chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report from a Health Professional concerns a 14 month old patient of unknown gender. Concomitant medications included cetirizine. On 07-Oct-2013 nasal FLUMIST Quadrivalent (intranasal) was administered to a child under two years old. On the same day the patient experienced wheezing, diarrhea, fever, and leg weakness on one side. The patient recovered from the wheezing, diarrhea, fever, and leg weakness on one side on an unspecified date, and the outcome of the administered FLUMIST quadrivalent to a child under two year old was unknown. The reporter assessed the leg weakness on one side and administered FLUMIST quadrivalent to a child under two years old to be serious as important medical events. The company physician assessed the wheezing, diarrhea, and fever to be serious as important medical events that required emergency room/doctor visit. Follow-up information received by AstraZeneca/MedImmune 26-Nov-2013 from Health Professional upgraded this case to expeditable: administered FLUMIST quadrivalent to a child under two year old patient was upgraded to serious, serious events of wheezing, diarrhea, fever, and leg weakness on one side were newly added. Patient details, FLUMIST Quadrivalent start date, and concomitant medication also added.
This spontaneous report has been received from a pharmacist concerning a 68 patient of unknown gender. The patient's concurrent conditions and pertinent medical history were not reported. On 22-DEC-2014, the patient was vaccinated with the first dose of ZOSTAVAX, (lot #, exp. date, strength, route of administration and dose were not provided). On 15-NOV-2015, the patient inadvertently received a second dose of ZOSTAVAX lot # L012477, exp. date on 10-JUL-2016, (strength, route of administration and dose were not provided. No adverse effect reported. Additional information has been requested.
A physician reported that a pt developed shortness of breath following receipt of flu vax 10 to 12 years ago. A dx of allergic reaction was made. The pt recovered. No further information was available at the date of this report.
Patient developed hives on her hips and back, rash under both arms and wrists. Patient was advised to take BENADRYL.
Multiple sclerosis; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 24-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jan2021 at 14:30 as dose 1, single (Lot number: EK5740) at the age of 24 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: INSULIN; LEXAPRO. The following information was reported: MULTIPLE SCLEROSIS (hospitalization, disability, medically significant) with onset 11Jan2021 at 12:00, outcome "not recovered". The patient was hospitalized for multiple sclerosis (hospitalization duration: 5 day(s)). The event "multiple sclerosis" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of multiple sclerosis.  Clinical course: If other vaccine in four weeks was no. Other medications in two weeks was Insulin, Lexapro. Almost immediately after getting the vaccine patient started getting numbness and tingling in my arms and chest then her trunk went and chest then my trunk went numb and began to have severe vertigo. Patient went to the emergency room where patient was diagnosed with Multiple sclerosis. Patient had never been diagnosed with MS prior and patient had never ever had these symptoms prior to the vaccination. Ae resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. Ae treatment was IV steroids. If covid prior vaccination was No. If covid tested post vaccination was No. Known allergies was No; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162b2 cannot be excluded for the reported event-Multiple sclerosis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
From initial information received on 08/12/03 from a health care professional regarding an adverse event occurring in the USA, it was reported that a four month old female pt received her second dose of DT ADS PED USF, Lot # U0746AE, administered in the left thigh and a dose of Pedvax (Lot # 0429N), administered in the right thigh on 08/11/03 at 11:15AM. The routes of administration were not reported. Tylenol was given prior to vaccination. Immediately following injection, the pt experienced excessive crying, which lasted for two hours. One day later, the pt vomited. There was no redness, swelling or warmth noted at the site. Reportedly, the pt has not recovered from these events.
Developed numbness and burning to left arm.  Had tingling on left side of face.  Given Benadryl 25 mg PO and sent to emergency room.
Patient called to the pharmacy to say that she developed pain in her arm that spread down to her arm.
This case was reported by a consumer via call center representative and described the occurrence of fainting in a 64-year-old female patient who received SHINGRIX for prophylaxis. On 1st June 2018, the patient received the 1st dose of SHINGRIX. On 1st June 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. In June 2018, the patient experienced woozy, disorientation, feeling unwell, groin pain, pain upon movement, heaviness in limbs and fall. On an unknown date, the patient experienced fainting. On 6th June 2018, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the fainting, woozy, disorientation, feeling unwell, groin pain, pain upon movement, heaviness in limbs and fall were unknown. It was unknown if the reporter considered the fainting, pain in arm, woozy, disorientation, feeling unwell, groin pain, pain upon movement, heaviness in limbs and fall to be related to SHINGRIX. Additional details were provided as follows: The patient was already aware of the sore arm and feeling unwell after vaccination with SHINGRIX but the patient's arm became more and more sore as the day and evening progressed. The patient was so painful once she returned for the night that the blanket's touch caused pain. At 3:00 am, after using the bathroom, the patient felt very woozy and was unable to get to the bed and fainted landing very hard on the carpet. The arm of the patient was extremely sore and felt like a dead weight. The patient was totally disoriented and feeling generally unwell, the patient's husband helped her to be back to bed. The next morning, the result of the fall was that the patient's right groin was sore enough that walking was extremely painful. The pain in patient's arm gradually subsided and was fully resolved. The patient's groin did not start feeling better till 5th June 2018. The patient notified her primary care physician the advised to contact GlaxoSmithKline and also to advised to wait for six months (rather than the two suggested by the pharmacy) to get the second dose. The patient was not looking forward to the second dose based upon what she experienced.
I was exposed on 01/01/2023 to the COVID-19 two days later I began to feel achy and had the sniffles the next morning I took a COVID-19 test and it was positive and took and additional test which was also positive. This was verified by the clinic. I took TYLENOL cold and flu and isolated at home. At the current date I am still testing positive but feeling much better.
(R) arm itchy. (-) SOB. Erythema 5 cm (R) arm. Swelling 10 cm (R) arm.
Left upper arm with (4 1/2" X 3") hot, red and raised lesion around DTAP site.
Felt feverish at 9:00 p.m. Friday evening after the shot that morning. Awoke 4:00 a.m. with fever that felt like I had been skinned alive and then broiled. My skin prickled with heat. I have never felt that kind of "fever" before. Temp reached 100.2 at most during Saturday. Fever continued until late Saturday night. Joints stiff especially hands and hips. Sore upper arm and  a lump developed. Slept most of Saturday and all Saturday night. Awoke Sunday feeling better, no fever, but tired. Monday I was fine.
Partial dose of 0.3ml as 2nd dose; 1st shot of Pfizer and second shot of Moderna COVID 19 Vaccine; A spontaneous report was received from a other health professional (nurse) concerning a 80-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273), received 1st shot of Pfizer and was given 2nd shot of Moderna COVID vaccine which was partial dose of 0.3ml.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, the patient received the first dose of Pfizer.   On 19 Feb 2021, the patient received their doses of mRNA-1273 (041L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 19 Feb 2021, patient received 1st shot of Pfizer and was given 2nd shot of Moderna COVID vaccine which was partial dose of 0.3ml.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of event patient received 1st shot of Pfizer and was given 2nd shot of Moderna COVID vaccine which was partial dose of 0.3ml was considered resolved.; Reporter's Comments: This report refers to a case of under dose, wrong product administered for mRNA-1273, lot # 041L20A with no associated AEs.
Information has been received from a company representative's friend referring to his or her approximately 15 year old daughter. The patient was not pregnant. There was no pertinent medical history and drug reactions or allergies. On unknown dates, the patient was vaccinated with first and second doses of GARDASIL or GARDASIL 9 (the vaccine was not confirmed by the reporter) (both lot number, expiration date and route were unknown, 0.5 ml). There was no adverse events with the first or second shot of the vaccine. On 12-FEB-2016 the patient was vaccinated with the third dose of GARDASIL or GARDASIL 9 (lot number, expiration date and route were unknown, 0.5 ml). Concomitant medications were unspecified. Later on 12-FEB-2016, the patient broke out in a rash. On 13-FEB-2016 (the following day), the rash was gone. But on 14-FEB-2016, the patient broke out in rash again from head to toe. The patient was planning on going to visit the doctor on 15-FEB-2015. No treatment was given for the event. The outcome of the event "rash from head to toe" was unknown. The causality between the event and suspect therapy was unspecified. Additional information is not expected because there was no contact details.
This spontaneous report as received from a registered nurse refers to approximately 4 year old female child patient. On 31-MAR-2015 the patient was inadvertently vaccinated with PEDVAXHIB Lot J000564, expiration date 02-NOV-2015, 0.5 ml once, intramuscularly instead of ACTHIB (manufacturer unspecified). The patient was not treated for the event. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
About 2 hours after vaccination, patient reported headache and numbness/pain in right arm. Blood pressure elevated to 254/110. Patient also described white " floaters" in view and shortness of breath. Patient also had anxiety and tension.
mom called on 8NOV96 stating pt was taken to on 7NOV96 w/febrile szz;states fever 102-103 while taking APAP & Ibuprofen;Blood & urine collected;mom states pt was takne to MD & was told has a sore throat w/pus on tonsils;
The day after vaccination I had significant headache.. I have measured my blood pressure and it showed 200/107.. My usual blood pressure baseline at that time was ~130/~87
This spontaneous case reported by a consumer, describes the occurrence of illness (sick) and asthenia (no energy/laid in bed/could not get out of bed) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 024M20A and 041L20A) for COVID-19 immunization. Concurrent medical conditions included immunocompromised. On Jan 22, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 17, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 17, 2021, patient experienced illness (sick) and asthenia (no energy/laid in bed/could not get out of bed). On Feb 18, 2021, illness (sick) and asthenia (no energy/laid in bed/could not get out of bed) resolved. No concomitant medication or treatment information provided.
Parents noticed warm, red area at injection site around 8:00 pm 7/5/2018. Parent called office today because area had increased to half dollar size and seemed tender. No fever or streaking. Will monitor and follow-up as needed.
A report was received from a health care professional on 2/24/04 concerning up to 8 vaccinees under 4 years of age and of unknown gender who inadvertently received a dose of Fluvirin vaccine on an unreported day in December 2003. On an unspecified day in December 2003, up to 8 vaccinees were inadvertently administered Fluvirin. The outcome of the event was not reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 3/22/04: Further information was received from a health care professional indicating that the vaccinee was a 47 month old male who inadvertently received 0.5ml Fluvirin on 12/18/03. No adverse event were reported at the time of the event. No follow up pending. All information received.
Per EMS report, within 15-minutes of vaccination, patient underwent an anaphylactic reaction. Patient's care was managed on site.
Patient states his throat swelled up the evening following his immunization. He reports he did not seek medical treatment for it. Also he attributes a long-standing rash on his hands to the vaccination. He went to his primary care physician about the rash who told the patient he did not believe it to be due to the immunization.
Information has been received from a physician concerning a 9-week-old male who on 10-SEP-2007 was vaccinated with a dose of Rotateq. Concomitant therapy included Pediarix, Prevnar and PedvaxHib (manufacturer unknown). On 14-SEP-2007, the infant experienced "horrible diarrhea." The infant had diarrhea 15 times per day. On 17-Sep-2007, the infant was admitted to the hospital and was positive for rotavirus.  The outcome was not reported. This is one of several reports by the same reporter. Additional information has been requested.
was given the Adjuvant only; was given the Adjuvant only; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2022, the patient received Shingrix. In December 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK receipt date: 12-JAN-2023 Reporter's comment: The pharmacist reported that a patient was given the adjuvant portion of the Shingrix vaccine only. This incident happened last month. The reporter did not have further details. The reporter did not consent to follow-up.  Additional Supportive Information: The patient was given the adjuvant portion of the Shingrix vaccine only, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered.
Onset of warmth, redness, tenderness and swelling about 48 hours after receiving vaccine. It ultimately lasted for around a couple of weeks. No treatment was given other than the patient iced the area to make it more comfortable.
On 2/4 I started having chest pain and bad heart palpitations.  I went to the ER.  They did testing and prescribed matropadol.
Pt developed headache, fatigue, feverish feeling on 9-15-12 with onset of stabbing pain back of neck and rash on (L) face (mandibular area) to (L) ear on 9-19-12. Exam on 9-21-12: classic papulovesicular lesions of herpes Zoster.
Fever (101.2), Chills,  sweating, severe head ache, muscle aches, trouble walking (very fatigued).
Immediately before the vaccination, patient things happened: intense screaming (first minute), facial expression of extreme fear or pain, his back arched, his eyes rolled upward (screaming ended abruptly at this time), he passed lost consciousness, and he began twitching.  I had no knowledge of seizures at that time, and because doctors insisted that vaccines were safe, I never considered the possibility that there could be something wrong.  I thought he just wore himself out crying and fell asleep.    The next morning, my baby who was usually happy and eager to nurse and play, was stiff and unresponsive.  He made no eye-contact, didn't seem to remember how to nurse, and didn't even seem to recognize me.  Before the vaccine, he was trying to talk.  Now, there was no attempt at speech.  He went from being an extremely intelligent baby to a disabled child within seconds.  Because I believed that the vaccines were safe, I continued to allow him to receive all of his vaccines.  Every time he got another one, he got worse.  For a month after his 4-year-old vaccines, he screamed intensely, destroyed things, and hurt people.  It was several years before I heard my son speak in a way that was meaningful.  Now, at the age of 7 yrs, he has been diagnosed with PDD-NOS, Bipolar Disorder, ADHD, Sensory Integration Dysfunction, Auditory Processing Disorder, and learning disabilities.  Doctors tell me that no matter what we do, he we will never see the child that we had before vaccines.  He can get better if we really work at it, but he will never be the child he was.  Nurse follow up on 06/10/04 states: "Complete."  As per annual follow up report: he has not had a complet recovery. He still has learning disabilities, Bipolar disorder, and lots of food allergies.
Pfizer vaccine administered 8/25/2021 at pharmacy at approximately 5:00 p.m. At approximately 5:30 p.m. on 8/25/2021, while still sitting inside pharmacy, I noticed redness on the inside of both arms, then the redness turned into small, red, raised bumps on both arms, top of each hand, and each finger. I notified the pharmacist who adminstered the vaccine. Her response was simply "do you need to go to urgent care?" I did not go to urgent care, but instead went home. Within a hour the raised, red bumps began to itch. The itching became intense an hour later. The bumps, redness and itching, continued from 8/25/21 to 9/06/2021. On 9/8/2021, areas around both wrists, and between each finger started to itch, with a few red bumps appearing. On 9/7/2021, I contacted doctor's office to inform him of my reaction to the vaccine. I was informed by the on-call nurse, that the doctor would not be in the office until 9/15/2021. I contacted doctor's office to add my immediate reaction to the Pfizer vaccine to my medical records. As of the date I am completing this form (9/9/21 @ 7:30 p.m.) I am experiencing only minor itching on both hands.
Pt was feeling well when he left the office, he went home, did not eat lunch, went to swimming pool, felt faint and fell & hit face. Temperature outside near 100 degrees.
Pt. started to have to exhibit chest pain and breathing, rapid pulse was 110.  911 was called for further evaluation.  EMT took EKG.  Normal sinus rhythm. Pt. stated the chest pain has subsided.  Pt. refused to go to emergency for further evaluation
On Oct 12 (5-6pm) left arm started twitching and numbness; especially on the hand/fingertips. Will follow-up with neurologist on 10/16. Today, symptoms are about the same and no other symptoms.
The wrong vaccine was given to a 4month old child, child is fine no reaction parent notified. Kinirix was given
No adverse event. During a mass vaccine clinic this patient, who is 13 yrs old, was given a Pfizer Vaccine Mother brought pt for vaccine. Mother reports no adverse event. She was notified that a second dose will need to be delayed until EUA is released for his age group (vaccine given out of age limit) (No Adverse Event) No Adverse Event. Vaccine given out of age limit.
swelling and numbness to lips, Benadryl 50mg administered. Patient waited in clinic 1 hour after vaccination administration
received only half formulation of engerix; Engerix B pediatric to adult patient; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 24-year-old male patient who received HBV (Engerix B pediatric) (batch number 7574E, expiry date 29th December 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th June 2022, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 6th June 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were 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: 06-Jun-2022 Reporter's Comments: Pharmacist reported a maladministration of engerix-b where a patient received only half formulation of Engerix-B The reporter consent to follow up. Additional Supportive Information: The adult patient received Engerix B pediatric, which led to underdose and adult use of a child product.
Patient left clinic after receiving COVID vaccine and waiting 15 min. but started to sneeze and become short of breath in her so she came back to the clinic. This RN had her sit down and evaluated vital signs. Employee called 911 for the ambulance. It was obvious with her breathing and stridor that she needed epinephrine; her epi pen was in her purse so this RN administered that one in left thigh at          4:59pm since . B/P 144/100 at that time. Within 5 minutes her breathing improved and sneezing stopped. B/P 134/84, Clear breath sounds, and resp rate WNL. AMR arrived and evaluated client. O2 saturation 98% on RA. Replaced her epi pen with one from our clinic. She was taken to the hospital for evaluation.
After ~5 minutes the patient got up and said he was feeling dizzy. We ran out and patient collapsed. They never lost consciousness, but were dizzy, pale, and sweating. We called 911. He started to feel better; however, paramedics took him away.
Noticed increased overall health decline of existing conditions in mid-July 2022.  Increase in number of Left Hemiplegic Events resulting in paralysis of left side - events lasting longer.  Inability for existing medications and procedures to control conditions.  New medications to try to address conditions.  Put on Domperidone (10mg - 4x per day) Linzess (72MG CAP ALLE (2 capsules in AM), Vyepti Infusions (every 90 days -  300 mg/ml Vial)