chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lump on top part of her left chest; Normal pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Normal pain) and SKIN MASS (lump on top part of her left chest) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced PAIN (Normal pain). On an unknown date, the patient experienced SKIN MASS (lump on top part of her left chest). At the time of the report, PAIN (Normal pain) and SKIN MASS (lump on top part of her left chest) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no treatment medication were provided. concomitants were not provided
can't  sleep, don't felt sleepy; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (can't  sleep, don't felt sleepy) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040821A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes (diabetes type 2), Blood pressure high and Arthritis. Concomitant products included LEVOTHYROXINE for Thyroid disorder, SITAGLIPTIN PHOSPHATE (JANUVIA) for Type 2 diabetes mellitus.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (can't  sleep, don't felt sleepy). At the time of the report, INSOMNIA (can't  sleep, don't felt sleepy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details not included. The other concomitant medication provided was blood pressure medicine.
got the shot and have had shingles / 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 got the shot and had shingles 11 times now. It was worse than every time. 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.
pt recvd vax 8SEP94 & devel swelling @ the inj site, nausea & lightheadedness;presented to MD following day;arm was bruised @ the inj site & underarm was red, swollen & sore;tx dicloxicillin;
RED HOT LUMP, DID NOT HURT .  AFTER FEW WEEKS OF NOT GOING AWAY WENT TO EMERGENCY WHERE THEY PRESCRIBED CEPHALEXIN FOR CELLLULITIS  SAID WILL HEAL IN FEW DAYS
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about concurrent condition, medical history and historical medication was unknown. On an unknown date in June 2015 (reported as 2 years ago), the patient received ZOSTAVAX (unknown lot number and expiration date) reconstituted with sterile water diluent (unknown lot number and expiration date) at an unspecified pharmacy. On 16-JUN-2017, the patient was administered a second dose of ZOSTAVAX (19400 plaque-forming unit (PFU), lot # M037655, expiration date 29-NOV-2017, dose route and frequency unknown) for prophylaxis. Diluent lot L008523, expiration date 26-NOV-2017. No adverse effect was reported.
Patient returned for her second Pfizer Covid vaccine on 7/20/21 and stated that she had been treated for a blood clot in her lung(s) on 7/12/21. She received her first Pfizer Covid vaccine on 6/29/21. Treatment for clot is ongoing
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination. No Medical History information was reported. In February 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided by reporter. Pharmacist gave 26 doses after the 30-day use by date. Pharmacist would like to know if those doses were viable or not. Dose administered after 30-day Use By Date or after manufacturer date of expiry. Date the vial was initially stored in the refrigerator 14-Jan-2022. Date(s) of administration of vaccines were reported as 14-Feb-2022, 15-Feb-2022, 16-Feb-2022, 18-Feb-2022, 21-Feb-2022. The vial did not undergo any temperature excursions. Treatment medication was not provided by reporter.
can't lift arm up; left arm and shoulder still very painful; Painful from the shoulder blade to the fingers; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 23Mar2021 at 10:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included muscle disease and chronic fatigue syndrome. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Mar2021 at 01:00, the patient's left arm and shoulder were still very painful and it was 8 days for now. The patient notified the doctor and had scheduled an appointment. It was painful from the shoulder blade to the fingers and the patient could not lift the arm up. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcomes of the events left arm and shoulder still very painful, painful from the shoulder blade to the fingers and can't lift arm up were not resolved at the time of the report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
At day 4-14 pt. had hearing loss in ear on the side that the injection was given.
pt recv vax w/o incident;an hr & 15min later mom called from home stating pt had diff breathing & was developing hives;advised to call 911 & go to ER;pt was seen & treated w/adrenalin & sent home on DPH;dx allerg rxn poss secondary to Hep B
Signed    Status Post Procedure(s): LAPAROSCOPY DIAGNOSTIC (9/28/2023)   9 Days Post-Op   Subjective: His pain is being controlled adequately with multimodal pain control.  He is NPO, tolerating nasogastric tube out.   He has ambulated.  He has expected incisional pain. No COVID sx.   Objective: Temp (24hrs), Avg:97.6 °F (36.4 °C), Min:97.5 °F (36.4 °C), Max:97.9 °F (36.6 °C)   BP 116/56  | Pulse 78  | Temp 97.9 °F (36.6 °C)  | Resp 18  | Ht 5' 10"  | Wt 74 kg (163 lb 2.3 oz)  | SpO2 97%  | BMI 23.41 kg/m²    Intake/Output Summary (Last 24 hours) at 10/7/2023 1454 Last data filed at 10/7/2023 1000  Gross over last 24 hours Intake ? Output 2320 ml Net -2320 ml     Physical Exam General appearance - alert, and in no distress Chest - clear to auscultation, no wheezes, rales or rhonchi Heart - regular rate and rhythm Abdomen - appropriate tenderness Extremities -  no clubbing, cyanosis or edema Surgical incision -  incision clean, dry and intact and no erythema or drainage Drain - minimal serous   Selected Lab Results, if applicable: Electrolytes  Recent Labs   10/07/23 0700 10/06/23 0428 10/05/23 0649 NA 138 138 138 K 4.8 4.5 4.4 CO2 26 25 24 CL 106 107 106 BUN 11 10 10 CR 1.08 0.98 0.87 RBS 129 129 113 CA 8.5* 8.2* 8.0* PHOS 3.8 3.9 4.2 MG 2.3 2.3 2.2   CBC  Recent Labs   10/07/23 0700 10/06/23 0428 10/05/23 0649 WBC 10.4 10.0 10.2 HGB 9.0* 8.7* 8.5* HCT 29.5* 28.3* 26.7* PLT 601* 541* 443* MCV 95 93 90   LFTs  Recent Labs   10/07/23 0700 AST 11 ALT 7 ALKP 91 TBILI 0.4   Lactate No results for input(s): "LACTATE" in the last 72 hours.   Assessment and Plan:  Active Hospital Problems   Diagnosis   ? (Principal) APPENDICITIS       With fecalith       Assessment:  Resolving post Op Ileus   Plan:  Increase activity/ambulate. Advance diet. Local wound care. D/C isolation.              Note Details  Author (M.D.) File Time 10/7/2023  2:56 PM Author Type Physician Status Signed Last Editor  (M.D.) Specialty Surgery, General  Admit Date 9/22/2023  ED to Hosp-Admission (Discharged) on 9/22/2023  ED to Hosp-Admission (Discharged) on 9/22/2023   Detailed Report  Note shared with patient Care Timeline  09/22   Admitted from ED 1955 09/28   LAPAROSCOPY DIAGNOSTIC 10/09   Discharged 2043
Patient complained of itching all over her body within minutes of receiving her COVID vaccine. She also had mildly diffuse erythema along both arms. EMS immediately placed an IV and administered 50 mg of Benadryl IV.  She remained in observation for 30 minutes with EMS with some improvement of her symptoms. Patient?s father drove her to ER for further evaluation.
fever, chills, severe nausea,   headache, joint pains, headache bordering on migraine, extreme pain at injection sight.
According to mother child awoke from sleep 12 hrs after receiving shot with fever of 105F, lethargy. Called on-call nurse line to report. Fever resolved child well.
Fever of 100.1. Extreme lethargy for 2 days. High pitch scream for 2 days.
Pt's mother reported she noticed pt's right arm was very swollen and warm to the touch. When she awoke this am. Pt is able to lift arm, good ROM, very large swelling, swelling extends beyond deltoid area below the elbow.
Patient was given Pfizer 5-11 year dose as second dose. Patient is only 4 years old.
2 days post injection, pain at the site of injection.  Now (as of 1/5/21) - the site is red, raised and very itchy.  Has taken Benadryl.
Case number PHEH2014US010907 is an initial spontaneous report from a nurse received on 28 May 2014. This report refers to a 30-year-old male patient. He received only the Men CYW-135 liquid conjugate component of MENVEO (batch number: unknown) intramuscularly on 16 May 2014. On the same day, post vaccination, he experienced localized injection site reaction (area was bruised) and joint pain in his elbow. The nurse reported that the joint pain was unrelated to vaccination and causality of the other events was not reported. Seriousness and outcome of the events was not reported. Seriousness and outcome of the events was not reported.
I noticed my heart rate was accelerating & it wouldn't stop & I had ulcers in my mouth, so I went to er I was achy had headaches & also diarrhea they gave me meds for Tachycardia.
On the night of Sept 30 around 11 PM while getting ready for bed I noticed the lymph node in my armpit was really tender on the left side, same side I got my COVID shot on. On Oct 1 I woke up at 7 AM experiencing such bad pain at my sciatic nerve that I was crying. I couldn't find a comfortable position in bed and when I stood up I could feel blood rush down both legs and the pain was awful. I applied ice packs to both sides of my low back where the pain was most acute and took a warm shower, and that plus 400mg of Advil got me feeling better. If my primary care clinic had been open I'd have gone in but they are closed on weekends.
Painful burning rash on neck and face feels like its cooking my eyes. I went back to pharmacy where I got shot they said just side effect it will go away but neve did. First time to see doctor was on 10-25-2021
3 days ago I developed a red, flat, itchy rash on the back of my neck that moved to the front of my neck and my chest. It also leaves raised marks when I scratch it.  Yesterday, it was also on my back and my hips as well as my groin. Today it spread to my wrists. I initially thought I was experiencing an allergic reaction to a new shampoo I used on Friday and again on Monday but because it was spreading and moving so much I made an appointment at the health clinic at my university. The doctor I saw told me that he saw a patient who exhibited the exact same symptoms and he had gotten his 3rd vaccine dose 10 days before his symptoms started, so he thinks that we both have been showing an immune response to the vaccine. He said he?s going to reach out to his colleagues and see if anyone else has seen patients with similar symptoms. I took a Benadryl on monday which stopped the itching but made me too drowsy, so yesterday i tied claritin and cortisone cream, both of which did not help much. The doctor I saw prescribed me tricinolone .1% cream and suggested i take allegra until the rash went away. I have taken pictures to document the progression of the rash which I would be happy to share. I know that the reaction isn?t very severe but if two of us have it, there are probably more people out there with similar symptoms so I wanted to report it
26May87 pt vax;  devel rash.  Recovered in 6 days.
Received immunizations at approximately 2:30pm and had developed fever of 104 degrees F 5 hours later. Was hospitalized same day. Received IV antibiotic Ceftrianone 1.25mg according to mother.
ventricular fibrillation cardiac arrest without significant past medical history admitted to the ICU after ROSC currently admitted to  Hospital
Slight headache evening of shot 09/19/2005 headache worse next morning, body aches around noon 09/20/2005. Arm became more swollen (where shot was given), red and hot. Fever by 6pm 102 lasted for 24 hrs. Arm still sore on 09/27/2005.
Slight itchiness on my right thigh on the 5/6th of January which I didn't think much of. Then the itchiness spread to my abdominal area and legs. I inspected the areas and discovered I had hives which I've never had in my life. The itching has spread to all over my body and gets worse and more visible when I try to relieve the itch.
Erythema multiforme treated with Atarax and an oral rinse for the painful oral lesions. Same day, dermatology consult accomplished. Immunology referral pending. Also started on Tetracycline by Dermatologist.
Syncopal episode within minutes of post vaccination. Client was sitting in waiting area of lobby - when mother hollered for "help" child had fainted and fell over in her chair to her side. Pale with circum pallor, and eyes rolled back. Place in Trendelenburg position immediately with fast recovery.
Patient under age 18 was vaccinated with Moderna, which is a vaccine error.  Troubleshooting: Scribe and vaccinator did not validate age;  screeners at the beginning of the process did not ask or turn her away on a Moderna-only day. An ID requirement has been put in place to prevent this situation from occurring in the future.  Follow up to be done Physician or delegee will include specific description of next steps for obtaining dose 2. Initial education provided by MD from DOD.
This spontaneous report was received from a health professional regarding a 10 week old male patient. Pertinent medical history, drug reactions/allergies were not provided. On 03-JUN-2013 the patient was vaccinated with an expired dose of ROTATEQ, first dose, orally. (Lot #1845AA, expiration date on 01-JUN-2013). Co-suspect therapy and concomitant medication were not provided. No adverse symptoms were reported by the healthcare professional. Additional information has been requested.
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) in a 55-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 12-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up).    Concomitant medication was not provided. It was unknown whether patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment medication information was not provided by the reporter.
permanent loss of vision in  left eye; retinal detachment; chickenpox herpes virus/shingles; Swelling; Bruising; redness (bloodshot) of  left eye; This case was reported by a consumer via call center representative and described the occurrence of loss of vision in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced loss of vision (serious criteria GSK medically significant), retinal detachment (serious criteria GSK medically significant), shingles, eye swelling, eye contusion and bloodshot eye. On an unknown date, the outcome of the loss of vision was not recovered/not resolved and the outcome of the retinal detachment and shingles were unknown and the outcome of the eye swelling, eye contusion and bloodshot eye were recovered/resolved.   It was unknown if the reporter considered the loss of vision, retinal detachment, shingles, eye swelling, eye contusion and bloodshot eye to be related to Shingrix.  Additional Information: GSK Receipt Date: 13-DEC-2022 Reporter's Comment: The case was reported by the patient.  The reporter reported receiving Shingrix in October of 2022 at their local pharmacy, in the left arm.  The patient reported that, they did not receive the second dose and had no intentions of doing so.  The patient reported experiencing swelling, bruising, and redness (bloodshot) of the left eye approximately 3 weeks after receiving dose.  The patient reported all symptoms occurred overnight.  The patient reported it appeared as though they had been hit in the eye.  The patient reported seeing optometrist and being referred to a retina center.  The patient reported retina center diagnosed them with the chickenpox herpes virus.  The patient reported receiving weeks of eye care and having to undergo two surgeries for detached retina.  The patient reported these events had left them with permanent loss of vision in the left eye.  The reporter consented to follow up. Note: For 2nd dose as per 2 to 6 month schedule for Shingrix there is still time to received 2nd dose, so no medication error was captured.
Seriousness criteria other medically significant (OMIC). Initial report received from the pts mother via a health care professional, on 11/14/06. A 14 year old female pt, received on 11/9/06, Menactra (lot number U2119AA), into the right deltoid (dose and route of administration not reported). The pt received on the same day (11/9/06) Gardasil (lot number 0688F) into the left deltoid, as concomitant vaccination (dose and route of administration not reported). The pt had no history of depression. At the eve of vaccination, 11/9/06, the pt had arm soreness (the reporter was unsure which arm). The pt also became very depressed, frustrated, angered, crying and attempted to cut her wrists with scissors. The wrist site described as scratch by the reporter. At the time of this report, 11/14/06, there had been no ER or medical doctor MD visits for the pt and the pts outcome was unk. No corrective treatment was reported.
diabetes is acting; can't sleep; swelling up her feet and arms; swelling up her feet and arms; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (159558).  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, UNKNOWN MANUFACTURER), for Covid-19 Immunization. The following information was reported: DIABETES MELLITUS (medically significant), outcome "unknown", described as "diabetes is acting"; INSOMNIA (non-serious), outcome "unknown", described as "can't sleep"; PERIPHERAL SWELLING (non-serious), PERIPHERAL SWELLING (non-serious), outcome "unknown" and all described as "swelling up her feet and arms". Additional information: Reporter was not a Healthcare Professional (HCP). Reporter's contact information available to you or a sub-contracted party was reported as 'unknown''. It was unknown if the Reporter was the prescribing HCP. It was reported that one of their ladies in the church was swollen after receiving the booster shot last week. right now, she can't sleep, her diabetes is acting and swelling up her feet and arms. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Immediate feeling of heaviness in chest followed by dull pain in middle of chest that is still currently happening along with headaches and confusion
pt had fever associated fever from a severe OM w/in 24hr of vax;ATB began;