chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Abdominal pain; chills; no nausea, vomiting; diarrhea or fever
It's zoster with ocular involvement; Shingles; blistering rash on her forehead; nerve-palsy; This case was reported by a physician via sales rep and described the occurrence of ophthalmic herpes zoster in a 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis.   On 20th August 2020, the patient received Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced palsy (serious criteria GSK medically significant). On 23rd August 2020, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), shingles and blistery rash. The patient was treated with antivirals nos. On an unknown date, the outcome of the ophthalmic herpes zoster, palsy, shingles and blistery rash were unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster, palsy, shingles and blistery rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was seronegative, had a history of rheumatoid arthritis but was not on immunosuppressive medication. After receiving Shingrix, the patient had blistering rash on her forehead. On 27th August 2020, the patient was diagnosed with shingles. It was zoster with ocular involvement. The patient was on oral and topical antivirals and had nerve-palsy presumed to be from the herpes zoster. The reporter consented to follow up. This was 1 of 3 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020178097:same reporter US-GLAXOSMITHKLINE-US2020178099:same reporter
Large local reaction; red, swollen. about baseball size in width. patients mother took a picture and showed the provider. appears to be the width of his deltoid. stayed about 7 days that way. no system reaction.
medical assistant gave 7 year old patient Pentacel, no AE; medical assistant gave 7 year old patient IPOL and Pentacel, no AE; Initial information received on 26-Aug-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a seven years old female patient who received vaccines IPV (VERO) [IPOL] (lot number and Exp. Date not reported) and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot U6208AG, Exp. Date 11-Nov-2020), on 26-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to  inappropriate age at vaccine administration and extra dose administered.  It was reported that the medical assistant gave 7 year old patient IPOL and Pentacel .   At the time of reporting no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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.  Information on the batch number was requested for Ipol.   List of documents held by sender: none.
vasculitis fingers, toes, nose, facial rash labs drawn to rule out systemic vasculitis
Started with watery eyes and runny nose. Face started to rash and swell. Appetite and fluids decreased to nothing.  fever spiked in the night. Rash spread throughout the body by next morning and temperature rose. Continues to refuse food and beverages. Brought to ER. Did blood work strep test influenza test. All labs normal and all tests negative. Child is continuing with poor appetite. Still has rash on day 3 and still low grade temp.
Had 1 episode of gasping for breath lasting 3 seconds, another one 5 minutes later lasting 3 seconds. Parents brought him back to office, was evaluated with no acute findings or respiratory symptoms. Three hours later at home a another episode lasting 5 seconds, lips turned purple, and was taken to ER. When arrived at ER, had another episode (4 total) lasting 2 seconds. On exam in ER, had hives on face, back, neck, and was wheezing. CXR showed reactive airway findings. Given steroids and Benadryl, observed and sent home four hours later with symptoms resolved. Mom denies any new foods or milk given that day.
Sore arm; It was so bad that she couldn't even put deodorant on; Upper arm was also swollen; Couldn't raise her arm; could hardly straighten her arm; Sinuses also hurt and this pain comes and goes; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021. The most recent information was received on 26-Apr-2021 and was forwarded to Moderna on 26-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PAIN IN EXTREMITY (It was so bad that she couldn't even put deodorant on), PERIPHERAL SWELLING (Upper arm was also swollen), LIMB DISCOMFORT (Couldn't raise her arm) and LIMB DISCOMFORT (could hardly straighten her arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PAIN IN EXTREMITY (It was so bad that she couldn't even put deodorant on), PERIPHERAL SWELLING (Upper arm was also swollen), LIMB DISCOMFORT (Couldn't raise her arm), LIMB DISCOMFORT (could hardly straighten her arm) and SINUS PAIN (Sinuses also hurt and this pain comes and goes). At the time of the report, PAIN IN EXTREMITY (Sore arm), PAIN IN EXTREMITY (It was so bad that she couldn't even put deodorant on), PERIPHERAL SWELLING (Upper arm was also swollen), LIMB DISCOMFORT (Couldn't raise her arm), LIMB DISCOMFORT (could hardly straighten her arm) and SINUS PAIN (Sinuses also hurt and this pain comes and goes) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Updated the outcome of the events ( Pain in extremity, Peripheral swelling, Limb discomfort, Sinus pain) from unknown to recovered.
From chart review: 15 minutes post injection VSS with no patient complaints. 45 minutes post injection patient developed whole body itching with erythematous skin. PIV started an normal saline administered. Given 125 mg IV solumedrol, pt started wheezing and took 2 puffs of inhaler (presume albuterol) without relief. Respiratory code called and transferred to ER. From ER note: "Found in respiratory distress, tripoding, mentating appropriately. Sats 100%. Lungs clear. Given epi 0.3mg- unfortunately this was given IV not IM. She developed emesis, improved after zofran and suctioning, was able to protect her airway through this episode. No benefit from the epi, and on reeval she had developed stridor. Next given racemicepi with BiPAP, benadryl 50mg IV, ativan 1mg and another epi 0.3mg now IM. Work of breathing worsened and lungs now severely diminished. Sats still 100%.  Decision made to intubate, which was done successfully as below, after which she was admitted to the ICU." Extubated 9/9 per chart review but remains in hospital.
Two inch diameter redness at injection site, left deltoid, otherwise patient is asymptomatic.
THe vanishpoint syringe retracted early. Could not tell if half of the vaccine was injected in the left arm. explained to patientin that case we sould inject again and he agreed. another dose was injected into the right arm.  Patient had nausea, fatigue and fever that night but felt better on Saturday 04/24/21.
Expired Menveo administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA418A, expiry date 31st October 2021) for prophylaxis.   On 21st February 2022, the patient received Menveo. On 21st February 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 22-AUG-2022 Reporter's Comment: The reporter stated that Menveo expired dose was administered to the patient. The reporter gave consent to follow up.
A week after receiving the covid vaccine I ovulated a full week early and became unexpectedly pregnant on or about March 18, 2021. This pregnancy resulted in a miscarriage on April 29, 2021.
Within one week of immunizations patient developed hip arthralgia, in (R) hip then both, crutches, seen 11/25/08 1st. Referred to Rheumatology at Med. Ctr.  1/21/09 Received Rheumatology clinic records of 12/3/08 FINAL DX: probable conversion reaction Records reveal patient had right hip pain x 3 weeks.  Seen by PCP & in ER for pain.  X-rays were WNL.  Now w/bilateral hip pain & unable to walk w/o crutches.  Sleep was disturbed.  Morning stiffness.  NSAIDS had not helped.  tx w/meds & PT
Administered vaccine to patient below recommended age population (under 18 years of age old); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered vaccine to patient below recommended age population (under 18 years of age old)) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered vaccine to patient below recommended age population (under 18 years of age old)). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered vaccine to patient below recommended age population (under 18 years of age old)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.
rash; This case was reported by a physician via call center representative and described the occurrence of facial rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced facial rash. On an unknown date, the outcome of the facial rash was unknown.   It was unknown if the reporter considered the facial rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine and now the patient experienced rash on the face.  This is 1 of 4 cases reported by same reporter.
Approximately 8 hours after receiving numerous vaccinations, I was attempted to be woke up by bunk mate who had felt me shaking down below. She said I was freezing cold, sweating and convulsions.
The day of the vaccine I felt sick in the evening by 6pm. I had a fever of 101.6 and I had chills and body aches. I had a headache coming on. The day after my temperature was 101 in the morning. The headache and and fatigue lasted three days. I got a rash on day four. My ankles were itchy at first. By lunchtime there was a rash across my back. A flat rash that spread up and down my back. It was different in spots like a round shape rash on my shoulder blade. My forearm and right knee also had a rash. The rash was redder and covered more of my body from my thighs up to my shoulder on the back. It was spreading very itchy for three days. I went to the doctor and started taking Allegra which improved the rash but it is still very itchy after 9 days.
Complaints of legs "giving way," feeling very hot for brief period of time and went away. No treatment needed.
Narrative: A 50yo female with PMH of Migraine, DVT, Bilateral Uveitis of eyes, Tinnitus, IBS, GERD. PTSD, Ankylosing Spondylitis, Rheumatoid Arthritis & Polyp of Colon. On March 15, 2022, physician reported the patient had a historical ADR of Pizer Covid-19 vaccine induced Skin Lesion. Patient's immunization record showed the first dose was administered on June 30, 2021 and the second dose was administered on July 21, 2021. NO other detailed information was provided regarding vaccine''s lot#, expiration date, which arm it was administered on , who administered the vaccine and where it was administered.
Extreme right sided neck pain. Still present and most problematic around occipital lymph node on the right side behind ear
This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On 8th June 2018, the patient received SHINGRIX. On 8th June 2018, less than a day after receiving SHINGRIX, the patient experienced sleepiness. In June 2018, the patient experienced fever, injection site pain and injection site erythema. On an unknown date, the outcome of the fever, injection site pain, sleepiness and injection site erythema were unknown. It was unknown if the reporter considered the fever, injection site pain, sleepiness and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient indicated that she received the SHINGRIX vaccine last Friday and less than a week after receiving SHINGRIX, the experienced a fever, a red mark at the injection site, and soreness at the injection site. The patient also stated that after the vaccination she went home and slept for the rest of the day. The reporter did not want to provide any additional details.
Mother reported on 12/7/00 by phone that pt's right leg was swollen. On the next well child exam on 2/7/01, mother reported that right leg was quite swollen for 3 days.
Immediate bilat legs tingling, 20 mins later face/head tingling, face red hot/flushed with lips ice cold -lasted 2hrs, day one to day three currently intermittent bilat top and bottom of feet sharp/stabbing pains, injection site muscle spasms constantly for 48+hrs, multiple episodes of nausea from day 1-3, woke up day after inj with head to toe aches/chills and fever x24+ hours, migraine started day two and current, fatigue- many naps, day 3- woke up with hot, redness from top of shoulder to elbow on inj site arm, also have a hx of pea sized scar tissue on inside of arm today skin is indented, painful and no scar tissue felt, difficulty raising L arm on day 3. Day 3- profuse sweating when still- had to change clothes as they were drenched. Spouse stated I smell different- like chemicals. When I bend down crown of head feels like it will explode.  I am completing this on day three unk if will have more issues. I am still currently having a migraine and body aches, redness  /hotness on L arm still present. Also filled out report for first vaccine-issues as well. Pls do note same vaccine lot #. After 1st vaccine did have 1 menses that was longer than usual by 4 days, heavier bleeding and increased clots.
Chills , joint pain , lightheaded , redness and swelling to left shoulder generalized malaise , bitter taste in mouth .  1/16/2021 discomfort to left side ; numbness as well .
AM following day of vax pt had partial sz in retrospect pt likely has sz disorder extending into neonatal period & now on Phenobarb
First symptoms experienced began  a few days later in the morning with skin sensitivity, it then turned into fatigue and a fever minutes later, I basically felt like I had the flu but was not not vomiting and had no diarrhea. I experienced one rather large and aggressive BM  and then that was over with.  I stayed home from work for 2 days and was exhausted. After those symptoms passed I began to feel strange as the weeks of February passed. I had thought as a full time student and full time employee that the lack of sunlight and socialization was causing some sort of seasonal depression. I noticed the severity of this around the weekend. I had become sensitive to loud noises and I did not really desire to be around ANYONE. During the last 14 day some new symptoms surfaced, I began to see rashes on my chest, nose, and scattered goosebumps that had no reason to be there. Ive been experiencing  some really difficult levels of anxiety- and I've had nothing to be anxious about- at least nothing thats out of the ordinary. It has effected my ability to sleep and I felt myself panicking  some days- I have had to go on Xynax daily to get through this. My skin has been itching me especially my head and calf areas. My eyes have been puffy and swollen some days and my hands have been quite cold during my evening classes where its difficult to complete my assignments on the computer. Ive also felt uncomfortably hot throughout the day and really thought there was something wrong so I schedule an appointment with my Hematologist. It was brought to my attention when I spoke with a friend that all of these symptoms were because of this vaccine. I HAD NO IDEA! Treatment will be through the use of various supplements
This spontaneous report as received from a physician in the format of a medical record refers to a patient of unknown age and gender. No medical history, concurrent conditions and concomitant medications were reported. Reportedly, PROQUAD was inferred to have experienced the following temperature excursions: 36.9 F for 10 minutes on 24-DEC-2016, at 00:31 hours; and 38.6 F for 20 minutes on 27-DEC-2016, at 07:51 hours. They were called out because of a digital data logger. On 30-DEC-2016, at 15:54 hours, the patient was vaccinated with the second, improperly stored, 0.5 ml dose of this vaccine (which had a lot # of M035143 with an expiration date of 30-JUN-2018), subcutaneously, in the left thigh, for prophylaxis. Despite this, no adverse symptoms were reported. All available medical records will be provided upon request. This is one of the several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA002579: US-009507513-1703USA011160: US-009507513-1703USA011161: US-009507513-1703USA010731: US-009507513-1703USA011158: US-009507513-1703USA011159.
Moderate to severe pain in large joints (elbows, primarily knees) and pain/extreme tightness in large muscles (thighs, hamstrings-also ACL of (L) knee, biceps) persistent full body aching with gradual let up over 4-5 days.
Slight-moderate dizziness; balance/equilibrium off; benefited by to holding or bracing while standing, turning, descending.   No other anaphylactic symptoms . Slight raised BP (153/84 vs normal 120s/70s.  More noticeable earlier AM 1st day after shot - but less noticeable later in day. Somewhat reduced in degree of dizziness 2nd AM but a bit more persistent through the AM.
fatigue, headache, muscle pain the evening of the injection.  Those symptoms subsided the next day. The second evening/night I experienced chills and diarrhea.  Those symptoms subsided as the day went on.
because leur-lock and needle disconnected from PFS; Pharmaceutical product complaint; Underdose/did not get full dose of vaccine; This non-serious case was reported by a physician via call center representative and described the occurrence of accidental underdose in a 4-year-old male patient who received MMR (Priorix) (batch number GX27P, expiry date 11-MAY-2024) and (batch number N94P2, expiry date 12-DEC-2025) for prophylaxis. This case was associated with a product complaint.   On 31-AUG-2023, the patient received Priorix. On 31-AUG-2023, an unknown time after receiving Priorix, the patient experienced accidental underdose (Verbatim: Underdose/did not get full dose of vaccine). On an unknown date, the patient experienced syringe issue (Verbatim: because leur-lock and needle disconnected from PFS) and pharmaceutical product complaint (Verbatim: Pharmaceutical product complaint).The outcome of the accidental underdose, syringe issue and pharmaceutical product complaint 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: 31-AUG-2023 The reporter requested data on re-vaccination of Priorix after patient received an underdose of Priorix, which led to accidental underdose. PQC (Pharmaceutical product complaint) filed because leur-lock and needle disconnected from PFS as nurse was administering the Priorix dose to patient and patient did not get full dose of vaccine. The reporter consented to follow up.
Within 2 days I couldn't move my left arm up or to the side without significant pain. Some pain at injection site, but the shoulder pain was the problem. Within a month I had pain when getting dressed and range of motion was decreasing.
inconsolable crying >40min in2-3hr time period;local swelling of both thighs @ inj sites;