chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Urinary tract infection 2 weeks after emergency department visit for backpain, nose ring removal, and COVID vaccination
Onset, 3/14/2000, left leg upper (shot) thigh, red (itchy yesterday and today) and swollen. On 3/20/2000, steroid cream applied to leg by parent and the foot looked swollen. She will go to MD on 3/27/2000 for follow-up on the leg.
With 24 hrs, I had nausea, diarrhea, lethargy, headache and generalized flu like symptoms which lasted for 10 plus/- days. A couple of weeks later, I began getting random "pox-like" eruptions over my body and particularly on my face. The eruptions are fewer now but I still am getting them on my face 2 1/2 months later. They are unsightly and look like a "chicken pox."
This spontaneous report was received from a medical assistant and refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were inadvertently vaccinated with the doses of PNEUMOVAX 23 that were improperly stored (route of administration, lot number, expiry date was not reported). No adverse events were reported. Additional information has been requested.
Severe site reaction with pruritis and baseball-sized erythema.  Intermittent stabbing pain at site lasting over two months.
This spontaneous report as received from a healthcare student (pharmacy intern) and a 50 year old female pharmacy technician who is the patient refers to herself. On 19-AUG-2014 the patient was vaccinated with ZOSTAVAX (strength and lot # not reported), 0.65 ml, subcutaneous in the right deltoid. The patient report that on day 1, on 19-AUG-2014, within the first 15 minutes therapy she experienced injection site redness, injection site became like a mosquito bite: it itched, got red and swollen. On the second date, on 20-AUG-2014, the redness went down, and the injection site had no discomfort or redness or itching; there was nothing at the site. On day 3, on 21-AUG-2014 the patient experienced the red circle came back, and it became a little hard and warm. The healthcare student also described the injection site, as it appeared on 22-AUG-2014, as 1.5" inch in diameter, warm to touch, and slightly firm. The patient explained on 22-AUG-2014, the injection site was still not resolved and she had not sought medical attention. The patient offered no other complaints. VZVIP faxed to the patient. Additional information has been requested.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 73-year-old female patient 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) .25 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that, there had been no power outages that would have impacted the Moderna vaccine. However, the healthcare professional reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at this time. It was reported that, no adverse reactions were reported by the patient.  No treatment medication was provided.
The pt developed swelling and redness at injection site (5in. diameter). Treated with Benadryl and Tylenol with ice compresses at ER. Doc's office prescribed Atarax in place of Benadryl.
This spontaneous report as received from a physician via a field representative refers to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medications were not reported. On an unknown date (also reported as "many years ago"), the patient was vaccinated with ZOSTAVAX (lot # and expiry date were unknown), intramuscular for immunisation. Other suspect therapies included SHINGRIX (lot # and expiry date were unknown) which the patient was administered on 19-FEB-2018. Approximately on an unknown date in February 2018 (also reported as soon as she got the vaccine), the patient had severe burning that was going up and down the left arm, that went across the chest and the sternum. It was reported that the patient also felt sick the next day with general malaise. The patient also had a hard induration that was red and very painful. The patient was still in severe pain. The outcome of malaise, pain, erythema, induration, chest pain and burning sensation was reported as not recovered. Causality assessment was not provided by reporter.
This spontaneous report as received from a registered nurse refers to a patient of unknown age with a history of kidney transplant. On an unknown date the patient was administered with the vaccine with the lot # 0590F, exp 10-MAY-2008, but could not confirm if the vaccine was ZOSTAVAX or (Merck) VARIVAX. (Merck) VARIVAX was the intended dose for this patient but patient might have received wrong vaccine, ZOSTAVAX instead. The patient was on several immunosuppressant medications at the time of vaccination. No adverse effects reported. Lot number 653964/0590F, expired date 10-MAY-2008 is valid for (Merck) VARIVAX. Additional information has been requested.
On 9/9 I had radiating pain down my spine, tingling in my legs and feet. Lower extremity weakness, headache , dizziness , vision impairment and brain fog. I drove myself to the hospital and there was a 5 hr wait. Next day I went back my mom driving me was seen and in ER for 8 or so hours given IV fluids, toridol for pain, meclazine for dizziness and discharged due to all blood work levels being normal and UTI negative. Following days severe brain fog and back pain and dizziness. Followed up with PCP yesterday who advised I stop meclazine and tested again for UTI (neg) and mono test (waiting results) I?m out of work and completely ?out of it? not myself! 8 days onset after 1st shot and several have told me same reactions due to the Pfizer shot. Doctor will set me up with neurologist is this doesn?t clear. Im a healthy 32 years old female who works and lives life snd now I am impaired. Very scary.
Sore arm; itchy; Red at the site of injection; swelling bump at the site of injection, crust on top, dot center; at the site of injection, painful to touch; she experienced a red raised swelling bump (Boil-like) at the site of injection/ red bump (boil-like; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th December 2021, the patient received the 1st dose of Shingrix. In December 2021, less than 2 weeks after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site pain, injection site papule and pruritus. On 20th December 2021, the patient experienced pain in arm. On an unknown date, the outcome of the injection site erythema, injection site pain and pain in arm were unknown and the outcome of the injection site swelling, injection site papule and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain, injection site papule, pain in arm and pruritus to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received first dose of Shingrix on 20th December 2021. The patient had a sore arm immediately after the vaccination.  Then about 7 to 10 days later, she experienced a red raised swelling bump (Boil-like) at the site of injection on left upper arm.  She stated that the bump was red and painful to touch from the sides, but not painful if touched from the top.  She also stated that the bump had a crust on top and a dot on a center.  She stated that it was itchy when she touched or if clothes touch the area, but not itchy all the time.  She stated that the red bump (boil-like) and itchiness were still present and not resolved.  She did not have the information about lot/exp date, route of administration and dose of Shingrix. The reporter consented to follow up.
Pt states he had fevers and chills and very ill for about 2 weeks following the vaccine.  Then he developed severe left BELLS PALSY on 7/19/19, 30 days after the vaccine.
swelling of penis; swelling of gums; swelling of lips; abdominal pain; skin rash; This case was reported by a nurse via call center representative and described the occurrence of penile swelling in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABxB29BA, expiry date 30th June 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 25th August 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 26th August 2021, 1 days after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced penile swelling, gum swelling, lip swelling, abdominal pain and rash. On an unknown date, the outcome of the penile swelling, gum swelling, lip swelling, abdominal pain and rash were unknown.   It was unknown if the reporter considered the penile swelling, gum swelling, lip swelling, abdominal pain and rash to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The nurse at the patient's health care professional office was the reporter.  The following day of the vaccination patient had symptoms such as skin rash, abdominal pain, swelling of the lips, gums, and penis.  The reporter consented to follow up.
Complained of flu like symptoms, felt she got the flu.  Unknown tx or time course, rested.
Severe pain in head. Worst headache Ive ever experienced. Increased heart rate and fever.  The pain in my head was so bad I considered going to the hospital.
After the 2nd Anthrax shot, (about  1 week later), I had a large hair loss on the back of my head. i saw my physician who said that it could have been related to the Anthrax shots. Hair is currently growing back.
Red areas about 1" across - about 5 areas on left arm below injection site chills - sweating - 1 night Low back soreness - generalized aches Resolved within one week
Patient begin having itchy reaction after receiving the vaccination about 40 minutes after the vaccination. 20 mg oral benadryl was given to the patients for the itchiness.
NO CURRENT ADVERSE EVENT PER PATIENT. A PEDIATIC PFIZER VACCINE WAS PULLED FORM THE REFRIGERATOR , NOT DILUTED WITH SALINE, AND ADMINISTERED TO PATIENT. 0.3ML OF THE UNDILUTED VACCINE WAS DRAWN INTO A SYRINGE AND ADMINISTERED TO THE PATIENT. I CALLED THE PATIENT TO TALK WITH HER ABOUT THE MISTAKE.
11/7 - In ED and admitted for lower extremity swelling in confirmed Non Hodgkins Lymphoma. Vitals BP 178/92, HR 117, resp 18 with SpO299% on rm air, Afebrile. Covid negative on admit.  12/6 - Due to inpatient exposure, tested and found Covid positive. Asymptomatic at this time. Received MAB. Saturating well on room air. 12/8 - Spiked Temp 38.2C, WBC 16, Has productive cough with sputum. Continuing to monitor and starting Remdesivir and Meropenem. while continuing Vancomycin 12/11 - No shortness of breath, Non productive cough .  12/14 - cough improved. WBC WNL, continues to sat well on Rm air. CRP 7 - Remdesivir x5 days complete. Vanco and Meropenem discontinued. Started Augmentin PO. Chest Xray showed no sig chang
Fifteen to seventeen hours following the patients immunization he awakened suddenly with nausea, stiff neck and pain in back. It resolved in approximately 12-15 hours. The patient reported 12 days later.
Had soreness/pain, swelling, redness. Went to Urgent Care on 12/18/2017 and received prescription for antibiotic.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild
Redness at injection site, swelling at injection site, painful to touch, feverish to touch, mild headaches, mild diarrhea, mild nausea, dizziness, fatigue, fever of 102.1 at its highest. Red mark slightly went below injection site by the next day and started to swell, harden and increase in size.
Narrative:  Patient presented for COVID moderna booster, had 3 previous doses with no reported side effects. apprx at 14 min post vaccine, patient reported feeling itchy on top of head and difficulty swallowing, fnp presented to eval patient, per provider instructions writer admin 12.5mg po liquid Benadryl, writer monitoring, patient reports symptoms worse, per provider instructions ems activated patient given additional 12.5 mg dose of liquid benadryl, epi pen ready and available Patient is a&ox3, resp even nonlabored, speech clear, answering approp, Mood is pleasant. Affect is congruent. Thought Processes are intact. no rashes / redness / swelling noted patient remained seated in private vehicle continous monitoring by writer while awaiting ambulance patient contacted 2 family members independ via his cell phone to notify he was being transmitted to hospital, No adventitious sounds (such as wheezing, rhonchi, or rales) heard when speaking over the phone, his voice is clear and can speak in full sentences without sob, ems arrived on site stand by assist patient to stretcher, report given by writer to ems attendent, problem list , med list provided, Local emergency room note indicates: EMS gave 2 doses of EpiPen injections and 2 doses of Benadryl. Patient able to complete sentences Normal no chest pain shortness of breath now. No nausea vomiting no headache or visual symptoms his throat feels tight. In the ER patient received methylPREDNISolone 125 mg Route: IV; Rate: bolus; Site: left forearm; 14:15 ED course: Patient is feeling better almost back base line. Mild itching in the right cvr ear area no rash. Vitals normal and her cardiopulmonary monitoring. Given prednisone RX to have on standby. Family to keep an eye on him overnight his daughter and son-in-law live with him They will come and pick him up.
Mother states pt was foaming at the mouth and breathing heavy, when she got home after reciving vaccines. Mom was instructed to take child to the emergency room or call EMS. she did not. Spoke with mom today 12/27/2019 mom states t is doing fine now just fussy.
At 5p, started to get a headache and body aches. By 6p, fever was 99.5. At 8p, fever was 101. The rest of the night featured a headache, body aches, chills, fever of 100.5 to 102.5 and nauseated (dry heaved twice)  Took tylonel every 6 hours to try and help. Next morning (current as of writing this), felt a little better as fever dropped to 99.5 and nausea significantly lowered. Still have a headache and aches in legs
1st event: Loss of consciousness, falling, no memory of questioning, directions or repositioning until after the event.  Vomiting upon awakening. 2nd event: Loss of consciousness while seated.  Falling. No memory of event. Eventual recovery of normal functioning.
Within a few weeks of vaccination patient complained of hip pain. Went to orthopedic - did x-rays -showed nothing. He recommended physical therapy - 14 sessions later pain traveled to knees - MRI next -showed nothing. Chronic joint pain, fatigue, sleeplessness, hair loss, anxiety, panic attacks, depression, dizziness, fainting.
HCP did not reconstitute the vaccine; patient was only administered the liquid portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA713A, expiry date 30th June 2023) for prophylaxis.   On 8th August 2022, the patient received Menveo. On 8th August 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 09-AUG-2022 Reporter's comment:  The nurse reported that she administered a dose of Menveo to patient, but she did not reconstitute the vaccine, so the patient was only administered the liquid conjugate portion.  At the time of reporting, dose had not been repeated.  The reporter consented to follow up. Additional Supportive Information: The reporter reported that a patient received liquid conjugate portion of Menveo without reconstitution, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
19 year old male is referred from primary care clinic for several concerns including: 1) SM has been keeping his smallpox site uncovered and has been living with a pregnant fiancee. 2) The SM has developed 2 suspicious skin lesions X 2d. Symptoms: Lesions, papule, Erythema, Pruritus.
ON 1/4/21 AT 4:00PM, DEVELOPED DIZZINESS, CHEST TIGHTNESS, 'HEAVY' ARMS AND LEGS, HEADACHE, HYPERTENSION  (DBP>100). WAS GIVEN 25MG DIPHENHYDRAMINE AT 4:25PM. SENT TO ER AT 5PM. REPORTS SHE WAS SENT HOME FROM ER AT 7:30PM WITH A DIAGNOSIS OF DEHYDRATION. PATIENT REPORTS SHE TAKES A NUMBER OF PSYCHOTROPIC DRUGS, INCLUDING VYVANSE, FLUOXETINE, AND WELLBUTRIN. SHE IS CURRENTLY ON A KETO DIET AND TOOK NAPROXEN EARLIER IN THE DAY.
hives and rash to hands, arms, legs starting the following morning.  Came to health department, recommended benadryll for relief of itching.  told family to continue to monitor and follow with primary care if persists beyond 2 weeks.
AD flared approximately 2 months post Booster shot.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Jan2021 08:30 (Lot number: EL0141) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ORTHO TRI-CYCLEN; DUPIXENT. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3248, Location of injection: Arm Left, Vaccine Administration Time: 08:30 AM), administration date: 11Feb2021, when the patient was 37 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: 301308A, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 11Oct2021, when the patient was 37 years old, for COVID-19 immunization. The following information was reported: DERMATITIS ATOPIC (medically significant) with onset Apr2021, outcome "not recovered", described as "AD flared approximately 2 months post Booster shot.". The event "ad flared approximately 2 months post booster shot." was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Feb2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of dermatitis atopic with Multiple topical steroids, oral prednisone, Dupixent. Clinical Course: Patient did not taken other vaccine  in four weeks. Patient taken other medication in two weeks are Ortho Tri-Cyclen, daily vitamin, dupixen.  No covid prior to vaccination. Covid test was done post vaccination.   No follow-up attempts are possible. No further information is expected.
A nurse reported that a pt received an injection of Pnu-Imune 23 vaccine on 11/4/99. Within 4 hours, the pt developed an injection site reaction characterized by redness, swelling, warmth and tenderness. The reaction was described as a "cellulitis type" reaction. The reporter indicated that 3 pts experienced this event following receipt of Pnu-Imune 23 from the same multi-dose vial. However, only 1 pt is presently identifiable. Additional reports will be generated when identifying information is provided.
34 yr old female w/ well controlled htn. received moderna vaccine 1/5/2021- and 24-48 hours post vaccine: and she had fever, chills, myalgias w/ axiallary lymphadenopthy.  +reports localized swelling. which id not respond to antihistamines.  the local site had greater than 10 cm of erythema  And on saturday- started vomiting: she was taken to ER medical Center- 1/10/2021        + axiallary lymphadenophy        + fever         + chills        + greater than 5 cm -10 cm of erythema        ---- In which she was rx'd        she is taking prednisone 50 mg         Tylenol w/ codiene        Allegra and benadryl. Discharged home in stable condition.
Vaccinated for varicella but developed chicken pox 030804. Mother reports less than 50 pox. Mostly in hair, few on legs/back, and pubic area. No fever. Mother reports was exposed at school.
PATIENT HAS NOT HAD ANY SYMPTOMS TO THIS POINT WHEN TALKING TO THEM ON 6/2/2021. PATIENT WAS GIVEN A DOSE APPOXIMATELY 2.5 HOURS AFTER THE GOOD BY DATE AND TIME. VIAL WAS FIRST PUNCTURED AROUND 752 AM AND EXPIRED AT 152 PM WITH 6 HOUR GOOD BY TIME.