chrisvoncsefalvay/vaers-outcomes huggingface dataset:
NauseaVomiting, Palpitations, pain and heat at injection site Narrative:  Arrived to vaccine clinic observation area after receiving second COVID vaccine dose. Per vaccination RN needed to be 30 min observation due to anaphylaxis history and had strong reaction after 1st COVID dose of left sided pain, weakness (unable to walk fully 24 hours post dose #1). After dose #2 had initial complaints of nausea and sensation of heart fluttering, pain and heat at injection site on left deltoid. She was given water and white flower smelling oil/balm. Vitals were 140/71, HR 97, Tem; 96.8, 99% on RA, RR 24. At 2:30pm She was given zyrtec 10mg tab and ice pack to left arm and neck. At 2:40pm nausea and heart flutter resolved and she was was able to return to work. Employee was contacted on 1/30 and she had complaints of sore arm and body aches on 1/28 as well and had to call off work.
Client's mother reported to clerk redness and swelling in left arm. Told apply clean, cool, wet washcloth over area for comfort. To call or come to health office if concerned. Client never returned to office.
Symptoms Started immediatly and got worse over several days, finally resulting in sever shoulder issues that include major range of motion limits, sever pain, swelling, and weakness.
got the shots, still get shingles/ suspected vaccination failure; dealing with shingles; This case was reported by a consumer via interactive digital media and described the occurrence of 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 1st dose of Shingles vaccine and the 2nd 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 was unknown and the outcome of the shingles was not recovered/not resolved.   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: The patient self reported the case. The age at vaccination was not reported. The patient received shingle shots and still got shingles. The patient dealing with the shingles. The patient now had the shots usually get them every couple of months. The follow up would not be possible as no contact details were available. This case was considered to be a suspected vaccination failure case, as the details regarding time to onset and laboratory confirmation for shingles were unknown.
DX: Varicella vs allergic reaction Plan: Caladryl clear RX: Benadryl 12.5 mg 15 ml 6 oz .75 tsp PO Q 4 degrees PRN itching - Acyclair 200/5 tsp PO QID x 5 days 100 ml. C/O red bumps x 2 for 2 days, currenting over entire body.
Systemic: Tingling-Medium, Additional Details: tingling on the arm and cold sensation. I recomend to go to the emergency room. I gave follow up on 10/21/2022 7:50pm he state is wating for x-ray results
Fever 3 degrees higher than normal. Sore arm at vacine spot. Dizzy and tired for the entire day.
Patient received Moderna vaccine dose #1 on 3/3/21 at approximately 0900.  In the afternoon of 3/4/21, patient had sudden onset shortness of breath while at home, as well as fatigue and low energy. Patient knew that a potential side effect of vaccine was fatigue, so he assumed this was just a normal side effect to be expected. States that his difficulty breathing and fatigue continued for about a week. After continued urging from wife to seek medical care, patient visited urgent care center on 3/15/21. The urgent care did a D-Dimer lab, and an x-ray of chest. X-ray "showed something abnormal" so they did a CT scan as well, which showed a "huge pulmonary embolism." D-Dimer lab was elevated. Patient was transported to hospital by ambulance and had immediate surgery to remove blood clot from lungs at approximately 2100 on 3/15/21. Per patient, the surgeon said the clot was about the size of his palm. Surgeon reported that there was "100% blockage to left lung from the aortic artery and 90% blockage to right lung from aortic artery."  A DVT in popliteal vein was identified, and the surgeon assumes the clot started in the popliteal vein and broke off and traveled to lungs. Patient was admitted and hospitalized until he was discharged home on 3/18/21. During course of hospitalization, genetic testing was done and it was determined that the "genetic marker for clots was negative, so they think the clot is from a one-time event--patient's family does not need to be concerned that they have clotting issues." Patient states that he was started on heparin in the hospital, and was discharged home on Eliquis blood thinner, which is being tapered. Patient states that the doctors think he will be on Eliquis for about 6 months and will not need to be on it for life. Doctors say the DVT in leg will dissolve on its own. During hospitalization, an echogram and cardiac cath was performed, which showed "an old heart attack on the left side, but that collateral vessels have built up already." Right side of heart was weaker from having to work so hard due to blood clots in lung, but prior to discharge from hospital, the right side of heart was already showing improvement. A heart cath was done to check vessels and it was determined no stents were needed, although there was a small clot in left anterior descending artery. Patient was also newly diagnosed during course of hospitalization with Type II Diabetes in a non-obese person, HTN (which patient had never had before), Coronary Artery Disease, Hyperlipidemia, 1st degree AV block. Was discharged home with metformin, losartan, chlorthalidone, atorvastatin, and Aspirin. The chlorthalidone was discontinued, due to "blood pressure dropping too low--they think his high blood pressure was situational" per wife of patient. Medical doctors advised against receiving the 2nd dose of Moderna vaccine. Patient being followed by Internist at hospital.  Patient's shortness of breath resolved "immediately after clot was removed" but is continuing to be followed while on new medications and blood thinner dosing.  The above information was provided during telephone interview of patient and his wife.
high pitch, unconsolable crying from 5PM-11PM; lump, edema & redness @ site on LMT lasting approx 24 hr; went to ER MD felt a nerve was nicked w/vax;
covid test result=postive; covid test result=postive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The patient had no known allergy.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid test result=postive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Nasal Swab.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300280960 same patient, different vaccine dose/event;
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death."Patient received "Patient received Moderna Vaccines on 3/3/2021 and 3/31/2021. Admitted 10/18 as transfer from an outside hospital. Transferred to ICU 10/19 due to worsening hypoxia. Placed on high-flow nasal cannula in ICU and had stable O2 saturations followed by worsening hypoxemia. Per patient and family request transitioned to DNR/DNI. Patient required non-rebreather mask on top of his high-flow nasal cannula in order to maintain O2 saturations. Remained on the settings for several days without significant improvement. On 11/01/2021 Epoprostenol with some improvement for 48 hours, O2 saturations up to 100%. Attempts were made to Additional information for Item 18:  wean off of non-rebreather mask, however, patient immediately desaturated to less than 80%. Patient had sudden decrease in oxygenation the morning of 11/03/2021 and was never able to achieve O2 saturations greater than 89%. Patient continue with significant hypoxemia in the afternoon followed by bradycardic episode, expired at 2:15 p.m.
3/9/2021 0800: Took dog outside. Upon coming in, I had sever chills and could not get warm the rest of the day and night.  3/10/2021 0630: Upon waking up, arm was very sore 3/11/2021-3/16/2021: Arm was in various stages of redness, swelling, and soreness 3/17/2020: Arm is still raised at the injection site, soreness has lessened.
It started with nausea, but later started with A fib worsening. Had my son take me to hospital and used Endoscopy and found all was fine at that time. Kept on having issues and returning to about 6 time during 6 weeks and found Gallstones. They were surgically removed. Later, was referred to a Gastroenterologist, who found I had Gastritis. Lymphoedema was discovered by PCP during a physical.  Compression wraps was issued for Lymphoedema. Protonix eventually discovered to help with Gastritis.
Body aches; Joint pain; 101.5 fever; Muscle pain; Injection site pain; Headache; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Sep2021 at 16:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. 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 COVID-19 vaccine. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date  as a single dose for COVID-19 immunisation. On 22Sep2021 at 02:00, the patient experienced body aches, joint pain, 101.5 fever (units unspecified), muscle pain, injection site pain and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/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 body aches, joint pain, 101.5 fever, muscle pain, injection site pain and headache were not recovered at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
6 days after the vaccination, my arm became itchy.  Next day there was a red rash the size of  a tennis ball.  10 days after vaccination the rash still there and grew a bit larger, tender to the touch and very hot.
Patient reported itching on arm first, then "all over" about 20 min after administration. She denied Benadryl due to extreme drowsiness. She did state that the itching "may be in my head". I watched her for 20 more minutes. She stated she is fine and good to leave. I asked her to call if anything outside of her normal happens.
Immunization given on 3/2/01. Presented to ER on 3/4/01 with complaint of red, swollen and painful right upper arm. Dx'd with right arm cellulitis. Treated with Benadryl and Keflex. Mother follow-up in physician's office on 3/5/01. No further orders.
Myalgia, Arthralgia, Fever, NauseaVomiting, Palpitations, shortness of breath; heavy sweating Narrative:  OTC Tylenol as needed
The first 2 hours after shot the left side of of the person's face was numb; This is a spontaneous report from a contactable consumer. A 48-years-old female patient received first dose of bnt162b2 (Pfizer covid 19 vaccine, formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 09Mar2021 10:00 (at the age of 48-years-old) as dose 1, single for covid-19 immunisation. It was unknown if patient received other vaccine in four weeks. Other medication in 2 weeks also unknown.  Medical history and concomitant medications were not reported. It was unknown that, Prior to the vaccination the patient was diagnosed with COVID-19. The patient experienced the first 2 hours after shot the left side of the person's face was numb on 09Mar2021. It was unknown that, since the vaccination the patient had been tested for COVID-19. Upon confirmation on query response, reported that patient was aware about date and that was evening of 09Mar2021. she also submitted a more detailed report on 10Mar2021. Therapeutic measures was not taken. The outcome of the event was recovered on an unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient was given Pfizer 6month - 4year monovalent as a booster  instead of Pfizer 5-11 year Pfizer bivalent
Expired 3rd dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired 3rd dose administered) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired 3rd dose administered). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired 3rd dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
SORENESS; FEVER; This spontaneous report received from a consumer concerned a 39 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A,  expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 on right arm  for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced soreness, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and soreness was not reported. This report was non-serious.
Underage before the 5/12/21 approval for Pfizer vaccine  Suspected falsification of DOB ? unable to contact guardian
Since taking the shot my left eye started twitching.  It started on sat and has not stopped.  It seems to be getting worse.
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 60-year-old male patient who received SHINGRIX for prophylaxis. On 21st January 2019, the patient received SHINGRIX. In January 2019, several hours after receiving SHINGRIX, the patient experienced muscle pain, influenza-like symptoms, joint pain, headache, foggy feeling in head, nausea, injection site hemorrhage, injection site pain and tissue damage. On 21st January 2019, the patient experienced localized erythema. On an unknown date, the outcome of the muscle pain, joint pain, headache, foggy feeling in head and nausea were recovering/resolving and the outcome of the influenza-like symptoms, localized erythema, injection site hemorrhage, injection site pain and tissue damage were unknown. It was unknown if the reporter considered the muscle pain, influenza-like symptoms, joint pain, headache, foggy feeling in head, nausea, localized erythema, injection site hemorrhage, injection site pain and tissue damage to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in left deltoid at the pharmacy and later that day, experienced miserable side effects further described as terrible muscle aches (like worst case of flu ever), joint aches, headache, felt like in a fog, and nausea. In addition, she stated that blood was dripping down her husband's arm after his injection. After a couple of hours, he experienced a redness area about 9cm below the injection site. The patient woke up on 23th January 2019 feeling better except his arm was still sore at injection site and there was a red spot below the injection site that was getting bigger. The area on the skin is red, somewhat circular, flat to the skin, about 9cm in circumference. The caller feels like this was an injection error by the pharmacist. She was concerned about possible tissue damage from the injection and absorption of the vaccine if given incorrectly. Referred caller to the health care professional. The reporter gave consent to follow up. This case has been linked with case US2019012757, reported by the same reporter.
RESTLESS; LACK OF SLEEP; LACK OF MOTIVATION; FELT ROSY IN THE CHEEKS; FELT HOT; FEVER; BODY ACHES; DIZZINESS; WEAKNESS; INJECTION SITE PAIN; EXTREMELY FATIGUE AND TIRED, FELT REALLY WORN DOWN; FELT OFF; SENSITIVITY TO LIGHT; SENSITIVE TO SYMPTOMS OF A SEIZURE ONSET; CRAMPING STYLE PAIN THAT TRAVELLED UP AND INTO THE SHOULDER AND UP INTO THE NECK MUSCLE INTO THE BASE OF SKULL WRAPPING AROUND HEAD CAUSING A MIGRAINE; HARD AND HOT TO THE TOUCH GOLF BALL SIZES LUMP SLIGHTLY PROTRUDING; DISORIENTED; This spontaneous report received from a patient concerned a 21 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included epileptic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 15:00 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On APR-2021, treatment medications included: paracetamol. On 10-APR-2021, the subject experienced sensitive to symptoms of a seizure onset. On 10-APR-2021, the subject experienced cramping style pain that travelled up and into the shoulder and up into the neck muscle into the base of skull wrapping around head causing a migraine. On 10-APR-2021, the subject experienced hard and hot to the touch golf ball sizes lump slightly protruding. On 10-APR-2021, the subject experienced disoriented. On 10-APR-2021, the subject experienced body aches. On 10-APR-2021, the subject experienced felt off. On 10-APR-2021, the subject experienced sensitivity to light. On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced weakness. On 10-APR-2021, the subject experienced injection site pain. On 10-APR-2021, the subject experienced extremely fatigue and tired, felt really worn down. On 11-APR-2021, the subject experienced felt hot. On 11-APR-2021, the subject experienced restless. On 11-APR-2021, the subject experienced lack of sleep. On 11-APR-2021, the subject experienced lack of motivation. On 11-APR-2021, the subject experienced felt rosy in the cheeks. On 11-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103.1 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dizziness, weakness, disoriented, fever, felt hot, felt off, sensitivity to light, and felt rosy in the cheeks, and had not recovered from injection site pain, cramping style pain that travelled up and into the shoulder and up into the neck muscle into the base of skull wrapping around head causing a migraine, extremely fatigue and tired, felt really worn down, body aches, restless, lack of sleep, lack of motivation, sensitive to symptoms of a seizure onset, and hard and hot to the touch golf ball sizes lump slightly protruding. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as case assessed as non-serious.
Arm is "burning" at injection site, sometimes the pain increase to a "stabbing" feeling. Pain is a 5 on the 1-10 pain scale Patient did not want any pain medication.  She will take some when she returns home if she needs to.  Denies any trouble breathing.  States she feels fine, but because this is a new vaccine she wanted to report her symptom. Patient asked to wait and extra 15 minutes.
acute severe vertigo (labrynthitis) beginning 36hr p/vax in MD office;
After receiving vaccines, the pt developed numbness of the right deltoid, onset date not specified, which had progressively improved. From correspondence received on 06/29/01 it was stated shortly after vaccination pt's arm was like it was dead. To hold a cup of tea left hand had to pick right hand up-weak. Gradually gone, reported 100% return to normal on 06/12/01.
Came home after 10am injection. At around 12 noon that day had severe vaginal bleeding, thick blood with little stones. After 3 hours we called GYN doctor.  She told me to go to MD and blood tests and other tests to see if there is a vaginal infection. If there is, go immediately to the ER.   I had tests at MD, and they told the doctor that there is no infection. Dr. told me, that since it was a holiday, to call the hospital the next day and make an appointment with a urologist.   Urologist performed many tests, including cystoscopy, where he discovered a tumor in the bladder. Dr. thought tumor was cancerous. Got a second opinion from PRIVATE who also performed surgery and took out 3cm tumor which was found to be non cancerous. Follow ups for the next year to ensure no cancer in bladder. I had another cystoscopy performed by same Dr. in November 2021 and he wants 3 more cystoscopies this year (2022).
I had 2 shots 3 yrs ago...theyre also painful; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for himself/herself. The age at the vaccination was not reported, however age group was captured as an adult as per vaccine indication. The patient stated he/she had vaccine 3 years ago and they were painful but having the disease was more horrible so better to have the vaccine. The reporter consent to follow up. This case has been linked with US2021AMR077251 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR077251:Same reporter.