chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cannot breath out nose; Arm feels really bad; he felt so exhausted like he was going to drop, felt super run down and he does not want to get up; Can barely lift arm; patient did not feel well; This non-serious case was reported by a consumer via call center representative and described the occurrence of difficulty breathing in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included smoker (the patient quit smoking about 2 years ago). Previously administered products included Shingrix (the patient received the 1st dose of Shingrix at the same time as a Covid booster and a pneumonia shot (unknown products) from his pharmacy and had pretty bad feeling, for the tolerance of previous dose refer case - US2023113475), Covid vaccine and Pneumococcal vaccine. Concurrent medical conditions included chronic obstructive pulmonary disease (diagnosed about 8 years ago), prostatic disorder and allergy. Concomitant products included tamsulosin and tadalafil (Cialis).   On 21-AUG-2023, the patient received the 2nd dose of Shingrix (right arm). On 21-AUG-2023, less than a day after receiving Shingrix, the patient experienced difficulty breathing (Verbatim: Cannot breath out nose), arm discomfort (Verbatim: Arm feels really bad), exhaustion (Verbatim: he felt so exhausted like he was going to drop, felt super run down and he does not want to get up), mobility decreased (Verbatim: Can barely lift arm) and feeling unwell (Verbatim: patient did not feel well).  The outcome of the difficulty breathing, arm discomfort, exhaustion and mobility decreased were not resolved and the outcome of the feeling unwell was not reported.   It was unknown if the reporter considered the difficulty breathing, arm discomfort, exhaustion, mobility decreased and feeling unwell to be related to Shingrix.     It was unknown if the company considered the difficulty breathing, arm discomfort, exhaustion, mobility decreased and feeling unwell to be related to Shingrix.   Linked case(s) involving the same patient:  US2023113475   Additional Information: GSK Receipt Date: 21-AUG-2023 The patient received 2nd dose of Shingrix between 12 and 1 PM on 21-AUG-2023 and came home and had half a beer with his lunch then all of a sudden about 2:30-3 PM, the patient felt so exhausted like he was going to drop, felt super run down and he does not want to get up, his arm felt really bad like it was run over by a freight train and he could barely lift it, and he could not breathe out of his nose at all. The patient took a couple of Allergy Relief Pills, prostate medication Tamsulosin and Cialis after he got home from his 2nd Shingrix. The patient reported all the information about other medications. The reporter consented to follow up. The consent to follow up with healthcare professional was obtained, however patient did not feel well and had limited information to provide.; Sender's Comments:  US-GSK-US2023113475:Same reporter
Administration of pediatric 2nd dose of Havrix to an adult patient; Administration of pediatric 2nd dose of Havrix to an adult patient; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 55-year-old female patient who received HAV (Havrix pediatric) (batch number 3JK57, expiry date 20th December 2021) 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 adult (1st dose received on an unknown date).   On 27th April 2021, the patient received the 2nd dose of Havrix pediatric and Havrix Pre-Filled Syringe Device. On 27th April 2021, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product 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 details were provided as follows: Nurse reported that, the administration of pediatric 2nd dose of Havrix to an adult patient, which led to underdose and adult use of a child product. No further information available. The reporter consented to follow up.
Limited ROM (L) arm, severe pain. ER visit suggest cold compress and F/U with PCP if not resolved w/in 1-2 days. Same day care visit- Tx with TORADOL/60mg IM, PO ibuprofen and NORCO. Pt will not take NORCO D/T constipation.
For 48 hrs after second shot - INTENSE brain fog. Thought I had given myself Alzheimer?s. Couldn?t form thoughts or sentences properly. Fever of 102 on Tylenol. Eventually subsided.   THEN: My periods are regular every four weeks. Two weeks after second shot, I skipped my period.  Feb - skipped March - skipped April - started two weeks early May - started one week late  June - started regular July - started regular
Left thigh area of swelling/redness, Pain and 3 blister formation (small).
Pt became pale and started feeling faint, needed to lay down, rested x 20 minutes then recovered.  Remained oriented, did not LOC. Was able to leave clinic without further intervention.
6/30/21 pt to hospital with acute respiratory failure and COVID pneumonia; (previous hospitalization at another hospital on 6/25/21 for COVID pneumonia); c/o severe SOB, weakness, cough; treated with steroids, remdesivir, Actemra, Decadron, pt transferred to ICU when O2 requirements increased; pt's condition worsened and he decided to stop aggressive therapy including O2 therapy; DNR; comfort measures; pt died in the hospital
The evening I received my vaccine, I started to feel achy, but it wasn't bad. The next day I woke up feeling ok but as the day went on, I started to feel worse. That afternoon, my fever got up to 101. That night I was unable to sleep from feeling so badly. I think I only slept 2 hours. I took over the counter medication to bring the fever down, but the fever continued to the next day. Saturday, I lost my voice completely. I continued to feel run down and had a headache through until Monday. I also felt stuffy but couldn't blow my nose. I did notice that I started my menstral cycle two weeks early. By Tuesday, my voice was returning but my teeth, nose, and face were hurting, and I could tell I was developing a sinus infection. I went to see my doctor who confirmed my concern of a sinus infection and prescribed antibiotics. At this point my voice is returning but still sounds strange. I'm also still in a lot of pain from my sinus infection in my face, head, teeth, and ears.
Arm very sore and couldn't raise above my shoulder. Body aches, chills, headache and just no energy. Took IB, lots of fluids and slept.
pt recvd vax 19JUN95;24-36 hrs post vax pt exp vomiting;
Cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced COUGH (Cough). At the time of the report, COUGH (Cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided. No treatment information given.
gotten both vaccinations and shingles/ suspected vaccination failure; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had gotten both Shingles vaccinations and still break out with the Shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Patient said that she had difficulty sleeping on 4/4/18 after receiving the vaccine. She also had soreness in her right arm. She already had a doctor's appointment scheduled for 4/5/18, so she mentioned it to her medical provider at her visit. She had on a shirt with tight sleeves, so her medical provider palpated it through the fabric of her shirt. She felt like it was a hematoma and instructed her to alternate ice and warm compresses. On the morning of 4/6/18, her arm was still sore and there a swollen red band encircling her arm radiating from the injection site. She presented to the pharmacy on 4/6/18 and the injection site did not look red or have discharge. The red band encircling her arm was hot to the touch. She visited her medical provider again on 4/6. They gave her a steroid injection, instructed her to take diphenhydramine OTC and sent in an antibiotic, Cephalexin to take for five days. She was instructed to go to the ER the following day on 4/7/18 if her symptoms had not improved because the doctor's office would be closed on the weekend.
It exacerbated my breathing issues. I had trouble breathing for a week straight, had to use my rescue inhaler more often than usual after getting my 1st dose of Moderna vaccine.
There has not been a reported adverse event. A third dose (0.5 mL) was given instead of a booster dose (0.25 mL).
Vaccine recipient called vaccine clinic on 02/25/2021 stating that she had a grand mal seizure 72 hours after receiving her first dose of COVID-19 vaccine. She did not seek medical treatment at that time. She has a history of seizures & takes Dilantin daily. She has been in contact with her neurologist.
Patient had seizure like action about 3 minutes after her flu shot, in her seat, and lasted about 3-5 seconds. Once she came out of the event she did not remember what happened and was stated she was "okay". Had patient sit down for 15 minutes to monitor her. Checked on patient every 5 minutes with no episodes that continued. Patient parents did not want to call 911 and did not want her take her to the ER, but wanted to monitor her. Discussed with patient's parents that they do not have a new PCP due to them recently moving here. Management was informed and parents did not want to file an incident report. After 15 minutes elapsed parents opted to go about their time. Will follow up with parents tomorrow. Follow up with patient, mother states they took her to urgent care the same night and it was diagnosed as fainting with seizure like action. They are not concern and patient went to school.
Elevated albumin/SCR; Elevated albumin/SCR; Elevated Neutrophil count; A spontaneous report  was received from a  concerning a consumer concerning a 81-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, elevated albumin/SCR / blood albumin increased / blood creatinine increased and elevated neutrophil count / neutrophil count increased.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Feb 2021, prior to the onset of the events, the patient received first of two planned doses of mRNA-1273 (lot/batch: 015M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 19 Feb 2021, the patient had a blood work done. On an unknown date, the patient had an elevated albumin, SCR and neutrophil.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events elevated albumin/SCR and elevated neutrophil count was unknown.
It was reported that a female patient received a dose of Fluzone SV 01-02 vaccine on 11/20/01 administered in her left deltoid, lot # U0671BA. Sometime after the vaccination (date not specified) the patient developed tingling in her left arm. Symptoms persisted for approximately 2 weeks, described as a painful tingling, Motrin was prescribed. Currently the tingling is still present, appears to be positional, comes and goes, somewhat alleviated by movement, more noticeable if leaning on arm for period of time.
Event occurred 09/08/2021: Pt had syncopal vs seizure like episode after vaccines. Patient received TDAP, MMR, Varicella, Hep A, HPV 9 and MCV4. Last vaccine given at approx 11:41am. Patient was scared and upset while receiving vaccines. As soon as last vaccine (HPV 9)  was given patient had syncopal episode, but also appeared to have a seizure. The seizure like activity only lasted for approx 10 seconds. Patient didn't appear to have a post-ictal period. 911 called at 11:45am. VS at 11:45am BP 110/64, HR 96 and O2sat 99. Fire Dept arrived at 11:52am. Patient evaluated. Mother refused for patient to to hospital. Fire Dept also believes that patient had a seizure based on the way patient was acting. Heavily educated mother on the need for child to go to the doctor to be evaluated. Fire Dept escorted patient to vehicle.  09/09/2021 Called mother this morning to check on patient. Mother states that patient is fine, and she did not take her to the doctor. Mother says that patient is at school this morning.
Feb-2-09 at 3:00 pm vaccines were given  Within 5 minutes of vaccines, she was feeling nauseated and  a numbness in right arm which started to spread to whole body, then was feeling shortness of breath and feeling very agitated.  I took her back to the same nurse whom gave her the shots and she had my daughter lay down for about 15 minutes and while laying down my daughter started to have episode of feeling ill the nurse told her to lay down for 15 more minutes and then told her she was fine to go home.
COVID vaccine admin 1645 around 1715 sudden onset heart palpitations feels like heart racing, employee heart rate was noted to be 170s, employee was escorted to the ED.   12/23/2020 1030 spoke with Employee she advised d/c from ED last pm, this am resting heart rate 90s, but 140's-150's with ambulation. Denies chest pain, shortness of breath, palpitations, cold symptoms, n/v/d. Has reported moderate fatigue this am.
Information has been received from a physician concerning a male patient with pain who in November 2009, was vaccinated with a dose of ZOSTAVAX (Merck) (lot # and route not reported) 0.65 ml. Concomitant therapy included ALEVE, BROMDAY, vitamin D (unspecified), CIALIS, erythromycin, folic acid, methotrexate sodium (since 1992), vitamins (unspecified), PERCOCET and SIMPONI. The physician reported that the week of 15-AUG-2011, the patient was diagnosed with shingles. The physician reported that the lesions were on his face in the eye area and that it was the worst case he had ever seen. The physician also reported that on an unspecified date, the patient was given VALTREX 1 g, tablet three times per day for one week, for the treatment of the event. At the time of the report, the patient was recovering. Shingles on his face in the eye area were considered to be disabling by the physician. Additional information has been requested.
Moderna COVID-19 Vaccine EUA Morbilliform rash appeared within one week, spread and itch increased in second and third week, still present four weeks from injection - patient was first prescribed antibiotic cream that had no effect, then prescribed steroid when rash was identified as morbilliform.
Infant received shots 5/23/06-child's grandmother brought him in for 4  month shots and reported that child was seen in ER after his first shots due to "high fever and blank stare." Which started about 4:30-5:00PM, the evening vaccines were given.  According to ER records: Child came in around 8:30 PM day of shots.  His gm stated he choked on juice and didn't act right.  His temp 101.3 rectual.  He was given MOTRIN and PEDIALYTE and did not choke.  He was released around 10: PM with orders for TYLENOL/MOTRIN prn fever d/c F 100.9 rectual.
pt recv vax 20FEB98 & awoke 21FEB98 approx 8AM had watery eyes, runny nose, & a tightness in chest;22FEB98 T102 sx;23FEB98 pt told it was an URI-chest was clear;did have dec appetite;poss allerg rxn;
SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19 TEST POSITIVE; SICK; This spontaneous report received from a consumer concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient was sick, tested positive for coronavirus disease 19 (Covid-19) virus test and had suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure, covid-19 test positive and sick was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority: 90000206372.; Sender's Comments: V0: 20211220917-Covid-19 vaccine ad26.cov2.s - covid-19 test positive. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211220917-covid-19 vaccine ad26.cov2.s- Suspected clinical Vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
A minute after receiving the Pfizer COVID-19 vaccine, started feeling numbness on the right side of the body starting on my arm, minutes later, the sensation had extended up to my right leg and later to my right foot. Ten minutes after feeling this symptom, my right eye started feeling dizzy and shaking, also a feeling of chest pressure, it was hard to breathe normal, I had hoarseness and my throat was itching at the same time my blood pressure went up to 160/89 and tachycardia at 128. All these symptoms lasted for about one hour. After the hour the blood pressure went down some to 134/89 but the general sensation on my body is not back to 100% normal.
This spontaneous report as received from a pharmacy technician (also reported as healthcare worker) refers to a 71 year old male patient. On 01-OCT-2014 the patient was vaccinated with expired ZOSTAVAX (subcutaneous, in the left upper arm, dose: 0.65 ml, lot#: H019042, expiry date: 17-JAN-2014. It was reported that the box lot and expiry date were different than the expiration on the vial itself. No adverse effect was reported at the time of the report. Product quality issue (PQC) was involved. Additional information has been requested.
Pt. seen 5/2/17 for MMR #1. Pt. seen 6/4/17 w/croupy cough and cold x 10 days, petechiae and ITP symptoms. Sent to ER.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided. On 02-JUL-2018, the patient was vaccinated with an improperly stored dose of PROQUAD lot # R003292, expiration date: 31-JUL-2019 (strength, dose, route of administration and anatomical location were not reported) indicated for prophylaxis which was reconstituted with MERCK STERILE DILUENT (lot# and expiration date not reported) properly stored. The administered dose of the vaccine PROQUAD experienced multiple temperature excursions of 6 degrees Fahrenheit (°F) to 14 degrees Fahrenheit (°F) for 303 minutes, as recorded by a data logger. There were no previous excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA002034: US-009507513-1809USA002035: US-009507513-1809USA002036: US-009507513-1809USA002033: US-009507513-1809USA002037: US-009507513-1809USA002032: US-009507513-1809USA002031.
48 hours after vaccine was administered a raised red dotted rash formed on both arms especially on the left arm where it was administered/The rash also covered his abdomen and back; 48 hours after vaccine was administered a raised red dotted rash formed on both arms especially on the left arm where it was administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 10 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Nov2021 12:00 (Lot number: FK5127) at the age of 10 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: RASH (non-serious) with onset 21Nov2021 14:30, outcome "recovering", described as "48 hours after vaccine was administered a raised red dotted rash formed on both arms especially on the left arm where it was administered/The rash also covered his abdomen and back"; VACCINATION SITE RASH (non-serious) with onset 21Nov2021 14:30, outcome "recovering", described as "48 hours after vaccine was administered a raised red dotted rash formed on both arms especially on the left arm where it was administered". Therapeutic measures were not taken as a result of rash, vaccination site rash.  No follow-up attempts are possible. No further information is expected.
Eyes rolled back in his gead, turned white, cold and past out...lifted legs to get nlood flow and had to spend additional 1 1/2 hour before he felt somewhat okay.
On 8/17 - patient fainted when shot was given. No adverse effects noted. On Sat AM - woke up with small spot on bridge of nose - rash spread to arms, legs, hands, face & trunk. Does not itch. No other swelling noted. No temperature. Advised to call MD.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 03/11/21 2nd dose 04/01/21 Diagnosed covid positive:08/18/21 Symptom onset:08/12/21 Exposure:home Symptoms:SOB, COUGH,FATIGUE,RUNNYNOSE
Developed hives on abdomen, arms. Also had redness of L arm which was the one that was injected. He did not have anaphylactic symptoms. He continues to have some discomfort and rash but overall improved. He self-treated with Benadryl.
Grandmother noticed welts and blisters around umbilical area approx. 26 hours after vaccination. Describes area about 100 mm "size of an orange". States "red and blistered". Irritation not present upon awakening 11/19/09. Prev. season Influenza vaccine-no difficulty.
Donor described reaction onset approximately 30min post immunization erythema up the arm and across the face.  Muscle soreness onset "a couple days" after immunization