chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of VARIVAX (Lot #: N021315, Exp Date: 07-AUG-2019) (Lot#: N029632, Exp Date: 23-OCT-2019) or (Lot#: N030571, Exp Date: 31-OCT-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK) (no more information was provided). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1805USA009899: Original Case: 1805USA006787; US-009507513-1805USA009900: Original Case: 1805USA006787; US-009507513-1805USA009901: Original Case: 1805USA006787; US-009507513-1805USA009902: Original Case: 1805USA006787; US-009507513-1805USA009903: Original Case: 1805USA006787; US-009507513-1805USA009904: Original Case: 1805USA006787; US-009507513-1805USA009905: Original Case: 1805USA006787; US-009507513-1805USA009906: Original Case: 1805USA006787; US-009507513-1805USA009907: Original Case: 1805USA006787; US-009507513-1805USA009908: Original Case: 1805USA006787; US-009507513-1805USA009909: Original Case: 1805USA006787; US-009507513-1805USA009910: Original Case: 1805USA006787; US-009507513-1805USA009911: Original Case: 1805USA006787; US-009507513-1805USA009912: Original Case: 1805USA006787; US-009507513-1805USA009913: Original Case: 1805USA006787; US-009507513-1805USA009914: Original Case: 1805USA006787; US-009507513-1805USA009915: Original Case: 1805USA006787; US-009507513-1805USA009916: Original Case: 1805USA006787; US-009507513-1805USA009917: Original Case: 1805USA006787; S-009507513-1805USA009918: Original Case: 1805USA006787; US-009507513-1805USA009919: Original Case: 1805USA006787; US-009507513-1805USA009920: Original Case: 1805USA006787; US-009507513-1805USA009921: Original Case: 1805USA006787; US-009507513-1805USA009922: Original Case: 1805USA006787; US-009507513-1805USA009923: Original Case: 1805USA006787; US-009507513-1805USA009924: Original Case: 1805USA006787; US-009507513-1805USA009925: Original Case: 1805USA006787; US-009507513-1805USA009926: Original Case: 1805USA006787; US-009507513-1805USA006787: Original Case: 1805USA006787; US-009507513-1805USA009928: Original Case: 1805USA006787; US-009507513-1805USA009929: Original Case: 1805USA006787; US-009507513-1805USA009930: Original Case : 1805USA006787; US-009507513-1805USA009931: Original Case: 1805USA006787; US-009507513-1805USA009932: Original Case: 1805USA006787; US-009507513-1805USA009933.
I had a slight tightness of heart; Nausea; This is a spontaneous report from a contactable Other-Health Care Professional. A 39-years-old female patient (who was not pregnant at the time of vaccination), received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, on 06Jan2021 (Batch/Lot number was not reported), as SINGLE DOSE for covid-19 immunisation. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive Other medications in two weeks of vaccination. Medical history included, the patient previously took doxycycline and caffeine, experienced drug hypersensitivity and allergy to raw tomatoes and peach peels. There were no concomitant medications. In Jan2021, the patient experienced a slight tightness of heart (chest discomfort) and nausea. The patient underwent lab tests and procedures which included COVID-19 Nasal Swab test and COVID PCR both were negative on 10Feb2021. The outcome of the events were recovered on an unspecified date in Jan2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pain in the right eye part; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2), administration date 27Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EYE PAIN (non-serious) with onset 27Mar2021, outcome "unknown", described as "pain in the right eye part". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
4 days from injection, pain arose at left clavicle. 5 days after injection, enlarged lymph node was visible above left clavicle, causing acute pain when patient turned head or lifted left arm. Patient went to urgent care on day 5 for evaluation and was released (details under Item 19). 6 days after injection, lymph node was larger and harder. 8 days after injection, lymph node began to get smaller and mobility without pain returned to patient. 10 days after injection, patient returned to normal level of physical activity with only minor discomfort. 12 days after injection, patient followed up with primary care physician.
pt first noticed one tender, enlarged lt mid-supraclavicular lymph node 1 day p/vax;node evaluated on 19OCT95 & was found to be slightly tender, mobile & approx 1-2cm in diameter;24OCT95 above node was no longer palpable;
Patient described severe pain in right arm, some swelling at admin site. The pain after a day travelled towards hip/legs area. Patient called in to inform us of reaction on 10/12/16. MD was informed and patient was seen. They feel reaction may be NOT related to vaccination. However, still can't rule out possibility. Patient doing better.
Initial report was received on 19 October 2011 from a consumer who is also the patient's parent. A seven year-old male patient (who was three-years old at the time of vaccination) had received in 2007 FLUZONE, lot number UT2459PA (route, site and exact date of administration not reported) and an unspecified amount of time following vaccination, experienced a "blank stare" in his eyes, his speech regressed and he was diagnosed with Autism. According to the parent, prior to vaccination the patient had been speaking in three word sentences and following vaccination he did not speak. No further information was available at the time of vaccination. The patient's outcome was not recovered. Documents held by sender: none.
Initial tickle in the throat. Took Benadryl approimately 1 1/2 hour later. By the next morning client noticed lips, nose, and eyes swollen and short of breath.  Treated by EMTs shortly after.
After receiving his dose of the janssen covid 19 vaccine, the patient took an unused/prefilled syringe back to his room and gave himself a second dose of the janssen covid 19 vaccine.
Stabbing joint pain at top of femur that radiates around to top of buttocks and down outer sides of thighs on both sides, also same type of joint pain at tops of both soldiers radiating around to upper back.  Diagnosed as rheumatoid arthritis and fibromyalgia.
Pain in (L) upper arm first day.  Hurt to raise my arm higher that my shoulder.  Still mildly sore to the touch today.  Last weekend my arm started to itch at the injection site and now there is a red circle around it.
On Friday night  1/22 ( one week post vaccine) I developed hives and a rash on my neck, by Saturday the hives and rash spread to my arms and back and by Sunday I was covered in hives to my toes.  I took Benadryl but nothing seemed to help so I contacted my doctor immediately on Monday to schedule and appointment. I have never experienced an allergic reaction to anything like this before and nothing has changed within my diet and environmental factors (such as soaps or detergents)  other than taking the vaccine. I was prescribed methyl prednisone (steroid taken orally) and  hydoxyzine (an oral antihistamine) . As a result from this allergic response i am unsure of whether or not it is safe to take the second dose of the vaccine.
Day 1: just super sleepy ~ unusual for me Day 5: Right ear and right side of neck mildly achy during day. Around 10pm, right armpit got super itchy Day 6: Lymph node in right arm pit area super swollen and very painful Day 7: Right arm lymph node still swollen and sore when I woke up, pain and swelling dissapated during the day, however around 11am the injection site area started to itch. When I felt it it had swelled. To say it itched is an understatement. Day 8: Right arm lymph node mildly swollen, no pain. Injection site red in area slightly larger then the area of my palm. Slightly warm and SUPER itchy. Day 9: Injection site still red, although slightly less so, slightly warm , and barely itchy.
Pt became pale and had tonic/clonic movement which subsided and recurred over 7 minutes, pt.
Tested positive for covid with symptoms; Tested positive for covid with symptoms; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Dec2022 as dose 3 (booster), single (Lot number: GJ6796) at the age of 46 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Lot number: EP6955) and on 06Dec2021 as dose 2, single (Lot number: FG3527) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Metachlopramide, reaction(s): "known allergies: Metachlopramide". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jan2023, outcome "not recovered" and all described as "Tested positive for covid with symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19. The patient did not receive other vaccine in four weeks. The patient did not have covid prior vaccination. The patient tested for covid post vaccination.; Sender's Comments: Based on the available information in the case, an association between the reported events DRUG INEFFECTIVE & COVID-19 and The suspected drug cannot be ruled out.
Initial report received from a healthcare professional on 17 September 2014. This case is a part of cluster of 12 cases (same reporter, vaccine and vaccine lot number) and is linked to case numbers 2014SA129888, 2014SA129904, 2014SA129919, 2014SA129922, 2014SA129926, 2014SA129934, 2014SA129950, 2014SA129951, 2014SA129956, 2014SA129960 and 2014SA129963. A male patient, whose age was not reported, had received an intramuscular dose of FLUZONE QIV, (batch number UI158AA, dose, dose in series and site of vaccination was not reported) on 15 September 2014. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were unknown. The patient's concomitant medications were not reported. Any other vaccination within 4 week of vaccination was unknown. On 16 September 2014, one day after vaccination, the patient experienced fatigue, headache and increased respiratory rate. Corrective treatment and laboratory investigations were not reported. At the time of this report the outcome of event was unknown. Documents held by sender: none.
Reported a 1" raised, hot, swollen area surrounding the injection site, and painful movement of left arm, following her Tdap shot. Stated it persisted several days, beginning to ease on 08/19/09.
High fever, vomiting, diarrhea, and muscle pain at shot site lasting four days. Large painful rash and swelling on upper arm lasting one week.
Pt had elevated pulse (130) and felt short of breath. Also had scratchy throat, fever, and vomited x 2. Pt took BENADRYL and TYLENOL on Friday and Sat. Symptoms gone by Sunday.
I had gastrointestinal issue. I having gas and diarrhea. I also have loss taste and smell. I had a headache, sore throat, and ear ringing. These last for about 2 weeks but the gastro issue is still ongoing. I was test positive for Covid-19 on Jan 22nd.
The left upper arm is inflamed. The physician treating it diagnosed it as cellulitis. According to the patient it started in the evening after the vaccine was administered, it got worse the next morning. The patient has been started on MEDROL dose pack and BACTRIM DS.
all of a sudden had GBS; Could not walk for months; Initial information was received on 25-Oct-2021 regarding an unsolicited valid serious case received from a consumer/non-health care professional via social media.  This case involves adult male patient who experienced all of a sudden had GBS (Guillain-Barre syndrome) and could not walk for months (gait disturbance) while receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious all of a sudden had GBS (Guillain-Barre syndrome) with their symptom could not walk for months (gait disturbance) (unknown latency) following the administration of INFLUENZA VACCINE. These both events were assessed as medically significant.  Additionally, it was reported that horrible side effect that truly does happen. Anyone can look it up and see it for themselves. We have all had the true flu in her house. She prefers to take chances with the flu herself. But she does respect everyone's choice.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was unknown for both events.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns adult male patient who experienced Guillain-Barre syndrome and gait disturbance after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. Additional information regarding patient's past medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
NOW GONE FROM THE DEATH SHOT; This spontaneous report received from a consumer via social media via a company representative concerned multiple patients of unspecified race and ethnicity. 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: unknown and expiry: unknown) 1 total, dose and start therapy date were not reported for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. On an unspecified date, patients were died from unknown cause. The reporter stated, "I know so many that were now gone from the death shot". It was unknown if autopsy is performed or not.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20211242638.; Sender's Comments: V0: 20211242746-COVID-19 VACCINE AD26.COV2.S-Now gone from the death shot. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: DEATH
I had a sore arm a few hours after the injection as well as swelling and redness at the site. It continued for a day or two. No problem until my arm started itching Thursday and I noticed the redness and itching as well as a little swelling.
right arm swollen and red from shoulder to elbow.  Pain in right upper arm.  Frequent urination.  Syncope x 1 on the evening of the injection.   Redness lasted for 3 days and gradually improved.
I felt dizzy after the shot and they told me to wait 15 more minutes and after that I was still a little dizzy then I started to feel better. I got back to my office and started having foggy brain. I got home and started feeling very sick. The day after I felt very sick and a couple days later I  started having migraines and was in a lot of pain. I was referred to a neurologist.
Pt. received their 1st Covid-19 dose on 2/24/2021, and their 2nd dose on 3/24/2021, and were subsequently hospitalized with COVID-19 on 4/9/2021.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 4 years old child patient and unknown gender. On 05-SEP-2014 the patient was vaccinated with (Oka/Merck) PROQUAD (lot # K006771, expiration date 07-NOV-2015) (dose, route not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. The reporter also stated that as of 29-AUG-2014 they had 18 doses left of this lot number. This is one of several reports received from the same source. Additional information has been requested.
Around 11:30 PM E.S.T. I started having severe pain in my chest and felt like I was itching around my trunk area.  The pain caused me to feel like I could not breathe as well.  I called my insurance company's 24 hour nursing line and was directed to go to the ER.  As I was also experiencing severe pain in my left arm, I did not feel as if I could drive.  I called 911 and EMS arrived.  The EMS technicians assessed me and I was convinced at the time that I was not having an allergic response that was keeping me from getting adequate oxygen.  I took 800mg of ibuprofen and 100 mg of Benadryl before calling 911.  I went to sleep after EMS left.  I continued to feel achy and sick until the following Tuesday.  Wednesday, 2/24/21, I had a good day until around 9:30pm when I started having severe pain in the area of my stomach.  I slept that night and then felt like I had pain in my stomach area off and on with lesser severity until the evening of Monday March 1st.  Around 10 pm, I started feeling severe pain in my abdomen.  Throughout this time, I had severe diarrhea.  On March 2nd, I went in to see my GI doctor who I had seen previously for chronic constipation due to a side effect from the trazadone I take for sleep.
floating particles were found in 1 vial of Boostrix lot #59TH3 and 2 vials of Boostrix LOT#775YF. These products were removed from circulation and all remaining stock was evaluated. Cold chain was reviewed and no deviation in storage temperature was observed.
Pt complained of redness of left side of neck 3cmx3cm red area. Pt also complained of difficulty of breathing. Beandryl 50mg IM given in left glutees. Lips cyanotic, nailbeds milder cyanotic. Epinephrine 1:1000, 1mg given with modest improvement. Pt transferred to ER.
Soreness at injection site, increased pain at injection site and shoulder (right). 4 days later swelling appeared, loss of motion, excruciating pain. Today no redness or swelling noted. Some improvement noted.
Client stated that area around Bandaid turned red Friday afternoon, then by Saturday AM the area was red, hot and swollen. Took Tylenol Saturday at noon. States she got a severe headache Friday night that still exists. Went to ER at 18:30 and was given Benadryl and Solu-Medrol IM. No breathing difficulties. Stated that a bruise appeared Monday around site, 4cm X 2cm.
Information has been received from a physician concerning a patient who was vaccinated PO with the first and second dose, respectively, of ROTATEQ. The physician reported that, a day after receiving the first and second dose of ROTATEQ, the patient developed diarrhea and a persistent cough. The physician's office was called on both occasions. The patient subsequently recovered after both instances while on therapy (unspecified). Additional information has been requested.
Arms numb; Pain travelling; Swollen; Stiff; Sore/pain in his arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen), MUSCULOSKELETAL STIFFNESS (Stiff), PAIN IN EXTREMITY (Sore/pain in his arm), HYPOAESTHESIA (Arms numb) and PAIN (Pain travelling) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and LOSARTAN for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swollen), MUSCULOSKELETAL STIFFNESS (Stiff) and PAIN IN EXTREMITY (Sore/pain in his arm). On 09-Mar-2021, the patient experienced HYPOAESTHESIA (Arms numb) and PAIN (Pain travelling). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Swollen), MUSCULOSKELETAL STIFFNESS (Stiff), PAIN IN EXTREMITY (Sore/pain in his arm), HYPOAESTHESIA (Arms numb) and PAIN (Pain travelling) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included eyedrops.   This case was linked to MOD-2021-109546 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow up document is received and contain no new information regarding dose 1. On 07-Jun-2021: Follow up document is received and contain no new information regarding 1st dose. Second dose details are added. On 26-Jul-2021: No new information reported.
Pt received both vaccines in (L) arm. PNEUMOVAX higher and to the left. Next morning patient developed an odd, raised, red rash that was painful to the touch. He also said it was hard to lift arm and was painful in the armpit. Had taken ibuprofen without relief. Pt went to ER and received a MEDROL dose pack.
strep throat; fever; This is a spontaneous report from a contactable consumer (Father). An 18-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 24Mar2021 (at the age of 18-years) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced strep throat, fever. As a result of events, patient missed the second dose. Reporter would like to know if there was any negative effect, since patient missed the second dose. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
11/30/11 4:45 PM Gave Flu and Varivax vaccine. pt went to bathroom to give urine specimen, RN went to check on him, coughing wheezing, returned to room, 4:55pm albuterol 2.5mg neb tx given called 911, Epi 0.3mg IM given LT no wheeze still itching O2sats= 99-100%on R/A HR 141 still itching 5:10 PM gave 2nd albuterol nebulizer TX and 2nd Epipen 0.3mg to RT paramedics arrived info given and taken to Hosp per Mom request mom to follow ambulance.
Patient called on 2/10/19, 2 days after receiving the vaccines complaining of red, itchy area around where she received her vaccine on her right arm. Patient declined trouble breathing. Recommend patient to try hydrocortisone cream and bendryl to help with the itching, but to contact her MD office for possible follow up.