chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A 13 year old girl came in for immunization update, accompanied by her mother. The RN administered four vaccines, beginning with Hep A in the right deltoid. By the time the 4th vaccine was administered in the left arm, the patient's chest had developed red blotches, and it appeared to be spreading up her neck. Red blotches were noted over her right shoulder also. There was only minor erythema around the other vaccine sites. Patient denied itching, difficultly breathing, difficulty swallowing. The physician was called in to examine her and he prescribed Benadryl 50mg, po (the patient had expressed and exhibited extreme anxiety over "getting shots"). Benadryl 50 mg po was given at 11:00 am. The red blotches on her chest and neck resolved over the next 20 minutes. Blotchy erythema remained present, though diminished, surrounding the bandaid over the Hep A site. Patient's vital signs were WNL, and she was allowed to leave with her mother at 11:30 am. Her mother was given a prescription for Benadryl 25 mg to be given every 6 hours over the next 2 days, and advised to call 911 for any difficulty breathing or swallowing. Per phone call to the patient's mother three hours later, the redness had completely disappeared, and she reported the child was doing well.
Complained of chest pain pressure and difficulty breathing starting at 8:00pm and lasting until 3:00 a.m. Took an aspirin ad sat in recliner until symptoms resolved.
Resident was noted to have a low blood pressure on 9/4/21 89/47 and oxygen was less than 90% with usual supplemental oxygen at 2L. On 9/5/21 oxygen need was increased to 5-6LPM for saturations in the low 80s and redness and petechia was noted to his left leg. (Was already being treated for venous insufficiency in right leg).  On 9/6/21 the resident was started on antibiotics (Levofloxacin) for pneumonia with pleural effusion. Daily INRs were initiated due to use of antibiotics and chronic Coumadin use.  Coumadin was given on alternate days of the antibiotic.  On 9/9 the INR was 5.4 and on 9/10 the INR was 5.8.  He received a one time dose of Vitamin K.  On 9/11/21 he was started on Doxycycline for cellulitis.  He continued to decline and had decreased lung sounds.  The resident was noted to have increase in pain and was started on morphine on 9/13/21.  The resident passed away on 9/17/21.
This case was reported by a medical assistant and described the occurrence of injection site cellulitis in a 24 month old female pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). Concurrent medication included acetaminophen (Tylenol). On 06Oct04, the pt received the fourth dose of Infanrix in the left him (lot DTPA614C9). Approx one day following the fourth dose of Infanrix, on 07Oct04, the pt developed swelling at the injection site that went from 9.5cm by 7 cm to 20cm in one day. The pt was hospitalized for three days with a diagnosis of injection site cellulitis. The events had improved as of the time of initial reporting.
Chills; Lack of energy; slight fever; This is a spontaneous report received from a non-contactable consumer, the patient. A 61-years-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6205) via an unspecified route of administration in the right arm on 12mar2021 at 1:30 for COVID-19 immunisation.  TMedical history included asthma and sinus. Concomitant medications included antibiotics received within two weeks. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. and prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced Chills, lack of energy and slight fever on 20Mar2021 at 9.00.The patient did not receive any treatment for reported events. The clinical outcome of the events Chills, lack of energy, slight fever was not recovered .   No follow-up attempts are needed. No further information is expected.
Per patient - 1/2 upper arm red, painful and hot to touch. Wheezes that evening and the following day - Sx improved with use of Benadryl PO.
Severe swelling at injection site, pain and discomfort throughout body. Burning sensation in hands and feet.
So, the next morning, when I woke up, I was having seemed like a lot of the "normal" reactions - headache, nausea, fatigue and some dizziness. I kind of assumed I was having normal reactions for the first 5-6 days. When it wasn't getting better, I contacted my doctor (on the 6th or 7th day). I went in and they did blood tests. Everything came back normal; blood pressure and everything was normal. They said call us if it continues after another week. I still wasn't feeling good - I didn't see any change. They had me go in for CT scan. Everything normal on that one as well. I let another week go by hoping it would get better. Still, everything stayed the same: Headaches - came in waves. I would feel better in the morning and then as the day goes - I have waves of headaches that turn into nausea and dizziness and then it goes back to headaches and that shifts back and forth like that throughout the day. Acid Reflux is a symptom that I have experienced in the past (I have had issues with that before the vaccine) so they decided to do an Endoscopy to make sure I didn't have an ulcer. 4-6 weeks after vaccine I had that Endoscopy. Nothing explained nausea - (off the Endoscopy results - normal results). I haven't found much relief from my symptoms. I have been taking Advil and Tylenol and those don't seem to do much for the headache part. Sometimes in the morning, I feel almost like it's gone and then by midafternoon, I start to feel not so good. 1st week after the vaccine was probably the worst - I had more fatigue at the beginning.  The fatigue is still an issue - but it comes more with the headache part of it - and when it shifts to the nausea/dizziness stage - I feel less fatigued and just more nauseous. Maybe, overall, it got a little better after that but then it has stayed the same in those 5 weeks. Headaches: Make my eyes feel hot. It feels generalized in my head - maybe more in eyes. There has not been a fever associated with it. Like a "hot face" feeling. It's like a light-headed dizziness (Not roomy spinning).
Fatigue; Sore arm; Chills; Low-grade fever; Nausea; Headache; Vomiting; Fainting; This is a spontaneous report from a non-contactable consumer (patient). A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 24May2021 12:15 (Batch/Lot Number: EW0173) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient is not pregnant at the time of vaccination. Concomitant medication includes: Vitamin C supplements (reported as List of any other medications the patient received within 2 weeks of vaccination). The patient was previously vaccinated with bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: Ew0172) on 03MAY2021 01:00 PM for COVID-19 immunization. It was reported that the patient experienced Fainting on 24May2021 at 16:00. The patient also experienced Fatigue, Sore arm, Chills, Low-grade fever, Nausea, Headache and Vomiting on an unspecified date. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination the patient has the patient been tested for COVID-19 which was negative on 07May2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the event fainting was recovering; for all other events was unknown.   No follow-up attempts are possible. No further information expected.
headache; bad taste; loss of energy; This is a spontaneous report from a Pfizer-sponsored program Pfizer-sponsored program. A contactable consumer reported that a male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced after the first dose of the vaccine caller experienced headache, bad taste, and loss of energy. The caller also mentioned that he would like to set up an appointment for his second dose. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with the ZOSTAVAX vaccine at a hospital as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 20-DEC-2015, she was treated at a hospital for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Confusion, unable to concentrate, lethargic, no appetite, loopiness all started suddenly 2 days post COVID booster shot.
Case number PHEH2014US024989, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 84-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 04 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
No adverse effects reported.; patient was administered a dose of improperly stored MMR II, ROTATEQ or PEDVAX HIB; This spontaneous report was received from a medical assistant referred to multiple unspecified patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not provided.  On multiple unspecified dates, the patients were administered a dose of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot number R030808, expiration date 24-OCT-2020; dose number, anatomical location and route of administration were unknown) for prophylaxis, Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (lot number R033252, expiration date 29-JUN-2020; dose number, anatomical location and route of administration were unknown) for prophylaxis or Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PEDVAX HIB) (lot number R000877, expiration date 24-SEP-2020; dose number, anatomical location and route of administration were unknown) for prophylaxis (product storage error). No lot information was provided for properly stored sterile diluent used to reconstitute improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II).  The time frame: above 47 Fahrenheit scale (52F) for 1 hour 15 minutes. There was previous temperature excursion. Data logger was involved.  This report was considered as non-valid due to lack of patient identifiers.  Follow up information has been received from a medical assistant referred to 12-month-old male patient on 11-MAY-2020. On 25-JAN-2019, the patient was administered a dose of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).  This is one of five reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA003150: US-009507513-2005USA003275: US-009507513-2005USA003277: US-009507513-2005USA003276:
Fever, lightheaded, ST, HA, 4 days after beginning oral TYPHOID vaccine/ sc HEP A #1.  Passed out & macular papular rash 6 days after vaccines.
administering an expired vaccine to a patient with no reported adverse event; Initial information received on 18-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 months old male patient to whom an expired Hib (Prp/T) Vaccine [Act-Hib] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine, Tetanus Vaccine Toxoid (Dtp); Rotavirus Vaccine (Rotavirus Vaccine); Polio Vaccine Inact (Ipv); And Pneumococcal Vaccine Conj (Pneumococcal Conjugate Vaccine) for Prophylactic vaccination.  On 16-Aug-2023, the patient received expired dose 3 at a dose of 0.5 ml of suspect Hib (Prp/T) Vaccine (Frequency: once, strength: standard, expiry date: 10-Aug-2023 and lot UJ739AB) via intramuscular route in the left thigh for immunization (expired product administered) (latency: same day).  It was reported "Medical assistant called saying she has questions on a vaccine that was administered but has already expired. She said that ACT-HIB which expired on 10Aug2023 was administered to a patient on 16Aug2023. She asked what are the guidance regarding this or what are the next steps following the situation? She also asked if they should re-administer the dose and where can they report the situation? This situation is reported as a medication error due to administering an expired vaccine to a patient."  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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 the 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.
Admitted on 3/10/2021 with altered mental status, hypotension, persistent orthostatic hypotension requring medications at discharge
Throat swelling; Inner ear swelling; inner ear swelling; Left ear imbalance when walking; Nausea; Severe headache; 103ºF - 104ºF Fever; Joints on fire; Big mass well on right; Convulsion; Uncontrollable shaking; Severe muscle cramps; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Convulsion) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939966 or 939906, 021B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Immunocompromised and Cancer. Concomitant products included EXEMESTANE for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced SEIZURE (Convulsion) (seriousness criterion medically significant), TREMOR (Uncontrollable shaking), MUSCLE SPASMS (Severe muscle cramps), MASS (Big mass well on right), NAUSEA (Nausea), HEADACHE (Severe headache), PYREXIA (103ºF - 104ºF Fever) and ARTHRALGIA (Joints on fire). On 04-Sep-2021, the patient experienced PHARYNGEAL SWELLING (Throat swelling), EAR SWELLING (Inner ear swelling) and BALANCE DISORDER (Left ear imbalance when walking). 04-Sep-2021, the patient experienced INNER EAR DISORDER (inner ear swelling). At the time of the report, SEIZURE (Convulsion), TREMOR (Uncontrollable shaking), MUSCLE SPASMS (Severe muscle cramps), PHARYNGEAL SWELLING (Throat swelling), EAR SWELLING (Inner ear swelling), INNER EAR DISORDER (inner ear swelling), MASS (Big mass well on right), BALANCE DISORDER (Left ear imbalance when walking), NAUSEA (Nausea), HEADACHE (Severe headache), PYREXIA (103ºF - 104ºF Fever) and ARTHRALGIA (Joints on fire) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 103ºf - 104ºf (High) 103ºF - 104ºF.         Treatment information was not provided.  Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The events "Uncontrollable shaking", and "Muscle spasms" could also be a manifestation of the event "Convulsion". The event "Balance disorder" may also be due o the event "Inner ear swelling".   This case was linked to MOD-2021-308340 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The events "Uncontrollable shaking", and "Muscle spasms" could also be a manifestation of the event "Convulsion". The event "Balance disorder" may also be due o the event "Inner ear swelling".
Given GARDASIL #1. Very little pain felt when given. 10 minutes later when she was leaving, she fainted when walking. Recovered in a few seconds. BP 114/64, glucose 87. Rested for half an hour, Had water and a cookie. Was feeling better when she left with father.
Within 24 hours of 2nd injection, pt had a headache, neck stiffness, sore throat and a fever of 102F with chills and swelling of eye.
Booster; a fever to 102.3; rigors; headache; malaise; myalgias; One episode of emesis; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient received bnt162b2 (COMIRNATY), administration date 06Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown, Manufacturer unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021, outcome "unknown", described as "Booster"; PYREXIA (non-serious) with onset Dec2021, outcome "unknown", described as "a fever to 102.3"; CHILLS (non-serious) with onset Dec2021, outcome "unknown", described as "rigors"; HEADACHE (non-serious) with onset Dec2021, outcome "unknown", described as "headache"; MALAISE (non-serious) with onset Dec2021, outcome "unknown", described as "malaise"; MYALGIA (non-serious) with onset Dec2021, outcome "unknown", described as "myalgias"; VOMITING (non-serious) with onset Dec2021, outcome "unknown", described as "One episode of emesis". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Approximately 13 hours after administration (captured as on an unspecified date in Dec2021), she experienced a fever to 102.3 (unit unspecified), rigors, headache, malaise, myalgias and one episode of emesis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Complained of feeling like her throat was closing up. First Epi given at 10:25 am and EMS called. EMS arrived around 10:35am reassessed and gave 2nd dose of Epi, started IV and gave Solumedrol. Recipient was alert and talking at time of transfer.
Patient received J and J vaccine . 2 weeks later had vision loss in  both eyes. No light perception in the right and counting fingers in the left. Diagnosis is central retinal artery occlusion in both eyes. Work up for other causes are negative
Redness and pain over his left arm. Temp of 100.8F body aches. Has 2 red welts. Looks like it is infected.
Pt received Varicella vaccine in right thigh on 10 Jan 2012. Pt taken to ER on 11 Jan 2012 for redness, swelling, warmth to right thigh. Pt brought to clinic on 12 Jan 2012 to be assessed by PEDS MD. No fever noted.
Hives noted on chest. Took 25mg po benedryl and hives were resolved within 3 hours.
Pt noticed hives on thigh, back and neck at 23:45 on 5/24/03. Took Benadryl, hives went away. On 05/25/2003 at 19:00 pt noticed tightening of throat. At 01:30 on 5/26/03 tightening of throat became worse and hives were noticed on body again. Pt brought to the ER. Epmephrine, Benadryl and Prednisone given. Sent home with Prednisone, Zyrtec and Benadryl. Client with complaint of lethargy for 1 week following ER visit. ER physician did not feel there was a correlation between vaccine and reaction.
11-30-07 presented to ER with diplopia (double vision) was given Compazine 2.5mg thru IV in ER. Referred to Neurologist same day. 12/05, 12/06, 12/07/07 given Soludro Medrol 1g IV infusion x 3 days. Follow up with Dr. bi-weekly. Follow up was also done with Ophthalmology. Follow-up with neurosurgeon on 12/18/07 and 2/05/08. Double vision cease on 12/21/08.
extended soreness in left elbow several weeks after injection on left arm. noticed some discoloration of skin around injection site for several days
Signs of Iron Deficiency Anemia showed up in routine bloodwork, 10 months later.
This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 37, via an unspecified route of administration, in the left arm, on Mar 1, 2021, at 12:00, single dose, for COVID-19 immunisation. Medical history reported as not applicable. The patient has no known allergies. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Mar 5, 2021, at 12:00,  patient felt like there was something constantly in his throat. The patient had a lot of phlegm and also got headaches regularly. He never had headaches before. This has not stopped since the first 5 days of the vaccination. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures taken as a result of the events. On Mar 12, 2021, patient underwent COVID-19 (nasal swab) test with negative result. Since the vaccination, patient has tested for COVID-19. The clinical outcome of felt like there was something constantly in throat, had a lot of phlegm and headaches regularly recovered with lasting effects on an unknown date in 2021. No follow-up attempts required. Information about batch/lot number cannot be obtained. No further information expected.
Nurse at school health center left to go get my second dose of the pfizer shot.  Another nurse came into the room.  She gave me the wrong dose of the Janssen vaccine . I asked to verify that it was the second dose of the pfizer vaccine, in which I was told it was. I then visually saw that it was the janssen vaccine, in which i then asked if I was given the second dose of the pfizer. She then told me it was the first dose of the vaccine of janssen.  She realized she had made an error.
Pt was given inadequate  dose of Moderna COVID vaccine; no signs or symptoms of adverse reactions noticed per mom