chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient who is 7 months pregnant presented today for the first shot in the Moderna series. Patient presented with mild anxiety, appeared worried, mild sweating occurring during vaccination. Patient reported no contraindications to vaccine prior to administration. About 10 minutes after vaccinating, the patient informed the pharmacy staff that she was feeling lightheaded. The pharmacy had the patient sit down and notified the Nurse Practitioner who also practices in our building. The nurse had the patient lay on the ground with her feet up on a chair and kick her feet back and forth to get blood moving. The NP reported the patient was having a vasovagal reaction. The patient reported nausea and lightheadedness during this time. The patient was eventually able to sit up and drink water. The patient stayed for about 20 minutes after the incident, and made a full recovery to normal prior to leaving.
Pt received PCV 13 injection yesterday from HC, redness/pain started 4 hours after visit on R deltoid injection site. No redness is noted, however, tender to touch 7/10 pain with localized swelling. Afebrile, temp 97.2F, no shortness of breath, no rash/hives, no other symptoms or complaints. Consulted POD, dispensed Ibuprofen 200mg 1-2 tabs q 4-6 hours, to take with food to reduce GI upset. Instructed pt to ice injection area for 20mins/hr until swelling/pain improves, icebag provided in clinic. Pt v/u, return precaution given if symptoms worsen.
Pt started complaining of chest heaviness and shortness of breath on the afternoon of 1/21/21. EMS was called to the patients home and she was found to have an O2 sat in the 70's. She was admitted to hospital and found to have a proBNP of 5000.  She tested negative for Covid-19. She was determined to be in acute-on-chronic heart failure and was referred for hospice care. She passed away on the evening of 1/24/21.
8 DAYS AND COUNTING AND STILL POSITIVE; This spontaneous report received from a patient via a social media (Twitter) and by a company representative concerned a patient of an unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series: 1) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series: 1). The patient received booster covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 26-APR-2022, following vaccination with covid-19 vaccine ad26.cov2.s, the patient was covid-19 test positive (Dose number in series: 2). Laboratory data included: COVID-19 virus test (NR: not provided) positive. It was reported that "I got my booster 8 days and counting & still positive". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from covid-19 test positive. This report was non-serious.
Your intern came to help out with the vaccines and processing them, at the store I was floating to. I took out the vaccine from the refrigerator to thaw. I indicated to her as such. But  there were 2 vials( 1 Pfizer+ 1 Moderna) left over from yesterday(12/13) sitting on the other side of the back counter, with a sticker on the bottom indicating the time and date. She thought I already prepared the vaccines and ready to go. So she started giving  vaccines from those vials.  After giving the 2 Pfizer and 3 Moderna vaccines, she realized that it was a bottle from yesterday. She alerted me as such .  None of the patients called back reporting any adverse effects. we reported to out patient care services manager.
Itching rash, developing small papules- vesicles and scabs. Began 2/5 - was seen 2/10 with lesion scabed, some on scalp diagnosis modified chicken pox post vaccine.
pt recvd vax & 2 days p/shots pt stopped walking; pt was unable to walk for 1 wk; pt had temp for 2 days; mom states pt is not walking but is dragging as rt leg; more agitated since shots;
dizziness around 8:00pm, fatigue, severe headache, neck & shoulder pain, body aches, joint pain, nauseous, mild shortness of breath
Recurring hives / rash all over body for the last few months, even worse and more immediate with 3rd Booster does, intense itching and swelling, visited allergist that did not determine exact cause after a few appointments and very expensive testing, antihistamines are not helping, neither is topical medicine like cortisone cream or antihistamine cream.
No additional AE reported.; product that experienced temperature excursion over the weekend was administered to a patient; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 13-FEB-2023, the patient was vaccinated with haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (dose, anatomical location and route of administration were not provided; lot # W021182, expiration date 27-FEB-2025). The nurse reported that the vaccine had experienced a temperature excursion over the weekend. During 2 hours 32 minutes, the temperature was above 9°C (13..25C). No previous temperature excursion had occurred. No adverse event was reported.
Pt arrived to receive covid vaccine booster, with grandmother's consent. Handed provider vaccination card, which showed 2 prior Pfizer doses. The above vaccine was administered, only for patient to then say "There was a sticker for my 3rd shot on my card, it fell off." Thus pt was inadvertently administered a 4th dose of the Pfizer Covid Vaccine. Pt is not immunocompromised, and thus did not qualify for a 4th dose. He was informed of what happened and left with no adverse reaction to vaccine.
Shortness of breath, chest tightness, elevated blood pressure, decreased HR, admitted through Emergency Dept.
Narrative:  Per nursing documentation, patient felt nauseous and began vomiting 5 minutes after receiving Pfizer COVID-19 vaccine. Denied N/V prior to receiving vaccine and denied history of vaccine side effects. Denied stomach pain, fever, diarrhea. Did not eat breakfast. Denied sick contacts. Pt placed in room for observation. VS 97.7 (temporal), HR 84 bpm, RR 20, BP 133/78 mmHg. Vomiting stopped and pt reported feeling better about 40 minutes after dose.
It started with numbness around the left side of my mouth and chin and progressed to the left side of my face and left forearm and left calf.  On July 3rd the numbness moved up my left arm and to my shoulder and left side of my head.  I went to the ER was admitted to the hospital.  Numerous tests were given which couldn't find any problem.  I was given prednisone and sent home.  My last day at the hospital, I experience and burning sensation in my left elbow and foot.  Once home, the burning progressed to both arms from my elbows to fingertips and both legs from my knees to my toes. July 15 the burning progressed to my center chest and left side of my brain. I went to the ER, was evaluated and sent home.
Information has been received from a registered nurse concerning a 30-year-old (also reported as 28) female with a history of chickenpox and two prior doses of MMR (MSD) who on 04-SEP-2007 was inadvertently exposed to ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process).  On the 04-SEP-2007 the patient was administering ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) to a child who was kicking and the vaccine splashed into her eyes causing a slight burning, but no redness.  The patient rinsed her eye with water but not immediately.  It was reported the patient did not have any further problems beyond the initial splash sensation.  The patient sought unspecified medical attention.  The patient recovered from the adverse experience.  A product quality complaint was not involved.  It is not clear of the child received a full dose because of the splash (WAES # 0709USA00294).  Additional information has been requested.
This is a spontaneous report from a contactable other healthcare professional via a Pfizer sales representative. A 17 year-old patient of unspecified gender and ethnicity received the first dose of TRUMENBA intramuscular on the arm on unknown date in 2015 (probably two months before this report) at 0.5 ml single dose. Relevant medical history and concomitant medications were not reported. After receiving the vaccine, the patient went home and immediately went to bed. The patient experienced fever of 101 degrees F and extreme fatigue that began right after the vaccine, on an unspecified date in 2015. The patient was recovering from fever while the outcome of fatigue was unknown. The physician thought that the patient experience was related to the vaccine.
Pt received vaccine while seated and when she stood to go to observation area she experienced syncope and fell supine to tile floor. No LOC, was A&Ox4 immediately. Pale, strong pulses, RRR P 60's, unlabored resp effort. BP not evaluated. Some nausea, no vomiting. Exam of head revealed mild TTP with  no open wound, swelling, or depression. Pt responded to rest and required no intervention. Pt was monitored x 60 mins with full resolution of sx and discharged to home in good condtion.
Report received from Plasma Center on 21-Oct-2008.  An employee received AFLURIA on 21-oct-2008 and has developed numbness in her arm and her fingers are tingling.  Additional information has been requested.  No serious criteria mentioned.  Causality:  Conditional/ Unclassified.  Follow-up information received on 22-Oct-2008 from Plasma Center.  A 19 year-old non-pregnant female received AFLURIA, lot 03549111A, on 21-Oct-2008 14:15.  Vaccine administered IM to right deltoid.  Immediately following vaccination, the patient experienced pain.  At 18:30, the patient complained of tingling and numbness in fingers that spread to entire arm.  Reactions occurred on the same arm as the vaccination.  Patient was warm to the touch and red; temperature was 99.1 F.  She continued feeling warm and became sweaty.  She was instructed to go to the emergency room for evaluation and treatment.  As of 22-Oct-2008, the tingling/numbness has resolved but the pain continues.  At the time of the vaccination, patient was not ill.  Patient does have seasonal allergies.  Additional information has been requested.  No change in assessment.  The company considered events to be probably related to the suspect drug.  Follow-up information received on 22-Oct-2008 from Plasma Center.  Per reporter, the tingling and pain (hurting) continues.  The patient has not contacted her physician about this reaction.  Follow-up information received on 05-Nov-2008 from Plasma Center.  Per the reporter, the symptoms resolved within a couple of days.  Patient did seek medical attention; details are not known by reporter.  Follow-up information received on 06-Nov-2008 from a nurse at Plasma Center.  Per the reporter, patient has recovered and did receive treatment (unspecified) at the hospital, and she was told to take IBUPROFEN.  Hospital told patient that it (reaction) was just the muscle pushing against the nerve.  Follow-up information received on 07-Nov-2008 from a medical staff associate at the Plasma Center.  Along with the tingling in her fingers, patient also had discomfort.  No further information is expected.  Information derived from this AE report does not change the current safety profile of AFLURIA (CSL influenza vaccine).  Results of batch review for 0354911A received on 18-NOV-2008:  All deviations related to the manufacture of this lot were assessed as having no impact on product.  All deviations related to the manufacture of this lot were assessed as having no impact on product quality.  All QC testing was satisfactory with no out of specification results reported.  There are no outstanding issues for this lot that would potentially affect product quality.  In conclusion, there has been no assignable cause drawn from this investigation that would indicate any association with the adverse event reported.
"whole body aches everywhere."/whole body is so sore today, my breast, my back, shoulders, my neck; My throat gets a little sore; I just threw up everywhere; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 22Dec2020 08:20 at single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient reported that her "whole body aches everywhere/her whole body hurts." Healthcare professional (HCP) had not been made aware of this at time of call. The patient further reported that her whole body was so sore today (23Dec2020), my breast, my back, shoulders, my neck. Also, her throat gets a little sore and she just threw up everywhere on an unspecified date in Dec2020. The patient was working in a nursing home. No treatment was given for the events. "Lab test: Consumer stated, "No, just the Covid test but I passed it so (sentence incomplete)." The outcome of the events was unknown.
Client received 1st dose of vaccine at 8:58 am via IM to L deltoid.  She is a 42 y/o female in observation area complaining of tingling sensation and itching to the back of the throat noted.  Encouraged client to rest and relax. County Fire Rescue arrived to the scene for further evaluation.  Vital signs: BP 120/78, HR 66, Temp. 98.6, O2 98% via room air, Blood Sugar 96 and EKG normal sinus.  Client observed for an additional 15 min.  Client states allergy but unable to state specifically what she is allergic to.  Post additional 15 min. observation time client states that tingling sensation and itching to the back of the throat has subsided and refused hospitalization and left observation area and recovered at 9:45am.  Client noted with no difficulty breathing or any additional adverse reaction.
Narrative: The patient received two doses of Pfizer COVID 19 Vaccine Jan/Feb 2021. The patient tested positive for COVID 19 on 22 Jan 2022. The patient presented to the ED with shortness of breath and bradycardia. The patient was admitted on 22 Jan 2022 with Symptomatic bradycardia with second-degree heart block and COVID infection without hypoxia. The patient was monitored and treated and discharged in stable condition on 26 Jan 2022.
3 days after vaccine administration ZOSTAVAX, patient presented to pharmacy w/ a red, tender area approx 2 inches in diameter surrounding the injection site on left arm. He denied swelling, denied that it was spreading/worsening. Advised to use Ibuprofen or NAPROXEN OTC and apply ice x 2-3 days, then seek medical care if no improvement after this time.
Narrative: Pt receivd covid vaccinations on 1/18/2021 & 2/8/2021 at nursing home facility where pt resided. Pt was transfered to home hospice on 6/4/2021. Pt died at home on 6/9/2021. Pt had history of dementia & unable to care for self. ALso pt had other medical issues listed below: J44.9 Chronic obstructive lung disease (SCT 13645005) N18.6 End-stage renal disease (SCT 46177005) D63.1 Anemia in end stage renal disease (SCT 707324008) M79.605 Pain in left lower limb (SCT 287047008) Z99.3 Dependence on wheelchair (SCT 105503008) I10. Benign essential hypertension (SCT 1201005) R63.0 Anorexia (SCT 79890006) M13.0 Polyarthritis (SCT 416956002) E03.9 Hypothyroidism (SCT 40930008) R69. Aggressive behavior (SCT 61372001) Z51.5 Seen by palliative care service (SCT 441874000) R45.1 Restlessness and agitation (SCT 274647009) R53.83 Malaise and fatigue (SCT 271795006) Likely pt's death soon after admission to hospice unrelated to covid vaccinations.
patient under required age limit being administered with Quadracel instead of Daptacel; Initial information regarding an unsolicited valid non-serious case received from a health care professional on 15-Dec-2020.  This case involves a 15 months old male patient who was under required age limit being administered with quadracel instead of daptacel (product administered to patient of inappropriate age), while he received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 7v (crm197) (Prevnar); HepB vaccine and hib vaccine conj (tet tox) (Acthib).  On 23-Oct-2020, the patient received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE at a dose of 0.5 mL daily via intramuscular route right thigh (lot number: C5772BA; Expiration date: 07-Oct-2022) for prophylactic vaccination.  On an unknown date, it was reported that the was under required age limit being administered with quadracel instead of daptacel (product administered to patient of inappropriate age) (non-serious event) (unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  No laboratory tests were reported.  It was not reported if the patient received a corrective treatment. At the time of report, the outcome was not applicable for the event.  Disclaimer: 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 2001/83/ec and module VI of the good pharmacovigilance 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.
METALLIC TASTE; This spontaneous report received from a consumer via other manufacturer (pfizer) concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: heart disease, and allergy (drug unspecified). The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808980, expiry: Unknown) dose was not reported, 1 total, administered at right arm on 01-APR-2021 for covid-19 prophylaxis. It was unknown whether the patient experienced any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822811 expiry: UNKNOWN) dose was not reported, 1 total, administered on 22-OCT-2021 at right arm for covid-19 prophylaxis. It was unknown whether the patient experienced any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 2). Age at time of vaccination 60 days old. Concomitant medications included rosuvastatin for drug used for unknown indication.   The patient also received Moderna covid-19 vaccine (elasomeran) (Dose number in series 3) (form of admin and route of admin was not reported, batch number: 016B21A , expiry: Unknown) dose was not reported, administered on 12-JUL-2022 10:00 at right arm for covid-19 prophylaxis.  The patient also received paxlovid (form of admin and route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, administered on 03-AUG-2022 to 08-AUG-2022 for the treatment of covid-19.  On 04-AUG-2022, the patient experienced metallic taste within 1 hour of the first dose (paxlovid) which lasted throughout 5 days treatment (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, elasomeran was not applicable and with paxlovid was drug discontinued. The patient recovered from metallic taste on 09-AUG-2022 (duration 5 days). This report was non-serious.
Cardiomyopathy Severe Sepsis  CHEST X-RAY MEASURE OF CARDIAC SAMPL & PRESSURE, L HEART, PERC APPROACH FLUOROSCOPY OF LEFT HEART USING LOW OSMOLAR CONTRAST FLUOROSCOPY OF MULT COR ART USING L OSM CONTRAST
woke up with irregular spotting. I am not supposed to have my monthly period for another 7-8 days but I have experienced irregular; heavier menstrual spotting; This is a spontaneous report from a contactable consumer or other non-healthcare professional. This 23-years old female consumer (patient) reported for herself that:  A 23-years-old female (non-pregnant) patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection), dose 2 via an unspecified route of administration, administered in Arm Left on 04May2021 12:15 (at the age of 23-years-old) (Lot Number: ER8734) as DOSE 2, SINGLE for covid-19 immunization at workplace clinic. The patient was not pregnant at the time of vaccination. Medical history was reported as no. There were no known allergies reported. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection) dose 1 via an unspecified route of administration, administered in Arm Left on 13Apr2021 12:15 (Lot Number: EN6208) as DOSE 1, SINGLE for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications were received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since vaccination, the patient had not been tested for COVID-19. On 06May2021, 12:00 AM the patient experienced woke up with irregular spotting. I am not supposed to have my monthly period for another 7-8 days but I have experienced irregular and heavier menstrual spotting.  The clinical course as follows, it was reported that 1 full day after the second dose of the Pfizer vaccine, I woke up with irregular spotting. I am not supposed to have my monthly period for another 7-8 days, but I have experienced irregular and heavier menstrual spotting when I am not supposed to be. I was not stressed, so I cannot correlate between the two. It's odd that this was not considered a side effect to the vaccine and women have not been fore warned that they could possibly experience early-on spotting before their period until it happens, and women worry about this abnormality. There was no treatment received for the events. Device date was reported as 06May2021. The clinical outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
After receiving a Men B vaccine patient reports erythema and swelling at the site of infection and has had persistent left arm pain with a notable cord of tissue down the left shoulder and arm.
Significant ?brain fog? with forgetfulness, difficulty paying attention, making mistakes on simple tasks losing things etc. exact start date I know but around the time of the second dose.