chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient has history of period v tach. 9:26 Vtach. 0xygen 99%, heart skipping, bp 140/90 (normal range (110/70) Some dizziness 9:35 BP 140/86 9:46 BP 130/96 P-100 with bcc skipped beat 9:55 Patient feels okay and dizziness has resolved.  Cleared by Dr.  Feels well enough to go home. Husband is paramedic so he will take her to the station for a cardio strip and she will go to ER if she feels unwell.
muscle soreness throughout body and at injection site, lethargy, slight headache - appears to be  resolved after 1 day.
Patient developed 2 hives medical to injection site. BENADRYL was given and patient observed.
Patient reports pain with injection that progressed to extreme pain which limited range of motion as well as shooting /nerve type pain. Pain reported in injection site arm only.
Please note that the administration of the 4th vaccine was given at the pharmacy location being reported. We do not have detailed information regarding the vaccine series 1-3.   An intern used the incorrect size needle to administer the Covid vaccine to the patients listed on this report. The needle size used was a 5/8 inch needle, when the correct size that should have been used was a 1 inch needle. The correct dose was given to all patients. Based on CDC recommendations, there is no need to revaccinate any patient that was administered the dose in the wrong location; in this case the vaccine was given SubQ rather than intramuscular, based on the length of the needle. All patients were notified of this error and were given advise on what to expect. All patients were informed that no harm was done, the vaccine was still effective, and no additional dose is required based on CDC guidelines. As a result of these errors, reeducation was given to the pharmacy student, and the area within the pharmacy that contains all vaccination related supplied were relabeled to make it more clear for everyone administering vaccines.
Within 2 minutes, the pt had blotting and itching of upper body. 1/2 hour post vax, the pt had a slight tightness in the chest. The pt received Benadryl and was observed for 2 hours. Returned 2 days later with soreness and numbness in left arm.
Felt terrible the day after the second dose of the vaccine; Received dose of the Covid Vaccine that had been expired for one hour; This is a spontaneous report from a Pfizer sponsored marketing Program. A contactable 33-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EE7938), (33-years-old at the time of vaccination), via an unspecified route of administration on 03Jun2021 as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: unknown), via an unspecified route of administration on unspecified date as dose 1, single for covid-19 immunisation. Reported that patient received a call from the pharmacy stating that her second dose received on that day was given to her after it was expired for one hour. She felt terrible the next day after the second dose. She heard that was a sign of a strong immune response. The pharmacy told her that she needs to come in and get another second dose and patient think if her vaccine was actually ineffective and wants to know was it safe to get another one as the pharmacy suggested. On 03Jun2021, the patient received dose of the covid vaccine that had been expired for one hour, on 04Jun2021, the patient felt terrible the day after the second dose of the vaccine. It was reported that seriousness for the events was unspecified. On 23Jun2021 patient was asking if the vaccine was ineffective to get another get 2nd dose shot. The outcome of events was unknown.  Information about lot/batch number is available. Follow-up attempts are needed  Follow-up(23Jun2021):This is a Follow-up spontaneous report from a Pfizer sponsored marketing Program. A contactable female patient reported for herself that included: new event, clinical course added and narrative amended.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021766790 Pfizer
Varicella-like rash on trunk and extremities - onset 8/24/07. Has underlying chronic skin condition that has not been treated yet by dermatologist. "Bullous dermatitis" which has recurred.
Initial information received on 10-Sep-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 16 years old male patient who received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect FLUBLOK QIV lot QFAA1803. It was a case of actual medication error due to Inappropriate age at vaccine administration. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Received a Prevnar-20 injection on 25 Sept 2023 in my left shoulder. On 27 Sept started feeling pain in my left arm and let chest that made sleeping difficult and interrupted. Pain has been increasing and spreading since then. Sleep is now very difficult.
PT STARTED TO CRY 3 HOURS OF VACCINE FOR 2 HOURS
feels like there is water inside my ear; impacted my equilibrium; I can't hear from left ear; tinnitus; This is a spontaneous report from a contactable consumer (patient). This 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in right arm on 18May2021 11:30 (Lot number: ER8735 7/21) at single dose for COVID-19 immunization. Medical history included allergy with Vitamin E oil and Hair dyes. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  In the afternoon of the day she had received the vaccine (18May2021) she got ringing (tinnitus) in ears which is unusual for her.  It went away by the evening time but when she woke up the next morning (day after the vaccine, 19May2021 07:00) she noticed that she can't hear from her left ear. It almost felt like there was water inside her ear but not quite really. It's a strange sensation that she had never felt before. She also felt that it had impacted her equilibrium somewhat. No treatment received for events tinnitus and can't hear from left ear. Lab data included antibody (blood test) on 30Apr2021: negative.  Patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19.  The outcome of tinnitus was recovered on 18May2021, outcome of she can't hear from her left ear was not recovered, outcome of other events was unknown.
On 3/12/21 about 24 hrs after taking the vaccine, pt unable to talk & has difficulty walking
Burning sensation; the rash is on her hands and feet, palms and soles/ rash on palm and sole after booster; really tired for two days after booster; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning sensation), RASH (the rash is on her hands and feet, palms and soles/ rash on palm and sole after booster) and FATIGUE (really tired for two days after booster) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced FATIGUE (really tired for two days after booster). On 02-Dec-2021, the patient experienced RASH (the rash is on her hands and feet, palms and soles/ rash on palm and sole after booster). On an unknown date, the patient experienced BURNING SENSATION (Burning sensation). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (Burning sensation), RASH (the rash is on her hands and feet, palms and soles/ rash on palm and sole after booster) and FATIGUE (really tired for two days after booster) outcome was unknown.            Concomitant medication details were not reported by the reporter.   This case was linked to MOD-2021-404181, MOD-2021-404182 (Patient Link).
The patient presented to hospital on 1/6/2021 with a primary complaint of Fatigue (pt had covid vaccine yesterday. Now displaying increased weakness, blood in urine, increased confusion and urinated on herself today. Fever of 101.9 ) 79-year-old female presents to the emergency room with fatigue. The patient states yesterday she had the Moderna COVID-19 The patient states today she had a temperature 101.8° prior to arrival. Her son noted that she was having episodes of urinary frequency and also that she was profoundly weak and fatigued. They denied falling or hitting her head. The patient also states she been having nausea vomiting with diarrhea.
Headache not abated by Tylenol  Stuffy/runny nose (So far that?s all the symptoms- positive experience)
swelling of injection site, diarhhea, pain in arch of foot, pain in left calf muscle, rash
Arm soreness and  stiffness, inflamation, partial paralyses of left arm.
Product storage error; Moderna COVID-19 vaccine was administered to a patient from a vial that was open for more than 12 hours; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to a patient from a vial that was open for more than 12 hours) and PRODUCT STORAGE ERROR (Product storage error) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer on 16-Apr-2021 and Pfizer on 07-May-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 28-Mar-2022 at 10:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2022 at 10:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to a patient from a vial that was open for more than 12 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to a patient from a vial that was open for more than 12 hours) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications was provided by the reporter.  Patient did not experienced any symptoms and sat for 15-20 minutes.  Vial was initially stored in the refrigerator on 25 Mar 2022 and was first punctured on 26 Mar 2022 at 8 30 AM. Vial was stored post puncture at room temperature and did not undergo any temperature excursions. Total amount of time vial was exposed to room temperature was more than 24 hours in the range (8 degree to 25 degree Celsius which was equal to 46 degree to 77 degree Fahrenheit) and was for about 48 hours.  No treatment medications were provided.
About 1 hour after getting vaccinated i noticed that my left eye got puffier and I could feel the tingling  on my eye.  Being little confused and not knowing the cause after reading online I noted that this could be possible from Covid-19 vaccine.  At this time few hours later my puffiness is slowly going away . I do have pictures taken at the time of being vaccinated and also when I noticed the possible reaction .
PAIN IN HER NECK; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (PAIN IN HER NECK) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported adverse event).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (PAIN IN HER NECK). At the time of the report, NECK PAIN (PAIN IN HER NECK) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
I had my vaccination on 10/12/2022. I woke up on 10/13/2022 with vertigo. As soon as I tried to sit up, I was overwhelmed with dizziness. I made several attempts to get up but threw up and had incontinence. I tried to drink water but vomited. I went back to bed and stayed there. I have had a history of vertigo but never this bad. It eased up on 10/14/2022. I went to the emergency room on 10/18/2022 and they prescribed me meclizine.
Initial medication error report received on 04 October 2013 from a medical assistant. A patients whose gender, age, medical history and concomitant medications were not reported, received a dose of PENTACEL (route, lot number and site of vaccination was not reported) on an unspecified date. Medical assistant reported that I gave the dtap/ipv without reconstituting the hib. From a medical standpoint, it is fine to give the ACTHIB alone if they gave DTAP-IPV alone. Because the child was not given the ACTHIB component of PENTACEL, he/she needs to be given a separate injection of ACTHIB reconstituted with saline diluent (0.4% sodium chloride). List of documents held by sender: none.
Day after 2nd dose of vaccine, affiliate was at work and began to not feel well.  She reported lightheadedness.  BP slightly lower at 90/58. Other vital signs stable. 911 called and patient sent to the ED.
pt recv vax & exp rt flank pain;MD did not believe that the pt sx were r/t to vax;
Information has been received from a nurse referring to a patient of unknown age and gender. Concurrent conditions and medical history of the patient were not reported. On 12-APR-2016 the patient was vaccinated with an expired dose of PROQUAD (Merck) (lot # K018143, expiration date: 10-APR-2016) (dose and route unspecified). No adverse effects reported. Additional information has been requested.
Initial and follow up information has been received from a registered nurse, concerning a 13 year old female patient, with no known medical conditions or allergies, who on 20-AUG-2007 was vaccinated IM in the right deltoid, with a dose, 0.5ml, of Gardasil (lot #658556/1060U), as well as, with the second dose, SC in the left arm, of Varivax (duration and dose not reported) (MSD) (lot #657754/0782U), with the second dose, IM in the left arm, of Vaqta (lot #AHAVB182AA) (manufacturer unspecified) (duration and dose not specified), and with the first dose, IM in the right arm, of MENACTRA (lot #U1821AA). There was no illness at the time of vaccinations. On 20-AUG-2007, following the vaccinations, and while still in the physician's office, the patient reported not feeling good and was pale, felt faint, dizzy and nauseated. At 4:50pm, her blood pressure (BP) was 100/60 mmHg, and her pulse was 48bpm. The patient had not eaten breakfast and was given crackers and juice and laid flat for 15 minutes. Within 20 minutes, she was feeling better, her BP was "good," and her pulse had increased to 60 bpm (previously reported as 64 bpm). The nurse considered the patient to be recovered and she was discharged to home. Additional information has been requested. Additional information is not expected.
This spontaneous case reported by a consumer, describes the occurrence of COVID-19 (tested positive for COVID-19 3 to 4 days after receiving 1st vaccine) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 vaccination. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced COVID-19 (tested positive for COVID-19 3 to 4 days after receiving 1st vaccine). At the time of the report, COVID-19 (tested positive for COVID-19 3 to 4 days after receiving 1st vaccine) outcome: unknown. Diagnostic results: On an unknown date, SARS-CoV-2 test: Tested positive for COVID-19. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medications or treatment information reported.
This spontaneous report as received from a healthcare worker refers to an unknown number of patients of unknown age and gender. No information regarding patients' medical history, concurrent condition nor concomitant therapies was provided. On an unspecified date in approximately 2015 (reported as between 08-SEP-2015 through 02-OCT-2015), the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 (dose, frequency, route of administration, lot # and expiration date were not reported). No adverse symptoms were reported. The reporter was not able to provide any further details at the time of reporting. This is one of several reports received from the same reporter. Additional information has been requested.
HIGH TEMP; FEVER; PAIN AND SWELLING AT INJECTION SITE; BODY ACHES; FATIGUE
No additional AE reported.; Medical Assistant reports that VAQTA was administered to a patient on January 25, 2023 after the product expired on January 16,; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 25-JAN-2023, the patient was vaccinated with expired hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter, lot #W007382, expiration date: 16-JAN-2023, administered for prophylaxis (strength, and route of administration were not provided) (expired product administered). The vaccine was properly stored prior to administration and had no temperature excursions. There was no adverse event reported.
Headache, Fever, shakes, chills, aches, right arm is incredibly sore Narrative:
redness occurred the day after I received  the Moderna booster; swelling; been experiencing pain in my arm pit area,; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (redness occurred the day after I received  the Moderna booster), SWELLING (swelling) and AXILLARY PAIN (been experiencing pain in my arm pit area,) 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, the patient experienced ERYTHEMA (redness occurred the day after I received  the Moderna booster), SWELLING (swelling) and AXILLARY PAIN (been experiencing pain in my arm pit area,). At the time of the report, ERYTHEMA (redness occurred the day after I received  the Moderna booster), SWELLING (swelling) and AXILLARY PAIN (been experiencing pain in my arm pit area,) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. No treatment medications were reported.
warmth at the site of the injection; itching at the site of the injection; pain at the site of the injection; swelling at the site of the injection; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Mar-2021 and was forwarded to Moderna on 08-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warmth at the site of the injection), INJECTION SITE PRURITUS (itching at the site of the injection), INJECTION SITE PAIN (pain at the site of the injection) and INJECTION SITE SWELLING (swelling at the site of the injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced INJECTION SITE WARMTH (warmth at the site of the injection), INJECTION SITE PRURITUS (itching at the site of the injection), INJECTION SITE PAIN (pain at the site of the injection) and INJECTION SITE SWELLING (swelling at the site of the injection). At the time of the report, INJECTION SITE WARMTH (warmth at the site of the injection), INJECTION SITE PRURITUS (itching at the site of the injection), INJECTION SITE PAIN (pain at the site of the injection) and INJECTION SITE SWELLING (swelling at the site of the injection) outcome was unknown.
Started with small rash under armpit same arm as injection.  Treated with topical cream, no better.  Within 2 weeks spread to whole armpit.  Went to dermatologist.  Steroid shot and topical meds given.  Meds helped for 1 week, then started spreading again.  By now, it's time for 2nd shot.  A couple of days after second shot, same rash was under both arms, itchy, whelps, burning.  Started moving onto my breast and side (right side).  Back to derm (more steroids and  creams - miserable).  A few days later, i began to have blisters and rashes all over my body.  Mainly arms, between fingers, entire stomach, top of thighs.  Moved into my mouth, gumlines bleeding and shedding skin, breast had blisters, vaginal area and rear end bleeding from blisters and rash.  Went to HCF and was given heavier dose of steroids, creams and added heavy antihistamine.  Worked and calmed for a few days for the itching, then came right back.  The rashes are no longer a huge issue but under my armpits (along with blistering) but the itching is intense.. My whole body itches.  Nothing helps, no rashing just horrible itching from the inside out.  Something has to be done
Flushed after 20 minutes blood pressure spiked to 205/105.   Waited additional half hour went home.  Blood pressure at home 225/125 called doctor who sent me to ER Remained at the hospital 5 hours and was released with pressure 187/80 Went to the hospital Jan 24 with pressure 205/95 released 4 hours later Pressure still out of control Jan 29 Never had pressure so high normally on meds 110/60
The patient was given a booster dose of primary pfizer vaccine when they were expecting a  booster dose of pfizer bivalent vaccine.  The patient was informed of the administration error and told that if they chose to receive the bivalent booster, they could after 60 days have past.  They had no further questions
11JAN91 mom phoned PHN stating child has vomitting, chills, & 105 fever since the "middle of the night". Told mom take to ER immediately. Denies sz, respiratory distress. Given tylenol.