chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via sales rep and described the occurrence of injection site swelling in a adult female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site swelling. The patient was treated with antibiotics NOS. On an unknown date, the outcome of the injection site swelling was recovered/resolved. The reporter considered the injection site swelling to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of SHINGRIX in unknown deltoid. The patient experienced swelling in her arm near the injection site which has lasted for 4 to 5 days, and was described as 6 mm in width. The event on set timing was not known, but the physician did say soon after the injection. The patient had denied permission to contact their physician. Field representative said that physician did not wish to be contacted. This case was previously reported to physician. The patient required to visit emergency room.
mom called stating that pt had the following sx on the following day p/vax; gagging, attempted vomiting, pupils fixed & dilated, non-responsive to verbal stimuli; mom also reported poss shallow resp;
I was 2 weeks post prolapse surgery and healing quite well.  I thought that would be enough time to wait to heal and get my vaccine.  I got the vaccine in the afternoon and that night at about 10 pm I started bleeding profusely with blood clots coming out of my vagina.  Before this I had no bleeding post surgery or any complications.  This lasted all night.  I went to the surgeon next day and the bleeding and blood clots had stopped.  2 days later it started again all night long.  I refrained, stupidly, to not go to ER because of the virus.  It stopped next day and then 2 days later I woke up in blood and clots and it would not stop.  I had to go to the ER my surgeon said to stop it.  He added more stitches to my previous surgery.
She got her booster (3), that night her hand swelled and got real red, severe pain and tight.  She could not use her hand, could not pick up a spoon.  That lasted for 2 days, then the pain went away.  Then the pain showed up in her right shoulder and right hip.  She went to her PCP but she had told her about the booster and how that had affected her, but told her that it felt like it was in her muscle and not her joint.  She went to an orthopedist and they took an X-ray that showed no fractures and no arthritis.  After that the pain got into her whole pain, severe pain.  It's across her shoulders, trapezius muscles, down to her elbows.  It was so severe it was like that her arms were stuck to her sides as she could not move them for the severe pain.  She also had pains in her hands.  She has it in both hips, and sometimes it comes and goes, but the part that didn't (had it in the ankles too), leave was in her shoulders arms, her hips and her right leg.  It got to the point that she could not walk much, the movement was awful because if she moved her arm to any extent it would shoot a pain that she could not bear on a continuous basis.  She is now scheduled to see a rheumatologist as they are thinking it is an autoimmune disease on 5/17/22.    She has been on Meloxicam, Tramadol, Celebrex, Prednisone, Hydrocodone, none of which have touched the pain.  The only thing that helped the pain was the orthopedic gave her a steroid dose pack.   The first time she took it it took away all the pain and was able to move, and then it came back 7 days after she got off the steroids.  Then they put her on a 2nd steroid and she got back the movement, but still had a lot of the pain.  So now she just finished her 3rd steroid dose pack and today she will start a fourth.  She was also given a steroid shot on 4/12/22.  She still has some pain in her shoulders, and feels like it has stripped the muscles in her arms some how.    She did not have any problems with the first two vaccines, and has never had any problems with the flu vaccines that she gets every year.
Matallic taste in mouth, then right leg coldness and burning.  EMT on site evaluated client in recovery area. EMS staff noted that symptoms progressed to right leg itching and right arm coldness and burning. At client request she walked to EMS unit outside and was transported to local hospital for evaluation.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sulfa" (unspecified if ongoing); "birth control" (unspecified if ongoing). Concomitant medication(s) included: ESTROGEN taken for contraception.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
"Extreme, almost out of body experience. Had to call someone to have them stay on the phone with me in case I passed out"
10 minutes after vaccine administered, pt developed nausea and vomiting. 5 minutes later developed acute laryngeal spasm with stridor, no angioedema, no bronchospasm, no rash. GIven .3 mg epi IM, 100 mg Benadry IM and 125 mg Solumedrol IM with slight improvement of stridor. Given 2nd dose of epi .3 mg IM. with marked improvement of stridor. Patient transported to ER. This is second report we have submitted for this new lot in one week.
Lip swelling 24 and 48hrs after vaccination. Previously had lip fillers. Some tingling, tenderness and noticeable swelling in lips
Diarrhea x1 week since administration resulting in diaper rash. Probiotic and Diaper cream prescribed.
Information has been received from a licensed practitioner nurse concerning a patient who on unspecified dates received the three doses of RECOMBIVAX HB (route, site, doses and lot numbers not provided). The nurse reported that on an unspecified date the patient was showing no immunity to hepatitis B. At the time of the report, the patient's outcome was unknown. No further information is available.
(+) red, swollen tender about 4x5 cm on (R) arm.
Blister at injection site 0.2cm. Erythema and swelling medial and lateral asjuct. Right forearm and arm.  Right arm pruritis
The morning after receiving her first Hepatitis A vaccine she awoke having urinated during her sleep with some apparent vomitus on sheet. She has never had enuresis. She seemed fine before going to sleep and after waking.
Pt reports 36 hrs after injection administered - localized swelling, warmth, redness & muscle pain - no treatment at this time.
Severe headache...nausea...dizziness..severe joint pain..uncontrollable body temps from cold to hot over and over
pt devel fever on PM p/vax given; rx w/APAP; fever cont x 2-3 day; pt awoke on the AM of 28FEB92 w/high fever devel 12-15 mins sz disoriented & drowsy afterwards; taken to ER for eval;
A week after shot, arm became sore again.  The next morning, more soreness developed with a rash at injection site.  It was also hot to the touch.  I also became queasy, sweaty and close to fainting.
Post vax, the pt developed a slight raised area on left deltoid. 20 mm redness on 10/10/00. In bed sleeping, pain in left upper arm woke employee up. She had radiating pain from left upper arm extending to fingers on left hand when left arm is moved. Left arm is sore when holding it still. She complained of headache for 3 days.
Awoke with very high blood pressure, pounding heart rate.  At times, my blood pressure was 145/97.  This lasted for over 15 days.   I visited Clinic twice within 3 weeks of vaccination.  They denied it was connected to vaccine.  I do not agree.  Severity of symptoms has subsided 04/01/2012.  Prior to this vaccination, my blood pressure has been controlled and kept normal for 20 years.  I was fearful of stroke or heart attack.  I was exhausted from my heart pounding.  I will never take this vaccination again.  Please ask medical people to take this more seriously.
This is a case of breakthrough COVID-19 disease plus  Multi-System Inflammatory Syndrome which occurred after vaccination and which was fatal in an adult.   The individual was vaccinated with the Moderna product on 03/24/2021 and 04/29/2021. The individual became symptomatic for COVID-19 disease on 01/09/2022 and tested positive for COVID-19 on 01/09/2022. They were admitted to hospital several weeks later, on 01/31/2022. They experienced multiple complications including: acute liver failure, acute renal failure, acute pulmonary edema, bilateral pulmonary infiltrates, acute hypoxic respiratory failure, and cardiac arrest. The individual was intubated after cardiac arrest on 02/02/2022. The individual also developed Stevens-Johnson Syndrome with toxic epidermal necrolysis overlap. They were also diagnosed with Multi System Inflammatory Syndrome. They were transferred to a hospital who had a burn unit (to manage the skin sloughing) on 02/06/2022. They remained hospitalized until they died on 02/07/2022.   The Report Form has already been submitted to CDC in regards to this case.
Flu-like symptoms developed 24 hrs after vaccine. Symptoms included: fever, malaise, sore throat, earache, abdominal pain, diarrhea, body aches, and congestion.
Patient completed his second dose of Shingrix and developed a rash on his lower abdomen approximately two weeks afterward. MD diagnosed patient with Shingles.
On 7/29/22 patient (healthcare worker) was vaccinated with JYNNEOS Monkeypox vaccine subcutaneous right arm. On 7/31/22 patient c/o burning at the right arm injection site. It was observed on 8/1/22 right arm injection site redness and swelling.  On 8/1/22 the patient c/o injection site burning sensation, itching, and swelling, patient was advised to take Benadryl. Patient indicated the symptoms worsen 8/2/22 -8/4/22 with a larger area of redness and swelling at the right arm injection site. Patient did take Benadryl on 8/4/22 and 8/5/22 during the evening. The patient has indicated the Benadryl has resolved the burning sensation and the itching has improved.
Client cancelled the original booster dose appointment which was scheduled 28 days after prime dose due to being out of town. He was rescheduled to receive the boost dose 23 days after the first dose. He received the second dose 5 days prior to the 28 day required time frame.
Patient stated they had the vaccine on Sunday (12Nov2023). Monday night at 5:30 pm she had severe vertigo.; This spontaneous case was reported by a patient and describes the occurrence of VERTIGO (Patient stated they had the vaccine on Sunday (12Nov2023). Monday night at 5:30 pm she had severe vertigo.) in a 56-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19. Previously administered products included for Product used for unknown indication: COVID-19 Vaccine (3rd vaccine) and Pfizer (first 2 vaccine). Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine and Pfizer.    On 12-Nov-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 13-Nov-2023 at 5:30 PM,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced VERTIGO (Patient stated they had the vaccine on Sunday (12Nov2023). Monday night at 5:30 pm she had severe vertigo.). At the time of the report, VERTIGO (Patient stated they had the vaccine on Sunday (12Nov2023). Monday night at 5:30 pm she had severe vertigo.) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Patient stated that she received the first 2 vaccine where Pfizer and that she does not remember the 3rd dose.  Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.
Rash immediately after vax given, 5 days following shot pt developed a thick lump that grew larger - no documented visit for this reaction.
12/15 injection given around  1pm - 7pm cough c/o ST no fever, ER visit did not do flu test c/o body aches 12/18 temp 100.3 axillary. Child crying c/o st and body aches
I did not have an adverse reaction to the vaccine. I began not feeling well on 01/25/2023. I tested positive for COVID-19 on 01/26/2023. I had sore throat and a fever. I contacted my doctor and got a prescription for PAXLOVID. I tolerated the medication with no complications. As of today, I do not have any lingering symptoms.
Started 8pm on 11-13-08, vomiting all night, last time was 2pm 11-14-08. Flu symptoms, low grade fever, diarrhea. Not a flu shot, sprayed up nose, live vaccine.
Swollen lymph node in left arm 1 week later  Swelling in left arm at injection site 1 week later
I've been experiencing pain, numbness, tingling feeling, soreness on my shoulder, my back and all over my left arm ever since I recived the vaccine. I am no longer able to lift heavy thing even like grocery.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 30-JAN-2015 the patient was vaccinated with an expired dose of PNEUMOVAX23 (lot# J009833, expire date 25-JAN-2015, 0.5 ml, intramuscular). No adverse experience was reported. Additional information has been requested.
Received vaccine at 1:00pm.  Waited 15 minutes in waiting area. No adverse effects. Returned to work. At 10:00 pm while sleeping on my back, felt liquid dripping in the back of throat.  Rolled over to side and felt liquid dripping from nose onto pillow. Woke up to blow nose and realized that sheets,blanket, and pillow were covered with bright red blood. Went to breakfast table to sit upright to attempt to stop bleeding. Bleeding continued for one hour until stopped. Note: The relative humidity in home was at 49%. This was a posterior nosebleed; not anterior from dry air.
Information has been received from a physician concerning a 17 year old female with no drug allergies who had recent urinary tract infection and completed a course of ciprofloxacin on 10-JAN-2009. She was intramuscularly vaccinated with the first 0.5 ml dose of GARDASIL on 12-JAN-2009. The patient developed a severe headache a few hours after receiving GARDASIL. The next day she developed a fever of 102F and a maculopapular rash on her face and trunk. On 14-JAN-2009 the patient developed abdominal cramping. She was examined in the office on 15-JAN-2009. A "rapid influenza test and monocyte test" were negative. Unspecified blood work was pending. The patient had been unable to attend school due to the severity of the headache. The patient did not recover at the time of reporting. No further information provided. Headache, fever, maculopapular rash and abdominal cramping was considered to be disabling. Additional information has been requested. 1/29/09-Follow-up from Merck on 1.28.09: PCP's nurse reported that the patient was given a Medrol Dose Pak and the symptoms of headache, rash, abdominal pain and fever resolved within a week
Face and neck tight, hot, itching, very red with small bumps under skin for several days followed by flaking and peeling of the skin ... this occurred within 48 hours of the vaccine and has been reoccurring approximately once a week ever since the vaccine with the flare up on May 13, 2023 being the 8th flare up.
Fatigue, soreness at the site, and wheezing within hours. 14 hours after (during the night), development of hives across upper buttocks, up the back, on both sides of torso, up the abdominal region mostly on left side, and onto left breast area. Woke up with hoarseness. Itchy. Left eye is a bit swollen. Feeling fatigued, not rested or refreshed.
thrombocytopenia 12/7/2009 PCP records for 11/7 and 12/2/2009, ck'd for decrease in wbc and plt counts post vaccine, patient with SLE, on Prednisone, both counts recovering by 12/2/2009, Dx thrombocytopenia, leukopenia
Redness and swelling at the site.  Warm to touch. Itchy at the site.
Patient was given Fluzone HD at around 11am. At 8 pm loss of balance, unable to stand. Patient is able to stand, but is unsteady at 12:30 pm. Patient is feeling tired. Not coordinated.
48 hours after being vaccinated, my muscles in my arm were really painful and sore abnormally. I couldn't pick up my newborn and then, I got a sharp pain by my kidney, and I felt like I was having labor contractions. I was in crippling pain, and nothing would relieve the pain. The pain radiated from my stomach to my back. Went to the ER the same day.
pt vaxed 20NOV92; pregnancy test 11JAN93 consistant w/4-5 wks pregnant; LMP 7DEC92; unable to comment on adverse reaction to the fetus until @ the time of delivery which is 13SEP93 @ that time congenital Rubella Synd can be checked for;
Severe migraine and fatigue. Lasted from 8pm the day of the vaccination until the morning 2 days after the vaccination. No treatment was done
This spontaneous report was received from a physician's assistant refers to a 9 year old female patient. No medical history was reported. The patient was vaccinated with 2 doses of VARIVAX (Merck) (lot #, dose, route not reported) on 28-OCT-2005 and 30-DEC-2002. No concomitant medications were reported. Since that time the patient has experienced two episodes of chickenpox. The first episode appeared on 03-NOV-2011. The chickenpox rash appeared on her abdomen, buttocks, and face and the rash eventually resolved. The second episode appeared on 12-MAR-2013 and was still ongoing. The chickenpox rash is disseminated all over her body. In addition, the patient has a sore throat and a headache. Patient sought medical attention. At the office the patient was tested for antibodies and the IgG was negative and were waiting for the IgM results. The outcome of sore throat and headache was reported as not recovered. The outcome of IgG was negative was unknown. Additional information has been requested.
Patient had nasal congestion and redness and swelling at site of injection at the site of injection within a few hours of injection. Knot under the skin. She iced it and had MD look at it at her appointment a few days later. He recommended some Benadryl. and to continue to ice and monitor.
his back around his waist "like a perfect circle all around my body" aches and still aches now/pain above his tail bone that goes all around the waist; This is a spontaneous report from a contactable consumer (patient). This 76-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on 08Feb2021 as single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 08Feb2021, at night, the patient experienced his back around his waist "like a perfect circle all around his body" aches and still aches now/pain above his tail bone that goes all around the waist. The patient read an article in the news about some doctor who states to not take Ibuprofen, Tylenol, or Advil 2 days before and 2 days after the vaccine because it may reduce the effectiveness of the vaccine. He asked if Ibuprofen, Tylenol, or Advil may reduce the effectiveness of Pfizer's COVID vaccine and if pain above his tail bone that goes all around the waist has been a reported side effect with Pfizer's COVID vaccine. The outcome of the event was not resolved.  Follow-up attempts are completed. No further information is expected.
red, raised warm area at the injection site 3.5 inches Narrative: recomended ice and Benadryl
The year my dad got flu shot he got the flu; Initial information regarding an unsolicited valid non-serious case received from a consumer (son of the patient) via social media on 10-Oct-2020.  This case is linked to case 2020SA294157(same source).  This case involved an unknown age male patient for whom it was reported that the year my dad got flu shot he got the flu (Influenza), while he received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, vaccination and family history of the patient were not provided. Concomitant medication was not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, it was reported that the year the patient got flu shot the patient got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  it was reported that the vaccine is only about 40% effective.   No relevant laboratory test was reported.  It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown at the time of reporting.
Pt came to pharmacy presented her CDC card for Moderna vaccine on the card 1st dose was dated 10/20/2021 on the back the dose for 2nd dose date 11/17/2021 and she stated she wants her 2nd dose . after the vaccine was administered and pt went home ,her daughter called the pharmacy and stated that her dose on the 20th of October was her 3rd dose . the pt herself never told the pharmacy staff that she been vaccinated before .the pharmacist who administered the vaccine verified with the pt if this her 2 dose the pt said yes
Vaccine administered only 1 month after the first dose.  Contacted the CDC and after realizing and told that 2'nd dose would be invalid.
Hep B and TDAP given this am - pt developed acute hives across (B) UE and torso approximately 5 1/2 inches after immunizations. Associated dizziness, N, anxiety, peri orbital itching.
FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination.  The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On APR-2021, the subject experienced flu-like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu-like symptoms. This report was non-serious. This case, from the same reporter is linked to 20210428195.
Information has been received from a physician concerning an 89 year old female with drug allergies to "non-steroidal anti-inflammatory drugs, STADOL, and DURAGESIC patch and a history of arthritis and strial fibrillation who on 19-OCT-2006 was vaccinated into th right arm with a dose of Pneumovax 23.  Concomitant therapy included digoxin, BUMEX, K-DUR and TYLENOL WITH CODEINE.  On 19-OCT-2006 the patient experienced redness, swelling and soreness to her right arm after an immunization with Pneumovax 23 in that arm.  The area involved "is hot" to the touch and extends down to the mid-forearm.  The patient sought unspecified medical attention.  As of 20-OCT-2006 the patient had not yet recovered.  Additional information has been requested.
First dose of COVID vaccine 1/30/21, second dose 3/3/21. In April, she developed an inflammatory polyarthopathy.
Left thigh redness, swelling, tenderness, warmth measuring 4x6 inches.