chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After giving Gardasil vaccine, had unwitnessed syncopal event.  Found on the floor next to exam table, within a few seconds of hearing a fall, eyes open, extremities shaking, shaking stopped after a few seconds, immediately returned to normal level of consciousness. No loss of bowel or bladder function.  Placed supine, with pillow under head.  Once awake, describes that he started to feel dizzy, leaned head back against wall, then doesnt remember further events. Complains of right sided posterior head pain, and also left shoulder pain. Initially tachycardic to palpation.  HR quickly returned to normal and then vital signs stable throughout.  Almost immediately returned to alertness, oriented X 3.  Noted < 1 cm hard lump on right posterior occiput, no step offs.  Initially pale, but color returned within a few minutes. Initially normal neuro exam, except c/o blurry vision, given water and snack, tolerated well, confirmed vision change on eye chart.  Soon after walked around office without assistance. Greater than 15 minutes after the event, reported b/l hand tingling, at tips of finger tips, with sensation and strength intact.  Resolved, but then reoccurred and spread up right arm.  While awaiting stat MRI, developed left sided facial droop, lasted < 2 minutes, resolved while walking to ER as did tingling in arms/fingers, otherwise symmetrical facial movements and continued to have otherwise normal neuro exam.
generalized macular papular rash body and face. Benadryl 11/2 tsp by mouth every 10 hours for 5 days.
Patient is 16 years of age.  Moderna is only approved in those 18 years of age and older.  Patient inadvertently vaccinated with family at a mass vaccine event.
Confirmed breakthrough  COVID-19 (Pfizer) 1 03/01/2021 Pharmacy  Pfizer EN6200   COVID-19 (Pfizer) 2 03/22/2021 Pharmacy  Pfizer ER2613   COVID-19 (Pfizer) 3 10/14/2021 Health Department Pfizer FF2590
Vaccine administered 9/16/2008. On 9/17/08, noticed welts on son's back. On subsequent days, welts multiplied and moved to arms, legs, neck, and face. Low grade fever, irritability and severe redness of the skin were also noted. Took son back to pediatrician on 9/22/08 regarding this rash. Was diagnosed with viral exanthem possibly due to hepatitis A vaccine. Benadryl was prescribed for the rash, as well as Tylenol for fever. As of today (9/27/08), rash/welts/redness more prevalent, covering most of his body. He has been given 1/4 tsp of Benadryl every 4 hours to no effect. No itchiness has been noted. Irritability has decreased. Contacted CDC in regards to this skin outbreak; was advised to report to VAERS. We would like someone to contact us in regards to treating this problem.
Patient had chills, shakiness, and fever of 103 degrees F approximately 4 hours after vaccines. Redness/swollen injection site. Took ibuprofen 200mg every 4 hours. 3 days later still feels sick with temp of 99 degrees F and redness and swollen present.
Information has been received from a Registered Nurse concerning an approximately 25 year old female patient with a history of seizure when received a "DPT" vaccine as a child, Pertussis, sulfa medications allergy and drug allergy to SEPTRA, who on an unspecified date was vaccinated with the Hep B series (manufacturer unspecified) (lot number not provided). The Nurse mentioned that the patient received "the hepatitis series" and developed a rash. It was unspecified if the patient received any treatment, sought medical attention or if lab diagnostics studies were performed. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Patient received DAPTACEL early. He had DAPTACEL on 11/28/2014 and again on 12/11/2014.
she is experiencing headaches.; A urinary tract infection.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Expiry date: Unknown), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced she is experiencing headaches, a urinary tract infection. The outcome of the event was unknown on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow-up#1(14Apr2021): New information was received from consumer included: No new information updated.
Pt presented with anxious behavior about 2nd dose Moderna vaccine. Pt reassured. Pt cleared screening questions. Medication administrated around 10:30 am. Pt sat with RN's in vaccine shed. At 11: 08 appeared pale, and reported feeling dizzy. RN elevated B legs with chair. Pt reported headache. RN provide crackers and water. Pt continue to report feeling unwell. 11:11 am RN called 911. charge RN notified and provided resources. Staff and medical equipment came to shed. Vitals collected at 11:15am BP 130/84, Hr77, RR44 100% O2,3LO2 via nasal cannula. No signs of respiratory distress noted. Pt remained alert. Ambulance arrival at 11:23.  Paramedics assisted pt to ambulance.   11:41am pt refused emergency follow up. Paramedics stayed with pt outside of shed until ride came to pick up pt. Pt left in stable conditions.
Swollen cervical lymph node on side of vaccination, approximately 1.5 cm in diameter and hard, lasted for 7 months.
This spontaneous report as received from a registered nurse refers to multiple unspecified patient's of unknown age and gender. Approximately on an unspecified date in November 2012 (reported as during the last two weeks) the patient's might have received RECOMBIVAX HB (Lot number, expiry date, dose and route were unspecified) exposed to unsupportable cold temperatures. No concomitant medications were reported. No adverse effect reported. No information was available as to whether any individual patient might have received more that one of the effected vaccines. This is one of the several reports from the same reporter (MARRS# 1212USA000871, 1212USA000867 and 1212USA000873) Additional information has been requested.
The patient was up by the front of the store with her husband and passed out. The manager on duty called 911. The paramedic came and took vitals and BP. Pt was deemed ok and she left with her husband. Did not go to hospital with paramedic.
MENACTRA WAS GIVEN TO PATIENT BEFORE THE AGE OF 2 PATIENT WAS 1 YEAR 8 MONTHS NO REACTION AT TIME OF INJECTION.
Persistent neck issues and headaches, I didn't know that was the first indication that it might have something to do with my vaccination. It could be. I had my CT scan last week and she asked me about the shot and I looked up the information and I reported it when I had a check in opportunity. I have been getting physical therapy and that started in September because I was having headaches starting then. It was reported to my doctor at the physical on 9/28. And I'm not one who runs to the doctor. Headache was the driver that made me go to the doctor. I was due for wellness check at the time and that's when it was brought up. I had been referred to physical therapy from another doctor that I was seeing for osteoporosis. Physical therapist thought there was a balance problem just to find that there was no problem. Cardiologist thought it had to do with ear crystals, but it wasn't. I thought that some of the dizziness and headaches that I had experienced was caused by my heart but it's not. And it's not caused by my ears either. Headache is not caused by any of those things according to the doctors. But there may be a relationship here that no one has discovered. There was a headache episode after the 2nd vaccination, but headaches became more persistent after the 3rd dose. Headaches are typically in the crown on the left side and sometimes it travels to the top of my head, but mainly on the left side. neck involvement on that side as well. don't know how it all fits together.
Intense fatigue, high fever (103), dizziness, intense headache, weakness, some confusion.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 11-MAY-2016, the patient was vaccinated with a dose of ZOSTAVAX that was not expired (dose, route of administration, lot # and expiration date were not reported). ZOSTAVAX was mixed with an expired STERILE WATER DILUENT lot # L001646, expiration date 20-DEC-2015 (wrong solution used in drug reconstitution and expired product administered. There was no adverse effect reported. Additional information has been requested.
No adverse events; received 4th dose of gardasil 9; This spontaneous report was received from a physician via company representative regarding a male patient of unknown age. The patient's medical history, concurrent condition and concomitant medications were not reported. The reported described that on an unspecified date in 30-NOV-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose 4 (extra dose administered) (strength, dose, route, lot # and expiry date were not reported) for prophylaxis. No adverse effects were reported.
On evening of initial dose, I had a very sore Arm at the injection site. I feel that it was extremely different from what others describe. I could barely lift the arm without a lot of pain. I wasn't too worried about it as I knew it could only be sore for so long. It faded throughout the next days. On 04/07/21, I woke from a sleep at 4am and as I rolled over, I had a massive wave of dizziness come over me. I thought it was very strange so I decided to sit up, in bed. As soon as I sat up, the room started spinning. It felt as if I were drunk as a skunk. I managed to steady myself and got out of bed and went to the bathroom, all the while fighting the dizziness/vertigo. The dizziness/vertigo has prevailed since then, but at a diminished rate. It is better if I am up and moving and worse if I am sitting/laying around. I've waited almost a week to file this VAER but feel like it needs to be done.
A week after receiving my vaccine I noticed vaginal spotting and thought I was getting my menstrual cycle. That spotting turned into heavy bleeding and hasn't stopped for 3 weeks
Runny nose, fever, 101.8, cough, sweats.  10/08 till 10/12.  Bed rest, fluids, aspirin, cough control.
No additional AEs or PQC; expired dose of PNEUMOVAX 23 was administered.; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 04-NOV-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe lot #U035117, expiration date: 18-AUG-2023 (strength, anatomical location, and route of administration were not provided) as prophylaxis. No adverse event was reported.
Pt experienced numbness in face, left arm and hand. Pt blacked out for about one minute. Pt experienced shortness of breath and muscle weakness.
Pain in shoulder, radiating down arm. Limited ROM, painful ROM and weakness in still 2 weeks after shot.
PER PATIENT: "WOKE UP AT 4:30 COULD BARELY MOVE LEFT ARM AND HAD STABBING PAIN IN LEFT SIDE. PAIN IS CONSTANT LIKE NEEDLE PRICKS BUT WHEN ARM IS LIFTED IT FEELS LIKE SOMETHING IS STABBING ME. TOOK A MUSCLE RELAXER AND IT EASES THE PAIN AND ALLOWS ME TO MOVE MY ARM AROUND."
Painful, enlarged axillary lymph nodes and body aches about 36 hours after first shot, resolved after several days CBC shows monocytosis and high MPV
I WAS IN SEVERE PAIN FOR THE FIRST 2 WEEKS AFTER SHOT TAKING 3 ADVILS EVERY 4 HOURS, THE FOLLOWING 2 WEEKS I WAS ON A REDUCING DOSE OF PREDNISONE.  MY WHOLE ARM FROM SHOULDER THRU THUMB AREA FEELS ACHING AND SOMETIMES TINGLING.  IT HAS BEEN OVER A MONTH SINCE MY SHOT.  I HAVE TAKEN AN MRI, HAVE NOT SEEN MY RESULTS YET.
The area were the vaccine was administered became swollen, reddish and itchy.  The course was about 4 hours.
Information has been received from a licensed practical nurse concerning a 32 year old male who in 1971 was vaccinated with MMR. In 1971, the patient had a "terrible reaction" possibly to the MMR vaccine, which was suspected to be due to a reaction to horse serum. The patient had a fever, constricted airway and a rash within hours of receiving the vaccine. The patient was hospitalized for one week. Additional information has been requested.
Day 1 included a rash and shortness of breath.  Day 2-3  leg pain, shortness of breath fatigue , nausea and headache.  Day 4 - started to feel better in the morning but in the evening got shortness of breath and nausea.
Left side - acute pain in shoulder joint - radiating towards scapula - down the arm  limited range of motion  tingling sensation down arm to hand
Nurse is calling to report that her coworker notified her that she gave a 17-year-old patient a Bivalent Moderna COVID-19 booster dose instead of first primary dose; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Nurse is calling to report that her coworker notified her that she gave a 17-year-old patient a Bivalent Moderna COVID-19 booster dose instead of first primary dose) and NO ADVERSE EVENT (No adverse event) in a 17-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE. Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Nurse is calling to report that her coworker notified her that she gave a 17-year-old patient a Bivalent Moderna COVID-19 booster dose instead of first primary dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Nurse is calling to report that her coworker notified her that she gave a 17-year-old patient a Bivalent Moderna COVID-19 booster dose instead of first primary dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Nurse is calling to report that her coworker notified her that she gave a 17-year-old patient a Bivalent Moderna COVID-19 booster dose instead of first primary dose).    Concomitant product use was not provided by the reporter. Patient received other vaccines  4 weeks prior to COVID-19 vaccine. Treatment information was not provided.
Extreme sensitivity and massive swelling of upper right thigh. Red blotches around injection sight.
a little bit of itchiness at injection site; a little bit of swelling at injection site; a little bit of redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (a little bit of itchiness at injection site), VACCINATION SITE SWELLING (a little bit of swelling at injection site) and VACCINATION SITE ERYTHEMA (a little bit of redness at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (a little bit of itchiness at injection site), VACCINATION SITE SWELLING (a little bit of swelling at injection site) and VACCINATION SITE ERYTHEMA (a little bit of redness at injection site). At the time of the report, VACCINATION SITE PRURITUS (a little bit of itchiness at injection site), VACCINATION SITE SWELLING (a little bit of swelling at injection site) and VACCINATION SITE ERYTHEMA (a little bit of redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Achy pain on the left side of my face for over 24 hours.  It woke me up during the night, and I had to lay down during the day today.
Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Headache-Severe, Systemic: Nausea-Mild, Systemic: Seizure-Medium, Additional Details: PATIENT BECAME STIFF AND SLUMPED OVER IN CHAIR APPROXIMATELY 2 MINUTES AFTER RECEVING VACCINE. HIT HEAD ON WALL. WAS INITIALLY UNRESPONSIVE BUT REGAINED CONCIOUSNESS. DIALED EMERGENCY NUMBER AND RPH STAYED WITH PATIENT. MONITORED VITALS, KEPT PATIENT STILL, PROVIDED A COOL COMPRESS, KEPT PATIENT ALERT. PATIENT WAS CONFUSED AND DISORIENTED. COULD NOT RECALL ALL EVENTS FROM MORNING. EMS ARRIVED AND TRANSPORTED PATIENT TO HOSPITAL.
Dose given 7 minutes after expiration. No signs or symptoms of reaction at administration, parent notified and had no report of signs or symptoms of reaction. Provider notified, call placed to manufacturer , awaiting guidance.
Information has been received on 13-APR-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 01-JUN-2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 11-MAY-2016, the patient was treated by a physician at a physician's office for a persistent vesicular rash, which was diagnosed as chronic herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 10-FEB-2017, the patient was vaccinated with incorrectly stored dose of M-M-R II, lot # L049314, expiry date 03-DEC-2017 (dose, route and site of administration were not reported). Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. There was no previous temperature excursion reported. Data logger was involved. No adverse effects reported. This is one of several cases received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
HCP called to report temperature excursion on GARDASIL 9 and VAXNEUVANCE; No additional AE/PQC; This spontaneous report was received from a nurse referring to multiple unspecified patients. The patients' information regarding concurrent conditions, medical history, and concomitant medications was not provided.   On an unspecified date, a call was received stating that a temperature excursion (Product storage error) had occurred; but the dates of vaccination were unknown. It was reported that among the vaccines included were HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot number valid, reported as W028573, expiration date 06-JAN-2025), pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) (lot number valid, reported as W027275, expiration date 09-JUL-2024; W039033 and W036242, expiration date for both 01-OCT-2024); (doses, routes of administrations and anatomical locations, were not provided) all for prophylaxis.  The vaccines presented a temperature excursion, at a temperature of 31.5 degrees Fahrenheit (F) for a timeframe of 2 hours and 45 minutes. There was no previous temperature excursion. There were no product quality complaints and no adverse events reported. ; Sender Comments: Keywords :
fever, aches, chills first 5 days.  now runs a lowgrade fever at night, swollen feet and legs.
c/o burning at injection site (1030); c/o dizziness, pale, diaphoretic, BP 92/60, p 38 (1040); Feet increase , BP 102/68, P 44, R20 (1042); P48R118, BP120/80 (1045);P60, R18BP140/92 (1047); Client with continued c/o dizziness, no diaphoresis; Client taken to MD office by son; Client denies Hx diabetes- reports didn't eat breakfast; Client reports Hx hypertension and currently has hiatel hernia that causes pain. 11/25/2002 Client did not complete consent for physician records to be obtained; Client did not agree for his RN to phone physician office and request a written documentation stating he couldn't receive the Flu vaccine; Client did report that MD instructed him not to take the Flu vaccine in the future; Client reports that MD told client that he remembered client coming to the MD office after receiving last years dose of the Flu vaccine and having a "problem" with the vaccine; When this RN questioned client, he couldn't recall what type of "problem" he had last year with the vaccine; Client did not indicate any problems with past Flu vaccines at the time of vaccine administration on 10/18/2002; When this RN spoke with MD" office nurse on 10/18/2002, she also verbalized that MD instructed client not to receive the Flu vaccine in the future since client had a similar episode with injection in the past; Client has had continued problems with hypertension during the past month requiring his medication to be changed and / or adjusted 3 times; Client also had hypoglycemic episode that MD office identified on 10/18/2002 during his visit just after the Flu vaccine; Client reports no further episodes of hypoglycemia; Client is under continued care of family physician, related to his health issues, including blood pressure regulation.
Covid arm - large red , tender, itchy 2"x3" spot around injection site at Day 7 post inoculation; lasting about 4 days so far, but almost gone; photo available if needed.
Dizziness. Petechiae in the lateral area of the left wrist and in the lateral area of the left arm that have been appearing little by little but are increasing.
A pharmacist reported that a female developed urticaria following receipt of flu vax. She recovered. No further information was available at the date of this report.
Body aches, Fatigue, Sore throat, Sinus/Nasal congestion, runny nose, Shortness of breath, Chest tightness