chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccine was too long in transit and they administered it yesterday; Initial information received on 25-Jan-2019 regarding an unsolicited valid non-serious case received from a Consumer/Non-HCP.  This case involves patient of unknown demography who received a dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot number not reported via unknown route in unknown administration site, that was too long in transit on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to incorrect product storage.  The Adacel was shipped on the 21st and we got it on the 24th. Reporter thinks that they were cold when they arrived but not sure of the temperature. They did not notice until after the vaccine was given that it took more than two days for vaccine to get here.  It was not reported if the patient had any adverse event.  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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.  Follow-up report received from a consumer or non-healthcare professional on 07-Mar-2019.  No new information received.  List of documents held by sender: none.
tested positive for covid after the first dose of vaccine; This spontaneous case was reported by a physician and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for covid after the first dose of vaccine) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for covid after the first dose of vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for covid after the first dose of vaccine) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, COVID-19: positive positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered SARS-COV-2 TEST POSITIVE (tested positive for covid after the first dose of vaccine) to be not applicable.
my body was aching with cold sweat; my body was aching with cold sweat; fever; headaches; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3248), via an unspecified route of administration on 12Feb2021 08:00 on Left arm at single dose for covid-19 immunisation. The patient medical history included Asthma, Eczema, Peppermint allergy. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3248), on 22Jan2021 15:45 on Left arm at single dose for covid-19 immunisation and experienced headache and Dizziness. Concomitant medications in two weeks include Montelukast (Strength: 10mg), Loratadine (Strength: 10mg) and cyclobenzaprine. On 12Feb2021 09:00, the patient reported, on his first shot he had headache and he was light head for 2 days. One the 2nd shot he was having headaches, my body was aching with cold sweat and he was having fever and temperature was 101. He states, he never had the covid at all. He started feeling better after 4th day. He started drinking emergency C one pack 1000 mg and had 3 packages in a 23oz water bottle. No other vaccine in administered in four weeks of vaccination. No treatment was given. No covid prior vaccination. Covid was not tested post vaccination. The outcome of events was resolving.   Information on the lot/batch number has been requested.
H&P: This is a 57 yo F, who presented  to the emergency department after being found by police outside a local methadone clinic.  Reportedly the patient had presented to medical clinic stating that she needed help.  She reportedly expressed suicidal ideation to police.  She was initially paranoid, threatening to staff and would not give her name. Eventually her husband called looking for her, and she was identified. She was placed on a section 12 and admitted. She did test positive for COVID 19 and she was admitted. She was completed asymptomatic for her covid. She did not require oxygen, did not require IV steroids or remdesivir. She was quarantined for 10 days, and she is no longer on isolation precautions
I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 on 02/18/2023. I had cold for about three days and then I tested positive for COVID-19.  I recovered and then I had pneumonia. I did not have to into the hospital, but I did go to an urgent care, but I was treated with antibiotics at home. As of today, I feel better, but my blood oxygen goes low at times. I was told it can take a few months to recover.
Fevers of 102.9 to 102 axillary for 3 days starting 7 days after MMRV and rash: macular pink diffuse blanching concentrated on the trunk 10 days after vaccine. Resolution of fever
Patient has redness, itching, swelling on one side of face from cheek to under chin. Feels warm to touch.
Pt. developed erythema & induration on (R) deltoid. Arm hot but not painful. Redness about 8cm x 8 around injection site. Pt given BENADRYL. Ice to arm recommended.
Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. Later in 2016, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
After receiving his first vaccine in series, patient was in recovery area with his wife. 5 or 10 minutes later, patient was feeling funny. Wife went to buy water. On returning she saw him fainting. I went over to help, place a cold ice pack on his wrist, and measured his BP. It was 105/61.  Pt had a cold sweat and was pale. After waiting for 30 minutes, his color had returned, and Pt was feeling better, and left with his wife.
Vomitting x 2 days, Diarrhea x 14 days, bowel movements as of 2/21/07, still not normal, she moans when she has a bowel.  2/26/07 Received medical records from hospital which reveal patient admitted 2/9-2/12/07 after experienced diarrhea, fever, poor oral intake & recurrent UTI.  Patient had been d/c from hospital 48 hours prior to readmission after being admitted for diarrhea & UTI.  Blood c/s at that time was neg.  Returned to PCP 2 days after d/c with Temp 102.6, poor intake & worsened diarrhea.  Admitted for IV hydration, labs & antibiotics.  By d/c, temp had resolved & was tolerating oral fluids.  D/C to home to be f/u by peds uro & VCUG, continued oral antibiotics to complete course & then prophylaxis. FINAL DX: Diarrhea; fever; hyponatremia w/dehydration; diaper rash; & recent UTI.
Within hours of injection full body raised rash with itchiness and swelling of the injection site.
Fever few days after vaccination (07-27-2006) varicella like rash developed on 08-07-2006.
Patient presents at pharmacy on 9-17-13 to show us his arm which is bruised from shoulder to elbow. The injection site seems hard but no warmth or redness. Patient reports reaction came on the evening of vaccination but he has no pain or itching, so he did not report until now. Patient says INR's have been slightly elevated. Advised to see MD.
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 52-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline), ENERGIX B. On 4 April 2011 the subject received 1st dose of TWINRIX in the left arm. On 25 May 2011 and 8 November 2011 the subject received 2nd dose (left arm) and 3rd dose (right arm) of ENERGIX B. On 5 January 2012, 58 days after vaccination with ENGERIX B, 7 months after vaccination with ENGERIX B, 9 months after vaccination with TWINRIX, the subject experienced not responding to therapy (non-reactive or non-quantitative titer drawn). The subject had no hepatitis B antibodies. No additional information was reported.
Muscle ache in arm. Headache. Stomach pains/throwing up. Body shaking - wrapped self in heavy blanket.
PT REPORTED REDNESS AND SWELLING IN HER ARM. WENT TO URGENT CARE, AND THEY PRESCRIBED BACTRIM IN CASE OF CELLULITIS. TOLD PT TO FOLLOW UP WITH PCP.
Sore arm, headache, nausea, fever of 101 degrees for 12+ hours, extreme fatigue--slept all day 4/27/18 and had to miss work.
At 3:30pm shortly after my first shot, the left side of my neck was very stiff and numb at lunch. Around 6pm my left bottom lip felt numb and part of my left side of face. The feeling was like when you have had Novocain for dental work but only about half numb.  Felt mostly better by morning the next day however I feel like the complete feeling hasn't returned mostly around my left cheek to chin.
About 3 minutes after receiving first booster (Pfizer), the pt reported feeling a tingling/tightening in her throat, a feeling of it being stuck. Denies difficulty breathing, but says she feels it ?where swallowing would happen?.  Pt also reported feeling light headed or having slight headache. Pt & vitals monitored for 30 minutes. Pt vitals remained stable throughout, no changes to speech or breathing, no increased work of breathing, accessory muscle use, and no observable or reported swelling to any area. Pt denied any side effects with previous doses during screening, but after reporting the tingling today, pt reported this had happened with her first 2 COVID vaccine doses. VS monitored, offered mat to lay down on if she felt more light-headed. Pt declined, reported improvement. Pt reported tingling decreasing by about 30% in first 10 min, then that it remained about the same for the rest of the time monitoring. Epi/Diphenyhdramine injection not indicated. Offered pt and family ambulance if wanted, recommended seeking further care at PCP, urgent care, or ER if sensation persisted or worsened. Pt and family declined, but said they would seek further care if they felt it was needed. Educated pt and family on signs and symptoms to look for if condition worsened. Recommended discussing with PCP, and bringing this up as an allergy if asked about reactions to medications etc. Recommended checking with PCP before receiving any additional COVID vaccine doses. Pt accompanied by family and safe upon ambulation out of clinic and to car. Able to ambulate independently and without difficulty. No increased work of breathing noted at this time either.
Pt said she noticed a baseball sized red mark at injection site, that was hot, red and itchy. Pt is calling Dr to report the event.
16 y/o VR present with father received vaccine and approximately 1 minute later became unresponsive, falling forward and hitting his face on the carpeted floor.  VR became rigid with posturing that lasted one minute.  VR regained consciousness.  VR had a 2.5cm laceration to the left eyebrow and abrasions to the left face.  Hemostasis is achieved with pressure.  NIHHS is 0 at the time VR regained consciousness.  CN exam intact as tested.  Cerebellar exam is intact  gait is deferred.  VR had been fasting. BP 90 /50, HR 50, 99% on RA, RR 16.  Sitting causes lightheaded/dizziness.  Ambulance was called and VR transported to Emergency Department. Father present throughout the likely multifactorial syncopal event.
pt recv vax 13DEC95 & 15DEC95 pt devel redness, soreness, swelling in the area from the elbow to one inch below the inj site on the rt arm, posterior position;the area was warm to touch;
Patient is a 40 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot ER2613 on 3/19/2021. The patient experienced the following reaction(s) during the immediate   of observation: 12:07pm Patient c/o numbness to bilateral hands. Denies tingling, shortness or breathing, or difficulty breathing. Patient reports anxiety. Patient was treated/managed as follows:   12:09pm VS BP 150/82, HR 80, RR 18, O2 sat 98% on room air. States symptoms are subsiding. 12:20pm VS BP 154/84, HR 74, RR 18, O2 sat 99% on room air. Patient reports feeling better. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. 12:28pm. Patient escorted to car by  RN.
Patient stated had swelling in arm after received vaccine. The swelling and arm pain radiated upwards towards neck and remained for since shot- 5 days later. Swelling had receded but was still have arm and neck pain.
Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Additional Details: Pt received both Pfizer Covid 19 booster vaccine and a Fluzone Flu shot. Pt was sitting down for about 5 minutes and he said he was not feeling too well. He stood up momentarily then passed out. He fell down and hit the back of his head on the ground. Pt was unresponsive for about 20 seconds. We called 911 immediately and EMT came in about 5 to 10 minutes after we called. Pt left with EMT to hospital.
Extremely dizzy and felt like I was going to pass out. Lasted a few minutes. Also I have noticed in the last couple of days a stiff neck on my left side (same as injection side) but not on my right side. It is sore when I turn my head to the left more that 90 degrees fro straight ahead
Arm was very sore; pain on my arm was very bad where on my whole arm and my whole side, back side of that arm; very strong pain on my arm, all back side, under my arm; very strong pain around my breast, all that side; Body ache; Chills; Fever; temperature; Last night I wasn't able to sleep because of the pain; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on 17Apr2021 (at the age of 60-year-old) as dose 2, single for covid-19 immunization. Medical history included blood pressure high from an unknown date and unknown if ongoing. Concomitant medications included metoprolol (METOPROLOL) taken as 50 mg once a day for hypertension, start and stop date were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8730) via an unspecified route, administered on 27Mar2021 as dose 1 single for COVID-19 immunization. The patient underwent lab test and procedure include fever result was unknown on an unspecified date in 2021. On an unspecified date in 2021, from Saturday morning and for the rest of the day the patient experienced arm was very sore, pain on her arm was very bad where on her whole arm and whole side, back side of that arm; very strong pain on her arm, all back side, under arm, very strong pain around her breast, all that side, all that side, body ache, chills, fever; temperature, last night she wasn't able to sleep because of the pain. Treatment received with 2 Tylenol 500 mg each. Consumer stated, no doctor, patient just went to get the vaccination where they were giving the vaccination. She just went herself. It was not facility but they were giving facility in big event for many people. Outcome of the event arm was very sore; pain on her arm was very bad where on her whole arm and whole side, back side of that arm; very strong pain on her arm, all back side, under her arm was not resolved, outcome of the event very strong pain around her breast, all that side, fever; temperature, last night she wasn't able to sleep because of the pain were unknown, outcome of the events body ache, chills were resolving.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
breakthrough case admission after 5 vaccines Moderna 1/12/21 Lot# 012L20A;  Moderna 2/9/21 Lot# 012L20A;  Moderna 10/15/21 Lot# 017F21A;  Moderna 4/6/22 Lot# 048L21A;  Moderna 10/13/22 Lot# 030G22B
Information has been received concerning pt that was vaccinated and subsequently experienced a sore arm and swollen lymph glands.
This spontaneous report as received from a licensed practical nurse refers to a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-AUG-2015, the patient was vaccinated with dose of GARDASIL (lot # K014191; expiration date, dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient is 4 mos postpartum  and is breast feeding  Became lightheaded, dizziness  and reported visual changes, Supine blood pressure 77/52 HR 100 / min Administered juice . After 5 min supine BP rose to 96/67  Patient continued to feel dizzy and EMS called  Extremities were cool to touch  Standing BP 60/42 following arrival of EMS (Patient felt weak and unable to stand  Placed on stretcher and transported to Hospital   Chest clear Airway Clear No wheezing .
severe joint main in right arm (especially wrist and elbow) almost a week after receiving the vaccine. Pain in arm pit and swollem lymph node.
Client had a hepatitis A exposure.  Came in for post exposure Hepatitis A vaccine.  Received Havrix IM in Left Deltoid on 5/27/21.   Phone call from patient this am.  Complained of some minor swelling and pain in the "middle part" of his arm.  Pain goes away when he rubs it.  Also stated he had a "bump" come up on one finger.  Stated he had a cyst in one knuckle that he thinks moved down to the finger.  Denies any hives or rash.  Denies any trouble breathing or other signs of anaphylaxis.  No other symptoms.  Instructed patient to seek medical attention or call his MD if he has any concerns.
Received Pfizer COVID vaccine 1/12/2021 and 12/22/20.     On 3/31 developed chills, headache, cough and sore throat.  Tested positive for COVID.
Patient describes a tingling feeling in his left fingers and weakness to his left hand (less strength) also has a red swollen area at site of injection (left deltoid).
fever of 101 degrees, nausea 3 days following vaccine.  No further symptoms since that day.
Injection site right arm pain radiating to and into anterior, medial and posterior shoulder joint, including arm pit, elbow and right neck.
Patient was given vaccine and vaccine information statement, walked to clinic area, sat down in waiting area, while nurse put the HPV vaccine in the computer and printed out her record. Patient  fell out of chair in waiting room onto the floor. Patient was pale, stated she was afraid she was going to pass out before vaccine so had a friend ready to drive her but told no one in the clinic.  Assisted her back into the chair, had a small superficial scratch on her right temple, no bleeding and no hematoma. No other injury noted. BP at 1:01 pm was 142/89, pulse 93. States she is terrified of shots and had not eaten. Gave her a pack of snack crackers and some water. She left with her friend after 30 minutes.
Has been sick; Doesn't feel good every day; Off balance; Light headed,been dizzy; Vertigo; Nauseous; Chronic fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Has been sick), FEELING ABNORMAL (Doesn't feel good every day), BALANCE DISORDER (Off balance), DIZZINESS (Light headed,been dizzy) and VERTIGO (Vertigo) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced ILLNESS (Has been sick), FEELING ABNORMAL (Doesn't feel good every day), BALANCE DISORDER (Off balance), DIZZINESS (Light headed,been dizzy), VERTIGO (Vertigo), NAUSEA (Nauseous) and FATIGUE (Chronic fatigue). At the time of the report, ILLNESS (Has been sick), FEELING ABNORMAL (Doesn't feel good every day), BALANCE DISORDER (Off balance), DIZZINESS (Light headed,been dizzy), VERTIGO (Vertigo), NAUSEA (Nauseous) and FATIGUE (Chronic fatigue) outcome was unknown.            Patient has no underlying issues, has had every test including a brain MRI.   Patient has seen other doctors besides his primary including an alternative medicine doctor, a Naturopath, and Homeopath.  Concomitant product information was not provided.  Treatment information was not provided.
had the flu; Initial information received on 28-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer/non health care professional.  This case involves an adult patient who got the flu (Influenza), while he/she received vaccine INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor. Concomitant medication(s) and family history were not provided.   On an unknown date, the patient received dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu (Influenza), unknown latency following the administration of INFLUENZA VACCINE. It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  Medication details and reason for taking the medicine was: Not provided.  On an unknown date, the event outcome was recovered (Flu for 3 weeks).  There will be no information available on the batch number for this case.
Red area (Rash, Rash) - not recovered/not resolved Itchy area (Pruritus, Pruritus)(Pruritus) - not recovered/not resolved Swollen (edema, Edema) (Edema) - not recovered/not resolved Tender (Pain, Pain) (Pain) - not recovered/ not resolved. A report was recieved from a health care professional on 5 November 2003 concerning a 41 year old female vaccinee who experienced a red, itchy area that was swollen and tender on the same day as receiving Fluvirin on 3 November 2003. On 3 November 2003 the vaccinee experienced a red, itchy area (40 x 60 mm) that was swollen and tender. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow-up pending.
At 10:30 pm Tuesday night massive diarrhea for 3 hours until stool ran clear.  There has been constant nausea everyday since then, including today.  Nausea gets less intense every day.  There has not been any fever.