chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Beginning afternoon on 3/7/21, I began to notice an angry red rash that was at first small appear around the injection site. It was not there before this time. As the day went on, it grew in size and is now is the size of a quarter. It is causing a stabbing pain, as if someone is poking me with a needle. The pain has not gotten worse throughout the day; however, it comes and goes and lasts for about 10 minutes each time.   I also experienced chills, severe migraine, sore throat, and severe back ache after receiving the 2nd dose on Friday evening and throughout Saturday. However, these symptoms are better today.
Elevated blood pressure (180/116 highest recorded); dizziness; weakness lasting several hours; This is a spontaneous report from a contactable consumer (patient).  A 44-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 20Jan2021 14:15 at single dose for COVID-19 immunisation at Public Health Clinic/Veterans Administration facility. The patient medical history was not reported. Concomitant medication included atorvastatin (LIPITOR), 40 mg daily, butalbital, caffeine, paracetamol (FIORICET). The patient experienced elevated blood pressure (180/116 highest recorded), dizziness and weakness lasting several hours on 20Jan2021 14:30 with outcome of recovering. The events were considered life-threating (immediate risk of death from the event) and resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care visit. No treatment was performed. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.
Patient in clinic to receive second COVID vaccine.  Nurse drew up dose of 0.5 mL Moderna vaccine and noticed needle was bent inside the vial.   The nurse changed out the needle ( it is not known if the volume in the needle was withdrawn into the syringe prior to needle change.   Also patient noted the nurse pushed on the plunger and expelled some vaccine.  Per patient, it looked as though she only received about 0.2 mL instead of 0.5 mL.  Her arm was a little swollen the next day but not sore and she did not suffer from side effects.  A group with quality, risk management, and pharmacy has reviewed and plans to reach out the patient.
Medication is listed as a subcutaneous injection, but it was accidentally delivered intramuscularly instead.  Patient did not report any issues besides normal discomfort when receiving an injection.
pain & reddness on lateral & anterior aspect of arm where Td given to elbow; pain disappeared 6JUN93; soreness abated 8JUN93; 10JUN03 reddness reappeared below inject down to elbow & cont 11JUN93; no soreness, edema or fever, feels well;
shingles 4 times; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as adult per the vaccine indication. Since getting the Shingrix shot, the patient gotten shingles 4 times.  The patient asked was the shot to blame.
Patient fainted 10 minutes after receiving HPV vaccine at the waiting room. Patient had had no breakfast. Event occurred at 11:00am. BP 87/58 Patient was awake within 30 seconds.
4-5 days after immunizations -> fatigue, swollen lymph nodes; 7 days after vaccine -> feet, ankle pain and swelling; 9 days after vaccine -> knees, wrist pain and swelling; No treatment, symptoms 95% resolved.
No reaction after the injection however, after a little over a week I began having alot of itching, swelling and red blotches along with soreness at the injection site.  (Covid Arm) I also was fatigued for a few days.
Coughing blood; Trouble Breathing; Lungs Damaged; Coughing; Headache; Fever; Body Shakes a Lot with Cold; Night Sweats, states it is like he took a shower; Diarrhea, states when he goes to the bathroom, it is water; Lost 14 Pounds; felt really bad; This is a spontaneous report from a contactable consumer reported for himself.  A 55-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left at 55 years old on 06Apr2021 08:45 (Lot Number: ER8733; Expiration Date: 31Jul2021) at single dose for covid-19 immunisation. Medical history included ongoing high blood pressure, diagnosed 20 years prior to the report. The patient's concomitant medications were none. There were no other vaccines Administered on Same Date of the Pfizer Suspect or within 4 weeks. The patient experienced coughing, headache, fever, body shakes a lot with cold, night sweats, states it is like he took a shower; diarrhea, stated when he went to the bathroom, it was water, coughing blood, trouble breathing, lungs damaged, lost 14 pounds, all on 06Apr2021. Patient stated he was calling because his doctor told him to call. Stated he got his first injection on 06Apr2021. Told to sit for 15 minutes, and he felt fine and went to work and felt really bad after 1 hour; 09:45-10:00. Since then he had been super sick and at the hospital 3 times, later confirmed ER, not hospitalized. Patient stated the doctor also told him his lungs are damaged and they were sending him to see a specialist. Patient was asking what was going on with his body, is this a normal reaction? Stated his doctor said to call because it had been too long, stated usually it lasted 2-3 days and with Tylenol, it was gone, then it should be clear, but it had been almost 16 days for him. Stated one hour after his injection, he started feeling really bad. Stated he was coughing up blood from coughing so much. Stated he was 154 pounds, but he has lost 14 pounds. Patient stated his first injection was on 06Apr2021. Stated his second vaccine is supposed to be on 28Apr2021 but he was not going because he was afraid to go back in case it got worse. Treatment received for the events included 3 Different Antibiotics; Tylenol and Drinking Hot Tea. Patient clarified that he has had 3 Emergency Room Visits (10Apr2021, 19Apr2021, and 20Apr2021), Physician Office on 21Apr2021, but he was never admitted to hospital. Patient stated one time they kept him in the ER for 20 hours. Patient stated once he went to Hospital and then yesterday and the other day, he went to Hospital because he was having trouble breathing. The outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.
This infant died of a rare heart tumor (left ventricular rhabdomyoma). The mother was vaccinated during pregnancy. The Forensic Pathologist requested VAERS reporting as the mother was vaccinated during pregnancy at 18 wks and at 22 wks (Moderna). It is unclear if there is any correlation between vaccination and tumor development.
Headache, 100 degree temp, aches, joint pain that includes neck, shoulders, knees, ankles and fingers. Cramps in legs. Skin sore to touch almost felt like sunburn. Gastrointestinal discomfort that included loose stools and gas. Frequent urination possibly due to water intake, but was unusual. Fever lasted about 24 hours. All symptoms starting to subside around the 24 hour mark.
Severe pain of left arm approximately 5 hours after 2nd dose, can not lift arm above 45°without assistance hand keeps going numb,
Patient described numbness with dull/aching pain around injection site starting 2 days after shot.
This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 70-year-old female patient who received SHINGRIX (batch number KB99G, expiry date 22nd February 2021) for prophylaxis. Concomitant products included SHINGRIX. On 24th September 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In September 2018, 1 day 12 hrs after receiving SHINGRIX, the patient experienced headache, jaw pain, inflammation, cervical neuralgia, nerve pain, chest pain and difficulty breathing. The patient was treated with medication unknown (Tablet). On an unknown date, the outcome of the headache, jaw pain, inflammation, cervical neuralgia and nerve pain were not recovered/not resolved and the outcome of the chest pain and difficulty breathing were unknown. The reporter considered the headache, jaw pain, inflammation, cervical neuralgia and nerve pain to be related to SHINGRI. It was unknown if the reporter considered the chest pain and difficulty breathing to be related to SHINGRIX. Additional details were reported as follows: At 12:40 PM the patient received a dose of SHINGRIX into right deltoid. The patient experienced a headache in her upper and lower jaw, neck and upper chest with inflammation and nerve pain. The patient had to go to the emergency room (ER) 36 hours later. The healthcare professional (HCP) at the ER told the patient that her symptoms were symptoms of a virus due to the live vaccine. They ran blood work and did not find anything, however, the ER thought her symptoms were related to the vaccine. The patient was provided pain tablets for her symptoms. The ER physician had done blood tests, which were normal, and the patient was sent home. On 27th September 2018, at 7:51 pm the patient called and left a massage that she experienced being poisoned by SHINGRIX. In September 2018, less than a week after receiving SHINGRIX, the patient experienced chest pain and had trouble breathing. The patient did not wish to give any demographic information. No additional details were available. This case has been linked to the US2018GSK184729, reported by the same reporter.
Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Medium
No reaction noticed immediatly.  Noticed sore left upper arm on 2.7 and some chills that day.  Arm continued to ache in area of shot and became red and swollen over time.  Then on Wed. 2/10 it became large area as big as my hand, swollen pillow but hard, red, hot, and itchy.  Toward 11 p.m.  my nasal passage and lips began to swell and I began to take benedryl to control the allergic reaction.  I took 25 mg tablets (2), then 45 min later 1 more, then 45 min later 1 more until the problem was not getting worse.  In morning problem was still at that level so I took another benedryl and called doctor.  They set up appointment for me  and I saw Dr.   on 2.12.21.  The problem area was reduced in hieght, not soft, not hot, not itchy but the area was still visiable and raised as big as my hand.  He suspected that it was a delayed reaction to the vaccination and prescribed prednosol.  Suggested that I do not take the 2nd part of vaccination series due to this reaction.  He did find some confirmation of rare but similar reactions on line.  Took a picture for his files and referred me to this site.
Stiffness, redness and sore feeling started 9/19/18 in evening (pt received vaccine in a.m.). Pt woke up in A.M. 9/20/18 with redness swelling and warmth in area of immunization. Redness started at injection site and travels down pt arm to elbow.
High blood pressure, high cholesterol, Insomnia, vision problem, diabetes mellitus, arthritis, pain right and left shoulder, pain feet, like a electrical shock. Initial report includes documentation of sick visit on 16 Jan. 2003 for fever and cough.  Txd with phenergan. Next visit 10 June 2003 discussing diabetes, HTN, and high cholesterol dx in Feb/March 2003, which placed him on limited duty to monitor response to diabetes tx. MR received from VA documenting multiple office visits for c/o dizziness, abdominal pain, chest pain, injury from bike accident, hand numbness and tingling, toenail avulsion, ear pain, sore throat, dysphagia, h/a, and upper and lower back pain between 06/2004 and 11/2006. Had carpal tunnel surgery 07/2006. Assessments: As above in PMH (Diabetes Mellitus dxd in 2003, HTN, lumbar disc herniation, bilateral rotator cuff tears repaired in 2004,depression, anxiety, hypercholesterolemia, elevated LFTs). As soon they put me the shoot my blood sugar raise until 557 and my joint start to pain red hard.  After that course me surgery in both shoulder and carpal tunnel in right hand also I have 3 bulgens on back (disk) I lost memory and deppresion I check with VA for this sickness I have to wear glasses because I lost vision  Per 60 day follow up: I never feel symptoms of diabetes, only after the vaccination occur. I sent evidence that all year, that I will be activated during regualr army and national guard never feel diabetes symptoms. Also army reserve. Those events "both sugery on my shoulders and carpal tunnel surgery" cause me highly depression.
about 5hr p/vax called & had blotches on ant neck & chest;started  by phone on DPH & zyrtec;by next day had diffuse hives;had inc swelling in arm;
the patient received two doses of HIB accidentallywith no adverse event; Initial information received on 10-Nov-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to case 2020SA317968.  This case involves a 1 years old male patient who experienced the patient received two doses of hib accidentallywith no adverse event (Product administration error, while he received vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation; QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) for Immunisation; and DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL (VERO)) for Immunisation.  On 10-Nov-2020, the patient received a 5 dose of suspect HIB (PRP/T) VACCINE lot UJ353AAA via intramuscular route in the left thigh for immunization.  On 10-Nov-2020, (same day) the patient developed a non-serious the patient received two doses of hib accidentally with no adverse event (product administration error) following the administration of HIB (PRP/T) VACCINE..  It was not reported if the patient received a corrective treatment.  The event outcome was reported as not applicable at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.
PT CALLED -- EXPERIENCING MILD HA, NO FEVER, CHILLS, LETHARGIC; NO STIFF NECK -- STARTED 8/27 PM
flu-like symptoms; did not feel well; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th January 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced influenza-like symptoms and feeling unwell. On an unknown date, the outcome of the influenza-like symptoms and feeling unwell were unknown.   It was unknown if the reporter considered the influenza-like symptoms and feeling unwell to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR118966   Additional Information: GSK Receipt Date: 12-Aug-2022 Reporter's comment: The patient self-reported this case. The patient received dose of Shingrix vaccine and experienced flu-like symptoms and did not feel well. In May 2022, she received a cortisone shot in her shoulder. Her doctor recommended that she wait 3 months before she got her second SHINGRIX dose. The reporter consented to follow-up. Additional supportive information: As per narrative it seems that the patient experienced adverse event before cortisone administration, hence it was not considered as suspect in the case.  For tolerance of 2nd dose refer case US2022AMR118966.; Sender's Comments:  US-GSK-US2022AMR118966:Same reporter
Aprox 24 hr after 3rd Gardasil Nausea Cover in sweat chills-Rash down arm and upper body "I feel like I have the flu" This is in follow-up to report (s) previously submitted on 11/14/2007. Initial and follow up information has been received from two licensed practical nurses, concerning a 26 year old female paralegal with an allergic reaction to antibiotics (also specified as no known drug allergies), who on 02-FEB-2007 was vaccinated IM in the left deltoid, with the first dose (lot #654702/0011U), on 13-APR-2007 was vaccinated IM in the left deltoid, with the second dose (lot #656539/0742U), and on 26-SEP-2007 was vaccinated IM in the left deltoid, with the third dose, 0.5 ml of GARDASIL vaccine (lot #654539/0742U). Following the third dose on 27-SEP-2007 ("within 24 hours"), the patient stated that she "felt something" and developed a rash around her upper body. She also experienced nasuea, chills, and stated she felt like she had the "flu". Treatment with BENADRYL was prescribed. At the time of this report, the outcome of the event was recovered (duration not specified). This is one of two reports received fromthe same source (WAES #5710USA00457). Additional information is not expected.
Few hours after shot I felt funny had a low grade fever then I went to bed woke up at 6am feeling funny my eyes were sealed shut and crusty my face was swollen bad and numb then followed by a sore throat. Went to the ER was hooked up to IV then at home was to take antihistamine and pharyngitis for five days.
delayed cutaneous hypersensitivity reaction   Narrative: Onset 8 days post 1st vaccination; duration  lasted approximately 2 days. size about a silver dollar.
After receiving first mRNA COVID vaccine, patient experienced flushing, headache, chest tightness, shortness of breath, and nausea. Patient was initially monitored in an observation area, given crackers and juice. After 35 minutes she was transferred to the ED. IV line was placed, labs drawn, and given acetaminophen and ketorolac, fluids and ondansetron. Patient was later discharged after remaining stable.
Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and HEADACHE (Headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received the 1st dose but did not receive the 2nd dose. Patient described the events as severe side effects.  No concomitant and treatment information were reported by the reporter.   Reporter did not allow further contact
PATIENT PRESENTED TO PHARMACY AFTER VISITING ED FOR THROAT SWELLING, DIFFICULTY SWALLOWING, NECK AND SHOULDER SWELLING, RASH OVER SHOULDER AND NECK AND FEVER.
This non-serious spontaneous case, initially received from other health professional (nurse) on 08-Oct-2018, concerning a 03-year-old male child patient. On 08-Oct-2018, the patient (under age of 4 years) was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230 and expiry date: 31-May-2019] (explicitly coded as inappropriate age at vaccine administration). The patient did not experience any adverse events after administration of the vaccine. Follow up received from other health professional (nurse) on 19-Oct-2018: Added patient's gender (male) and date of birth in the patient's tab. Added start date 08-Oct-2018, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230 and expiry date: 31-May-2019 of the product in the product tab. Added onset date 08-Oc-2018 of the event inappropriate age at vaccine administration in the event tab. The narrative and case comment were amended accordingly. Non-significant follow up received from reporter on 12-Nov-2018: No new information was received. Hence, no changes were made in narrative.
immediately after receiving the vaccinations she screamed for 5 minutes and fell asleep and was under continuous sleep all day and night after receiving the vaccine. Baby does not sleep during the day in normal circumstances longer than 1hr nap every 1.5hrs.
Patient states she had pain immediately following the vaccination on 10/02/2019. She went and saw her primary care physician on 10/29/2019 because she was still having pain. She was then to follow up with an orthopedic surgeon to further assess the issue. She had an appointment with Dr. 11/27/19 where he prescribed a steroid medication. Prior to the appointment he ordered a MRI which was resulted on 12/2/19 and showed a bone bruise, fluid in the shoulder area and a partially torn rotator cuff per the patient. She was later prescribed an anti-inflammatory on 12/13/19 for persisting pain and inflammation. During this time she has also seen her PT that noted that she was unable to perform shoulder exercises due to her condition. She is following up with Dr in the coming weeks.
AFTER VACCINE WAS GIVEN THERE WAS A BRUISE AT THE SITE. ABOUT 24 HOURS LATER THERE WAS A RED, RAISED RASH AREA ABOUT 4 CM IN DIAMETER. DTAP & VARIVAX WERE GIVEN IN THE RIGHT THIGH
Pt recvd 1st dose of Hep B on 15MAR91; & on 18MAR91 pt devel h/a, malaise, & fatigue; pt was given APAP;
Syncopal episode post vaccination. VS obtained. Reported she felt dizzy and lightheaded and "woke up on the exam room floor". Observation of patient for at least one hour. Pt. struck head on floor - ice to head.
Patient fainted.  recovered immediately.  EMS was called and patient was checked out and determined to be fine
mom of pt stated pt had an episode  w/shaking all over & eyes rolled back in head 2wk p/1st immun;