chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Two days after the shot had ringing in ears. First, it was both ears but the left ear stopped ringing.  Now the right ear stops and starts ringing. It is a mild noise.; Dose received 3/ dose number=3; This is a spontaneous report received from a contactable reporter (consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient (not pregnant) received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 18Nov2021 at 13:00 (Lot number: FH8027) at the age of 80 years as dose 3, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number: EN6201, Anatomical site: left arm), administration date: 23Feb2021 at 10:15, when the patient was 79 years old and BNT162b2 (DOSE 2, SINGLE, Lot Number: ER8732, Anatomical site: left arm), administration date: 23Mar2021 at 10:00, when the patient was 79 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021 at 13:00, outcome "unknown", described as "Dose received 3/ dose number=3"; TINNITUS (non-serious) with onset 20Nov2021, outcome "not recovered", described as "Two days after the shot the patient had ringing in her ears. First, it was both ears but the left ear stopped ringing. Then the right ear stopped and started ringing. It was a mild noise". Therapeutic measures were not taken as a result of tinnitus.  Additional Information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
20 minutes after injection, mild hives appeared on roof of mouth and lips. 4 hours after injection hives appeared on arms and chest, with general itching all over body. Moderate pain at injection site from 4-48 hours after injection, fatigue, and headache also present. 30 hours after injection redness and itching from elbow to shoulder on injected arm appeared and lasted approx 5 hours before subsiding. Hives flared up and went away throughout the last 48 hours after injection, both on body and in mouth and lips. Treated at home with benadryl and cortisone, cold compress at injection site.
Mouth broke out in extreme  sores and blisters, headache. Couldn't figure it out, heard from other women my age experiencing same strong  ridge along inner cheeks in mouth. Extreme headache returned a month later. Mouth would  break  out periodically. Went to two  doctors who determined it was  varicella/zoster  virus running  rampant  since vaccine cause immune system to overreact. Extremely painful herpetic outbreaks now come when immune stem down. Have seen a number of doctors and have appt w neurologist to get MRI to see if trigeminal nerve affected by varicella/zoster. Debilitating when it comes
Red swollen Left arm.  Patient came back to clinic 1 day after receiving injection.  Patient treated with Prednisone taper, benadryl OTC, and intermittent ice packs.
PAIN, TENDERNESS AND SWELLING IN THE  SAME ARM, HEADACHES, JOINT PAIN MUSCLE PAIN, CHILLS, NAUSEA AND  VOMITING AND FEVER. DIFFICULT BREATHING, WEAKNESS, FAST HEART BEAT, DIARRHEA
Low grade fever, chills, joint and muscle aches, headache, nausea, fatigue. Indurated swelling about 2-3? diameter near injection site like a medallion, noticing left axillary tender lymph nodes on 2nd  day. Itching near injection site.  Headache, nausea, Vomiting on 3rd day. Taking Tylenol and Advil for the symptomatic treatment
Patient received booster dose (0.3ml) of Pfizer vaccine after being screened by the clinic staff. No indications found to hold the dose based on previous history. Ten (10) minutes after vaccine administration, patient reported dizziness with a red rash developing on his face and top of the head. Blood pressure was taken and reported at 160/100, then 180/120 with pulse of 100, then 120 respectively. Patient then reported that his "throat felt tight." At this time 911 was called and the patient was given an epinephrine 0.3mg injection. Paramedics arrived approximately 5 minutes later and took patient to the hospital.
Vaccine was 4/22/21.  On 4/27/21 my menstrual cycle began - I am 4.3 years post-menopausal and 55 years old!  On 4/25 I began to have sore lower back, cramps, abdominal bloating, and sore breasts.   I have not had these symptoms for 4.3 years.   The period began on 4/27/21 and is still active.
Red band about 1.5-2" thick on upper arm covering about half the circumference of the arm. Appearance is blotchy and irregular. Location is about 2" below injection site. Pt reports it is very painful and hot. She reports that it first developed the following night after receiving the vaccine.
Entire left upper arm shoulder to elbow 20 cm was red, hot and tender. Mom came in clinic next day, I saw it and sent her to ER to evaluate for possible cellulitis. They gave RX for antibiotics just in case of infection-they were not sure either if it was just vaccine reaction or infection, his arm swelling is gone per father per phone report.
right arm started hurting shortly after vaccine. Thought it would go away but got progressively worse. Talked to MD in Nov or Dec and was referred to an orthopedic MD who gave her a cortisone shot. Shot was ineffective. MD thought vaccine must have hit a nerve which has been causing the problems. She has been receiving therapy for a few months to help movement of arm since she is now needing assistance to move arm and has since been having problems driving due to the pain and lack of being able to move it.
Pt recv vax on 9/22/98; on 10/5/98 pt exp sore LA w/ limited ROM due to pain; tx=Tylenol, heat&ice
Persistent swelling, redness and pain on left arm (site of injections) for 2 weeks following visit on 11/28/2018. Resolved spontaneously.
12 hours after recieving vaccine, I started to get chills and shivering. The shivering got worse and my temperature rose to about 102 degrees. I started sweating and could not stop shivering. This lasted about 2 hours and then stopped. I was exhausted afterwords.
Generalized urticaria & angioneurotic edema of face, hands & feet; also exp generalized itching, joint pain, malaise, & h/a;
chest pain, dyspnea, tachycardia, and acute pericarditis symptom onset 6/3/21, continuous, worsening x 5 days leading to admission to hospital after developing acute pericarditis admitted to hospital on 6/6/21
No adverse events occurred that we are aware of. This is a vaccination error   EMR/computer malfunction. I (provider) was unable to access vaccine record in EMR at time of visit. I accessed vaccine record via vaccine registry. Ordered/Gave IPV based on record/system recommendations. In system it showed the patient as only receiving 2 IPV doses. Once computer started working again, I was able to review vaccine record in EMR. It appears that a 3rd  dose IPV was given already and was not showing on patient's record in system. Record discrepancies led to patient receiving a dose of IPV that was not needed. I attempted to notify the family of this error but have not been able to get in contact with them.
Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 58-year-old female patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd December 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 22nd December 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-DEC-2022 Reporter's comments:  The reporter reported that an expired dose of Havrix was administered to a female patient.  The reporter was consented to follow-up. Additional Supportive Information: The patient received expired Havrix, which led to expired vaccine used.
Became lightheaded, dizzy; WEAK; HOT FLASH; anxiety; feeling foggy; heavy to achy feeling in my heart for 6 hours after dose; headache; nausea; arm pain for the next three days.; This is a spontaneous report from a contactable consumer or other non-hcp (patient herself). A 30-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EW0183, Expiry date: Unknown) via an unspecified route of administration in Arm Left on 20Aug2021 13:45 as dose 1, single (at the age of 30-years-old) for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. The patient medical history was not reported. There were no known allergies and no concomitant medications. Patient did not receive other vaccine in four weeks. Patient did not have other medication in two weeks. Patient was not tested for COVID post vaccination. No COVID prior vaccination. On 20Aug2021 13:45, the patient experienced lightheaded, dizzy and weak 15sec after dose, followed by hot flash, this occurred four times within one hour, had prolonged anxiety, feeling foggy and heavy to achy feeling in my heart for 6 hours after dose and also experienced headache, nausea and arm pain for the next three days. Patient didn't receive treatment for the events. The outcome for events was unknown.  Follow-up attempts are completed. No further information is expected.
Information has been received from a physician assistant, concerning a patient who received a dose of GARDASIL. The patient had a reaction after receiving GARDASIL. The physician assistant refused elaborate on the nature of the reaction. There was no product quality complaint. Additional information is not available.
This case was reported by a other health professional via call center representative and described the occurrence of myelitis transverse in a 29-year-old female patient who received ENGERIX B adult (batch number Y9424, expiry date unknown). On 1st June 2016, the patient received the 2nd dose of ENGERIX B adult. On 29th June 2016, 28 days after receiving ENGERIX B adult, the patient experienced myelitis transverse (serious criteria GSK medically significant and other: serious as per reporter) and urinary retention (serious criteria GSK medically significant). On an unknown date, the patient experienced constipation. On an unknown date, the outcome of the myelitis transverse, urinary retention and constipation were recovering/resolving. The reporter considered the myelitis transverse, urinary retention and constipation to be probably related to ENGERIX B adult. Additional details were provided as follows: In 2016, less than a year after vaccination, the patient experienced constipation. The healthcare professional did not have expiry date of the vaccine.
A few hours after the first dose: severe fatigue, sinus migraine and lack of appetite. Two days after first dose: I started mensturating heavily and suddenly with severe menstral symptoms.  I continued to sporadically have light bleeding for 3 weeks. Prior to this event, I had not had a period in almost a year due to my birth control method. I have cramps, bloating, breast pain, irregular bleeding and weight gain. I received the second dose on 03/25/21 and by 03/30/21 I was experiencing yet another round of extreme PMS symptoms like severe breast pain, severe cramps that leave me bedridden, and intense food cravings. I have not had cyclic periods for several months prior to either of these events. It was jarring enough for me to start tracking my period symptoms because it was so out of the normal. I have been filtered into thinking any issues with my period are just something to deal with and to not seek medical attention, but I have missed approximately 6 days of work due to various symptoms after both of my doses.
Swollen lymph node right on her collarbone; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 (Lot number: ER8735) at the age of 61 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Manufacturer: unknown), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 01May2021, outcome "unknown", described as "Swollen lymph node right on her collarbone".  No follow-up attempts are possible. No further information is expected.
Subsequent to receiving the varicella virus vaccine live the pt experienced a flat rash on his back from which he recovered the next day. The pt also experienced inflammation and redness at the injection site.
Redness, sore - mild tender with deep palpation developed around vaccine site 1 week after vaccines watching - if increase red, fever, increase tender. Abx treatment (Crx GIVEN).
Pt devel neck pain & stiffness & "hot rashes" at inject site. This is 1 of 6 pts receiving vax 12-24 hr later devel similar rxn.
Patient found to have pulmonary embolism 22 days after receiving vaccine. Onset of symptoms occurred 18-19 days after receiving vaccination, however, very likely PE related to patient hx of small cell lung cancer. He is currently hospitalized for respiratory distress as of 4/30/21
Child got hives on arms and legs next morning - hives were extremely hot, red, and extremely itchy - couple of hours later they went to face - brought child to Urgent Care. Given BENADRYL - had hives for 3 days.
Developed chest pain hives throat tightness, minimal wheezes and shortness of breath within 10 minutes of vaccine. Symptoms worsened the following day prompting EMS to be called. ED evaluation.
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
URTICARIA ON BOTH THIGHS AROUND THE VACCINE SITE.  NO NEW FOODS GIVEN
WEDNESDAY, 1/4/2023, PATIENT RECEIVED 0.5ML MODERNA BI-VALENT BOOSTER WITHOUT HAVING RECEIVED THE PRIMARY, MONOVALENT SERIES.  THURSDAY, 1/5/2023, WE CONTACTED HEALTH DEPARTMENT AND WE WERE ADVISED TO GIVE THE FIRST MONOVALENT VACCINE IMMEDIATELY.  WE DO NOT HAVE THE MONOVALENT VACCINE IN STOCK SO THE PATIENT HAS MADE AN APPOINTMENT WITH HEALTH DEPARTMENT TO RECEIVE HIS FIRST MONOVALENT VACCINE ON WEDNESDAY, 1/11/2023.  PATIENT HAS NO ADVERSE REACTIONS TO REPORT.
DIZZINESS Lymph node swelling, injection site soreness Narrative: Injection site soreness x 3 days day 2-3 dizziness day1-3 lymph node swelling.
Patient reported 5 days of joint pain and fatigue after the second covid vaccination Did not seek medical advise, symptoms resolved on their own after 5 days with rest, hydration
A spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. In 2014 (exact date unspecified, reported as between 26-NOV-2014 through 01-DEC-2014) those patients received an improperly stored RECOMBIVAX HB (dose, units, route of administration, anatomical location, lot number were not reported). No adverse symptoms reported. The temperature excursion for all vaccines was found to be supported with in-house stability data. This is one of several reports from the same reporter. Additional information has been requested.
Delayed site reaction including warmth, redness, swelling and localized rash. Began on 1/23 and fully resolved on 1/25 Treated with Benadryl 50mg x1
Sharp pain during injection. Has had left shoulder pain since, with raising and reaching. Pain will occasionally radiate down her arm, left side neck pain.
Had typical arm pain with swelling. Had really bad Acid Reflux and affected Menstrual Cycle.
given the adjuvant portion only; given the adjuvant portion only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number D4PA4, expiry date 10th February 2023) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The Clinical Coordinator reported that, the patient received the adjuvant portion of Shingrix only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was linked with case US2021180797, US2021180799, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021180797:same reporter US-GLAXOSMITHKLINE-US2021180799:same reporter
Narrative: 80 yo male with hx of copd II, niddm, htn, ckd, carotid stenosis, gerd, & chronic low back pain died on 8/2/2021. No information in data system regarding pt's death. Pt had received one covid vaccine on 3/29/2021. Likely death is unrelated to vaccine given >90 days post vaccine admin & pt's advanced age & medical history.
Arthralgia Neck stiffness/pain/limited movement , soreness at inj site Narrative:
Lightheaded, 124/82, 79, throat tight, weight on chest. Symptom free 6pm.
Patient developed redness/hives all over body and face. States this usually occurs when he eats certain foods and/or is stressed. States his breathing/airways are fine. Checked lips and tongue, which were normal and not swollen.
The next day I started to feel strange and had a racing heart and some leg pain. Slowly over the course of four days (Friday to Monday) I continually felt "off" but differently than others explained post-vaccine (not necessarily flu like). This was an extremely high heart rate (up to 130+) and palpitations, chect pains, and calf discomfort. Finally on Monday, March 1, I went to my primary doctor because I felt so off and I knew something was wrong.  My doctor sent me to the ER where they found a new DVT in my upper leg. This time it was deemed unprovoked, though it was right after the second vaccine.
3/22-5/2 reactions included: abscesses tooth, congestion, irritation, anger, chicken pox and shingles external and internal  mild to moderate anaphylaxis, hives, fever, eating issues, pain, excessive crying, cough, behaviors such as spitting and OCD behaviors, bowl issues, and loss of all remaining verbal speech.
- Fever 38.1 C (5 - 7 days, diarrhea, abdominal pain, lassitude, profound malaise, hypotensive,  - supportive treatment - short course antibiotic therapy for bacterial diarrhea.
Tested positive for COVID; Tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) as dose 2, single and administration date Jan2021 (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: COVID-19 (medically significant) with onset 26Nov2021, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Tested positive for COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Nov2021) positive. Clinical course: Patient tested positive for COVID on 26Nov2021 following exposure from his young daughter. Experiencing mild symptoms (runny nose and slight cough). The lot number for bnt162b2 was not provided and will be requested during follow up.
2 days after shot HORRIBLE ITCHY OOZIND SPREADING RASH over 1/3 of  my body & continuing to spread.  Tried betamethasone didn?t work.  Now  trying oral steroids.
Right after vaccination, patient reported having a metallic taste in her mouth, tingling of her tongue and tingling in her hands. Spoke to patient the following day on 1-15-21. She reported having a rough night sleep with joint pain, headache, nausea and a sore arm. Patient reports that the metallic taste throughout her mouth is dissipating now. The tingling of both tongue and hands started to go away after 24 hours.
No side effects reported; Vaccine administered experienced a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about patient's medical history, concurrent conditions and concomitant medications was provided.   On 20-JUN-2023, the patient was vaccinated with improperly dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #W026137, expiration date 05-FEB-2024, exact dose and route of administration were not provided) for prophylaxis (Product storage error).  On unknown day, the suspect vaccine experienced a temperature excursion of 8.74 degrees Celsius (C) for 35 minutes. There was no previous temperature excursion. No side effects reported (No adverse event). No other medical information known. No product quality complaint (PQC).  This is one of several reports received from the same reporter.
pt recv first vax 23APR98 & c/o abd pain, nausea & feeling that was going to throw up;29OCT98 c/o severe cramping;shaking & could not control self;felt like was going to throw up;h/a;constipated; joint pain
Patient was reported to have fainted in an aisle about 10 minutes after administration of the vaccine. Upon arriving the patient was conscious but appeared to be disoriented, sitting in a chair.  911 was called and a police officer responded; patient was evaluated and EMT services were called in afterwards.
Fully vaccinated, not boosted. Symptomatic COVID-19 breakthrough infection. End stage cancer diagnosis.
9/26/22- headache 9/27/22- headache/fever 9/29/22- headache, neck pain, seizure, confusion  Admitted to Hospital on 9/29, dx with encephalitis.  Discharged 10/6/22 w/ ongoing neuro symptoms/neuropsych follow up
1st Dose:  05/21/21;  2nd Dose:  06/11/21  After first dose, experienced ringing in left ear on and off and reduced hearing ability.  After second dose, developed constant ringing in ear and hearing loss in left ear (tinnitus) at 9 pm on 6/13/21 which has not gone away since.  Visited family care practitioner on 06/18/21; confirmed no visible blockage in left ear and referred to ENT doctor.  Appointment and hearing test scheduled for 07/22/21.  As instructed, taking Flonase (2x/nostril, 2 x/day) until 7/22 appointment.  If any change so far, problem has gotten worse.  No issue w/ right ear.  Note:  Experienced trauma on left side of head resulting from car accident in 2011, but no recurring problems as a result.