chrisvoncsefalvay/vaers-outcomes huggingface dataset:
04/30/2003- immunizations. 05/02/2003- urine 4+ glucose- no symptoms. 05/05/2003- urine 4+ glucose, Glu 170 no symptoms. New onset diabetes
Patient has chest pain, difficulty breathing and nausea. Sent to ED then admitted to hospital. treated for acute myopericardits. Currently on Colchicine for 6 months. Follow-up with cardiologist in February indicated condition the result of Covid Vaccine
50 days after 2nd shot, severe injection site nerve pain. (Severe Radiculopathy)  also experiencing moderate bilateral swelling from knee down through foot.
Woke up itching all over my body, b/l feet with burning sensation and pins and needles sensation. The next day had hives with itching. Itching improved but burning sensation of feet intensified without improvement. Took 60mg prednisone for 3 days, took 50mg Benadryl without relief
ringing in ears, migraines, pain in ears-worse after second vaccine. continuing, nauseous loud noises, sounds bad hurt. sleep horrible.  lifechanging  worse after 2nd vaccine. and continuing worse on left side that shot was given on. First time right arm
Information has been received from a physician concerning a 20 year old female with allergies and attention deficit disorder who on 17-AUG-2007 was vaccinated with the first dose of GARDASIL, the second dose was given on 18-OCT-2007, and the third dose was given on 21-FEB-2008.  Concomitant therapy included montelukast sodium and CONCERTA.  On 27-AUG-2007 the patient developed hives and the hives continued throughout the series and then disappeared in May 2008.  The hives appeared on her face, legs, arms, feet and stomach.  The hives were described as "large welts, like golf ball size".  The patient was seen twice in the emergency room and received EPIPEN administration on each of the visits, she was then discharged home.  The patient had been seen by two allergists.  Skin testing was performed, but it could not determine the cause for the hives.  The physician stated that the allergist believed that the hives were hormone related.  Upon internal review, hives requiring epinephrine was determined to be and other important medical event.  Additional information has been requested.
a little tired after both first and second doses; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (a little tired after both first and second doses) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported.).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced FATIGUE (a little tired after both first and second doses). At the time of the report, FATIGUE (a little tired after both first and second doses) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: high (High) Higher than normal..         Action taken with mRNA-1273 in response to the event was not applicable. Concomitant drug was not reported. Treatment for the event was not reported.   This case was linked to MOD-2021-072612 (Patient Link).
Received H1N1 FLUNASAL vaccine - Developed shingles on nose and facial area 2-3 days following vaccination.
States 2 days after receiving Moderna Booseter, about 2 pm began having rigor type chills, uncontrollable shaking for about 8 hours or until 10 pm.  Rigors were "bad enough to shake bed" when laying down.  Associated nausea without vomiting that lasted several days after shaking resolved.  Nausea bad enough to keep from eating.  No symptoms since.   States original vaccine was by Pfizer.
Given .05ml instead of the dose of .25ml. Patient did not experience any adverse reaction after 15 minute wait time
The first night after receiving the shot I had pain in my arm, this was not severe, but enough that it woke me up in the night on the night that I had the injection (Friday).  The pain went away after about 2 days.  Today, (eight days later) I woke up with a horrible itch at the injection site.  I started to scratch the area (still half asleep) and could feel it swelling with every scratch.  When I got up and looked in the mirror, it was hard as a rock, swollen, and about the size of a baseball.  The swelling in the center was white and looked almost like cottage cheese bumps under the skin.  I drew a circle around the swelling and went to see clients for the rest of the day.  Tonight, when I got home I drew another circle to see how much the swelling had increased.  It had increased quite significantly.  The area (that is rock hard) is about 8 inches from top to bottom and four inch width.  It is rock hard still, itchy, and hot to the touch.  The area is red, but the white cottage cheese bumps are down a bit.  I have also had a headache for two days prior to the swelling.  I thought this was unrelated, but I don't think that anymore.  I normally do not get headaches.  If the swelling has increased by tomorrow, I will seek medical attention.
Difficulty in swallowing; Nervous; allergies are kind of heightened right now; This is a spontaneous report from a contactable consumer (Patient).A 59-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: EN6207; Expiration Date: 31Jul2021), via intramuscular route of administration, administered in Arm Left on 13Mar2021 as dose 1, 30ug single (at the age of 59-years) for COVID-19 immunization. Medical history included Allergy, breast cancer, allergy to pollens, allergy to grass, allergy to dogs, cats, weeds and trees. Patient took allergy shot once a month and Zyrtec as needed. Concomitant medications included tamoxifen (TAMOXIFEN) taken for breast cancer (It's for the follow up therapeutic type of drug probably) and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, 10 mg as needed. On an unspecified date in 2021, the patient experienced allergy and on 13Mar2021, 20 minutes after she had the shot, she had the difficulty in swallowing. So, did take an allergy pill immediately and symptoms start to subsided but she was getting nervous. The patient stated it's just she do have regular allergies. She got allergy shots as well. So, her allergies are kind of heightened right now. The patient stated she already reported her side effects. She was scheduled for another dose on Saturday 03Apr2021. So, she wanted to see, also she doesn't know if can say, can she take a allergy pill before she get it, should she take the 2nd dose or do check with someone else. She was scheduled to have her second dose 03Apr2021 and was wondering if she should continue with the second dose if she had side effects after the first dose. Therapeutic measures were taken as a result of event allergy and Swallowing difficult. The outcome of allergy was unknown and patient was recovering from difficulty in swallowing and nervousness.  Follow-up attempts completed. No further information expected.
Pt said he noticed redness at injection site about 24 hours post vaccinations. He then redness and swelling that extended from injection site to right below elbow around 48 hours post vaccination which was accompanied by fever of 102.2 degrees F. Fever subsided with Tylenol. Today pt no longer has fever, but continues to have redness and swelling between injection site and elbow
pt had one-minute episode of trembling, foam @ mouth, felt warm to touch, llowered level of consciousness groggy occurring approx 5 1/2 hrs p/vax;
Patient has not reported signs/symptoms of adverse effects; Expired PROQUAD (08/02/2023) was administered on 08/21/2023; PROQUAD had undergone prior TE on 08/08/2023; This spontaneous report has been received from a nurse and refers to a patient of unknown age and gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 21-AUG-2023, the patient was vaccinated with an expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection that had also undergone a temperature excursion (expired product administered, product storage error). (lot number w004028 has been determined to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), with an expiration date established as 02-AUG-2023), administered for prophylaxis (strength, and anatomical site of administration were not provided).
From initial information received on 14Jun04 from a health care professional regarding an adverse event occurring. It was reported that a 16 year old male pt received a dose of Typhim VI, lot number W13443, administered IM in the left deltoid and a dose of Hep A vaccine, lot number VHA814A2, admin IM in the left deltoid on 12Jun04. After receipt of the Hep A vaccine and while the Typhim VI was being administered, the pt experienced paleness, sweats, nausea, dizziness and blurred vision. He was treated with Benadryl and oral fluids and the events resolved within five minutes.
Fever up to 100.4.  Body aches.  Difficulty sleeping.  Shoftness of breath - relieved with Albuterol Inhaler.
PATIENT WAS AT WORK WHEN FEELING BAD, WAS CHECKED FOR VITALS WHERE HER PULSE WAS THE ONLY THING ABNORMAL. SHE STATES THAT IT WAS ELEVATED, BUT DID NOT PROVIDE  A LAB VALUE. PATIENT LEFT WORK AT 5PM DISORIENTED TO THE POINT OF MISLOCATING THE KEY SWITCH OF THE VEHICLE AND DRIVING THE WRONG WAY. PATIENT STATES TO HAVE NAUSEA AND VOMITING FOR 2 DAYS AND PASSED OUT TWICE. SHE STATES THAT SHE IS STILL NOT OVER IT 4 DAYS LATER.
Febrile seizure, lasted about 15 seconds on 7/11/00; sent to ER. Temperature was 103.3 and was given Tylenol.
Pt's rt. arm was sore 1 hr. after vax. The next morning, it was swollen, red & warm. Later that day, the area doubled in size, increased redness & warmth. Also, had blotchy red spots in the underarm area. Tx'd w/Prednisone & Lipex cream.
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a male patient who received BEXSERO. Concurrent medical conditions included allergy to vaccine (occurred when the patient was 3 years old). Concomitant products included GARDASIL. On 9th August 2016, the patient received BEXSERO. On 10th August 2016, 1 days after receiving BEXSERO, the patient experienced injection site swelling (serious criteria other: As per reporter) and difficulty breathing. On an unknown date, the outcome of the injection site swelling and difficulty breathing were unknown. It was unknown if the reporter considered the injection site swelling and difficulty breathing to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO and GARDASIL in two separate arms. Following vaccination the arm that received BEXSERO swelled up massively and the patient had trouble breathing. The patient was taken to the emergency room (ER) where he was stabilized. The reporter did not have the vaccine lot or expiration date or any patient information other than sex. The reporter was unaware of what does in the series either the BEXSERO or GARDASIL was.
Patient vaccinated x3 (Pfizer + Moderna: 4/19/21, 5/10/21, 11/19/21).  Patient tested COVID positive while hospitalized.
dizziness, nausea and heavy arm. After observation vitals are taken BP 140/80
LIGHTHEADEDNESS; WEAKNESS; SEVERE BODY ACHES; LACK OF SLEEP; CHILLS; INJECTION SITE SORENESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no loss of appetite. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, one total, administered on 20-MAR-2021 in left deltoid for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced lightheadedness, weakness, severe body aches, lack of sleep, chills, and injection site soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe body aches, chills, and injection site soreness, had not recovered from lightheadedness, and weakness, and the outcome of lack of sleep was not reported. This report was non-serious.
AFB patient. MEDICATIONS: Diltiazem ER 240 mg, XARELTO 20 mg, citalopram 20 mg, meloxicam 1/2 tab = 7.5 mg. 11/20/2018 - Late afternoon muscles started to tighten up - body very painful - pain and stiffness all during the night - felt as if the muscles were paralyzed - neck and head felt if ready to explode this continued all the next day. 11-21-2018 around supper time, stiffness started to go away, the next day 22 Nov 2018 my mind felt as if I had had a minor stroke - never had one before but mind was slightly confused in remembering - this was a very frightening experience. I simply rested quietly those days - am doubtful if I will get the second shot.
Patient felt dizzy and lightheaded, had slight blurred vision and was seeing spotty. He was given water/snacks/candy. We had him lie down and complete a couple of breathing exercises for about 15-20 minutes. Was complaining of dizziness intermittently in between lying down and sitting up. Vitals were checked by nurse, pulse ox and heart rate were normal. Patient felt better after about 30 minutes, EMTs were called and checked vitals - completely fine. Patient did not feel the need to go to the hospital.
Had been not been nursing well during the night prior to vaccine.  Seen in clinic 8/22/02 with normal exam except slow gain.  Received DTaP, IPV and Comvax.  Over the next day became much more lethargic, evavuated for sepsis at ER and admitted to Hospital for 2 to 3 days.  No source of infection found.  Seen again 9/6/02. Gaining weight well.  Not seen again until 12/6/02 with severe failure to thrive readmitted to Hospital.  No diagnostic work up.  Has continued with increased developmental delay poor growth.  Episode of admission for sever resp distress.  Now diagnosis of cerbral palsy.
Pt felt light headed and fainted for few seconds then woke up. We called emergency services and then the paramedics came and assessed her and left Pt was free to go home.
expired vaccine administered to the patient; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to the patient) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to the patient). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to the patient) had resolved.            Concomitant drugs were not reported. Treatment medications were not provided.  No other adverse event was reported.
ON 10/14/2016 PATIENT CAME TO THE PHARMACY COMPLAINING OF A RASH ON HER ARM WHERE SHE RECEIVED THE VACCINE.
CHF (congestive heart failure)  Pneumonia Respiratory distress Hypoxia Suspected COVID-19 virus infection
My 12 month old baby developed a chickenpox like rash all over her body. It is pink in color and bumpy.
flu-like symptoms.  Maximum fever of 102.2, body aches, shivering/cold chills, nausea, fatigue.  Unable to stay awake for more than thirty minutes on first day.  Loss of appetite.  Dry mouth.  Inability to preform basic tasks.  Anhedonia.  Severe to moderate symptoms lasting twenty-four hours, mild symptoms persisting.
DVT blood clot in the right foot, then spread to lower leg and knee and thigh, groin
Rt. arm swollen, red & warm at injection site softball size. Slowly resolving.
Headache Malaise and frequent stools but not considered diarrhea Narrative: She states that she had immediate pain at the injection site. On Saturday at 7AM, she developed malaise and frequent stools but would not classify them as diarrhea as well as a headache. She has never had a fever. Today, she continues to feel weak but reports that she is improving.
Swelling and burning at injection site and left arm. Intensely red and swollen. Entire arm to wrist. Prescribed prednisone and ZYRTEC.
When I first started getting the ocular migraines, I thought they I had a brain tumor. They were occurring only once a month so I would not say anything to my doctor because I was afraid, I would have to have brain surgery and I was having the vison problems with it. The headaches then started coming more frequently, I went in to see my doctor about the frequent headaches. I mentioned the migraines to him with the visual problems. He then told me I was having ocular migraines.
Within a minute of receiving Pneumovax-23 patient came to consultation window saying she could not breathe. Upon coming out to check on patient, she was very flushed and gasping for air. I asked her to please get on the floor and lie down to prevent a fall. 911 was called and I administered 0.3mg of epinephrine intramuscularly in her right leg and monitored her. Within a minute, she began to breathe on her own and never lost consciousness. A ambulance arrived and took her to the hospital. Upon follow, the patient was discharged later the same day of the adverse event and went to work the following day.
Information has been received from a registered nurse, concerning a 20 year old female patient, with a penicillin allergy involving a rash, who on 12-JUN-2007 was vaccinated IM, with the first dose, 0.5ml, of Gardasil (Lot # 657737/0522U). Concomitant therapy included ethinyl estradiol (+) ferrous fumarate (+) norethindrone acetate (LOESTRIN FE). On 14-JUN-2007 when the patient woke up in the morning, she had hives all over her body. At the time of this report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
A bruise appeared immediately; This is an initial spontaneous report from a contactable consumer. A 80-years-old female patient received frist dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration, administered in left arm on 13Apr2021 18:40 at a single dose for COVID-19 immunization. No medical history and concomitant medications were reported.The patient had a bruise appeared immediately, they put a Band-Aid over it, it spread about 2 inches in diameter on on left arm at injection site. She had the vaccine first one Tuesday, it never hurt, I didn't even have to take Tylenol. She don't know if it was a reaction to that or the Xarelto, it is local, never got reddened or anything. Her second dose of vaccine scheduled on 04May2021.The outcome of the event was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient experienced severe pain and was unable to raise arm 4 hours after vaccination. Patient went to Emergency room 24 hours later and received Percocet and Zofran. ER Physician believed needle placement may have played a part in pain.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 30-year-old female patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT .5 ml. On an unknown date, 1 day after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain, injection site induration and injection site swelling. On an unknown date, the outcome of the injection site pain, injection site induration and injection site swelling were unknown. The reporter considered the injection site pain, injection site induration and injection site swelling to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient developed pain localized to deltoid where the vaccine was injected and induration (small bump at injection site). The reporter did not have any vaccine information including batch number.
My menstrual cycle became irregular after having he COVID-19 Moderna 1st shot. I'm still having irregular periods that are becoming more frequent and painful.
Localized reaction at site of injection. Distal urticarial rash to right ankle and posterior calf. Diffuse coalescing papular rash to groin, upper legs and posterior thighs with interspersed lace like rash to lower extremities.
Expired Bexsero Administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB58AA, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th October 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 11th October 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-OCT-2022 Reporter's comment: Medical assistant reported that an expired dose of Bexsero was administered to the patient. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional Supportive Information:  The patient received a dose of Bexsero which was already expired, which led to expired vaccine used.
TWO YEARS LATER STILL HAVING MAJOR ISSUES; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient via a company representative concerned a 5 decade old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was healthy at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 05-JAN-2021 for covid-19 prophylaxis. The drug was associated with Off label use. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 45 years old. No concomitant medications were reported. On 05-JAN-2021, the patient experienced off label dosing frequency. On an unspecified date, the patient experienced two years later still having major issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from two years later still having major issues, and the outcome of off label dosing frequency was not reported. This report was non-serious.