chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning an approximately 28-year-old female with no medical history or allergies who as a child was vaccinated SC with the first dose of MMR. There was no concomitant therapy. Titers were listed as equivocal. In approximately 2003, the patient was vaccinated SC with a booster dose of MMR. There was no concomitant therapy. In 2008 the patient's titers were also listed as equivocal. At the time of this report, the outcome was unknown. Additional information has been requested.
Headache, extreme fatigue, low-grade fever (1 day), body/muscle aches Vaccine on Friday.  Stayed in bed all day Saturday.  Sunday felt a little better but still very fatigued that prevented me from doing anything.  Monday still fatigued and stayed home from work. As of late Monday morning, feeling a little better but still not well enough to resume normal activities. Hoping Tuesday am better.
Pediatric vaccine was diluted with 0.13 ml instead of 1.3 ml so the patient got a more concentrated dosage.  No adverse effects were reported.
Ten minutes after receiving Imm pt. c/o not feeling good. Pt told to sit down, few seconds later pt. was unresponsive in chair lasting about a second responded to stimuli (shaking & calling name). Pt responded by asking what had happen. Left on own with parent 20 mins later.
Gardasil #2 given 4/11/08 right deltoid.  Acute pain right deltoid - seen 4/18.  Doing light weight training.  Pain in deltoid only.
Hospitalized on  5-23-22 for COVID 19 and died on 7-4-22
I have had a fibroadenoma in my right breast since  I was 18 years old  After the Covid shot I found it to be growing and changing in size  I completed a herbal cleanse in May 2021 and the fibroadenoma decreased in size  After the cleanse a few months later the fibroadenoma began changing and growing again  At this point I went for a mammogram and ultrasound followed by a  biopsy  I was diagnosed with breast cancer on November 23rd 2021
PATIENT GOT FLUZONE HD AND PNEUMOVAX 23 ON RIGHT ARM ON 10/14, THAT AFTERNOON PATIENT STATED SHE HAD UPPER ARM SWELLING AND IT HURT, HAD CHILLS ON THAT MONDAY AND TUESDAY, AND ON TUESDAY AREA WAS PURPLE/RED, CURRENTLY SOME ITCHINESS IN THE AREA, AND STATED THAT AREA THAT HURT EXTENDED INTO HER CHEST FROM THAT RIGHT ARM BUT THAT SHE WAS DOING BETTER ON THE WEDNESDAY.  SINCE PATIENT STATED SYMPTOMS WERE GETTING BETTER ADVISED PATIENT TO MONITOR, AND CONTACT PHARMACY. AND/OR MD, TAKE TYLENOL, BENADRYL  AND APPLY COLD PACK IF NECESSARY.
This case was reported by a consumer via call center representative and described the occurrence of headache in a patient who received SHINGRIX for prophylaxis. On 29th November 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced headache, injection site pain, loss of energy and sleepiness. On an unknown date, the outcome of the headache, injection site pain, loss of energy and sleepiness were unknown. It was unknown if the reporter considered the headache, injection site pain, loss of energy and sleepiness to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX a day before the date of reporting and experienced severe headache, sore at location site. The patient had slept all day and had no energy.
This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 26-SEP-2016 the patient was inadvertently vaccinated with PROQUAD (lot # M010478 and expiry date 01-SEP-2017) and a dose of VARIVAX (M023379 and expiry date 11-MAY-2018) (dosing regimen was not known for both vaccines). No adverse effect were reported. No product quality complaint (PQC) filed. Additional information has been requested.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. Since 04-NOV-2015, on unspecified dates, the patients were vaccinated with unspecified dose of improperly stored VAQTA (lot # was reported as L031196, expiry date 05-FEB-2017) (strength, dose and route were unspecified). No adverse effects had been reported. This is one of several reports received from the same source. Additional information has been requested.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-Jul-2022; No adverse event; Patient administered the vaccine after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 54-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-Jul-2022).    No concomitant product use was reported.  Patient had received half dose.  Vial did not undergo any temperature excursions.  No treatment information was provided.
Pt began with left eye, arm, and leg twitching, followed by tongue fasciculations, trouble breathing & wheezing that lasted 10-15 minutes  Per mother patient became tired after the event & was subsequently brought to ED by ambulance.  Peripheral IV; @9:50am seizure like activity, lt eye twitch, followed by fist clenching - lasted 10-15 min. Pt was apneic- bagging & 2 doses ativan given Treated further with keppra, Neurology consulted & pt. observed. No further episodes, d/c home 1/28/21 on keppra. Neuro f/u in 2 mos. PCP 01/29/2021
60 y/o female with baseline chronic urticaria (stress is a trigger) who was late on XOLAIR injections (to control her urticaria) and she was having minor urticaria flare. Pt received XOLAIR dose in clinic and after wait time, pt received her 2nd SHINGRIX vaccine. For her first SHINGRIX pt developed flu like symptoms and myalgia. This second time, pt had flu like symptoms, myalgia and worsening/full body urticaria. Pt will be treating with increasing ZYRTEC to control her sx. Suspect that pt is a strong responder to vaccines and this 2nd SHINGRIX dose was a stressful event for her body, resulting in worsening of chronic urticaria condition.
Patient was given pneumococcal vaccine 11/22/02. Patient stated after leaving the office she experieince a red itchy rash and bumps. Area affected was chest, back and both arms. Patient did not report this adverse reaction until a month later. Patient felling better. Rash is clearing.
On 4/28 had fever of 100.7,  joint pain, tired and sick. On 5/3 began having a reaction on chest, chin line, eyes, and lips. I have itchy bumps on these areas of my body and some sores on my chest. My eyes are itchy and have dry patches around the eye. They are also red and swollen.
Took benadryl for injection site inflammation; Swelling; Itching; heat at injection site occurring over the week post-injection; Knot; diarrhea which is like I had when I had Covid last fall.; This is a spontaneous report from a non-contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL3249), on 01Feb2021 at 15:00 (at the age of 66-years-old) at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at Doctor's office/urgent care. No other vaccine was given within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Other medical history included irritable bowel syndrome (IBS), and high blood pressure. Concomitant medications included linsinopril, estradiol, naproxen sodium (ALEVE), tocopherol (VIT. E), colecalciferol (VITAMIN D), multivitamin. On 03Feb2021 the patient experienced swelling, itching, knot, heat at injection site occurring over the week post-injection, injection site inflammation, as well as diarrhea which is like she had when had Covid last fall. The events resulted in emergency room/department or urgent care. As treatment received it was reported the patient took Benadryl for injection site inflammation. The events were resolving. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Pt came in for her yearly well child. Pt was due for her second HPV. Pt's mom said pt had a reaction to the previous shot - severe headaches, swelling and redness in the arm. "Mom said she laid on the couch x 5 days". Treated with rest and TYLENOL. Symptoms subsided (mom didn't think to call at the time). (Mom refused the 2nd HPV dose).
I had chest congestion, productive cough, fatigue, and a fever. I did not test positive for COVID-19, and I took several tests. I was not prescribed medications. I am feeling better now, but I am still dealing with a cough.
Hospitalization: 3/31/2023 - 4/3/2023 (3 days) Presentation to the ED: generalized abdominal tenderness, explosive diarrhea for 2-3 weeks. COVID + date: 4/1/23 Treatment: PREDNISONE & ABX Discharge to: HOME.  011L20A 1/4/2021 012M20A 2/1/2021 037F21A 9/10/2021 059M21A 5/21/2022 Moderna BiValent 015H22A 11/4/2022
Swollen and very sore lymph nodes in left axilla starting the day after the injection.  It has only been 2 days so I do not know how long this will last.  You can feel the nodes are swollen and my son is complaining that it is very sore especially when he is lifting or using the arm.
Left arm I could not lift, rotate internally or externally, or even have a position without undue pain. High fever 101.7. Bad bad headache. Terrible nausea. Unbelievable fatigue. I could barely sip water or eat ice chips. I took several rounds of tylenol. Zofram twice. Phenergen suppository. Finally, 20 hours after the shot, I was able to eat a piece of toast and take Advil Allergy Sinus and 600 more mg of Advil. That broke the fever. Then I was able to eat a little food at 24 hours later. I was worried about fluid intake and really worked hard to get in what I could without starting to vomit. I did not want to go to a hospital. Now, at about 40 hours post shot, I'm able to eat food, not take any Advil, and move around a little bit. My left arm is still very limited. I'm a physical therapist and am concerned about work tomorrow. My second shot I had a milder version of what I experienced after the third shot. After the second shot I had much of what I had yesterday, but to a lesser degree of severity. If I were to rate the experiences on a pain scale, after the second shot I was 6-7/10. Yesterday and the evening of the shot I was at 9-9.5/10. I considered going to the hospital for fluids. But, with the hospitals full of COVID and the ERs overrun, I didn't want to go. I simply kept eating ice chips each time I woke up. Even if I woke up for seconds.
Redness on left arm, 7.5 cm slightly warm circular nodule, no streaking, no pus, little itching.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 08-FEB-2012, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 15-DEC-2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Pt. was mistakenly given a PEDS dose of Moderna (0.25mL) instead of a 0.5mL adult dose.
pain at injection site for ~ 2 days after then 4 days after injection a 2 in diameter raise red hot bump appeared a few inches down the arm from injection site.
pt recv vax 13FEB96 & w/in 1-2 of vax pt exp fatigue/weakness, h/a, pharyngitis, upper resp infect, diminished appetite, influenza, cough, vertigo, dizziness, paresthesia, visual disturbance, tinnitus, tachycardia, dyspnea, arthritis;
Information has been received from MA and Physician concerning a retired 69 year old white female with a history of hypertension, osteoporosis, fibromyalgia, anxiety and allergies to sulfa, Daypro and bee stings who on 11/17/03 was vaccinated in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (Lot # 647657/0947N). Concomitant therapy included "premorin", acetaminophen (+) propoxyphene napsylate (Darvocet-N), risedronate sodium (Actonel), hydrochlorothiazide, doxazosin mesylate (Cardura) and "torprol". Subsequently, the pt experienced swelling, redness and erythema. The reporter was "concerned because the swelling practically encompassed the entire arm length." As of 11/21/03, the swelling was still there. Unspecified medical attention was sought and no treatment was required. There was no product quality complaint involved. Follow up indicated that on 11/17/03 the pt developed an inflamed, swollen and tender left upper arm, an 11x18cm area, which was almost around the arm. The pt was seen by a physician. There were no lab or diagnostic tests performed. On 11/26/03 the pt recovered. No further information is available.
This case was reported by a pharmacist via sales rep and described the occurrence of gastrointestinal disorder in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced gastrointestinal disorder and pain in arm. On an unknown date, the outcome of the gastrointestinal disorder and pain in arm were unknown. It was unknown if the reporter considered the gastrointestinal disorder and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient's age group was taken based on the product indication as no other patient details were provided. The reporter mentioned that, one female patient experienced gastrointestinal issues for 3 days after the second dose, but she also mentioned that this same thing could happen when patients experience shingles so she was not concerned. The patient also reported that her arm did hurt with the 2nd injection. This case has been linked with case US2018GSK152348 reported by the same reporter.
Initial information received on 08-Jan-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case is linked to case ID 2019SA010539 (same reporter, patient received TUBERSOL). This case involves a 13 years old male patient who was administered MENACTRA, (Single dose prefilled syringe) lot U6152A and Exp. Date 20-Mar-2019 via unknown route in the left deltoid on 07-Jan-2019. The patient's medical history and concomitant medications were not reported. No concomitant vaccines were given. It was as actual medication error case due to incorrect product storage. It was reported that reporter called about stability of MENACTRA, TENIVAC (Td) and TUBERSOL MDV (1 each opened/unopened) and FLUZONE 0.5 ml single dose. Temp 33.6 and below 32 F from 1100 to 1230 reaching a min of 26.8 F for 1.5 hours. 2 people received vaccines with medication that was outside of the recommend stability standard guideline: one person received a TB test and one received MENACTRA. No adverse reaction reported. 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 Directive and Module VI of the Practices. 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. List of documents held by sender: none.
My first period since having the 2nd shot was very heavy.  I usually bleed very lightly, and I have consistently since having the Mirena IUD inserted 3 years ago.  This past period (began 4/21 and still bleeding) started last Wednesday and was very heavy from the start. I bled through 3 normal tampons in the span of an hour; I even bled through onto my clothes.  This never happens for me. I was also passing large clots, some of them were around the diameter of a golf ball.  I also had stronger cramps than normal, and when I would cramp I would feel nauseous, which is also different.
Patient received 2 IM vaccinations. She went to sit after being vaccinated for observation. About 20 seconds after sitting she fainted and fell from chair. She did not seem to hit head but she was monitored for any signs and symptoms of a concussion. Patient claims that she had a long lecture and had not eaten for 4 hours. She also stated that she felt nauseated after vaccination but did not mention this to immunizer. She was observed for over 30 minutes and was given a banana and some fruit. She felt better within 30 seconds of the fainting episode and did not show any symptoms of a concussion. She then went to health services at the school to get checked up for safety.
This child had a fever of 105 on day 5 after vaccine, both associated with respiratory illness / concomitant clinical diagnosis pneumonia day 5.
Provider discharge summary "65 year old female with history of intellectual disability, mood changes, anxiety, hyperlipidemia and GERD presents from her home due to cough and not eating right per staff. She is chronically non-verbal at baseline. In the ED, she was febrile, hypoxic on room air and tachypneic. Labs notable for hypernatremia with a free water deficit of 2.5L, hypokalemia and hypomagnesemia. She subsequently tested positive for COVID-19 and was started on decadron and remdesvir. D-dimer minimally elevated and continued to trend downward. No CT Chest imaging was performed. Patient was started on D5W maintenance fluids with correction of sodium. Concern for need of increased fluid intake at prior home living arrangement, so her case was discussed with staff and patient's PCP regarding need for increased hydration and nutritional intake. She is to obtain BMP in one week with results sent to PCP for further resolution of hypernatremia. Labs indicative of iron deficiency anemia repleted with iron therapy during this inpatient stay. She will continue iron supplementation and complete an additional 5 days of decadron on discharge to her home. She is medically stable for discharge home on January 21, 2022."
Syringe leaking; Not knowing if the full dose was given; A spontaneous report was received from a consumer concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and there is an issue with the syringe like leakage and not knowing if the full dose was given.   The patient's medical history was not provided by the reporter. No Concomitant medications were reported.  On an unknown date, the patient received their one of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.    The reporter reports the incident that there is an issue like leakage and not knowing if the full dose was given. They are also unspecified that it is Moderna COVID vaccine or a Pfizer product.  The reporter works at a medical distributor for Moderna vaccine. They have also contracts for convenient kits that go out with the customer for use with the Moderna and the Pfizer vaccines. The convenient kits are disposable to administer the vaccines. The complaints are coming that the syringe bent or one of the retractable syringes malfunctioned or there was leakage. She doesn't have any specifics.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events, syringe like leakage and not knowing if the full dose was given was resolved on an unknown date.; Reporter's Comments: This report refers to a case of accidental underdose and device connection issue for mRNA-1273 (lot # unknown) with no associated AEs reported.
SHAKING; OVERBEARING HEAT; CHILLS VERY BAD FOR A FEW HOURS AT NIGHT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced shaking, overbearing heat, and chills very bad for a few hours at night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills very bad for a few hours at night, and the outcome of shaking and overbearing heat was not reported. This report was non-serious.
Fever of 104 for about 1.5 hours, then went down to 102.  Was ok the next day except for being tired
Random hives that move around the body, intense itch and feeling of hot patches. Palms were painful, skin raised in welts
Tender, erythema and hard at  (R) arm injection site. Ice and antihistamine ordered.