chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Urinary tract infection; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (Urinary tract infection). At the time of the report, URINARY TRACT INFECTION (Urinary tract infection) outcome was unknown. Not Provided          Patient received second dose of Moderna vaccine and wanted to know if it can cause Urinary Tract Infection in women.  No concomitant medications were reported. No treatment was reported.  Action taken with mRNA-1273 in response to the event was not applicable.
pt in a nursing home; nurse found him not breathing; EMS contacted; CPR started and he was brought to the ED; pt not intubated when arrived at ED; pt was bagged, IV access was obtained, and a round of three epinephrines were given; asystole without spontaneous respirations; pt had a positive COVID test previously on 12/28/21.
Pt experienced a hot to touch, painful, and edematous area to the right thigh. Right thigh was twice the size of the other one. Pt experienced edema down to the knee causing painful undulation. Negative inguinal nodes, testes normal. Treated with Ancef. Recheck on 2/7/00, symptoms decreasing.
patient received a dose from a vial that had been punctured for more than 12 hours and left at room temperature for more than 24 hours; patient received a dose from a vial that had been punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received a dose from a vial that had been punctured for more than 12 hours) and PRODUCT STORAGE ERROR (patient received a dose from a vial that had been punctured for more than 12 hours and left at room temperature for more than 24 hours) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 04L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received a dose from a vial that had been punctured for more than 12 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patient received a dose from a vial that had been punctured for more than 12 hours and left at room temperature for more than 24 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received a dose from a vial that had been punctured for more than 12 hours) and PRODUCT STORAGE ERROR (patient received a dose from a vial that had been punctured for more than 12 hours and left at room temperature for more than 24 hours) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The reporter reported that, from the vial a shot was given on 09-May-2022 and then the vial did not get thrown away. But on 10-May-2022, from that vial a pharmacist gave the dose. Vial sat out between the time, for 29 hours.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-565190 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2022: Follow-up information included no new information.
Bronchoconstriction and shortness of breath with cough lasting about 2 hours. Red, itchy eyes with discharge upon waking the next morning. Soreness and swelling at injection site.
Patient reported that about 3 hours after receiving vaccine got very achy, muscle cramping, lower back pain, headache, fever or 103*, lasted all night. 11/9 am when she called me her fever was 100.7 without any antipyretic. Reported she was going to see her dr in the afternoon
Information has been received from a certified medical assistant concerning a 25 month old male with no medical history and no drug allergies who on 10/18/05 in the AM was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine 0.5ml IM lot 649695/0512P, in the right thigh. There was no concomitant medication. On 10/19/05 the patient experienced a red, tender and swollen at injection site. It was also reported as patient got a severe erythematous 6cm circular region at injection site. The pt was treated with diphenhydramine HCL Benadryl and acetaminophen Tylenol. Symptoms resolved within a few days. There were no lab diagnostic testes performed. No additional information is expected.
DIZZINESS; VOMITING; NAUSEA; ELEVATED BODY TEMPERATURE; METALLIC TASTE IN THE MOUTH; MIGRAINE HEADACHES; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: cold, and warm body, and other pre-existing medical conditions included: The patient had extreme sensitivity to all medications and supplements. The patient had not changed her diet nor was she exposed to anything. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 07-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, Laboratory data included: Body temperature (NR: not provided) 98.4-98.8. On 07-JUL-2021, the patient experienced migraine headaches. On 07-JUL-2021, the patient experienced metallic taste in the mouth. On 07-JUL-2021, the patient experienced nausea. On 07-JUL-2021, the patient experienced elevated body temperature. Laboratory data included: Body temperature (NR: not provided) 98.8-99.2. On 08-JUL-2021, the patient experienced dizziness. On 08-JUL-2021, the patient experienced vomiting. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 97.4-97.8. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, and vomiting on 11-JUL-2021, nausea on 10-JUL-2021, and elevated body temperature on 28-JUL-2021, had not recovered from migraine headaches, and the outcome of metallic taste in the mouth was not reported. This report was non-serious. This case, from the same reporter is linked to 20210829031.
Nerve Damage Symptoms; its achy all on the left side; shoulder pain; Being lower back pain; the pain in shoulder went to the arms, back across to the front of the chest; dull aching pain; she didn't sleep; groggy; The pain in shoulder went to the arms, back across to the front of the chest; This is a spontaneous report from a contactable consumer (patient). A 57-year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot number EK9231) (at the age of 57-years-old), via an unspecified route of administration on 20Jan2021 as a single dose for covid-19 immunization.  The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the left arm. The patient medical history included acid reflux She has been good for last 2 months. She was on Pepcid but not anymore; uterine polyp removal in 2019 (reported as 2 years ago) polyps removed from uterine wall, it was done outpatient but they still put her to sleep, but it had took her 2 weeks to get over the reaction of being put to sleep, it was the anesthesia, it wasn't pain, but she was very tired and groggy after. She does not know the name of the Anesthesia or have any Lot or Expiry; receives flu shot every year with no issue. The patient was not taking any concomitant medications. She has had No positive antibody or Covid test prior to the vaccine. She took the first shot last Wednesday 20Jan2021, she had a weird, not the usual reactions like she had read about. She even went to the Nurse Practitioner yesterday because of it. She was told she has nerve damage from the shot and a high immune response to the shot, which is a good thing, but her question is does she take the second shot. The nerve damage started at 10 o clock that night causing shoulder pain, back pain, being lower back pain, because of it she didn't sleep, only 3 hour Thursday night. She's a teacher and even had to miss school on Friday. It is just a constant dull aching pain. She was groggy. Some symptoms were typical. She never ran a fever, the pain in shoulder went to the arms, back across to the front of the chest, she can follow with the hand here, its achy all on the left side. She went to the Nurse Practitioner and she said it sounds like nerve damage. The NP did not do any test, she really just left the office hoping that it would resolve on its own.  Caller states that this is not going away.  She actually read to not even take Tylenol or Advil 2 days prior as it can lessen the effectiveness of the vaccine. That's why she didn't take Tylenol till Friday Afternoon on 22Jan2021. She toughed it out for 2 days. The doctor told her she can take Advil right now. The clinical outcome of the event: Low Back pain recovered; event Nerve damage was recovering; events achy all on the left side, Dull aching pain, shoulder pain, chest pain, Pain in arm, she didn't sleep, groggy unknown. She is scheduled for the second dose on 10Feb2021.
My deltoid was weak and 5 days later very sharp, painful and localized. Could not move arm. Waited about 5mo. to see doctor on 7/5/2021 and mentioned to PHP and it was very tender. Was referred to PT and I waited until I saw an orthopedic specialist on 09/07/2021. Gave a cortisone injection to be able to do physical therapy. Was determined that the vaccine may have been injected too high into the bursa. Been going to for a month to PT and seems it has only gotten worse.
22 y/o was in his usual state of excellent health prior to Feb-Mar 2010. At the time, he was attending college. Looking back, around Feb 2010, former SM recalls developing fatigue and the feeling of being run down - "activity taking more out of me". He recalls experiencing polydipsia and polyuria during the month of March 2010. He was not aware of weight loss, but he recalls a few people asking him about how much weight he had lost. He did not experience visual changes, N/V, polyphagia or numbness and tingling in his extremities. By 21 Apr 2010, his symptoms had increased significantly to the point they were interfering with his daily activities and he sought evaluation with his PCM. At that time, glucose level of 318, trace positive urine ketones, and HgbA1c of 10.5 led to his diagnosis of T1DM. Insulin was initiated as outpatient at time of diagnosis. Patient then received DSME and his insulin was titrated as needed. Around May, he was evaluated by his Endocrinologist and in August 2010, he was placed on an insulin pump. He was medically discharged from Army National Guard in Feb 2011. He currently is working and has found a local PCM, but continues Endocrinology follow up. SM received Hepatitis B and influenza vaccines in Nov 2009 and MMR vaccine in July 2009- See left column for Vaccine History. He denies any unusual or prolonged reactions within the first 1-2 weeks following vaccine receipt. He does not recall any viral-type symptoms just prior to or on the days of vaccine receipt. Patient does not recall a history of infection or symptoms of cough, fever, sinus symptoms, congestion or diarrhea in months prior to his diagnosis of T1DM. He denies a history of an elevated glucose levels, elevated blood pressure levels or history of hypertension prior to diagnosis of TIDM. He was not overweight and stayed very active. He has no family Hx of T1DM.
Red, raised, indurated area 7cnx51/2cm positive itching started evening after vaccine plus is hot to touch. TX with Ice and Benadryl
Hives and swelling on face approximately 8 hours post-administration, no difficulty breathing, no treatment used, symptoms are still present at 0930 the following morning but have started to subside and are not as significant as initial presentation according to patient. Pt has follow up appointment with primary care provider on 2/12/21.
fever and malaise began 4/12/21 followed by migratory headaches and myalgia, several days morbilliform rash, brief diarrhea and abdominal pain
Patient called pharmacy to complain of persistent pain in arm after vaccination. Pain is mainly in shoulder of left arm, not severe but distracting and constant. Pain radiates up/down arm & shoulder. Patient's ability to grip objects is impaired. Symptoms have not improved and may have even worsened. Patient states injection site appears normal. I reinforced over-the-counter measures (APAP, ibuprofen, cold/hot application) and referred to physician for evaluation.
Patient was newly pregnant when she received her first Covid vaccine. Was later diagnosed with a missed miscarriage
Patient had tachycardia and c/o chest tightness and palpitations s/p covid vaccine. BP 140/60 and HR of 110. O2 sats at 98% EKG performed. Patient was deemed ok to discharge and patient went home without further incident
Swelling of arm at site of injection & extending around the arm, down to the elbow.  Fever 99.7 degrees F.  * Right arm swelled (no swelling of left).
On Wednesday 10/25/06 received the Flu vacine (via shot) along with his 3 year old twin brother and 5 year old sister.  All children were perfectly healthy prior to the vacination.  By early evening he was showing a 103 degree tempature, which progressively worsened.  On Friday night simptoms included sore throat with swelling (unable to swollow), aches, pains, continued high fever requiring a trip to the emergency room, where they suggested it might be a virus and (incorrectly) prescribed antibiotics.  We did not fill the antibiotic prescription as we know they have no affect on a virus.  Giving him over the counter Tylenol and Motrin throughout this event provided very little if any releif.  On Saturday morning we returned to the doctor where the vaccine was received.  The doctor ran throat cultures and performed an complete checkup determining that he has the flu.  I understand that the vaccine (shot) is prepared with dead cultures, but find it very difficult to believe that (being the only one sick in the home at this time) this event was not due to the vaccine.  He has had fever reaction to the vaccine in the past, but nothing like this.  The child has just returned from the doctor and now has a 104.2 degree tempature.  My child is more sick then he has ever been in his life and I am extremely upset that the media representation of this vacine does everything to insure the public of it's safety and nothing to report that there is a chance (however slight) that an adverse reaction could include full blown Flu.  I am also extremely concerned for my childs saftey in the immediate since, as well as longer term issues.  We will now be returning to the emergency room for the second time to try and obtain some relief.
Accidentally gave an 11 year old patient an Adacel dose on 01-Sep-2021 that expired on 15-Aug-2021 with no reported adverse event; Initial information received on 02-Sep-2021 regarding an unsolicited valid non-serious case received from a physician.  This case involves an 11 year old male patient for who accidentally gave an DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] dose on 01-Sep-2021 that expired on 15-aug-2021 [expired product administered].  The patient past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA); and HPV VACCINE (HPV VACCINE).  On 01-Sep-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot C5655AA and expiry date: 15-Aug-2021] via an intramuscular route in the right arm.  It was a case of actual medication error due to expired product administered [Latency: on the same day].  Details of laboratory data not reported.   It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This case was reported by a consumer and described the occurrence of chills in a 64-year-old female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced chills and tremor. On an unknown date, the outcome of the chills and tremor were unknown. It was unknown if the reporter considered the chills and tremor to be related to SHINGRIX. Additional details were provided as follows: The patient was the reporter's mother. The patient after receiving SHINGRIX got the chills or shakes later that evening of vaccination.
Narrative: COVID infection following COVID vaccine series 12/22/2020, Pfizer, dose #1 01/14/2021, Pfizer, dose #2 08/18 pt cc: exposure: unknown 08/18 COVID swab, result: detected 08/18 CXR impression: 1 portable AP view of the chest.No significant change. No coalescent lung consolidation. No pneumothorax. No pleural effusion. Cardiac silhouette within normal limits. No acute osseous abnormality seen. Clear lungs. 08/25 pt admit to ED cc: Decraesed O2 saturation, dx: COVID pneumonia LOS: 9 days 08/25 lactic acid result: 1.23 08/25 procalcitonin result: <0.05 08/25 PT/INR 18.3/ 1.63 08/25 DDIMER result: 0.28 8/25 BNP 168.7 08/25 ABG i-pH 7.52, iPCO2 30.7, i-PO2 68 - HCO3 24.9 08/25 SARS-COV-2 IGG result: 0.01 08/25 CXR impression: 1. Patchy bilateral lung opacities are likely related to underlying viral infection, mildly increased since August 21, 2021. 2. No effusion. No pneumothorax. 08/26 FIBRINOGEN result: 399 08/26 DDIMER result: 0.40 08/26 ESR result: 26 08/27 FIBRINOGEN result: 331 08/27 DDIMER result: 0.28 08/27 ESR result: 12 08/27 DDIMER result: 0.26 08/28 FIBRINOGEN result: 253 08/28 DDIMER result: 0.50 08/28 ESR 8 08/29 DDIMER result: 1.25 08/30 DDIMER result: 1.97 08/31 FIBRINOGEN result: 172 08/31 DDIMER result: 1.75 08/31 ESR result: <1 09/01 FIBRINOGEN result: 180 09/01 DDIMER result: 1.31 09/01 ESR result: <1 09/02 FIBRINOGEN result: 175 09/02 DDIMER result: 1.00 09/02 ESR <1 09/03 FIBRINOGEN result: 168 09/03 DDIMER result: 0.84 09/03 ESR result: <1 09/03 clinically resolved
Pain; swelling; tingling in arm; warmth; redness. Large red swollen area - size of palm; swelling in hand.
No adverse effects; patient was  vaccinated with improperly stored MMR II; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.   On 16-FEB-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot # R008031 and expiration date 18-MAR-2020 for prophylaxis (dosage schedule, route, and anatomical location were not reported). Other suspect therapy was sterile diluent for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). The administered dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) experienced a temperature excursion above 9 degrees Celsius (8.59 C) for 15 minutes, and for sterile diluent experienced a temperature excursion above  1.18 degrees Celsius for 33 hours, as recorded by a data logger.There was no previous temperature excursion. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA001733:
Rash on top of hands about 2 weeks after the 1st vaccination. The rash does not itch or burn, but the skin is extremely dry compared to the rest of my hands. The rash is a brighter color red and more noticeable in the evening. The skin is also very sensitive in hot water.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 20-AUG-2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2015, the patient was treated at a medical center for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Initial and follow-up info has been received from a nurse via a company representative concerning a 12 month old male pt with a history of an ear infection 3 weeks ago and unknown allergies who on 5/24/05, at approximately 16:00, was vaccinated, SC, in the right arm with a 1st dose of MMRII (lot 645584/0850P). Secondary suspect concomitant vaccination included a 1st dose of varicella virus vaccine live (lot 649269/0986P), also given, SC, in the left arm and a fourth dose of Prevnar, given IM, in the right thigh on 5/24/05. Other concomitant vaccination on the same day included a 4th dose of Hib, given, IM, in the left thigh. It was reported that on 5/26/05, the pt developed a few papules on the arm, puffiness under the eyes and on the dorsal hands and feet and also irritability. On 5/26/05, at 07:36 AM, a call was made to the doctor office to report that the pt had a rash with bumps on face, right arm and right leg (also reported "few small papules on left arm"); small bumps; not red, with mild swelling, decreased activity that day. Gave ibuprofen (Motrin) earlier. was fussy. It was also reported that the pt had an ear infection 2 weeks and was on amoxicillin (unspecified). The pt was able to move extremities and they were not hot or red. The nurse indicated that the pt could have a "possible hypersensitivity to MMRII. The nurse also reported that the pt was treated with Benadryl and the experience was not considered serious. Other advice given included to give the pt Tylenol or Motrin; as needed, oatmeal/baking soda bath as needed, fluids and call the office it need additional advice, subsequently, the pt recovered on an unspecified date. There was no product quality complaint involved. Additional information is not expected.
Moderna Omicron vaccine was administered Friday 9-23-22.  This morning, 9-25-22, I have a bright red rash across the back of my neck, which is now spreading down to my chest, over my right shoulder. I took 40mg Prednisone and Claritin for it this morning. The rash later got more red and started to spread. I then took 25mg of Benadryl. I did not go to the hospital because I already had the same medications that they would have used. No other symptoms other than flu-like symptoms for the first 24 hours after the vaccine. If it's not better by tomorrow, I will go to the ER.