chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain; raised rash on my arm.; arm was on fire near the shot; This case was reported by a consumer via interactive digital media and described the occurrence of skin warm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 31st August 2021, the patient received the 2nd dose of Shingles vaccine. On 1st September 2021, 1 days after receiving Shingles vaccine, the patient experienced skin warm. On 2nd September 2021, the patient experienced raised rash. On an unknown date, the patient experienced pain. The patient was treated with non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the skin warm and raised rash were unknown and the outcome of the pain was recovering/resolving.   The reporter considered the skin warm, raised rash and pain to be possibly related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient reported that he/she never had shingles. The patient received 2nd dose of shot 2 days ago on an unknown arm and last night his/her arm was on fire near the shot and now he/she had a raised rash on his/her arm (about 3 inches rough circle). The patient's some pain was took away by ice pack, but he/she could not let clothes touch that. The patient asked were any hints to relieve that and the patient was assuming it's a shingles reaction. The follow up could not be possible as no contact details were available.
Rash, tingling throat this started about 30 to 45 mins later and 24 hrs later had a migraines.
2 days after injection in left arm the tendon going across the top of my left hand going out to my left  thumb started feeling kind of weird like I had pulled a muscle or something. And the tendons on the  backside of my left leg from the knee joint all the way down to my foot started feeling unusually tired all  the time. its been over two weeks now and both the hand and the leg haven't got any better
Temporary hearing impairment, blurred vision, nausea, diaphoresis, shaking that was brought on within 30 seconds of immunization. Patient began to feel better within 2-3 minutes of sitting upright. Symptoms were fully resolved after 10 minutes. No treatment was administered.
terribly sick; fever of 102 degrees; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): EC-2022-111115.  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; pembrolizumab (KEYTRUDA), (Batch/Lot number: unknown) and on 06Apr2022 (Batch/Lot number: unknown); lenvatinib mesilate (LENVIMA), as 20 mg (Batch/Lot number: unknown) and on 13Apr2022 (Batch/Lot number: unknown) for endometrial cancer. The patient's relevant medical history included: "Endometrial Cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete), for COVID-19 IMMUNIZATION. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "terribly sick"; PYREXIA (non-serious), outcome "unknown", described as "fever of 102 degrees". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for pembrolizumab and lenvatinib mesilate was temporarily withdrawn.  Additional information: Patient was taking Lenvima 20 milligrams for Endometrial Cancer and it had been put on hold due to her platelet count being low (previously reported). Keytruda was also put on hold. Patient states she resumed Keytruda on 04/06/2022. Her platelet count was better so the Lenvima was resumed on 04/13/2022. Patient reports last Wednesday she received her Covid booster and got terribly sick. She had a fever of 102 degrees.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient presented to emergency room on 12/11/2021 with shortness of breath and productive cough. He had tested positive for COVID-19 on 12/9/2021. Patient was treated with dexamethasone and supplemental oxygen. He was discharged home on 12/14/2021.
Pt received update on immunization on 9-30-10 at approx 9:30 am. Pt mother called on 10-1-10 am stating she noticed a raised rash from shoulder to knees this morning. Pt was seen by PAC on 10-1-10. Mom was instructed to give pt. her ZYRTEC as prescribed QD. At office visit the reaction was improved from what was seen by parent this am.
Swollen lymph nodes. Ongoing swelling under the chin, breath odor and mild pain in the area of swelling.
Patient inadvertently received the second dose in the series of phizer covid vaccines, one week early. Patient should have received the vaccine on 5/14/21, and instead received the second dose on 5/5/21.  First dose of phizer covid vaccine was administered on 4/23/21. Patient currently has had no side effects from this vaccin error.
Administered a dose to a patient from a vial that had already been punctured for 8 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered a dose to a patient from a vial that had already been punctured for 8 hours). On 30-Mar-2021, EXPIRED PRODUCT ADMINISTERED had resolved. Not Provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided. Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: 037A21B) with no associated AEs.
Patient complained of having flu-like syndromes approximately 5-6 hours after vaccination. Muscle aches began and got progessively worse as the night wore on. By 10/5 patient had full-on symptoms of flu with feeling feverish and having painful joints and muscles. Patient did not leave home all of 10/5 but by 10/6 was back feeling "normal".
no energy; This case was reported by a consumer via call center representative and described the occurrence of loss of energy in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   In October 2021, the patient received the 2nd dose of Shingrix. In October 2021, less than a week after receiving Shingrix, the patient experienced loss of energy. In October 2021, the outcome of the loss of energy was recovered/resolved.   It was unknown if the reporter considered the loss of energy to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received 2nd dose of Shingrix vaccine a week before the date of reporting. The patient had no energy for 3 days following vaccination but now had resolved. The reporter did not provide any additional information. The reporter did not consent to follow-up.
I have a complex medical history with very little in the way of diagnosis, but I have had some of these symptoms before vaccination.  Afterward they got worse, or returned when they had previously been gone, and now they are still giving me some problems.  Anyway, basically I had an episode of syncope (passed out on my feet, fell and hit my head on a door frame), liver issues like clay colored stools and diarrhea, fatigue, and an inability to concentrate.  I could not work for several months and had my disability denied because I "didn't have a diagnosis".
PATIENT REPORTED ARM TO BE STILL SORE AT SITE OF INJECTION. SITE OF INJECTION IS RED, ABOUT 4 INCHES IN DIAMETER AND WARM TO THE TOUCH. NO REPORTS OF PUS/DISCHARGE. RECEIVED VACCINATION 2 DAYS AGO. NO REPORTS OF TROUBLE BREATHING, RASH, HIVES, OR TIGHTNESS IN THE CHEST. PATIENT COUNSEL TO TAKE BENADRYL IN CASE OF ALLERGIC REACTION, COOL COMPRESS TO SITE OF INJECTION AND TO CONSULT WITH PCP SOON. WE ALSO ADVISE PATIENT THAT WE WILL CALL THEIR PCP ALSO TO FORWARD THE INFORMATION AND CHECK WITH THEM IF PATIENT NEEDS TO BE SEEN.
I had a minor sore throat and that was the first symptom I had. That was on day 1 and I sprayed some chloraseptic mouth wash in my throat. After that, my throat didn't hurt. The next day, I had the sniffles and the day after that was when I actually had a cold. Runny nose, no fever. On Sunday evening of that week, I took a quick view at home COVID-19 test and I was positive. That Monday, I was able to see a physician. My doctor wasn't available but someone else at the clinic was, and they prescribed PAXLOVID. I took that for 5 days and I would say probably on the 3rd day, my cold symptoms were gone. I also did the 5 days of isolation then wore my mask for 5 days after that.
Initial unsolicited report received from nurse on 12-Sep-2018. This case involves a five-year-old male patient who was vaccinated with a 0.5 ml dose of PENTACEL (Batch number: C5527AA, expiration date: 04-Oct-2019, route: intramuscularly in right thigh on 14-Aug-2018. The patients concomitant medications included was HEPATITIS A VACCINE, VARICELLA VACCINE and MMR. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration. It was reported that the patient was due for his fourth dose of HIB and final dose of DTaP and IPV. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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. List of documents held by sender: none.
extreme breast pain, like a knife stabbing my breasts.  piercing pain, more so in left breast- side of injection.   was relived with time and advil
rapid heartbeat around 120; diarrhea; low-grade fever; vomiting; This spontaneous case was reported by a nurse and describes the occurrence of TACHYCARDIA (rapid heartbeat around 120), DIARRHOEA (diarrhea), PYREXIA (low-grade fever) and VOMITING (vomiting) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TACHYCARDIA (rapid heartbeat around 120), DIARRHOEA (diarrhea), PYREXIA (low-grade fever) and VOMITING (vomiting). At the time of the report, TACHYCARDIA (rapid heartbeat around 120), DIARRHOEA (diarrhea), PYREXIA (low-grade fever) and VOMITING (vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: around 120 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No treatment information was provided.
excessive crying 3 hrs p/DTP; poss limp or pale episode w/ ?sl sz activity;
Initial misuse report received from healthcare professional on 11 July 2013. A patient (No information was provided regarding the patient) had received a dose of only Dtap-IPV portion as the 4th IPV and 5th DTAP of PENTACEL to the patient as KINRIX on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Arm swelling and visible bruising all up the right arm on 2/15/2021.  Bruising all along the armpit down to waist started three days prior to the second shot on 3/9/2021.    Contacted his cardiologist who stated it was a spontaneous bleed and not related to the vaccine.    Received 2nd vaccine on 3/12/2021 in the left arm this time. The swelling and bruising  on the left arm started the next day.  Called ems on the 17th after a fall and was unable to get up.
Patient feels heart rate increased or pacing, dizziness and tightness on throat a little bit then went away. Vital signs 110/78 mmHg, 78bpm, 98% O2 RA, 18 cpm  #21.  pt was sent home
dizzyness, fever, hot and cold chills, fatige, diahria, muscle aches
Patient received a sub-optimal COVID-19 vaccine due to a storage and handling error. Vaccine was stored in a regular freezer prior to being refrigerated and then administered. The requested that a  form be submitted for this patient.
Nauseated; Vomiting a lot; fever chills; Arm was sore; chills; shaking a lot; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nauseated), VOMITING (Vomiting a lot), PYREXIA (fever chills), VACCINATION SITE PAIN (Arm was sore) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2001, the patient experienced TREMOR (shaking a lot). On 13-Feb-2021, the patient experienced NAUSEA (Nauseated), VOMITING (Vomiting a lot), PYREXIA (fever chills), VACCINATION SITE PAIN (Arm was sore) and CHILLS (chills). At the time of the report, NAUSEA (Nauseated), VOMITING (Vomiting a lot), PYREXIA (fever chills), VACCINATION SITE PAIN (Arm was sore), CHILLS (chills) and TREMOR (shaking a lot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Suspeced vaccination failure; have had two Shingrix shots have since gotten shingles twice; This case was reported by a consumer via interactive digital media and described the occurrence of Suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, 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 Shingrix and Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group of patient was not reported but was captured as an adult as per vaccine indication. The patient experienced 2 times Shingles after 2 Shingrix shots. The patient asking if need another Shingrix shot. This case was considered as suspected vaccination failure as details regarding TTO was  unknown at the time of reporting.
This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 60-year-old female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema and injection site irritation. On an unknown date, the outcome of the injection site erythema and injection site irritation were recovered/resolved. It was unknown if the reporter considered the injection site erythema and injection site irritation to be related to SHINGRIX. Additional details were provided as follows: The medical student who was working at a primary care office said after vaccination the patient had a local reaction from SHINGRIX. The health care professional stated these reactions had resolved within a few days. No further information was provided.
pt veryy fussy had fever 101 2hr p/vax;fever cont & fussiness next day gave APAP;very fussy & crying, would not stop;fever got higher 102-103;sz;cont to cry uncontrollable nothing helped;p/sz stared off & did not respond to verbal calling;
I'm not reporting an adverse event, but rather a vaccination error. This patient wanted to get the Pfizer Bivalent booster dose, but instead was inadvertently given a dose of an UNDILUTED Pediatric Pfizer Booster dose of 0.3mL. I spoke to a Pfizer representative who confirmed that the undiluted concentration is the same as that of the adult vials, so because the patient received 0.3 mL of the undiluted dose it was equivalent to 30mcg, which is the same as 0.3 mL = 30mcg of the adult vial. I also contacted out counter public health department and spoke to Dr. who advised not to revaccinate the patient because they received the intended dose.
Fever; Sore throat; This is a spontaneous report from a contactable consumer (patient).   A 12-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number/Expiry date: Not reported) via an unspecified route of administration, administered in right arm on 21Aug2021 at 15:45 (age at vaccination was 12-years) as dose 1, single for COVID-19 immunisation. Patient medical history included seasonal asthma from an unknown date and unknown if ongoing. Concomitant medication was not reported. On 21Aug2021 at 03:15, the patient experienced fever and sore throat. Patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and not tested for COVID-19 post vaccination. The patient underwent lab tests included body temperature: fever 2 days later on 21Aug2021. The patient did not receive any treatment for the events. Outcome of the events was not recovered.  The lot number for BNT162B2 was not provided and will be requested during follow-up.
Administered HIGH DOSE FLUZONE to patient at around 6:30 PM on 10/17/2013. After 1 to 2 minutes after administration; pt complained of leg pain in the site. Contacted ambulance. Pt refused to go to hospital at the time.
Initial report received from a nurse on 02 August 2007. A 23 year old, female patient (with a history of no unknown allergies) developed a migraine, headache and had difficulty breathing that evening after she received DECAVAC (lot number, route and site of administration unknown) on 24 July 2007, for stepping on a nail. She went to the emergency room and was treated with BENADRYL. It was reported that she recovered. She had her last Td >10 years (before). The patient was pregnant at the time of the vaccination. She has had 2 previous pregnancies - with 1 normal/viable pregnancy outcome and full term delivery and 1 spontaneous abortion. Her last menstrual period was 20 April 2007 and her expected date of delivery is 25 January 2008. She had an ultrasound on 19 June 2007 with normal results - 8 weeks 4 days. She was taking Prenatal and CITRACAL PRENATAL RX + DHA - for pregnancy. Follow-up information was received on 07 September 2007 from the health professional with provided DECAVAC lot number as U1880DA. No other medically significant information was provided.
2 hrs p/DTP vax pt became very tired & groggy; mom took t103 R; APAP given & temp cont to rise; vomiting; called MD & they recommended APAP & alcohol sponging over noc; t104 & pt fussy; to MD office; adm to hosp;
My husband who also was double boosted had been out of the state. He came home and developed symptoms 2-3 days before I did. My symptoms began with a sore throat first. I had a slightly hoarse voice. I felt kind of warm, but my temperature was 97.2. I felt warm and had a slightly runny nose. But that day my COVID test was negative. Sunday the 15 was negative. Tuesday the 17 was still negative. The sore throat on the 17th was pretty much all day. It was a bit intermittent. Wednesday May 18, the sore throat would not go away. I had nasal congestion; I was sneezing. My voice was hoarse, and I had no appetite. I was also unusually thirsty. Couldn't get enough to drink. On that day, first thing in the morning with the sore throat. I was still afebrile. My temp was 98.4. I waited to see how the day would go. Felt lousy all day. Symptoms did not go away, just did not feel well. By 2PM, nothing felt better, and I took my temperature. I did a COVID test on May 18 at 2PM and it was positive. My temperature was 99.9 at 2:20PM. At that point, I got on the phone with my doctor for telemedicine. She prescribed molnupiravir, the antiviral 200mg. Take 4 capsules twice a day for 5 days. I began that the evening of May 18. The last dose was yesterday morning May 23, 2022. Took it twice a day all those days in between. May 19, no more sore throat. Temp was 98.1. Afebrile. A little bit of a runny nose, not really congestion, Sunday-Today I'm symptom free. We did some have malaise. No energy and no ambition to do much on Saturday. But everything Sunday on has been better. I was feeling absolutely normal on Sunday. I did another test and that remained positive May 22, 2022. Finished the antiviral.
pt had t105 ax p/vax; fine red rash over body; dx viral infection;
PAIN, SWELLING, TENDERNESS, WARMTH, AND ERYTHEMA AT INJECTION SITE.  STEADILY ENLARGING AREA OVER PAST TWO DAYS.  7 CM X 13 CM ON 8/4/2010, 9 CM X 18 CM ON 8/5/2010.  PATIENT WAS STARTED ON AB RX FOR POSSIBLE CELLULITIS AT INJECTION SITE
Pt reports feeling fait, dizzy, 1 episode of emesis, palpitations, scratchy throat. Given Cetirizine, MD assess.
mother reports after 1st series, infant developed rash at injection site, approx. 11cm in diameter.  After 2nd series, infant developed temperature of 104 within 12 hours of issue vomiting x 3 days, iv fluids x 2 days by PMD, temperature 104 lasted for 4 days.
Presented with shortness of breath and was hypoxic requiring supplemental O2. He was found to have covid 19 as well as high suspicion for bacterial pneumonia. Tx w/abx, steroids, O2, zinc; weaned to RA for DC home.
She received the vaccine around 11AM and about 2 hours later she started having a rash on the right side of her face and some hives. About 1:35PM it spread to the left side of her face. At 1:50PM I gave her Benadryl and she started improving after that. We went to see the Urgent Care Dr. about 2:45PM and they checked vitals were ok. Her blood pressure was a little low at first, but it they determined it was ok.