chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within twenty-four hours I had a 102.7 degree temperature which lasted a day then gradually went away, I took Tylenol for the fever. For then next couple days just felt rundown. Then three days post vaccine I began having some chest discomfort and shortness of breath. That night around one thirteen the morning I went to Emergency Department. they took a ECG and drew labs. the ECG showed normal rhythm just a little elevated and my Blood pressure was elevated. Upon the attending physician getting my lab work back i was admitted for my triponin levels being elevated. I was taken for chest X-rays and a Cat Scan per their pulmonary embolism protocols. Both of which showed nothing.  The next day i had a Echocardiogram, and Cardiac Catheterization, and a Cardiac MRI.
Patient reports that within the hour after receiving the vaccine and leaving the health department he developed a red itchy rash. He works at a local NP office and was given BENADRYL and dexamethasone. He then began to have trouble breathing and was taken to ER where he was given Epinephrine, BENADRYL, and another medication that he didn't know the name of. He stated that today 3/21/19 he is feeling better but his blood pressure is still high and he has some tremors.
Red, bumpy rash from neck to elbow on right arm (injection was in right arm).  Rash itchy.  Employee health advised to take Benadryl and apply corticosteroid cream to the rash.
Headache post nasal drip, intermittent numbness of arms and  legs Narrative:
The pt was found pulseless and apneic in crib at 08:00 on 9/20/00.
Several hours after injection my arm hurt down to almost the elbow.  Not bad.  Next day same until about 3:30 and I started to get chills, body aches and pains then nausea and headache.  Shivering for 4-5 hours under the covers in bed with extra blankets and clothes.  Can?t say I?m overly concerned as searching online I?ve seen reports of similar reactions but best to report. Today feeling a bit better, not shivering but still achy but not as bad and still a little nauseous.
5 minutes after the vaccination, she developed urticaria, chest tightness and she felt clammy.  She was given Benadryl, atarax in the ER.  She was sent home.  She continues to have a rash and a feeling like blisters on tongue.
received vaccine at community outreach event. Vaccine History pulled prior to event, however child had vaccination during the time between the Vaccine History being pulled and the vaccine event in the community. Received meningococcal and Tdap vaccine on 4/6/23 AND again on 4/21/23.
Patient reports, Loss of hearing in L ear including tinnitus and muffled noise from sound, and similar in R ear but not as severe as L ear.
Not LTCF. PCR(+) 05/10/2021. Noted to be asymptomatic for Covid in May 2021. Died at home. Last hospital encounter 5/1/21 notes: dx of malignant neoplasm of esophagus, dehydration, malnutrition, hyperosmolality and hypernatremia. C/M: HTN, current smoker, immunosuppressive condition. Fully Vaccinated (Pfizer): 02/27/2021 & 03/28/2021.
Runny nose, rash on face, temp 100.3R,rash by evening was all over body-looks like sunburn; By afternoon sitter reports no temp, rash almost gone; just a little on neck & face;
Information has been received from a physician assistant via a company representative referring to a 21 year old non-pregnant female patient with type 1 diabetes mellitus. On 06-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX23 (lot # L014420, once, in the right deltoid, route and dose unknown) for diabetes (product use issue). Concomitant therapies included influenza virus vaccine (unspecified) in the left deltoid. On 06-NOV-2015, after vaccination, the patient developed pain in the right deltoid where she received the shot (injection site pain), limited swelling (injection site swelling) and nausea. The patient visited the physician fro medical attention and received ibuprofen for treatment. The patient recovered from the injection site pain, nausea and injection site swelling on 12-NOV-2015 (also reported that "all this events lasted for five days after receiving the vaccine"). Vaccination with PNEUMOVAX23 was reported as 'not discontinued'. Additional information has been requested.
5/27/99 p/rash on neck, 5pox total;5/28/99 2 days later all over body in patches;some purple looking rash, 20pox total;fever 2 days later 103;5/31/99 nl temp but still evidence of rash;
Information has been received from a nurse, concerning a patient of unknown age and gender. The patient's medical history, allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On an unspecified date, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot number N022015 with expiration date on 10-MAR-2019 (strength and dose number were not provided), for prophylaxis. The ROTATEQ was stored at a temperature range of 47 degrees Fahrenheit (°F) to 77 °F (55°F), for a time frame of 30 hours and 43 minutes. There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1808USA002487: US-009507513-1808USA002488: US-009507513-1808USA002489: US-009507513-1808USA002490: US-009507513-1808USA002453.
PATIENT HAD INJECTION SWELLING AND REDNESS AND HEAT ONE WEEK AFTER INJECTION
Prolonged, intermittent pain in deltoid at site of injection. Tenderness to touch (interm.) and subjective wkness (intermittent). Normal exam in office 8/30/16.
Information has been received from a physician assistant concerning a 30 year old female patient with no pertinent medical history and no known drug allergies who on 13-NOV-2008 was vaccinated IM with a second 1 ml dose of RECOMBIVAX HB (lot # 660951/0398X).  The patient was vaccinated with the first dose of RECOMBIVAX HB (lot # 660951/0398X) on 13-OCT-2008.  There was no concomitant medication.  On 17-NOV-2008 the patient experienced swelling of her lips, mouth and throat. It was reported that the patient felt generalized pruritus and a feeling of heaviness in her chest.  She also felt her throat was closing.  The patient was examined in the emergency room on the same day.  The patient was not admitted and there were no lab studies performed.  The patient was prescribed PREDNISONE 40 mg once daily for 5 days.  The patient stated that her symptoms were "merely annoying."  At the time of the report, the Patient's status was unknown.  There was no product quality complaint involved.  Additional information has been requested.
Patient states that she started having flushing, burning, sweating, trembling and throwing up about 20 minutes after receiving the flu shot. The next day she was just very tired.
unexpected benefit; This case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic effect in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes simplex type ii (developed in 2008). Previously administered products included Shingrix (received on unknown date).   In March 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown.   It was unknown if the reporter considered the unexpected therapeutic effect to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 57 or 58 years. The patient had noticed that, the vaccine was helping with her hsv2 (Herpes simplex virus).   The patient heard that there has been some reports of this happening and wanted to know if we have any studies. The reporter consented to follow up.
Reporting administration errors as per Agency.  We contacted Pfizer for expiration dates, Pfizer vaccine specialist advised expiration dates and deemed  vaccine viable at the time of vaccine administration. Pfizer vaccine vials only incude manufactuarer dates on the box and vials. Therefore, we contaced Pfizer to attain expiration dates directly from them.  No adverse reaction reported from the patietn at the time of the vaccination and no adverse reaction reported since given vaccine.
Kidney Pain, chills, brain fog, shivering, hot and cold flashes, nausea, and body aches.
Itchy rash on cheek bones (small bumps), later spread to chest, under eyebrows and behind ears; This is a spontaneous report from a contactable consumer. A 47-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 23Apr2021 at 14:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol and seasonal allergies. The patient has taken unspecified concomitant medications. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 01Apr2021 at 14:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Apr2021, the patient experienced itchy rash. It was reported that the patient experienced itchy rash on cheek bones (small bumps), later spread to chest, under eyebrows and behind ears. The patient has taken benadryl (MANUFACTURER UNKNOWN) as a treatment for the adverse event. It was unknown whether the adverse event resulted in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event itchy rash was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt recv vax & 2 days later pt devel a rash @ the inj site on each leg;the rashes persisted as of 23MAR98;
PT WENT PALE AND FELT FAINT AND NAUSEOUS FOR SEVERAL MINUTES. SHE RECLINED AND ELEVATED HER FEET FOR SEVERAL MINUTES. SHE SIPPED WATER AND GINGER ALE AND FELT BETTER AFTER A FEW MINUTES
This spontaneous report as received from a healthcare worker refers to unspecified patients. It was reported that an unknown number of doses of ZOSTAVAX (lot # unspecified) (dose, route and location unspecified) that were exposed to unspecified conditions outside of the recommended storage conditions, might have been administered to unspecified patients. No adverse effect reported. Additional information is not expected.
A report has been received from a Health Professional concerning, female patient. No information regarding relevant history, concomitant disease and concomitant medications were provided. The patient received nasal FLUMIST in August or September of 2012. It was reported that the employees tested positive for the flu during Oct-2012, after receiving FLUMIST. Action taken with FLUMIST was not applicable. The Flu lasted for about three days and all recovered. The reporter considered the event to be non-serious.
2/5- administered 2nd Moderna vaccine dose. 2/6-chills, body aches and pains, arm pain and welt, alternated Tylenol and Motrin q4 around the clock. 2/7-2/8 rested and was off of work (no symptoms- felt fine) 2/9- returned to work, passed safepass and while on zoom call at 9am developed wheezing and cough and slight low grade temp (99.5). Took symbicort (I have normally well controlled asthma). Called clinic and was advised that I was fine and could continue to work and to follow up with MD if symptoms got worse. Did virtual visit with Pulmonologist at 0945 and he advised me to get COVID swabbed and prescribed prednisone taper and albuterol MDI. COVID swabbed 2/9 at 5pm. Out of work 2/10 & 2/11 awaiting test results. Returned to work 2/12 after negative COVID result- passed safepass- worked, still SOB, but manageable. 2/13-2/14 had increasing SOB- albuterol MDI 6x/day. Monday 2/15 returned to work- saw doctor in person- increased prednisone from 20mg (tapered down) to 40mg (original dose) and added Spiriva. 2/17- Went to ED for status asthmaticus after using albuterol MDI 5-6x/day without any relief. Admitted 2/17 for asthma exacerbation- discharged 2/20. Discharged home with nebulized albuterol, prednisone slow taper, symbicort, Spiriva, Singulair & Claritin. 2/23-2/24 Albuterol nebs 5x/day, still SOB. Pulmonary visit 2/24 - added inhaled budesonide nebs. Out of work 2/25-2/26. Returned to work 3/1- finally feeling better!
This is an initial spontaneous report from a contactable Pfizer internal colleague. A 58-year-old female patient received PREVNAR 13 via an unspecified route of administration on her forearm on 10May2012 at 15:00. Medical history included ongoing high blood pressure. Concomitant medication included lisinopril for high blood pressure (unspecified date-present). On 10May2012, at an unknown time after the administration of PREVNAR 13, the patient experienced redness at the site of injection. On 16May2012, the patient mentioned that the site of injection was swollen, hard to touch, and sore. The outcomes of the events were not recovered at the time of the report.
Palpitaton; Couldnt lift her arm; Diarrhea; Pain in arm; Lightheadedness; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitaton), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (Couldnt lift her arm), DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Pain in arm) and DIZZINESS (Lightheadedness) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL, MONTELUKAST SODIUM (SINGULAIR) and ATORVASTATIN for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PALPITATIONS (Palpitaton), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (Couldnt lift her arm), DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Pain in arm) and DIZZINESS (Lightheadedness). At the time of the report, PALPITATIONS (Palpitaton), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (Couldnt lift her arm), DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Pain in arm) and DIZZINESS (Lightheadedness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other concomitant medication includes Mobocertinib Oncology trial drug. Treatment information includes fluids and nutrition drinks.
Headache and dizziness-given water and rest-feeling  much better. She did not have anything to eat or drink this morning. Rested for 35 min and felt better with dinking a bottle of water.
Superficial thrombophlebitis of the left lower extremity over the medial calf.
Information has been received from a physician concerning a 17 year old female with no pertinent medical history or drug reactions/allergies who on an unspecified date was vaccinated with Gardasil 0.5 mL IM.  Concomitant therapy on the same day included influenza virus vaccine (unspecified).  Subsequently after receiving the Gardasil vaccine, the patient fainted and convulsed.  The patient was administered smelling salts, was revived and went home.  No additional information was given.  The patient recovered on the same day.  Upon internal review the convulsion was considered to be an other medical event.  Additional information has been requested.
temperature excursion/ABOVE 46F (46.73F) for 46 hours 5 minutes and 0 seconds; No additional AE/PQC reported at this time.; This spontaneous report was received from a nurse practitioner and refers to a 6-month-old patient of unknown gender.  The patient's pertinent medical history, drug reactions or allergiesand concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liqud administered orally (lot number 1707585 and expiration date 21-FEB-2022 were verified as valid) (dose and vaccination scheme frequency were unknown) for prophylaxis. It was reported that this was the third dose of the vaccine administered to the patient. The vaccine was exposed to a temperature excursion as it was improperly stored at 46.73 Fahrenheit degrees for 46 hours, 5 minutes (product storage error), which was detected by digital data logger. The recommended range temperature was minus 58 Fahrenheit degrees to 46 Fahrenheit degrees. There was no previous temperature excursion. No adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA001947:
Information has been received from a physician concerning a 34 year old female patient with migraines and no previous pregnancies who on 16Aug2000 was vaccinated with a second 0.5cc dose of varicella virus vaccine live (Pl: 11Jul2000, 0.5cc dose). Prior to vaccination on 22Jun2000, the patient tested negative for varicella antibodies. The patient was not vaccinated for immigration purposes. The patient did not develop a local reaction at the vaccination site, varicella symptoms or herpes zoster symptoms post vaccination. Subsequent to vaccination, the patient became pregnant with a LMP of 15Oct2000. During the entire pregnancy, the patient was treated with prenatal vitamin tablet daily for pregnancy supplementation. On 13Feb2001, an ultrasound for dating was normal and an amniocentesis was normal (46X4). In approximately June 2001 at 32 wees. The patient developed pre-term contractions. From 02Jul2001 to 02Aug2001. The patient was treated with "Surtak" one tablet twice a day as needed for constipation. The reporter indicated that there were no infections or illnesses during pregnancy. On 02Aug2001 at 41 weeks, the patient underwent induction and artificial rupture of membranes secondary to "post dates". Oxytocin (pitocin) augmentation was used secondary to a prolonged labor. On 02Aug2001 at the time of delivery, AMA was 354. On 02Aug2001, the patient delivered a normal, healthy male child weighing 7 pounds, 8 ounces. The reporter indicated that there were no complications during labor or delivery. There were no congenital anomalies and no features of congenital varicella zoster syndrome. Additional information has been requested.
Intense neck pain; Upper back pain; soreness in the arm where I received the vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8732), via an unspecified route of administration in the left arm on 28Mar2021 at 14:45 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had not received any concomitant medications within 2 weeks of vaccine. The patient had no known allergies to medications, food, or other products. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021 at 08:30, the patient woke up with intense neck and upper back pain, in addition to soreness in the arm where he received the vaccine in the next morning. That was still ongoing. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures and treatments were not taken as the result of adverse events. The clinical outcome of neck pain, upper back pain and vaccination site pain was not resolved.   No follow-up attempts are needed. No further information is expected.
On 11/10/99, the pt experienced a fever of 103, a dime size swelling at the injection site, redness, and tenderness at the injection site and the pt would not ambulate on his leg. The pt sought unspecified medical treatment.
About 45 minutes after the 2nd dose vaccine, I noticed a fullness feeling in my chest and head then it went away. That evening around 8PM, my resting heart rate was 94. Then 11 days later 2/24/21 at 3:15PM, my heart started racing, it felt about 160 BPM. I waited it out and after 45 seconds it resolved. I felt tired afterwards. The following day, I felt very anxious and nervous and my heart rate was 110. I decided to go to the ER. They did blood work and EKG and everything came back normal so I was discharged. I did follow up with my cardiologist. The doctor recommended doing an ablation to correct the problem. On 4/28/2021, I did the ablation procedure and have not had any cardiac symptoms since.
Information has been received from a physician's office worker concerning a female who on 18-SEP-2007, was vaccinated with a dose of rotavirus vaccine live (human-bovine). Concomitant vaccinations administered that day included a dose HIB conj vaccine (OMPC) (MSD), a dose of Pediarix and a dose of Prevnar. Subsequently, the patient experienced diarrhea for over two weeks. The patient was being treated in the office and the lab culture was pending at the time of this report. The patient's recovery status was unknown. Additional information has been requested.
Patient received Pfizer COVID vaccine and immediately felt flushed. She felt like her heart was racing and palpitating. Patient also reported trouble breathing. Vitals stable. EMS was called and she left with EMS.
Morning after injection, I woke up feeling lower energy, a bit lightheaded, borderline nauseous and 100.4 fever. Headache off and on. Body aching throughout the day with fever spiking to 101.7 by 6 pm. Symptoms passed by morning of 2nd day.
arm was swollen and red and fevered, and itchy; patient claimed to have memory lose and chills over 48 hours after receiving vaccination