chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mother states that 24 hrs after shots were given in L arm (LOT) arm became red, firm and warm, Child complained when are was touched. See by PMD was given tylenol and benadryl. 1/27/03 arm is much better.
This initial spontaneous report was received from a healthcare worker referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. The healthcare worker noted that on unspecified dates, the patients were administered improperly stored PNEUMOVAX 23 injection (dose, route, lot number and expiration date were not provided). No adverse effects were reported. It was unknown if the patients sought medical attention. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
shingles; Subsequent to the ZOSTAVAX inoculation, the pt was treated by a physician at a healthcare center for shingles.; This initial spontaneous report was received from a lawyer regarding a case in litigation involving a male patient (pt) of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in 2013, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not reported) at a pharmacy as prescribed and/or administered by a healthcare provider, for the long-term prevention of shingles and herpes Zoster related conditions. On an unknown date, subsequent to the zoster vaccine live (ZOSTAVAX) inoculation, the pt experienced shingles (herpes zoster). The pt was treated by a physician at a healthcare center due to herpes zoster (vaccination failure). It was reported that the pt would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the herpes zoster and vaccination failure was not reported.   The reporter considered the herpes zoster and vaccination failure to be related to Zoster Vaccine Live (ZOSTAVAX).
Left wrist became very sore and painful; This is a spontaneous report from a contactable consumer, the patient. A 84-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Apr2021 at 11:30(at the age of 84-year-old) as a single dose for COVID-19 immunisation. The patient no medical history. The patient did not take any concomitant medication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01May2021 at 11:30 about 24hours after the vaccination, the patient experienced Left wrist became very sore and painful started. Called for assistance and information but only received message that she was 'next party in queue' for over 45 minutes. The clinical outcome of the event Left wrist became very sore and painful was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
He started having diarrhea the same day as his vaccination. At first, he was going two to four times per day. He hasn't had a fever and has been acting normal. We tried the BRAT diet. I contacted his doctor when I noticed it had been going on for a while. They collected a stool sample. She prescribed fiber gummies for two weeks. There was no improvement. She referred us to a gastroenterologist. We had an appointment a little over two months later. They did blood work and took a different stool culture. They set him up for an endoscopy and a colonoscopy that took place about two months later. Before that appointment, he experienced extreme diarrhea. He was crying and complaining of extreme pain in his stomach. He was also talking non-stop from the time he woke up until almost midnight. He was also prescribed Omeprazole 40mg. They scheduled an appointment for an MRE of his small intestine a little less than two months later.  He was diagnosed with Crohn's Disease. He is still experiencing diarrhea, but he goes once or twice a day now.
The area around and slightly above the injection site was red in color. The area was warm to touch and pruritic. The area was not swollen or raised. The patient presented to the pharmacy where the immunization was delivered approximately 24 hours after the adverse event was first noticed.
I had Moderna vacinne 1/14 , shot #1. First few days had redness on are two places by day five all redness was gone . yesterday ( which was day 10) the redness returned. still two seperate spots and raised "rash " warmer than other areas on arm, no fever or other simptons.This morning the two areas are connected and hot and i can feel that they are there. These have returned larger and now connected ....they were gone for 6 daus.
This is a spontaneous report from a contactable Physician. An 8-month-old female patient of an unspecified ethnicity received second dose of PREVNAR 13 (lot#: S06832, expiry date: 31Aug2018), intramuscularly at left vastus lateralis on 25Oct2017 at 0.5 ml, single for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced minimal fever in Oct2017 and second dose of vaccine was on 25Oct2017. The patient underwent lab tests and procedures which included body temperature: minimal fever in Oct2017. The outcome of the event was unknown.
High fever, chills, body aches, headache, sore arm, swollen arm, red rash on arm,  lasted almost 48 hours. Worse than when I actually had covid in early January 2021.  Arm still swollen and painful.
Maximum temperature 103'F relieved by acetaminophen and ibuprofen. Erythema and edema painful to walk, fussy
within 24 hrs - swelling like a cold sore under lower lip - 3 days - chapped lips- ongoing for a week and diminishing
Severe Dermatographia all over the body. Its started after 2 weeks of vaccination. I have visited my PCP and she said that its very commonly seen in various patients. Its starts always in the evening and I can?t even sleep properly. I have to take allegra every day to sleep.
Night sweats, body aches, nausea, vomiting, diarrhea, loss of taste and smell
every time I got a vaccine or a booster, my PSA readings go up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PROSTATIC SPECIFIC ANTIGEN INCREASED (non-serious), outcome "unknown", described as "every time I got a vaccine or a booster, my PSA readings go up". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller mentioned that he already 2 doses of the Pfizer Covid-19 Vaccine and the booster dose. He took Paxlovid as well. He wanted to know if there is correlations between Paxlovid and Pfizer Covid-19 Vaccine with his PSA increase. Patient read several things saying they've been test and show high PSA levels, He had 2 vaccines and 2 boosters and then the Paxlovid, because he contracted Covid 19, he had a chart showing when I've taken the vaccine and when he got back his PSA readings back and every time he got a vaccine or a booster, his PSA readings go up. He also heard that they go up when you contract Covid 19, but there's no information about Paxlovid because it's so new, but when you have covid 19 and you feel terrible, anything that helps is considered. He wanted to know if the chemical make up of Paxlovid is the same as the booster and the vaccine. He also read in case studies that if you contract covid, that also elevates the PSA, there's a test, 91 people PSA levels went from 1.58 to 4.34 on average, He was wondering if you heard anything about that. He figured you might have heard about it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COULD NOT HOLD IN POOP; CRAMPS IN BUTT MUSCLE; TIRED; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a 39 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe adult Crohn's disease, and other pre-existing medical conditions included: No reported medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported, and dose was not reported, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe adult Crohn's disease. No concomitant medications were reported.  On 03-MAY-2021, the patient had off label use, and inappropriate schedule of vaccine administered. On an unspecified date, the patient experienced could not hold in poop, cramps in butt muscle, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient was recovering from tired, and could not hold in poop, and the outcome of cramps in butt muscle, off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
pt initially reported injection site pain. Patient also of numbness, lightheaded, while in the car, patient had memory loss and blacked out.  While in the car, Patient slid out the side door resulting in two abrasions- one on each knee. he did not fall or hit his head. he takes Zoloft 150mg last dose last night. he reported similar response to blood draws. patient was brought to the medical tent with the following vital signs: BP100/52  PR 59   OXYGEN SAT 98% . When pulse was rechecked it was PR62  OXYGEN SAT 98% Patient knee were bandaged and was encouraged to stay hydrated. Patient left with partner in the stable condition
Initial unsolicited report received from consumer (Patient) on 28 Mar 2018. This case involves 62 years old male patient who was vaccinated with dose of Influenza vaccine (batch number, expiry date, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medication were not reported. On unspecified date post vaccination patient was weak and beats him down and blood glucose increased. On an unspecified date in 2010, patient got his first flu shot in 2010 and since then he got sick with every flu shot. Other laboratory investigation and corrective treatment were not reported. Outcome of events was not reported. List of documents held by sender: none.
2/9 vaccine #1 around 0930.  Around 5pm notice neck was itchy, red and ?hot? feeling.   Over the next few weeks the neck got a more widespread redness, the creases of my elbows became red and itchy then behind my knees became red and itchy.   2/23 I noticed the rash has spread to my truck and was starting to itch on my shins. Called dermatology clinic.   2/24 Derm appt #1- saw the NP. She thought it looked like a viral rash. Started oral steroids 60mg x3 days then tapered down over 10 day period. Ordered Triamcinolone cream for topical treatment and Zyrtec twice a day, 25mg hydroxyzine at night for sleep  3/2- vaccine #2 due... was told to hold off until the rash cleared just to make sure   3/7- itching and redness returned to neck and spread to truck.   3/9- Derm appt #2. Noted the rash had changed in appearance and biopsied arm. Received a steroid shot, Ordered pepcid twice a day, Allegra twice a day.   3/17- severe redness (the most extreme pic), burning and itching. It felt like a terrible sunburn with itchy hives under it. I can?t even begin to describe that pain. Called the Derm clinic. They ordered clobetasol ointment and go see Dr the next day.   3/18- biopsy with no eosinophils and only extreme inflammation. Received a loading dose (2 shots) of dupixent.   3/25- reddness and itching return to neck and shoulders/trunk.   3/26- Called Derm. Ordered a 40mg steroid taper that will last 20 days total.   4/1- Dupixent shot (2mL)   4/6- Appointment with Dr. Ordered Singulair and keep other taking medications. Lab work ordered.
By 1240-1 pm my shoulder started hurting and feeling very painful. By 230 I took pain meds and tried to get relief at 431 on I called 911 because the pain had spread and become so severe and my arm was locked to my side and I was having issues breathing. I was transported to the Er
6 hours after receiving YF vaccine client c/o abdominal pain and was taken to the ER by father who is a physician.  Given Lortab for pain, but no relief and returned again to ER with same c/o.  Telephone call from mother with above information and she stated that they were going to check her liver enzymes at that time.
Fever, night sweat, fatigue, and diarrhea. Feel a little tired, but not extremely tired.
Tinnitus in right ear.  Symptoms began as loud ringing sound and transitioned to random tapping noise that lasted for 48hrs.  Occasional episodes of  tinnitus occurs on a daily basis > 1wk after vaccination.
has had a hard time going to the bathroom.  (Asked what that meant: urination or defecation and he said defecation; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 26Aug2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unknown date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. On an unspecified date in Aug 2021, since the vaccination the patient had a hard time going to the bathroom (defecation). He had only gone twice in the last 5 days. The clinical outcome of the event was unknown.  Information on lot/ batch number has been requested.
shrill cry for 2hr;leg was red, hot to touch, swollen;low grade temp-gave advil, applied cool compresses to leg-lt leg only;
This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well), PAIN IN EXTREMITY (Legs hurt really bad) and PRODUCT DOSE OMISSION ISSUE (61 days post first shot) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. Concurrent medical conditions included Neuropathic pain, Blood pressure and Cholesterol. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (61 days post first shot). On an unknown date, the patient experienced MALAISE (Not feeling well) and PAIN IN EXTREMITY (Legs hurt really bad). At the time of the report, MALAISE (Not feeling well) and PAIN IN EXTREMITY (Legs hurt really bad) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (61 days post first shot) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. In the follow up it t was reported that patients leg pain is not due to the vaccine. Concomitant medication including blood pressure medicine, cholesterol medicine and pain medicine was reported. Treatment using pain killer medicine that the patient  takes every day for pain in the leg (no name specified) was reported. Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Additional Information received and Medical History Neuropathic pain was added. New "event 61 days post first shot" was added.
Pt has stage IV metastatic small cell lung cancer and has been receiving chemotherapy.  He has had increasing shortness of breath, and was exposed to a family member with COVID.
Fever lasting about 15 hours, headache lasting about 24 hours, fatigue, nausea, diarrhea (possibly related to eating too much cabbage soup). All symptoms began about 8-9 hours after vaccination.
Right arm achy and sore Monday and Tuesday, Wednesday has reddened area below injection site which has increased and is traveling down arm. She has not had a fever.
sleepless; soreness; muscular aches; shivering site; This case was reported by a consumer via call center representative and described the occurrence of sleeplessness in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th April 2019, the patient received the 1st dose of Shingrix. On 8th April 2019, less than a day after receiving Shingrix, the patient experienced sleeplessness, injection site pain, muscle pain and shivering. On an unknown date, the outcome of the sleeplessness was unknown and the outcome of the injection site pain, muscle pain and shivering were not recovered/not resolved.   It was unknown if the reporter considered the sleeplessness, injection site pain, muscle pain and shivering to be related to Shingrix.  Additional details were provided as follows: The patient got the a dose of Shingrix injection. The patient experienced sleepless night with shivering, site soreness and muscular aches. The reporter wanted what to do about the events.
pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant) in a 39-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and UNK) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included IRON FERROUS SULFATE and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 28-May-2021. On 21-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnant). On 21-Mar-2021, EXPOSURE DURING PREGNANCY (pregnant) had resolved. Not Provided          No treatment information was provided by the reporter.
LEFT ARM SWOLLEN, REDDNESS AND COPLAINS OF PAIN.  PATIENT WAS TREATED WITH ANTIBIOTICS CLINDAYCIN 150 MG.
FEELIGN COLD; CHILLS; Fatigue; Muscle aches; Dose received: 3; This is a spontaneous report from a non-contactable pharmacist. The reporter is the patient.   A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date an unknown date in 2021 (Lot number: unknown) at the age of 36 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: unknown, Route of Administration: Unspecified, Anatomical Location: Unspecified), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: unknown, Route of Administration: Unspecified, Anatomical Location: Unspecified), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset an unknown date in 2021, outcome "unknown", described as "Dose received: 3"; FEELING COLD (non-serious) with onset 09Dec2021, outcome "not recovered", described as "FEELIGN COLD"; CHILLS (non-serious) with onset 09Dec2021, outcome "not recovered", described as "CHILLS"; FATIGUE (non-serious) with onset 09Dec2021, outcome "not recovered", described as "Fatigue"; MYALGIA (non-serious) with onset 09Dec2021, outcome "not recovered", described as "Muscle aches". Therapeutic measures were taken as a result of feeling cold, chills, fatigue and myalgia.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events and included treatment with OTC products- dayquill. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt received the Pfizer COVID vaccine (lot #EW0150, exp 07/2021) at 1030. At 1034, patient was sitting in chair in the observation area when she informed to EMT  that she felt dizzy. EMT  reported to PHN  who came over to assess the patient. Patient reported feeling dizzy, stating she was short of breath and felt like she was going to faint. PHN  and EMT  helped the patient lie down on the floor. Vital signs: O2 100%, pulse 79, blood pressure 116/90, respiratory rate 14. At 1037, PHN  called 911. Patient reported no known allergies. Medical condition includes asthma, last asthma attack was 1 year ago. Medications include Brio inhaler, albuterol rescue inhaler. Per patient request, EMT Noor attempted to find patient's rescue inhaler in her purse but was not able to. At 1042 vital signs: blood pressure 110/80, O2 96&, pulse 82, respirations 18. Patient reported her symptoms had resolved but both her hands were starting to feel numb. At 1045 EMS assumed care. At 1051, patient refused transport to the hospital. PHN  advised patient to follow up with provider and call 911 if symptoms of severe allergic reaction return. Patient called family member to drive her home. At 1112, patient left walking with steady gait.
Patient received a mixed series of COVID-19 mRNA vaccine.  On 5/5/21 he received a dose of Moderna COVID-19 vaccine.  On 6/3/21 he inadvertently received a dose of Pfizer COVID-19 vaccine for his second dose.
The vaccine was administered after the "Beyond use date".  It was given on day 74 of refrigeration and it should not be used after 70 days of refrigeration.
Woke up and started vomiting around 11:30 that night(2/5.)  This lasted approximately 1-2 hours.  Was unable to eat anything  until late afternoon on Sat. the 6th.  Had a bad headache throughout and bad soreness at the injection site.  Still have headache (approx. 5pm on Mon. 2/8) but soreness at injection site has almost disappeared.  I do not have a primary physician so have not called anyone. Am now taking Advil for headache which helps but it returns if I stop.
Body aches, SOB, Chills, swelling at injection site all about 8 hours after injection.
Started feeling under on 7/24/2022. Positive for Covid 19 on 7/25/2022. Fever, chills, congestion, runny nose, sore throat, muscle aches and fatigue.
3/17/07 Mom took child to Dr. Child had temp of 103, face red, throwing up formula> lumps, diarrhea. Dr sent to ER to get fever down and check infant out. ER ordered-off formula start Pedialyte and flat sprites. Had redness at injection sites. 3/20/07-now again taking formula-reduced amount. Fever dropped on 3/19/07. No fever now.