chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 03-MAR-2012 at 11:30 ZOSTAVAX (Lot # 672476/1605AA) was exposed to -12 degrees C for an estimated total time out of range of 4 hours.  on 14-MAR-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 672476/1605AA, expiration date 13-JAN-2013) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Fluctuating fever high 104.00 to Low 100.4; muscle aches; chills; headache; lethargy
I did not have an adverse reaction to the vaccine.  I began not feeling 02/17/2023 with a cough and fatigue. I was diagnosed with bacterial pneumonia on 02/19/2023. My doctor put me on an antibiotic for a week and I started feeling better. As of today, I am feeling better with no other symptoms.
Patient received a vaccine beyond its use date.  The Janssen vaccine was drawn into syringes at 0811 on 6/18/21 and left at room temperature. The patient received this vaccine at 1142. Based on the Janssen package insert, the vaccine is only viable for 2 hours at room temperature.
Urinary Tract Infection came on suddenly 5 days after receiving the vaccine; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 25Apr2021 08:30 (at the age of 63-year-old) as dose 1, single for COVID-19 immunisation. Medical history included allergy to sulfa. Concomitant medication(s) included betacarotene, bioflavonoids nos, biotin, calcium ascorbate, calcium pantothenate, calcium phosphate, choline bitartrate, chromic chloride, colecalciferol, copper sulfate, cyanocobalamin, folic acid, hesperidin, inositol, iron amino acid chelate, lycopene, lysine hydrochloride, magnesium oxide, manganese sulfate, molybdenum trioxide, nicotinamide, phytomenadione, potassium iodide, potassium sulfate, pyridoxine hydrochloride, retinol acetate, riboflavin, selenomethionine, silicon dioxide, colloidal, sodium borate decahydrate, thiamine mononitrate, tocopheryl acid succinate, ubidecarenone, zinc oxide (MULTIVITAMIN & MINERAL) taken for an unspecified indication, start and stop date were not reported. Patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination included multivitamin. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient reported that urinary tract infection came on suddenly 5 days after receiving the vaccine on 30Apr2021 03:30. This was very unusual as she had not had a UTI in 10 or 15 years (estimated). Seriousness of the events was reported as non-serious. Hospitalization prolonged was reported as no. The adverse event resulted in doctor or other healthcare professional office/clinic visit and doctor prescribed antibiotic for the event. The outcome of event was recovered on an unspecified date of 2021.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Information has been received from a field consultant from an unspecified doctors office concerning a 12 month old male patient who on approximately 29-NOV-2010 was vaccinated with a first 0.5ml dose of MMR II (Lot# not reported), IM. The field consultant stated that a patient experienced a reaction to MMR II therapy. Allergy test was performed with no results provided. The field consultant also stated that they did not specify what the reaction was. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. No further information is available.
severe malaise; immune-related hypophysitis; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 66 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "mRCC" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for COVID-19 immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "severe malaise"; LYMPHOCYTIC HYPOPHYSITIS (non-serious), outcome "unknown", described as "immune-related hypophysitis". Relevant laboratory tests and procedures are available in the appropriate section.   Additional information: Patient receiving pembrolizumab/axitinib for mRCC since 12Feb2021and with no major side effects, received a Pfizer booster shot and within 24 hours experienced severe malaise and immune-related hypophysitis, diagnosed by MRI on 18Sep. Since then, she has experienced decreased response to pembrolizumab/axitinib, with plans to change therapy.  The lot number for bnt162b2 was not provided and will be requested during follow up.
The area around the injection site became swollen, itchy and very sore for 3 days.
Head ache, arm was sore and felt fatigue the first day, March 9, did not feel had a COVID test prior to second dose and it was negative. When on second dose on March 12, 2021 second dose got really sick fever, breathing issues, had congestion and head aches and was in bed for a few days. Had to get pregnazone and ex-rays show phnemonia and was having issues Cardiovascular and still having appointment. Two months of having issues with breathing and activation of Asthma. hands for rash, and swelling and Fatigue.
Vaccine given 9-15-15 AM. Arm very sore that night, not able to sleep. Nausea 9-16-15. Reports continued (n/v) nausea on 9-17-15 and also had decreased fetal movement. Was evaluated at labor and delivery for fetal well-being. She had a reactive fetal monitor strep and then discharged.
No sign or symptoms reported; temperature excursion on MMR-11 and Varivax.Both products were given. MMR-11 was stored in recommended range; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-MAR-2021, the patient was vaccinated with dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # T025942, expiration date: 30-JUL-2022, 0.5 milliliter (formulation, route of administration and strength were not reported) for prophylaxis.  On an unknown dates, the doses of the vaccine were exposed to temperature excursion at 5.9 Celsius degrees (C) for 20 minutes. There was no previous temperature excursion reported. The call was not due to digital data logger. No additional adverse event was reported.
Patient states on January 3 she noticed an enlarged lymph node under her right arm, she had received her H1N1 Injection in her right arm , 3 weeks prior. She went to her PMD and the lymph node was removed, she is awaiting biopsy report, initial report stated it was not melanoma. Her PMD had told his patient that the enlarged lymph node was not related to the H1N1 vaccine, patient is awaiting call from oncologist concerning biopsy results.  She states she contacted the H1N1 information line asking about enlarged lymph nodes trying to rule out possible causes for the enlargement. Patient states she did have a viral infection in October 2009, diagnosed by her PMD after she recovered from the illness she received a seasonal flu shot and pneumonia shot in November but she cannot remember the date. She also notes she has developed lesions on both hands that look like shingles. She plans to discuss with her PMD.
Susoected vaccination failure; confirmed I had shingles; had a burning; had a, itchy, rash; had, painful rash; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received original shot when it was available).   On an unknown date, the patient received Shingles vaccine. On 30th May 2021, less than a year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, burning sensation, itchy rash and painful rash. The patient was treated with medication unknown (Cream (Medication Unknown)). On an unknown date, the outcome of the vaccination failure, shingles, burning sensation, itchy rash and painful rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, burning sensation, itchy rash and painful rash to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient received the original shot when it was available. The patient received the new shots in last fall (2020). On this past Sunday, 30th May 2021, the patient had a burning, itchy, painful rash on the lower left quadrant of back. A trip to clinic confirmed shingles. The patient stated shingles were miserable and she was taking the script and using the cream from the doctor. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation for shingles infection and time to event onset was unknown.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information on the patient's pertinent medical history, concurrent conditions, concomitant medications drug reactions or allergies was provided. On 05-OCT-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 injection, lot # M043987, expiry date: 14-OCT-2017 (strength, dose, frequency, route of administration were not reported) for prophylaxis. The temperature excursion and the time frames were unknown by the reporter. No previous temperature excursion was noted, data logger was not involved. No adverse effects reported. Product quality complaint (PQC) was not involved. This is one of 2 reports from the same reporter. Sender's Comments: US-009507513-1710USA013048.
Vaccine administration error.  It is suspected that a 1/2' needle syringe was used for administration instead of a 1" IM needle syringe.
4 hrs after receiving injections pain started in left arm. Pain from neck to hand. Scale 0-10 - Rated 9 in intensity - continued to be in pain for 48 hours. Still has soreness in shoulder to date. Used ice packs PRN 48 hours. Did not contact physician.
About 30 hours after receiving the vaccine, my son took a hot shower. Upon exiting the shower, he was covered in hives (head to toe).   Upon calling the pharmacy I was advised to administer Benadryl and t he n go to the ER (we are away from home and normal pediatrician cannot give consultations due to us being out of state).   By the time we were seen, in the ER, the Benadryl seemed to have nearly wiped out the hives.
Patient states he experienced hives bilaterally on his forearms two weeks after receiving first dose of Pfizer vaccine. Patient states symptoms lasted "a few days" and resolved on their own without intervention. Patient did not seek medical care. Patient received dose #2 of Pfizer on 5/28/2021.
On 06/15/2021 pt. presents to ED with c/o weakness, SOB, cough, increased sputum production, pleuritic pain, and leg edema. Pt. cont. to smoke. Pt. reports having difficulty getting out of her chair at home to go use the restroom. Pt. states that she collapsed in the hallway, a soft fall and was unable to get up. Pt. was able to activate her life-line button for assistance. Pt. was found to have an O2 saturation on RA of 84%. Pt. had IV placed, received an Albuterol HHN UD breathing treatment, a dose of Levofloxacin 500 mg, lab work, EKG and CXR. Pt. was transferred to higher level of care.
This spontaneous report as received from a physician refers to a 14 year old female patient with anxiety, and no known allergies. The patient's medical history included biliary atresia at birth and kasai procedure. On 12-MAY-2014 the patient was vaccinated with the third dose of GARDASIL (lot # H020901, expiration date 05-JUL-2015) (dose and route were not reported). There were no concomitant medications. One week post vaccination, 09-MAY-2014, mother of client called the doctor office stating her daughter was complaining of intermittent abdominal pain, lightheadedness, and dizziness. Physician stated he asked the mother and child to come in for an office visit, but they had not. Patient's mother told the physician that she wanted the Lot number checked for GARDASIL. Physician stated that the patient did not experience any adverse effects after the first of second dose of GARDASIL. The outcome of intermittent abdominal pain and dizziness/lightheadedness was reported as not recovered/not resolved. No treatment was given for the adverse events. No lab diagnostic studies were performed. The relationship between GARDASIL and the events was not reported. Patient's mother called to the doctor office. Additional information has been requested.
Information has been received from the Merck Pregnancy registry via a health professional concerning a 19 year old female with no pertinent past medical history who on 09-MAY-2007 was vaccinated intramuscularly in the right deltoid with a 0.5 ml dose of Gardasil (lot #). On approximately 21-JUN-2007 the patient developed vaginitis and on 21-JUN-2007 treatment with DIFLUCAN was initiated. Subsequently the patient became pregnant. A urine and serum beta-human-chorionic gonadotropin were positive. The patient's last menstrual period was 08-JUL-2007 and the estimated date of delivery was 13-APR-2008. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Pt arm became red swollen & patient developed low grade fever. Arm was very sore day after injection. 2 days from injection pt was seen at UC & given antibiotics for possible infection. Antibiotic was cephalexin for 10 days.
When immunizing at a LTCF there was an employee under age (17 years old) who was vaccinated and the FDA approval is for 18 years old or older.  No adverse effects have been reported from the patient o representative.
Information was received on 28-MAR-2017 from an administrator regarding an approximately 25 year old female. Medical history, concurrent conditions and concomitant medications were not reported. On 24-MAR-2017 the patient received a dose of ZOSTAVAX (lot # M013377 and expiration date 25-MAY-2017) in her right arm, instead of VARIVAX. The administrator did not know why the error happened.  Action taken in not applicable, outcome of events is unknown.  No further information was provided. Additional information has been requested.
I gave 3rd doe to 11 year old. Correct dose, but should have waited for the youth bivalent to be given
This spontaneous report was received from a nurse regarding unknown number of patients with unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients received unknown number of doses of VAQTA lot# M018644 with expiry date: 20-SEP-2017 following temperature excursions to -1 C for 30 minutes and 9C for 13 minutes for prophylaxis (dosing details not reported). There was no previous temperature excursion. The call was due to data logger. No adverse effects were reported in any patients. No product quality complaint was involved. This is one of the several reports due to the same reporter. Additional information has been requested.
2 minutes post Moderna vaccine pt experienced acute onset of palpitations, shakiness, profuse sweating, dizziness/lightheadedness, no chest/throat/lung complaints.  HR 137-150, SpO2 97% room air. in the middle of interview, pt reported sudden onset worsening palpitations, tightness in chest. abnormal lung exam. Epinephrine and Benadryl provided in urgent care, ALS transport called to ER.
i GOT my first shot march 5 2021 and second one 3/26/21/ both in left arm cause day after first shot, i got pain in RIGHT ARM! THEN IT GOT PROGRESSIVELY WORSE SO had 2nd dose in same left arm// now my shoulder arm neck back hurting all on opposite side / sent to orthopedic and he said no surgery needed but Bursa might be involved and he gave me cortisone shot which didn't work at all/ i have been researching and seems some incidents of opposite side effects called brachial neuritis/ i would love to know your thoughts and any suggestions about specialists/ perhaps just coincidence but i had not falls or events to trigger this pain/ mobility is unlimited though certain movements cause me to scream/ i have had falls in past and no diagnosed injuries but undiagnosed arthritis pain during weather etc but nothing like this/ my brother also reporting shoulder problems enough to also go to same orthopedist / we had shots same place around same time thank you for all you are doing/ tomorrow i go to my clinic for physical and see what my nurse practitioner says about it 5/62021 thank you
I full on started a menstrual cycle I believe a few days after injection. I went through all of the normal side effects including vomiting, and went into work three days after said injection. Shortly after, I started spotting, and now I appear to be having my full on period even though I am on birth control. I have also felt very tired, and I ended up sleeping all day today 12/30/2021. I also believe I was constipated for a period of 3-4 days which is unusual for me having a history of Crohn's. I have had a ton of prolonged bowel movements over the past two days. As of tonight, I have now developed the strangest sensation of enhanced hearing of low frequencies. I believe it is only in my right ear, but here is the following description I gave my mother: "idk what is going on, but tonight I have been hearing like, bass sounds over-amplified in my ear? like, walking sounds from upstairs and sometimes vehicles and the music from the bar across the st are abnormally loud. I can hear normal sounds fine enough though? maybe slightly muffled.... my ears do feel "full" though if I focus on it. hopefully it's gone tomorrow but it's fairly jarring to hear sounds that you should not normally be able to hear well heard OVER normal sounds. it's like I have super hearing for sounds no wants wants to hear lol. it would be cool if it was in normal hearing range, like voices, but instead it's like BOOM. someone took a single step nearby." I do not know if this is vax related, but I figured it should be included as it is something that happened shortly after with the constipation and odd super early period. I am hoping it will be gone tomorrow, but I have included it as an adverse event that is currently affecting me as I worry it may be some sort of swelling.
Was okay the day of receiving the vaccination. The next day I woke up at 7am to use the bathroom and I did not turn my head any certain way and my neck locked up to where I couldn't move the pain was so severe. I went to the ED via EMS and was diagnosed with cervical dystonia/ Adult torticollis.  I have degenerative disc disease and do not know if this was related to the vaccine or not. I have never experienced this before and the pain was severe.
patient came to our pharmacy on 5/27/22 and received one monderna booster dose on left arm. It was originally a small dot (pen head size) at the injection site after the vaccination, however, it slowly grows up to 1/4 inch size and the color changed from red to purple then to black, approximately 2 months after the vaccination, patient decided to see the ddermatologist dr, and dr did the biopsy at the tissue and found out it was squamous cell carcinoma level 2 skin cancer. The doctor then did the surgery to remove it and after the recent visit with the doctor, the surgery turns out to be successful.
SM was participating in SPV protocol and was noted to have a low plt ct prior to receipt or SPV on 4/15/08.  Subsequent blood draws indicated thrombocytopenia and anemia as well. Symptoms: Ecchymosis.
Pt recvd flu vax & w/in 48 hrs pt devel baseball-sized induration;
Very painful, raised lump, tender to touch, warm to touch, circular in shape-- 4 inch diameter, severe reaction went away after one week.
Assuming left arm due to records. Forgot to ask wife and didn't answer phone. Severe arm pain 5 days after 2nd Moderna radiating from top of arm to wrist. Seen Family MD and given motrin for 2 to 3 weeks l, also tried a dosepak. Neither were effective. last Wednesday, May 12th was started on gabapentin. Helping a little, still having night sweats. Also saw cardiologist to rule out heart pain...no issues with heart.
Burning feeling in mouth that lasted about 2 hrs. Feeling of throat closing about an hour after shot had mild wheezing, eyes got red & puffy & swollen. Took 50mg BENADRYL - sxs lasted about 4 hrs.
Premature Ventricular Contractions (PVCs) after first dose (4/18/21) that stopped on 5/4/21. Second dose was administered 5/9/21 and PVCs began again 4 days after on 5/3/21. PVCs are still continuing to happen randomly throughout day. Pulse can be felt hitting twice rapidly with a lengthy pause and chest fluttering.
Left arm was swollen; Fever up to 100F; Nausea; Headache; Left arm still in a little pain in the scale from 1 to 10, she has a 3.; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Left arm was swollen), PAIN IN EXTREMITY (Left arm still in a little pain in the scale from 1 to 10, she has a 3.), PYREXIA (Fever up to 100F), NAUSEA (Nausea) and HEADACHE (Headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018BZ01A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 22-Feb-2021. Concomitant products included VITAMINS NOS and CALCIUM for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Left arm still in a little pain in the scale from 1 to 10, she has a 3.). On 26-Mar-2021, the patient experienced PERIPHERAL SWELLING (Left arm was swollen), PYREXIA (Fever up to 100F), NAUSEA (Nausea) and HEADACHE (Headache). On 27-Mar-2021, PERIPHERAL SWELLING (Left arm was swollen), PYREXIA (Fever up to 100F), NAUSEA (Nausea) and HEADACHE (Headache) had resolved. At the time of the report, PAIN IN EXTREMITY (Left arm still in a little pain in the scale from 1 to 10, she has a 3.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, SARS-CoV-2 antibody test: positive. On 26-Mar-2021, Body temperature: 100 f had fever up to 100F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications taken by the patient were not provided. Patient had taken acetaminophen for COVID treatment and had a blue pill like the one for the flue for a week. Treatment activities for event was done with acetaminophen.