chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient smiling / cooing one moment and screaming in pain the next.  Patient became inconsolable / screaming / legs stiffened.  Right leg from thigh (vaccine location) to calf became fevered, red, swollen.  Doctor's office advised us to look for fever, rigidity, lethargy of which none occured.  Leg swelling, redness disappeared by next morning.  Doctor's office indicated patient had severe, localized reaction to the HIB vaccine.
This spontaneous report was received from a physician via a company representative concerning an approximately 26 year old (also reported as under 50 years of age) male patient. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On an unknown date in 2013 (between 25-FEB-2013 and 19-MAR-2013), the patient experienced an unspecified reaction on his arms after being vaccinated with PNEUMOVAX23. It was a more severe reaction that required an antibiotic treatment. The outcome of the event was unknown. It was unspecified if any lab tests were performed. The relatedness for the event was unknown for PNEUMOVAX23. This is one of the two reports from the same source. Additional information has been requested.
First attempt at administering the patient's second dose of the Moderna COVID-19 Vaccine led to detachment of the syringe barrel from the needle. Unclear whether any vaccine entered the patient's arm. Called  MD who advised that we administer a half dose (0.25 mL) of the vaccine to the patient, which we did immediately.
patient has a knot on her arm and redness about 1.5 inches out around her injection site , as well as, soreness I told patient to use cold compresses for about 15 minutes at a time , and to take benadryl and ibuprofen
Depression/malaise. Woke up in tears. Burst into tears several times throughout the day for no reason. Really bad headache. Slight nausea. Extreme fatigue. Stiff neck. Still feeling like this now (3:00 PM).
Persistent L shoulder pain, MRI consisted with minimal fluid deep to the deltoid muscle. Rest of the shoulder  MRI was normal.
Patient was given 2nd Moderna vaccine at about 7:30. Patient was pale and diaphoretic and was lowered to the floor by RN and another patient receiving the vaccine who was a cardiologist. He had several beats of clonus and then woke up. He was awake when his first vital signs were obtained. HR 110, BP 190/96, O2 sat 100%. When he was more awake he was assisted in to a reclining chair. BP monitored every few minutes and dropped as low as SBP 104, HR 70-80s. Pt reported that he periodically syncopizes, last 6mo ago. He reported feeling lightheaded after seeing his arm bleed and be swollen after vaccination. After about 1 hours the patient's vital signs were stable but he continued to have symptoms of lightheadedness which worsened when I sat him up (though BP was stable). EMS was called and he was transported to the ED.
A serious report of trauma has been received from a study investigator concerning a four-year-old female participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 04-Dec-2008, the subject received FLUMIST. The subject was admitted to the hospital for trauma on 28-Dec-2008. The length of stay was one day. The outcome of the event was not reported. The investigator assessed the causality for the event to FLUMIST as not related. The severity of the events was mild. The sponsor also assessed the causality for the event as not related to FLUMIST.
Pt. had painful red swollen 4 X 3 1/2" area on left arm after vaccination
Chills, fever, headache, nasal congestion, sore swollen, red site of injection, itching at site, injection site leaking fluid and weeping, muscle soreness, joint pain, flu like symptoms, diarrhea 3 days out from inj. Lasted 5 days.
Loss of hearing in right ear ( next day ) Went to ER prescribed steroids 50 mg  Taking from 10-24-10 31 no changes still unable to hear
Developed full-body hives starting 8 hours after receiving vaccine. Hives gradually dissipated over ~5 days, started taking Allegra as needed on second day. Had telehealth visit with doctor on day 3 (Monday) to confirm that no other treatment was needed  Confirmed w/ allergist that I'm not allergic to PEG; took double dose of Allegra for 1 week prior to receiving booster. Received Moderna booster and did not have any hives after booster
With Both Shingrix Vaccines, pt Reports fever, flu like illness, Painful injection site. Rigors. Rash/welts on (L) side of face. Attached Notes for Review.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 28-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, 0.5 ml, (lot # K009105, expiration date 21-JAN-2016) (route and dose were not reported. No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 72, 47 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Deep vein thrombosis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Large area 7 inch X 4 inch area of swelling, redness, warmth, redness around injection site. Treated with ice. Began approximately 12 hours after injection lasted 4 days.
Patient stated her arm swelled up and she did not feel well after vaccine (felt like she had the flu). In addition, she indicated she had pain on her calves.
Sores in mouth and tongue after 1st injection. Still have them; Sores in mouth and tongue after 1st injection. Still have them; This is a spontaneous report from a contactable consumer (patient). A 45-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: El1284, Expiry date: unknown), via an unspecified route of administration, administered in left arm on 01Jan2021 at 16:45 pm (age at vaccination was 45 years) as a 1ST DOSE, SINGLE for COVID-19 immunization. The patient's medical history included high blood pressure, diabetes and chf (congestive heart failure). The patient's allergies to medications, food, or other products included sulfa allergy. The patient received concomitant medications within 2 weeks of vaccination and the details were unknown. On 03Jan2021 at 16:00 pm, the patient experienced sores in mouth and tongue after 1st injection, still have them. The facility where the most recent COVID-19 vaccine was administered was Public Health Clinic/ Administration facility. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: Ek9231, Expiry date: unknown), via an unspecified route of administration, administered in left arm on 21Jan2021 (age at vaccination was unknown) as a 2ND DOSE, SINGLE for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The event was reported as non-serious. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
This case was considered medically important (OMIC). Follow up information was received from an investigator providing additional information, correct dates of administration, onset of event dates, additional events, patient outcome and concomitant medications. Information was received from an investigator regarding a 6 year old male who received a dose of Prevnar and Recombivax HB vaccine on 12/5/01. The vaccines were administered as part of clinical trial. The participant developed an injection site erythema, injection site reaction, headache, and fever. The patient's concurrent illness includes HIV infection. Indication for Prevnar was immunization. Product was administered on 12/5/01. Dose regimen was 1 dose (IM). Concomitant therapy included Recombivax HB, Nelfinavir, Epivir, and Retrovir. On 12/6/01, the subject developed a fever of 100 degrees F and a headache. Tylenol was administered, and the events resolved later that day. The patient also developed an injection site erythema greater than quarter size on the right arm, at the Prevnar injection site that was rated Grade 3 (diameter of erythema was greater than or equal to 25mm, but less than 50% of the extremity) and injection site reaction on the same day which also resolved later that evening. The reporter also indicated that on a subsequent follow up phone call on day 7, no signs or symptoms were reported. The investigator(s) considered injection site erythema and injection site reaction definitely related to the study product; while headache and pyrexia were considered possibly related to the study product. The medical monitor(s) assessment for injection site erythema, injection site reaction, headache and pyrexia was unknown.
Patient was accidentally given a third dose of the vaccine.  Computer system did not register 2nd dose given the week before and vaccine card was not filled out to show 2nd dose was given during the previous week.  Patient reported no symptoms or side effects post discharge from clinic.  Followed up with wife that same evening and wife reported that patient was feeling fine with no symptoms.
Severe 10/10 headache ?I have no history of headaches?nausea, body aches?I was completely incapacitated and unable to do anything. These symptoms started about 5 hours after my vaccine injection. I Went to convenient care and was given iv fluids, toradol in my Iv, and nausea meds. I had already tried Tylenol, ibuprofen, and Zofran at home with no decrease in pain.
8 hours after administration of vaccine patient experinced hives and itching covering her entire body that worsened over the next 24 hours.
The patient states that on March 20 he was vaccinated with the Johnson and Johnson COVID-19 vaccine. He states that over the past several days he has developed erythema of the palms and a change of appearance of the palms that ?looks like they aged 3 years.? He states that he has developed new onset pain of the thigh, which has made ambulation difficult. He states that these symptoms were not present prior to obtaining the vaccine.
Shortly after first injection (approximately 72 hours), I started with alternating between diarrhea and constipation every few days. This had continued to this day (07 Aug 2021).
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) 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 01-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   Reporter did not allow further contact
Anaphylaxis-throat closing within minutes followed by vomiting with O2 sat 90%.  All sx resolved within 2 minutes of receiving epi-pen-ambulance transport to hospital 7/5/07-records received from facility for DOS 6/26/07-DX: Anaphylaxis to varicella vaccine. Twenty minutes after he received his second booster of Varivax, complained of tightness of throat and began vomiting. Oxygen saturation 89%, administered an EpiPen. Throat felt better. Upon arrival at ER developed hives and facial redness. HX of asthma induced by common cold. Treated with Benadryl and Orapred. Observed and discharged
This spontaneous report was received from the physician via a company representative and refers to a 71 year old female patient. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 25-MAY-2014, the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml, single dose (route and site of administration, lot # and expiration date were not reported) for prevention of shingles. On unknown date (reported as after vaccination), the patient experienced shingles. The physician prescribed valacyclovir hydrochloride (VALTREX) for the shingles. The outcome of the event was reported as recovered. Causality assessment was not provided. Additional information has been requested.
severe fatigue; fever; aches; nausea; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date at SINGLE DOSE for covid-19 immunisation.  Medical history included had lung cancer a few years ago. The patient's concomitant medications were not reported.  2 weeks after taking the second Covid vaccine she experienced fever, aches, severe fatigue and nausea for 2 days. The outcome was unknown. She would also like Pfizer to tell the facilities that are giving the shots side. effects can still appear weeks after the last shot.  They are telling patients if they have any it will be within 24 hours. She thought her cancer had came back because she was not told this.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Numbing pain left arm, sharp pain left foot, difficult hearing of left ear and palpitations.
I had a blood clot in my leg and it was difficult for the nurses to take blood.   Before I delivered the baby, the nurses had difficulty trying to take blood from me.  Three nurses attempted to take blood from me and it was hard for them to do so. I delivered my baby on 07/08/2021. I had a C-section. On 07/16/2021, I went to the ER.   When I was at the ER, three other nurses had trouble getting blood from me. When they were able to get a little bit, they said the blood was clotting in the tube - so they proceeded to try to take more blood, but it was still difficult. I was sent home and was given blood thinners. I am still experiencing pain in that leg.  I had three C-sections prior to this adverse event and never had any issues before.
The pt complained of left shoulder pain the day of the immunization, saying she had been lying next to the cold air vent and thought pain was from cold air. The day following immunizations (5/2/00) in the evening, the pt developed a rash that traveled down l arm. Eventually rash traveled up left arm to neck and ears. ON 5/3/00 called MD and was told to see her PMD. Saw MD on 5/4/00 and was diagnosed with shingles. Treated with Tylenol and codeine. MD told her she could resume Hep B immunizations.
I am 5 months pregnant. Have body aches. Tired and itching everywhere. No redness or rash. Just persistent itch that won?t go away. I have had 3 Benadryl and am seeing a doctor
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) 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) all with onset 02Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Aug2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: patient received COVID 19 Treatment Paxlovid from 02Aug2023 to 06Aug2023. Positive COVID test on 02Aug2023, immediately started Paxlovid the same morning.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Localized red, warm, hardened, swollen area on left thigh, morning after injection given.
left arm was infected; left upper arm was swollen; left upper arm was quite warm; left upper arm was red; left upper arm was tender; really really tired, like couch-potato tired".; temperature of 102 degrees Fahrenheit; really really cold; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (left upper arm was quite warm), VACCINATION SITE INFECTION (left arm was infected), FEELING COLD (really really cold), VACCINATION SITE SWELLING (left upper arm was swollen) and PYREXIA (temperature of 102 degrees Fahrenheit) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure and Cholesterol. Concomitant products included NIFEDIPINE for Blood pressure, METOPROLOL SUCCINATE for Blood pressure management, ROSUVASTATIN CALCIUM for Cholesterosis.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced FEELING COLD (really really cold) and PYREXIA (temperature of 102 degrees Fahrenheit). On 20-Mar-2021, the patient experienced FATIGUE (really really tired, like couch-potato tired".). On 22-Mar-2021, the patient experienced VACCINATION SITE WARMTH (left upper arm was quite warm), VACCINATION SITE SWELLING (left upper arm was swollen), VACCINATION SITE ERYTHEMA (left upper arm was red) and VACCINATION SITE PAIN (left upper arm was tender). On an unknown date, the patient experienced VACCINATION SITE INFECTION (left arm was infected). The patient was treated with CEPHALEXIN [CEFALEXIN] at a dose of 250 milligram three times a day. On 19-Mar-2021, FEELING COLD (really really cold) had resolved. On 21-Mar-2021, FATIGUE (really really tired, like couch-potato tired".) had resolved. At the time of the report, VACCINATION SITE WARMTH (left upper arm was quite warm), VACCINATION SITE INFECTION (left arm was infected), VACCINATION SITE SWELLING (left upper arm was swollen), PYREXIA (temperature of 102 degrees Fahrenheit), VACCINATION SITE ERYTHEMA (left upper arm was red) and VACCINATION SITE PAIN (left upper arm was tender) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Body temperature: 102 (abnormal) 102 degrees  Fahrenheit. On 19-Apr-2021, Blood pressure diastolic: 80-90 (High) 80's and 90's. On 19-Apr-2021, Heart rate: high (High) high.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Patient states she think she had COVID-19 back in Mar 2019 but her doctor told the immunity won't last that long, patient states she was not going to receive the second dose of Moderna Covid-19 vaccine as she doesn't want problems with her blood pressure again.
Patient stated "I feel funny" tingling in arm" noted redness in lower arm not at injection site , pt stated similar reaction after donating blood before, no SOB noted. Followed up with patient today 1/22/2021 and no further reactions reported
At the injection site a big blister ended up forming and is quite painful to the touch as well as the expected muscle pain, as well as the next day it felt like I had gotten hit by a truck, about every muscle was sore in my body and I was running a low fever
Pregnant patient; Fever; Chills; Headache; Pain at injection site; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and INJECTION SITE PAIN (Pain at injection site) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 23-Dec-2020 and the estimated date of delivery was 20-Sep-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and INJECTION SITE PAIN (Pain at injection site). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant patient) outcome was unknown and PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and INJECTION SITE PAIN (Pain at injection site) was resolving.            No concomitant medicines were reported.  Action taken with the drug in response to events was not applicable.
INCORRECT PRODUCT STORAGE; THE HIGHEST TEMPERATURE REACHED WAS 46.6 DEGREES F/THERE WERE PATIENTS GIVEN INJECTIONS DURING THESE 3 EXCURSIONS; This spontaneous report received from a health care professional concerned multiple patients. 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, and batch number were not reported) dose was not reported, administered on 29-JUL-2022 for covid-19 prophylaxis. The drug was associated with Medication error. The batch number was not reported and has been requested. No concomitant medications were reported.  On 29-JUL-2022, the patient experienced the highest temperature reached was 46.6 degrees f/there were patients given injections during these 3 excursions. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the highest temperature reached was 46.6 degrees f/there were patients given injections during these 3 excursions and incorrect product storage was not reported. This report was non-serious.