chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 3-5 minutes after I felt so out of it.  I felt like I was under the influence of something.  I tried to read my email and the words were there but didn't have meaning.  I had to drive home after my 15 minute observation and plugged my home address into my gps so I wouldn't get lost even though I drove home from Medical Center for years.  I got home and laid down and slept for a couple hours and woke up fine.  I felt ok the following day and was doing laundry around 6 pm and my arm stopped being sore and I got really dizzy and nauseated and my vision had shadows (reminded me of an ocular migraine) and drank 2 x 16 oz glasses of water and laid down and felt better in about 20-30 minutes.
I was hospitalized with severe lung infection.  Covid was suspected but proved negative after testing.  Ugly green phlegm was being expelled.
Approximately one hour following injection, had a headache and dizziness. The following day, extreme fatigue, headache dizziness. In the 10 days following, tinnitus,  joint pain, chest heaviness, palpitations, daily headache, brain fog, dizziness. Felt a little better after a day or so, but after receiving a Botox injection on April 1st, symptoms came back. More notable was heart palpitations, dizziness,  shortness of breath. Inability to stand for long duration. Exhausted after minimal amount of physical activity.
This is a spontaneous report received from a contactable consumer or other non-HCP). A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced chills, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Patient is a 79 y.o. male with a PMH of COPD, HLD, hypothyroidism, HTN, DM, and corectal cancer. Patient presented to the ED for generalized weakness and fatigue x 1-2 days.  Stated prior to coming to the ED he had a mechanical fall. + Dry cough that started 1 night PTA.  + SOB, mildly worse than his baseline.  + Conversational dyspnea; patient stated that is his baseline 2/2 to his COPD. + BLE edema; unchanged from baseline per patient.   The patient was admitted for further evaluation and management. He had a positive urine culture for enterococcus. He was initially treated with Rocephin, then Zosyn prior to changing to Amoxicillin 1 g PO TID to complete a 7 day course. The patient was also positive for Covid. He was given dexamethasone in the ED, and Regeneron on 10/29 with subjective improvement in symptoms per patient. Cardiology was consulted for new onset afib. The patient's metoprolol was increased to 100 mg daily and they recommended a Ziopatch which was placed prior to discharge. He was also started on Lovenox during his admission and changed to Eliquis at time of discharge. Prior to discharge, the CM arranged additional services as the patient will be quarantined through 11/11 and lives alone.   The patient was eating and ambulating at the time of discharge. Answered all questions and the patient was comfortable with the discharge plan. Medications as listed below. The patient will follow up with Dr. after his quarantine ends.
temperature excursion; This spontaneous report was received from a registered nurse and refers to a 4-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 18-DEC-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD), lot# T021638, expiry date was reported as 21-FEB-2021, but upon internal validation established as 21-DEC-2021 (formulation, strength, dose, dose number, route of administration, anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of -13.3 degrees Celsius for 4 hours 15 minutes. There were no previous excursions related. Data logger was involved.
DIZZINESS, HOT, BURRY VISION. PATIENT WAS GIVEN COLD WATER AND A SMALL PIECE CANDY
PATIENT CALLED THE EVENING OF 8-23-22 AND WAS CONCERNED THAT HER ARM WAS STILL PAINFUL AFTER ONE WEEK, MENTIONING THAT HER PAIN HAD BEGUN THE DAY OF THE INJECTION AND WAS STILL OCCURRING ON 8-23-22.  SHE ALSO WAS QUESTIONING IF THAT LENGTH OF TIME WAS NORMAL.  SHE ALSO STATED THAT SHE WONDERED IF IT WAS POSSIBLE THAT THE IMMUNIZER HAD HIT THE BONE.  I ADVISED HER THAT WHILE IT WAS UNUSUAL FOR ARM PAIN TO LAST THAT LONG AFTER A VACCIANATION, IT WAS NOT UNHEARD OF AND ADVISED HER TO CONTINUE TO MONITOR THE SITUATION, TAKE OTC PAIN RELIEVERS, USE COLD OR WARMTH, AND WATCH FOR WORSENING SYMPTOMS.  I DID VERIDY WITH THE PATIENT THAT SHE HAD MOBILITY IN THE ARM BUT THAT IT STILL HURT WHEN SHE MOVED IT.  SHE WAS ADVISED TO CALL HER PHYSICIAN IF SHE WAS NOT FEELING BETTER IN ANOTHER DAY OR SO.  I ASKD HER IF THE PAIN WAS THE SAME, WORSE, OR LESS THAN THE FIRST DAY AND SHE WOULD ONLY STATE THAT IT STILL HURT AFTER NEARLY 7 DAYS AND NEVER HAD WITH OTHER VACCINATIONS IN THE PAT.  i PHONED HER ON 8-24-22 (THE NEXT DAY), AT ABOUT 11:30AM TO ASK IF SHE WAS FEELING ANY BETTER AND THE PATIENT RESPONDED THAT SHE DID BELIEVE THAT THE PAIN WAS LESS AND THAT HER ARM WAS FEELING BETTER.  THEPATIENT THANKED ME FOR THE CALL AND I AGAIN ADVISED HER TO FEEL FREE TO CALL US BACK WITH ANY OTHER CONCERNS OR TO REACH OUT TO HER PHYSICIAN.
Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. Information about the patient's pertinent medical history and drug reactions/allergies was not reported. On 09-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L049536, expiration date 08-DEC-2017, dose and route unknown). Concomitant medication was not reported. No adverse effect was reported. The vaccine was exposed under 36 F for 2 hours and 7 minutes without previous temperature excursion. The call was because of data logger. This is one of several reports received from the same source. Additional information has been requested.
Patient experienced nausea/vomiting, lightheadedness/faintness, and multiple falls. Patient has not gone to the hospital yet but will do so if symptoms worsen
Patient had vaccine on Monday and Noticed Tuesday that he has redness and swelling of the upper arm. Patient states that the ability to move the upper arm was decreased. Area around the elbow is warm to touch. Patient has a 15 cm erythema area that starts at elbow and radiates upward.
Pt. received vaccines around 10:30am 12-16-10, pt went home ok. Next morning mom came back with pt and stated that pt developed fever at night and a generalized seizure lasting for a few minutes & subsiding when taken to the ER. Pt was given ROCEPHIN inj in the ER.
swollen lymph node under his left arm; I feel tingling in my arm; I turn my neck to the right side, I feel like little pain on the neck side; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231) via an unspecified route of administration on 23Jan2021 at a single dose for COVID-19 immunization. Medical history included blood pressure (abnormal) and diabetes. Concomitant medication included lisinopril for blood pressure, amlodipine, atorvastatin and metformin for diabetes. The patient previously received first dose of BNT162B2 on 02Jan2021 for COVID-19 immunization. The patient had his second shot of his COVID 19 vaccine and then the first day was okay but the second day (24Jan2021) was, he had like swollen lymph node under his left arm. And also, he felt tingling in his arm. And when he turned his neck to the right side, he felt like little pain on the neck side. "I don't know if this will go away or what. This is the third day I had the vaccine." Consumer stated, "I took Ibuprofen." The patient underwent lab tests and procedures which included lab on an unspecified date with unknown results (the patient don't have it, his primary care have it). Outcome of the events was not recovered.
Child was12yo and was given a pediatric dose of COVID vaccine instead of the adolescent/adult dose
swelled immediately after the shot and was given 2 benadryl before leaving the drive through. Experiened chills, fever and was vomiting all night. Feeling tired and dizzy afterwards and ever since.
redness, pain, swelling at injection site, muscle ache, fever and chills - treatment unknown
Absolutely no symptoms in the hours immediately after the shot.  About a week later at approx. 2am on Wednesday 14th April I woke in the night and felt that my left armpit was tender/swollen/ached.  When I woke up later in the morning of Weds 14th (around 7am) I noticed a circular swelling around my vaccine site. The site itched.  I woke up on Thursday 15th April at around 8am and found that the area of  swelling/redness/itching has increased in size, but has remained situated above my elbow.   I also woke up with an unusual headache. The itching comes in waves every 30 minutes or so.  The site feels hot to the touch and also feels like it's radiating heat.  I took ibuprofen and Benadryl and both appear to have helped with the headache and the annoying itching.
Complained to n school nurse of itching. Nurse said arm injection was given and was red around site, warm to touch. Seen by nurse 12-10-09.
Lips and eventually tongue began to tingle and feel slightly numb and thick.  Was not a significant incident. Lessened a bit by the time my 30-minute observation concluded. Took about 1.5 hours from time of vaccination to time lips and tongue were back to normal.
08/30/2002- swollen arm, slight fever. Benadryl/ Tylenol/ Cool compress/ Elavate arm
Patient received her 3rd Booster as Pfizer Bivalent and within 15 minutes was complaining of "significant Nausea and Abdominal Pain" and was leaning against the check in window.  Nurse was called to assist and  she was taken to a room.  RN assisted her to room and noted she was not SOB but seemed weak. She had another RN come get me to help evaluate her. Once I was in there 1st RN obtained VS equipment and started evaluation. I, FNP-BC came in and due to her Pulse ox being a little on low side at 95% asked her if she had COPD and she reported that she did and was not on oxygen. Patient was in no apparent distress.  Lungs were evaluated and seemed to be clear and patient able to take deep breaths.  Throat visualized and no swelling was appreciated.  PCP office notified of patient status and patient advised to follow up with PCP. VAERS report filed as well.  Patient was assisted out to her car after about an hour and her BP had come down and she was feeling better. She had also admitted she hadn't anything to eat since AM so she was provided with water and crackers and she felt better after awhile.  Finally I did write down her BP's for her and provided her a card.
Initial pregnancy report received from a healthcare professional on 23 JULY 2013. A 33-year-old female patient, whose medical history and concomitant medications were not reported, had received first dose of ADACEL (lot number: U4617AA, expiry date 22 OCTOBER 2015, anatomical site of administration was not reported) intramuscularly on 22 JULY 2013. The patient's last menstrual period date was 08 NOVEMBER 2012 and expected date of delivery was reported as 15 AUGUST 2013. Laboratory investigations were not reported. As of the time of this report, the patient did not experience any adverse event. List of documents held by the sender: none.
ringing in the ear; very frustrated; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS, FRUSTRATION TOLERANCE DECREASED, and DIZZINESS in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced TINNITUS, FRUSTRATION TOLERANCE DECREASED, and DIZZINESS. At the time of the report, TINNITUS had not resolved and FRUSTRATION TOLERANCE DECREASED and DIZZINESS outcome was unknown.            Concomitant medications were not reported.  Patient had ringing in her ears since last spring, and there was no cure for it. She was very frustrated because it happened every single day. She never had it before she had the first Modern dose. She stated she would not be taking a third one.  The patient stated that she had to pay for lipoflavonoid.
Patient had an allergic reaction to vaccine. Redness on arm and swelling. Also secretion from injection site.
she did not dilute the Pfizer COVID-19 vaccine orange cap when she gave the vaccine to the patient; she did not dilute the Pfizer COVID-19 vaccine orange cap when she gave the vaccine to the patient; only side effect was that he was very sleepy that day, otherwise the was fine; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  An 11-year-old male patient received BNT162b2 (BNT162B2), on 06Jul2022 as dose 1 (orange cap), single (Batch/Lot number: unknown) at the age of 11 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SOMNOLENCE (non-serious) with onset 06Jul2022, outcome "unknown", described as "only side effect was that he was very sleepy that day, otherwise the child was fine"; PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 06Jul2022, outcome "unknown" and all described as "she did not dilute the Pfizer COVID-19 vaccine orange cap when she gave the vaccine to the patient".  Additional Information: Patient went to get the second dose of the Pfizer COVID-19 vaccine orange cap. Patient got the undiluted dose before.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Headache started after about 4 hrs increasing gradually becoming severe after about 8 hrs and continuing through the night.. restless night. Arm sore at night but less sore this time and subsided by dawn. Flu like symptoms next day, nausea, fever, pain in calf muscles and around hip. Mild exercise. 10 hr sleep night of day-02. Regular exercise. Body returned to normal when awake.
Swollen lymph node in armpit. Painful to touch. Tender. Size of testicle. In my armpit! Gross.
Phone call received from patient's mom on Monday 12/17/18, stating that he had had a fever, joint and muscle aches, lethargy and fatigue on the two days following vaccination, 12/15-12/16/18. He also had significant redness, swelling, and pain in the R arm, in which he had received HPV and Meningococcal vaccines. Mom took him to a local Urgent Care. He was afebrile at visit. Chart notes state "The patient presents with a chief complaint of constant pain of the upper right arm since Friday, December 14, 2018. Pt with an erythematous growing painful rash that is expanding. R shoulder with a 4 cm x 6 cm area of erythema and bright red, with TTP (tenderness to palpation?) that is mild. No crepitus, fluctuance. No pain out of proportion. There is increased warmth. No streaking. Diagnoses: cellulitis of right upper limb".
Pt states develop what looks like shingles on the site of injection, however no blister. The area redness and swelling subsided now. She took ibuprofen for pain and redness. She has felt fatigue and feels like she's sleeping more than usual. Her fatigue is ongoing and wondering how long this fatigue feeling will last. Advise patient myalgia and fatigue may last for a week.
At 11:50 am patient received COVID 19 Pfizer vaccine, asked to remain in waiting area for 30 minutes due to a severe allergic reaction to Phenergan in the past.  At 12:10 pm she stated she felt a lump in her throat. No hives or swelling noted at this time. Benadryl 50 mg administered PO. PA & physician came and assessed, patient stated the symptoms were getting worse and she felt her throat closing.  Administered Epinephrine 0.5ml at 12:25 pm. 991 was called. Second dose of Epi was given at 12:40pm EMS arrived at 12:41pm and transported to Emergency Room.  Observed in ED for 2 hours and then discharged home, no additional symptoms or treatment noted.
Described slight left side facial drooping (visible to her, but husband does not notice), upper lip "vibrating" and "tingling". Feels like it is traveling to lower lip.
Received shot at 8:30 AM. Side effects started around noon with chills, shakes, headache, and fever. Vomiting that night around 11:00 PM.
Immunization update secondary DM. Hep A #1, PNEUMOVAX administered (L) arm Hep B #1 (R) arm at appt. 12/5/12. PM sx of local rxn left arm red swelling & nausea & fatigue 12/6/12. Tx Amox.
Within 5 min my mouth tingled and felt my tounge felt bigger.   Metallic taste in my mouth.   Happens when I eat shrimp.   Did not report after 1st vax.  But did notify staff after the 2nd vax. Because it was very predominant.   They watched me for over an hour.    3-4 days after the 1st and 2nd vac I developed severe epigastric pain and severe N/V.    I?m a CRNA.   I now believe I had an inflammatory response to the vaccine and I had pancreatitis.    Lasted about 5 days each time.
Herpes outbreak on lips and inside mouth. Began two days after vaccine and continues to worsen today, three days after vaccine.
The patient received her second dose of Moderna too early.  She did wait the 28 days between the two doses.
The adverse events was a reaction that began 5-6 days after the vaccine in the site of vaccination. There was a red indurated stripe of inflammatory swelling extending from the upper deltoid at the site of vaccine to the mid upper arm. It was itchy and tender.
TENGO UNA BOLA DURA  Y UNA RONCHA ROJA DE 3"3 Y ESTA CALIENTE , EN MI BRAZO DERECHO DONDE ME VACUNARON
Shortly after injection felt dizzy, itchy and had shortness of breath. Dizziness & itchiness went away in 24 hrs. Shortness of breath lasted 2-3 days and was treated w/ an inhaler.
t104 on 2JUL followed by rash x 3 days; second rash on 10JUL-no fever
Mild rash / slept it off; So tired they slept; This case was reported by a nurse and described the occurrence of rash in an unknown number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash and tiredness. On an unknown date, the outcome of the rash was recovered/resolved and the outcome of the tiredness was unknown.   It was unknown if the reporter considered the rash and tiredness to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not applicable for this report. It was reported that the patients had experienced a mild rash following Shingrix and then slept it off.  The reporter believed it occurred after the second dose. These patients were so tired they slept and by the next day the rash was gone. The reporter didn't think it was of any severity because they didn't report it. They just mentioned it. No information was available regarding patients or product (lot/expiry dates). The reporter consented to follow up.
Body aches; Headache; Fever 100; Painful injection site; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced general body pain, headache, fever and injection site pain. On an unknown date, the outcome of the general body pain, headache, fever and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the general body pain, headache, fever and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The age group of the patient was not reported but selected as an adult as per vaccine indication. The reporter stated that, after vaccination with Shingrix, experienced Body aches, headache, fever 100, painful injection site. The patient asked about how long side effects from shingrix to last.      Lab Comments: lab test performed on an unknown date
Immediately after IM injection, pt developed arm numbness, weakness along with rash at injection site.  Pt's symptoms gradually improved over 30 minute monitoring period.  Denied any CP, SOB, abdominal pain.
Patient stated she had immediate shoulder pain which she attributed to normal injection site reaction. Pain did not recede, and patient required physical therapy and medications to manage. Stated potential need for surgery in future
syncope 10min later;closed head trauma @ fall;bradycardia <- 40-02 applied & transported to ER in arms;
This spontaneous report as received from a pharmacist refers to a 71 year old female patient. None drug reactions or allergies reported. On 02-AUG-2014, the patient was vaccinated with ZOSTAVAX lot # K007177, expiry date: 21-AUG-2015, single dose, subcutaneous in the left arm. Concomitant therapies included aspirin. On 03-AUG-2014, the patient experienced a sore, hard knot at the injection site. The knot was initially the "size of the bottom of a glass", but was now getting smaller and less sore. No treatment was given. The patient sought medical attention by calling the pharmacy. None lab studies were performed. The patient present status was reported as recovering. Causality was not reported. Additional information is not expected because the reporter refused further follow up.
expired dose administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   On 26th October 2022, the patient received the 1st dose of Havrix. On 26th October 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 27-OCT-2022 Reporter's Comment: The reporter did not provide patient information. The reporter reported that, expired dose of Havrix was administered to a patient. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. Additional Supportive Information: The reporter reported that, expired dose of Havrix was administered to a patient, which led to expired vaccine used.
Began having headache morning of 12/30/2020 Arm pain at injection site with multiple nodules under skin surrounding area. Headache continued through 01/02/2021 - no improvement with Tylenol, Motrin. Joints locked up in hands and feet 12/31/2020 Severe hip pain, reduced by 01/02/2021. Arm pain continued for one week after vaccine administration, along with intermittent headache of varying intensities and durations. Joint discomfort remains as of 01/12/2021.
Swelling in body. Particular face and eye. One one is completely shut. Lots of discomfort and inability to work. Can send a picture. It has not started healing yet. Swelling is still very high.
Pt developed bruise 8 inches long and 3 inches wide on arm between elbows and wrist on same arm as Flu shot less than 2 hours later. Bruise is 15 inches away from Flu shot injection point. There is a pen sized knot and pt states there is no discomfort.