chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Experiencing severe acid reflux within approximately one hour after injection. The acid reflux has not stopped. Over the counter antacid has not worked. Prescription antacid medication has not resolved the issue. Causing extreme discomfort.
I got COVID; I got COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I got COVID".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Lungs filled up with fluid; could not breath after the second dose; This a spontaneous report from a contactable consumer via a Pfizer sales representative. An 89-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 2nd dose, single for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD). The patient's concomitant medications were not reported. On an unspecified date, the patient died due to lungs filled with fluid and could not breath after the second dose. It was not reported if an autopsy was performed.  Information on the batch/lot number has been requested.; Reported Cause(s) of Death: Lung filled up with fluid; could not breath after the second dose
MOTHER STATED ON 5/1/17 HAD A FEVER IN THE EVENING AFTER RECEIVING SHOTS AND IN THE MORNING ON 5/2/17 CLIENT HAD RASH TO HER BODY AND SWELLING TO HER FACE.
Violently ill, bedridden for 7 days. Still have coughing, began with sore throat, aching in body, ear ache, weakness and poor appetite.
LESS THAN 12 HOURS AFTER INJECTION I BEGAN HAVING CHILLS AND COMPLETE BODY ACHES.  THESE LASTED 24HRS WITH TYLENOL 1000MG Q6HRS HELPING BUT COMPLETELY RESOLVING SYMPTOMS. 24-48HRS I STILL FELT MY MUSCLES WERE WEAK, BUT NO ACHES OR CHILLS. BY 72 HOURS AFTER INJECTION I FELT NORMAL/BASELINE.
Study conducted to determine Ab response to PEDVAXHIB in 30 consecutive premature infants who required supplemental oxygen because of chronic lung disease; 6 failed to complete study & 2 died; chronically ill infants do not respond as well;
Large red mark (2"x5")  Hard to the touch Local hot temperature  (101.1F) Pain from shoulder to elbow
I got achy, headache chills, racing hearr. Took temp it was 100.7, took a half hour later it was 101.9. Got a hold of triage nurse. She said to go to ER. Temp over 102 at ER, heart rate 117. Blood tests given. White blood cells elevated, potassium was low. Given IV fluids, tylenol, ibuprofen. Had me stay until midnight. Temp down to 99, heart rate down to 100. Today 8/25, temp 100 @ 2pm.
Pulmonary Embolism diagnosed after a CT of the heart showed clots in the lungs on 7/18/2022
Soreness,  hard at the site. Went to ER got Benadryl.  Took 2 days to got down after taking the meds.
Initial report was received from a health care professional on 22 June 2011. A female patient (age and date of birth not reported) had received MENACTRA (lot number, route and site of administration not reported) on 21 June 2011 and an unspecified amount of time later experienced joint pain, malaise and GI upset. The patient was not evaluated by a physician. No further information was provided at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Patient, was administered a meningococcal vaccine by Medical Assistant.  the patient had already received a meningococcal vaccine on 04/28/2020.  Neither Medical Assistants verified the vaccines needed through Agency.  This resulted in an unnecessary vaccine given to the patient.
received an expired dose of the Moderna COVID-19 Vaccine as a booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID-19 Vaccine as a booster dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     Medical history was not provided.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID-19 Vaccine as a booster dose). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID-19 Vaccine as a booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided. Date the vial was initially stored in the refrigerator initially stored in 22-Oct-2021
Information has been received from a 24 year old female health professional with a urinary tract infection who on an unspecified date was vaccinated with a 1st dose of GARDASIL vaccine (yeast) (lot# not reported). Concomitant therapy included cephalexin (KEFLEX). Subsequently the patient bled for 3 weeks after dose 1 and "was not on her period". On an unspecified date the patient was vaccinated with a 2nd dose of GARDASIL vaccine (yeast) (lot# not reported). After dose 2, the patient immediately started to bled and has been bleeding for 1 week. The patient sought unspecified medical attention. The patient has not recovered from the bleeding. Additional information has been requested.
Received shot and after checking out start feeling hot and dizzy. This is a familiar reaction to her whenever she got poke by needles. In observation with medics for 15 minutes. BP/ P stable . 1:35pm client went home on her own.
7 days after vaccination with "covid arm" redness, swelling, itching, heat now 4th day of symptoms. recommended antihistamine, steroid cream 2.5% icing, monitoring. hope to see resolution in next 24 =48 hrs.
Red spots appeared on his face and arms. The area where the injections was, was all clear. We are treating him with 25mg of Benadryl every 6 hours until symptoms go away.
At 35min post vaccine patient noted with redness to the chest, neck and going up to face and bilateral ears. Ears were swollen. Patient transferred to the Emergency Department where she was noticed to have swollen lips
Seriousness Criteria: Other - Medically Significant (OMIC). Initial report received on 28 December 2006 from a consumer, who is also the patient. A 56 year old female patient, received on 19 October 2006, (approximately) 0.25 ml (half dose) of Fluzone vaccine and 15 minutes post vaccination began coughing, wheezing and experienced difficulty breathing. The patient was treated with levalbuterol hydrochloride (Xopenex) and oxygen. The wheezing and difficulty breathing lasted for 2 hours. The coughing lasted for 2 days. The patient had recovered. The patient's medical history included: asthma and allergy to sulfa and IVP dye (anaphylaxis). The patient's concomitant medications included: "Macadis", calcium and ASA.
Developed headache shortly after receiving vaccine.  Developed dry chest cough and chills later in the evening which lasted until 11/13/2009 AM.
On 3/11/22 @1415 I received the Moderna first dose. After about 10  minutes, my throat starting feeling really tight and I lost consciousness. Felt discomfort and pain in chest, neck and lower back.
Pt vaccinated with MMR/HIB developed hives over body day after the immunizations were given.
Tenderness and muscle soreness entire (R) upper arm (shoulder to elbow). No redness or fever. States discomfort began 11/12/07 and continues to present.
Minor left arm weakness; Stinging at site of injection; Sweaty palms; This is a spontaneous report from a non-contactable consumer, the patient. A patient of unknown age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date, the patient experienced minor left arm weakness, stinging at site of injection, sweaty palms. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events minor left arm weakness, stinging at site of injection and sweaty palms was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected
Roughly 8 hours later: Felt what seemed like Severe acid reflux in belly, chest neck and head. Then I felt left arm muscle where injection; then I noticed whole body aching; fatigue,; then nose bleed; then I was super chilled/shaking; then legs aching. Dry mouth, thirsty.  Today, roughly 22 hours later,  all body aching, glands tender, neck achy, small headache; extreme weakness and feeling like flu and still queasy. Not functional for normal task.
Right upper arm swollen, red, warm to touch, and painful. Mom states "cool compress was applied around 9 pm & ibuprofen given to child. Further states it not as painful as yesterday."
Herpes Zoster diagnosis in a 2 dose varicella vaccine recipient. Painful unilateral rash lasting less than 4 weeks, nausea, and fever. No antiviral treatment.
MOM C\O ERYTHEMA AND EDEMA TO R DELTOID OF CHILD- AREA APPROX 7 CM.
This case was reported by a other health professional via call center representative and described the occurrence of memory loss in a 56-year-old male patient who received SHINGRIX (batch number P539L, expiry date 31st January 2020). Concomitant products included PRILOSEC and lisinopril. On 12th January 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 18th January 2018, 6 days after receiving SHINGRIX, the patient experienced headache (serious criteria hospitalization). On 19th January 2018, the patient experienced influenza-like symptoms (serious criteria hospitalization). On 20th January 2018, the patient experienced memory loss (serious criteria hospitalization, disability and other: As per reporter) and mental status changes (serious criteria hospitalization). On 21st January 2018, the patient experienced positron emission tomogram, computerized tomogram and lumbar puncture. In January 2018, the outcome of the memory loss, mental status changes, headache and influenza-like symptoms were recovered/resolved. On an unknown date, the outcome of the positron emission tomogram, computerized tomogram and lumbar puncture were unknown. The reporter considered the memory loss, mental status changes, headache and influenza-like symptoms to be possibly related to SHINGRIX. It was unknown if the reporter considered the positron emission tomogram, computerized tomogram and lumbar puncture to be related to SHINGRIX.  Additional details were provided as follows: This case was reported by a pharmacy intern. The patient received SHINGRIX vaccine in the left deltoid. On 19th January 2018, 7 days after receiving SHINGRIX, the patient experienced influenza-like symptoms. On 20th January 2018, 8 days after receiving SHINGRIX, the patient experienced memory loss and mental status changes. The patient's memory issues involved not being able to recall names and not recognizing his wife or children. On 21st January 2018, 9 days after receiving SHINGRIX, the patient experienced positron emission tomogram, computerized tomogram and lumbar puncture. The patient was taken to the hospital and positron emission tomography, computerized tomography and lumbar tap were done and those were all negative. No evidence of stroke, transient ischemic attack or bacterial infection was present. The symptoms resolved after lumbar tap. The patient remained in the hospital, at the time of reporting.
EXTRA SALIVA PRODUCTION; LETHARGY; HOT AND COLD SWEATS; UPSET STOMACH; WASN'T FEELING HIS SELF; GAS PAIN; ARM PAIN AND TENDERNESS; NAUSEA; HEADACHE; FEELING VERY TIRED; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included kidney stones. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced extra saliva production. On 08-APR-2021, the subject experienced lethargy. On 08-APR-2021, the subject experienced hot and cold sweats. On 08-APR-2021, the subject experienced upset stomach. On 08-APR-2021, the subject experienced wasn't feeling his self. On 08-APR-2021, the subject experienced gas pain. On 08-APR-2021, the subject experienced arm pain and tenderness. On 08-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced feeling very tired. Treatment medications included: ibuprofen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extra saliva production, hot and cold sweats, upset stomach, gas pain, nausea, and headache on APR-2021, lethargy on 10-APR-2021, and arm pain and tenderness on 11-APR-2021, and the outcome of feeling very tired and wasn't feeling his self was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Muscle pain in the arm continues to this date. Site is slightly warm to the touch. Not sharply painful, but muscle soreness that has continued for months.
05/20/04-vaccines given in AM 5/20/04 pt returned approx. 4 pm with red, swollen legs & irritability.
high pitch cry over 3 hrs starting the evening p/shot administered; given rondec DM 19APR;
arm started hurting; arm and hand trembling; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm started hurting) and TREMOR (arm and hand trembling) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm started hurting) and TREMOR (arm and hand trembling). At the time of the report, PAIN IN EXTREMITY (arm started hurting) and TREMOR (arm and hand trembling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication includes blood pressure pills and cholesterol medication.  No Treatment medications was provided by the reporter.   This case was linked to MOD-2021-103051 (Patient Link).
Pt reports she started to notice bruising which worsened and became hot and red. The redness under bruised site began spreading down her arm so she was seen 2 days after vaccine administration at walk in where she was prescribed antibiotic and prednisone.
Redness and pain around injection site, still there 36 hours later now. The night of the shot, all my joints and muscles in horrendous pain, skin super sensitive, could not sleep at all. In the morning, took 3 Advil and slept about 3 hours sitting up on sofa which helped a lot but didn't feel mostly better until late on Sunday. Today is Monday, and I am achy but functioning again. I have to travel by plane tomorrow and I feel I can do that where on Sunday morning I would not have been able to.
Information has been received for the pregnancy registry for GARDASIL vaccine (yeast) from a nurse concerning an 18 year old female with pertinent medical history reported as none and no known drug reactions or allergies who on 17-APR-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 657621/0387U) 0.5 ml, IM. The second dose of GARDASIL vaccine (yeast) (lot # 657736/0389U0), 0.5 ml, IM was given on 15-JUN-2007. Concomitant therapy included prenatal vitamins (unspecified) and ferrous sulfate (unspecified). The third dose of GARDASIL vaccine (yeast) (lot # 659055/1522U), 0.5 ml, IM was given on 26-DEC-2007. Subsequently the patient became pregnant. She sought medical attention via an office visit. Her last menstrual period was reported as 29-NOV-2007. Her estimated delivery date was 04-SEP-2008. No adverse event was reported. Follow-up information was received from a licensed practical nurse which reported that on 23-AUG-2008 the patient gave vaginal birth to a live born male weighing 5 lbs. 12.3 oz, APGAR = 9/10. She was 37 weeks from her last menstrual period. The infant was reported to be normal and there were no congenital anomalies or complications. Additional information is not expected.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-395985 (Patient Link).
Fever first day and a half. 6 Days after vaccine body has broken out into a rash all over. Woke up on 3/18 and rash was gone. Around 2:30pm on 3/18 , rash came back all over body. Doesn't itch but it does burn.
Patient reports that patient got shingles after receiving shingrix vaccine. she got the rx from ER for shingles on 08/04/2022
Area around injection site became swollen, reddened and hard in texture. By the following day, 9/26/12 and 9/27/12 the area became angry red in color, area around injection site was swollen and hard. Skin is intact, no openings, no drainage.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 31-JUL-2014 the patient was administered with an expired dose of M-M-R II HSA (dose, route not reported), lot # H013042, expiration date 17-JUL-2014 (reported as 15-JUL-2014). Concomitant medications were not provided. No adverse effect was reported. Additional information has been requested.
Fever/myalgia/swelling starting a few hours after vaccination. Pt iced and took ibuprofen. Fever was no longer present following morning, swelling no longer present 3 days after.
Received flu vaccine on 10/21/03 2PM. Noted some discomfort 10/22/03 about 5:30PM to injection site. Noted to be red and indurated at site and was swollen.
Fatigue; Myalgia; Achiness; difficulty getting out of bed; Swelling at the injection site; Pain  at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 11th January 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 11th January 2021, less than a day after receiving Shingrix, the patient experienced injection site swelling and injection site pain. On 12th January 2021, the patient experienced fatigue, myalgia, pain and mobility decreased. On an unknown date, the outcome of the injection site swelling, injection site pain, fatigue, myalgia, pain and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site pain, fatigue, myalgia, pain and mobility decreased to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received the 2nd dose of Shingrix and on the same day, she had pain and swelling at the injection site and on the next day, she had difficulty getting out of bed due to myalgia, fatigue, and achiness. Till the time of reporting, the patient continued to have these symptoms. The reporter did not consent to follow-up.
Severe pain in arm, from shoulder to elbow. Very limited use of arm. Not able to sleep on right side due to throbbing pain. Limited range of motion and strength. NSAIDS and prescription Naproxen (500 mg), and applied heat give no relief from pain. Doctor has referred to physical therapist.
presented to clinic w/signs/sx of herpes zoster on lt, sp varicella vaccine 23SEP98;
Rash (red, papular rash) over face, chest and extremities. No treatment.
Pt had varivax at 12 months, on 04/23/2002. On 08/14/2002, pt came to office with dew drop rash, crusted on extremities. Diagnosed with chicken pox, Varivax failure.
There is approximately a 3 inch X 3 inch bruised area.  The patient had very bad soreness originally and bruising.  On 11-5-19, the patient said the bruising was not as severe and not sore any more. He said he still had a knot at the injection site.