chrisvoncsefalvay/vaers-outcomes huggingface dataset:
complains of burning pain with rash medial to right shoulder blade x 2-3 days.   Cluster of vesicles over one dermatome near scapula, no drainage or erythema.
mixed PENTACEL with the wrong diluent and administered it to a patient with no AE; mixed PENTACEL with the wrong diluent and administered it to a patient with no AE; Initial information was received on 02-Dec-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old female patient for whom pentacel was mixed with the wrong diluent and administered it to a patient with no adverse event after receiving diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included influenza vaccine, measles vaccine, mumps vaccine, rubella vaccine (MMR) and varicella zoster vaccine (varicella vaccine) for Immunisation.  On 01-Dec-2022, the patient received 0.25 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine (Suspension for injection) (lot: UJ662AAA, expiry date: 04-May-2023, strength: Standard, frequency: once) via intramuscular route in the right vastus lateralis for Immunization.    On 01-Dec-2022 the patient had a non-serious event mixed pentacel with the wrong diluent and administered it to a patient  with no adverse event (incorrect product formulation administered) (Product preparation error) same day following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  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.
pt recv vax JUL96 & 2-3 wk p/vax pt devel swelling in both feet;2 bone scans, mult x-rays, & MRI were performed;pt had inflammation;
Pfizer vaccine was administered outside of our facility - reported by patient- ? NO LOT NUMBER WERE SUPPLIED ---------------------------------------------------------------------------------------------- I95.9 HYPOTENSION 12/26/2021 UNSPECIFIED ATRIAL FLUTTER
Awoke next am with large local reaction to rt arm.  Site was tender, red and warm to touch with firm center. Approx size of fist.  Did not seek treatment symptoms improving when reported. Reports local reaction with previous flu vaccine and each time reaction larger.
Office manager calling to report adverse event with PROQUAD and VARIVAX. Caller states PROQUAD was inadvertently administered concomitantly with VARIVAX to a patient.; No additional AEs; This spontaneous report was received from a other concerning to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.     On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S031883 and expiration date since it makes match with the autopopulated expiration date 07-APR-2021), 0.5 milliliter (route of administration and indication were not provided), and it was inadvertently administered concomitantly with varicella virus vaccine live (oka/merck)(VARIVAX)  (lot # T002843 and expiration date since it makes match with the autopopulated expiration date 23-JAN-2022), 0.5 milliliter (route of administration and indication were not provided).  No additional adverse event was reported.
bilat. arm meuropathy, myositis; stiffness and soreness in all joints; severe headaches; nausea; muscle twitching in chest and extremities; spasms and muscular and joint pain has continued to the present. Follow up 01/23/2004: Patient continues to have muscle and joint pain which impedes everyday activity. Regular migraine headaches also continue. Walks with support of a cane. Continues with numbness in both hands which impedes fine motor movement. Due to inactivity, patient gained > 20 pounds which led to development of other problems such as hypertension, sleep apnea.
Whole body itched skin for two days. Swollen glands in throat pain swallowing. First Moderna shot two days after the injection my glands in my throat swelled And I had two weeks of excruciating throat pain swallowing.
Patient reported today (08/08/2016) that about 48-72 hours following his vaccine administration on 07/28/2016 that he had onset of 4-5/10 level back pain to the area of prior back surgeries. He described this pain as musculoskeletal in nature and that it radiated to the immediate area but with no neuropathic pain. He states that this pain has now almost completely resolved (now more than 1 week later). He has had an event like this previously with a flare of back pain, but it was caused by a fall and injury and this time he had no such injury. He is not sure if this is related to the vaccines he received or not.
Medical assistant administered expired ROTARIX vaccine to a child. Medication expired on 10/26/2018 and was administered on 11/27/2018.
when she took the 1st dose of the vaccine she lost hearing in her left ear for three days and felt stopped up; she had sinus problems and everything; This is a spontaneous report received from contactable nurse. The reporter is the patient. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in deltoid left, administration date 10Nov2021 14:00 (Lot number: FF2593, Expiration Date: 30Mar2022) at the age of 57 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DEAFNESS UNILATERAL (medically significant) with onset 2021, outcome "recovered" (2021), described as "when she took the 1st dose of the vaccine she lost hearing in her left ear for three days and felt stopped up", she did not know when the hearing loss began and felt like her ear was stopped up like a cotton ball was there but she did not loose hearing and was not able to being able to hear like if you are flying on a plane the pressure changes and it felt like that; she did not know when the hearing issue began but it was just a few days after the 1st dose of the vaccine and was not ongoing but lasted like 3 days. She took a nasal congestion tablet and Flonase and with blowing her nose those products did not work and she could not hear from her left ear and it was stopped up; she had never woken up not able to hear out of one ear and, SINUS DISORDER (non-serious) with onset 2021, outcome "unknown", described as "she had sinus problems and everything". Therapeutic measures were taken as a result of deafness unilateral, sinus disorder. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event deafness unilateral and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Fever of 104 within about 12 hours after GARDASIL vaccine. Tingling of hands, subjecting weakness, chills, loss of appetite, headache, muscle aches.
Nausea - Vomiting  - Hand tremors - Loss of balance - Extra sensitivity to light and smells - Body aches, especially her arms - Moodswings - Joint pain - Extreme tiredness that worsens to the point of sleeping for hours at a time - Her hands and feet turn extremely cold and the nails turn blue - Great difficulty concentrating (she has always been an A+ student). The more she pushes her brain to concentrate the intensity of the headaches increase as well. - Brain fog - Heart palpitations - Changes in her sleeping patterns - Aberration to certain food - Change in sleeping patterns
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On an unspecified date the patient was vaccinated with a dose of improperly stored GARDASIL (Lot#, dose, route not reported). No other co-suspects were reported. No concomitant medications were reported. It was unknown if the patient sought for medical attention. No adverse event reported. Additional information has been requested.
child born in 2015 was given a KINRIX Vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 7-year-old male patient who received DTPa-IPV (Kinrix) (batch number 7D2Y4, expiry date 22-AUG-2025) for prophylaxis.   On an unknown date, the patient received Kinrix (injection, left thigh). On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: child born in 2015 was given a KINRIX Vaccine). The outcome of the inappropriate schedule of vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 26-OCT-2023 The reporter was a medical Assistant.   Health care professional (HCP) called today (on the day of reporting) to report that a child born in 2015 was given a Kinrix vaccine.   She stated the child had never had vaccines since birth and the reason was unknown.   HCP stated MMR, Kinrix, and Varicella were given at the same visit. The patient received Kinrix as a 1st vaccine, which led to inappropriate vaccine schedule.  The reporter consented to follow up.
Patient received both Hep A vaccines in 2007: 6/5/07 and 12/12/07. Possible vaccine failure.
Client given normal saline instead of Pfizer vaccine. Client re-vaccinated 4/24/2021 with Pfizer ER8736 IM in right deltoid.
This spontaneous report was received from a pharmacy intern referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug and allergy history were not reported. On 21-APR-2017, the patient was vaccinated with the second dose of GARDASIL 9, injection (strength, route, lot and expiration date were not provided) for prophylaxis. Two months 1 day after, on 21-JUN-2017, the patient received the third dose of GARDASIL 9, intramuscular injection, lot # M020103, expiration date 15-FEB-2018, (strength was not provided) for prophylaxis. The patient's concomitant medication was not reported. Adverse effects were not reported.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 6-month-old male patient who received FLUARIX Quadrivalent (batch number MN5CS, expiry date 30th June 2017. Concomitant products included influenza vaccine. On 6th December 2016, the patient received FLUARIX Quadrivalent (intramuscular) .5 ml. On 6th December 2016, less than a day after receiving FLUARIX Quadrivalent, the patient experienced fever, irritability, lethargy, wrong patient received medication and inappropriate age at vaccine administration. The patient was treated with Acetaminophen. On an unknown date, the outcome of the fever, irritability and lethargy were unchanged and the outcome of the wrong patient received medication and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the fever, irritability and lethargy to be related to FLUARIX Quadrivalent. Additional details were provided as follows: This case was previously reported to a doctor. On 5th December 2016, the patient received a flu vaccine that was possibly a non-GlaxoSmithKline vaccine. On the date of reporting at 9:15 hours, the patient received his 7 year old sister's vaccination FLUARIX Quadrivalent (in his left thigh), which led to wrong patient received medication and an inappropriate age at vaccination. In the evening, the patient exhibited a fever of 102.3 degrees F (rectally), he was fussy, which was abnormal for this patient. The patient appeared lethargic. On 7th December 2016, in the morning, the patient's body temperature was 101.7 degrees F. The patient was treated with acetaminophen at a dose of 80 mg.
Tinnitus       Constant ticking, pulsating noise in left ear.  Started exactly two weeks to the day after 2nd dose of vaccine.
Fatigue starting 3/22, lasting until 3/24 Fever starting 3/24, lasting approximately 6 hours
expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. The Vial was initially stored in the refrigerator on 04-Nov-2021. No temperature excursions happened. No treatment medication was reported by reporter   This case was linked to MOD-2022-501813 (Patient Link).
9/22 - began feeling tightness in chest, cough, and soreness around injection site. 9/23 - increased congestion, fever, fatigue, noticed several pox around inj. site. 9/24 - 9/27 - increased congestion in chest, wheezing, fever (intermittently 100 degrees F - 101 degrees F). 9/29 - visit to provider.
Patient reported severe pain and left arm weakness with limited range of motion after the vaccination.  Seen in the clinic on the same day afternoon. She has been doing ice compression and Tylenol.  Pain slightly improved  in 48 hours but still with left arm weakness and limited ROM. The injection site was higher than expected.
nauseous; joint aches; temperature 102 degrees Farenheight; headache which lasted for several hours; eyes blood shot; face red; Chills/shaking; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (eyes blood shot), ERYTHEMA (face red), CHILLS (Chills/shaking), NAUSEA (nauseous) and ARTHRALGIA (joint aches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included PARACETAMOL (ACETAMINOPHEN) for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (Chills/shaking). On an unknown date, the patient experienced OCULAR HYPERAEMIA (eyes blood shot), ERYTHEMA (face red), NAUSEA (nauseous), ARTHRALGIA (joint aches), PYREXIA (temperature 102 degrees Farenheight) and HEADACHE (headache which lasted for several hours). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, OCULAR HYPERAEMIA (eyes blood shot), ERYTHEMA (face red), CHILLS (Chills/shaking), NAUSEA (nauseous), ARTHRALGIA (joint aches) and PYREXIA (temperature 102 degrees Farenheight) outcome was unknown and HEADACHE (headache which lasted for several hours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 degrees farenheight (High) 102 degrees farenheight.
I had a persistent sore throat that did not progress to any other cold symptoms. I made an appointment to see my doctor to see if I had strep throat, the test came back negative. I was advised to go home, ride out the symptoms, if they got worse to contact her again. The symptoms eventually did go away.
the patient didn't receive very much of the vaccine with no reported adverse event; Initial information received on 28-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 69 years old female patient who didn't receive very much of the vaccine with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ELASOMERAN (MODERNA COVID-19 VACCINE) for Prophylactic vaccination.  On 28-Sep-2022, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation and strength not reported; lot UJ875AE and expiry date: 30-Jun-2023) via intramuscular route in the right deltoid for prophylactic vaccination.  On 28-Sep-2022, (latency: same day) the patient didn't receive very much of the vaccine with no reported adverse event (incorrect dose administered) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported, "staff member stating when she went to administer FLUZONE HIGH DOSE QUADRIVAENT on 28SEP2022, "it exploded where it screws on to the needle. It popped off and sprayed everywhere". Stated that she screwed the needle on securely, got the air out and when she administered the vaccine, "the screw part on the medication went faulty and where it was attached popped off but the needle was still in the patient". Wanted to know if the dose needed to be repeated, since she assumed the patient didn't receive very much of the vaccine".  Action taken was 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.
Initial misuse report received from a health care professional on 21 October 2013. The cases were received at GPV on 21 March 2014. It was reported that 2 year-old patient had received 0.5 ml dose of FLUZONE. No adverse event was reported. List od documents held by sender: none
Information has been received regarding a case in litigation concerning a male child who was injected with vaccinations containing the toxic mercury based preservative thimerosal, during the child's developmental years. The alleged result of these vaccinations is that the pt now suffers from, and allegedly in the future will continue to suffer from, the toxic neruological effects of mercury poisoning. The info indicated the pt received first dose of hep B vaccine recombinant (lot not reported) on or about 4/4/96 at the age of approximately 2 months old and the second dose on or about 10/3/97, MMR II (lot not reported) on or about 10/3/97 at the age of approximately 20 months old, a first dose of haemophilus influenzae vaccine on or about 4/4/96, and a second dose of haemophilus influenzae vaccine on or about 10/3/97. Upon internal review toxic neurological effect and mercury poisoning were determined to be other important medical events (OMIC). No further info is available.
Pfizer 1/15 and 2/5. Positive on 12/24
IM PREVNAR immunization, given under aseptic technique on 10/31/18. Patient reported on 11/7/18 that she experiencing redness and swelling at injection site. She was seen in the office 11/08/18. On examination the patient had erythema, swelling and tenderness in a circular area (approximately 9 cm in diameter) surrounding the injection site.
In arm that had the vaccine: Have limited range of motion. Pain. Dr prescribed physical therapy. Arm was normal before vaccine. Now doing physical therapy daily at home.
Pt received vaccine on 8/10/16. Pt was seen in ED for c/o HA, diarrhea, nausea, SOB on 8/11/16. On 8/11/16 pm pt seen in clinic with same complaints and pt was referred to ED. Pt was seen at hospital on 8/11/16 pm and D/c'd home.
pt recvd vax & about 12 hrs after vax had fever w/ t 105; had 5 min of twitching; seen in er;
Imm. 2 days ago.  No pain or fever.  Itching @ site - no one else has had reaction very large redness & swelling right ant thigh 10.5 cm X 9 cm
Apparent allergic reaction: 14 x 7 cm red plaque, warmth, swelling at site of admin. 4 x 2 cm hard knot in center of swollen area.
LOW BLOOD PRESSURE 65/50; LOW WHITE BLOOD CELL COUNT(2.5); FLU LIKE SYNDROME; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the patient experienced low blood pressure 65/50, low white blood cell count (2.5) and flu like syndrome. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 65/50 LOW, Pulse rate (NR: not provided) 90, and white blood cell count decreased (NR: not provided) 2.5 LOW. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low blood pressure 65/50, low white blood cell count(2.5), and flu like syndrome. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210345110-covid-19 vaccine ad26.cov2.s-Low blood pressure 65/50; Low white blood cell count (2.5). These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Violent chills Headache Profuse Sweating Nausea Diarrhea Light-headedness Weakness