chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site it began to have discoloration/discoloration is now about 6 inches big; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (injection site it began to have discoloration/discoloration is now about 6 inches big) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (injection site it began to have discoloration/discoloration is now about 6 inches big). At the time of the report, VACCINATION SITE DISCOLOURATION (injection site it began to have discoloration/discoloration is now about 6 inches big) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.
Information has been received from a physician concerning a 13 year old female who on 12-FEB-2008 was vaccinated intramuscularly with a first dose of Gardasil (Lot# 659441/1446U). Concomitant vaccinations given 15 minutes prior to Gardasil included VARIVAX and MENACTRA. On 12-FEB-2008, 5 minutes after vaccination with Gardasil, the patient "stiffened up and looked as though she was having convulsion that lasted about 30 seconds". The physician diagnosed it as "carpo-pedal syndrome." It was reported that the physician "did airway straightening and applied ammonia salt and the patient recovered." The physician considered the patient's "carpo-pedal syndrome" as an other important medical event. No further information is available.
under the weather; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that the first Shingles shot was not too bad, was fairly under the weather for a week. The second shot was needed before 6 months. The patient enquired if the shots must be working. The follow-up would not possible as no contact details were available. This case was linked with US2021AMR254592, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR254592:Same reporter, same product, same patient, case for different dose
pt recv vax & 10 to 14 days post inj pt devel a diffuse macular rash on chest & trunk, mild fever, mild polyarthralgia & a 4cm indurated red area around the inj site;it was reported that pt was otherwise healthy & post child birth rubella n
11:30 am- rash and tingling under left side bottom lip 12:10 am- left ocular headache 1:30 pm- left ear ringing and pressure  1:45 pm- 600mg acetaminophen taken * rash subsided by 3:00 pm 8:07 pm- left ocular headache with pressure 8:24 pm- slurred/ delayed speech, left side of face tingling and mouth twitching 10 pm- seen in ER still experiencing symptoms
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 35 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Dec2020 as dose 1, single (Lot number: EK9231), on 16Jan2021 as dose 2, single (Lot number: EL3802) and on 25Sep2021 as dose 3 (booster), single (Lot number: FE3592) for covid-19 immunisation. The patient's relevant medical history included: "type 1 diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Shortness of breath, chest pain- 4/28/21- 10:30pm continued through 4/29/21- 9:30am
Increase dizziness, Nausea, (client had not eaten today) No Respiratory Distress, flushing or itching. HR was 40-50 per electronic monitoring. Other VS WNL. Was called on recommendation of EMS on site and transported to ER.
Information has been received from a registered nurse concerning a 6 month old male with no pertinent medical history and no drug allergies, who on 01-jUL-2009 was vaccinated with the first dose of ROTATEQ, on 20-AUG-2009 the second dose, and on 06-NOV-2009 a third "premetered dose" (lot # 664244/0651Y) via oral administration. The patient had been given the first dose and the second dose without any problems at another office. Concomitant therapy included PENTACEL and PREVNAR. The patient returned to the office 0.5 hour later with hives and swelling, shaking, level of consciousness was lower, tongue thrusting, and repetitive tapping of the left arm. The office called 911 and the patient was transported to the emergency room. The patient was diagnosed with an allergic reaction with focal seizure. The patient was not admitted. She was treated in the ER (treatment unknown) and released. The patient was "still working on tests" at the emergency room. The patient recovered from the event, but will be followed by a neurologist because of the focal seizure. The reporter said it was unknown if the events were caused by the vaccines. Allergic reaction with focal seizure was considered to be immediately life-threatening. No further information is available.
7-10 days after shot had a A-Fib attack that lasted over 5 hours causing heart to race from normal to 150 beats per minute and blood pressure of 97/68, 89/60 can?t remember rest of readings taken. BP never registered over 100 for either value for the whole period. Pulse raced constantly. This happened after the 4th Covid shot from Moderna, but not as long or drastic.. In the same time period after the shot but thought it was a coincidence. Did report it and talked to a woman on the phone. Was never told to file a report, and also did not see a doctor that time. Again the first time was not as drastic as the this last episode was.
She was given the wrong flu shot for her age group. We have tried contacting the family to see if there were any adverse reactions but have not been able to reach them.
In the afternoon I had a odd feeling in my throat and woke up the next morning(7/12/2021) tired with a fever. Extreme exahustion w/ no appetite. PCR(neg) pharmacy. (7/14/2021) Sought care at Urgent care and was assessed with probability of pharyngitis, streptococcal pharyngitis w/  a fever of 103.0 Swab for Mono and Strep type A(neg). Was treated with 24 days of Augmentin. 7/28/2021 Revisted same urgent care for follow-up. Throat issues cleared up with no further complications after course of antibiotics.
T102-104, vomiting, lethargy, tachycardia (180-220), cyanosis; pt adm to hosp for sepsis septic work up neg including spinal tap; pt improved during the hospitalization & w/o sequalae; pt is doing well now;
Chills, uncontrolled shaking (felt like convulsions at times), and tightening of hands and leg muscles for an hour and a half, fever of 104. Had a fever a few times after but not over 101. Headache for 36 hours. Body aches for 24 hours. Arm soreness for 24 hours. Fatigue for 48 hours. (I had a red, itchy rash a week after my first vaccine on 2/13/21 but I didn't think I needed to report it at that time)
Client received Moderna 3/18, then came to clinic and was not able to check for previous vaccination. Client lied and reported no previous COVID vaccine and received first dose of Pfizer 4/20/2021, then came in 5/11 and received second dose of Pfizer due to clinic screening failure.
Information has been received from an 84 year old female with high blood pressure and diabetes and a history of shingles in 1991 who on 26 Oct 2006 was vaccinated SC with a dose of Zostavax. Concomitant therapy included "several medications" (not further specified). "About one month later, " on approximately 26 Nov 2006, the patient developed a new outbreak of shingles. The patient noted that she would be going to visit her doctor on 04 Dec 2006. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been requested.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted for less than a minute shortly after injection was given. Patient had full AROM, normal gait, and was oriented to person, place, and time immediately after event. Patient's vital signs were stable with no acute distress noted. Patient's mother was present to drive pt to ER if necessary, but pt declined.
It started as what I thought was a sinus infection or allergic infection. I had double ear infections. I developed pain throughout my arms and leg. I went to urgent care; they sent to the ER. They did bloodwork and CT scan. They diagnosed me with acute pancreatitis but leptin was high.
Patient's parents deny patient to have any signs and symptoms like nausea, vomiting, fever, or allergic reaction to vaccine.
Pt developed mild hives nightly starting after 1st dose, continuing x 1 month, 2nd dose -  provoked worse reaction
At 10:00 pm I started getting severe chills I had a severe headache, joints and muscles starting to hurt and I had I was nauseous
Developed herpes simplex around mouth after dose 1 and dose 2. Both incidents happened 1 week after each injection. Very painful. In addition, several canker sores in mouth after both injections as well.
G40.311 EPILEPSY, GENERALIZED CONVULSIVE, INTRACTABLE 2/16/2022 EPILEPSY, GENERALIZED CONVULSIVE, INTRACTABLE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/1/2022 EPILEPSY, GENERALIZED CONVULSIVE, INTRACTABLE G40.311 EPILEPSY, GENERALIZED CONVULSIVE, INTRACTABLE 2/16/2022 EPILEPSY, UNSPECIFIED J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/1/2022 EPILEPSY, UNSPECIFIED G40.311 EPILEPSY, GENERALIZED CONVULSIVE, INTRACTABLE 2/16/2022 ANEMIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/1/2022 ANEMIA
Employee states had vaccine on 12/20 and was monitored in Emergency Department for approx. 4.5 hrs r/t which started with metallic taste, then within 10 minutes lips/throat/tongue tingles, full feeling in throat followed by heaviness in chest with self-resolving (only IV fluids administered in the ER).  Employee states took 50 mg of Benadryl when she went home after the ER.  Employee endorse body/headache post vaccine on 12/21.  Patient is unsure to take second dose and seeking advice, has already contacted her PCP.
pain in upper arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 15-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Oct2022 at 12:00 as dose 4 (booster), single (Lot number: GJ6665) at the age of 15 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 23Oct2022, outcome "recovering", described as "pain in upper arm". Therapeutic measures were taken as a result of pain in extremity.  Additional information: The treatment included Ibuprofen. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.   No follow-up attempts are possible. No further information is expected.
Wed, 12/30/2020 muscle ache in a horseshoe shape above injection site. Tues, 1/5/2021 right clavicle lymphadenopathy. Wed, 1/6/2021 broken blood vessel right sclera at 4-5 o?clock.
Initial and follow up information has been received from the Merck Pregnancy Registry for Gardasil from a Registered Nurse (R.N.) and doctor's office concerning a 22 year old female patient with a history of spontaneous abortion and exercise induced asthma who on 27-NOV-2007 was vaccinated with a first dose of Gardasil (lot # 659439/1267U).  The nurse reported that the patient received her first injection and found out she was pregnant.  On 12-DEC-2007 and on 14-DEC-2007 urine beta-human chorionic gonadotropin test (HCG) was done.  On 18-DEC-2008 she had an ultrasound done where fetus was determined to be 6 weeks and one day.  The ultrasound did not demonstrate any defects at that time.  The last menstrual period (LMP) was reported as 05-NOV-2007 and estimated delivery due date (EDC) reported as 11-AUG-2008.  No adverse effects to pregnancy at this time of this reports.  The patient was placed on prenatal vitamins (unspecified).  No additional information is available.  In follow up information from the doctor's office it was reported that on 28-FEB-2008 a quad pregnancy screen test was done and the result was negative.  On 29-MAR-2008 patient experienced a fetal death (> 20 weeks) which was "20.4" weeks from her LMP.  The products of conception were examined and was described to have 17 weeks demise.  The weight of product conception was one hundred twenty five grams and was reported as visually normal.  It was also reported that it was unknown if the fetus was normal.  Upon internal review fetal death > 20 weeks determined to be an other medical event.  No other information is available at this time.  Additional information is not expected.
I had the Pfizer vaccine for Covid.  My neck started to break out in hives on my neck around 45 min after the shot.  Then my face started to turn red and swell up.  I then started to have more urticaria hives on my face.  I went to the Urgency room and they gave me a epinephrine shot, steriods, Pepcid and Benadryl.   The hives and redness started to disappear right after the shot.
Neighbor brought child to HD for vaccines. Varicella vaccine given and then found another immunization record stating she had already had her 2nd Varicella. No adverse event reported.
pt after injection had pain in injection site with tingling down to the fingertips.  Pt stated next day he felt nauseas w/ swelling of the right lymph nodes and hot/cold flashes with vomiting.  pt also experienced body aches and fatigue w/ rapid heart beat and sore throat, cough and lost his voice.
Patient slunk down and fainter very briefly, 10 seconds or so.  When he came to, he was totally aware of his surroundings and answered all of our questions. We had called 911 in the mean time. EMt's checked him thoroughly. His apple watch showed his pulse dropped to 42. EMT's stayed for about 15 minutes, We gave him water and his wife stayed within reach of him.  We escorted him to his car in one of our wheel chairs after about half hour.
three severe gallbladder attacks; elevated liver enzymes and bloodwork; This is a spontaneous report from a contactable consumer (patient). An 18-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in left arm on 29Apr2021 (lot no: EW0151) (at age 18 years old) as single dose for covid-19 immunisation. Medical history included neoplasm tumor in leg when young and food allergies in childhood. No COVID prior to vaccination. The patient's concomitant medications included antibiotics. The patient previously received the first dose of BNT162B2 in left arm on 08Apr2021 (lot no: EW0171) (at age 18 years old) for COVID-19 immunization and experienced severe eye pain, difficulty seeing after the first vaccination. On an unspecified date, within a few weeks after the second vaccination, the patient experienced three severe gallbladder attacks, two emergency room (ER) visits. The second ER visit resulted in admission in hospital for 4 days and removal of the gallbladder and cleaning of the bile ducts; elevated liver enzymes and bloodwork. The events were reported as serious (hospitalization). The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Antibiotic for the eye/surgery for gallbladder att. The patient underwent COVID test (nasal swab) with negative result on 24May2021. The patient was recovering from the events.
chest pain similar to heart burn.; high fever; headache; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 15May2021 at 12:00 (at the age of 32-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported and the patient did not have a history of allergies to any food or medications or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 17May2021 at 00:00, about 36 hours after second vaccination shot the patient started to have chest pain similar to heart burn, high fever and headache for the last 30 hours as well. No therapeutic measures were taken for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events chest pain similar to heart burn, high fever and headache were not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
I had the same "Covid arm" symptoms that I had after the first dose. Looked like a 2" bee sting, with accompanying muscle soreness, at the injection site, this time in the left arm. Last time I had the same symptoms roughly 6-7 days after the shot; this time I had symptoms the next day. I also had a fever of 100.4, muscle aches and chills throughout my body, and a white tongue.
This is a spontaneous report from a contactable consumer via Pfizer sales representative. A patient of unspecified age, ethnicity and gender received TRUMENBA, on an unspecified date at single dose. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced lethargy, headache and severe redness at injection site. The outcome of the events was unknown. No follow-up attempts are possible.
Sluggish, sore throat, (coughing excessively), headache, fever.
largest fever blister on their upper lips; very sore arm lasted for 2 weeks; swelling in their lymph node under their arm area on the side tissue that lasted for 2 weeks/swollen lymph nodes after flu vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (largest fever blister on their upper lips), PAIN IN EXTREMITY (very sore arm lasted for 2 weeks) and LYMPHADENOPATHY (swelling in their lymph node under their arm area on the side tissue that lasted for 2 weeks/swollen lymph nodes after flu vaccine) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu vaccine. Past adverse reactions to the above products included Swollen lymph nodes with Flu vaccine. Concomitant products included AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3) for an unknown indication.    On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ORAL HERPES (largest fever blister on their upper lips), PAIN IN EXTREMITY (very sore arm lasted for 2 weeks) and LYMPHADENOPATHY (swelling in their lymph node under their arm area on the side tissue that lasted for 2 weeks/swollen lymph nodes after flu vaccine). The patient was treated with DOCOSANOL (ABREVA) at an unspecified dose and frequency and CAFFEINE, PARACETAMOL (EXCEDRIN ASPIRIN FREE) at an unspecified dose and frequency. At the time of the report, ORAL HERPES (largest fever blister on their upper lips), PAIN IN EXTREMITY (very sore arm lasted for 2 weeks) and LYMPHADENOPATHY (swelling in their lymph node under their arm area on the side tissue that lasted for 2 weeks/swollen lymph nodes after flu vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative.         Patient took Vitamin [Melaleuca peak performance total health 50+] as concomitant drug product with an unknown date and unknown indication.   This case was linked to MOD-2021-387016 (Patient Link).
Post clinic, when processing paperwork, it was discovered the patient's second Moderna dose was given on 6/16/21, making her booster dose on 11/30/21 given at 167 days instead of 180+ days. Patient experienced headache and fatigue - "feeling bleh" - the evening of her vaccination (received mid-afternoon). She took the next day off work to rest.
Can increasing severity in arms pains; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Can increasing severity in arms pains".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.