chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. In July 2014 the patients were vaccinated with COMVAX (dose, route of administration and lot # were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
the sx was draw up & jerking the time was about 4PM; the sign was that pt cried like it hurted; the treatment was ACTH gel & hospitalization now takes a new med; pt has infantile spasms;
Migraine headache with visual aura preceding headache. Headaches continued until today 11/09/09. Went to PMD and received IM Toradol injection and prescription for migraine medication.
AFTER THE PT. GOT HER HPV & MCV IMMUNIZATION AND AS THEY WERE CHECKING OUT, PT' COMPLAINED OF WEAKNESS. SHE TURNED PALE & STARTED FALLING. MOM CAUGHT HER AND LAID HER ON THE FLOOR. HER EYES ROLLED UPWARD AND PASSED OUT. STERNAL RUB WAS DONE BY THE MA AND SHE IMMEDIATELY OPENED HER EYES. THIS LASTED A FEW SECONDS ONLY. WHEN THE DR. GOT THERE, PT. WAS AWAKE, LOOKED DAZED AND PALE BUT SHE WAS COHERENT. DR. ASKED HER IF SHE KNEW WHERE SHE WAS AND THE PT SAID ON THE DR.'S OFFICE. SHE KNEW THE DR. BY HER NAME. OXYGEN SAT WAS 98-99% WITH HR 110-1208. After the px got her HPV and MCV immunization and as they were checking out, px complained of weakness. She turned pale and started falling. Mom caught her and laid her on the floor. Her eyes rolled upward and passed. out. Sternal rub was done by the MA and she immediately opened her eyes. This lasted a few seconds only. When I got there, she was awake, looked dazed and pale but she was coherent. I asked her if she knew where she was and she said she was at the doctor's office. She knew me by my name. Oxygen Sat was 98-98% with HR 110-120s. Legs were elevated as well. After a few minutes we helped her get up and she walked with support going back to the exam room. Oxygen Sats continued to be 98-99% and HR started going down. She laid on the bed for several minutes and her color came back. She started getting better and said she wasn't dizzy or weak anymore. We slowly make her sit and then later stand and walk around. Sats continue to be 98-99% and highest HR when walking was 102. Continued to be coherent. She continued to do well and was acting normal by the time they checked out and left the office.
Severe Migraines not responding to rescue medication; 10/10 on pain scale; multiple episodes (2-3 per day).  Migraines Lasting 1 week in duration; Headaches still on-going.  Severe Depressive Symptoms with Suicidal ideation 1 week post-dose.  Still ongoing.  Initiation of anti-depressant has somewhat alleviated symptoms
Noon. -severe pain in arm from shoulder to elbow., elbow joint remains sore. 6 pm fainting and low bp and slow pulse. Tingling or numbness in hands and feet. Taken to hospital.
Took Vivotif doses on every day instead of every other day; Spontaneous report received on 21MAY2020.  A pharmacy manager reported that a female consumer who "took Vivotif doses on every day instead of every other day" (PT: Inappropriate schedule of product administered). She was receiving Vivotif capsule for immunization. The consumer took the Vivotif doses every day instead of every other day. The reporter assumed that she took first dose of Vivotif on 17MAY2020. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took Vivotif doses on every day instead of every other day (Inappropriate schedule of product administered). The causality of the event is assessed as not applicable to Vivotif due to the nature of the event.; Sender's Comments: A consumer took Vivotif doses on every day instead of every other day (Inappropriate schedule of product administered). The causality of the event is assessed as not applicable to Vivotif due to the nature of the event.
This spontaneous report was received from a nurse refers to an unspecified patients of unspecified demographics. There was no information about the patients' medical history, concomitant therapies and concurrent conditions. On unknown multiple dates, the patients were vaccinated with improperly stored VARIVAX lot # K021935, expiration date 10-NOV-2016; lot # L027287, expiration date 21-JUL-2017 (strength, dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of -12 degree Celsius till an unknown duration. No data logger was involved. No product quality complaint was reported. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Expired Dose of Heplisav-B was Given; Initial Report Received 30-Sep-2021  A pharmacist reported that a 49-year-old male received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history was reported.   The patient was reportedly not taking any other medications.   On 29-Sep-2021, the patient received the first dose of HEPLISAV-B (Lot # 933624, Expiration Date 10-Aug-2021, Serial Number 101467482917, NDC # 43528-003-05) was administered in the right deltoid by a pharmacy technician.   The dose was expired at the time of vaccination.  No adverse reactions were reported at the time of report.    No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Testing positive for COVID after receiving vaccine; Testing positive for COVID after receiving vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events for 14 patients. This report is for 5th of 14 patients. An elderly patient (more than 65 years old) of an unspecified gender received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced testing positive for COVID on 21Jan2021 after receiving vaccine. Since they were testing positive, physician wanted to administer Bamlanirimab (drug being administered under FDA EUA). The event resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was unknown.  Information on the lot/ batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported testing positive for COVID  based on the known safety profile. However the short duration of 8 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.,Linked Report(s) : US-PFIZER INC-2021063794 Same reporter/drug/event, different patient
Sore arm on day of vaccination.  Lethargic on Saturday, March 6.  No adverse symptoms on or after Sunday, March 7.
This case was reported by a nurse via call center representative and described the occurrence of injection site rash in a 47-year-old female patient who received MENVEO (batch number M15023, expiry date May 2016). Concomitant products included YELLOW FEVER VACCINE. On 20th April 2016, the patient received MENVEO. On 23rd April 2016, 3 days after receiving MENVEO, the patient experienced injection site rash and injection site itching. On an unknown date, the outcome of the injection site rash and injection site itching were not recovered/not resolved. It was unknown if the reporter considered the injection site rash and injection site itching to be related to MENVEO. Additional details were provided as follows: The patient received MENVEO on unknown arm and the yellow fever vaccine on the opposite arm. Rash (55 mm by 45 min) appeared on the same arm where she received her MENVEO vaccine. It was reported that the rash itched a little bit.
mom states pt cried from 230PM-8PM p/vax; states pt would take 5min naps p/placing ice on site;denied any redness or swelling @ site;called PMD;stated MD did not see pt t102;
Immunizations administered Fri 8/1. Fri/Sat temp to 101.3 relieved with children's Tylenol. Sun AM seemed "OK" per mother about 4 PM, child became fussy, irritable, wouldn't eat. Temp 99.3. Began crying, Mom reports crying "nearly all the time" from Sun eve to Thurs when she called HD. Catnaps 30-45 minutes only. Saw pediatrician Wed 8/6, told child OK. Went to hospital ER 8/7/03, told to give child Benadryl which relieved symptoms, child slept more.
Racing heart,  lasting roughly 30 minutes Flushed face lasting 2 hours Sweat face lasting roughly 30 minutes Dizziness coming in waves lasting roughly 30 minutes
This spontaneous report was received from a pharmacist regarding a female patient of unknown age. Her medical history, concurrent conditions and concomitant medications were unknown. On an unknown date in May 2017 (reported as one month before the second dose), the patient was vaccinated with GARDASIL 9 (dose 1) (route, lot number and expiration date unknown) for prophylaxis. On 02-JUN-2017, the patient was vaccinated with GARDASIL 9 (dose 2) (route, lot number and expiration date unknown) for prophylaxis. The patient's second dose in the human papilloma virus (HPV) vaccine series with GARDASIL 9 was only 1 month (date unspecified) after she received her first dose of GARDASIL 9. Pharmacist stated that the second dose of GARDASIL 9 should have been administered two months after the first dose. Additional information has been requested.
Patient and her husband came to our pharmacy to receive their bivalent Moderna boosters. One syringe was drawn from the correct bivalent vial and the second was drawn incorrectly from a monovalent Moderna vial. After review of video footage, we could not determine which patient received the incorrect monovalent dose. The patients were notified. No adverse events to report. We are in contact with Moderna and the CDC to determine if re-vaccinating with the bivalent dose in 2 months is appropriate.
On 5/3/05, patient received MMR and Prevnar at 15 month WCC. Previously healthy child. After vaccine, developed fever on 5/9/05 for 4 days up to 103 then when fever was decreasing developed right facial swelling. Showed at home; none in office with facial swelling and lower lip drooping. Resolved within 3 days.
Pain in arm, shoulder, and connective tendons. Inflammation and swelling at injection site and muscle pain grew progressively worse over four weeks. Eventually patient could not lie on her side or move arm or use it to bear weight, at which point she contacted a doctor. Patient recovered after a course of physical therapy.
Pt received 2nd dose on 2/27/2021.  3/1/2021 reports onset of fever, headaches, loss of taste, fatigue, nausea and vomiting, body aches and shortness of breath.
Taken to Urgent care after 1 week of rash. Was Diagnosed with cellulitis and allergic reaction on 10/19/18.
extreme malaise and headache  within 24 hrs of taking 2nd dose. Patient reports numbness and tingling in hands and feet.
At 2:57pm on Oct 22, 2020, I gave Afluria to the patient in her right arm. No swelling or adverse reaction occurred at the time of vaccination. Approximately 15 minutes later, a coworker told me that the patient lost consciousness. When I arrived with the emergency kit, the patient was sitting up and speaking. Her mother who was with her did not want us to call 911. I checked the administration site, and there was no indication of an allergic reaction. Patient said she did not have any swelling in her face or mouth. An ice pack was given to her because she hit her head on the floor when she passed out. She seemed lethargic. We helped her into a wheelchair and I advised the mother to take her to the hospital to get checked out. I asked the patient if she had eaten, and she said yes. We got her some orange juice and she drank it. While she was drinking the juice, I tried to take her blood pressure twice, but both times I had an error message "ERR 5", which according to the manual meant that there was "an unacceptable difference between systolic and diastolic pressures".  The mother wheeled her out of the store and said they were going to the hospital. I asked her to call me and keep me updated.
severe local rxn-erythema & swelling, w/fever, myalgia, arthralgia, malaise & nocturnal diaphoresis;
INDURATION 135MM x 76 MM, MUSCLE SORENESS, LOCAL REDNESS. TEMP 98.4, B/P 126/89, P 91, R 16.  PT SEEN BY MD, GIVEN BENADRYL PO.  PT INSTRUCTED TO RETURN TO CLINIC IF CONDITION WORSENS, OR PERSISTS.
"started shortness of breath when outside in the cold, palpitations, feeling on edge, ringing in ears with normal hearing"
Forceful and repeated vomiting, continuing for at least 12 hours, with subsequent facial petechiae.
Started with itchy sensation on 9/18/07 and noted swelling on 9/19/07. Sore throat 1 day swelling left upper outer arm 5" x 3" with an indurated area 2" x 3" with an indurated area 2" x 1". Further redness on the forearm, 4 x 3 1/2". Rise of temp upper arm.
3 days after moderna vaccine,  burning sensation on lower back and both thighs, developed highs on entire back and both thighs above the knee, swollen lymph nodes under left arm.  Spoke with a doctor who recommended benadryl and claritine.  Symptoms went away a few days  but from time to time feels a itching sensation strong enough to prevent her from completing her work task.  Associate states she will be speaking to an allergist.
Approximately 2 months after I got my 4th dose vaccination I contracted COVID-19 and had the following symptoms: nasal congestion, cough, sore throat and low grade fever. I did not take anything for treatment and decided to consult with my doctor instead. My doctor prescribed me with PAXLOVID for 5 days and started taking on my 05/16/2022, my symptoms started improving the next day and today as of 07/05/2022 I am feeling so much better.
This spontaneous report was received from a registered nurse and refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-AUG-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N012488 with expiry date: 20-APR-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
Initial report was received from a healthcare professional on 16 May 2013. A male patient (age and date of birth not reported) had received a dose one intramuscular injection of MENACTRA, lot number not reported) in 2008. In April of 2013, the patient was diagnosed with meningitis after a spinal tap was done because of the symptoms of fever and stiff neck. As of the date of the report, the patient had no symptoms and was going to the doctor for clearance to return to college. Illness at the time of vaccination and past medical history was unknown. Outcome was recovered. Documents held by sender: None.
Pt was exposed to a 15 month old who was vaccinated with varicella virus vaccine live. Subsequently the pt experienced chickenpox and was covered with lesions and her body ached all over.
feels tired; Exacerbation of anxiety; feels shaky; feels flushed; feels like his pressure his up; Jitteriness; This is a spontaneous report from a contactable consumer (patient). A 64-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 11Jan2021 at single dose on Left arm for covid-19 immunisation. Medical history included ongoing anxiety (had for many years), Quadraple Bypass from 2008, TAVR valve replacement from 2020, Pegylation of lung from Mar2020.  There were no concomitant medications. The consumer reported he took Covid 19-vaccine (Verbatim): for protection from Covid-19 because he has comorbidities, had a few ailments. The patient experienced feels shaky, feels flushed, feels like his pressure his up, jitteriness on 11Jan2021, feels tired and exacerbation of anxiety on 12Jan2021. The event outcome of feels tired was recovering, outcome of other events were not recovered.  Information on the Lot/Batch number has been requested.
Got vaccine in November noticed heart palpitation. Increased over time. I was in class and checked my pulse, and notices a skipped heart beat in February. EKG conducted in January. Visited Cardiologist in March.
Chief Complaint: SOB.  rib pain which worsens when he coughs.  Reports having a pre-procedural COVID test which was negative last week.  Start oxygen protocol to keep saturation greater than 92%.  Start dexamethasone 6 mg daily for 10 days.  Acute hypoxic respiratory failure- sec to covid pneumonia-. Initially required O2 and later  breathing well on RA.  COVID-19 pneumonia- on steroids and remdesivir day 4/5. Was supportive care with sinc, cit C, vit D.  Discharged today to against medical advice.
DT vaccine administered 05/01/03 to left deltoid. On 05/04/03 pt complained of itching, tenderness to left arm, chills, fever and body aches. Tx with Prednisone 40 mg PO x1, Benadryl 50 mg PO x1 and MD appt next AM.
Patient became faint as walking through waiting room after flu immunization. Patient laid down on floor. Hydrated with water, then assisted to sitting position. Doctor notified and examined patient.
Patient had blood in stool. Starting 10 days after the first dose. The blood in stool stopped one day before it was time for the second dose. The doctors said she had a milk allergy, but I still drink milk while breastfeeding and there has been no more blood. Even used hemmocult cards.
Moderna vaccine administered to patients post temperature excursion/patient received moderna vaccine after it had undergone freezing in refrigirator the day before for about a five hours period; 1st dose administered on 05-feb-2022 and 2nd dose administered on 10-may-2022; Poor quality vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna vaccine administered to patients post temperature excursion/patient received moderna vaccine after it had undergone freezing in refrigirator the day before for about a five hours period), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 05-feb-2022 and 2nd dose administered on 10-may-2022) in a 77-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 005M21A and 005M21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 05-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .25 milliliter. On 10-May-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 10-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna vaccine administered to patients post temperature excursion/patient received moderna vaccine after it had undergone freezing in refrigirator the day before for about a five hours period) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 05-feb-2022 and 2nd dose administered on 10-may-2022). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna vaccine administered to patients post temperature excursion/patient received moderna vaccine after it had undergone freezing in refrigirator the day before for about a five hours period), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 05-feb-2022 and 2nd dose administered on 10-may-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that it was a refrigerator excursion where the lowest temperature reached was 26 Fahrenheit for about 15 minutes and the average temperature was 28 Fahrenheit. The entire excursion duration was about 5 hours. Reporter stated that the Moderna vaccine was used post excursion and administered to patients. The patient did not report any adverse effects. The event did not cause the patient to seek medical care.  No treatment medications were reported.
Excruciating shoulder pain, stiffness, weakness, very limited range of motion . Difficult doing most anything that requires me to to bring my arms up or to move them side to side. Loud sounds of popping and crackling, crunchy sounds upon the slightest movement. Extremely painful when I?m trying to get to sleep. I wake up several times in such pain that it causes me to scream out loud. to I can hardly turn my steering wheel to drive, I have a difficult time carrying most anything. Started in my left arm after first vaccine and my right arm after the second one. I?ve never had any problems or issues with my shoulders prior to this.
Rash on R mandible, anterior & posterior torso.  1 teaspoon children BENADRYL.  10 minutes rash was cleared.  Pt alert and responsive on exit.
Chills, sweats, muscle aches, fatigue Later, rash on legs and arms.
Shortly after vaccine receipt client complained of general not feeling well, progressing quickly to c/o nausea, headache, cough, chest tightness.  B/P initially 174/88, P=64, subsequent B/P 188/110 and c/o "severe" headache.  EMS called and client transported to emergency room
On 1/26/21 client went to her exercise class at 5:30am, she became extremely cold, clammy, nauseated, and said she couldn't sit up. She called her husband to come and pick her up. She was afebrile. Blood sugar was 86. She said she just wanted to sleep. She sleep most of the day and through the night until 3:30 am today. She woke up and said she feels fine. She said at one point her body felt frozen and she couldn't move at all.
SHINGRIX received. 24 hours later patient noticed approx. 3in by 3in "bump" on portion of arm where vaccine was received. No itching and cool to the touch. Over night redness was gone and turned purple. Pt took ibuprofen 800 mg every 8 hours after 3 days bruise-like bump seemed to be healing. No longer purple but still tender on day 7.
This 4 year old child received the 5-11 year old dose of Pfizer COVID vaccine as the second dose in his series, instead of the 6 month- 4 year old dose.  No adverse outcomes.
pt rec'd vaccine (grey cap pfizer) that was left in freezer for 22 days- they will be in at somepoint for replacement dose
This case was reported by a consumer via call center representative and described the occurrence of shivering in a male patient who received SHINGRIX for prophylaxis. On 17th February 2019, the patient received the 1st dose of SHINGRIX. On 17th February 2019, less than a day after receiving SHINGRIX, the patient experienced shivering and upset stomach. On an unknown date, the outcome of the shivering and upset stomach were unknown. It was unknown if the reporter considered the shivering and upset stomach to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. At night, the patient experienced very bad shivering and upset stomach. The patient was wondering at the reporting time, if there were any reports of people getting chicken pox afterwards. The patient asked if he would experience the same side effects with the second shot.