chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After injection got 3 welt, called us 6-16-14 told pt to call MD - MD told pt to take BENADRYL and come to office in AM. Pt went to MD - MD said pt got acute shingles break out and prescribed VALTREX.
Vaccine was not diluted before administering, a dose of 0.2 ml was given.
A nurse reported that a 3 year old male received FLUSHIEL. The child has a past history of asthma. Concomitant therapy included montelukast sodium, loratadine, and fluticasone propionate. The vaccine was inadvertently given under the deltoid. On 6 NOV 2001, the child developed an injection site reaction characterized by redness, heat and a large induration. As of the date of this report, the symptoms have improved. No additional information was available as of the date of this report. Follow up information received 28 DEC 2001. On 9 NOV 2001, the symptoms resolved and the patient recovered.
Case number PHEH2015US008501, is an initial spontaneous report from a pharmacist received on 30 Apr 2015 and with follow-up information from a pharmacist received on 30 Jul 2015. This report refers to a 70-year-old male patient. Medical history and concomitant medications were not reported. Previous vaccinations were well tolerated. He was vaccinated with FLUVIRIN (batch number: 1413401) at a dose of 0.5 ml intramuscularly on 23 Apr 2015 at 02:45 PM. It was reported that he was administered FLUVIRIN from an open multi-dose vial that was out of temperature range at 50F for up to a week. The final outcome of the event was unknown. The event was reported as non-serious. Causality was not reported. Follow-up information from pharmacist received on 30 Jul 2015: Vaccine details (dose, time and route) and other clinically relevant information updated in the narrative.
Most painful shot ever-felt like it hit bone. With swelling, fever, and redness in left arm from elbow to shoulder-left arm redness, sore for several weeks (still tender at site of injection). Within three months-left hand lost motor skills.
Submandibular glands are inflamed but currently benign. A right ear infection was detected on onset and treated with antibiotics for 5 days. However, glands have remained inflamed. 6/5/2021-pressure on the right side of the chest by the heart necessitated an emergency room visit.
Patient administered Pfizer Covid 19 vaccine. approximately 6:15 pm 9/2/21. Less than 5 minutes afterwards, patent experienced severe itching, redness, arm swelling in localized vaccination arm. Benadryl 25 mg oral tablet given cold compress applied, Ems called for further eval. No swelling of face, no SOB. taken by EMS
Employee woke up with a head ache then began having hot flashes and nausea throughout the day. At 9am the employee also developed localized swelling, redness, tenderness and localized heat to the injection site.
Pt presented to the clinic 5/16/16 asking for a cough medication for new onset cough. Pt has a sleep study tomorrow at the clinic, concerned the cough will interfere with that process. Stated, I slept a little better last night, I took some TYLENOL but I just wanted something if I need it. Pt received the PREVNAR 13 vaccine 5-10-16. Cough started 5-12-16. Stated, it feels like my bronchial tubes are being ripped out every time I cough. Concerned this is a reaction to the vaccine. Cough is mostly nonproductive, if any phlegm is expectorated color is white. Reports occasional increased shortness of breath with activity, this is not a new finding for him. Denies any fever/chills or congestion. VS entered into CPRS, noted increased irregular heart rate. Pt stated this is known to him with DX of A fib managed by Anticoag/Warfarin therapy. Increased heart rate may be attributed by coughing episodes. Has not taken any OTC cold medication only cough drops. Lungs clear anterior/posterior chest. O2 sat 97%. Afebrile. Medications reconciled, complaint with prescribed regimen. Took am medications this morning 8am. Complaint with BiPAP. Reviewed case with PCP's colleague, prescription written and given for contract pharmacy for cough medication with Codeine. Reviewed potential side effects of drowsiness. To take medication with him and inform the sleep lab staff. Instructed to drink plenty of fluids, warm fluids can ease the cough reflex. To call if symptoms worsen or fail to clear. Pt verbalized understanding. Cough wheeze and tachycardia. Codeine/guaifenesin 10 ml QID.
Day2 and 3, soreness at the injection site, headache, low fever, fatigue,
This spontaneous report has been received a vaccine coordinator, concerning an unspecified patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 29-MAY-2017, the reporter stated that the patient received an improperly stored doses of VARIVAX lot # M003440 and expiration date 20-JAN-2018 (dose and route of administration were not provided) for prophylaxis which was reconstituted with an improperly stored of sterile diluent (manufacturer unknown) (lot # and expiration date were not provided). No adverse event was reported. The vaccine was stored at a temperature of 9° Centigrade to 25° Centigrade (11° Centigrade), time frame of 1 hour; no previous temperature excursion was reported. Digital Data logger report was involved. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1706USA010114.
he wasn't feeling good; Over slept; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program. The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "he wasn't feeling good"; HYPERSOMNIA (non-serious), outcome "unknown", described as "Over slept".  Additional information: Caller wanted to schedule appointment. He wasn't able to make his second dose appointment because he wasn't feeling good and over slept.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I95.9 HYPOTENSION 5/27/2023 ACUTE PANCREATITIS J96.00 ACUTE RESPIRATORY FAILURE 5/27/2023 ACUTE PANCREATITIS I95.9 HYPOTENSION 5/27/2023 DIARRHEA J96.00 ACUTE RESPIRATORY FAILURE 5/27/2023 DIARRHEA
I was having heart palpitations and increased resting heart rate. I was concerned enough that I had called 911 because I was concerned I was having a heart attack. I had gone from about 80 beats per minute up to 160 beats per minute. I was laying down and this does not seem like it would be something that would be occurring. Paramedics came and they took my blood pressure and my vitals and everything was in a normal range and I did not get taken into the hospital.
PEG Tube with extension to small intestines (Scheduled for J tube on January 18, 2022)
10AUG92 pt recvd vax & devel itching & blistering @ the skin test site;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6208), on 01Apr2021 as dose 2, single (Lot number: ER8737), on 29Oct2021 as dose 3 (booster), single (Lot number: FF2593) and on 21May2022 at 14:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "depression" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: levoquin, reaction(s): "Known allergies: levoquin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: negative on day 8; (2022) positivity, notes: Started paxlovid on 1st day positivity; (08Jul2022) Positive, notes: Then tested positive again on day 10 after. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are needed. No further information is expected.
pt had intussusception w/resulting surgical correction @ hosp 5/23/99;
This spontaneous report was received from a healthcare worker and refers to a 10 week old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 01-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ (dose was not provided) lot # K016261, expiration date: 23-JUN-2016, orally. No adverse effects were reported. Additional information has been requested.
Significant pain, redness, and swelling from the left hip down to the left knee. Circumference of left leg measures 12.5 inches. Circumference of right unaffected leg measures 10.75 inches. Treated with Tylenol, ibuprofen, and ice to the site. Returned to the clinic the next day for an evaluation. Was told it is a mild localized reaction and no treatment necessary. Physician did recommend using Benadryl. Benadryl given 9/25/2018 at bedtime. Circumference of left leg measured 12 inches the next morning.
Sore arm, early morning hours malaise, muscle aches, pronounced shivering, dizziness upon standing and felt faint although didn't pass out.
This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient. A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Oct2021 at 02:00 as dose 3 [booster], single (Batch/Lot number: unknown) at the age of 65 years, in left arm for Covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: No, reaction(s): "Allergy", notes: Known allergies: no. Vaccination history included: Covid-19 vaccination (Primary immunization series complete., Manufacturer unknown), for COVID-19 immunization. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 25Apr2022 at 06:00, outcome "recovered" and all described as "COVID-19 Treatment". Therapeutic measures were not taken as a result of suspected Covid-19, drug ineffective. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Copied from internal reporting system: "7 year old patient scheduled on adult covid vaccine clinic, arrived more than an hour early with her 12 year old sibling for flu and covid. While reviewing screening questions and speaking with the father, the Pfizer bivalent 12+ was prepared and given to patient. Pfizer 5-11 yr vial had not been opened in the clinic today and was planned to be opened closer to the time of the scheduled appointment to ensure patient came and to minimize waste. It was not noted she would be with a sibling possibly coming earlier."  No immediate adverse effects noted. Patient and her sibling both diagnosed with strep throat 1 week later on 12/22/22, treated with amoxicillin.
A little tenderness and redness at the injection site; A little tenderness and redness at the injection site; A spontaneous report was received from a nurse who was a 31-year-old, female patient who received Moderna's COVID-19 vaccine and experienced a little tenderness and redness at the injection site.   The patient's medical history was not provided. Concomitant medications were not reported.   On 23 Dec 2020, prior to the onset of the symptoms, the patient received her first of two planned doses of mRNA-1273 (Lot number: 037K20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 23 Dec 2020, she experienced a little tenderness and redness at the injection site, but she reported that that was normal for her after receiving any vaccine. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, a little tenderness and redness at the injection site, was not reported.; Reporter's Comments: This case concerns a 31-year-old female patient who experienced the events of Injection site pain and Injection site erythema, occurring on the same day when the first dose of mRNA-1273 vaccine was administered. Because the location of the events matched the injection site and there was a temporal association between the onset of the events and the administration of the drug, the events are assessed as possibly related to mRNA-1273.
1ST VACCINATION PRODUCED NO SYMPTOMS AND WAS ADMINISTERED ON 12/21/20 2NS VACCINATION WAS APPROX. 6:30 PM ON 1/11/21 AND SYMPTOMS BEGAN WITH BEING AWAKENED BY FEELING ITCHINESS ON STOMACH AT APPROX 01:30 A.M. ON 1/13/21. PATIENT (I) OBSERVED BUMPINESS AND REDNESS COVERING ENTIRE STOMACH, BACK OF NECK AND ITCHINESS DOWN THIGHS AND ALONG UNDER SIDE OF ARM. TOOK BENADRYL OTC AND WENT BACK TO BED. AWOKE FOR WORK AT 04:30 AND SYMPTOMS ARE BETTER. NO SHORTNESS OF BREATH OR OTHER ALLERGY RELATED SYMPTOMS
After the pt. received Havrix 0.5ml IM (ped dose), she started feeling unwell on the drive home. Symptoms reported are: nausea, fatigue, headache, vertigo, fever (100.5). The next morning she reported a bit of shortness of breath upon waking up, but that went away. There was no redness or swelling at the injection site. Mom called our office (11/5/15) and was encouraged to see her family doctor.  They went to Clinic 11/5/15. Lab testing showed a high white cell count and the provider prescribed a Z-pack. Mom reported that patient slept most of 11/5/15.
I received shot 1 on March 11. On March 19th, I woke up with pain going up and down my right arm and was swollen and at first thought I slept on it wrong but later in the day, I noticed my arm looked really swollen and looked like someone had inserted a round disk into my arm. Circular , puffy and itchy centralized reaction.
High fever of 104.2 and for approximately 12-15 hours. Fever of 102 and next day with total body rash. Immunizations were given approximately 8-9 days prior to symptoms.
Pt presented to clinic today for his 2nd dose Moderna vaccine at approx 1033.  Pt was brought back to conference room and was given his 2nd dose Moderna vaccine at approx 1040.  Pt reported no allergies to medications, no severe allergic reaction in the past.  Pt states doing fine with the 1st dose of the Moderna vaccine.  Pt was waiting his observation time of 15 min and began itching face, arms, and legs.  Nurse questioned pt if he was feeling ok? If he is itching?  Pt reports that he is itching but he has some anxiety but that he is hanging in there. Nurse offered pt some water.  Pt declined.   Pt started clearing throat and coughing.  Nurse questioned pt if he was still feeling ok and again offered pt some water.  Pt declined.  Pt reports that he is feeling ok.  Pt's timer alarmed and pt got up ready to leave.  When asked if he is doing ok, pt reports that he is.  Nurse questioned pt if his cough is normal for him and pt reports that he has asthma and proceeded to walk out.  Pt was escorted by nurse.  Nurse questioned pt again if he is feeling ok.  Pt states that he is.  Nurse notifies pt that if he not feeling ok then he should come back.  Pt states understanding and exits building.  Nurse seen pt returning back to clinic from window. Nurse meets pt upon entering building.  Pt reports trouble breathing. Nurse observes that pt has voice change, trouble completing sentences, cough is worsening, and itching is intensified.  Pt grabs the wall while ambulating.  Nurse provided stand by assist.  Nurse immediately escorts pt back to exam room and gets assistance from nursing staff and provider presents to exam room immediately.   Crash cart arrives.  Epi 0.3mg autoinjector administered  IM to LT at approx 1100.  IV NS ordered. At approx 1104 pt O2 sat of 98% on RA, HR 96. Approx 1105 Duo Neb administered via nebulizer mask as ordered.  Approx 1107 IV inserted to RAC with 18g on 2nd attempt. Approx 1108 Diphenhydramine 25mg/0.5ml administered IV as ordered. SoluMedrol 125mg/2ml administered IV as ordered.  Pt O2 sat 97% on RA, HR 102.  Approx 1110 pt BP 140/85, O2 sat of 93% on RA. Pt has coughing spell. EMS was called.  Approx 1113 pt O2 sat 90% on RA.  Ongoing coughing spell. Approx 1114 O2 2L administered via mask as orderd by provider.  Pt's wife contacted via pt's cell phone.  Approx 1116 Epi 0.3mg administered IM to LT as ordered.  Pt O2 sat 97% on 2L O2, HR 87.  Pt reports itching getting worse.  Approx 1121 Diphendydramine 25mg/0.5ml administered IV as ordered. Approx 1123 pt O2 sat 97% on 2L O2, HR 119.  Approx 1125 EMS arrived.  Approx 1127 BP 183/75.  Pt taken by ambulance with EMS to ER at approx 1135.  Report called to ER by provider.  ER transfer form faxed to ER.
Reported redness, itch on 4/22/11. Instructed if not better in a day or two to call office, voiced understanding. Denied pain, swelling, numbness, fever, no decrease in ROM. Pt seen by RN on 5-7-11 socially, still has quarter size red on underarm which is scaly, itch persists. Declines to come to doctor to have it checked.
Difficulty in breathing.  Congestion in upper part of lungs and cough.  Trerated with Alvesco and Ventolin.  Symmptoms went away after three weeks.
Within four hours of shot, low grade fever, 101.4, chills, nausea, exhaustion. Asleep by 9:00p.m., slept 13 hours, On March 17, woke at 10 am. Nausea, fever, chills gone, but totally exhausted with burning sensation at shot site and soreness in upper right arm. Remained in bed all day, asleep by 6 pm. Remained exhausted through March 23. Any physical activity caused shortness of breath and further tiredness. Exhaustion dissipated by March 24, 2021
Patient received Fluarix vaccine, which is not approved for children under the age of 18.  Mom reports no adverse reaction.
mom called said pt was angry & held breath on 7JUN94 turned blue, eyes rolled back & stopped breathing; mom shook pt & blow in face & started breathing;
6in redness and swelling and itching.  5 x 5 in arm redness.
Deathly Ill; This spontaneous case was reported by a consumer and describes the occurrence of ILL-DEFINED DISORDER (Deathly Ill) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOFACITINIB CITRATE (XELJANZ XR) for an unknown indication.    No Medical History information was reported.   On 06-Jan-2021, the patient started TOFACITINIB CITRATE (XELJANZ XR) (Oral) 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced ILL-DEFINED DISORDER (Deathly Ill). At the time of the report, ILL-DEFINED DISORDER (Deathly Ill) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
-sore arm at injection site -fever, chills, muscle aches, fatigue (onset ~4 hours post-injection; in bed mostly for ~18 hours after onset)
Site redness, pain, warm, red, swelling, "hard rock" under the skin and itchy.
Information has been received from a physician concerning a 17 year old male who on 06-FEB-2012 was vaccinated with the first dose of GARDASIL (lot # 669796/0840AA). The patient did not receive any other vaccinations that day. The physician reported that approximately two minutes after vaccination with GARDASIL the patient experienced jerking movement with eyes closed for approximately 20 seconds. The patient was lying down at the time and opened his eyes after approximately 20 seconds. The patient was given fluids and observed for 20 minutes. The patient declined to go to the emergency room. The physician stated that the patient was recovered before he left the office on 06-FEB-2012. Follow-up information was received from a physician refers to a 17 years old male patient with no illness at the time of vaccination and no relevant adverse events following prior vaccination. The patient's medical history included previous vasovagal syncope. On 06-FEB-2012 at 09:30 AM, the patient was vaccinated with the first dose of GARDASIL, intramuscularly (IM.) (dose not reported). No other co-suspects were reported. No concomitant medications were reported. On 06-FEB-2012 at 09:30 AM, (also reported as "two minutes after receiving GARDASIL"), the patient started presenting jerking movement and loss of consciousness for few seconds (an approximately 20 seconds). No treatment information was reported. No diagnostics tests were performed. It was reported that on 06-FEB-2012, the patient recovered spontaneously. The relatedness for the patient's events was not reported for GARDASIL. Upon internal review, lost of consciousness was considered to be other important medical event. This is one of several reports received from the same source. Additional information has been requested.
8 days later developed some fullness and itching at injection site,  no redness or warmth
A legal complaint was received from an attorney alleging that a male child received series Hib-Titer, Acel-Imune, and Recombivax-HB (Merck) vaccines as well as Tripedia (Aventis) vaccine from 16-Jun-1997 through 23-Jul-1998 and subsequently "suffered devastating injuries through mercury toxicity and associated complications and sequelae and the aggravation of other conditions directly through exposure, via intramuscular injection of mercury in the "thimersosal- containing vaccinations." According to the legal complaint, the child "was born a perfectly normal, Healthy boy whoses APGAR score at birth were well within the normal range." It is alleged that at apprx. 18 to 36 months of age, the child " was neurologically devastaed by the accumulation of Mercury in his body, having been exposed via intramuscular vaccinations, and suddenly regressed developementally, losing milestones of neurologically development previously achieved, specifically including but not limited to becoming withdrawn, unable to speak, unresponsive to his environment, engaging in repetitive behavior and the loss of language skills, motor skills and affect." According to the legal complaint, the child "suffered severe and permanent injuries" and sustained and will sustain in the future a mental, intellectual, development and neurological incapacity and associated learning disabilities, affect disorders and impairments."
Chills, pain in chest, pain in stomach, elevated heart rate  Still some pain this morning, but seems to be subsiding.
Case number PHEH2016US027162, is an initial spontaneous report from a nurse received on 17 Oct 2016. This report refers to a 24 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUCELVAX QUADRIVALENT (batch number: 185888) at a dose of 0.5 ml, intramuscularly on 17 Oct 2016. It was reported that, a temperature excursion occurred with FLUCELVAX Pre-filled syringe in a closed refrigerator, vaccines were cool to touch upon discovery. The patient estimates the time of excursion was 02 to 03 days and max temperature was estimated to be less that 77 degrees Fahrenheit. This was the first temperature excursion. It was stated that, vaccine has been given to 07 people this morning  on 17 Oct 2016. No adverse event was reported following this medication error.
Lethargy approximately 12 hours after injection, lasting approximately 24 hours Swollen and tender lymph node under right armpit approximately 48 hours after injection