chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient brought to office by mom with c/o vomiting x6 and green pasty stools x 4. Decreased appetite, lethargy, and squealing with pain. Patient admitted to hospital for dehydration. In the hospital pt developed billous enemis and abdominal distention. Surgery showed ileocolic intussusception with partial volvulas. 1/22/07 Received medical records from hospital which reveal patient admitted 12/20-12/25/06 after 2 day hx of emesis, progressive lethargy & increasing abdominal distention.  Seen in ER & admitted to outlying hospital overnight & then transferred to Childrens.  Progress notes, labs & rad from 1st hospital included.  Taken to OR for exp lap & found to have ileocolic intussussception, partial volvulus secondary to mobile cecum in LUQ both of which reduced w/o complication & Meckels diverticulum.  Appendix was also removed. FINAL DX: Ileocolic intussussception with partial volvulus s/p surgical reduction; appendectomy; & Meckels diverticulum.
We saw her on 6/28/17, 2 days after receiving vaccine PREVNAR 13. 6 cm (R) upper arm red/sore with shoulder pain.
no adverse event; Vaccine administered via the intramuscular rather than subcutaneous route.; This spontaneous report was received from a pharmacist and refers to a 58-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 01-JUL-2020, the patient was vaccinated with properly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), intramuscularly, lot number reported as S031483, has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), expiration date was reported as 07-OCT-2021 (formulation, strength, dose, frequency were not reported) for prophylaxis.  Albumin status for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) has been verified as recombinant human albumin (rHA).  The vaccine was reconstituted in properly stored sterile diluent lot S033778, has been verified to be a valid lot number for sterile diluent, expiration date was reported as 27-AUG-2022. No additional adverse event was reported. The outcome of incorrect route of vaccine administration was unknown.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 67 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: E19263), in left arm, on 24Feb2021 as dose 2, single (Lot number: EN6203), in left arm, on 06Oct2021 as dose 3 (booster), single (Lot number: EWO187), in left arm and on 24May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperthyroidism" (unspecified if ongoing); "Known allergies: Crustacean shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Developed pain, redness & swelling top of rt shoulder approx 27 hrs after Flu vaccine into upper rt. deltoid. Treated at Health Unit on 10/20/10 with cold pack and given Ibuprofen 400mg.
Information has been received from a certified medical assistant referring to an unspecified number of unspecified patients of unknown age and gender. On unspecified dates, the patients were vaccinated with an unspecified number of improperly stored doses of GARDASIL (lot # K011325, expiration date 08-APR-2017, lot number # K014191, expiration date 10-MAY-2017) (dose, frequency and route not provided) (incorrect product storage). No adverse effect was reported. The minimum of temperature was 0.8 degree C and the time frame was unspecified. There was no previous temperature excursion. M-M-R II appeared in the product list since it was involved in the excursion; however no improperly stored doses of M-M-R II were administered. There was no product quality issue (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Breakthrough COVID infection. Patient fully vaccinated July 7, 2021. Patient tested positive for COVID on Oct 18, 2021.
P/receiving Influenza vax, reporter devel erythema, induration, & swelling @ inject site 2 days later & impotence seven days later;
Patient received vaccine,  that evening "around supper time" her arm began to swell. Then that next morning it was swollen, sore and red from shoulder to elbow. Patient came into clinic today with a swollen, red, raised, sore area that was about 7cm x 4cm over and around the injection site
This spontaneous report as received form a registered nurse refers to a patient of unknown age and gender. On 04-MAY-2010 the patient was vaccinated with the first dose of GARDASIL (dose, route and lot number not provided). On 20-JUN-2012 the patient received the 2nd dose of GARDASIL (dose, route and lot number not provided) late. On 20-SEP-2012 the patient received the 3rd dose of GARDASIL (dose, route and lot number not provided). No adverse effects were reported. Additional information has been requested.
Caller tested positive for COVID-19 with a "1287" result of antibodies on her test; Caller tested positive for COVID-19 with a "1287" result of antibodies on her test; a urinary tract infection; This is a spontaneous report from a contactable consumer or other non-health care professional (patient) via medical information team.  A 70-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown, Expiration date not reported), via an unspecified route of administration, administered on an unspecified date in Feb2021(at the age of 70-year- old) as single dose and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown, Expiration date not reported), via an unspecified route of administration, administered on unspecified date (at the age of 70 years old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller wants to know if the high COVID-19 antibody levels that she presented on her physical test could be due to a urinary tract infection that she developed recently. Caller and her husband received the second dose of the Pfizer COVID-19 vaccine on Feb, shortly after receiving the vaccine caller had no antibodies against COVID-19 and now a year later she resulted with a high level of antibodies relatively closely after experiencing a urinary infection. Caller will have a new medical test performed on Sep. As far as she knows she never had COVID-19. Caller heard that the type O blood is more protective with the vaccine. Caller also read that according to Pfizer withheld after 6 months of receiving the second dose of the vaccine patients have less immunity. E-transmitting neglected probable lack of efficacy. The patient tested positive for covid-19 with a 1287 result of antibodies on her test on 29Jul2021, and a urinary tract infection in 2021. The outcome of event urinary tract infection was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Narrative: Patient's caregivers reported adverse reaction to first dose of Moderna vaccine with behavior change. Patient has history of moderate to severe vascular dementia with bipolar disorder and cognitive impairment.
Patient described acute sharp pain radiating from right upper back to right leg similar to sciatic nerve pain. Resolved past taking 3-baby aspirin. Said very scary, almost went to ER. Injection site right arm swelled to size of baseball per patient.
Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face/Eyes/Mouth/Tongue-Mild, Systemic: Chills-Mild, Systemic: Exhaustion/Lethargy-Mild, Systemic: Hypotension-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extremities)-Medium, Additional Details: Patient had allergic reaction beginning around 10 minutes after Moderna vaccination. Patient has rash/hives on trunk, arms and legs. She stated she was lightheaded/dizzy, which lasted around 30 minutes. Her hands, arms, body had tremor and were shaky. She had blue/purple coloring of palms, which were cold and swollen. BP was 84/65 on my machine. HR was 110 bpm, minor lip swelling. Patient was given Benadryl oral 25 minutes post vaccine and EMS were called 35 minutes post vaccine due to concern.
Chills, dizziness, slight fever. Started at 8:30 pm. Went to sleep at 12:30 am. Woke up fine.
Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PYREXIA (Fever) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received 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 HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.            No concomitant medications were provided. Treatment information was not provided.  Patient had no side effects from the first dose.
Received booster on Sat and on Sunday felt funny, slightly  sob. Thought I was getting an infection, drove to my daughter's house.  Had to wear oxygen while driven because of increase sob. My daughter took me to urgent care  to get antibiotics and  steroids. They sent me to the hospital. They did bld work , cat scan,  ekg, and was diagnosed with a bad clot and admitted to hosp. Started on heparin and switched to eliquise
Hospitalized with left arm weakness and limitation of use and bilateral hands and feet numbness, tingling and sensitive to environment. Multiple exams performed and diagnosis in question is Guillain-Barre or Acute Inflammatory Demyelinating Polyneuropathy. Neurologist  treatment was IV prednisone for 3 days while in the hospital and then home care with  oral prednisone tapper for 5 days. I have not fully recovered. I regained use of the left arm but my hands and feet still tingle and currently unable to return to work.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 10May2022 at 18:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 59 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 25Mar2021 at 11:00 as dose 1, single (Lot number: 039A21A), in left arm, on 22Apr2021 at 15:30 as dose 2, single (Lot number: 007C21A), in left arm, on 03Dec2021 at 17:00 as dose 3 (booster), single (Lot number: 027H21B), in left arm and on 04Oct2022 at 17:45 as dose 5 (booster), single (Lot number: AS71G4D), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Allergies" (unspecified if ongoing). Concomitant medication(s) included: CLARITIN [LORATADINE], start date: 01Jan2001, stop date: 18Oct2022; CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM PHOSPHATE;CHROMIC CHLORIDE;COLECALCIFEROL;CUPRIC OXIDE;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;MAGNESIUM OXIDE;MANGANESE SULFATE;NICKEL;NICOTINAMIDE;PANTOTHENIC ACID;POTASSIUM CHLORIDE;POTA, start date: 04Dec2017, stop date: 28Oct2022. Past drug history included: Succinylcholine, reaction(s): "Known allergies: Yes - succinylcholine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had received other medication in 2weeks included Multivitamin. Patient was treated with Paxlovid form 19Oct2022 to 23Oct2022 as a treatment for covid-19.  Rebound of COVID-19 symptoms, verified by positive rapid test, five days after finishing 5-day Paxlovid course of treatment.
I have a series of cold sores appearing on my lip. Have had these before in the past but not more than one. Having several suddenly. Could just be a coincidence but felt it should be mentioned.; This is a spontaneous report from a contactable consumer or other non hcp. A 34-years-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 12:00 (at the age of 34-years-old)(Lot Number: EW0150) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included eczema from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took ceclor and experienced Known allergies. It was reporter that on 10Apr2021 23:00 patient experienced a series of cold sores appearing on his lip. He previously had these before in the past but it was not more than that. It was several suddenly. He also says that could just be a coincidence but felt it should be mentioned. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated that she was not tested positive for covid 19 prior and post vaccination. The outcome of the event was resolving/recovering.  No follow-up attempts are possible. No further information is expected.
fully vaccinated (Pfizer, 3/27/21, 4/17/21).  developed symptoms on 7/17/21
That next Tuesday, I felt a swelling in right armpit, I went to the urgent care. It was warm and swollen and looked like the start of the infection. They prescribed sulfameth/trimethoprim 800/160mg 2x a day which didn't help anything and I went back 2 days later. The abscess had swollen to golf ball size. I also had swelling at injection site, hot, red, & painful. Doxycycline 100mg. That started helping but the arm was still painful. Hidradenitis suppurativa was the diagnosis. Dermatologist says that it was caused by a autoimmune response. Armpit was injected with a steriod/lidacaine injection. I had to have wound treatment. Clindamycin lotion, 1% to help would site clean. The issue was the injection site area that took 2 weeks to resolve. It was hard, red, raised and hot. They were not sure if it was an allergy or infection. I also felt like I was in a brain fog during this.
sore red and swollen 2 days later upper arm at injection site became a large red itchy rash then 2 days after that a red rash over my whole body
pt received with (R) arm slightly swollen at injection site. Warm to touch with local redness. pt was running a low grade fever of 99.1 all signs of mild reaction to vaccination-Advised mom that pt can taken Benadryl for itching but if distress occurred go to ER
Patient reported to vaccinators that she needed her booster dose and that she had already received the first two doses.  A booster dose was administered.  The Nurse overseeing the clinic from the facility stated that the patient had not received the primary series and called the family to verify. Once the family verified an additional 0.25 mL dose was administered in the opposite arm to total a full 0.5mL first dose in the primary series.
Moderna 4/8/21, 8/9/21. Positive on 8/30/22
Pt recvd 3 doses of Engerix-B & did not respond when titer was checked; booster vax will be offered;
Case number PHEH2014US025544, is an initial spontaneous report received from a medical assistant on 12 Dec 2014. This report refers to a patient of unknown age and gender. Past medical history and concomitant medication were not reported. The patient was vaccinated with MENVEO (batch number: unknown), on an unknown date, which was at 49.2 F for 3.5 hours on 29 Nov 2014. No adverse event was reported following this administration error.
Itchiness at the injection site; Rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE RASH (Rash at the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included Lupus syndrome (Lupus for almost 40 years.) since an unknown date. Concurrent medical conditions included Dermatomyositis (atypical dermatomyositis). Concomitant products included LISINOPRIL, MULTIVITAMINS [VITAMINS NOS], FOLIC ACID, VITAMIN D NOS, CYANOCOBALAMIN (VIT B12), VITAMIN C [ASCORBIC ACID], CALCIUM and ATORVASTATIN for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE RASH (Rash at the injection site). At the time of the report, VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE RASH (Rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   As treatment the patient used some scentless cream on skin.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2021: No consent for further follow up.
almost fainted; blood pressure elevation to 150/90; felt entire body was on fire; tremors; seeing black spots; dizziness; pressure on chest; palpitations; This is a spontaneous report from a contactable nurse (patient). A 46-year-old non-pregnant female patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in Arm Left on 23Oct2021 09:00 (at the age of 46-year-old) (Lot Number: FE3590) as single dose for covid-19 immunisation. Medical history included Hypothyroidism, known allergies: Flagyl, Benadryl, Latex, Pork and kale. Concomitant medications included levothyroxine. The patient experienced almost fainted, blood pressure elevation to 150/90, felt entire body was on fire, tremors, seeing black spots, dizziness, pressure on chest, palpitations on 23Oct2021 09:30. Blood pressure elevation to 150/90 (baseline B/P is 110/60), she felt entire body was on fire, tremors, was seeing black spots, almost fainted, dizziness, pressure on chest and palpitations. AE resulted in Doctor or other healthcare professional office/clinic visit. Unknown if treatment received. The outcome of the events was not recovered.
Three hours post vax, the pt turned red and jaundiced with chest tightness. Treated with oxygen and Benadryl.
Vaccines given at 11 AM with no immediate adverse reaction. Pt reported being asymptomatic for next seven hours. She then awakened from a nap at approx. 6 pm with shortness of breath, sensation of throat swelling, nausea/vomiting. Treated in ER with BENADRYL and steroid injection, released.
Blurred vision and eye pain, headaches, mild cough, leg pain, and tiredness
I have had unexplained fever events since my second dose.  All five fevers would start at 5:00 at night.  Usually the fever would peak in the middle of the night.  The highest it would be was about 101.8 or so.  A few times I would wake up in a pool of sweat.  I would wake up the next day and by mid day the fever would be gone.  Twice of  I did have a severe rigger in the evening  before going to bed.  The first unexplained fever was July 5, 2021; two June 10 and 18 of 2022; and two other times I am not sure of the dates.  On two different occasions my blood panel showed high white blood cell counts indicating infection but no infection determined.   In  July 2021 my white cell count was so high the nurse contacted me and told me to go the ER.  The ER visit was 10 days after the fever event so by the time I went to the ER my blood panel looked normal.
This spontaneous report was received from a medical assistant referring to a 26 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 25-JUN-2018, the patient was vaccinated with a dose of PROQUAD subcutaneously lot number N020011 and expiration date of 13-JAN-2018 for prophylaxis (dose was not reported). No adverse effects were reported in the patient.
Immediate and extreme back pain next day after second vaccine injection. On May 1, 2021 developed shoulder pain which lasted for 3 days. On May 18 got shoulder pain again, became feverish, vomiting and had to go to ER by ambulance. Had emergency exploratory surgery early on May 19 in abdominal cavity due to extreme shoulder pain and air in cavity. Surgeon found a GASTRIC PERFORATION in stomach that he patched up.  Abdominal leakage and high white blood count, fever. This was the cause of the shoulder pain. Spent over one week in the hospital to recover from this surgery. There was NO prior history of gastric ulcers.
had medication taste in mouth and it lasted for a few hours, throwing up saliva, stinging in arm that vaccination was given,  2nd dose she experienced she had pain in her left arm up to her shoulder and that pain is still there, swelling in the shoulder, the pain began in her lower back, and both sides of lower body and pelvic area bones began to hurt, an area she got antibotidics 45 years ago began to hurt as well, pain in her knees, her feet were swelling so badly, woke up with pain in her left knee, the next morning she called the ambulance and went to the hospital, on a sunday morning and she came back home that day, after a few days from the hospital her leg began to shut down, she would fall because her leg would give out, this has happened to her 8 times,
Pt had sore upper left arm 3hrs after FLUZONE vaccine. She can only lift her left arm halfway due to sore upper left arm. She said she works retail and had to lift boxes daily. Still in pain 12/13/09. Pt had surgery on sore area 10 yrs ago for Calcium deposit.
3 day ache in shoulder/upper arm after initial covid vaccine. This re-occurred 7 days later. Rash developed at this time along with indention and bruising at injection site. Rash better at time of this report (April 11, 2021) but still some welts and itching. Injection site has left a round indention scar like inoculation guns used to do in 20th century.
Fully vaccinated, boosted 12/2/21.  Symptomatic COVID infection with inpatient hospital stay on a general medical unit.
Pt. with nausea, feeling flushed, and swelling in both hands approximately 1 hour after FluMist vaccine.