redness.   The arm remained the same for another 10 days.  Leaving a discoloration where the redness was, but no hardness.   Sunday, 03/27/2021 only a very mild headache.  Monday no symptoms at all.  None since then.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain
Clinical narrative: Headache and body/joint ache.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: patient fainted after only about 2 minutes in chair.  he came to immediately, was surprised, he sat in observation area for 25min as he recovered.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Fatigue, Oropharyngeal pain, Pain
Clinical narrative: Cough (in the nights) Pressure in the chest Fatigue Muscle or body aches, specially back and chest Sore throat
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Limb discomfort
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Weakness-Severe, Additional Details: DIZZINESS AND LEGS \"FELT LIKE JELLY\". RESOLVED AFTER AND HOUR OR SO.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vision blurred
Clinical narrative: Blurred vision,  fever,  chills
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Bell's palsy, Corneal reflex decreased, Facial paralysis, Insomnia
Clinical narrative: Systemic: Bell's Palsy-Severe, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Severe, Systemic: Unable to Sleep-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patients' entire right face is drooping, with lack of mobility. Patient cannot blink which is causing additional issues, such as the visual changes. As of this morning patient has experienced some tingling to her face but she states it has not state consistent. She has difficulty eating and sleeping. Patient is also experiencing moderate to severe anxiety about the entire ordeal. Ringing in ear is constant and has not subsided since thursday (4/1). still experiencing symptoms since last week
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Paraesthesia, Tinnitus, Visual impairment
Clinical narrative: Systemic: Bell's Palsy-Severe, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Severe, Systemic: Unable to Sleep-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patients' entire right face is drooping, with lack of mobility. Patient cannot blink which is causing additional issues, such as the visual changes. As of this morning patient has experienced some tingling to her face but she states it has not state consistent. She has difficulty eating and sleeping. Patient is also experiencing moderate to severe anxiety about the entire ordeal. Ringing in ear is constant and has not subsided since thursday (4/1). still experiencing symptoms since last week
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Pruritus, Wound secretion
Clinical narrative: 1 inch long sloughed skin/blister, reported itching under bandaid - took bandaid off and saw clear gel looking fluid oozing from sore.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: IRREGULAR MENSTRUAL CYCLE(S)