chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse practitioner concerning a female who in June 2008 was vaccinated with the first dose of GARDASIL (route and LOT# not reported). At the time of the reporting, it was reported that the patient currently had an odorous vaginal discharge. On 12-NOV-2009, she would received the second dose of GARDASIL (route and LOT# not reported). Unspecified medical attention was sought in the office. The patient's outcome was not recovered. Follow-up information has been received from the nurse practitioner who indicated that the patient received the first dose of GARDASIL at another office and she planned to follow up with a primary care office. The nurse practitioner stated that they told her to get it as soon as possible. The culture test haemophilus influenza was performed on an unspecified date and results not provided. The patient was treated with METRONIDAZOLE. The nurse practitioner doubted the adverse events were related to GARDASIL. The patient's outcome was unknown. Follow-up information has been received from the nurse practitioner who reported that they had just called Merck and to see if it was too late for second vaccination. The patient had bacterial vaginosis at time of vaccination. The patient had not had the second vaccination and she would get the second and third vaccinations in 12 weeks. The patient was taken METRONIDAZOLE, 500 mg, BID X 7 (days) for foul smelling discharge. It was noted that foul smelling discharge was not related to vaccination. No further information is available.
Severe pain, chest.  By Friday, 10/18/2013, blisters appeared on chest, left side, and back.  Diagnosed as shingles.
1:30 pm client complaining of "lungs hurting", cough, pressure in the head, ears.  5:30 pm fever of 103 F, lips and eyes swelling, difficulty breathing.  She took 6.25 mg of Benadryl and motrin.  Fever broke at 11:00 pm and has not had one since. Lips still swollen today.
swollen lymph node left supraclavicular approx. 30 hours post injection, mildly tender, on same side as vaccination
I had my period two weeks ago and fell on it again. It?s really heavy and contains lots of clots. Menstrual cramps.
Right arm swollen, hard, reddened area about 4", fever 100.1. Rx with Tylenol and cool water soak at home.
Pt reported rash and soreness around the site of injection. Rash decreased in 1 day but still red lower region of side arm.
6 HRS AFTER VACCINE, FEVER AND SEIZURE(LEFT FOCAL SEIZURE)
Coughing/cough has worsened; Tiredness; Sinus congestion; Runny nose; Dizzy; Didn't feel well; Sneezing; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3246; Expiration date was not reported) on 09Jan2021 (11:00) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at a clinic (not a military facility). Medical history included ongoing rhinosinusitis from 2019; ongoing allergy multiple; bronchitis from Mar2020; upper respiratory tract infection from Mar2020; sleep apnea; bipolar depression; and post-traumatic stress disorder (PTSD). There were no concomitant medications. On 09Jan2021 (06:00), the patient had sinus congestion and runny nose. On 09Jan2021, the patient was dizzy. On 10Jan2021, the patient was coughing, and then cough was reported to have worsened; and had tiredness. In Jan2021, the patient did not feel well; and was sneezing. The patient had used a nose rinse with an alcohol rub, and took and Epsom salt bath, and had some soup as treatment for the sinus congestion and runny nose. The patient had two COVID-19 virus tests on unspecified dates, and both were labeled as inconclusive. The outcome of the events was not recovered for 'sinus congestion', 'runny nose' and 'cough/cough has worsened'; and was unknown for 'dizzy', 'tiredness', 'did not feel well' and 'sneezing'.
Pt developed an area of erythema and induration that covered the entire lateral aspect of her left arm. Some areas urticaria. Given Benedryl and cold compresses.
Patient received 1st shot on 10/31/02. On 11/7/02, patient noticed a large knot on back of arm about size of medium apple. Noticed a black/blue mark at injection site. Patient stated noticed hot flashes since received shot.
Headache, Angina & sore throat ALTEPLASE 2 MG ONCE left upper arm@ 12/17/20@1522
Patient came in to get a flu shot at a vaccine clinic at her employment. When she signed up, she put her age on the form as 74 thus we gave Fluad. On data entry at the pharmacy, actual patient's age is 64.  Patient was contacted and notified that she was given the dose that is intended for 65+. We told her to let us know if there are unusual side effects from the vaccine that she will notice.
Body that itches really bad; Breaking out in a rash on her arms; This is a spontaneous report from a contactable consumer (patient) via the Regulatory Authority. A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: FA6780; expiration date: 01Sep2021), via an unspecified route of administration, administered in the left arm on 23Jul2021 (at the age of 69-years-old) as dose 1, single for COVID-19 immunization. Medical history included lupus and thyroid disorder. Concomitant medications included gabapentin, prednisone taken for lupus, and SYNTHROID taken for thyroid disorder. The patient reported that she received her first dose of BNT162B2 vaccine on 23Jul2021. The following day on 24Jul2021, the patient experienced a breaking out in a rash on her arms and body that itches really bad. The patient was taking Benadryl at night, so that she doesn't wake up itching. The patient was also using poison ivy medicine to try and relieve the rash and itching because she doesn't know what else to do. The patient wanted to know how long does the side effects last and if she should get the second dose scheduled for 23Aug2021. The patient was also wanted to know if she does get the second dose, will the side effects be even worse. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
myocarditis presented with chest pain. elevated troponins to 16,263 pg/mL, viral studies negative. MRI showed revealed late gadolinium enhancement involving the basal inferior, basal to mid inferolateral, mid anterolateral, apical lateral, apical septal, and apical inferior wall segments in a subpericardial distribution pattern, consistent with myocarditis
muscle soreness, redness of skin at injection site and skin around site ~6sq in in size I do have photographs of the redness
sore arm on injection after first shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm on injection after first shot) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03DMD0A and 621B217.) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm on injection after first shot). At the time of the report, PAIN IN EXTREMITY (sore arm on injection after first shot) outcome was unknown. Not Provided          Treatment medications included Advil and Tylenol at least 6 hours in between and for almost 14hours, and a Benadryl. No concomitant medications were provided.
4 month old patient received a dose of FLUZONE QUAD QIV with no reported adverse event; Initial information received on 24-Oct-2022 regarding an unsolicited valid non-serious case received from medical assistant and physician.  This case involves a 4-month-old male patient who received a dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunization; DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for Immunization; ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunization; and HIB VACCINE (HIB) for Immunization.  On 24-Oct-2022, the 4-month-old patient received suspect INFLUENZA QUADRIVAL A-B VACCINE at (unknown: formulation, strength) at dose 0.5ml once (lot: UT7683MA, expiry date: 30-Jun-2023) via intramuscular route in the left thigh for immunization with no reported adverse event (product administered to patient of inappropriate age) at same day latency.  Action taken: Not applicable.  No corrective treatment was received for the event.  At time of reporting, the outcome was Unknown for the event.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
LEFT SIDE WEAKNESS ON BODY LIKE ARMS & LEGS, NEEDS ASISSTANCE TO TIE SHOES,  FEEL  SHAKY
CHILLS/SHIVERING MUSCLE/JOINT ACHES HEADACHE - STARTED 2AM 9/27 FOR 24' - HEADACHE REMAINED 9/28
face got numb, rapid heart beat both lasted about 2 min. Felt weak the rest of the day.
pt recvd vax;hives over 70% of body w/ shoulder arthralgia,swelling of face;in er,given atarax;17apr,face & lip swelling inc w/ nasal flaring;dph,hisminol,prednisone given;19apr devel "skipped heartbeat";nl hearbeat;all events resolved
On 2/24/2023, patient presented to the emergency department due to shortness of breath, chest pain, and being ill since 2/16/2023. An EKG was done upon arrival and did not show any evidence of cardiac issues. Patient had had a positive COVID-19 test on 2/20/2023 in the emergency department so the test was not repeated; She was not hypoxic but did have dyspnea upon ambulation. Her chest x-ray showed a slight focal alveolar opacity in the left lung possibly representing pneumonia; The results of her CTA Chest scan showed no evidence of pulmonary embolism but did show bilateral ground glass and alveolar opacities diffusely, consistent with a history of COVID, possible superimposed pneumonia. Patient was given Toradol for chest wall pain, DuoNeb treatment which did not improve her respiration status however, Decadron for COVID-19 pneumonia, and Levaquin for possible superimposed bacterial pneumonia. Patient was diagnosed with pneumonia due to COVID-19 virus infection and superimposed bacterial infection. She was admitted to the hospital for further evaluation and treatment.   Submitter does not have access to further medical information on this case including discharge date. If more information is needed, please contact the admitting hospital.
Pt arrived at office on 4/19/21: Pt states got 1st of 2 Pfizer Covid vaccines on 2/28/21 and within 5 days, developed cracks on side of mouth and tongue. Pt states her tongue "feels burnt" and that the skin on the inside of her mouth "feels like leather". Pt states that brushing her teeth "burns horrible".  Pt states she saw her oncologist and they gave her a fungal cream which did not help. Pt states she still has mild cracks and redness at sides of her mouth and her tongue and inside of her mouth continue to burn and feel like leather. Pt states she had the second Pfizer Covid vaccine on 03/21/2021 and did not notice any additional side effects.  Pt has not improved to her pre vaccine state as of the date of this office visit 04/19/2021.
Initial misuse report received from a healthcare professional on 07 January 2014. Some patients (no information was provided regarding patients) had received a dose of tetanus toxoid (tetanus Toxoid Adsorbed) on an unspecified date. it was reported that an expired dose of vaccine was administered. No adverse event was reported. List of documents held by sender: none.
No symptoms reported.; a patient received a dose of improperly stored PEDVAX; This spontaneous report was received from a nurse referring to a 13 months old male patient. Information about pertinent medical history, drug reactions/allergies and concomitant therapies was not provided.   On 09-JAN-2020, the patient received a dose of improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # S006470, expiration date 15-JAN-2022) intramuscularly for prophylaxis (product storage error). The vaccine underwent temperature of 30.7 Fahrenheit for a duration of 16 hours and 24 minutes. There was no previous temperature excursion and the call was because of data logger. No symptoms reported.
Two days post vax, the pt experienced a rash on her face, trunk and extremities. There were no hives. No treatment was given. The most recent information received reports the symptoms resolved after one week.
The patient complained of pain and swelling of the arm the day after her injection. She later complained of fever and joint pain.
Shooting pain down left arm, Swollen Lymph node in neck,  slight fever, hand pain between ring and middle fingers, Tylenol , appointment with PCP
Shortness of breath, fatigue, heart palpitations 2 days after. Doctor wouldn't treat
developed itching within a few hours of vaccine administration. developed a rash all over body on 12/20/2020. Took Benadryl and symptoms now resolved.
high heartrate 150 + pm, dizziness, fatigue.  Diagnosed typical atrial flutter . 1st treatment:  Cardioversion & medication. Last treatment: Catheter ablation & medication. Still being treated. Still having symptoms of irregular heartrate.
11/4 Reported 5 p.m. fever 102 degreees F continued through night. 7 p.m. felt achy, "could barely move" especially through ribcage abdominal very painful. 11/5 7 a.m. fever 100 degrees F. Started feeling better in the afternoon. Called Health Department 11/9. Still complaining of sore intestines and severe constipation. Did not seek medical attention. 11/10 states feels good today.
Tested positive for Covid; Arm pain; Flu like symptoms; nose congestion; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for Covid), PAIN IN EXTREMITY (Arm pain), INFLUENZA LIKE ILLNESS (Flu like symptoms) and NASAL CONGESTION (nose congestion) in a 57-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 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), INFLUENZA LIKE ILLNESS (Flu like symptoms) and NASAL CONGESTION (nose congestion). On 23-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for Covid). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for Covid), PAIN IN EXTREMITY (Arm pain), INFLUENZA LIKE ILLNESS (Flu like symptoms) and NASAL CONGESTION (nose congestion) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. The patient's current conditions or medical history were not reported. On 01-JUL-2014, the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX vial 1350U  (dose, route, lot number and expiration date not reported). On 22-JUL-2014, three weeks after the first dose, the patient received the second dose of (Oka/Merck) VARIVAX vial 1350 U (dose, route, lot number and expiration date not reported). No adverse effect reported. Additional information has been requested.
About 15 minutes after patient received vaccine he started sweating really badly and felt very light headed.
At exactly the 10 minute mark, I started feeling very flushed  and hot. 1-2 minutes later, I was very lightheaded and dizzy. Felt like my heart was going to beat out of my chest and that I might faint. Walked down to tell the RN and she could tell I didn?t feel well as I approached. She said she could see my pulse bounding in my neck. Asked me to sit down arm she checked my pulse. Said I was tachycardic, over 100bpm. She asked me to sit there another 15 min for observation and gave me some water. I started to feel less flushed but then a second round of flushing came. The bounding/tachycardic episode never stopped. They suggested I go to the ER for observation. I text the Dr I was working with and she came down and spoke with the vaccine nurses saying she was comfortable monitoring me for the next several hours. I continued to feel this way for 3-4 hours. Also very pale and shaky. The above symptoms finally lessened around lunch time. For the remainder of the day, I felt very exhausted and had a lingering headache. The next day (today) I feel better. Other than soreness in the injection arm and some general body aches.
Hives all over body; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old, non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Er8737) via an unspecified route of administration in the left arm on 29Mar2021 at 10:30 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no allergies to medications and food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Er16199) via an unspecified route of administration in the left arm on 08Mar2021 at 17:30 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. The patient underwent lab test post vaccination, which included nasal swab test on an unknown date in 2021 and the result was unknown. On 30Mar2021 at 16:00, the patient experienced hives all over the body. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient had taken self-dosing of BENADRYL as treatment for event hives all over body. The clinical outcome of the event hives all over body was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Had shortness of breath and cough 3 hours after flu shot given, then chest pain for about for about an hour later that night.
When I am in a stressful situation, I feel a tingling, burning sensation at the injection site that hurts.  I thought it might last a couple of weeks, but I still have these symptoms.
Mom reported that Patient began to cry and was inconsolable for at least 30 continuous minutes and was "whining and miserable". She said his leg was warm, with " half-dollar " sized swelling at injection site on left thigh. it began about an hour after receiving vaccine. Dr.advised her to give Patient 1/2 tsp. Benadryl .
7 hours after injection (6:00 pm)  my arm started to hurt. 11 hours after injection (10:00 pm) the below symptoms started and increased as the night progressed  Injection site on left arm swollen and VERY sore. Unable to raise hand above head.   Whole body severe pain   Headache  Sore neck muscles Swollen hands and feet Weakness Flushed cheeks 21  hours after onset of symptoms (after talking with my doctor)  I took 2 extra strength Tylenol     There was some improvement.
Chest pain, pulmonary embolism diagnosed June 25, 2021 at Hospital treated with Eliquis and discharged from ER.  Still undergoing treatment and symptoms still persisting as of today.
Information has been received from a licensed practical nurse concerning a child who was vaccinated on an unspecified date with ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process).  A month and a half after being vaccinated with ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process), the patient experienced "for approximately three days", 100-150 chickenpox, decreased appetite and vomiting.  The patient had no fever as well as no scabs.  It is reported that the patient attends daycare where a lot of children have gotten chickenpox.  It is unspecified if medical attention was sought.  No further information was provided.  No product quality complaint was involved.  This is one of several reports from the same reporter.  Additional information has been requested.
8 hours after vaccine I got severe chills. Shivering. Couldn?t get warm. Mild headache. Overnight severe cold sweats more intense headache. Fatigue that lasted about 24 hours.
On March 2, he woke up feeling bad and had a fever of 102.7. He took tylenol and liquids all day and the fever came down to around 100. The next morning he woke up complaining of excruciating pain in his left arm (site of the injection). He couldn't stand to have anything touch it, couldn't move it and couldn't sleep because of the pain. The next morning he woke up very weak, wasn't able to speak clearly, wasn't making sense. He had a telemedicine appointment scheduled that morning for another matter. The doctor took one look at him and said we should have him evaluated asap. I took him to the emergency room at Hospital. They did some tests and said he was septic and immediately put him into the ICU.  He was started on IV antibiotics while the blood cultures were growing out.  It was determined that the bacteria was Strep G but they were unable to identify the source.  He was put on a ventilator and an echo cardiogram was done.  It was believed that the source of the infection was his pacemaker and I was told the pacemaker would have to be removed.  They couldn't do it at that hospital.  He was transferred to another hospital.  The doctors at that hospital determined the pacemaker was not the source.  It was believed by some doctors that the source of infection was the injection site.  The infection was cleared from his body and the ventilator was removed after 2 weeks.  He lived another 2 weeks but never was able to recover. Until the day he was put on paliative care, he expressed pain in the arm where he had received the vaccination. He died at 5:30 a.m. on April 1, 2021.