chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt called at 1644 5/19/2021 c/o covid vaccine side effects. Verified pt with 2 identifiers. Proceed the screening questions of covid vaccine side effects and noted 1 s/sx of emergency covid vaccine side effects. Pt stated pt got 1st covid vaccine Moderna at 12 pm 5/6/2021 at. After covid vaccination pt had pain, muscle tightness feeling on injection site and it last over a week and half. Pt said pt noticed that pt is not able to control his balance to walk, not able to walk, pt expressed "swining" since yesterday after dinner. Pt described it's not dizziness but pt is swinging while pt is walking such as walk to the left or walk to the right, not straightly. The symptoms of "swinging" happened last night and this morning. Since pt is not able to control his balance, pt's sitting on the chair or bed all day today. Noted pt has hx of epilepsy. Pt said pt is taking gabapentin and Lamictal TID for seizure and well controlled for 12 years. The writer recommended pt to call 911 or go to ED d/t pt shows emergency s/sx of covid vaccine side effects. Pt is educated covid vaccine side effects. Pt agreed and verbalized understanding.
Swelling at injection site; Redness at injection site; Pain at injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 10-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 43E4T, expiry date 1st October 2021) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, less than 6 months after receiving Boostrix, the patient experienced injection site swelling, injection site erythema and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site pain were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain to be related to Boostrix.  Additional information received were as follows: The age at vaccination was not reported. The healthcare professional reported that the patient had redness, swelling and pain at the site of Injection with Boostrix. The reporter consented to follow up. The batch number was updated from 43E47 to 43E4T as per sales data sheet. This was one of the 6 cases, reported by the same reporter.
PT with pain in arm. Decreased range of motion. No mention of redness, swelling, induration, numbness, weakness, fever within 24 of administration.  Pt with progressively worse pain with movement. Seen at convenient care center on 6/6/2014. Analgesics and warm compresses prescribed.
March 4 (6 days after shot) a rash where shot entered arm.  Itchy red breakout on both arms, neck and chest. Went to  a clinic on March 5 and was given hydroxyzine 25 mg every 6 hours for the itch.  Told to see an allergist before second vaccine date  to see if there is something in the vaccine that I am allergic to.  Appointment is on March 8
They gave me the shot and handed me the card and was told to move forward and hang out for 30 minutes since I am allergic to penicillin. Once I was sitting in the car I felt a cold stream of fluid rushing through my body and then cold sweats and my through where my lymph nodes are feel heavy and like someone was choking me and then my breathing was low then high from 45 to 75 had my apple watch on it kept saying to breath. Then I started freaking out and we called for the EMT he took Vitals And asked me about any issues I did mention I do have anxiety he asked if i take anything I said I do cardio. He said to roll down the windows step out of the car and when I Did I felt week in my legs, The EMT told me to wait for another 15 minutes if I could go home monitor myself and if anything occurs call 911 so I left  and when I got Home MY throat still felt like someone was choking me and I was Sweaty and my throat was very read and I kept Freaking out . I then drank water and tried to breath but was very hard  drinking the water was a struggle the same night I could not sleep I used a heating pad on my throat to help and messaged my doctor .
Symptoms: June 02, 2021 (Day 1)?..Stiff Neck, left shoulder pain with restricted movement. June 02, 2021 (Day 2)??Stick Neck, Shoulders, Pain.  Restricted left arm  & shoulder movement.  Crying pain was so bad.  Nausea. Also back pain & body pain.
had refused to walk, bear weight on rt leg;won't move no swelling, no red, no foot drop site inj was clear & in proper location;pt had definite weakness in rt leg;this was followed & has now improved, no obvious limitation;
I was positive for COVID-19 on 06FEB2023, I had just returned from a trip. I was congested, I had a bad earache and headache. My back was hurting me a lot, I took the test and tested positive multiple times. I didn't not seek treatment.
CHILD HAS A RASH; WAS SEEN IN CLINIC ON 09/01/2023; TX: BENADRYL 12.5MG/5ML ORAL LIQUID TAKE 5ML QID X 5 DAYS CETIRIZINE 5MG/5ML TAKE 2.50ML QD FAMOTIDINE 40MG/5ML TAKE 0.80ML BID X 14 DAYS
03jan90 pt vax hepta B. 6hrs follwing vax devel. low-grade fever severe gen. body aches, malaise. sx resolved w/i 2days. pt ex mild weakness in thighs while climbing stairs for the next 7 days.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was inadvertently administered a dose of PNEUMOVAX 23 (dose, route, lot number and expiration date not reported) which expired in August 2014. At the time of the report the outcome of the event was unknown. Additional information has been requested.
HIGHER THAN NORMAL HEART RATE; VIRAL NODULES; SHORTNESS OF BREATH; KNEE PAIN; FEET PAIN; MILD HEADACHE; This spontaneous report received from a patient concerned a 51 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-MAR-2021, the subject experienced knee pain. On 23-MAR-2021, the subject experienced feet pain. On 23-MAR-2021, the subject experienced mild headache. On 30-MAR-2021, the subject experienced shortness of breath. On APR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) Viral nodules. On 02-APR-2021, the subject experienced viral nodules. On 08-APR-2021, the subject experienced higher than normal heart rate. Laboratory data included: Heart rate (NR: not provided) Higher than normal heart rate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from knee pain, and feet pain, and mild headache on 30-MAR-2021, was recovering from higher than normal heart rate, and had not recovered from shortness of breath, and viral nodules. This report was non-serious.
Feels like struck in a circle; Bumpy; Very warm at the injection area; Swollen/ big knot; This spontaneous case was reported by a consumer and describes the occurrence of CLAUSTROPHOBIA (Feels like struck in a circle), INJECTION SITE HAEMORRHAGE (Bumpy), INJECTION SITE WARMTH (Very warm at the injection area) and PERIPHERAL SWELLING (Swollen/ big knot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concomitant products included CITALOPRAM for Depression, OXYCODONE for Pain.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CLAUSTROPHOBIA (Feels like struck in a circle), INJECTION SITE HAEMORRHAGE (Bumpy), INJECTION SITE WARMTH (Very warm at the injection area) and PERIPHERAL SWELLING (Swollen/ big knot). At the time of the report, CLAUSTROPHOBIA (Feels like struck in a circle), INJECTION SITE HAEMORRHAGE (Bumpy), INJECTION SITE WARMTH (Very warm at the injection area) and PERIPHERAL SWELLING (Swollen/ big knot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication include anxiety medication.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: TCR added. Reporter declined for e-mail address and further FU.
Continued pain at injection site from the 2nd SHINGRIX given on 1/31/19. Complains on 02/25/2019 pain is now shooting up to his neck and down to his elbow.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11May2022 at 14:00 as dose 1, single (Lot number: FN2908) at the age of 56 years, in left arm for Covid-19 immunisation; Janssen CoviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 27May2021 at 12:00 as dose 1, single (Lot number: 043A21A), in left arm for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, Covid-19.
Experienced lightheadedness and dizziness and "funny feeling swallowing, like my throat was going to clog up" Felt better after taking Benadryl.
Patient came today to receive his Janssen Covid vaccine and experienced feeling faint and light headedness few minutes after administering the vaccine. He has no history of allergic reactions to a vaccine, medication or food. There was no visible swelling or localized reactions to the injection site. I cleared the table next to him and had the patient lie flat on the floor with feet elevated for several minutes. He still continued to report feeling faint and stated ?I am about to pass out?. we called 911 to seek further medical assistance. I checked his blood pressure and it was 122/84. EMS arrived minutes later and patient started to stabilize. Patient asked to be transported to the hospital & EMS took patient to the hospital for further evaluation.
Patient received her first dose of Pfizer COVID19 vaccine on 1/23/2021 in her left deltoid. The morning of 2/11/2021 she woke up to see  both legs covered in a reddish purple flat rash  from her mid thigh area to her toes. She also developed a similar looking rash, but lighter in color, on her left upper arm. The rash on her arm starts several inches below the injection site and extends to her elbow.
FEVER, STARTED ON NORMAL SALINE, ADMNISTERED TYLENOL, ORDERED LABS, RESIDENT DIED LESS THAN 24 HRS AFTER TEMP SPIKE.
A few hours after receiving the vaccine my arm was sore. It has stayed sore since then, Yesterday it was bothering me so I looked and noticed there was knot about the size bigger the a dime but smaller then a quarter.  Slightly red area the injection site and has been itching. Feels warm to touch. I haven't really bad or anything. Since Saturday I have been trouble with my stomach which isn't anything unusual. It seems like it is upset.
Numbeness in left hand, and fulness in neck, with 15 minutes later adding facial sensation in her left side of face. Waited in waiting area for about an hour, didnt get better hut dodnt get worse. Staff told her to go to urgent care to seek further treatment
Severe brain zaps, falling, having to hold onto walls to walk, numbness on my left side (face, arm & side), headache
thigh on leg swelled up twice the size as the other as described by mom;on 2nd day p/vax appeared like hive resolved in about 2wk;
Complained of fever last night (2/3/09)and today complains of sore throat, red spots on neck,trunk and arms. Acyclovir 200mg every 4 hrs ordered.  Brother diagnosed with varicella 1/23/09.
4 hours after receiving the vaccine. 1-my body felt cold and I felt tightness in my chest 2-not easy to take my breath 3-left and right foot started swollen. Gotten worse over night but i was able to sleep. 4-next day I can't even step on my foot at all and can't sleep. Constant pain all day. 5- symptoms got better but I haven't really 100% recovered. 6-I still have pain and if got worse after my 2nd vaccine shot on 07/30/2021 which I will be reporting on a separate form.
Very next day after the vaccine I started feeling intense lower back pain. Visited the Chiropractor for the back pain but he was unable to determine what was the cause for my pain. About 2 weeks later I was unable to walk and was in so much pain that Emergency Services was called. I was admitted to the hospital that night and was treated for pain, extreme fatigue. I was treated with IV drip antibiotics for a Muscular Skeletal infection. I was then transferred to a rehabilitation center and began receiving physical therapy I was there for 2 weeks discharged and needed home care for an additional two weeks. I received physical therapy at home and can drive for short distances. More than anything the muscular pain is unbearable.
This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patients' medical history or concurrent conditions were not provided. On 22-APR-2015, the patient was vaccinated with the first dose of GARDASIL (0.5 ml, intramuscular, lot number and expiration date were not provided). Then on 17-JUN-2015, the patient was vaccinated with the second dose of GARDASIL (0.5 ml, intramuscular, lot number and expiration date were not provided). On 24-JUN-2015, the patient was vaccinated with the third dose of GARDASIL (0.5 ml, intramuscular, lot number K007828, expiration date 02-MAR-2017). No adverse effect was reported. Additional information has been requested.
I went to the chiropractor, and I told him I was having terrible joint pain. He asked if I had dots on my back. He looked and told me that I had some little red dots that he believed to be shingles. He told me that I was having nerve pain and that is what shingles does. This was only happening to my upper body. This pain lasted for about two nights.
Narrative:   PATIENT WAS IMMUNIZED IN A TIMELY MANNER 1/15 AND 2/5 RESPECTIVELY WITH PFIZER MRNA VACCINE. PATIENT TESTED POSITIVE AT OUTSIDE FACILITY 9-17, AND CAME TO FACILITY 9-24 WITH WORSENING DIZZINESS AND WEAKNESS. PT RECEIVED SUPPLEMENTAL O2 DURING HOSPITALIZATION, TREATED WITH REMDESIVIR, HE RECOVERED AND WAS LATER DISCHARGED.
Hours after injection, developed red skin rash on both forearms and face (? related to sun exposure?). No redness at injection site. Advised oral Benadryl. Next am, took Benadryl, began itching, scratchy throat. Seen in ER. Given IV's, Cortisone, Hydroxizine, Cinetadine.
The injection site was sore for 48 hours. The day after the injection (4/7/18) she felt extreme tiredness and chills. Her arm also started feeling "heavy" and weak starting at 1 PM on 4/8/18. Pt. states that it "feels like a deep muscle ache and has not resolved". As of this writing at 8:15 PM on 4/11/18 it still has not resolved. Patient is scheduled to see her primary care physician on 4/12/18.
Redness,  Swelling of  Right  leg  after receiving vaccine on Tuesday. Fine on Tuesday  oain & swelling Wed. after going on water ride at theme park
Day of the shot 1/13/21 my arm got very sore by the evening I felt the soreness move under my arm into my armpit down the side of my breast, which lasted several days- 1/14/21- extreme Fatigue and body aches- and chills worse than when I had Covid- 1/15/21-shortness of breath, very dizzy with pain in arm and side was still very painful- 1/16/21 I decided to go to the Walk in clinic to make sure what I was experiencing was normal, they recommended I go straight to the ER- I went to park west ER and was checked out and released- my injection site was getting bigger each day, and felt hard and hot; 1/17/21 - arm was still sore headache and dizzy nauseous with some diarrhea , 18th 19th about the same  1-20/21 Headache, very dizzy felt like I was going to pass out, diarrhea in the evening- arm is looking a lot better 1/21/21 arm was numb and tingling all day - tried to get back in with a dr and was not able to! Starting to feel back to normal after having 10 days of symptoms- injection site still slightly tender but looks better
Severe gastro; fever > 103 at home; viral gastroenteritis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 11 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 17:30 (Lot number: FK5618) at the age of 11 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Batch/Lot No: FK5127, Location of injection: Arm Left, Vaccine Administration Time: 05:30 PM), administration date: 15Nov2021, when the patient was 10 years old, for COVID-19 immunization. The following information was reported: GASTROINTESTINAL DISORDER (medically significant) with onset 07Dec2021 11:00, outcome "recovering", described as "Severe gastro"; PYREXIA (non-serious) with onset 07Dec2021 11:00, outcome "recovering", described as "fever > 103 at home"; GASTROENTERITIS VIRAL (non-serious) with onset 07Dec2021 11:00, outcome "recovering", described as "viral gastroenteritis". The events "severe gastro", "fever > 103 at home" and "viral gastroenteritis" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: body temperature: (07Dec2021) >103; sars-cov-2 test: (07Dec2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of gastrointestinal disorder, pyrexia, gastroenteritis viral.  Clinical course: Patient Was sent home from school on 07Dec with severe gastro and fever > 103 at home. Diagnosis at ER was viral gastroenteritis. Patient had no known allergies. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are needed. No further information is expected
delayed cutaneous hypersensitivity that showed up 7 days after first dose, Rash on arm for 3 days. No treatment.
I went to get immunzation pt from waiting room and when called mom responded.  When brought to exam room it was noted that 2 patients with similar names were both ready to be seen.  I had asked mom is this is correct patient and she said yes. Mom was very sleepy during the visit as she had just worked night shift.  She kept falling asleep during the visit and one point daughter had to wake her up.  I then realized I had wrong patient in my room and had given him the wrong immunizations.  Mom was very understanding and knew that there was confusion over the names/patients.  Pt received tdap, meningococcal, HPV, and MMR.  The first 3 were not supposed to be given at this time. Mom was informed of this and still very understanding. Was present and I also had informed her what happened. They had spoken with mom and explained everything.  Appointment was made for child to return on 12-1-22 for dtap and varicella vaccines.  I also contacted his school nurse so that they would not put him out of school.
Burning sensation in my right foot; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning sensation in my right foot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (Burning sensation in my right foot). At the time of the report, BURNING SENSATION (Burning sensation in my right foot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product information was provided. Treatment information was not provided.
I have experienced two to three events over the last two years the events are all similar in that the symptoms were reduced blood pressure and increased heart rate. After experiencing these events I brought it up at my annual physical with my doctor that was 01JAN2023. I have an annual physical every year, I am physically active swimming, elliptical, hand weights, two three times per week. When I brought this up to my doctor I said I am wondering as this has happened two to three times spaced out over time should I be concerned, he immediately asked me to see a cardiologist. I went the same week with no symptoms at the time and the cardiologist I have arrhythmia and scheduled two tests an Echocardiogram and a Stress Test, these were completed within two weeks with no abnormal findings and a four month follow up was scheduled. I will follow up with my doctor in June due to heartburn issues and my high cholesterol.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 97 and receiving hospice care on 2/21/21. He was previously admitted on 1/29/21 to hospital for a fall resulting in a dens fracture and eventually suffered from a DVT. He passed away on 2/23/21. Comorbidities include advanced age, CKD, coronary arteriosclerosis, sleep apnea, and cognitive decline.
This is a spontaneous report received from a non-contactable reporter(s) (Other HCP), Nurse from product quality group. A 47-year-old male patient received bnt162b2 (BNT162B2), administration date 12Oct2021 (Lot number: FF2589) at the age of 46 years as dose 3 (booster), single, administration date 18Mar2021 (Lot number: EL3247) as dose 2, single and administration date 23Feb2021 (Lot number: EL3247) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Mar2022, outcome "unknown" and all described as "PCR was positive"; ILLNESS (non-serious) with onset 29Mar2022, outcome "unknown", described as "Sick"; ELECTROCARDIOGRAM ST SEGMENT ABNORMAL (non-serious) with onset 01Apr2022, outcome "unknown", described as "mild ST"; FATIGUE (non-serious) with onset 01Apr2022, outcome "unknown", described as "Fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Mar2022) positive, notes: COVID test name post vaccination: PCR. Clinical Course: There were no Seriousness criteria that Resulted in death, Congenital anomaly/birth defect and Disabling/Incapacitating. There were no seriousness criteria that was Life threatening and that Caused/prolonged hospitalization. It was unknown whether patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. COVID test type post vaccination was Unknown. Device Date was 01Apr2022. No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of COVID-19 and Vaccination failure due to temporal relationship.
soarness of arm and discoloration at injection site, pain radiating through back of shoulder/neck to elbow. Self care at home