chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt devel progressively worsening hives that began 12hr post vax;irregular size welts started on stomach, spread side to side, spreading to neck;nurse does not feel that rxn is vaccine related because progressively getting worse;
Unknown influenza vaccine in 2008, caused flu symptoms for several days afterward, including cough, sore throat, congestion, headache, fatigue, body ache, fever, etc. Possibly re-aggravated childhood allergies, eventually required allergy shots again after vaccine, continue to suffer severe allergies, which had been under control for years before vaccine. Link is not certain, but possible. Was not aware of reporting system until now.
The day of vaccination I started feeling the  left side of my body heavy (starting from my face to my leg). My column also hurted a lot and I had a severe headache. It?s been almost 3 weeks since vaccination and I?ve been to several doctors and the emergency room and right now they have me taking B12, Neurontin and Cortisone. During my second week after the vaccine both my legs started feeling heavy to the point where there are days where I can?t feel them or they feel extremely heavy to move, my column still hurts till this date. Tomorrow I have another doctors appointment in order to continue investigating what I have. I?m still waiting for an official diagnosis which is why I can?t give an official answer for item 21 (I still don?t know if the damages will be permanent). Due to this situation I haven?t been able to go to work.
Incorrect mRNA COVID-19 vaccine administered for the second dose. Patient in clinic for second dose. Received Moderna on 8/19/2021. Staff did not confirm primary dose in error. Patient did not suffer any adverse effects or complications as a result. Left clinic in no distress. No treatment indicated.
This spontaneous report as received from nurse refers to unspecified patients of unknown age and unknown gender. On an unknown date, the unspecified patients was received improperly stored VAQTA (lot# K012457 and expiry date: 04-JUN-2017; lot# L004743 and expiry date: 01-JUN-2017; lot# L023232 and expiry date: 25-FEB-2017. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Patient called on 09/04/21 and stated she had redness and swelling at the injection site and itching around the site
The day after the covid-19 shot, Friday 3/19, I felt nausea and light-headed.  On Saturday 3/20, I felt fine.  On Sunday 3/21, I woke up with a very sore throat and had flu-like symptoms:  headache, congestion, runny nose, coughing, chills, fever of 100.8, body aches and light-headedness.  These symptoms continued for the next several days.  It is now Wednesday afternoon and it is the first time I have felt that the symptoms are starting to subside.  I reported these symptoms to my doctor's office.  I had a covid test on Tuesday 3/23, which came back negative.  I am now taking Tylenol and Theraflu and drinking lots of fluids under the advice of my doctor's office.  They asked that I report my symptoms.
Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: Patient was given vaccine and walked to observation area, with mom. He sat down and few minutes later he started shaking, seemed to faint/was unresponsive. He slipped/was lowered to ground where he came to, but started vomiting. He vomited several times and was confused. 911 was called and the paramedics arrived. Water was offered by pharmacy staff, but was not taken. Paramedic stated to pharmacist that patient did not show signs of being post-seizure. Patient was put on strecther by paramedics
Arm swelling, pain, sensation of hardness, blisters, itch. Body aches and chills.
Caller stated he went to the ED with a "large red bump on my arm" and "they numbed it and lanced it and blood and pus came out.; the same thing happened on my face, around my mouth; got bumps on my left arm shoulder where I got the shot; Also got bumps on my arms, hands, back, left side of my chest and my left shoulder where I got the shot; the same thing happened on my face, around my mouth; This is a spontaneous report from a contactable consumer, the patient. A male patient of unspecified received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 2 via unspecified route of administration, 31Mar2021 (Batch/Lot number not reported) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 on 10Mar2021 for COVID-19 immunisation and had after my 1st dose, my mouth and lips developed cold blisters outside and inside my mouth. I had bumps on the inside of my mouth, and it took 7-10 days for the cold blisters to go away. Bumps inside my mouth are still there and the size of kidney beans. On an unspecified date in 2021, the patient stated, when I got my 2nd vaccine dose the same thing happened on my face, around my mouth and I also got bumps on my arms, hands, back, left side of my chest and my left shoulder where I got the shot. The patient stated he went to the ED with a large red bump on my arm and they numbed it and lanced it and blood and pus came out. They gave me antibiotics but that did not help with the bumps on my body. The patient stated his HCP said that was what you get for getting vaccinated. The patient stated his HCP does not wear a mask or believe we need the vaccinations. Can you tell me what these bumps are and is it a normal reaction to the vaccine? The outcome of the events was not recovered.  No follow up attempts are needed, information about lot/batch number cannot be obtained.
Started with chills and fatigue. Advanced to very hot body but no sweat, chills, body aches, pounding headache, fatigue, weakness, muscle aches, difficulty swallowing, burning eyes
pt recv vax & exp red itchy spot in face occurred w/in 1 1/2hr-antihistamine started-some rash to inner thigh that evening;8OCT96 sx subsiding;
Info has been received from a Pharm. D. concerning a pt who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot number not reported). Subsequently the pt developed itching, swelling and redness on the underside of the arm that was injected with pneumococcal vaccine 23 polyvalent. The outcome of the pt's itching, swelling and redness was unknown. The Pharm. D. reported that the pt sought unspecified medical attention. Additional info has been requested.
Pt recvd measles vax on 22AUG91 & the following day pt devel diarrhea which persisted 4 days; no further details were provided;
NEXT MORNING, INJECTION SITE WAS RED, WARM, AND PAINFUL. AFFECTED AREA EXPANDED ON FRIDAY. SATURDAY WAS SLOWLY RESOLVING.
Patient given Prevnar in left thigh on IPV in left thigh and DTAP in right thigh on 07/15/2003.  On 07/16/2003 Mother called with Lencren of refusal to walk, fussy and leg pain.  Patient seen in office 07/17/2003 with edema to left thigh and refusal to walk.  CPK labs within normal limits.  Patient fine 07/18/2003.
Rec the second Hepatitis B vaccination on 6-8-05 at Pvt MD office. The reason she contacted me was because I have previously given her the yellow fever vaccination on April 1, 2005. A couple of days after the 2nd vaccination of Hep B, around June 11th she stated she got a knot in her back and went to a chiropractor to assist with the pain. At that time the chiropractor asked if she had sone anything different and the vaccination was the only thing she could think of.  Then on the 18th she developed enlarged lymphs that she thought was related to her teeth. She went to the dentist who assured her nothing was wrong with her teeth.
Patient was administered an expired vaccine/ no AE; Initial information was received on 26-Oct-2021 regarding an unsolicited valid non-serious case received from a Physician via Medical Information (MI) (Reference number- 00829192) and transmitted to Sanofi on 26-Oct-2021.  This case involves a 69-year-old female patient who received an expired DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] with no adverse event (Expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided   On 26-Oct-2021, the patient received a 0.5 ml (total) dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot C5657AA and expiry date 26-Sep-2021] via intramuscular route in left arm for prophylactic vaccination.  Product used: Used. Still using product : No.  It was a case of actual medication error due to Expired vaccine used (latency was on same day).  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
t102 orally 12 hrs following vax; temp elevation lasted 48 hrs; local reddness & swelling @ inject site; nausea x 12 hrs following vax; dx by MD as having strep throat from vax;
Patient received Flu vaccine at 12:30pm. At home she had symptoms of tachycardia x 1 hour, oxygen level decrease 90% for 10 minutes, and  face & neck swelling from nose to neck area x 1 day. She took Benadryl 25mg with improvement.
This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient). A male patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had vaccination site pain/mild soreness at the injection site after their 1st dose of Pfizer COVID-19 vaccine, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Approximately 24 hours post vax, the pt developed localized swelling and redness in right arm. The pt experienced serum sickness like symptoms. Pt was treated in office on 3/31/00 with Allegra and Singulair.
This spontaneous report as received from a certified medical assistant refers to a 2 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 05-JAN-2016, the patient was vaccinated with a dose of M-M-R II (lot # L02464, expiration date 01-JUL-2017; dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
This spontaneous report was received from a registered nurse concerning a 17 months old female patient. On 04-JAN-2013 the patient was vaccinated with her first dose of VAQTA (Lot number unspecified). On 15-MAY-2013, the patient received her second dose of VAQTA (Lot # AHAVB692AA). The nurse practitioner reported that the patient did not experience any side effects related to the second dose of VAQTA given off schedule. This is one of two reports received from the same source (other MARRS#1306USA013101). Additional information has been requested.
This spontaneous report as received from a vaccine coordinator refers to a patient of unknown age and gender. No medical history and concurrent condition were reported. On 14-JAN-2019, the patient was vaccinated with an improperly stored second dose of PROQUAD (lot # R020677, expiry date 15-JAN-2020) for prophylaxis. The suspect vaccine was reconstituted with an properly stored sterile diluent. The vaccine was exposed to the temperature of -14.6 degree Celsius (C) for 30 minutes. Previous excursion included exposure to 0.1 C for 2 hours and -13.7 C for 45 minutes. A data logger was involved. No adverse effects were reported. No product quality complaint was present. This is one of the several reports received from same reporter source. Sender's Comments: US-009507513-1901USA006017.
fatigue ,headache ,myalgia ,arthralgia ,diarrhea , stomach ache ,bloating & blood pressure dropped down . still have stomach ache ,  bloating & low blood pressure
Are is red and warm, tender to touch, approx.  8.5 cm in diameter with moderate elevation.
Ringing in ears; This is a spontaneous report received from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6205), via an unspecified route of administration in the left arm on 05Mar2021 at 12:00 (at the age of 55-years-old) as a single dose, for COVID-19 immunisation. Medical history included sulfa allergy. Concomitant medication included propanol (MANUFACTURER UNKNOWN) for unknown indication. The patient previously received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: El9267), via an unspecified route of administration in the left arm on 12Feb2021 at 12:00 (at the age of 55-years-old) for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 20Mar2021 at 07:00, the patient experienced ringing in ears. The adverse events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if any therapeutic measure were taken for the event. The clinical outcome of ringing in ears was not resolved.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a registered nurse refers to a 39 year old female patient. On 25-AUG-2014, an adult patient was inadvertently vaccinated with PROQUAD (Merck) dose 0.5ml in left deltoid, Lot # K002999, expiry date 27-AUG-2015. No adverse effects were reported. Additional information is not expected.
Unknown adverse effect. Pfizer pediatric vaccine mixed with bacteriostatic 0.9% Sodium Chloride for Injection rather than the NON-bacteriostatic recommended per manufacturer.
About 20 minutes after the shot patient first complained that his ears felt "weird".   Later he complained of distorted hearing.  Patient complained that his ears were hearing shouting when we were just talking, especially his right ear.  He had a hard time understanding what we were saying.  The next morning when we asked more questions and noticed it was still bothering him, he said it sounded like a constant ringing in his ears and when he heard sounds they didn't go away.  He complained again that it sounded like we were shouting when we weren't.  The school nurse checked his ears and although he could hear all the sounds, when the beep of the test stopped, he still thought it was going.  She recommended we take him back to the pediatrician where he got the live flu nasal mist vaccine the day before.  We went and they did a hearing test and said that since he could still hear, we shouldn't worry and that if the ringing was still happening on Monday to bring him back.  He still is having a hard time understanding what he is hearing from his right ear and is still hearing constant ringing in both ears.
First started with flu symptoms and then fever and persistent cough that lasted about 3 weeks. After had vision problems and total blindness of left eye. Diagnosed with optic neuritis and was given steroids.
Information has been received from a licensed practical nurse concerning an approximately 11 month old patient who on 10-AUG-2007 was vaccinated with a dose of VARIVAX (Merck) (lot# 626960/0847H). On approximately 27-AUG-2007, the patient experienced varicella. At the time of the report, the patients' outcome was unknown. This is one of several reports received from the same source. No further information is available.
Patient was given a high dose influenza vaccine instead of the age appropriate vaccine for influenza due to error in pulling stock.
Information has been received from a pharmacist via a field representative referring to a 49 or 50 years old female patient. The patient had unspecified comorbidity. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, dose number, route and lot# were not reported). After receiving PNEUMOVAX 23, the patient was "unable to lift" her unspecified arm due to experiencing "a lot of pain under the arm" on an unspecified time. The outcome of the events was unknown. The causality was not reported. Additional information has been requested.
From initial report received on 13/Mar/2003 from the patient's parent regarding an adverse event occurring in the USA. It was reported that a 14-month-old male patient received ACTHIB (lot number UA680AA) given Intra-muscular in the right thigh, IPOL (lot number U0903-2) given subcutaneous in the left thigh, Diphtheria, Tetanus and Acellular Pertussis (lInfanrix, lot number 548A2) given in the left thigh, Hepatitis B (Engerix B, lot number 5252A2) given intra-muscular in the right thigh, and Prevnar (lot number 486-811) given intra-muscular in the left thigh on 09/Jul/2002. On 11/Jul/2002, the patient experienced a generalized rash and became irritable with a fever of 101 degrees Fahrenheit. Two weeks later, the patient's hair fell out. He was diagnosed in July with platelet pool storage disorder. The patient has recovered from this event. No other information was reported.
Swollen lymph nodes on left collarbone; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8730) via an unspecified route of administration in the left arm on 26Mar2021 at 16:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included no serious illness and had full left hip replacement. The patient had no known allergies The concomitant medication was taken by the patient (unspecified) within two weeks prior to COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: En6205) via an unspecified route of administration in the left arm on 05Mar2021 at 16:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 08:00, eight days after vaccine, the patient experienced swollen lymph nodes on left collarbone and fatigue day three through eleven. The events resulted in doctor or other healthcare professional office or clinic visit. The patient did not receive any treatment for the reported event. The clinical outcome of the events swollen lymph nodes and fatigue was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient reports on 9/12/2021 that within 2 hours of Pfizer vaccine dose #1 she experienced facial spasms and over the course of 24 hours experienced various body spasms which lasted 24 hours - Patient consulted with her Doctor and was told it was most likely not due to the vaccination but patient reported to us anyway. She says she is still experiencing some pain in temples but has been checked by Primary MD
swollen lymph nodes (still occurring) flu-like symptoms: hot flashes. cold sweats, fever (12-24 hours following vaccination) soreness at site (still occurring)
Shortly After I got the (Fluzone) Flu shot,. I started itching I right away I started using Clamine lotion to try to stop the itching. It did not stop, then I start seeing a lot of bumps all over my Arms, And legs. Immediately I went to my PC Doctor, she said I have hives. She diagnosis it And prescripted medication for me to take, After taking A number of different prescriptions, Knowing seemingly had helped. Dr. suggested that I go to An Allergist And Dermatologist. I have been under the Allergist cares I still have bad Breakouts(Hives)?
Within 15-minutes of vaccination, the patient reported lightheadedness, nausea, and dry mouth. EMS evaluated the patient on-site. The patient stated they were currently taking Augmentin for a UTI. Patient was hypertensive (162/82) with a FSBG of 84 mg/dl. EKG demonstrated NSR, rate 99bpm, no ST elevation. EMS administered 250mL IV saline en-route to  Emergency Department. In the ED, the patient reported lightheadedness, nausea, dry mouth, left arm injection site pain, and feeling like her throat was closing. Patient remained slightly hypertensive (144/81). Physician administered 1L IV saline bolus and 10mg IV Decadron. The patient was discharged with diagnoses of Dizziness and Vaccination reaction.
5/3/21 this gentleman reported several days of Left lower leg pain. Ultrasound completed positive for left lower leg DVT. Pt was on chronic Coumadin therapy at that time with therapeutic PT/INR 2.7. Symptoms progressed and ongoing despite initiation of Eliquis. On 6/8/21 he underwent placement of IVC filter to protect from further clotting injury.
Pharmacist stated FLUBLOK was given to an 11 year old child in error over the weekend with no adverse event; Initial information regarding this unsolicited valid non-serious case was received from a pharmacist via Medical Information (Reference number- 00327558) and transmitted to Sanofi on 22-Oct-2020.  This case involved a 11 year old patient of unknown demographics who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (product administered to patient of inappropriate age).  Relevant medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.  It was a case of an actual medication error due to inappropriate age at vaccine administration.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
Client's aunt discovered swollen red arm this morning before bathing child.  Egg shaped lump at site of Td, L arm vaccination.  Red and firm upon palpation observed by RN at TST skin test reading.  Ice applied and client referred to urgent care to treat or r/o cellulitis.
Headache; Feel nauseated; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and NAUSEA (Feel nauseated) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache) and NAUSEA (Feel nauseated). At the time of the report, HEADACHE (Headache) and NAUSEA (Feel nauseated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported . No treatment medication was reported .
Blood pressure increased rapidly, ambulance called, paramedics took to ER. 188/99 205/105.