chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a report from Pfizer sponsored Interventions Study. A 68 years-old male subject received four vaccination with PCV 13 vaccine, intramuscularly, on 03-SEP-2010, 12-OCT-2010, 09-NOV-2010 and 16-MAY-2011. On 27-JUN-2011 the subject received first dose of PNEUMOVAX 23, intramuscularly. Other post-study vaccines given in January 2012 included: influenza vaccine; Tdap vaccine; polio vaccine; and, Hib. Post-study on 06-JUL-2012; one year after last study vaccine with PNEUMOVAX 23, the subject developed nephrotic syndrome, and progressive renal failure (Creatinine 2.19 mg/dl) which required hospitalization. A renal biopsy showed membranoproliferative glomerulonephritis and cyclosporine toxicity. There were no signs of graft versus host disease or hepatitis infection. Serology was negative with no signs of an autoimmune process. Tests included the anti-nuclear antibody (ANA) titer, anti-ds DNA antibody, and cryoglobulins. Serology results for hepatitis B, and C infection were negative. Treatment with diuretics was initiated. Treatment with corticosteroids was planned. On 03Jul2013, the investigator reported that the patient was in chronic hemodialysis treatment and was still alive at the time of reporting. Relevant medical history included primary thrombocytosis in 1999 complicated by secondary myelofibrosis, prior treatment with ruxolitinib, a JAK2 (tyrosine kinase gene) inhibitor, and stem cell transplant in 2010 followed by mesenchymal stem cells because of delayed haemotopoietic recovery. Relevant AEs during the study include cutaneous graft versus host disease (GVHD) in November 2010, which resolved. Follow-up (03-JUL-2013), new information received from the investigator includes: clinical and outcome details. The Investigator wanted to bring to the attention of the study team the occurrence of the membranoproliferative glomerulonephritis in this subject. The investigator had no explanation for the development of this event. Nephrotic syndrome after allogeneic hematopoietic stem cell transplantation had been described in the literature as a manifestation of chronic GVHD. GVHD-associated membranoproliferative glomerulonephritis was extremely rare and had been reported in the literature as single cases only. The investigator was unable to exclude prior vaccines including the study vaccines, other medical treatments including ruxolitinib and mesenchymal stem cells, as possible underlying causes of this disease. Upon internal review, membranoproliferative glomerulonephritis was considered to be other important medical events. Additional information is not expected.
Patient inadvertently received DTaP even though she was due for Tdap.  She was subsequently administered Tdap immediately after.  No adverse reactions in clinic.  Error was discovered after patient left office.
she woke up with a buzzing noise from head; vomiting,; ache-ness to the point where she can't bend down; felt like her back was broke; incredibly cold; nausea; feverish; very tired; soreness in arm too; soreness; aches/soreness; she had chills; bad headache; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (she woke up with a buzzing noise from head), VOMITING (vomiting,), BACK PAIN (ache-ness to the point where she can't bend down), MUSCULOSKELETAL DISCOMFORT (felt like her back was broke) and FEELING COLD (incredibly cold) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer (left deltoid) on 19-Mar-2021 and Pfizer (left deltoid) on 09-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Dec-2021, the patient experienced TINNITUS (she woke up with a buzzing noise from head), VOMITING (vomiting,), BACK PAIN (ache-ness to the point where she can't bend down), MUSCULOSKELETAL DISCOMFORT (felt like her back was broke), FEELING COLD (incredibly cold), NAUSEA (nausea), PYREXIA (feverish), FATIGUE (very tired), VACCINATION SITE PAIN (soreness in arm too), MYALGIA (soreness), MYALGIA (aches/soreness), CHILLS (she had chills) and HEADACHE (bad headache). On 19-Dec-2021, TINNITUS (she woke up with a buzzing noise from head), VOMITING (vomiting,), BACK PAIN (ache-ness to the point where she can't bend down), MUSCULOSKELETAL DISCOMFORT (felt like her back was broke), FEELING COLD (incredibly cold), NAUSEA (nausea), PYREXIA (feverish), FATIGUE (very tired), VACCINATION SITE PAIN (soreness in arm too), MYALGIA (soreness), MYALGIA (aches/soreness), CHILLS (she had chills) and HEADACHE (bad headache) had resolved.            No concomitant medications provided. No treatment medications provided.
PATIENT REPORTED NAUSEA, PAIN ON LEFT THIGH AND HEADACHE.  PATIENT SAID THAT SHE HAS AN APPOINTMENT COMING UP ON 7/15/21 BUT HAS NOT RECEIVED ANY TREATMENT YET.
10cm area of edema lt upper arm, warm, firm, mildly tender; Mom states area looks slightly better than 13JUN91; No tx indicated MD visit 14JUN91;
Noticed 3days after injection arm swelled up and hurt some to the touch.  Started to ice the area
I tested positive on 02/22/2023. I had a mild case. I had a low grade fever, coughing, and a runny nose. We called the health line and I was prescribed PAXLOVID. They also gave me a steroid pack benzonatate to take for 6 days. I did also have a rebound case 12 days later. That started on 03/03/2023 and I just had a low grade fever for one day. I stayed positive until 03/15/2023. I did have a bit of a chronic up until last week.
2 days after vaccination, patient developed large red mass to right cheek.  Approx 3in across with small redder lesion in the center and a little bruising.  Tenderness noted as well.  No fever
Extremely fatigue. Went home and took a nap. Woke up with a bloody nose 1 hour later. Stopped bleeding went back to sleep 30 minutes later. 2 hours later woke up with bloody nose.
sever chills and shakes approximately 10hrs after vaccination lasting 4-6hrs followed by fever with body aches within 24 hrs  symptoms subsided by 48 hrs after vaccination 3 200 mg tabs ibuprofen taken
Systemic: Fainting/Unresponsive-Medium, Additional Details: Patient was checking blood pressure directly after the vaccine with a self-use upper arm blood pressure kiosk. Lost consciousness when cuff tightened and fell backward hitting head on a metal chair arm. Patient unconscious for about 10 seconds. Lay on floor with feet elevated for about 30 minutes and then went to ER for head pain. This was a Pfizer booster dose. He had no reactions to previous 2 Pfizer doses.
Patient received COVID vaccination (unknown manufacturer) and experienced a cardiac arrest roughly an hour after vaccination.  Patient lost consciousness and became unresponsive. Bystander CPR was initiated and EMS arrived. EMS applied an AED which recommended defibrillation and rhythm was reportedly VFib. Single shock returning to sinus tachycardia, CPR continued and patient returned to VFib. Second shock restored sinus tachycardia. Patient was intubated during CPR and started on amiodarone.  Admitted to ICU, currently hospitalized on medical floor.
Patient started feeling pain in upper back, neck, and behind ears on 10-1-15 around 3:00PM. Woke up on Saturday 10-3-15 with face drawn to one side. Patient went to Emergency Room on Monday 10-5-15 and diagnosed with Bell's Palsy.
no adverse event; two vaccines were administered to a 5 month old in error.; This spontaneous report was received from a licensed nurse practitioner and refers to a 5-month-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 12-AUG-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) rHA 1 dose lot # S037497, expiration date 20-NOV-2021 (exact dose, route of administration and anatomical location were not reported) for prophylaxis. On the same day, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose, lot# S031496, expiration date 07-OCT-2021 (exact dose, route of administration and anatomical location were not reported) for prophylaxis. The reporter stated that the vaccines were administered to the patient in error. The reporter did not report if error occurred due to labeling or actual products involved. No adverse event was reported.
Fever 103 degrees - limping on left leg- sl. diarrhea - "acting normal" - Dr. prescribed 2 antibiotic according to mother et encouraged to have one immunization @ a time.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 26-AUG-2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 17-MAR-2016, the patient was treated by a walk-in clinic for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. The patient was prescribed valacyclovir for management of his painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Next day (following vaccination) onset of fever up to 101.4 with vomiting/malaise; also with local erythema/induration/pain at Pneumovax injection site (R) deltoid. Fever persisted thru 9-2-07, N/V resolved on 8-31-07; (R) arm site with persistent s/s reaction on 9-6-07.
This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 79-year-old male patient who received SHINGRIX for prophylaxis. On 16th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was not recovered/not resolved. It was unknown if the reporter considered the generalized rash to be related to SHINGRIX. Additional details were provided as follows: The patient had developed a rash. The rash moved to different locations on the patient's body each day. Caller did not have any additional details at the time of the call. Emergency room visit required.
pt recv vax 21MAR97 & was seen in emergency facility on 28MAR97 w/pain & edema in the rt deltoid & pain in rt neck;also is reported to have exp tingling @ the inj site, swelling of the skin around the inj site;also numbness in neck & arm;
Had vaccination at 4:15pm observed for 15 minutes at the clinic by medical personell.. whilst driving home, felt dizzy and nauseated, pain in my back through to my stomach like Indigestion. After one hour vomited and continued to vomit x 4 over a 12 hour period. also felt like I had indigestion  from my back through to my front and aches and pains  in my joints, this is my 4th day
8-12 hours later. After vaccines (incl. ROTATEQ)- developed temp 100 and loose watery stools 6-8x/d, vomited twice, decreased appetite, decreased fluid intake, decreased urine output, fussiness, nasal congestion, poor sleep. Sent to ER for fluids after 1 pound weight loss in 2 days in 12 pound baby.
It's very sore to touch; Arm was and still is very sore; Lymph nodes behind my left ear have gotten big and very sore; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (It's very sore to touch), PAIN IN EXTREMITY (Arm was and still is very sore) and LYMPHADENOPATHY (Lymph nodes behind my left ear have gotten big and very sore) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced LYMPH NODE PAIN (It's very sore to touch), PAIN IN EXTREMITY (Arm was and still is very sore) and LYMPHADENOPATHY (Lymph nodes behind my left ear have gotten big and very sore). At the time of the report, LYMPH NODE PAIN (It's very sore to touch) and LYMPHADENOPATHY (Lymph nodes behind my left ear have gotten big and very sore) outcome was unknown and PAIN IN EXTREMITY (Arm was and still is very sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided. No relevant concomitant medications were reported. Treatment details were not provided.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of GARDASIL (route, dose and lot number not provided). On an unknown date the patient was having problems due to receiving GARDASIL. The physician did not give the specifics of the problem. The patient's outcome was unkonwn. Additional information is not expected.
BROKE OUT WITH BUMPS  THAT ARE RED AND ICHE LIKE CRAZY ON BOTH ARMS.    I HAVE BEEN USING SOMETHING THAT STOPS THE ICHE FOR A LITTLE WHILE  BUT BUMPS ARENOT GOING AWAY AND THEY ICHE REALLY BAD!
"tightening" of the right side starting with face on down to leg; lasts for a few seconds; started  2 days after shot; continuing off & on throughout day for last 2 weeks.
Mother came today asking for school letter to not get mmr. She said that child had  following vaccination fever followed by a neurological reaction. There is documentation of temp 100F, om and uri on 10/31/2016 However more notable is the exam on 2/2/17 were a regression in speech was documented also decreased socializing.  A work up was initiated and child was referred. Speech therapy was started  diagnosed with receptive expressive language disorder, as well as occupational therapy. By age 4 his language has improved and therapy stopped This may or may not be a vaccine reaction but was unusual (documented temporary regression following vaccination).
LUMP AT THE INJECTION SITE WAS PURPLY COLOR; INJECTION SITE WAS WARM; SORE ARM; This spontaneous report received from a patient concerned a 27 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced lump at the injection site was purply color. On 08-APR-2021, the subject experienced sore arm. On 08-APR-2021, the subject experienced injection site was warm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 12-APR-2021, and was recovering from lump at the injection site was purply color, and injection site was warm. This report was non-serious.
Fever, pain, injection site redness and hard to the touch and also trouble breathing. Patient ended up at the emmergency room and got KEFLEX MEDROL DOSE Pak.
itchy; her arm was a little puffy, there was a red blotch and it was sort of swollen; red blotches; 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 72 year-old female patient received bnt162b2 (BNT162B2), administration date 21Apr2021 (Batch/Lot number: unknown) at the age of 71 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: ER8730), administration date: 21Mar2021, for COVID-19 Immunization. The following information was reported: RASH MACULAR (non-serious) with onset 21Apr2021, outcome "not recovered", described as "red blotches"; PRURITUS (non-serious), outcome "not recovered", described as "itchy"; SWELLING (non-serious), outcome "recovered", described as "her arm was a little puffy, there was a red blotch and it was sort of swollen". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pruritus.  Additional information: They had put a band aid over where she had her shot and a few days afterwards she decided to take the band aid off, because it had started to peel, and it was a little puffy, there was a red blotch, and it was sort of swollen. But that had went down then it was itchy. Since then, she had been experiencing red blotches even on that same arm and now she experienced some in other parts of her body as well. Since she had been using skin soap it takes away the itching and stuff like that and the blotch fades away in certain areas but then it would pop up somewhere else. Inquired for outcome and she said that there were a lot more now than there were in the beginning. When she had taken the band aid off, she didn't give it a second thought because when you have a shot you may have a little swelling and redness. Then a few days after she had started itching so she had looked at her arm and there was the red blotch below the area where she had her shot at. She didn't think anything about it, but she had rubbed it and it had itched and then she had to go use her skin soap to stop the itching. After that every now and then there will be another red blotch that will pop up and a lot have started popping up on the same arm, but she does have some on her other arm, the right arm, and she has had some on her chest and her stomach and her leg but they sort of stated to fade away since she had been using her skin soap, but she still had some pop up. She also had one on her shoulder and it was quite a few there. It looks like it was almost like measles. She would like to know if this had been reported before, she was not sure if it was a side effect but when it showed up after the vaccine, she thought that maybe it could be one.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a Registered Pharmacist (R.P.) concerning a 64 year old male patient, with none drug reactions/allergies and none pertinent medical history, who on 24-MAY-2012 was vaccinated with a dose of ZOSTAVAX (Merck) (lot# 672606/1655AA, Expiration date 21-JAN-2013) (dose not reported), SQ. There was no concomitant medication. Pharmacist reported that on 24-MAY-2012, within an hour of being administered ZOSTAVAX (Merck) the arm where the vaccine was administered swelled and that the patient was having difficulty breathing. The patient spent the night at the emergency room but was not admitted to the hospital and had his heart monitored. When the patient left the emergency room he was fine. At the time of reporting the patient status was recovered. The arm where the vaccine was swelled and that the patient was having difficulty breathing were considered to be immediately life-threatening. Additional information has been requested.
About six weeks after receiving the second vaccine I noted a red hard very sore lump the size of an almond in my right breast encircled by a big red orb that was hot to the touch and very very painful to the touch.  I felt inordinately exhausted as well.  The exhaustion lasted about 24 hours, the soreness, lump and redness at least 10 days gradually shrinking.  Then another same scenario popped up in my right armpit and then another on my left breast and today 6.23.21 I'm experiencing the same intense exhaustion for no reason, and a soreness in my right armpit which I've explored and found another almond sized hard red sore lump.
I felt tired on Sunday, 6/6 and the next day I went to work. By 10:45AM I started feeling really bad. I left work at 12:00PM and took my temperature. It was over 100 degrees. I did have a COVID test done on 6/7, and it came back negative. On 6/8, I had a tele appointment with my doctor and she thought I might have been dehydrated. On 6/9, I actually felt dehydrated. My pulse ox was at 93, but I didn't need to use my inhaler. My doctor started me on azithromycin. I went to see my doctor on 6/10. She didn't hear anything in my lungs, but I did have an x-ray and there was a node in the middle of my left lung. She noticed a bout of pneumonia. I started to drink a lot of fluids and my fever finally broke on 6/11. I still felt very fatigued and did not return to work until 6/18.
High fever for 1 week after shots - reached 105.4, loss of appetite, resulted in hospitalization for 4 days. She was given antibiotics by IV until cultures reported negative. Did have CRP test elevated to 3.5 (increase inflammation). 05/29/07-records received for DOS 4/27-5/1/07-DX:Fever. Presumed sepsis. Nasal Congestion. Four day history of fevers 99-100.
lightheaded dizzy and stiffness of body.    felt better.  dispo home.
Was very ill for a week; This case was reported by a consumer via interactive digital media and described the occurrence of illness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced illness. On an unknown date, the outcome of the illness was recovered/resolved.   It was unknown if the reporter considered the illness to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. Age at vaccination was not reported. The patient received dose of Shingles vaccine prior to the pandemic and felt very ill for a week. The follow-up would not possible as no contact details were available. For 2nd dose, refer case US2021AMR194168, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR194168:same reporter
5 minutes, post vax of 4 injections, the child became limp and blue with very shallow breathing. Called 911. O2 was applied and within 2-3 minutes, the child pinked up. O2 sats were 100%. Watched for 15-20 minutes. No additional problems.