chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10/4/21 @ 10 am she developed significant angioedema of her lips (and slightly to her left infraorbital region), but no other allergic reaction symptoms. Apparently she had filler injected into both her lips a couple weeks ago and less filler, longer ago to her left infraorbital region. We spoke with her plastic surgeon and came up with a plan to properly treat her reaction. No hospitalization required, but was seen by our emergency dept, Of note, the patient was not eligible for a third booster dose yet, and she was not immunocompromised and in otherwise good health. She is a healthcare professional.
Received flu vaccine 10/26/13 felt some discomfort at the time. Over the last 3 weeks arm has become "heavy" and painful. Unable to lift (L) arm up, straight.
Pt experienced fleeting moment of syncope 5secs while sitting on a chair in the recovery hall. He was aroused to consciousness when his name was called and chest rub applied. V/s bp 103/64, res 12, temp 94.8, hr 83, o2 97% RA. He was taken to a cubicle in a wheelchair and made to lay down on a cot for further observation. Pt was noted to be perspiring profusely. 2pkts of small apple juice and  a bottle of water were offered, Pt drank all. At 10:15 a m v/s obtained read - bp 116/84, rr14,hr75, temp 96.6, O2 97% RA. Pt. verbalized feeling well, denied any pain. He was advised to see his caregiver for further medical evaluation .He walked away from the room unassisted at 10:28 a m.
On 12/3/2022, in my right leg, I had pain and a large, red spot on my upper thigh. The spot was swollen and hot to the touch. I went to the ER, where I underwent an ultrasound of my leg. I was diagnosed with a superficial blood clot that ran from my right ankle to my groin. I was prescribed a blood thinner whose name I forget, and I was told to follow up with a vascular doctor. I saw a vascular doctor within a few days afterwards. While I was at the vascular doctor's office, I underwent another ultrasound of my leg and bloodwork. It was determined at that time that the blood clot extending from the ankle to the groin was still present. The vascular doctor prescribed me XARELTO, which I am currently still taking. She told me that I should see a hematologist, which I did. At the hematologist's office, I underwent blood tests. It was through the blood tests that it was discovered that I have Factor V Leiden mutation; it was mentioned that I had one such gene rather than two. The vascular doctor advised me to come back to her office for a follow-up either four or six weeks later. When I came back for the follow-up, I underwent another ultrasound of my leg. At that point, the blood clot was still present. She told me to just continue taking the medication and that she would check my progress during follow-ups. The last time I saw my vascular doctor, the clot had shrunk, but it still extended from the ankle to the groin. The doctor said that she wasn't sure that the blood clot would go away, but she wasn't very concerned, since improvement had been made. She did not arrange for me to come back for another follow-up, and she has just advised me to continue taking the XARELTO. The vascular doctor told me to come back for a check-up in a year. Of course, if I experience symptoms like the ones that brought me to the ER, I should come back sooner.
I had Shingles three years ago and was diagnosed with Shingles again on 04.22.21. It effects my left leg and thigh. Rash/blisters started on 04.18.21. It is possible the Covid Pfizer vaccine reactivated the virus.
After receiving varicella, HPV & MCV4 vaccines, pt appeared pale and diaphoretic and nearly fainted. We placed him lying down and raised his legs and fanned air around his face. His BPs were 106/68, 98/56, 104/68. We offered him apple juice. After 20 minutes he felt better and was discharged.
"pt recv vax 28DEC93 & lab eval was negative for rubeola antibody, IgG;"
Patient received the vaccine on 4/5/12. She complained of rash on chest and body morning of 4/6/12.
Had experienced joint pain and headaches, fever, fatigue, large lump at site of injection, sore lymph nodes in neck surrounding the #2 AVA immunization, "nothing debilitating".  Received AVA #3 on 2/21/2003, followed by initial dose of Larium(Mefloquine) on 3/2/2003.  On 3/7/2003, while sitting at desk, sudden onset of chest tightness with pain. Sudden jabbing sensation in chest. Deep breathing made the chest pain worse. Went to office next door for help, medics called. Sensations lasted > 4 hours before starting to taper. Felt dizzy, disoriented, off balance(about to fall on face). Medics noted low, then high B/P. To ER, on oxygen, tests done, observation for several hours, eventually d/c to home. Felt back to normal, not worried about going home. Similar symptoms have occurred off and on since that date, lasting several days at a time, with 1-3 weeks between episodes. Usual pattern is surprising, sudden onset of dizziness, severe headache with vision disturbances sometimes, shest tightness with sharp pain in anterior mid-sternal pain, cold sweats, feet and toes and hands numb, hands appear blanched. Has had to go to ER 5-6 times due to the severity of the symptoms.Tests have shown normal results, normal EKg.
Injection site reaction, itching at injection site, cellulitis at injection site that increased in size daily from 3/15/2021-3/19/2021.  Low grade fever, nausea.  Developed shaky hands and legs during same timeframe.  Essential tremors still exist and are still present.
Pink urine. Visited urgent care on 12/17 ( the day after first notice bloody urine). Tested urine, no bacteria or infection, only blood is positive.  No medicine is given,  recommend to see urologist to do different test. Also visited family doctors in the afternoon of 12/17, got a referral to urologist and made an appointment.
1.  Bulging veins appeared the day following first vaccination.  From inside the left nostril onto the upper lip. on right temple above end of eye brow and between hair line, legs, behind the right knee.  Behind the left knew were several large clots.  1.a. Had vein work done from November 2020 to January 2021.  Clots had disappeared.  1.b.  Feb. 27, 2021 clot on right temple was "in" or on top of area treated.  There was pain that lasted for three days.  1.c. Told primary care doctor and saw Vein Doctor.  Then there was not much concern about clots. 2.  Eyes:  02/26/2021 through 02/27/2021 shooting pains around and through the eyes.  Started right after vaccination. 3. Two bulging painful masses Center of forehead right and left of center of nose. 4.  Lega and feet swelled  5. Toes: 03/03 toes separated and cramped on feet.  Each foot two toes went left stuck together and two went right. 6.   Feet 03/03/21  sore spots on top of feet.  Pain made it hard to walk.  Pain extended toward and over ankles and wrapped around heel..  I use a walker   7.  Dizzy when looking down, shortness of breath.  Contacted cardiology 8.  Belching and air bubbles originating in the chest area 9.  Sleep:  Slept almost around the clock for first 5 days. 10.  Very thirsty even after drinking water 11.  Urinated more than usual.  some burning.  Reported to doctor. 12.  Vaginal etching and dryness for 2 weeks  13.  Joint Dryness;  All joints but very painful and extra dry rough feeling in right hip. For 3 days 14.  Stubbled when waling March 11, 12, 13, and 14 2021 15.  Mind and body not working to
Shortly after receiving the vaccine (1/5/21) while waiting the 15 mins I experienced phlegm in my throat and kept trying to clear it, that resolved within 7min, I felt strange ...kind of dizzy and felt weird out of body feeling. They gave me water and crackers and said try to eat something for second shot. After 30 mins I felt OK to leave. During the rest of the day I had a headache which worsen and next day (1/6/) the same and had that weird out of body sensation off and on. I also had mild achy feeling, fatigue and both hips and shoulders mild pain. I did take this day off from work. These symptoms resolved towards the end of that night. Doing much better today (1/8/21). I aslo had mild swelling and sore at the injection site which I expected like a flu shot. I have not had any reaction to any vaccination prior years.
pain from shot site; shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain from shot site) and ARTHRALGIA (shoulder pain) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain from shot site) and ARTHRALGIA (shoulder pain). At the time of the report, VACCINATION SITE PAIN (pain from shot site) and ARTHRALGIA (shoulder pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.
pt recvd vax; red swollen areas down lt arm, states appears to be fluid filled;f/u 29nov95 swelling resolved after 1 wk; no problems since;did not require hosp or med;
Vaccine administered 4pm on 4/12 8am 4/13: headache and soreness at injection site Noon on 4/13: chills and achiness, fever 99.5. Significant swelling, heat and redness and injection site Fever, chills, achiness resolved by 4/14 AM Redness, swelling and itchy rash at injection site 4/14 through 4/16
A report has been received from a Physician concerning a 4 year old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST (Intranasal) started on 03-May-2013. It was reported that expired FLUMIST administered to patient which started on 03-May-2013 and experienced rhinorrhea. The outcome of the event of rhinorrhea and expired FLUMIST administered is unknown. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune on 08-May-2013 from physician: New non serious event of rhinorrhea added.
Fever: 100.5, aches and pains, chills. Sore deltoid at injection site. Headaches.
The site below the injection site became red and swollen, warm to touch. Her family Dr. observed the site. Prescribed CEPHALEXIN 500mg 3 times/day. With a week later, swelling was down, redness gone.
edema started Thursday noc; had t101 relieved w/APAP; pain in arm from time of inject; still having pain but much better; had h/a;
After the vaccine I was in the waiting room, then I had seizure-like tremors full body and complete energy loss, was taken to the triage for CBC and EKG testing. Full body tremors subsided after 1 hrs and was left with extreme arm tremors. Given Ativan for tremors stopped momentarily but after 20 minutes tremors in arms began. Moved to the Health ER where was given a CT scan and Benadryl. Calmed the tremors. Left hospital at 1:30AM and the following day (02/05/2021) ran a fever of 101 for almost 16hrs,  treated with fever reducers.
No addtional AE reported; VARIVAX had been administered when out of recommended range; This spontaneous report was received from a pharmacist and refers to a patient of an age of 25 (units not provided) and unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On 01-JUN-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 mL, lot # T012551, expiration date: 10-APR-2022 (route of administration, anatomical location not provided) for prophylaxis, which was out of the recommended storage range. Temperature excursion details were unknown. No adverse events were reported.
The day after the booster shot I felt achy and everything hurt.  I was like this for about 2 -3 days.  But  was able to return to work on Monday.    I began feeling symptoms on June 12 of Covid.  I thought it was a sinus infection but then began to have all over body aches.  The following day I called my doctor.  I was prescribed meds for sinus infections.  I  had labored breathing, severe sore throat, loss of taste and smell, but no fever.  But ultimately got help online with a doctor and was prescribed Paxlovid for 5 days.  I quarantined for five and then masked myself for five.  Other than the bad test of the pill, they helped a lot for all of my symptoms.  My taste and smell are slowly returning.
Hep A given to patient instead of Hep B. MA noticed the error immediately and notified MA Supervisor. Clinician was also notified. Dr stated that no adverse effects should be experienced by patient.
Patient tolerated well no adverse reaction, dose was given after vial was in fridge longer than 30 days
Delayed local reaction.  Approximately 10 days after receiving vaccine, injection site developed a local skin reaction, induration and pruritus. No systemic symptoms.
fever; chills; Paralyzed right diaphragm and breathing difficulty; Paralyzed right diaphragm and breathing difficulty; This spontaneous case was reported by a consumer and describes the occurrence of DIAPHRAGMATIC PARALYSIS (Paralyzed right diaphragm and breathing difficulty) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced DIAPHRAGMATIC PARALYSIS (Paralyzed right diaphragm and breathing difficulty) (seriousness criterion medically significant) and DYSPNOEA (Paralyzed right diaphragm and breathing difficulty). On an unknown date, the patient experienced PYREXIA (fever) and CHILLS (chills). At the time of the report, DIAPHRAGMATIC PARALYSIS (Paralyzed right diaphragm and breathing difficulty) and DYSPNOEA (Paralyzed right diaphragm and breathing difficulty) had not resolved and PYREXIA (fever) and CHILLS (chills) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Lab data included Xrays, CT scans, MRI's and pulmonary function test. No results provided.  No concomitant medication information was mentioned by reporter  No treatment medication information was mentioned by reporter  Company comment: The case concerns a 65-year-old female patient with concurrent medical history of asthma who, presented with unexpected event of paralyzed right diaphragm and breathing difficulty 14 days after receiving the second dose of mRNA 1273 vaccine.  The patient was not responsive to use of inhalers for underlying disease and no result of diagnostic tests performed (X-ray, CT scan, MRI) were provided. Rechallenge was not applicable, as the event only occurred after the last dose. Causality assessment for the event was not provided by the reported. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: The case concerns a 65-year-old female patient with concurrent medical history of asthma who, presented with unexpected event of paralyzed right diaphragm and breathing difficulty 14 days after receiving the second dose of mRNA 1273 vaccine.  The patient was not responsive to use of inhalers for underlying disease and no result of diagnostic tests performed (X-ray, CT scan, MRI) were provided. Rechallenge was not applicable, as the event only occurred after the last dose. Causality assessment for the event was not provided by the reported. The benefit-risk relationship of Spikevax is not affected by this report.
Information has been received from a health care professional concerning a 9 year old Indian male pt with no known drug allergies who on 7/2/96 was vaccinated, SC, with a first dose of varicella virus vaccine live (lot 612216/1126B). There was no concomitant medication and no illness at the time of vaccination. On 12/27/01, the pt was seen in the physician's office with 20-25 vesicular lesions over his body. Follow-up information indicated that the pt developed several vesicles on his back, arm, trunk, neck and scalp. Additional information has been requested.
Started to get severe pain at injection site 3 hrs after injection. Took aspirin and relieved pain a little. Pain worsened 2nd day. By 3rd day better. Reported to me around 5pm 3rd day.
Dizziness, Myalgia, Fever, Fatigue, pain at injection site and chills Narrative:
Just started yesterday.  3 inches lower then injection site and about 3 inches long. looks like a sunburn.  did virtual Dr apt. recommended ice pack topical solution
Tinnitus after 2nd dose in May starting about a week after shot. Has not stopped since then. Went to an ENT which showed no visual symptoms in outer ear. Went to an audiologist and had a hearing test. Test showed no sign of hearing loss. Was put on round of antibiotics which did not help. Was put on fluticasone propionate to take every day. I have taken it every day for 3 weeks with no relief.
Constantly itching- all over; red rash-irritation from scratching  around neck; red rash-irritation from scratching  around neck; This case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included heart attack (2 heart attacks) and difficulty breathing (breathing problems in the last 3 years).   On 22nd June 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 25th June 2022, 3 days after receiving Shingrix, the patient experienced generalized pruritus, red rash and skin irritation. The patient was treated with medication unknown (Cream (Medication Unknown)). On an unknown date, the outcome of the generalized pruritus was not recovered/not resolved and the outcome of the red rash and skin irritation were recovered/resolved.   It was unknown if the reporter considered the generalized pruritus, red rash and skin irritation to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-SEP-2022 Reporter's Comment:  The patient received first dose of Shingrix and 3 days later he experienced constant itching all over body, that was still ongoing. The reporter also mentioned he had red rash like irritation from scratching around neck. The reporter stated that he went to health care professional, and they ordered cream, but it did not help.  Medical disclaimer provided.  The reporter referred to health care professional, medical information phone number provided. Spoke per content. The reporter consented to follow up.
Nasal Congestion; Runny nose; Watery eyes; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Nasal Congestion), RHINORRHOEA (Runny nose) and LACRIMATION INCREASED (Watery eyes) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history was reported.).   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced NASAL CONGESTION (Nasal Congestion), RHINORRHOEA (Runny nose) and LACRIMATION INCREASED (Watery eyes). At the time of the report, NASAL CONGESTION (Nasal Congestion), RHINORRHOEA (Runny nose) and LACRIMATION INCREASED (Watery eyes) outcome was unknown.            The patient's medical history was not provided but the patient claims that he has no history of allergies.  Concomitant product use was not provided. Treatment details included the use of fexofenadine.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.
Dose 2 of Shingrix on September 15, 2020; Nausea; Fever; Redness below the injection site; This case was reported by a consumer via call center representative and described the occurrence of nausea in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient  reported that it was 1.5 months past 6 month Shingrix dose window and he was not received it till the time of reporting, which led to incomplete course of vaccination.   Follow up report received from consumer on 17th September 2020: On 15th September 2020, the patient received the 2nd dose of Shingrix. In September 2020, less than a week after receiving Shingrix, the patient experienced nausea, fever and redness below the injection site.  The patient received 2nd dose late which led to lengthening of vaccination schedule. Patient does not wish physician get contacted. It was unknown if the reporter considered the nausea, fever and erythema to be related to Shingrix.
side effects /dry skin patches; prickly sensation on my back; itch; This case was reported by a consumer via interactive digital media and described the occurrence of dry skin in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced dry skin, tingling sensation and pruritus. On an unknown date, the outcome of the dry skin, tingling sensation and pruritus were unknown.   It was unknown if the reporter considered the dry skin, tingling sensation and pruritus to be related to Shingles vaccine.     Additional Information: Additional Information: GSK Receipt Date: 26-OCT-2022 Reporter's comment: This case was reported by consumer via interactive digital media. The patient had the 2 shots, after the second, he/she had side effects, dry skin patches, prickly sensation on his/her back and itch. Additional Supportive Information:  The follow-up would not possible as no contact details were available.
Case number PHEH2013US019091, is an initial spontaneous report received from a consumer on 10 Sep 2013. This report refers to a female patient on unspecified age. Past medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: not reported), on an unspecified date. After vaccination on 03 Jul 2013, she experienced right side facial paralysis and recovered on 20 Jul 2013. On 06 Jul 2013, she also experienced eye vision was blurred on the right eye and recovered on 26 Jul 2013. The seriousness and causality of the events was not reported.