chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ED visit for wound check - treated. Hospital admission for planned surgery for Closed displaced trimalleolar fracture of left ankle. patient underwent close reduction percutaneous pinning with provisional K wires to allow for soft tissue rest secondary to significant blistering noted around his left ankle. Recovery in hospital. Hospital admission within 6 weeks of receiving the COVID vaccine.
anaphylactic reaction; This case was reported by a nurse via call center representative and described the occurrence of anaphylactic reaction in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concurrent medical conditions included latex allergy.   On an unknown date, the patient received Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced anaphylactic reaction (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylactic reaction was unknown.   It was unknown if the reporter considered the anaphylactic reaction to be related to Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The age at vaccination was not reported. The patient had anaphylactic reaction following a flu vaccine. The patient had severe latex allergy and asked if the facility was latex free. The agent further prompted to ask if it is GlaxoSmithKline vaccine and for more information but health care professional ended chat session abruptly. No other information was available.  The agent did not consent for follow up due to chat ending.
Localized erythema, swelling 8x9 cm tenderness at injection site 24 hours post vax. Mom gave Tylenol, Afeb. decreased activity
High Fever, weakness, fatigue, flu-like symptoms for 15 hours. Afterwards, Weakness, felt much more winded when taking my normal uphill walks. For what it's worth, my VO2 max dropped precipitously from 34 to 28 and stayed down till now, it's still only 29. I began to have fluid in my ears within a couple of weeks. On Feb 23 I went to the Dr's thinking it was wax. I'd used wax softening solution and heat to try to treat me muffled hearing and discomfort. I believe it started in the right ear, mildly, then moved to the left ear. It was stopped up enough to visit the dr. I don't normally use Dr's. I had been under the weather since the vaccination, so I didn't notice that I likely had a systemic infection. The dr prescribed antibiotics and I took them becasue he cautioned that the ear really looked quite bad. I was not in any localized pain, just general symptoms of fatigue , etc. I had not taken antibiotics in 40 years, but I did take them this time, since my body seemed to be very challenged since the vaccine.  My ear did heal eventually. As I said, my VO2 is not what it was. Although it would be worth checking if some change in measurement happened around Jan 25, 2021. I'd say my energy level has returned to normal , but it took months, and my tendency to be winded lasted several months. I now feel normal, as far as I can tell . It's not easy to remember what I felt like a year ago.
After vaccinations and during the observations period, patient turned pale with white lips and vomited.  Her BP was 99/52 then later 99/62 after 1/2 hour of observation she was joking and feeling better.  Both of her parents were with her when she left the store.
The patient started having a burning sensation and pain in left arm after receiving the influenza vaccine on 4 Oct 11.
Information has been received from a 57 yr old female with hypertension and drug hypersensitivity to cephalexin (Keflex) who on 26Aug05 was vaccinated IM in the left arm with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included atenolol (Atenol), omeprazole (Prilosec) and nizatidine (Axid). Subsequently on 26Aug05 the pt experienced pain at injection site (left arm), dizziness, difficulty walking and red blotches in upper part of her left arm. Unspecified medical attention was sought. No laboratory diagnostic tests were performed. The pt's adverse experiences had not improved since being vaccinated. There was no product quality complaint involved. Additional information has been requested.
has had an upset stomach every day since; This case was reported by a consumer via interactive digital media and described the occurrence of upset stomach in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced upset stomach. On an unknown date, the outcome of the upset stomach was not recovered/not resolved.   It was unknown if the reporter considered the upset stomach to be related to Shingles vaccine and Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR158042   Additional Information: GSK Receipt Date: 29-OCT-2022. Reporter's comment: This case was reported by the reporter via interactive digital media. The reporter stated that his wife had two injection of shingles vaccine. She has had an upset stomach every day since. The reporter had also asked that for how long it would be like that. Additional supportive information: Follow-up would not possible, as no contact details were available. Since, we do not know after which dose the event is occurring, it is better to create a single case with both doses as suspect rather than assuming that the latest dose is the only suspected product or its occurring after each dose and hence, dose no. was also not mentioned for any dose.
The next morning 11/11/18 - Legs were hurting and all my joints, I couldn't move, went to church, the pain was very severe. I drove myself to ER - told Dr. received - SHINGRIX shot day before, took blood test, IV. I was in so much pain - gave me pain in IV. Doctor said that's all she could do. Drove home still in pain - I couldn't walk. I did make it home. Had to take 2 days off, all my joints was so painful, also. I still could not walk. I still get pain in my joints - continually I feel this is from the shot. No one can tell me how long it will last.
Menquadfi stored at 31.5F upto 2 hours 45 minutes with no reported adverse event; vaccines were administered to the patients after post excursion with no reported adverse event; Initial information received on 03-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 13-year-old male patient, MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] stored at 31.5f upto 2 hours 45 minutes with no reported adverse event and vaccines were administered to the patient after post excursion.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for Immunisation.  On an unknown date, the patient received 0.5 ml total dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE Solution for injection (strength, lot number, expiry date: unknown) via intramuscular route in unknown administration site for immunization and menquadfi stored at 31.5f upto 2 hours 45 minutes with no reported adverse event (product storage error) (latency: unknown). Information on batch number and expiry date was requested.  On an unknown date the patient had an event of vaccines were administered to the patients after post excursion with no reported adverse event (poor quality product administered) (latency: same day) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.  Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) was 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.
Low grade fever for 24 hours. Pain in muscles and joints, similar to flu. Pain in left ear still present 48 hours later. Fogginess of mind for first 24hours.
Itching, swelling, redness, rash 2 inch diameter (round) at injection site beginning on day 6 after vaccine, lasting about 3 days.
I have APS and am on warfarin maintained at a therapeutic level of 2.5-3.5. I received the Johnson & Johnson Vaccine on April 7,2021. On April 9,2021, I noticed swelling and tightness in my left leg, on April 13,2021 I noticed severe swelling in my right leg too. I met with my primary care physician who sent me for imaging which confirmed clotting. I was referred to the Emergency Room since my INR was 3.7 but I was still clotting. I was sent home with out treatment from Medical Center because I was therapeutic on my warfarin. On Friday April 14, I went to the ER after speaking with a hematologist at the facility. I was admitted and was put on fondaparinux.
Developed fever 103 deg within 1 hour of shot's. Then began diarrhea. Fever and diarrhea Lasted for 8months solid. Now off and on; Pattern started Loosing Speech, eye contact. 7/17/07 diagnosed w/autism.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild
On 11/6 redness, swelling at injection site, body aches, headaches. 11/7 pt. doing better and less symptoms. 11/9 per pt everything is gone and she feels fine.
Vomiting one full day after 3rd dose. Diarrhea one week.
5-9-13 came to office with 102.7 fever since Tuesday (1 week after vaccines).
This spontaneous report as received from a healthcare worker refers to a 23 months old patient of unknown gender. Healthcare worker stated that on 20-MAY-2013, VARIVAX (Merck) (lot number, dose and route were not reported) that was stored improperly, was administered to the patient. Concomitant medications were not reported. Healthcare worker stated that VARIVAX (Merck) was storage with multiple temperature excursions up to 13F since February 2013 (vaccines were received in November 2012) exceeding one week (168 hours), then progressively up to 22F for an estimated 96 hours through June 2013. The healthcare worker did not believe overall temperature was maintained at 5F. No adverse effects reported. This case is linked to cases MARRS # 1307USA002434, 1307USA002437. 1307USA001233, 1307USA002436 via same reporter link. Additional information has been requested.
After administering varicella and Influenza on 4-25-19 @ 4P in (L) thigh, noted immediate redness, swelling and hives surrounding the site where varicella was given. Benadryl given within 5 min and ice pack applied
A non-serious spontaneous report of runny nose has been received from a registered nurse concerning a male child, subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's medical history and concomitant medication were not provided. The patient received a total of one dose of FLUMIST on 07-Sep-2009. The patient's mother reported that he has had a runny nose since he was administered FLUMIST on 07-Sep-2009. The patient's was rubbing his nose so much that he was getting a rash under the nostril area. As of 21-Sep-2009, the event was ongoing. All follow-up attempts have been made per company SOP.  No further information is available.  19-Feb-2010.
I've received the two Pfizer mRNA shots at the clinic location on the days of 3/3/21 and 3/24/21 respectively, and as someone who NEVER had ANY allergic reactions to ANYTHING (including shellfish/seafood, pollen, hair dyes, metals, soy, etc, etc ). But I suddenly began experiencing, probably about a month or so after the Pfizer shots, an intense itching in my hands about 10-15 minutes after applying hair dye, which I've been using without any issues at all for a few years; the deep under-skin itching lasts only about 3-5 minutes, but I find this new experience exactly the same with another acquaintance who also suddenly began having allergic reactions AFTER receiving his Pfizer mRNA shots.
pt recv vax; fever x 12 hr; T 102; fussy, irritable;
This spontaneous report as received from a nurse practitioner via healthcare worker refers to a multiple unspecified patients of unknown demographics. On an unknown dates the patients received improperly stored, oral, ROTATEQ suspension 2, lot # K020181 with expiration date: 24-JUN-2016; (strength, dose number, dose and route was not reported). Concomitant medication was not reported. No adverse effect was reported. Product quality complaint (PQC) was not involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Hard lump, swelling and pain at the injection site. Day 2 produced a red itchy rash. A little fatigue but not too bad.
Immunization administered (L) deltoid. Pt rested head on nurse's shoulder. Pt alert & oriented. Cold compress applied to pt's neck & forehead pt given juice & crackers.
chills; fever; headache; she became nauseous; This is a spontaneous report from a contactable consumer (patient) received from a regulatory authority. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 03Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received the first dose of BNT162B2 on 02Feb2021 for Covid-19 immunisation. The patient experienced chills, fever, headache and she became nauseous on an unspecified date. The outcome of the events was unknown.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
After taking the shot at 11am, I felt fine, until about 5:00pm. I started feeling cold and nausea. Back of my eyes were heavy and painful. my right pinky started feel tingly, then both hands became very cold. Very similar symptoms to flu, except I didn't have any throat pain which I usually get when I'm sick. I ate dinner at about 6:30pm and rested on the couch. I started feeling very hot, and was running the fever of 102.2 F. My arm and legs were tingly. I took advil at around 8pm which relieved some headache, but still feeling hot. Took shower and cutrently resting on the couch.
No additional AE reported; 16 year old consumer was administered an adult dose of V AQT A rather than the recommended pediatric dose; 16 year old consumer was administered an adult dose of V AQT A rather than the recommended pediatric dose; This spontaneous report was received from a medical assistant referring to a 16-year-old patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 25-FEB-2021, the patient was vaccinated with an adult dose of hepatitis a vaccine, inactivated(VAQTA), 1 milliliter (route of administration, lot number and expiration date were not reported) for prophylaxis, instead of the recommended pediatric dose (Incorrect dose administered and product administered to patient of inappropriate age). No additional adverse event reported.
felt hot and big; red and itchy / itchy like a mosquito bite; swelling like a tumor on my arm / it was swollen, red and itchy and a little bit sore; red; little bit sore; coupe little bumps / swelling like a tumor on her arm; got bruised; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (coupe little bumps / swelling like a tumor on her arm), VACCINATION SITE BRUISING (got bruised), VACCINATION SITE PRURITUS (red and itchy / itchy like a mosquito bite), VACCINATION SITE WARMTH (felt hot and big) and VACCINATION SITE SWELLING (swelling like a tumor on my arm / it was swollen, red and itchy and a little bit sore) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE MASS (coupe little bumps / swelling like a tumor on her arm), VACCINATION SITE BRUISING (got bruised), VACCINATION SITE PRURITUS (red and itchy / itchy like a mosquito bite), VACCINATION SITE SWELLING (swelling like a tumor on my arm / it was swollen, red and itchy and a little bit sore), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PAIN (little bit sore). On 13-Mar-2021, the patient experienced VACCINATION SITE WARMTH (felt hot and big). At the time of the report, VACCINATION SITE MASS (coupe little bumps / swelling like a tumor on her arm), VACCINATION SITE BRUISING (got bruised), VACCINATION SITE PRURITUS (red and itchy / itchy like a mosquito bite), VACCINATION SITE WARMTH (felt hot and big), VACCINATION SITE SWELLING (swelling like a tumor on my arm / it was swollen, red and itchy and a little bit sore), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PAIN (little bit sore) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications were provided.  No treatment was reported for the events.
Patient was given Moderna as first Covid Vaccine and we gave Pfizer as second dose.   Patient had no complaints, no adverse outcome, and no treatment was required
Initial misuse report received from a health care professional on 03 OCT-2013. A patients who gender, age, medical history and concomitant medications were unknown, received a dose of FLUZONE (lot number, route and site of vaccination were unknown) on an unspecified date. The needle was leaked and patient did not get full dose. List of documents held by sender: none.
A small amount cam out of the syringe; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number x2x35, expiry date 12th May 2023) for prophylaxis.   On 4th May 2022, the patient received the 2nd dose of Shingrix. On 4th May 2022, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 04-May-2022 Reporter's Comments:  The reporter stated that, he/she was administering shingrix, and a small amount came out of the syringe where the needle and syringe connect. The reporter asked if he/she needed to repeat the dose. The reporter consented to follow up via postal. Additional Supportive Information:  The small amount of vaccine came out of the syringe during administration, which led to incomplete dose administered.
I developed fluid filled blisters which itched to an extreme  located on my buttocks, groin, and upper legs.  Painful, constant  extreme itching disrupting sleeping and sitting .  Had an almost three week waiut to get an appointment with my primary physician who then referred me to a skin specialst with another 4 week wait to get my appointment with him.   He made a visual diagnosis of  Bullous pemphigoid and took two biopsies and a blood draw.  I am still waiting for results and have a June 14,, 2021 appointment to remove biopsy stitches and get his report.
Case number PHEH2012US012757 is an initial spontaneous report received from a nurse on 25 Jun 2012: This case refers to 23-years-old female patient. She was received only Men C, Y, W-125 liquid conjugate component of MENVEO vaccine (batch number:  X10131), without being reconstituted with Men A component on 25 Jun 2012. No adverse reaction occurred following this administration error.
Patient began experiencing hives within 5 hours of receiving COVID vaccine #1.  Patient noticed hives on stomach, back, legs, and buttocks. Patient reported them being itchy.  Patient's PCP was notified and a telehealth visit was performed.  Patient's PCP recommended Benadryl every 4-6 hours.  Hives would wane and return for the next 4 days.  Hives were on arms, chest, back, buttocks, and legs throughout the five days.  Patient began Zyrtec on Monday morning and continued Zyrtec through Wednesday.  Allergy was e-consulted to discuss the second dose of the vaccine and if patient should receive it.  Allergy recommended Zyrtec one hour prior to second dose and have PCP prescribe epi-pen in case of more severe reaction.
his temperature was 103 °F, he was given 1 L of normal saline, but then his COVID-19 swab resulted positive and therefore normal fluid was given.  At baseline, he lives with a sister, he drives around and uses a front wheeled walker (very hunched over).   He was on room air at the time of admit, never required supplemental oxygen.  He was managed with COVID while admitted with remdesivir, completed a 5-day course.  He was seen by physical therapy who recommended SNF.   His baseline creatinine is around 1.3-1.4, with supportive care and gentle IV fluids his creatinine returned to 1.4 by 12/21/2022 after peaking 1.6-1.8 range.   He had a smooth night into 12/21/2022, since the creatinine was normalizing, now ready for discharge to skilled nursing facility, discharge orders were entered and we are looking into the logistics of this.
swollen; redness; This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2019, the patient received the 2nd dose of Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced swelling arm and erythema of extremities. On an unknown date, the outcome of the swelling arm and erythema of extremities were unknown.   It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that, the patient experienced redness which spread from the top of his shoulder area and down his deltoid. Symptoms began at an unknown time. The reporter did not consent to follow up. Pharmacist declined to provide more information.
A few months after the second dose- I had a full on heart attack. SOB, profuse pain, arms numb and tingly. This led me to being hospitalized and  having to see a specialist in another state.