chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HCP used an expired vaccine  in a patient; This case was reported by a other health professional via sales rep and described the occurrence of expired vaccine used in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number unknown, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th February 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 14th February 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, the Healthcare professional administered an expired Kinrix vaccine to the patient, which led to expired vaccine used. The reporter learned of this adverse event about 1 hour ago from the time of reporting. No other information was known. The reporter consented to follow up. Gave the reporter the Medical information number and time for the Healthcare professional to call.  The reporter gave permission for GlaxoSmithKline to contact them.
Patient indicates about 2 days after vaccine had onset of swollen tender lymph nodes in back of neck, head and groin. Patient also had stuffy nose and achy, lasted about 1 week. No treatment sought.
1 week after shot. Sore chest muscles, ear ringing, severe anxiety, winded easily, racing heart, heart palpitations, fast pulse with minimal activity. Waking in night with rapid pulse 140BPM, resting pulse between 90-110.  Headache, severe muscle aches and night sweats.  These severe symptoms lasted two weeks. Symptoms slowly have been subsiding, but it took nearly two months. Still have a slightly elevated resting heart rate. Other than that, feel fully recovered. Very scary experience! Grateful to be vaccinated though.
Patient reports pulling sensation right side of neck; 11cm(L)x8cm(W) red-raised -hot- painful & tender to the touch right Deltoid with painful ROM. MD Evaluation: +Rash; +Warm & erythemous local skin reaction Right Deltoid - no induration. Treatment: Rx Motrin 800 mg One tab orally every 8 hours as needed for Pain.  Return in 1 week if worse or fail to improve.
Shortness of breath, chest tightness, and injection site reaction warm to touch with swelling.
2 hours after receiving the seasonal flu shot, the subject started feeling weak, tired, and nauseous. She then began shivering vigorously and fell, but was conscious throughout. This lasted for 3 hrs. She was taken to the ER where she had an episode of vomiting, chills, and  fever of 101 deg. She experienced malaise, fatigue, decrease appetite, numbness/tingling of limbs, muscle pain, difficulty walking, and difficulty moving arms/legs. Blood tests were non-conclusive. She received IV fluids and was discharged from the ER the same evening. The subject experienced continued weakness for 1 week.
This is a spontaneous report from a contactable pharmacist. A 55-year-old female patient received PREVNAR 13 via an unspecified route of administration on 25Jul2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced that the injection site area was still very red, with big circle area around it and hardened in the middle, hot to touch and tender. It was stated that the patient did not have a fever but had a local reaction and felt "kinda icky" and still not 100% self. The reporter wanted to know if this was common as it had been 7 days since the injection. The outcome of the events injection site area was still very red, with big circle area around it and hardened in the middle, hot to touch and tender was not recovered, while outcome of the event felt "kinda icky" and still not 100% self was unknown. Information on batch and lot numbers has been requested.
muscle ache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of MYALGIA (muscle ache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (muscle ache). At the time of the report, MYALGIA (muscle ache) outcome was unknown.        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.  Treatment information was not provided. Lab details were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-035118, US-MODERNATX, INC.-MOD-2021-035118 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-035118:Cross link case for Reporter's mother neighbor (unknown gender, no patient identifer) US-MODERNATX, INC.-MOD-2021-035118:Reporter's husband case (male patient)
Pt bruised up after injection & had some soreness. Pt was called the next day & Pt stated that the soreness was still there but not any worse. On 10/21/2009. Pt spouse called the pharmacy to state that the Pt couldn't lift her arm to do her hair or put on jewelry. The arm is still sore.
redness of the arm she got the injection; swelling 2-6 inches long and its traveled to the back of the arm she got the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness of the arm she got the injection) and VACCINATION SITE SWELLING (swelling 2-6 inches long and its traveled to the back of the arm she got the injection) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Constipation, Heart disease, unspecified, Blood pressure abnormal, Anxiety, Dementia and Clot blood.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness of the arm she got the injection) and VACCINATION SITE SWELLING (swelling 2-6 inches long and its traveled to the back of the arm she got the injection). At the time of the report, VACCINATION SITE ERYTHEMA (redness of the arm she got the injection) and VACCINATION SITE SWELLING (swelling 2-6 inches long and its traveled to the back of the arm she got the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included medications for blood clots, constipation, heart condition, blood pressure, anxiety and dementia. Treatment details included ice on the arm.
soreness in shoulder; extremely tired and Exhausted; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (soreness in shoulder) and FATIGUE (extremely tired and Exhausted) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011421A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (soreness in shoulder) and FATIGUE (extremely tired and Exhausted). At the time of the report, MUSCULOSKELETAL DISCOMFORT (soreness in shoulder) and FATIGUE (extremely tired and Exhausted) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided No Treatment information provided   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Date of Birth, 1st Dose Batch number and second dose added
dizziness; rapid heart beat; This is a spontaneous report from a non-contactable consumer, the patient. A 59-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 at 18:15 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Other medical history included food allergy and environmental allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, the patient experienced dizziness and rapid heartbeat lasted for 1 to 2 minutes. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of dizziness and rapid heartbeat was recovered on an unknown date in Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
she then felt like her "face was a little bit swollen" along with her "neck"; she then felt like her "face was a little bit swollen" along with her "neck"; Dry mouth; also had very little arm pain; face felt weird/little weird when she was trying to swallow; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on 03Apr2021 16:00 as single dose for COVID-19 immunisation. Medical history included contrast dye allergy, pistachio allergy and concomitant medications were not reported. The patient previously took amoxicillin and experienced allergy and took cephalosporin and experienced allergy. On 04Apr2021, she felt like her face was a little bit swollen along with her neck, dry mouth, face felt weird/little weird when she was trying to swallow and also had very little arm pain. It was reported that, she received the first dose of the Pfizer-BioNTech COVID-19 vaccine on 3 April 2021. She explained she had listed the following allergies to the vaccination provider: contrast dye, amoxicillin, pistachio, and cephalosporin; then was monitored for 30 minutes after the injection. She specified she develops hives in reaction to the contrast dye but takes Benadryl before it to prevent the reaction. She explained that, she was scheduled at 4pm for the 1st shot, she left the facility at 4:30pm. At night, she woke up from sleep at 12:45 AM which is 8 hours later after receiving her 1st shot. She said her face felt weird, both sides of her neck were swollen. She stated it was a little weird when she was trying to swallow. She had a very dry mouth but her tongue was not swollen. She took two Benadryl 25 mg each total of 50mg. The next morning, she felt kind of the same thing: a little bit swollen, puffy in the face, her mouth was really dry and about 10 am until 11am in the morning she was fine until the rest of the week. She was scheduled to take the 2nd dose on 24Apr2021 at 10:30 am. Concerned what will happen next for the 2nd dose of covid vaccine. Therapeutic measures were taken as a result of events. The outcome of the events was Recovering/Resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
11/15/00, 17:00, received Prevnar shot and that evening complained of sore right leg at injection site. On 11/16/00 at 11:00, had a fever of 101.1F, muscle aches which resulted in child not wanting to put weight on right leg, legs shaking, complaints of muscle aches in arms, wrists (polyarthralgia). Fever and irritable for 36 hours, through 11/17/00.
Site: Itching at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium
Information has been received form a physician concerning a 16 (also reported as 14) year old male who on 30-OCT-1996 was vaccinated with the first dose of MMR II. On 19-FEB-1998, the patient was vaccinated with the second dose of MMR II. It was diagnosed on 24-DEC-2009 that the patient had left parotitis. First blood work was performed on 24-DEC-2009 (results not reported). The patient felt weak with no fever (also reported as afebrile). On 25-DEC-2009 the patient experienced mumps. At the time of the report the patient's outcome was not reported. Follow-up information was received from the physician indicating that on 18-JAN-2010, the patient developed mumps. It was diagnosed on 20-JAN-2010 that the patient had bilateral parotitis. The patient was not vaccinated with the third dose of MMR II. The second blood work was reported as no. No further information is available.
On 6/16/2023 at approximately 10:00 AM, client requested Hepatitis A vaccine from nurses. Nurse asked client for demographic information and confirmed client's immunization record and vaccine eligibility in electronic database. Upon assessment by RN, client denied having any history of allergies and completed the screening questions for Hepatitis A vaccine. Client reported history of stroke, anxiety, PTSD, hypertension and was hospitalized yesterday for hypertension. Client reported he went AMA at the hospital, but has an appointment today with his cardiologist at 11:30 am, and primary care provider at 4 pm. Client denied having any headache or blurry vision today, and denied prior vaccine reactions. At 10:17 am PHN administered Havrix lot # 772YT exp 9/23/2025 in the right deltoid intramuscularly. At 10:20 am client complained of a headache on the left side that started after the vaccine was given. Client denied blurry vision, denied feeling dizzy. Upon observation by PHN client had no visible rashes, no trouble breathing, client denied signs and symptoms of itching. Vitals taken by PHN at 10:22 am :HR 64bpm, SpO2 97%, RR 18 (no labored breathing observed), BP 170/98 in the left arm. Client alert and oriented to person, place, time, and situation.  At 10:25 am PHN continued to asses client's symptoms but client stated he was more anxious to the point where he has to "run out of here. I've reached a point where I'm going to start throwing tables. " Client then stated "its not my head anymore. Its just my PTSD." Client remained sitting at the table. Client refused a second set of vitals and refused to answer anymore questions, stating his "anxiety was getting too high." PHN walked away from the client and sat on the other side of the table. Client remained sitting and calmly continued to eat his breakfast. Client initiated conversation again with PHN about other topics, and stated this helps to distract him. At 10:40 am, client calmly stood up and walked away with a steady gait and refused assistance. Client stated he is worried about his blood pressure and plans to walk now to his doctor appointment.
The hives started on the 24th or 25th of July 2021. I started getting hives around my ribs, collar bone, and arms. They went away and the come back on my chest and arms. Sometimes I get them on my hand.
Pain, fever w/diarrhea on 4/24/10 AM very bad swelling w/pain all day fever of 101 and 103 on 4/25/10 began to burn, light chest pain, dizziness. 4/26/10 unbearable went to hospital.
Hospitalized 01/16/2022; COVID-19 positive 01/16/2022; fully vaccinated  Discharge Provider:  DO Primary Care Provider at Discharge: FNP Admission Date: 1/16/2022 Discharge Date: 01/20/2022  Discharge Disposition: Home at AFC Fever   HOSPITAL COURSE: Patient is an 81-year-old male who was admitted on 01/16/2022 for COVID-19 pneumonia with acute on chronic hypoxia.  Patient has received 5 days of steroids and 5 days of remdesivir he has been weaned down to his baseline 2 L of O2 via NC.  I did not continue steroids at discharge.  Patient's D-dimer was elevated at greater than 35,000 we did check a CTA thorax and Dopplers and there was no evidence of PE/DVT.  Did discharge him on prophylaxis Eliquis at 2.5 mg 2 times a day for 30 days.   Urinary tract infection with Aurococcus urinae and  Enterococcous faecalis Received Rocephin for 2 days then switched to amoxicillin 500 mg 3 times a day.  At discharge gave him 5 days worth of this to finish a 7 day treatment.   PT and OT saw him today patient is weak but appears to be at his baseline and the AFC home are able to do his ADLs and give assistance.  Home health PT, OT, and Nurse initiated. Vitals are stable, patient is medically cleared for discharge.
Injection site swelling, redness and itching. Area is extensive, trailing down the arm 5 inches in diameter. Advised patient to take BENADRYL and contact the doctor.
Migraine, joint pain, tiredness, generally feeling unwell, chest pain, stomach ache, aching muscles, period abnormal
Guillain Barre Syndrome, per medical records. Admitted to hospital 12/5/09.
Information has been received from the physician, via company representative referring to 6 months old patient of an unknown gender. No information was provided regarding the patient's medical history, current conditions or drug reactions or allergies. On 13-MAR-2019, the patient was vaccinated with the third dose of ROTATEQ orally for prophylaxis, with lot number R034700 and expiration date on 16-JUN-2020 (strength, dose, dose number, route of administration and anatomical injection site were not reported). In March 2019 (also reported as "within about 12 hours"), the patient started to have fever of 102. The fever resolved within 24 hours after TYLENOL was given. Other unspecified vaccinations were given at the same time as the dose of ROTATEQ. At the time of the report, the patient recovered from the adverse event and the causality assessment between ROTATEQ and the pyrexia was not reported.
Got 2nd dose vaccine on  4/15/21.  I  started to have menstrual bleeding  on 4/18/21. My last period JUST ended on 4/10/21. I NEVER had bleeding during ovulation in my entire life.  Today is 4/21/21, it is getting heavier than beginning.
fatigue; This is a spontaneous report from a contactable consumer (Patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: Unknown), via unspecified route of administration, on an unknown date, as dose 1, single for COVID-19 Immunization. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced fatigue after first dose for three weeks. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Syncope, nausea, vomiting, sweating, aching, and chills.
Was admitted via ED 4 days post injection of second dose and was diagnosed with pericarditis and NSTEMI. Since hospitalization a series of symptoms persisted or developed including altered vision, chronic intense headaches which are exacerbated by noise/lights/eyes moving to certain angles, dizziness, severe lethargy, severe intolerance to stress, emotional abnormalities including anxiety and depression, muscular stiffness, flu-like symptoms, vertigo-like symptoms, decreased reaction time, compromised memory recall and articulation fluidity.
pt recvd vax;mom states redness at site;size of quarter;began to spread p/ several hrs;25aug whole thigh covered;to MD 25aug; MD states leg infected;on pcn x 10 days;mom states leg improving now;
Patients husband was bringing his daughter to a vaccine event.  Spouse spoke of concern over his wife having a Pfizer COVID-19 vaccine in January and withing 24 hours being found unresponsive.  Patient details that she did not show symptoms of distress  after this second vaccination.  He went to check on her in the morning on 1/28/21 at different points in the morning but when checking on patient at around 11:00 AM she was found laying on her side unresponsive, not breathing.  Emergency medical profesisonals arrived but resuscitation efforts were unsuccessful.
Hives and itch rash (like sandpaper) on inside of both lower arms. Appeared about 1.5 hours after shot was administered. Symptoms still there 21 hours later.
Muscle Aches, very sore arm at injection site, nausea, low grade fever, headache
client notice large redden area around site of injection, No swelling , some tenderness at site. Otherwise client feels physically fine. RN recommended marking all area of redness with marker to watch for spreading. RN recommended ice occasionally and ibuprofen.
pt seen @ clinic 10APR95 1PM-12 hr later pt crying, t106 A; parents referred to VIS & gave APAP; checked temp in 1 hr t104A; checked again 1/2 hr t106; took to ER;
This is a spontaneous report from a contactable consumer (patient). A 27-year-old (non-pregnant) female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0164), at the age of 27, via an unspecified route of administration, in left arm, on May 3, 2021, at 09:30, single dose, for COVID-19 immunisation. No medical history reported. The patient has no known allergies. Prior to vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications not reported. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# ER8733), at the age of 26, via an unspecified route of administration, in left arm, on Apr 1, 2021, at 09:30, single dose, for COVID-19 immunisation. On May 4, 2021, at 06:30, patient experienced rash on bilateral forearms. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures taken as a result of the event. Since the vaccination, patient has not tested for COVID-19. The outcome of rash over forearms: resolving (at the time of report). No follow-up attempts needed. No further information expected.
There was only mild discomfort with the first dose.; This is a spontaneous report from a contactable healthcare professional (patient herself). A 21-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date not reported), via an unspecified route of administration in the right arm on 21Dec2020 11:30 at single dose for COVID-19 immunisation. Medical history was none. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included aminobenzoic acid, biotin, choline bitartrate, cyanocobalamin, folic acid, inositol, iodine, iron, nicotinamide, pantothenic acid, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine hydrochloride, zinc (HAIRVITE), and ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE). The patient experienced that there was only mild discomfort with the first dose on Dec2020. No therapeutic measure was taken as a result of the event. Clinical outcome of the event was unknown.