chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via call center representative and described the occurrence of hemorrhage in a 23-year-old female patient who received MENVEO (batch number M17002, expiry date October 2018) and (batch number X17002, expiry date January 2020). On 13th March 2018, the patient received MENVEO. On an unknown date, the dose was an unknown dose. On 13th March 2018, immediately after receiving MENVEO, the patient experienced hemorrhage (serious criteria GSK medically significant), laceration and pain. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the hemorrhage was recovered/resolved and the outcome of the laceration and pain were not recovered/not resolved and the outcome of the pharmaceutical product complaint was unknown. The reporter considered the hemorrhage, laceration and pain to be related to MENVEO. Additional details were provided as follows: The age at vaccination was not reported. The call was transferred from the GSK Vaccine Service Center. A nurse from the physician office reports that yesterday on 13th March 2018 a different nurse who was experienced with MENVEO was preparing the product for administration. When that nurse attempted to withdraw the MenCYW-135 liquid conjugate component from its vial, she was unable to withdraw any product into the tuberculin syringe with 5/8ths by 25 inch needle. She then looked to realize there was no product to withdraw because the vial's bottom was broken. She also realized she was bleeding and that her left hand's middle upper finger had been cut by the vial. She removed a little piece of glass out of the cut too. The physician examined her finger to see if it needed stitches because it would not stop bleeding, and the physician decided the cut did not require stitches. Pressure was applied to the cut and it was elevated for about 15 or 20 minutes and then a band-aid was applied. She did not know exactly when it stopped bleeding. She removed the Band-Aid about 9 o'clock last night. The band aid was full of blood, but the cut had stopped bleeding by that time. The cut was today covered with a Band-Aid and was still painful upon touch. She had not required any pain medication for the pain. There were pieces of broken glass in the bottom of the box, so the reporter said that the vial had broken inside its product box. Looking from the top, the vial had first appeared normal. But it was spiky near where part of the bottom had broken off. The product as well as the glass inside the product box was discarded already into the sharps container. The product was not administered. It was stored in the refrigerator. The reporter also provided a lot number of X17002 and expiration date of 01/2020 from one of the other MenCYW-135 component vials within the box. Related QA notes continued: Credit for one dose status pending callback from reporter. The physician examined the cut. The lot number above was from the product box.
Information has been received from a physician concerning a 17 year old male patient who on 12-OCT-1994 and 11-FEB-1997 was vaccinated with the first and second dose of MMR II (HSA). The patient was diagnosed on 11-NOV-2009. The patient did not have a fever. Blood works were performed on 11-NOV-2009. The serum immunoglobulin M test result was negative. The serum immunoglobulin G was 5.16 and the serum amylase was 61. On 08-DEC-2009 the patient experienced mumps. At the time of the report, the patient's outcome was unknown. Follow-up information has been received which reported that on 13-NOV-2009 the patient experienced left parotitis. The patient had blood work performed on 16-NOV-2009. The serum immunoglobulin M test result was <1:10. The serum immunoglobulin G was 6.93 and the serum amylase was 459. On the same day, the patient was diagnosed with mump. At the time of the report, the patient's outcome was unknown. This is one of several reports from the same source. No further information is available.
I woke up with chills at 3:30 a.m. added blankets and slept until about 5:30 and woke up sweating and feeling nauseous. Also had a fever of 100. Took Tylenol and slept a few more hours. Felt okay for a little while. Ate a plain English muffin and drank some water and went back to sleep. Painful muscle and joint aches throughout the day. Would sleep a while, wake up and feel better for a short time. Had fever of 99.8 during the day. Could only eat a few crackers for lunch. Slept most of the day. Took naproxen for joint and muscle pain after eating the crackers. Ate a little dinner and felt okay. Didn't feel "normal" until about 9 p.m.
Rectal adenocarcinoma metastatic to liver. Operation - Laparoscopic liver resection. Hospital admission within 6 weeks of receiving the COVID vaccine.
Local reaction pink area extending around all 3 injection sites with some swelling, slight tender around deltoid from.
Following administration of Typhoid vax, pt devel a large area (11 cm x 9 cm) of erythema & warmth around inject site (lt forearm); Following day exp systemic rxn of fever & malaise; Took APAP for sx; 2wks later area was still erythematous;
Moderate to severe flu-like symptoms: fatigue, body aches, sore arm, neck and shoulder (hard to lift arm), fever.  Would have stayed home from work if it was a week day.
Red, irritated blotchy rash at PNEUMOVAX site starting 1 day after immunization and cleared on 2-3-09 (said she is sensitive to many things). Feels tired, blood pressure elevated ~152/80, heart feels like it misses a beat, will check with cardiologist on 2-10-09.
Therapy non responder; Therapy non responder; Underdose; This case was reported by a consumer via call center representative and described the occurrence of therapy non-responder in a 11-year-old female patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis, Hepatitis B vaccine for prophylaxis, HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received the 1st dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine and the 3rd dose of Hepatitis B vaccine. On 28th August 2018, the patient received the 4th dose of Engerix B .5 ml. On 29th July 2019, the dose was .5 ml (.5 ml daily). On 29th July 2019, the patient received the 5th dose of Engerix B .5 ml. On 29th July 2019, not applicable after receiving Hepatitis B vaccine, Hepatitis B vaccine, Hepatitis B vaccine and Engerix B, not applicable after receiving Hepatitis B vaccine, Hepatitis B vaccine, Hepatitis B vaccine and Engerix B and unknown after receiving Engerix B, the patient experienced underdose. On an unknown date, the patient experienced therapy non-responder and therapy non-responder. On an unknown date, the outcome of the therapy non-responder, therapy non-responder and underdose were unknown.   It was unknown if the reporter considered the therapy non-responder and therapy non-responder to be related to Hepatitis B vaccine, Hepatitis B vaccine, Hepatitis B vaccine and Engerix B.  Additional details were provided as follows: This case was reported by the patient's mother. The age at vaccination was not reported. The patient could be of less than 1 year at the time of 1st vaccination. The patient received her initial 3 dose series of Hepatitis B vaccine in her first year of life. Last year in 2018, when the patient was 10 years old, she was found to have a titer level that was indeterminate, which led to non responder to therapy and hence the pediatrician decided to give her a booster dose of Engerix B 0.5 ml. This year in 2019, titer was checked again and it was still indeterminate, which led to non responder to therapy. On 29th July 2019, the patient received 2nd booster dose of Engerix B 0.5 ml, which led to underdose. As the patient was 11 years old, and the recommended booster dose for an 11 year old patient was 1 ml. The reporter consented to follow up.
RASH AROUND INJECTION SITE, RADIATING ITCHING FROM INJECTION SITE TO FINGERTIPS. REDNESS, AND SKIN WARM TO THE TOUCH.
This case was reported by a other health professional via sales rep and described the occurrence of headache in a 16-year-old female patient who received BEXSERO. On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced headache (serious criteria other: as per reporter) and nausea. On an unknown date, the outcome of the headache and nausea were not recovered/not resolved. The reporter considered the headache and nausea to be related to BEXSERO. Additional details were provided as follows: The GSK sales rep did not have the patient's details, lot number or expiration dates. The patient experienced severe headache and nausea lasting longer than 7 days. The patient required Emergency Room/doctor visit.
shoulder pain at the injection site; decreased mobility in the left arm; not so much weakness as soreness/ guarding the arm because of the soreness; guarding the arm because of the soreness; Charley horses; This is a spontaneous report received from a contactable nurse from medical information team.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the arm (shoulder), administration date 09Jan2021 (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "shoulder pain at the injection site"; MOBILITY DECREASED (non-serious) with onset 2021, outcome "unknown", described as "decreased mobility in the left arm"; MUSCULAR WEAKNESS (non-serious) with onset 2021, outcome "unknown", described as "not so much weakness as soreness/ guarding the arm because of the soreness"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "guarding the arm because of the soreness"; MUSCLE SPASMS (non-serious) with onset 2021, outcome "unknown", described as "Charley horses".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021289893 same reporter, same suspect drug, similar events, different patient
Nauseous, sharp pain in upper abdomen, sweating, passed out. Spouse called ambulance
Syringe nipple and luer-lock connector broke from syringe barrel. In one instance the break occurred at the time of attachment of safety needle to syringe. In two occurrences the break occurred when safety device on needle was activated after injection was completed.
Patient had dizziness after receiving vaccine.  Evaluated by clinic staff - then reporting throat tightness and reported having left shoulder pain for the prior 1.5 hours.  patient was sent to the ED by EMS.  The pt states that she had her first covid vaccine injection today and less than 30 minutes after her vaccine she developed acute central chest pain radiating to her left shoulder. She was given a full dose asa and 1 SL nitro by EMS. She states her chest pain was a 9/10 and it was pressure and tightness. She had associated lightheadedness. She states her pain is much worse than her typical chest pain she gets at home and takes nitro for. She states she is unsure if it is exertional, it is not worsened by deep breathing or palpation. She denies syncope, facial swelling, diaphoresis, n/v, abdominal pain, and hx of allergic reactions from vaccines.
Very dark urine for two days starting on Thursday after the covid booster on Monday.  Test the following Monday (11/22/2021) did not show blood in urine. Tests on 11/30/2021 showed low red blood cell count. Subsequently diagnosed as cold AIHA. I'm still undergoing tests to determine cause.
Onset of crying unconsolable 2 hrs /p admin of DTP (pt's 3rd vax) given /w OPV & HIB.Duration of cry approx 2 hrs /w no sz or LOC, but pt hypotonic
Fever  101 degrees for eight hours. Currently have Muscle aches, no energy, headache,  loss of appetite
pityrias rosea; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female non-pregnant patient received second dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9264), via an unspecified route of administration in arm on 09Feb2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL1283), via an unspecified route of administration in arm left on 13Jan2021 as a 1st dose, single dose for COVID-19 immunization. It was reported that, no other vaccine in four weeks and no other medications in two weeks. No covid prior vaccination and tested for covid post vaccination. The patient stated that, exactly 2 weeks after her 2nd dose experienced pityrias rosea on 23Feb2021. Stated that, the vaccine may not have caused this reaction but just wanted to inform the manufacturer in case there were rising numbers of this incident. Treatment medication included hydrocortisone. On 25Jan2021, the patient underwent lab tests and procedures which included COVID test, resulted as negative, nasal swab. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
My son got his chickenpox vaccine on Mar. 6th (2013) at his 1 year check-up visit. On Mar. 11, I found a few rashes on his face when I got home around 6:30pm. The rashes turned out more and more in the evening and I found them on his scalp, back and chest. Then the next day morning (Mar. 12), I brought him to doctor's office because some of the rashes have blisters. The doctor checked him and told me it was the chickenpox rash due to the vaccination 5 days ago. She told me to do symptomatic treatment - using TYLENOL if he has fever and BENADRYL if he feels itchy. He had a mild fever around 102F in the night of March 12. Then on Wednesday of March 13, more rashed were seen even on his bottom and his penis. The baby was very fussy and looked very tired, with much less appetite than usual. He had a high fever of approximately 103F through the night on Wednesday. I gave him one dose of TYLENOL based on his weight around 4am. The fever was retreated but came back around 8 am Thursday (Mar. 14). During the day of Thursday, the baby has mild fever but new rashes stopped coming out. The old rashes began to dry. There was no fever on Thursday night and Friday (Mar. 15th). I completed the adverse effect report form on Friday (Mar. 15th). By the time I reported, my son has not fully recovered.
pt. c/o dizziness after vaccination at observation unit  VS checked B/P 144/73, P 73, SATS 99%,  R 20. Patient observed and water given, stated that she is feeling better.
arm started to itch again and was red again; small little red itchy spots; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (small little red itchy spots) and PRURITUS (arm started to itch again and was red again) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 02-Feb-2021, the patient experienced RASH MACULAR (small little red itchy spots). On 08-Feb-2021, the patient experienced PRURITUS (arm started to itch again and was red again). The patient was treated with PARACETAMOL (TYLENOL) at a dose of unknown and IBUPROFEN at an unspecified dose and frequency. At the time of the report, RASH MACULAR (small little red itchy spots) and PRURITUS (arm started to itch again and was red again) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 09-Feb-2021: treatment medication has been updated.
Ever since getting the COVID 19 vaccine, my period have been highly irregular and heavy. The first 3 months after vaccination, my period came on average every 2 weeks. This past cycle it was over a week late.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On an unspecified date of approximately 2013 (reported as about a year ago) the patient was vaccinated with first dose of GARDASIL (dose and lot number not reported). On an unspecified date of approximately 2013, after receiving the GARDASIL the patient developed fever. The physician also reports the patient received the first dose of GARDASIL the patient developed fever. The physician also reports the patient received the first dose of GARDASIL about a year ago, and had not received the second dose yet. There was no product quality complaint (PQC). The outcome and causality of fever was unknown. Additional information has been requested.
Information has been received from a health care professional concerning a 27 year old Caucasian female patient with allergy to penicillin and a history of possible febrile urinary tract infection who on 11/19/97 was vaccinated with the first dose of varicella virus vaccine live SC in the left deltoid. Concomitant therapy included ciprofloxacin hydrochloride. On 12/1/97 the patient developed small, red, raised blemish at the injection site which did not vesiculate or blister. On 12/2/97 through 12/22/97 she also developed 1 to 2 lesions that appeared every 2 to 3 days, one of which appeared by her right ear. These lesions were described as looking like an ant sting bite and they never vesiculated, blistered or crusted over. On 12/10/97 she also reported two lesions on the inner lining of her nose. On 12/28/97 the lesions resolved and on 12/29/97 she returned to work. It was reported that patient's non-vaccinated child had a similar experience. No further details is available.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 26-SEP-2017, the patient was vaccinated with M-M-R II albumin status: recombinant human albumin (rHA), 1 dose, lot # L036853, expiration date: 24-SEP-2017, for prophylaxis (route of administration was not provided). Other suspect therapy included sterile diluent (manufacturer unknown) lot#: M033585 and expiration date: 21-APR-2019. No adverse effects were reported. The reporter also stated that the M-M-R II that was administered did not have temperature excursions.
Developed frontal headache ,neck stiffness and fatigue 24 hrs after 1st vaccine
Was told I could get the Moderna Booster and Flu shot together.  within 24 hours I had a fever of 104.  Sat in cool bath for 90 minutes and took Tylenol to get it down to 100.  Stayed around 100 for the remainder of the evening.  I do not know which seasonal flu shot was given, so I just picked the top one.
Fever 3 or 4 hours after immunization, then 4 hours later febrile seizures when to ER otitis was diagnosed.
Narrative: Pt tested positive for COVID-19 on 8/19/21 after receiving two doses of COVID-19 vaccine at Facility on 4/8/21 and 4/29/21. Pt arrived at ED on 8/4/21 with SOB on exertion, tachypnea, and hypoxia. Patient received BAM infusion on 8/24/21.
FLU-LIKE SYMPTOMS/ BODY ACHES/ SORE THROAT/ TROUBLE BREATHING; WEAKNESS; This spontaneous report received from a patient concerned a 41 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A and  expiry: 23-JUN-2021) dose was not reported, administered on 10-APR-2021 to Left Arm for prophylactic vaccination.  No concomitant medications were reported. On 10-APR-2021, the subject experienced flu-like symptoms/ body aches/ sore throat/ trouble breathing. On 10-APR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from weakness, and flu-like symptoms/ body aches/ sore throat/ trouble breathing. This report was non-serious.
had shingles after being vaccinated / suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had shingles after being vaccinated. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
5/11/07 Received Varivax booster RA. On 5/12/07 woke up with small red, tender area at shot site. On 5/13/07 area 7-8 inches in diameter, very tender, raised red, areas. 5/14/07 area of redness decreased. Now erythema 2 inch diameter. Ice and Benadryl advised.
began itching @ site 1 1/2 hrs post vax; on observation site was warm to touch, & indurated by 2 in & red @ border;
Thunderclap headaches during sexual activity, High Blood pressure, Brain fog,  all have not gotten better to date
p/ pt recv vax approx 1yr later devel mild case of varicella lasting 3 days.
Narrative:  78-year-old male veteran reports diarrhea for the past 3 weeks. He  states that every time he eats food "I can't grumbling in my stomach and then after  going to the bathroom" His appetite has been normal. This been no blood in his  bowel movements blood tarry stools. He does state that the bowel movements  "smelled different." He also states that the stools are watery but has "droplet" size  formed stools and denies any presence of mucus. There is no associated  abdominal pain, nausea, or vomiting. There is no fever or chills. There has been  no recent travel or camping. There has been no eating a game meat or any other  atypical foods. He relates his symptoms back to started after receiving his  COVID-19 vaccine 3 weeks ago. There has been no recent antibiotic use. There  are also no known sick contacts or similar symptoms in others. see gi issues that  patient relates to starting after receiving his COVID-19 vaccine 3 weeks ago.
The pt received the vax on 9/9/00. On 9/23/00, the pt experienced a fever of 100.2, a vesicular rash, neck stiffness.
profuse sweating, loss of use of limbs, disoriented, temp drop to 85 degrees. Body started to shut down. Hypothermia, shock near death! by minutes if my son didn't get to the hospital exactly when he did! This was a nightmare and no one could explain it.
Hospitalization for hypoxia due to COVID-19 on dates 8/17/2022- 8/23/2022.  Treated with dexamethasone, Remdesivir, vitamin C 1,000 mg PO daily, zinc 50 mg PO daily.
On Sun., 4/11/21 I awoke with sharp, burning needle-like pain in EVERY joint on my RIGHT SIDE ONLY from my toes all the way to the right side of my neck (including toes, ankle, knee, hip, shoulder, elbow, wrist, ENTIRE right hand). Pain was only on the RIGHT side of my body. Very odd.