chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A week later, I had an anaphylactic reaction to a kit kat bar. I had previously ate kit kats with no issue. I had to be intubated and hospitalized. After extubation, I continued to have anaphylaxis at least once a day with no correlation to what I was eating or drinking. I also began having a severe auto immune flare up with body pains in my legs, back, and stomach immobilizing me with generalized weakness.
Nausea, paleness, felt warm & very dry; c/o not being able to feel legs; rapid thready pulse; c/o weakness all over;
Information has been received from a nurse practitioner concerning a toddler female patient who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient developed shingles. Unspecified medical attention was sought. A product quality complaint was not involved. The reporter also mentioned a male patient who developed chickenpox post vaccination with varicella virus vaccine live (WAES #311USA01416). Additional information has been requested.
shingles; Information has been received from a lawyer regarding a case in litigation, referring to a patient of an unknown age and gender.  information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. In or about 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (route of administration, strength, dose, lot # and expiration date were not provided) by a pharmacist at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date (reported as subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation), the patient was treated by a healthcare provider due to shingles. It was reported that the patient would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of shingles was not recovered. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Within an hour of having shot arm became painful.  Took Advil, effective until Advil wore off.  Arm bad again, exercised last night.
A 12 year old young man received a 0.5 mg dose of KINRIX instead of a Tdap.
20 minutes, post vax, pt became dizzy, slightly nauseated and skin color was pale, fingers tingling, red hot. BP 139/80, P 76, no SOB. Benadryl 25mg po given and pt felt better after 10 minutes. At 14:40, 20 minutes after Benadryl, pt ready, no dizziness, no tingling and felt good. BP 130/80 and P 66.
Information has been received from a pharmacist referring to a patient of unknown age and gender. Pertinent medical history, drug reactions and allergies were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose and route of administration were not provided). No information regarding concomitant medications were reported. The second day after injection of ZOSTAVAX, the patient experienced a localized injection site reaction. The patient recovered from this event on an unknown date. Causality between the event and ZOSTAVAX was not provided. This is one of several reports from the same reporter. Additional information has been requested.
Vaccination give on 3/21/07 in deltoid.  Pt with what appears to be shingles Rt buttocks, swelling, erythema.
Per Dr.: Notified of immediate redness and swelling @ left thigh after injection of varicella.  On examination of left leg, noted 2-3 small 1 cm hives and surrounding redness and swelling @ right leg at MMR injection site as well.  No swelling @ mouth or problems breathing. Right leg with 8x6 cm redness and swelling,  Left leg with 8x8 cm redness and swelling. 12.5 mg of Benadryl give and ice packs placed. Rechecked at 5:35 PM, hives resolved, redness and swelling appear improved in both legs.  Child walking normally.  Mom advised to monitor closely and id comfortable with monitoring him at home.
patient received an expired dose of Adacel / no AE; Initial information received on 28-Feb-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves male patient of unknown age who was vaccinated with an expired vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number and Expiry date unknown) via unknown route in unknown administration site on an unknown date for Prophylactic vaccination (Expired product administered ).  Medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  It was an actual medication error case due to expired vaccine used (Expired product administered).  At a time of reporting no adverse event reported.  Information on the batch number was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
4YO administered Boostrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number YR7AA, expiry date 14th April 2024) for prophylaxis.   On 17th August 2022, the patient received Boostrix. On 17th August 2022, unknown after receiving Boostrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 17-AUG-2022 Reporter's comment: The registered nurse reported that the four year old patient received a dose of Boostrix. The reporter consented to follow up. Additional Supportive Information: The patient received a dose of Boostrix at inappropriate age, which led to inappropriate age at vaccine administration.
Left lateral upper arm - erythematous circular patch at the injection site, warm and slightly tender to touch, site induration of 2x2.5cm, symptom started 10days ago.
Hives on arm shot received on, flu-like symptoms, 102 fever, painful body aches, dizziness, little urination, nausea, swollen sore hot arm.
This case was reported by a consumer and described the occurrence of injection site reaction in a female patient who received SHINGRIX. Previously administered products included ZOSTAVAX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown. It was unknown if the reporter considered the injection site reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter was at a public Food and Drug Administration (FDA) hearing on the time of reporting and one of the speakers noted that the patient had ZOSTAVAX previously and after the a dose of SHINGRIX injection developed a fairly significant injection site reaction (she said half her upper arm). She saw from the label that swelling and redness was quite common. She actually read the label very carefully and noted that patients with ZOSTAVAX were excluded from the trials, and wanted to know if there was any data on risk of such reactions in patients with previous ZOSTAVAX (as Centers for Disease Control (CDC) does recommend SHINGRIX even with prior ZOSTAVAX). She also wanted to know about getting the 2nd injection.
Pain & swelling in left wrist with limited range of motion since IM injection in left deltoid
Less than 5 min post vaccination pt became unconscious, rigid and incontinent of urine. Assisted to floor, regained consciousness, felt weak and no memory of event, transported to hospital for eval by paramedics. Mom reports was fine with no further events, tests negative and sent home. 6 days post vaccination child appears to have recovered without issues.
shivering; headache; nausea; sore arm; touch sensitivity increased; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th April 2019, the patient received the 1st dose of Shingrix. On 10th April 2019, less than a day after receiving Shingrix, the patient experienced pain in arm and touch sensitivity increased. On 11th April 2019, the patient experienced headache, nausea and shivering. On 11th April 2019, the outcome of the shivering was recovered/resolved. On an unknown date, the outcome of the pain in arm, touch sensitivity increased, headache and nausea were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, touch sensitivity increased, headache, nausea and shivering to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose and within 2 hours her arm became very sore. She could not even touch it without pain. It was still sore at the time of reporting. On 11th April 2019 at 1:00, she experienced shivering, a headache and nausea.  The shivering resolved after 5 hours. The headache was better but was still present. The nausea was also better but not completely resolved.  The reporter did not consent to follow up.
Severe Headache, stomach cramps, and body aches with nausea, diarrhea, dizziness, weakness, chills, photophobia, and urethritis.
Client had painful arm starting Sat evening it continued to hurt Sunday and Monday very stiff at the shoulder  dr thinks he has bursitis and the shot could have been given to high.
Sharp pains in the upper chest; This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (Sharp pains in the upper chest) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy. Concomitant products included BUPROPION, ROSUVASTATIN CALCIUM, ACETYLSALICYLIC ACID (ASPIRIN 81), CETIRIZINE and SAMBUCUS NIGRA FRUIT (ELDERBERRY [SAMBUCUS NIGRA FRUIT]) for an unknown indication.   On 15-May-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021 at 8:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Sharp pains in the upper chest). At the time of the report, CHEST PAIN (Sharp pains in the upper chest) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. Allergies to medications and other products was reported   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Significant follow up and received concomitants; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
3rd dose not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 88-year-old male patient who received HAB (Twinrix) 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 (1st dose received on an unknown date) and Twinrix (2nd dose received on an date more than 12 months ago).   On an unknown date, the patient did not receive the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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: 21-SEP-2022 Reporter's Comments:  Reported stated that a patient still did not receive the third dose of Twinrix. Reporter consented to follow up.  Additional Supportive Information: Till the time of reporting, the patient did not receive 3rd dose of Twinrix, which led to incomplete course of vaccination.
No additional AE reported; Nurse reports PROQUAD that experienced temperature excursion over the weekend was administered to a patient; This spontaneous report has been received from a registered nurse regarding patient of unknown age and gender. Patient's pertinent medical history, drug reactions and allergies and concomitant medication were unknown by reporter.  On 13-FEB-2023, the patient was vaccinated with an improper storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (albumin status rHA), subcutaneous injection, administered as prophylaxis, (strength, dose, route of administration, anatomical location; lot number W024547 had been verified to be valid; expiration date was reported and established as 31-JAN-2024) (product storage error).  The excursion occurred with a temperature of -10 °C up to 8 °C (-9.91 C) for 1 hour and 40 minutes and 0 seconds. There was no previous temperature excursion reported. No additional adverse event provided (no adverse event).
Patient was brought to the emergency room for altered mental status.  Patient was admitted to the hospital with bilateral Covid pneumonia and hypoxemia.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 09-May-2014 the patient was vaccianted with (Oka/Merck) VARIVAX. Past medical history and concomitnat medications were not reported. The physician stated that an unspecified number of patients were vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX, Lot # Joo5689 (expiration date: 07-MAY-2015). No adverse effects reported. No additional information to report. This is one of several reprots received from the same reporter. THis case is linked to 1411USA000763, 1411USA004435, 1411USA004436, 1411USA004438, 1411USA004439, 1411USA004440, 1411USA004694, 1411USA004695, 1411USA004696, 1411USA004696, 1411USA004700, 1411USA004701, and 1411USA009185. Addtional ifnormation has been requested.
Nine hours after immunization, mom reported that patient complained of tenderness of left deltoid area; was red about 4cm diameter. The morning of 9/28/02, area about 6-7cm diameter, red, hard, warm. Measured today 9/30/02 by school nurse: 3"x2.5", erythema and induration. Pain on palpitation. Afebrile.
significant vaginal bleeding with large orange size clots for 12hrs.  stopped by taking megace 40mg bid.
One hour after shot, my throat closed up.  I did have EMTs come and check me out and I am OK.  I have had this happen a few times ..last time was 2 years ago.  So I do not know for sure if it was the shot, but wanted to report it. I will not be getting the second shot.
Information has been received from a physician concerning a female patient who was vaccinated subcutaneously with a 0.65 ml single dose of Zostavax. Subsequently the patient returned to the office with a rash. The location or type of rash was not reported. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. 06/22/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Initial and follow up information has been received from a physician concerning a 63 year old female patient with no known allergies and unspecified medical history, who on 20-MAR-2007 was vaccinated subcutaneously with a 0.65 ml single first dose of ZOSTAVAX (Oka/Merck) (lot # 656394/0162U). Concomitant therapy included amitriptyline hydrochloride (MSD), NEXIUM, PREMARIN, SYNTHROID and MOBIC. There was no illness at the time of vaccination. On 22-MAR-2007 the patient returned to the office with what the physician considered to be a minor reaction. The patient developed an itchy rash. The patient developed papules on her face, chest and back. The patient was treated with prednisone for one week. It was also noted "new medication added to regimen for many months". There were no other significant complaints. No lab tests were performed. One week after treatment, on approximately 29-MAR-2007 the patient recovered. No product quality complaint was involved. Additional information is not expected.
Subsequent to receiving one dose of varicella virus vaccine live, the pt experienced a varicella like rash with 2-3 lesions at a time at random sites on the body. The lesions resolved and reappeared elsewhere. They were relatively dry and were not weeping. The pts rash persists.
body aches; chills; This is a spontaneous report from Pfizer. A contactable Consumer reported for a 69-Years-old female patient that: who received bnt162b2 (BNT162B2) solution for injection, via an unspecified route of administration on an unspecified date aa unknown dose single dose for covid-19 immunisation; palbociclib (IBRANCE), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unknown single for an unspecified indication. The patient medical history and concomitant medications were not reported. On an unspecified date the caregiver verbally stated that the patient had body aches and chills after getting the Covid Vaccine. Outcome of thew events was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
No complications, estimated date of delivery 4/06/2016, birth weight 6 lb 15 oz. Baby born with MTHFR heterozygous gene mutation of C677T type; severe tongue-tie and lip-tie and consequent inability to breastfeed. Symptoms included ceaseless crying, starving. Undernourishment was detected by pediatrician at two months old (June 2016) and doctor prescribed formula supplementation to breastfeeding and pumping breast milk. Most symptoms such as crying and gas remained undetected until baby reached six months of age (October 2016), when newly hired lactation consultant diagnosed tongue tie and lip tie and recommended courses of therapy: craniosacral therapy, chiropractic, and also child development assistance and therapy for baby's related sensory processing disorder and consequent discomfort and pain.
Information had been received on 14-JUN-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a male patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 14-AUG-2013, at a medical group facility as recommended for routine adult health maintenance for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of Herpes Zoster. On or about 29-JUN-2015, the male patient was treated at a medical group facility for a vesicular outbreak that was diagnosed as Herpes Zoster (shingles).  The male patient has been prescribed Gabapentin for management of his ongoing symptoms.  As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Patient developed pain at site in right upper arm, associated with redness. Redness lasted approximately 2 days, pain persisted approximately 14 d.
Information has been received from a pharmacy technician concerning a female who in approximately June 2007, was vaccinated with a dose of Zostavax (Oka/Merck).  In approximately July 2007, the patient developed a widespread rash that was red, itchy and bumpy.  The rash had been persistent, with newly developed lesions in a widespread distribution.  The patient was examined by her unspecified physician and was treated with an antihistamine.  The symptoms have not improved thus far.  It was noted that the patient was scheduled for a dermatologic consult in the near future.  There was no product quality complaint.  Additional information has been received from a pharmacy technician indicated that the patient was sent to a dermatologist and was given antihistamine.  The rash cleared two weeks after the original adverse event was filed.  No additional information was provided.  Follow-up information received indicated that there was no additional information in regards to this case.  No additional information is expected.
On Friday May 9th I received a combination shot of TDAP. Saturday May 10th I woke up with right lymph gland swollen larger than a lemon. Did not hurt for a few days. Then about the third day it swelled even worse. I started to experience a terrible pain that wouldn't let up. Pain that ran all the way under my ear. The whole side of my head swelled, even the back of my neck. I ached all over. I have never had worse pain - ever. Could not open my mouth to eat for several days. Could not work and stayed in bed for most of those days. Today is the 27th May and today is the first time I've been out of the house except to go to the ER. I finally went to the ER on 05-18-08. Dr didn't know for sure the cause but I do. Nothing had changed, nothing out of the ordinary. Nothing new except the shot. Dr put me or LORTAB 5/500 mg and AUGMENTIN 875 mg. Tried to use warm moist heat. 9 days after my visit to the ER, I'm better, but still not completely over it.
Awoke at 1:34 AM and my left foot hurt.  I had a marble-size lump and a few small lumps on the vertical bone above my heel that were tender to the touch.  My foot on top was slightly swollen and shiny and red on the side and both were tender to the touch.  I massaged my foot and went back to sleep.  When I awoke the marble-sized lump was much smaller.  I got up, ate, and in the afternoon after research, I realized it was gout and I had tophi for the first time ever.  I had my first gout flare in November 2003 without tophi, and never had another flare until 2/14/2021!  I walked and suddenly my Achilles? tendon hurt and my heel hurt a little.   I took 2 Colchicine and took one more an hour later.  It seemed much better and didn?t hurt but some of the pain returned.  I couldn?t sleep until 4:05 AM and awoke around 6 according to my Fitbit watch.  I contacted my doctor and he said to take one Colchicine every day until the pain is gone.