chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a child who was vaccinated with a dose of Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine). It was reported that the patient experienced intussusception. The physician reported that there was no other information. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information from a health professional indicated that she had no idea about the cases of intussusception. She also indicated that no one else here would know about it. Intussusception was considered to be an other important medical event (OMIC). The physician also reported another case of intussusception following vaccination with Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine) (WAES0607USA02327). Additional information has been requested.
This spontaneous report was received from an office manager referring to a 13 month old male patient. The patient's medical history or concurrent conditions were not reported. On 02-MAY-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot number N021720, expiration date 10-AUG-2019, for prophylaxis) (dosage information, route and site of administration were not informed). Concomitant therapies included Merck sterile diluent. It was also reported that the temperature/time frame was: 14 degrees C to -10 degrees C ( -12 degrees C ) for 45 minutes. Temperature/Time frame : -9 degrees C to 8 degrees C ( - 6 degrees C ) for 1 hour. There was no previous temperature excursion. A "data logger" was involved.
11MAY91 temp 101.9, vomitting; 12MAY91 temp 101.9, spots on face, legs, neck coughing & cold sx; 13MAY91 chills, temp 103.9; started on Amoxicillin by MD & antihistamine;
Immediately (within five seconds or less) after intramuscular injection in the left deltoid the patient experienced syncope and then rapidly fell into whole body convulsions. Patient was unresponsive to my voice or touch for about twenty seconds during which I held his wrist to be ready to lower him to the floor gently if necessary as the convulsions slowly subsided.  He was then briefly able to rouse himself to track my face with his eyes, then lapsed back into syncope with lack of muscle tone and a heavy deep breathing. The patient was steady in his chair, though in a slightly awkward position, so I allowed him perhaps thirty seconds or a minute for him to recover. After a time I snapped my fingers at him and he immediately roused enough to sense his situation, but was not fully conscious. He held his finger up indicating that he needed a moment. After another minute or so I addressed him and he was able to open his eyes and reply. He appeared pale, sweaty, and weak but present. I confirmed he did not feel he was in immediate danger and he told me that incidents like this were common for him, and that he would be fine. I found him some orange juice and a bag of frozen peas nearby, and allowed him ten or fifteen minutes alone in the shot room to recover, checking on him every few minutes. After a time he put his sweater back on and seemed steady. He confirmed that he was experiencing no symptoms of hives or swelling in the throat. He remained in the store for five minutes or so then left.
piercing screaming, irritable, body shakes, fever during 3 days p/vax;
12/21/2021, 5:00PM generalized muscle aches started; swelling, redness, and increased pain at injection site; approximately 9:00PM increased heart rate, headache, and increased joint pain and tightness noticed.  12/22/2021 3:00AM lymph nodes in left clavicle, left armpit, and left groin area painful with/without touch; visual check of said lymph nodes at approximately 5:00AM, all are visibly swollen, pain intensified; 11:00AM, headache, dizziness, "fogginess," eye pain, gum pain, intensified body aches, loss of appetite, fever of 100.1 degrees F, pulse 100+BPM (baseline is 80-86); required assistance ambulating; 6:00PM blood pressure 136/88 (baseline is 114-120/74-80, no medication was missed).  12/25/2021 9:00AM:  signs and symptoms noticeably decreased; lymph nodes still swollen, but have decreased approximately 50% in size, not visible, but palpable and painful with/without touch; headache; body aches (minimized, but present); fatigue and joint tightness remain, especially in right total knee replacement; occasional nausea secondary to headache; temperature 98.8 degrees F; heart rate 80; blood pressure 120/84.
Severe arm soreness 9/10, highly limited mobility, began 12 hours after injection, mostly cleared up within 48 hours. Severe fatigue and muscle weakness 8/10, began overnight, felt drained and difficulty getting around during the 12-36 hour window, light headed/feint feeling after extended periods out of bed, mostly gone by 48 hours. Chills and low fever 6/10, mostly in the 14-28 hour window. Mild headache 4/10, came in waves throughout the day, increasing in severity, cleared up by 36 hour mark.
pt reports soreness and aches that started 10/17.  by midday the chills were uncontrollable and fever reported.  ended up with pneumonia and newly diagnosed pulmonary hypertension.
Per dr - pt had sx - congestion, body aches, wheezing and chest tightness. Tx: KENALOG 40 mg IM, BENADRYL 25 mg PRN. Note to remain out of work until 10-28-13.
1 week after vaccine administered, pt developed erythematous rash with warmth to palpation on the L arm deltoid muscle (at the location of the vaccine admin site). Also noted headache and nausea. She was started on treatment for presumed cellulitis of the L arm.
14 year old received Moderna Covid 19 vaccine in administration error for off label use.  There are no side effects known at this time.
pt stated to the nurse that she feels like she will pass out.  She lost consciousness soon after for about 10-15 seconds.  Afterwards, she woke up and was alert and oriented.  Vital signs within normal limits.  Dr assessed, pt stated she has history of syncope with needle procedures.
Patient called after getting the vaccine saying she started to feel itchy all over. She does not see any rash or bumps however just feels itchy all over her body and wants to scratch everywhere. Patient took "a lot of Benadryl" she said and went to sleep and was fine next day. Next day however she felt peripheral nerve damage in her hand that she said reappeared from an injury that was a few years ago. she said it seems like the vaccine reaggravated that injury.
shingles; had ear infection; red spots on ear; Otitis Media; Ear Ache; ear feeling sore, swollen, stopped up; ear feeling sore, swollen, stopped up; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in right arm on 10Feb2021 11:30 (lot number: EL9265) at the age of 65 years old, as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included Grave's disease. There were no concomitant medications. The patient previously took morphine (lot number and expiry date unknown) and experienced allergy. On 18Feb2021, the patient had earache, ear feeling sore, swollen and stopped up. On 25Feb2021, found red spots on ear. Clinical course: The patient had ear infection two weeks after the dose and was given antibiotics and eardrops. Four days later, the patient had spots and the doctor said it was shingles. Patient was given meds and cream. Patient is scheduled for the second dose on the 03Mar2021 and wanted to know if she can get the vaccine. 10 days after the first shot, her ear began to ache and so she went to doctor on Monday 22Feb2021, and the doctor said it was an ear infection and prescribed antibiotic and drops. Then on 25Feb2021, she had little red spots on ear and went back to the doctors and he thought it was shingles, but she has already had the shingles vaccine. Her earache was on 18Feb2021, she woke up with her ear feeling sore, swollen, stopped up. It is still ongoing but feels better. She made the doctor's appointment for her earache on 22Feb2021 Monday, he diagnosed her with Otitis Media. He prescribed Azithromycin, Z-pak 250mg 5 tablets. Patient confirmed it was generic azithromycin prescribed. The doctor also prescribed ear drops neomycin polymyxin hydrocortisone 3.5mg, 3 times a day. Her red spots appeared on 25Feb2021, it is ongoing, she has scabs now so it has improved. The doctor's appointment for the red spots was on 25Feb2021, she woke up, her husband is the one that puts the drops in her ear and so he was the one that noticed the spots, the doctors diagnosis was shingles or herpes zoster. He prescribed Valacyclovir 1 gram, 1 tablet by mouth 3 times a day for 7 days. He also prescribed a mupirocin ointment. Patient stated that she got her Shingles vaccine 10Nov2016. She is scheduled for her second dose of the COVID vaccine on 03Mar2021. The patient was recovering from earache, ear feeling sore, swollen, stopped up, and red spots on ear. Outcome of the remaining events was unknown.
I had gone to bed at around 8pm because I was very tired, I woke up around 10pm because my face felt strange and realized that the left side of my lip and mouth had swelled. I then proceeded to take two Benadryl pills. I stayed awake and could feel the swelling continue to progress. I eventually fell asleep and when I woke up the next morning it had gotten worse and spread to the other side of my lip / facial region
Sweating, thought she was going to vomit, close to fainting,  was talking the whole time 15 minutes later she felt tightness in her throat Called 911 and paramedics came and took her to hospital
Tenderness in cheeks, where I received Volume/Juvederm facial filler 3/20
No additional AE/ PQC; temperature excursion MMR II (stored in freezer),VARlVAX, and RECOMBIVAX HB.; This spontaneous report was received from a physician who was reporting on 58-year-old female patient. There was no information about the patients concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 21-JUN-2021, the patient was vaccinated with improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) thiomersal free, lot # T035865, expiration date 28-APR-2023, dose of 1 milliliter administered into unspecified body part on left side (strength, route of administration and anatomical location were not reported) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion was stored in temperature of 68.7 degrees Fahrenheit for 56 hours and 22 minutes (temperature to high) and 23.3 degrees Fahrenheit for 24 hours and 0 (temperature to low). Data logger was not involved. There were no previous excursions reported. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck; devicelotnumber: T035865; expirationdate: 28-APR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Arm erythemic, swollen 5cm around vaccine site, extending past elbow, tender. Rx: BENADRYL 25mg 1-2 PO Q 6 hours prn, return prn.
her eye is still swollen with chills; low grade fever; chills; muscle cramps; general muscle ache; Tiredness; scratchy throat which got worse with time; tenderness around the injection site; it felt really bad almost like a flu; it felt really bad almost like a flu; This is a spontaneous report received from a contactable consumer (patient). A 44-year-old female patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date: 30Apr2021, NDC number: 59267100001), intramuscular in the left deltoid, on 08Jan2021, at 0.3 mL, single, for COVID-19 immunization. There were no medical history and concomitant medications. The patient reported she had side effects after receiving the first dose (Jan2021). She had a scratchy throat which got worse with time. She had a general muscle ache, tenderness around the injection site. The muscle ache increased with chills and low grade fever. She said it felt really bad almost like a flu. She reported her eye is still swollen with chills and low grade fever. She further clarified that she was given the vaccine on 08Jan2021, Friday afternoon. On 09Jan2021, Saturday, she had muscle aches, tiredness, and by Saturday night she had a scratchy throat. On 10Jan2021, Sunday, she experienced tiredness and muscle cramps. She worked half day on 11Jan2021, Monday, and by the afternoon she had chills and low grade fever. On 12Jan2021, Tuesday morning, she woke up and her eyes were swollen. She noticed the swelling has decreased a little bit. She didn't have any symptoms such as difficulty breathing. The reporter asked what have caused these side effects and why did her immune response react this way after receiving the vaccine. She mentioned that her second dose is set up for the end of January and asked if she will be able to get the second dose since she had a reaction and she was wondering if had an illness when she got the vaccine could that have caused her to have a hyper response in her immune system to the vaccine. The outcome of the events scratchy throat which got worse with time, general muscle ache, tiredness, muscle cramps, eye swelling and low grade fever was recovering; chills was not recovered; and the outcome of the remaining events was unknown.
A little after the booster I began to feel facial numbness including my tongue. Feeling in my tongue returned around 3pm.  My facial numbness persisted until 1/7. I visited my doctor who prescribed a steroid to help w/ the numbness.
10/23/2022  In the middle of the afternoon, I felt fatigued. The next day I started getting a scratchy throat and felt like I was having allergies.  I tested negative for COVID, antigen test.  Later that day I began having a sore throat.  10/25/2022 I tested positive on 2 PCR tests and negative on antigen test. Started having a stuffy nose, sore throat and not feeling great. I spoke with my physician, and he told me to take Vitamins C and D and zinc which I started. He said if I was worsening, to call him back the next day. I continued not feeling well and declining through 10/26/2022 and had to take off from work that morning.  I called my doctor back on 10/26/22 and he prescribed Paxlovid and Solumedrol pack, and a cough medicine.  10/27/2022 < I still did not feel well. On 10/28/22 I began feeling better, but still not feeling well. I lost my sense of taste and smell.  10/29/22 I was feeling better. I continued to test positive. 11/2/22 I began feeling very fatigued. The next morning, I was still very tired.  My antigen test was barely positive.  On 11/4/22, throughout the night I had a sore throat, feeling hot and cold. I woke up on 11/5/22 I did not feel well at all. I began to test positive again.  11/7/22 , I called my doctor and he diagnosed me with a rebound case of COVID  and he prescribed another round of prednisone.  I began feeling better last night than over the week-end. I am still testing positive today, but am feeling better.  I have a runny and stuffy nose, still no taste or smell and a mild headache.
Pt was given DTaP injection left thigh IM. Immediate golf size lump appeared and a welt hive appeared. Pt was to have Tylenol and Benadryl and cold compress.
Shivering; Fatigue/tiredness; Upset stomach; This case was reported by a consumer via call center representative and described the occurrence of shivering in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included paracetamol (Tylenol).   On 27th December 2022, the patient received Shingrix. In December 2022, less than a week after receiving Shingrix, the patient experienced shivering, fatigue and upset stomach. On an unknown date, the outcome of the shivering, fatigue and upset stomach were not recovered/not resolved.   The reporter considered the shivering, fatigue and upset stomach to be related to Shingrix.     Additional Information: GSK receipt date: 28 DEC 2022 Reporters comment: The reporter was the patient. The patient reported that had a Shingrix shot yesterday (day before reporting) around mid-day. The patient experienced shivering, fatigue or tiredness, and upset stomach.  The reporter provided limited information.
Received first dose of covid 19 vaccine on 12/18/2020 and  experienced side effects of joint pain and fatigue that extended until next dose.  I was unable to return to pre vaccine workout schedule feeling completely exhausted after 30 minutes of sustained exercise, when previously I could work out without issue and for rest of day.  Fatigue and joint pain improved slightly and then I received 2nd dose on 1/8/2021.  Fatigue and joint pain worsened and I continue to not be able to exercise experiencing tired muscles and joints very quickly with fatigue that does not resolve.  I have not been able to return to pre vaccine activities.
Fever, headache, nausea, fatigue, decreased appetite, vomiting, diarrhea.
ear infection; This is a spontaneous report from a non-contactable consumer and a employee.  A 12-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dosefor covid-19 immunisation.  Medical history was none.  Patient was not pregnant. There were no concomitant medications.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced ear infection on Aug2021.  The event resulted in Doctor or other healthcareprofessional office/clinic visit. Treatment included antibiotic. The outcome of the event was recovered on an unknown date.  Follow-up attempts are completed. No further information is expected.
On 11/06/2002 received pneumonia shot in left arm and flu vaccine in the right arm. Later that evening, patient complained of right arm aching. On 11/7/02 she did not feel good all day and on 11/8/02 she broke out in bright, red hives on her legs, chest, lower back and neck. She saw a doctor and was given an injection of Kenalog. She was also given methylprednisolone and hydroxyzine to take.
pt immun were hard to get on the scheduled frames because of other illness;pt had brief periods of no sz;MD stated pt to have DT;pt given DTAP & had 2 myoclonic sz & some infantile spasms;pt fell;bump head;poss  epilepsy;
Patient came in to receive his first covid shot (COVID19 PFIZER AGE 12+ GRAY CAP NDC 59267-1025-01) and his flu shot. COVID PFIZER BIVALENT BOOSTER shot given by mistake. 5 minutes after receiving his vaccines patient passed out for about 10 seconds. When he came to he was coherent and just was not sure how he fell. EMT was called and gave the all clear that patient was okay and able to leave with wife.
345Pm recv vax 25NOV97;430PM left medical pt states feeling fine;545Pm pt went to K-mart started feeling sick sx n/v, cramping, inc fever/chills;630PM temp 103;ASA given;930 temp inc to 104.5 went to ER;
Patient arrives at the Pharmacy to notify that after administering the vaccine he had felt pain tiredness and dryness in the mouth beside the area of administration is red.
Information has been received from a physician concerning an 8-week-old male infant who on 08-NOV-2011 was orally vaccinated with a dose of ROTATEQ (Lot number: 670481/0677AA, expiration date 28-FEB-2013). The physician stated that on 09-NOV-2011 the patient developed diarrhea. The child presented at the office on 14-NOV-2011, with diarrhea and vomiting for the last 5 days. The child was examined and sent home. On 21-NOV-2011, the child was admitted to the hospital through the emergency room and remained there until 23-NOV-2011, after which the child was released. The representative did not have any details of the hospital stay and it was not the reporting physician who admitted the child. A test was done for rotavirus and it came back negative. On a call taken by the nurse with the reporting physician in the background stated that concomitant vaccines included a dose of PEDIARIX, ACTHIB, and PREVNAR 13. Patient did not present with vomiting at the 14-NOV-2011 office visit (as previously reported), the only symptom at that time was diarrhea, which was not tested for presence of blood: the hospital records had been received. Baby was seen again in the office on 29-NOV-2011, no vomiting; no blood or mucous in the stool; stool was getting thicker; patient was considered as recovering. No further information is available.
Tested this week and did not see antibodies; This spontaneous case was reported by a consumer and describes the occurrence of DRUG SPECIFIC ANTIBODY ABSENT (Tested this week and did not see antibodies) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DRUG SPECIFIC ANTIBODY ABSENT (Tested this week and did not see antibodies). At the time of the report, DRUG SPECIFIC ANTIBODY ABSENT (Tested this week and did not see antibodies) outcome was unknown.            It was reported that the patient had Rituxtan which is an infusion that makes body not make antibodies. The patient has tested and did not see antibodies.  No concomitant drugs were reported.  No treatment medications were reported.
01/26/2021 Had difficulty breathing, lips swelled to ER started on Prednisone.  Release same day symptoms improved.
Arm vaccine administered in became swollen within 5 hours of vaccine. Swollen painful joints - shoulder, elbow, wrist redness on whole arm. Resolved in 3 days. No treatment.
No additional AE reported.; Patient was administered improperly stored VARIVAX; This spontaneous report was received from a healthcare business professional and refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies and medical history were not provided.  On 18-APR-2022, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U022320, expiration date: 15-JUL-2023 (strength, and route of administration were not provided) administered for prophylaxis (Product storage error).  Administered vaccine experienced the temperature excursion of -11.45 degrees Celsius for 1 hour on 18-APR-2022 and -14 up to -10 degrees Celsius for 30 minutes on 04-MAR-2022.  There was no adverse event reported (No adverse event).
Pt/mother reported anaphylactic reaction approximately 2 hours post-vaccination.  Shortness of breath, went to ER and was treated.
Erythema multiforme, 3 wks p/vax recvd;
reporter describes having mild s/s w/in 2hr of vax;states began w/h/a, weakness & progressed;started Friday, 16APR99, had fever to 103, chills, diff remembering things, tingly finger tips;seen in ER 17APR99;seen by MD 19APR99 tx w/fluids;
Within an hour after the injection I developed stomach pain. Within 5 hours after the injection, I developed a fever of 1-2 degrees with chills and lethargy. In the next hour (6 hours after the injection), I believe my ulcers ruptured with extreme stomach pain and discomfort.  Pressure began building in my stomach and I felt worse and worse. By the evening, I was in pain, had pressure, was chilled, nauseous, and sick.  I felt unwell the next day, but did not begin passing blood and black stool until 2 days after the injection.  I saw my doctor that day. I went on a low fiber restricted diet. This continued for 10 days. I am still recovering.