chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have, started on May 31, 2021 had very bad hive rash that flared up and traveled all over my body. I have also been experiencing worse than ever asthma attacks worse than ever, where my face gets very bright red, lips turn blue and can hardly breath. When I take my inhaler, and usually after about 15 minutes it calms down. I get headaches, get dizzy often and just feel very fatigued. I am also flushed in the face a lot, my lungs hurt like there is a lot of pressure on them and I also experience cold sweats. I contacted my DR on June 5th 2021 and I could not get in to see my DR so I went to Urgent care on June 6th 2021. They prescribed me with prednisone, a steroid to control the rash and asthma attacks. This did help a bit and then upon ending the steroid, when getting down to two per day, the symptoms came back. At that point I visited my PCD, on Tuesday June 15th 2021. She put me back on the steroids, 3x daily and that did help, she put me on those until I could see my pulmonologist. On Thursday June 17th 2021 and they took me off the steroids, and said there is nothing they can do. I have an appointment with an allergist and a dermatologist in August 2021, which is the earliest they could get me in.
In 2 years 9 months since my last colonoscopy I developed a 22mm Adenocarcinoma polyp in my rectum.  Treatment will be 5 weeks of chemo & radiation therapy followed with surgery to remove rectum and anus. Installing a colonostomy bag.
After my vaccine I experienced soreness to my left arm with light headiness. My symptoms resolved within a few days.
Adverse event: Acute pulmonary embolism, Demand Ischemia, Prolonged Ptt, Thrombocytopenia. Treatment: Eliquis 6 months with follow up with hematology, pulmonolist, and cardiologist
mom reports local redness w/hives on rt arm @ the site of Hep B inject;
Received booster on 5/20/22 at 1300h. Almost immediately experienced stiffness and pain at the injection site. Around 9 p.m. developed low grade fever and slight headache.  By 1 am I experienced high fever (105.3), chills, nausea, severe body ache and headache. I used cold compress and took ibuprofen 600 mg to relieve the fever. It subsequently went down to about 102F. By 10 am, I felt very weak and my fever rose to 104F. I took  ibuprofen 300 mg, and called the doctor. I was seen at 1130h and the NP registered a fever of 103.2. She also found that my heart rate was very high. I was administered IV saline at the office and kept for observation. By 1300h I felt better and asked to be discharged. The NP advised me to visit the ER if my fever went above 103F or if my heart rate was above 120, and to stay well hydrated. She also performed a PCR test for Covid-19 as there have been several positive cases in the area. After I returned home, my fever lingered between 100-103F. I took another ibuprofen 600 mg as I had chills, body ache and headache. At 1 am on 5/22/22, my fever broke, I was drenched in sweat. After that my temperature started normal, my body ache was resolved. As of 5/22/22 2315h the only symptoms that remain are moderately painful headache and a slightly racy pulse,  feelings of nausea, and a poor taste in my mouth.
Pt states he felt some tingling in his hands and feet along with dizziness after 2nd dose of HPV vaccine. Repeat vitals are stable. As a precaution, pt was sent to the ER for further monitoring. BP is 110/72, pulse 77 and normal, spo2 is 97% on room air. The patient was monitored for 20 minutes prior to instruction to go to the ER for further monitoring. Mom in agreement. Duration of visit was 20 minutes spent monitoring, counseling, answering questions and performing a physical exam.   The patient was sent to ER for monitoring and sent home the same day and diagnosed with "mild reaction to HPV vaccine " per patient case note.
Information has been received from a physician concerning a patient with no known history who was vaccinated with a dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 2/25/03 the patient experienced stridor, a croupy cough, facial erythema and mild swelling. The patient's lungs were clear. The patient was given epinephrine 1:1000, 0.1ml SC followed by a racemic epinephrine nebulizer treatment. The patient was also given diphenhydramine hcl and prednisolone sodium phosphate 22.5mg po. It was reported that these symptoms resolved in 15-20 minutes. She was observed in the office over the following 30 minutes and was then allowed to leave. Later that day, the patient developed wheezing requiring an ER visit for bronchodilator nebulizers. No other information was provided. Upon internal review, the patient's experienced was considered to be an other important medical event (OMIC). Additional information has been requested.
reoccurrence of the symptoms (second shingles outbreak) 2 months ago; lingering pain in her left side; since October 2020 she has had 2 massive shingles attacks; my eyeball looked like it was popping out; pain in her left eye; dizziness; vomiting; Zostavax given intramuscularly; This spontaneous report was received from a female consumer of unknown age reporting on herself. The patient's concurrent conditions included spinal operation, bone disorder and drug hypersensitivity. The patient's medical history, historical drugs and concomitant medications were not provided.  On an unknown date in 2009, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) along with sterile diluent, intramuscular (incorrect route of product administration) (dose, lot number and expiration date were not reported) for herpes zoster.        Since October 2020, the patient had experienced 2 episodes fo shingles (herpes zoster). The first outbreak occurred in October 2020, when the patient developed eye pain and that her eye was popping out (exophthalmos), vomiting and dizziness. The patient managed the outbreak with valacyclovir. Two months ago, in September 2021, the patient experienced a second outbreak of herpes zoster that was followed by a lingering pain, and once again, the patient treated the herpes zoster with valacyclovir.      The outcome of exophthalmos, vomiting, dizziness and eye pain was unknown. The outcome of the first outbreak of herpes zoster was reported as resolved on an unknown date. The outcome the second event of herpes zoster was reported as resolving. The outcome of pain was reported as not resolved. The causal relationship between the events and the vaccines were not reported.  Upon internal review, the event of exophthalmos was considered medically significant.
received Moderna Covid-19 Vaccine at the age of 14 years old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received Moderna Covid-19 Vaccine at the age of 14 years old) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received Moderna Covid-19 Vaccine at the age of 14 years old).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
administration of tenivac that was expired for 1 day with no adverse event; Initial information received on 29-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 56 years old male patient who was administered Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] that was expired for 1 day with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Influenza Vaccine Inact Split 4v (Fluzone Quadrivalent) for Prophylactic vaccination.  On 25-Sep-2023, the patient received 0.5 ml total (1 X) dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult Suspension for injection (lot number: U7183AA, Expiry date: 24-Sep-2023) (Frequency: Once, Strength: Standard) via intramuscular route in the left arm for prophylactic vaccination (Immunisation).  On 25-Sep-2023, the patient was administered Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] that was expired for 1 day with no adverse event (expired product administered) (Latency: same day).  It was reported, HCP called to report about the administration of TENIVAC that was expired for 1 day. No adverse reaction was reported by the patient.   Action taken: not applicable.  Outcome: Unknown   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 the 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.
This child had a 2 x 3-4 cm pink raised area on her upper right arm.
Felt "miserable". Fever, cold and hot flashes, headache, weak, and extreme sensitivity to arm the received the shot. Could not properly lift arm for 7 days.
My back and neck pain/stiffness is gone. I noticed this 2 hours after the vaccine. I have been taking ibuprofen for pain and inflammation. I did not take it the day before, nor the day of the vaccine, to prevent any reactions. I usually wake up daily with pain, neck stiffness, and a pounding head, and a feeling of my head about to explode. Today I did not have any of that. I believe this experience was worth noting. I battle inflammation and its symptoms daily, so I am aware of anything new going on with my body. This happens to be a new, great symptom I noticed.  I am not in the medical field, but I don't think this is a random coincidence.
Moderate intermittent muscle fatigue in arms, legs and fingers since the day after the injection.
pt fainted,  the pt was sitting in the chair and fell off. the pt immediately woke up after falling. the pt said he was ok. he said he just wanted to lie down. he did so for about 10 minutes and then sat back up in the chair. we said he was feeling ok.  he said he fainted because he was nervous. he did not think that it was because of the covid shot.
Eight days after inoculation, around 5:00 pm I noticed a red welt to the right and slightly below the injection site.  I still have the red welt today.  It does not hurt, but is tender to the touch and somewhat raised.  For the initial 7 days post-vaccine there was no reaction whatsoever, not even a tiny red mark.
She could not breathe; she broke out; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (She could not breathe) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bronchitis. Concurrent medical conditions included Asthma.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (She could not breathe) (seriousness criterion medically significant) and VACCINATION COMPLICATION (she broke out). On 07-Apr-2021, DYSPNOEA (She could not breathe) had resolved. At the time of the report, VACCINATION COMPLICATION (she broke out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified medications used for asthma and bronchitis.  Treatment of these events were not reported.  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Patient complaining of arm and shoulder pain a week after the immunization. Patient say pharmacist hand slipped off syringe and he was punched in the arm.
RIGORS/CHILLS; VOMITING; PAIN/GENERALIZED ACHING. Information regarding Flumist (2003-2004 formula) nasal solution (frozen)) was received from a 45 year old female who experienced chills, vomiting and body aches, approximately 2.5 hours after administration. At 45 years of age, the patient received a dose on 17-Dec-2003. On 17-Dec-2003, approximately 2.5 hrs after Flumist administrtion, the patient experienced chills, vomiting and body aches. All symptoms were resolved at the time of this report. No additional information was available at the time of this report.
11:09 am.  During the injection of the vaccine, patient heard a sound like "pfft"  and later noted a tiny drop of liquid by the vaccine site. Discussed with RN vaccinator.  He stated he didn't encounter any problems during injection.  Sound may have represented a loose connection between needle hub and syringe body.  No additional vaccine administered to patient.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 62-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (in January 2016). Previously administered products included ZOSTAVAX (received in October 2016) and SHINGRIX with an associated reaction of pyrexia (1st dose received on 26th September 2018 (refer case US2019GSK030794). On 18th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 18th January 2019, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, chills and sweating. On 9th February 2019, the patient experienced shingles, blister and pruritus. In February 2019, the patient experienced skin red, skin warm, skin irritation and scab. On an unknown date, the patient experienced exhaustion. The patient was treated with acyclovir. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the shingles, skin red, exhaustion, skin warm, blister and skin irritation were not recovered/not resolved and the outcome of the influenza-like symptoms, fever, chills, sweating and pruritus were recovered/resolved and the outcome of the scab was unknown. It was unknown if the reporter considered the shingles, influenza-like symptoms, fever, skin red, chills, exhaustion, sweating, skin warm, blister, skin irritation, pruritus and scab to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX in the left arm. Less than a day after vaccination with SHINGRIX, at 9:00 pm, the patient experienced flu-like symptoms which included sweating, fever and chills. Less than a month after vaccination, the patient was feeling exhausted after all of the other symptoms resolved but only for an evening. On 9th February 2019 on Sunday, 22 days after vaccination, the shingles blisters started appearing on chest and spread to both sides of neck over the next couple of days. On 10th February 2019 on Monday, the patient was diagnosed with shingles. The patient was prescribed with Acyclovir. The patient reported that, the itching was insane on the first day. At the time of reporting, she had the episodes of itching and then it stopped. Less than a month after vaccination, some of the blisters had scabbed over; some looked like white pustules and the skin around the blister were red, hot and irritated. The reporter consented to follow up. This case was linked with case US2019027673 (husband's case), reported by the same reporter.
Red fine rash on both thighs on injection areas. Intervention per mother to MD, Cortaid creme.
Arm extremely sore, could not lift it, next day at school became nauseated, picked up early, came home and went to sleep for remainder of the day and complained of stabbing pain in right hip, limping to get around.
This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced headache, diarrhea, vomiting, general body pain and sickness. On an unknown date, the outcome of the headache, diarrhea, vomiting and general body pain were unknown and the outcome of the sickness was recovered/resolved. It was unknown if the reporter considered the headache, diarrhea, vomiting, general body pain and sickness to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported, however it could be 75 or 76 years. The concomitant medication included Thyroid medication. The patient received the SHINGRIX vaccination approximately three months before the date of reporting. She reported that the next day after receiving the vaccine the patient experienced events. She was sick for three weeks. The reporter was angry and would not provide any additional information. The patient had denied permission to contact their physician.
This spontaneous report was received from a Nurse Practitioner, regarding several patients of unknown age and gender, with no pertinent medical history reported. The Nurse practitioner stated that several patients, throughout the year (2013) had come in late (vaccination dates not reported) for their third dose of GARDASIL vaccination, (lot number and expiration date not reported) (dose and route not specified). No adverse effects were reported. Additional information has been requested.
Information has been received from a medical assistant concerning a 62 year old female with penicillin allergy who on 14-JUL-2010 was vaccinated with ZOSTAVAX (Merck) 0.65ml S.Q. (therapy site unknown). Concomitant therapy included aspirin and other unspecified medications. On 14-JUL-2010 the patient developed redness, swelling, warmth and itching at the injection site an hour after administration. The patient saw a physician. At the time of this report, the patient had not recovered. Additional information has been requested.
Information has been received from a consumer reporting that her nephew now 30 month old male who in approximately 2006 was vaccinated with MMR II (dose and route not reported) when he was 12 months old. Subsequently, the patient developed autism 3 months after receiving the vaccine. The patient's autism persisted. The patient sought medical unspecified medical attention. Upon internal review, autism was determined to be another important medical event. Additional information is not expected.
Nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Gluten, latex, amitriptyline, prednisone.  Concurrent medical conditions included Drug allergy (Allergy to Amitriptyline), Drug allergy (Allergy to  prednisone), Drug allergy (Allergy of Gluten) and Latex allergy.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form once. On 01-May-2021, the patient experienced NAUSEA (Nausea). On 10-May-2021, NAUSEA (Nausea) had resolved.            Concomitant product use was not provided.  Treatment for the event is IV fluids due to dehydration.
This spontaneous report as received from a physician refers to a 14 year old male patient. On an unknown date the patient started therapy with of M-M-R II (route, dose, frequency and lot # not reported). It was reported that the patient was administered two doses of M-M-R II as indicated (on an unspecified dates) and subsequently had titers drawn on an unspecified date which came back negative for Rubella. The physician reported that the patient was administered then with the third dose of M-M-R II on an unspecified date because of this. The outcomes of the events and relatedness between the events and M-M-R II were not reported. Additional information is not expected as there is no consent to contact physician.
suspected vaccination failure/I had the shingles vaccine / got shingles; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Shingles vaccine and still got shingles. Follow-up would not be possible as no contact details available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
slight redness & warmth on upper arm, hardness to touch. Area is 60mmx60mm, child's temp is 98.9.   Examined in clinic- explained to mother she should take to physician for evaluation especially if worsening.
Vaccines were administered at 1350. Pt stated she was feeling dizzy. I placed the bench to 45 degrees and let her get comfortable. Pt leaned back and said she was getting dizzy closed her eyes and stopped responding for about 5 sec then opened her eyes.  I put the bed flat and called for help while keeping my hand on the pt knee since she seemed unaware that I was still there or where she was. help arrived almost right away, (1351)we put her in Trendelenburg position, administered epi and got vitals. between 1351-1353 pt become responsive but still dizzy flushed and nauseous. ER staff arrived and we transported her over at 1354.
Information has been received from a nurse concerning a female patient who was vaccinated with a dose of Gardasil.  Concomitant therapy included "multiple vaccinations" given on the same day.  Five minutes after receiving the vaccine, the patient experienced syncope.   Unspecified medical attention was sought.  Subsequently, the patient recovered quickly.  No product quality complaint was involved.  Additional information has been requested. 02/23/2010 Follow up information from the physician states that her patients have had not adverse effects. Additional information is not expected.
Fatigue, left axillary node swellign and pain day six and seven, then right axillary area became painful day nine. Day nine developed facial, neck rash, then more on chest day ten. Temperature of 100F. Itching. Face, neck, upper chest and back with scattered eyrthamatous papular-vesicular lesions, few pustules.
ED visit for right shoulder pain, treated and released. Hospital admission for insertion of power point for metastatic colon cancer. These visits were within 6 weeks of receiving the COVID vaccine.
Immediately, post vax, red, patchy area about 7cc in diameter, hot to touch, appeared. Informed MD, and after he observed area, he applied ice pack. Pt denies any pain, itching or any problems.
Pain at injection site. Fever, body aches, joint aches, headache, fatigue, cough, chest pain.