chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I went to the ER for a 2nd degree burn to my hand, they pushed the tetanus vaccine on me. I didn't realize it was Tdap (3 concoctions) until after. My neighbor had to fill out paperwork for me because my hands were in pain. A week after the ER visit I started experiencing flutters/tingling in my chest, where the heart is. I began having difficulty breathing and became dizzy. A couple of days later I went to my chiro/homeopath and he adjusted me. I felt better, but a few days later it intensified. ALL of my muscles turned to mush. I felt like a blob of slime. It was so bad all of the joints in my body, including the most important ones (the spine) were moving all over the place. I had to support my ribcage to lay down comfortably. Only after a few days of this I realized it was the vaccine. I've never experienced these sensations before in my life. My left eye has blurred vision. I have flutters/tingles throughout my chest. It's the worst at night. The muscle mush has subsided some, hence me filling out this form, but I am extremely weak. I've had to have a friend bring me groceries. I can't even drive well. I did, however, drive myself to my chiro/homeopath this week for the first time but barely. I have tingling/flutters and numbness in my chest today. My left arm feel half numb. Sometimes it's hard to breathe. Today I did some light cleaning and my heart was racing. My heart seems to race when I do very little. I'm also experiencing mild hallucinations. I am so upset. I feel like I'm on the verge of death. At night the left side of my face goes numb. I'm afraid I will stroke. When I wake up in the morning the left side of my face feels like it hasn't had enough blood circulation through the night. It's very hard to see in the morning and takes a long time to adjust like the normal person I was before this vax.
morbiliforme rash on the body, corisa, congestion, no lymphadenopthy.
After receiving vaccine client stated he was experinecing dizziness, having tremors. He was lowered to the ground by staff and mother, both  legs elevated on chair. Mother stated " he has a way with needles and gets like this sometimes". MD on site and paramedics responded accordingly. Vitals taken by paramedics  and assessment done by MD.Client is now verbally responsive , sitting in chair, hydration fluid given PO. Mother stated client has a hx of black out spells along with auto immune disease. Escorted to observation area in wheelchair with parents and MD.  Last Vitals  Bp 106/68 HR 73 O2 98%  blood glucose 104
This case was reported by a nurse via sales rep and described the occurrence of flu syndrome in a 51-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included splenectomy (had no spleen due to Immune thrombocytopenic purpura). Concurrent medical conditions included immune thrombocytopenic purpura. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced flu syndrome, pain, fever and weakness. On an unknown date, the outcome of the flu syndrome, pain, fever and weakness were unknown. It was unknown if the reporter considered the flu syndrome, pain, fever and weakness to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the nurse for her brother. The age at vaccination was not reported, but the patient was 51 years old at the time of reporting. The patient experienced significant reaction which described as a flu syndrome with horrible aching, fever, and staying in the bed. The case has been linked with cases US2019AMR045682 and US2019GSK049611 reported by the same reporter.
3 days post vax, the pt experienced right arm soreness, hot to the touch, welts and swelling from the injection site to elbow, redness and itching. Complaint continued from 1/6/01/ through 1/12/01. The pt saw her PMD and was treated with Aleve and Allegra.
Skin sensitivity all over the body: itches, rashes when scratching. Worst when it's hotter and areas where it might get sweaty like the crotch and armpit. I'm taking allergy medication cetirizine hydrochloride every day since I took the moderna vaccine last year may 2021.  My skin would mark up with redness and slight puffiness. Also, my niece, who took the moderna booster two weeks ago, is getting the exact same side effects.
One week after the vaccine I got the chills, nauseated  ,aches , exhausted. Then a very sore and red arm with a rash about 4 inches down  and  2 inches across. Very hard, red and swollen.
Information has been received from a registered nurse concerning a 12 year old female who in approximately August 2008, also reported as last couple of weeks, was vaccinated with a first dose of GARDASIL (lot number, injection site and route not reported).  Subsequently the patient had a delayed menstrual. The menstrual period was delayed by seven days.  Unspecified medical attention was sought.  Subsequently, the patient recovered from the event.  Additional information has been requested.
Per patient on 5/15/19 patient had a fever, felt lethargic with flu-like symptoms. On 5/16 patient broke out with erythema and swelling not near the injection site
no adverse event; patient received improperly stored vaccine; This spontaneous report was received from a healthcare professional and referred to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 10-MAR-2023, the patient was vaccinated with improperly stored vaccine, varicella virus vaccine live (oka/merck) (VARIVAX) (1 dosage form, lot #w008711, expiration date: 14-MAR-2024; anatomical location, strength, and route were not reported) for prophylaxis (Product storage error). There was no adverse event. The temperature was -3.2 degree Celsius. The time frame was 3 hours. There was no previous temperature excursion.
Pt states that about an hour after vaccine their arm was in pain. Pain has not gotten worse, but has remained the same today. Pain is minimal when still, but more painful when moving. Pt is traveling and cannot come back in, told to put ice and take an antiinflammatory, and will seek medical attention if it gets worse.
This case was reported by a healthcare professional and described the occurrence of local reaction in a 3-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included ACTHIB (Sanofi Pasteur MSD), HAVRIX (GlaxoSmithKline) and SYNFLORIX (Wyeth Labs) all given on 3 November 2010. There were no concurrent medications. On 3 November 2010 at approximately 12:00 the subject inadvertently received a dose of BOOSTRIX at 0.5 ml in the right thigh. On 5 November 2010, 2 days after vaccination with BOOSTRIX, the subject experienced a large local reaction and injection site redness. At the time of reporting the events were resolved. The healthcare professional considered the events were probably related to vaccination with BOOSTRIX. Additionally, administration of BOOSTRIX was a maladministration (asymptomatic/child too young).
3 hours after injection, mom brought patient back to clinic to report patient had vomited and had mild back pain. No fever, vitals were all normal. Alert, oriented. Patient was assessed by this provider, no chills, no shakes, no hives, no throat closing, no swelling. Discussed with mom to go home and rest and do a BRAT diet with patient and TYLENOL for pain; if patient has hives, throat closing, confusion, fever, then mom agreed to take her to urgent care or ER. However, I did contact CDC who referred me to health department and was connected with local epidemiologist, who said although it is highly unlikely the patient is undergoing a reaction due to the vaccination (based on timing and symptoms) to err on the side of caution and refer patient to go to urgent care. I did call mom and leave a detailed voice mail at this time for her to go to urgent care and to call me back. At this time I am waiting her call back, will attempt to call her again in a bit.
exposed to below freezing temperatures and were administered; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received HAV (Havrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix, Boostrix, Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix, Boostrix, Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 details were provided as follows: The age at vaccination was not applicable to this report. On 25th August 2021, Havrix, Boostrix, and Pediarix were exposed to below freezing temperatures and were administered to an unknown group of patients, which led to incorrect storage of drug. The reporter consented to follow up.
Mother phoned at 15:50 on 7/11/02. States that child woke from nap at 15:30 and temperature was 99.5F (ax), "twitching" "like she is chilled". Had given ibuprofen before nap and gave Tylenol after nap. States acts like arms are "sore". No crying. Now is crawling and playing without problems. On 7/12/02 and 7/16/02, mother reported temperature of 103.7F (ax) at 12:30 on 7/12/02. Decreased with cool baths, Tylenol and ibuprofen. Emesis Friday 7/12/02 afternoon but OK. No further temperature or emesis by later in day of 7/12/02.
Arm swollen for 4 days after shot; also body aches, chills, and stomach upset. Lost 2 days of work due to adverse reaction. 1st time ever.
Myalgia, NausaVomiting, injection site pain Narrative:  Reports severe body aches 13-72 hours following the vaccine, severe nausea, fatigue for 7 days, injection site pain for 7 days
This is a 56-year-old female here for a possible vaccine reaction.  2 days ago, on Monday, she received the Covid vaccine and yesterday she started to feel achy and noted some pain to the left side of her neck.  Now she also has noticed some numbness to the left lower lip.  She does have bad teeth and does have some dental pain which is not unusual for her and proceeded the past couple days. Does not have any numbness or tingling to her extremities
I woke up 6 hours after vaccination and started getting the chills with a fever of 101.3. I took some Tylenol which brought the fever down for a few hours but it later shot back up to 104. I had a headache, muscle pain, and fatigue. On Monday, I got a sharp pain on the side of my head causing my eyes to hurt. I called doctor who said that it sounded like a sinus infection and prescribed me Azithromycin. Days later the doctor called me and I told him that I wasn't feeling better and was referred to take a Doppler test which showed nothing wrong. I went to another doctor that prescribed me Bactrim which cleared up my sinus infection and I felt a little better. I still feel fatigued, have brain fog, and double vision. I went to a neurologist and was given a CT scan. That was two weeks ago and I never heard about the results. I'm scared to drive because I don't know what will happen. The vaccine also threw off my cycle and I have gained so much weight since my vaccination.
note: type of flu vaccine unknown, flu and shingles vaccine given at same time. moderate to severe headache x ~24 hrs   headache resolved moderate to severe myalga x-24hrs, currently mild to moderate at 48 hrs after injection, improving weakness x 48 hours after injection and continuing but improving stomach discomfort and loss of appetite x24 hrs after injection, improving light headded x 48 hrs and continuing but not as bad after 24 hours, improving
On 1/8/21 this individual called in to report that on 1/7/21 she started with a localized injection site reaction that is approximately the size of a 50-cent piece that is reddened and warm to the touch. She was unable to report this to her v-safe account
appendicitis 3 days after vaccination requiring laparoscopic appendectomy 2/1/2021 (5 days later)
Headache, Chills, Fatigue, LLE amputee noticed purple spotty in places on end of amputation are Narrative:
discussed treatment options with the patient and we discussed risks and benefits. Given that his exposure to his wife was 3 weeks ago, we discussed that it's possible he's simply been asymptomatic this whole time. In this setting, we opted to defer treatment unless he develops symptoms or hypoxia.    vaccine given, no lot number on EHR
It started off with yeast infections. I developed irritation and swelling on the vulva. I didn't know what it was. I had irritation and a lot of discomfort sitting due to the pain. I used a lot of yeast treatment. Finally, it appeared to be a rash. I was all this swelling and redness. What remained was a ring of thick red rash in the vestibule. It was about 2 cm on the side. An oval ring rash that is thick. I went to the doctor on January 12th, and they gave me Greers Goo which I used for 40 days but it did not work. So, they started me on Nystatin, and I used it for 2 weeks and had to go back to the doctor because it was not helping. I went to the doctor about 2 weeks ago and they gave me Clobetasol Ointment. I also put Nystatin on it, and I did see some improvement. I stopped using it once the doctor advised me too. That has been helping someone. I use it twice a day and it helps. It's still uncomfortable. Its disrupting my life but I am functional. I go back to the doctor tomorrow.
Accidental urination and she cant control/hold urine; Arm is a little bit sore; Sleeping a lot; This spontaneous case was reported by a consumer and describes the occurrence of URINARY INCONTINENCE (Accidental urination and she cant control/hold urine), PAIN IN EXTREMITY (Arm is a little bit sore) and HYPERSOMNIA (Sleeping a lot) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced URINARY INCONTINENCE (Accidental urination and she cant control/hold urine), PAIN IN EXTREMITY (Arm is a little bit sore) and HYPERSOMNIA (Sleeping a lot). At the time of the report, URINARY INCONTINENCE (Accidental urination and she cant control/hold urine), PAIN IN EXTREMITY (Arm is a little bit sore) and HYPERSOMNIA (Sleeping a lot) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Heart rate: elevated (High) Elevated.         No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-035903 (Patient Link).
This spontaneous non-valid report was received from a registered nurse and refers to an unspecified patients of an unknown age and gender. The patients' pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies were not provided. Since 17-JUL-2018, also reported as "beginning 17-JUL-2018", the patients were administered an unspecified number of doses of improperly stored Oka/Merck VARIVAX lot # M046005 with an expiration date 05-NOV-2018 (also reported as 18-NOV-2018) (dose, route of administration and anatomical location were not reported) for prophylaxis, STERILE DILUENT (doses, route of administration and anatomical location, lot# and expiration date were not reported) for prophylaxis or and Oka-Merck) PROQUAD N014759 with an expiration date 30-NOV-2018 (also reported as 08-NOV-2018) (albumin status was not reported) (dose, route of administration and anatomical location were not provided) for prophylaxis. No adverse effects were reported. Administered doses of medicines experienced the temperature excursion form 15 degrees Fahrenheit to 46 degrees Fahrenheit (25.2) for 14 hours. There was no previous temperature excursion. A digital data logger was involved.
Moderna Bivalent Booster 0.25mcg was given to patient, was to be given 0.5mcg. Wrong dosage given.
ischemic stroke; vision changes; When looking up her vision was blurry & unclear; fuzzy; This is a spontaneous report from a contactable consumer (Patient) reporting on herself. A 73-year-old female patient received BNT162B2 (Pfizer BioNTech Covid 19 vaccine, Solution for injection, Lot no: ER0734) on unspecified route of administration on right arm (at the age of 73-year-old) as SINGLE DOSE on 28Mar2021 (between 14:30-15:00) for covid-19 immunization. There were no prior vaccinations within 4 weeks reported. The patient's relevant medical history included ischemic stroke, breast cancer, lymphedema in left arm and tendonitis in her right arm. The patient's concomitant medications were not reported. On 29Mar2021, the patient experienced vision changes. Upon follow-up (30Mar2021); When looking up her vision was blurry & unclear and the symptoms lasted for around one-two hours. On 29Mar2021, the patient looked at the clock on top (about 10' away), all the numbers were fuzzy. The patient said the numbers on the clock were 1 in height & she couldn't read them & her vision was very fuzzy. The fuzzy vision lasted approximately between 1-1/2 to 2 hours. It was reported that the patient vision recovered completely 1-1/2 to 2 hours afterwards. On an unknown date, the patient had ischemic stroke. The outcome of the events ischemic stroke, vision changes and vision blurred was unknown  Follow up was needed, further information has been requested.
patient was administered an extra dose of fluzone high dose qiv with no reported adverse event; Initial information received on 25-Jan-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 79 years old female patient where patient was administered an extra dose of fluzone high dose qiv with no reported adverse event while receiving vaccine influenza quadrival a-b high dose hv vaccine [fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.   On 26-Oct-2022 patient received 0.7 ml daily (QD) dose of suspect influenza quadrival a-b high dose hv vaccine (batch number- UJ933AC) via intramuscular route in the left arm (formulation, strength and expiration date: not provided) as Immunization and on 17-Nov-2022, the patient also received same vaccine lot number not reported via intramuscular route in the right arm.   On 17-Jan-2023 the patient was administered an extra dose of fluzone high dose qiv with no reported adverse event (incorrect dose administered) 2 months 22 days following the administration of influenza quadrival a-b high dose hv vaccine.  Action taken- Not applicable.  At time of reporting, the outcome was 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.
trouble breathing, sever pain lower abdomen( on the left) and which turned into a knot at the same time my back (left lung) I had a bad pain felt like I couldn't catch my breath I was fatigued and it has been over a month and I am still feeling very fatigued and I have had a significant amount of weight loss since the vaccine.
pt recv vax 28JUL95 & 15APR97 pt was seen in MD office 15APR97 w/herpes zoster eruptions on lt arm & lt chest wall;pt exp malaise, nausea, listlessness & irritability;MD verified dx of zoster & tx w/acyclovir;pt recovered;
Employee Vaccinated at 9:05 a.m. and observed in clinic for 15 minutes. He was released, but returned to the health center in less than ten minutes with pallor, cold clammy skin, nausea. He was under care of RN in the health center where he eventually had an episode of emesis. After a period of approximately 1 hour, he sated he was feeling better and released to go home. Employee contacted the health center 11/17 to report he would be going to care with severe headache, nausea , vomiting (when attempting to eat or take medications), body aches, and fever.
pt recv vax on 31MAY95 & exp gen varicella like rash & head to toe lesions; No further details were provided;
Erythematous patches, positive blanching, in (R) deltoid area with multiple large bullae, extends from lateral acromion to distal humerus.
1"x1" induration/erythema/faint 1 wk post injection. Addendian-dev optic neuritis 12/8/02.
Expired Havrix administered; 1st dose 20 years ago, 2nd dose on 11Oct2022; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix (1st dose received 20 years ago).   On 11th October 2022, the patient received the 2nd dose of Havrix and Havrix Pre-Filled Syringe Device. On 11th October 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used and drug dose administration interval too long. On an unknown date, the outcome of the expired vaccine used and drug dose administration interval too long 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: 12-Oct-2022 Reporter's Comments: The pharmacist and also patient called to report that 2nd expired Havrix dose was given on yesterday. The HCP (Health care professional) also reported that 1st dose was administered 20 years ago. The reporter wanted to know does patient need to restart the series.  The vaccine administration facility was the same as primary reporter. The date of birth was not asked during conversation. The lot number obtained from research as HCP was not aware of this information. The reporter consent to follow up via email. Additional Supportive Information: The patient received an expired dose of Havrix, which led to expired vaccine used. The patient received 2nd dose of Havrix later than the recommended interval, which led to lengthening of the vaccine schedule.