chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of hives in a 73-year-old female patient who received SHINGRIX for prophylaxis. On 12th September 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a month after receiving SHINGRIX the patient experienced hives and itchy rash. On an unknown date, the outcome of the hives and itchy rash were not recovered/not resolved. It was unknown if the reporter considered the hives and itchy rash to be related to SHINGRIX. Additional details were reported as follows: The patient developed rash across upper chest which looked like bed bug bites and was very itchy. The patient had hives which was very amorphous in shape, also itchy on arms, legs and buttocks. The patient was not sure if the events related to SHINGRIX or not and they would see a dermatologist later this week. The patient requested to remain anonymous. The patient had denied permission to contact their physician. This case has been linked with US2018178311, reported by same reporter.
I started noticing swelling in my right forearm and some tingling in my fingers. I've had a right vasectomies' 2020 May a couple weeks later flare up of lymphedema and then it went away gradually. It came back after the first injection but I noticed it more after the 2nd dose. I still have the lymphedema. I go twice weekly for drainage.
Eyes began to swell, sneeze, nasal congestion, cough - photo sensitive - eyes more swelling took BENADRYL -> bed. 10/24/12 eyes swollen shut - went to MD - steroid shot, more BENADRYL, missed work 10/24/12.
Patient had a 6" red circle around the injection site that was firm to the touch. Patient was diagnosed with cellulitis and given Keflex with relief.
pt recvd vax & approx 1 1/2 hrs (1130AM) later pt started shrill crying which continued; tremors began @ 12N; mom reports that hands, feet & lips were cyanotic; taken to ER seen @ 1230PM; temp 104; blood drawn for WBC-nl; observed & releas;
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 35-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was an internal medicine manager.  Concomitant medication of the patient was not reported.  The reporter reported that because their facility had not been able to download the digital data logger, they had been put on hold at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment was made. There had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, this issue was treated as a temperature excursion. The reporter was unable to download the data logger for the months of December 2021, January 2022 and February 2022. The reporter was filling out a temperature excursion assessment.  The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient.  No treatment information was provided by the reporter.
Discomfort and pain to rib cage area starting 4 hours after shot and lasting to this date still.
Pt vax; devel red, tender, indurated at inject site.  6cm in diameter.
I first noticed a pain in my left armpit on Sunday 04/04/2021, but I just thought I pulled a muscle or something. Then on Monday, it wasn't any better, and when I looked in the mirror I realized my lymph node was very swollen and tender. This brings me to today where the lymph node in my left armpit is still swollen. I talked to a nurse to be safe, and she told me it should go away within a week-10 days, so I'm not too concerned.
My face became very red as if my face had the color of sunburn. My skin color is normally farely pale. My forehead and upper cheeks also developed small red spots. The spots and redness reduced to close to normal after approx 90 mins. I did not report this reaction to anyone. I was also extremely tired most of the day of the vaccine. I felt fine the next day and had no redness on my face.
arm was hurting/ Arm soreness; hives/ hives again and they are even worse; Fatigue; Anxiety; Odd dreams; Runny nose; Congestion; Allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 23Feb2021 at the age of 42-year-old as dose 1 single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. On 23Feb2021, patient received first dose and that day had normal reactions her arm was hurting, In the morning she woke up with hives. Patient had seen a primary care physician and told that she had a delayed allergic reaction and given a dose of steroids which  was finished on 02Mar2021. On 03Mar2021 she woke up with hives again and on 04Mar2021 they are even worse. Patient also experienced arm soreness, fatigue, anxiety, odd dreams, runny nose, congestion. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
About 25 minutes after receiving vaccine, Patient complained of weird feeling and tightness in her jaw and throat. Upon trying to drink water, she started to feel sick and dry heaved (never vomited) then she said she had problems trying to swallow.  She did not report trouble breathing.  I called 911, they had me ask her a series of questions.  As soon as she said her throat was bothering her again, I administered the EpiPen at 12:10. We also called her emergency contact person.
Patient reported to vaccine clinic to receive second dose of Pfizer Covid vaccine.  First dose received on 1/12/2021 without any problems or reaction.  Patient reported history of anaphylaxis to shellfish so she was asked to wait 30 minutes post vaccination for observation.  Around 15-20 minutes after receiving vaccination, it was noted patient was rubbing her throat.  RN at vaccine clinic asked patient if she was ok and she reported she was fine, she thinks it is in her head.  RN noted she continued to rub her throat and asked her to describe what it felt like.  Patient felt sensation of tickle in her throat and asked for water.  Patient also noticed began to itch all over.  Patient provided water and 25 mg PO Benadryl.  Patient noted it felt  like her throat was starting to close and her tongue felt it might be swelling.  Epinephrine 0.3 mg IM was administered at 12:07 and patient arrived in ER at 12:08.  Patient received another dose of IV benadryl and famotidine and kept for observation.  She was discharged home after a couple of hours.
This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 06-APR-2018, the patient was vaccinated with a dose of VAQTA injection (dose, route of administration, lot number and expiration date were not reported). The patient might have not gotten full dose of VAQTA because they moved. No adverse events were reported.
1st dose 02Jun2022, 2nd 03Dec2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 51-year-old female patient who received HAB (Twinrix) (batch number J477Y, expiry date 20th May 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 2nd June 2022).   On 3rd December 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 3rd December 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-DEC-2022 Reporter's comment: The pharmacist reported that the patient received second dose of Twinrix late. The health care professional did not have information of expiration date and batch number from first dose because it was not given at her facility. Consent to follow up was asked and agreed but HCP said did not have a reachable email. The reporter consented to follow up. Additional supportive information: The patient received the second dose of Twinrix later than the recommended interval, which led to lengthening of vaccination schedule.
Client received 3 vaccines today. After 3rd vaccine administered, HPV, the client's eyes started closing an she began to tilt her head back. Client did not respond to verbal stimuli. Unresponsiveness lasted for less than a minute. Client later began feeling nauseous. Symptoms resolved by the time the client left the clinic.
On 1/17/01, approx. 12:15, mother complained of redness at child's injection site on right and left legs. No distress noted, happy affect and no respiratory problems noted. Ice packs were applied bilaterally and instructed mother to give Benadryl. At 14:00, per telephone call to mother, she verbalizes pt is doing well. On 1/18/01, father brought child to office. Examined by MD. Left leg had no redness noted. Right leg had redness and was warm to touch. MD instructed parents to give baby Benadryl. On 1/22/01, telephone call from parents, states per interpreter, baby not laughing and temperature 103F today. Instructed to go to ER. On 1/23/01, mother states she saw MD and he treated her for ear infection.
PATIENT RECIVED BICILLIN, AND YELLOW FEVER VACCINE THEN DEVLOPED THE FOLLOWING SYMPTOMS AFTER 30 MINUTES: LIP SWELLING, DYSPNEA, WHEEZING, EAR ITCHING. PATIENT REPORTED BACK TO THE CLINIC; WAS GIVEN EPIPEN INJ. 0.3 MG 1:1000, AND BENADRYL 50 MG. I.M.. PATIENT'S SYMPTOMS RESOLVED AND WAS RELEASED WITH THE FOLLOWING MEDS: ZANTAC, ALLEGRA, PREDNISONE. BED REST FOR THE DAY AND FOLLOW UP THE NEXT DAY.
07/13/2022 she woke up and was lethargic. She had a fever of 103 and a cough. She was sleepy for the rest of the day. She did not eat much, but she did drink. The next day she still had a fever but was more perky. She tested positive with a home COVID test on 7/14/2022. We gave her a dose of TYLENOL and has had none since. She has bounced back and is back to normal.
administered a 4th dose; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 4-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 7p2y3, expiry date 8th April 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th February 2022, the patient received Pediarix (intramuscular) .5 ml and Pediarix Pre-Filled Syringe Device. On 14th February 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information were received as follows: The medical assistant reported that one of their patient was administered a 4th dose of Hepatitis B in the form of Pediarix in her right thigh, which led to extra dose administered for hepatitis B. The reporter consented to follow up.
10/26/18 4 pm painful stiff arm at injection site. 10/27/18 6:30 am, body aches all over, 10/27/18 6:30 am fever 101.5, 10/27/18 6:30 am chills, 10/27/18 6:30 am headache.
Within 45 min, patient had nausea, dizziness, and was given ondansetron and fluids with improvement
sore arm; Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FATIGUE (non-serious), outcome "unknown", described as "Tired".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vial was initially stored in the refrigerator on11-Jan-2023 and Dose was administered on 16-Mar-2023; No adverse event; Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on11-Jan-2023 and Dose was administered on 16-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 64-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7172B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 16-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on11-Jan-2023 and Dose was administered on 16-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on11-Jan-2023 and Dose was administered on 16-Mar-2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on11-Jan-2023 and Dose was administered on 16-Mar-2023).    It was unknown patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.  Date the vial was initially stored in the refrigerator on 11-Jan-2023. The vial did not undergo any temperature excursions. Dosage text reported as unknown. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-720388, US-MODERNATX, INC.-MOD-2023-720382, US-MODERNATX, INC.-MOD-2023-720423 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720388:Same reporter US-MODERNATX, INC.-MOD-2023-720382:Same reporter US-MODERNATX, INC.-MOD-2023-720423:Same reporter
Patient experienced polyarthralgias following receipt of his fourth anthrax vaccine. He was diagnosed with Reactive Arthritis. Has been treated with Remicade, NSAIDS< Prednisone, and MTX. Symptom: Joint pain, multiple joints. Comment: affects toes, ankles, hips, shoulders, elbows, knees, and neck.
Head to toe purpura raised/unraised, itchy and non itchy reddish-purple scattered spots. Developed one week after receiving flu vaccine. Prednisone, Dapsone. Please excuse patient from getting the flu vaccination from this point forward. She has been diagnosed with leukocytoclastic vasculitis, which was due to the flu vaccine, so we recommend that she not receive it in the future.
Patient received expired vaccine. Pfizer recommend revaccination. Patient was contacted to schedule an appointment.
Headache.  Muscle aches. Face red and rashy.  No fever.  Herpes Zoster-type symptoms.  Blister on left side of face around eye.  Blisters in nose and lips. Burning sensation. Felt like needles.  Still have scarring.  May be a coincidence. PT suspected it was shingles.  Sx presented the day after the Covid Shot.
Patient rec'd dose #1 of Pfizer without incident 3 weeks ago. Has hx of anaphylaxis to ant bites and PCN. Noted L ear "pressure", sounds are "muffled", sudden onset approx 30seconds after injection of dose #2. Nurse practitioner at chairside assessing patient. VS stable. Denies chest pressure, difficulty breathing, any other s/s reaction. Peripheral IV started and 60mg solumedrol given IVP through free flowing saline line. Patient notes relief within 5 min after solumedrol. Monitored for additional 45min. Patient reports relief of symptoms. Discharged with instructions to take PO benadryl and go to ER immediately if any sx reoccur. MD team notified.
Immediately post vax, the pt developed an injection site reaction characterized by swelling and bruising.
Massive skin reaction which increased in severity until vanishing on day five. The child's hands, arms, feet, legs, and face were covered in a splotchy red rash. Swelling was present on hands, feet, and face.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 05-SEP-2014 the patient was vaccinated with and expired dose of PNEUMOVAX 23 lot # J009827, expiration date: 10-AUG-2014, 0.5 ml, intramuscular. No adverse effects were reported. Additional information is not expected due to the reporter did not want to be contacted again.
Patient reported that 2 & 1/2 HOURS after the immunization she began to feel badly.....with heart racing, a-Fib, her blood pressure was high 150/74 at 5pm pulse 96 and at 5:45pm BP was 158/78 pulse 79. She called the pharmacy, we told her to call her doctor or go to the ER and she called the doctor but they were closed. She refused to go to the ER. She said after eating and using her oxygen and lying down she felt better at 9:30pm.
For about an hour I had severe nausea and vomited and had a bad headache.  However, I hadn?t eaten that morning which may have been a contributing factor.  I took some ibuprofen and symptoms subsided after about two to three hours
8-13-21 likely afternoon exposure  8-14-21 all day likely exposure  8-15-21 morning start headache nose, congestion  8-16-21 slight cough, night vertigo fever full body shivers and heavy sweating  8-17-21 deep cough, joint aches, night vertigo fever  8-18-21 deep cough, joint aches, night fever, no vertigo  8-19-21 no headache, lite nose congestion, infrequent deep productive cough, night no smell, no fever,  8-20-21 infrequent deep productive cough, lite sinus congestion, no smell, no fever  8-21-21 no smell, intermittent cough 8-22-21 congestion and cough 8-23-21 congestion and cough 8-24-21 congestion and cough 8-25-21 started on 2 inhaler prescriptions
Patient experiencing shakes, decrease in muscle strength, fever, disorientation, and increase in blood sugar
About 20 minutes after the child was immunized the person administering the vaccine caught that the patient was given the adult dose of pfizer, not the children's dose. The PIC was alerted and I contacted mom and spoke to her about what happened. This was the 2nd dose, previous children's dose of pfizer was administered at another pharmacy.  The child had no issues with the 1st vaccine and I instructed mom on what to look for as far as side effects with this vaccine. I will reach out to VAERS on Monday to discuss any other issues
Patient received first dose of vaccine at 1215 today and had no complaints immediately post vaccine.  Left vaccine area independently and once by elevators became lightheaded and dizzy and lowered herself to the floor without injury.  Was then assisted to ambulate back to the recovery area by a passerby/witnessing staff.  Was monitored for 30 minutes by EMS without further incident.  Vital signs reported by EMS at 1231: BP 153/107, HR 74, Sats 98% on RA.  Repeated prior to discharge: BP 131/94, HR 73, Sats 96% on RA.  Patient stated that symptoms had fully resolved. Released to self-care.
PATIENT CAME IN ON NOV.18.19 TO GET ADVICE ON THE ADVERSE REACTIONS FROM FLUAD VACCINATION. SORE/TENDERNESS/THROBBING PAIN/REDNESS/WARM TO THE TOUCH SENSATION/REDNESS/SWELLING ON THE INJECTION SITE.  THE SIZE OF THE LESION WAS ABOUT 2X3
Pain in left arm worse than after the 1st dose shot. I developed fever and chills, nausea, diarrhea about 18hrs after vaccination. Multiple trips to the bathroom, achy and unable to go back to sleep. Took acetaminophen around 5:15am. Fell back asleep around 6am and slept for a few hours. Fatigued and lightheaded throughout the day. Little appetite. Slightly improved as the day went on.
Patient reported the start of left side face tingling within 30 minutes of receiving the COVID 19 vaccine. patient called the pharmacy and was advised to go to the emergency room. Upon arrival to the emergency room patient started having left side face and neck burning and had  left side face drooping. At the emergency room the patient was told that she had a TIA, and was hospitalized for several days.