chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via company representative refers to a 22 year old female patient. Information on the patient's medical history, drug reactions, allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dosing details and batch/lot number and expiration date unknown) for prophylaxis. It was reported that the patient received two doses of GARDASIL (inappropriate schedule of drug administration), which the patient described as the full (human papillomavirus) HPV vaccination. Either on 21-AUG-2018 or 22-AUG-2018, did a first time pap smear on the patient and showed positive for HPV (papilloma viral infection) low grade SIL (cervical dysplasia). The patient did not received any treatments for the events. On an unknown date, the patient sought medical attention to doctor's office. It was reported that the patient was sexually active and asymptomatic. Outcome of the events was unknown. Causality assessment was not provided. No product quality complaint was involved.
90mm red, swollen, area at injection site- No fever; mild tenderness- treated with cold packs and Motrin.
Patient is a 75 y.o. male who presented with general malaise, sore throat, dry mouth, subjective fever and chills, poor PO intake for past 1-2 weeks. His friend was concerned he was so sick and contacted his doctor and encouraged evaluation in the ED.  In the ED he was found to be febrile with temp 38 and O2 saturations 90% and above on room air.  Significant workup included BUN 23 creatinine 1.6 (previously BUN 13 and creatinine 0.86).  COVID-19 PCR was detected. Patient had been vaccinated, but not boosted. CT angiogram thorax showed findings consistent with viral pneumonia due to COVID.  There was no pulmonary embolism.  He was given gentle fluid bolus, Zofran and Tylenol. On admission, he was started on IV fluids for presumed prerenal AKI due to poor oral intake, however kidney function did not improve. CT scan of the abdomen did show distended urinary bladder and mild prostatomegaly. Straight catheterization was attempted to assess for urinary retention but catheter was unable to be advanced. Urology was consulted and able to place a Foley with subsequent drainage of 1300 mL of urine. Kidney function also subsequently improved and returned to normal. Urology recommends leaving Foley in place for 7-10 days and will arrange follow up for patient in office for removal. Of note, patient has known left renal mass that Urology recommended be evaluated. However, patient adamantly has refused and understands that this could result in death as it could be malignant. Patient continues to refuse. Urology attempted to contact guardian to discuss this, and guardian was unable to be reached. Patient remained stable from a COVID standpoint on room air and was discharged home in stable condition.
Patient reported a circular red itchy area, slightly raised, around injection site. Said that it started today.  Has not treated the reaction at this time.
Face was red and hot right after. When I got home I checked my blood pressure, it was 190/111 and heart rate was 102.
If I perfumed I can''t smell it; if I eat the food I can''t taste it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 17Sep2021 (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: ANOSMIA (non-serious) with onset Sep2021, outcome "unknown", described as "If I perfumed I can''t smell it"; AGEUSIA (non-serious) with onset Sep2021, outcome "unknown", described as "if I eat the food I can''t taste it". Additional information: Consumer stated, "had got the vaccine like first shot probably three days ago, don't know if its normal to loose my (Incomplete Sentence).  Follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Not being able to sleep at normal bed time; Fall asleep during the day; Circadian rhythm seem to be disrupted; no energy during the day; fatigued; wide awake at 9 to 10pm; This is a spontaneous report from a contactable (consumer). This 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN5318) via an unspecified route of administration in the left arm on 30Jan2021 at 09:15 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included multiple vitamins from unknown dates for unknown indications; the patient also reporting starting ixekizumab (TALTZ) 2 weeks after vaccination for an unknown indication. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported not being able to sleep at his normal bedtime and falling asleep during the day; further reporting his circadian rhythm seemed to be disrupted; awake and energetic at night, sleepy and no energy during the day. He reported it started 2 days after the vaccine and had been getting worse. Three weeks since the vaccine he was wide awake at 10PM, normal bedtime, could not sleep until 5 or 6AM then slept for 6 or 7 hours. He reported being wake and very fatigued during the day and getting wide awake at 9 to 10PM. The events were reported as non-serious and did not require hospitalization. Treatment was not provided for the events. The clinical outcomes of not being able to sleep at normal bedtime, falling asleep during the day, circadian rhythm seemed to be disrupted, no energy during the day, fatigued, and wide awake at 9 to 10PM were not recovered. It was also reported the patient was not tested for COVID-19 since vaccination.
Adverse Events: pain, swelling, warmth at site of injection as well as up to 4" below injection site Treatment: Acetaminophen Outcome: Still swollen but beginning to improve
Evening.  Shooting pain down arm got flu shot. To wrist. Transient, severe pain. Tingling in both hands as well as lips tingling. Sore throat and chest feels heavy. Increased fatigue.
10/21, she began to feel very tired and had a headache.  10/22, she worsened and spiked a fever at 104.  Mother treated with medications and essential oils and she was better the next 2 days.  Fever returned 10/25, and rash appeared that evening.  Rash worsened overnight despite Benadryl.  10/26, PA at an Urgent Care diagnosed her with Measles.
fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medication included, a blood thinner was reported.   Treatment information was not provided.  Patient stated that the fatigue was due to something else and she is fine now.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: The event outcome has updated to Recovered from Not recovered.
Started with chills in the evening of the day of my vaccination, had body aches, headache and fever of 102 by the next day at 2 pm.
Ten minutes after getting the second dose of the vaccine I was sitting waiting. I felt like I couldn't get enough air. Suddenly I felt like someone was standing on my chest. I felt like I needed to go outside and get air. The doctor came over and I was taken to the ER. I did not take Benadryl because I had to drive home. I felt like I was slipping in and out of consciousness. I was observed but not very often but I was not given anything else. I was discharged after three hours and I managed to get myself home. The day after the vaccine I had a low grade fever, severe body aches and lack of appetite. It lasted for thirty six hours.  I had bad pain in my arm for five days. My arm was also swelled up for a week which started a week after the shot. It was swollen up like I had cellulitis.
adult dose / administrated to 4 year old male; adult dose / administrated to 4 year old male; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 4-year-old male patient who received HBV (Engerix B adult) (batch number h2t35, expiry date 29th May 2022) for prophylaxis.   On 10th August 2021, the patient received Engerix B adult. On 10th August 2021, unknown after receiving Engerix B adult, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.  Additional details were provided as follows: The nurse reported that an adult dose of Engerix-b was administrated to 4 year old patient, which led to overdose and adult product administered to child. No adverse event was reported. The reporter consented to follow up.
Shot given at 16:00 and child, immediately, became ? in car on ride home and then slept until 06:30 the next day; (febrile illness began 4 days later).
Approximately 4-5 hours after my 2nd dose vaccination I experienced the following symptoms: I broke out with hives (It was really itchy). I went to the doctor the next day and he advised me to just wait it out and prescribed me with a cortisone cream. It took me about 1 week to get rid of, then I was back to my normal self.
10/17/2003: Mother reported swelling of left arm.  Stated she had not given her Tylenol or tried ice to site.  Nurse recommended Tylenol or Motrin every 4-6 hours with ice to site.  10/20/2003: Mother in clinic-states she took child to ER 10/17/2003 PM-is on antibiotic and Motrin.  States arm was swollen from her shoulder to wrist left arm was slightly warm to touch with moderate swelling at injection site.
A legal complaint was received on 2/12/02 from an attorney concerning a male child who received injections of Hib-titer, Tri-Immunol, Recombivax HB, and DTP vaccines during the time frame from December 1996 through February 1998. The legal complaint stated that "as a result of the mercury in the timerosal containing vaccines, he subsequently experienced toxic neurological effects of mercury poisoning, including but not limited to autism." These events were considered medically important (OMIC).
Pt states shingles lesion occurred 3 days after vaccine given on (R) ear auricle - It was "painful and lasted for 5 days."
Within 8 hours I became extremely fatigued I went to bed early and stayed in bed the entire next day. I was too fatigued to get up. Over that weekend, I was continuously tired but not so much that I had to lay down. The worst of it was in the first 36 hours after which it resolved.
Within 50 minutes, I started experiencing that facial numbness. After that, I got the arm pain about 3 hours in - not as painful as last time. I was tired. I got a really bad headache that evening and I took Tylenol for it. When I went to sleep, I didn't have a temperature - at one point - it was 96. something. All night I felt hot and feverish internally. I had body aches, groggy, tired and my muscles hurt like I'd worked out - for the next three days. I felt feverish randomly for the next couple of days as well. The facial numbness only lasted about an hour. Still am  experiencing irritation under my axilla from the first reaction to the vaccine.
Information has been received from a physician concerning an 11 year old female, who was vaccinated with Gardasil. On 12-NOV-2007 the patient experienced flu-like symptoms. She was very pale, feverish, lethargic and throwing up. The patient's symptoms persisted. The patient did not have this reaction to her first or second dose. Additional information has been requested.
Small rash of hives around the area of injection and some itching "inside" his ears.
Experienced immediate rapid heartbeat, dizziness, followed by swelling of my lips, congestion b/w my right ear and eustacian tube, wheezing, heart palpitations, elevated BP.  Given 25 mg of Benedryl immediately and then following by 25 more at one half hour.  Had to wait in a emergency Tent for an hour to an hour and 15 minutes for all symptoms to resolve.  Took Benedryl 4 hrs later for lips that continued to swell. Some more heart palpitations the rest of the day, but these resolved. Did not have to go to the emergency room, but did have to stay in the emergency tent.
Patient is breastfeeding her 5 month old son. Two nights after her 1st Moderna dose, he had violent vomiting, diarrhea, body rash, and hematuria.
first shot, on and off dizzy, lightheaded,  a bit nauseou  2nd shot,  heart tightness, fullness,  some tingling in fingers,
Grand Mal seizures; Dose 1 on 25Mar2021, Dose 2 on 08Apr2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 14:00 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient was not pregnant when administration. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, lot number unknown, administration time=02:00 PM), administration date: 25Mar2021, for Covid-19 immunization. The patient didn't receive other vaccines in 4 weeks. The patient was not diagnosed with COVID-19 prior to vaccination and she has not been tested for COVID-19 post vaccination. The following information was reported: GENERALISED TONIC-CLONIC SEIZURE (hospitalization) with onset 08Apr2021, outcome "not recovered", described as "Grand Mal seizures"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 08Apr2021 14:00, outcome "unknown", described as "Dose 1 on 25Mar2021, Dose 2 on 08Apr2021". The patient was hospitalized for generalised tonic-clonic seizure (hospitalization duration: 3 day(s)). Levitrecem was taken as a result of generalised tonic-clonic seizure.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Heart beat is felt when laying down Not tachycardia Not detectable on EKG No heart arrythmia
Information has been received from a health professional concerning a 61 year old female who was vaccinated with pneumococcal vaccine 23 polyvalent (lot 633102/1217J). Subsequently, the pt experienced injection site redness and blistering. Medical attention was sought. No further information is available.
had antibody titers drawn that showed the patient is not protected; This spontaneous report as received from a nurse and refers to a 17-year-old male patient.  His concurrent conditions, medical history and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with all 3 doses of hepatitis B vaccine (recombinant) (manufacturer unknown) (dose, route of administration, lot # and expiration date were not provided) for hepatitis B prevention.  On an unknown date. the patient had antibody titers drawn that showed the patient was not protected. It was not confirmed if the patient was originally vaccinated with hepatitis B vaccine (RECOMBIVAX) or another hepatitis B vaccine, because the reporter did not have the patient's previous records. The patient sought medical attention. He received treatment for the event, he was being revaccinated. No additional information was available. The outcome of the event was reported as not recovered.  The causal relationship between the event and of hepatitis B vaccine (recombinant) (manufacturer unknown) was not reported.
Pt phoned to report onset of flu-like illness 22OCT91, 1 wk p/receiving flu vax; pt reported to work 22OCT, but was unable to work next 3 days; c/o fever, sore throat, dec appetite;
Tuesday morning, I woke up with a pain. It was in my upper stomach area. I thought it was gas, so I tried to sleep it off. I told my wife that I needed to go to the hospital because I was vomiting every hour. I went to the emergency room. They performed a CT scan because they thought there was a blockage, but it was clear. When they got to my appendix, they noticed that it was starting to change. They performed an appendectomy the next morning, but they did keep in the hospital overnight. I was in there for about four days. They noticed that I have a lump on my spine. They performed an MRI with dye and said that it looked benign. I have to go back in six months to check for any growth progress. As of today, I feel great.
Pain in arm and fatigue 1-2 days after receiving vaccination. Was 12 weeks 2 days pregnant on vaccination date, estimated due date of 9/27/2021. Fetus confirmed healthy day prior to vaccination via ultrasound on 3/18/2021. Had routine prenatal check on 3/31/2021 and fetal heartbeat could not be found. Fetal demise confirmed via ultrasound the same day, 3/31/2021.  Estimated fetus age at demise was 13 weeks 1 day.
Became dizzy, light-headed, no loss of consciousness but BP slightly low. Had client lie down. Complained of gas pains. Client felt fine after half hour. Next day mother called to say child running 102-103 fever, severe headache, nausea. Vomited once on 7/1 and twice on 7/2. Advised to call family doctor/emergency room and to call back. No return call to see how child doing. Called again 7/6 with no return call from parent.
8x6 cm redness with about 4cm no indurated center left upper arm with Dtap site non tender no fever not ill.
Patient was administered the Moderna (1st dose) vaccine. She stayed in the pharmacy area for 15 minutes and then decided to shop. While shopping she experienced difficulty breathing and throat tightening. Patient came back to pharmacy and described her symptoms to pharmacist. She was having an allergic reaction. Patient has many allergies and had an epi-pen with her. She administered her epi-pen herself. Management called EMS and the paramedics took over.
facial paleness/ patient's lips went a white hue; dizziness/ woozy feeling; do not feel good.; This spontaneous report was received from a medical assistant, via Company representative, referring to a 13-year-old female patient. Information regarding the patient's medical history, concurrent conditions and concomitant therapies was not reported.   On an unspecified day in 2023 (reported as "on an unknown date this past week"), the patient was administered the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliters administered intramuscularly in the left deltoid (lot number X005044 has been verified to be valid, expiration date reported and established as 02-JAN-2025) for human papillomavirus (HPV) prevention.   The patient was laying down when the vaccine was given, and after giving the dose she was on the way to sit in the waiting room. Then, she began to have symptoms of facial paleness, her lips wen a white hue (pallor), she had dizziness, and woozy feeling (dizziness). In addition, the patient stated that she did not feel good (malaise). Hence, she was given water as a treatment. Once she was feeling better, her vital signs were checked, and all were within normal limits. At the time of the report, the patient had recovered from the events.  The reporter's causality assessment was not provided.   This is one of three reports received from the same reporter. ; Sender's Comments:  US-009507513-2308USA003477: US-009507513-2308USA003553:
Patient began having eye pain and redness on one side of face. She began vomiting and was getting weak. I called paramedics and sent her to the ER.
I started running a fever on Nov 29th.  I developed a sore throat and body aches.  I was very fatigue.  I had a lot congestive and the developed into a dry cough.  I had pain in my ear, chest and sinus. These symptoms are ongoing till today.  I went to the clinic to get test for strep and flu. (Both was negative)
About one minute after receiving vaccine passed out and struck head against wall at the front desk. Patient regained consciousness and was A/0 x 3.
Severe body aches, headache, pain under arms, pain at injection site and could not lift arm for 26 hours
pain in groin area; hard to walk on my right side; pain in joint,pain in knee area; This spontaneous case was reported by a consumer and describes the occurrence of GROIN PAIN (pain in groin area), GAIT DISTURBANCE (hard to walk on my right side) and ARTHRALGIA (pain in joint,pain in knee area) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced GROIN PAIN (pain in groin area), GAIT DISTURBANCE (hard to walk on my right side) and ARTHRALGIA (pain in joint,pain in knee area). At the time of the report, GROIN PAIN (pain in groin area), GAIT DISTURBANCE (hard to walk on my right side) and ARTHRALGIA (pain in joint,pain in knee area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants medication were provided. No treatment medication were provided. No lab data has been provided by the reporter.    This case was linked to MOD-2021-245626 (Patient Link).
Tachycardia, Nausea, Burning Feeling bilateral arms, lightheaded, itching upper legs, Temp 96.5, increased BP 154*114 - 180/110 monitored 5 hours.
In October 2022, I noticed that both sides of my throat were hurting, swollen, hard to swallow. I went in to see my doctor a few times about this eventually I was referred to an ENT. After both my primary care physician and the ENT prescribing many rounds of antibiotics for tonsillitis, we have determined this is a new normal for me. My left ear had also started ringing during this time my tonsillitis started. I was diagnosed with tinnitus. In November a significant amount of hair loss. I went to my primary care physician about this, he suggested I try taking biotin supplement. So far it has not helped. I do have next week to be tested for alopecia.
pt recv vax 13NOV96 & 14NOV96 pt devel an inj site rxn 3inches in diameter w/redness, induration & erythema;pt seen in MD ofc 15NOV96;pt exp aches, malaise & nausea;