chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe body aches, joint pain, headaches, chills, diarrhea, sweating for 1.5 days. Severe headaches have continued but not as frequently. Swollen lymph nodes near right breast and under right arm (pain went away after 3 days).
This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine; solution for injection; batch/lot# EN6208), at the age of 66, via an unspecified route of administration, left arm, on Tuesday, Mar 9, 2021, at approximately 12:20, single dose, for COVID-19 immunization. Medical history included diabetic (diagnosed about 25 years ago). Patient has no known allergies. Patient did not receive any other concomitant products. On Mar 10, 2021, around 19:00 on Wednesday, patient experienced an itchy red face, a little swelling and facial rash (still there today). She wanted to know if there was anything she needed to worry about. Patient had no treatment for it. She thinks it has gotten better. Patient was thinking about taking Benadryl. The outcome of the events: unknown. No follow-up attempts needed. No further information expected.
pt recv vax 20NOV97 & 18JAN98 pt dx w/haemophilus influenza type b meningitis;pt underwent a prolonged hosp;
Had expected fevers and chills day following vaccine. Started approximately 12 hours after shot and abated approximately 36 hours later. Of note, had a fever and chills when falling asleep night of 5/28  On 5/29 woke with specific chest pain localized to heart area. Waited approximately one hour to see if symptoms abated, then proceeded to ER to get checked out. EKG showed left branch block. Administration of Nitro and asprin alleviated chest pain. Was admitted to hospital for observation and testing to ensure heart functioning properly.
Information has been received on 05-FEB-2019 from a lawyer and a female patient regarding a case in litigation. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) on 02-FEB-2009 at a medical office as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles and other complications. The patient was treated at a medical office for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the vaccine ZOSTAVAX and/or despite receiving ZOSTAVAX for 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 and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
pt recvd vax & was crying; c/o leg hurting; area felt hot not red; 1sep94 pt c/o thigh hurts,looks lethargic; pt tired easily;
Shoulder to elbow tingling on the side of injection peaking 2hours after injection, went to bed and resolved over night. Woke up at 8am left arm injection site knot, pain, warmth, redness, tender for even a tshirt to touch took 1000mg Tylenol and ice pack, minimal improvement. Around 3 pm started headache and upper body aches: neck, left arm and torso 8pm took 600mg ibuprofen.  No fever but on fever reducers.
Fever; Chills; Dizziness randomly; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 06Jul2021 at 12:30 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included shellfish allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 07Jul2021, the patient experienced fever, chills and dizziness randomly. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever, chills and dizziness randomly were resolved with sequelae on an unknown date in 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Stomach pain, severe diarrhea, muscle pain, headache, unable to sleep, cold all over & sensitivity to smells.
Patient had an injection of Moderna in her left arm on 9/28/2022. Vaccine was administered by the Pharmacy Technician. At the injection time, patient felt pain that radiated into her neck.  Patient stayed and sat for her 15 minute wait period.    Spoke with patient about her symptoms, which were still hurting in her neck area.  Vaccination site was at the top of the deltoid. She suggested that she go to the urgent care/walk in clinic. She refused. She discussed using a cold pack to help with the discomfort.  PharmD called her on 9/29/2022 to see how she was feeling. Patient stated the neck pain stopped a couple hours after the injection. The only symptom today is a sore arm.
Pt recvd 2 doses of Engerix-B 5SEP & 11OCT91 & 2 days p/2nd vax pt devel red lump swollen, itchy @ inject site & red vesicles @ inject site; no systemic symptoms;
Noticed arm was itching after waking up on 04/08/21.  Arm has continued to itch.  On 04/11/21 a light red circle around the injection site was visible.  I researched if this was a known issue and found a lot of info on the web.  I took a Benadryl tablet on 04/11/21.  As of today it is still slightly itchy.
Patient says arm is still sore after receiving the vaccines 2 months ago. Says he feels the pain in the bicep if he moves his arm certain ways.
On 8/16/99, the pt experienced a rash with fine, red, raised spots as big as pencil eraser which began below the navel and spread upward toward the chest. No lesions appeared on the arms, face, and back, but the rash was still spreading. The pt treated herself with Benadryl, but the rash persisted.
Swelling at the injection site and itchy rash described as hive like on trunk resolved with no treatment within 1 week.
This spontaneous report as received from a physician via a company representative refers to a 76 year old male patient. On 13-MAR-2014 the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX subcutaneous. On 25-MAR-2014, the patient was diagnosed with shingles. The patient sought medical attention by office visit. The patient had been prescribed an unspecified antiviral medication. The outcome of shingles was reported as not recovered/not resolved. Additional information has been requested.
LUMP IN UPPER RIGHT LEG; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's past medical history included: toxemia when pregnant. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1821281 expiry: UNKNOWN) dose was not reported, administered on 03-AUG-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 13-AUG-2021, the patient experienced lump in upper right leg. The action taken with covid-19 vaccine was not applicable. The outcome of lump in upper right leg was not reported. This report was non-serious. This case is associated with Product Quality Complaint number: 90000189496
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 39-year-old male patient who received ENGERIX B (batch number EB993, expiry date 13th March 2019). Co-suspect products included ENGERIX B (batch number 94S22, expiry date 4th September 2020). On 12th March 2018, the patient received the 1st dose of ENGERIX B (intramuscular) 20 ug. On 13th April 2018, the patient received the 2nd dose of ENGERIX B (intramuscular) 20 ug). On 13th April 2018, not applicable after receiving ENGERIX B and immediately after receiving ENGERIX B, the patient experienced injection site pain. On an unknown date, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain and injection site pain were unknown. The reporter considered the injection site pain to be almost certainly related to ENGERIX B. The reporter considered the injection site pain to be almost certainly related to ENGERIX B. The reporter considered the injection site pain to be almost certainly related to ENGERIX B. Additional details were provided as follows: The pharmacist reported that the patient experienced pain at the injection site after receiving ENGERIX-B. At 3:30, the patient received 2nd dose on right deltoid. The patient experienced much more severe pain in the middle of the injection compared to the 1st dose. The patient commented that this dose hurt much more than the 1st dose.
SEVERE REACTION - SWELLING OF ARM AND CHEST/BREAST AREA. DR SUGGESTED TO ICE IT AND NOT TO RECEIVE THE SECOND DOSE
This spontaneous report was received from a registered nurse and refers to a 1 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were reported as none. On 16-FEB-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot number N023960 with expiration date on 01-SEP-2019, subdermaly as prevention of varicella virus (strength, dose and anatomical location were not reported) reconstituted with a properly stored diluent (manufacturer unknown) lot number N026288 with expiration date on 08-FEB-2020. On the same day, the patient also received one dose of PREVNAR 13 (lot number S58703 with expiration date on 31-OCT-2019) and one dose of an unspecified flu shot influenza virus vaccine, manufactured by Sanofi (lot number UT5949JA expiration date on 30-JUN-2018). The administered dose of the vaccine experienced a temperature excursion in the range between 6°F to 14°F with a time frame of 30 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions. On 19-FEB-2018, the patient's mother call the physician office and stated that on an unspecified date in February 2018, the patient developed fever, was fussy, and was vomiting, therefore she was told by the staff at the physician office to push fluids and keep the patient hydrated, however, later on the same day the patient was at the emergency room due to the aforementioned events, the patient was not admitted to the hospital and was sent home from the emergency room that same day with the instruction to push fluids and keep the patient hydrated. Additionally, it was reported that he patient recovered from the events pyrexia, irritability and vomiting on an unspecified date. On 23-FEB-2018, the patient was seen at physician office and was diagnosed with Roseola. On approximately 02-MAR-2018, reported as "approximately two weeks after", the patient developed a hardened dark spot at the injection site. The outcome of the events injection site induration and injection site discoloration was not reported and the reporter did not provided the causality assessment between the aforementioned events and therapy with VARIVAX.
PT was administered a 2nd booster dose despite not being eligible and 2nd doses boosters not being approved. Pt stated that she was told by her PCP a 4th dose in necessary. Upon looking at pt's CDC card it appears as though  her booster was given 4 months after her she completed her  original series
I had excessive fatigue, my whole body ached and I had shortness of breath and heart palpitations. So I wasn't getting any better and I had very tight chest pains and then I decided it was time to see my doctor.
Pt complained of itching on left arm with swelling and itching primarily in left hand. Onset occurred approximately 5 hrs after injection. She stated that there was no pain, swelling or itching at the injection site. Was given a steroid shot 2 BENADRYLs an Rx for a dosepak in ER.
approx 30-45 min after injection, pt stated she felt lips swelling. Tx SOLU-MEDROL, BENADRYL, ZANTA. Breathing tx @ ER
This spontaneous report as received from a physician via a company representative refers to an unknown number of patients, referred to as multiple. Demographic information was not reported. On an unknown date the patients were vaccinated with PNEUMOVAX23. The dose number, dose, lot number and expiry date were not reported. On an unknown date the patients experienced pneumococcal disease. Treatment information and the outcome of pneumococcal disease was not reported. The reporter stated that PNEUMOVAX23 was not working in the patient population, the drug was like a placebo. He furthermore stated that he was going to prescribe PREVNAR for his patients, rather than PNEUMOVAX23. This case is linked to case 1307USA002300, based on same reporter. Additional information has been requested.
I developed a rash at the injection site about 8 hours after the shot. It impeded my sleeping for a little bit. I also got some small itching bumps about 72 hours afterwards and lasted for about a week. That resolved, then 10/5/22, I woke up with severe back pain and abdominal pain in all four quadrants. I took Celebrex after several hours and that helped a little. Then, I took Pepto-Bismol and that made me throw up immediately.  That made me feel better to where I was able to eat and drink a little. I was also at altitude and took Acetazolamide. On the evening 10/5/22, I was pain free without medication and went to bed. I woke up 4:30AM on 10/6/22, with severe abdominal pain and back pain and vomited.  I then took Celebrex and had some relief. I had a telehealth appointment and they told me to go to the hospital. They ran a bunch of tests and discharged me with pain meds. I have a follow up with my doctor soon. I stopped taking Acetazolamide morning of 10/8/22 because I was back at sea level.
On 3/31/2021 Patient developed blurred vision and excruciating headaches with extreme weakness.  Pt went to an urgent care where they found bleeding in brain so they sent her via ambulance to ER at another hospital.  She had MRI, CT and blood work.  She was admitted into the ICU where she was treated for 3 days and then transferred to telemetry.  Pt was discharged to FU w/ Neurologist and Ophthalmologist.
Systemic: Needle stick from needle used to reconstitute. Only used with saline and the needle had not been used to inject a vaccine into anyone and had not touched skin for any other patient
DISCHARGE DIAGNOSES:  Principal Problem:   Acute hypoxemic respiratory failure due to COVID-19 (HCC) Active Problems:   HTN (hypertension)   Intellectual disability   Cerebral palsy   Spastic paralysis   Dependent for wheelchair mobility   Quadriparesis (HCC)     DISCHARGE FOLLOWUP PLAN:  Followup with PCP in 2 wks , Eval if further cardiac eval needed, watch BP, update records w POLST, consider BMP recheck,  IMPORTANT PENDING TEST RESULTS: None CONSULTS: Pt OT dietary PROCEDURES PERFORMED DURING HOSPITALIZATION: none COMPLICATIONS IN HOSPITAL: None    HOSPITAL COURSE: Briefly, this is a 73 y.o., female, w a PMH of CP, intellectual disability, spatic paralysis, HTN, who was admitted on 1/15/2022, with hypoxia due to COVID19.. For more detail, including PMH, PSH, PFH, Social Hx and further info please see admission H&P.  Hospital course dictated by problem:  Acute hypoxemic respiratory failure due to COVID-19 (HCC) (1/15/2022)   Assessment: Vaccinated, last 3/2021, missed booster. Staff Report positive COVID 1/5/22- had mild cough prior. Sent from group home with being off x 2d, new SOB x1 day, patient complained of headache, fever. PTA chest pain,EMS spo2 85%, requiring 7 L while sleeping, CXR/CT bilateral infiltrates, elevated D-dimer 2.5, Pro-Cal low 0.1, no antibiotics indicated.  Treat with therapeutic Lovenox.  Supplemental oxygen was titrated off to remain on room air by time of discharge.  Did not need IV Lasix.  Stopped on time of discharge.  Follow-up with primary care.  Continue PTA DNR/DNI per guardian.Previously Vaccinated for COVID19, last shot, 3/2021, but had been scheduled for booster but became ill before, recommend boost in a few wks if remains afebrile, will follow-up with staff to get that rescheduled.    Intellectual disability ()  Cerebral palsy ()  Spastic paralysis ()  Dependent for wheelchair mobility (12/31/2020)  Quadriparesis (HCC) (4/25/2019)   Assessment: History of severe cognitive developmental delays Does best w yes/no answer.  In a group home.  Wheelchair-bound.  Requires assistance for all ADLs.  Standby transfer with belt. Able to feed self food minced. . Speak w pt. at HCF-PTA minced/ ? dysphagia diet was continued here..  Seen by PT OT as noted above.    HTN (hypertension) (3/31/2017)-maintained on PTA amlodipine, on time of discharge she was resumed on PTA lisinopril HCTZ.   Troponin elevation, mild CP was a presenting sx w COVID19 SOB.  ECG x2 nonischemic, trend trop-- > 33-- >16 with a 50% drop but could be appropriate for age.  Possible nonMI demand ischemia d.t covid19.  Has remained chest pain-free ever since.-1/17 echocardiogram normal EF 60-65%, no WMA.- outpt f.u w PCP, consider nuc stress   Hypothyroidism  -PTA Synthroid 150 daily   Constipation--PTA docusate 100 twice daily, fiber, senna 1 twice daily    Depression-PTA Wellbutrin continues   IDA-PTA iron 324 daily   Vit D deficiency- incr vitamin D here.  Reeval twice daily dosing outpatient.   Incidental renal cyst and nephrolithiasis-PCP follow-up for further evaluation and management.   Mild hypernatremia, resolved Mild hypokalemia, resolved  -Encourage nursing staff and CNA staff on ensuring adequate oral hydration for this patient.
15 minutes after received the vaccine, Patient started feeling dizzy and having a hard time breathing. Assisted patient to the vital room and check pulse and oxygen. Notified provider. *CHEST & THROAT TIGHTENED *EPINEPHRINE GIVEN, PATIENT TRANSPORTED BY EMS TO ER.
Patient was a 17 year old that received the Moderna vaccine in error. No adverse events reported.
Information has been received from a medical assistant concerning a 3 year old female patient who on 27-OCT-2003 was vaccinated with a dose of varicella virus vaccine live. On approximately 28-DEC-2005, the patient developed chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available. Additional information has been requested.
Immediate soreness in arm - headache after a couple hours. By 9:00pm, I was freezing cold but body warm. Chills lasted for hours and couldn't stop shaking, so took Tylenol at 12:15am. Around 1:00am the chills subsided. Around 2:00am fever burnt off, sweating and hot. Couldn't sleep the rest of the night. Slept from 8am-10am and woke with just headache. Took Tylenol around 10:30am to help with headache and it did start to subside. Was mostly fatigued and muscle aches the rest of the day until 6pm when I started to get cold again. Feels like the fever and chills are coming back and it's currently 7:30pm, so assuming it'll be another night of this.
He received his COVID-19 vaccine on 07/14/2022.  He didn't show any signs of discomfort. The first signs of anything wrong was on 07/17/2022 he had a high fever.  He responded well to Tylenol and Ibuprofen to break his fever.  We had a telehealth visit with his doctor, they recommended that he should be seen at an urgent care center. He tested positive for COVID-19 on 07/18/2022.  They recommended to keep comfortable by taking Tylenol, Ibuprofen and stay hydrated.
Shingles; Information has been received from a lawyer referring to a female patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 19-OCT-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered a bad outbreak of the shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event shingles was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the event shingles to be disability.
This spontaneous report as received from registered nurse refers to a patient of unknown age. The patient was vaccinated with (Merck) VARIVAX (lot number not provided) on 24-SEP-2012. This vaccination was within 28 days of the M-M-R II vaccination (07-sep2012). No adverse event was reported. Additional information has been requested.
Headache & Myalgia Narrative:  1/21, 1/22/21 h/a myalgia called in sick
11/23/21 presents to L&D triage for "CC of nausea and vomiting". PMHx of "PTD @ 25w2d, COVID during pregnancy, Obesity, Hx of gastric bypass, Rh neg, HSV2, GBS bacteruria, AMA, hx PPD"
Developed < 20 lesions, scratched them developed impetigo, Rx with Keflex and developed hives. lesions papules not c/in 10d of vaccine mom associates the two.
Infected with COVID and experiencing symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Infected with COVID and experiencing symptoms) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Infected with COVID and experiencing symptoms). At the time of the report, COVID-19 (Infected with COVID and experiencing symptoms) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter. COMPANY COMMENT: This is a Spontaneous case concerning an unknown-year-old  patient with no clinical history who experienced the unexpected event of COVID-19 (AESI) The event occurred unknown days after 3rd dose of mRNA-1273. The rechallenge was not applicable since only information about 3rd dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is a Spontaneous case concerning an unknown-year-old  patient with no clinical history who experienced the unexpected event of COVID-19 (AESI) The event occurred unknown days after 3rd dose of mRNA-1273. The rechallenge was not applicable since only information about 3rd dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.