chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse and refers to a currently 14-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 lot # R002344, expiration date: 16-NOV-2020 (dose and route of administration were not provided) for prophylaxis. Temperature and time frame were reported as: below 0 degrees Celsius (-0.6 degrees Celsius) for 7 hours and 38 minutes and 9 degrees Celsius to 25 degrees Celsius (13.3 degrees Celsius) for 1 hour and 14 minutes. Previous temperature excursion was reported as: 9 degrees Celsius to 25 degrees Celsius (11.7 degrees Celsius) for 3 hour and 53 minutes and 9 degrees Celsius to 25 degrees Celsius (23 degrees Celsius) for 11 hours and 21 minutes. Digital data logger was involved. No adverse effects were reported. Sender's Comments: US-009507513-1811USA007952: US-009507513-1811USA007948: US-009507513-1811USA007949: US-009507513-1811USA001303: US-009507513-1811USA007951: US-009507513-1811USA007946: US-009507513-1811USA007945: US-009507513-1811USA007947.
The patient was mistakenly given the adult dose of the Hepatitis A HAVRIX vaccine instead of the pediatric dose. No adverse reactions noted at time of vaccine. The mistake was noted after the patient had already gone home. Immunization Program was immediately notified of the event for further instruction. The case was then discussed with public health nurse, who reassured the author that no adverse reactions would be expected giving the adult dose of HAVRIX to a 5 y.o. patient. She stated that the dose does not need to be repeated and that he will be due for the pediatric HAVRIX in 6 months. Outgoing call made to his step-mother, but there was no answer. Left message on her voicemail to call back. I plan to discuss the mistake with her and reassure her that no adverse reactions are expected and that he will be due for his 2nd dose (the pediatric HAVRIX) in 6 months.
Full body pain; fever above 102; This is a spontaneous report from a contactable consumer. A 46-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date ( at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have any allergies to food, medications and other products. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Apr2021, the patient experienced full body pain and fever. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 13Apr2021, the patient underwent body temperature test and the result was above 102. The clinical outcome of the event full body pain, fever was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Headache, Myalgia, Arthralgia,  continuous migraine headaches; aches; joint pain; fatigue OTC Tylenol alternating with Motrin as needed
Intense pain in arm started a few hours after injection, moved its way to my back within 2 more hours, then involved overall muscular pain a few hours later.  I began to feel very nauseated and started vomiting by early evening.  I then lost the ability to feel when I needed to urinate and I was incontinent of large amounts of urine, not being aware until I could feel my clothes getting wet- this continued until the following day.  By late evening, I felt hot to touch, had severe chills that didn?t resolve for about 16 hours and felt very ill overall.  I became unable to walk without falling and my husband had to get me into bed.  All of these symptoms became lesser the next day and I was functional by the 3rd day.  I?ve never experienced anything like this and it was horrifying.
Patient reports "Fatigue, lymph nodes in neck, groin, R underarm sore and swelling.". Right underarm swelling is reported as being the size of an "egg."
This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received PREVNAR 13 (Lot number and expiration date were not reported), with route of administration and therapy dates unspecified at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had flu-like symptoms and severe arm pain/soreness. The outcome of the events, 'flu-like symptoms' and 'severe arm pain/soreness', was unknown. No follow-up attempts are possible. No further information is expected.
11:00am the next day began experiencing significant fatigue, then by 1:30pm I had a 100 degree fever that climbed to 102 as the afternoon went on. I took Tylenol at 5:00pm and by 6:30 my fever was down to 100 degrees. By 11:00pm I was down to 99 with no increase in temperature after that.
Shortly after receiving the vaccine, the patient reported feeling flushed and hot with rash, shaking, shivering, and pain in upper chest, which the patient described as being normal because of her COVID pneumonia. I would rate the reaction as moderate. Diphenhydramine 25mg capsule was given by mouth, ice water was offered. Patient was closely monitored but no further intervention was necessary. After about 25 minutes, symptoms subsided and patient decided to leave.
Syncopal episode with epistaxis post vaccination and confusion to occipital region. Patient complains of blurry vision, headache and stomach ache after 10 minutes of vaccination. Ice pack was applied on head and provided with water. Follow up if symptoms worsen or as needed or post x-rays.
a 13-year-old who received the Moderna vaccine 1st dose today 20Jul2021 on her right arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a 13-year-old who received the Moderna vaccine 1st dose today 20Jul2021 on her right arm) in a 13-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a 13-year-old who received the Moderna vaccine 1st dose today 20Jul2021 on her right arm). On 20-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a 13-year-old who received the Moderna vaccine 1st dose today 20Jul2021 on her right arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow-up received included no new significant information. Reporter information updated.
Fever, fatigue (3 months), vertigo (severe for 3 months), headaches (3 months).
I had the vaccination on 10/21/2022. On 10/26/2022 at 2AM I woke up with short of breath and chest tightness. My O2 state was at 92%. I could not lie flat and could only breath standing up. I waited until 10/29/2022 to go to urgent care. I had a chest x-ray and prescribed albuterol. I went to my doctor on 10/31/2022 and ordered blood panel. My D-dimer was high. It showed fluid on lungs and around my heart. On 11/04/2022 I had and Echo and EKG and it came back as trivial. I didn't have any more issues until 11/09/2022 in which I had another episode of shortness of breath. At 430AM on 11/12/2022 I went to the emergency room and diagnosed with Pericarditis. Sent home with ibuprofen high dose for 3 weeks. I have a follow up appointment with my doctor on 11/15/2022.
medication error due to administering dose post temperature excursion outside acceptable guidelines per stability standard with no reported adverse event; Adacel reached negative 2.1c from 07mar2022 until 31mar2022 due to temperature excursion due to a refrigerator malfunction with no reported adverse event; Initial information received on 19-Apr-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2022SA143416(CLUSTER) and 2022SA143406(CLUSTER).  This case involves a 54 years old female patient who experienced adacel reached negative 2.1c from 07mar2022 until 31mar2022 due to temperature excursion due to a refrigerator malfunction with no reported adverse event and medication error due to administering dose post temperature excursion outside acceptable guidelines per stability standard with no reported adverse event while receiving vaccine diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included varicella zoster vaccine rge (cho) (Shingrix) for Prophylactic vaccination.  On 25-Mar-2022, the patient received a  dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine lot C5963AA via intramuscular route in the right deltoid for immunization.  Adacel reached negative 2.1c from 07mar2022 until 31mar2022 due to temperature excursion due to a refrigerator malfunction with no reported adverse event (product temperature excursion issue). On 25-MAR-2022, same day, the patient developed medication error due to administering dose post temperature excursion outside acceptable guidelines per stability standard with no reported adverse event (Wrong technique in product usage process).  Action taken: Not applicable for both  Corrective treatment: Not reported for both  Outcome: Unknown for both   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 guidelines. 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.; Sender's Comments:  01068650: 01068813: 01068814: 01068816: 01068817: 01068825: 01068827: 01068828: 01068830: 01068831: 01068834: 01068835: 01068838:
Knot, Itchy nose, Heart Pounding Narrative: Knot -big about quarter size - not at injection site, nose started itching, heart pounding last 3 days
Sudden sensorineural hearing loss (SSNHL) of right ear Currently taking high dose of Prednisone and have received 2 injections into ear. Hearing is returning
Patient claims to have had cellulitis and recieved Augmentin as her treatment on 10/29. There was no symptoms or sign of rash upon reporting to the pharmacy today, 11/2/20
Only liquid portion was administered.; Only liquid portion was administered.; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA710A, expiry date 30th April 2023) for prophylaxis.   On 24th August 2022, the patient received Menveo. On 24th August 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 14-NOV-2022 Reporters comment: The health care professional reported that after vaccination of 5 patients they became aware one of them was administered only the diluent of menveo without the lyophilized part but did not know which patient was. The reporter consent to follow-up by email. This case was for 5 of 5 linked patients, reported by same reporter. Additional Supportive information: The patient received the menveo vaccine before reconstitution with only the diluent portion which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022168209:same reporter US-GSK-US2022168203:same reporter US-GSK-US2022168204:same reporter US-GSK-US2022168199:same reporter
The employee received 2 doses for he M-M-R II vaccine; The patient was tested for serology, which was negative for the measles disease, test was under 25; The employee received 2 doses for he M-M-R II vaccine; This spontaneous report was received from a nurse referring to a non-pregnant 40-year-old female patient. the patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.  The patient received at her place of employment, two doses of the with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # N032750 (expiration date: 20-NOV-2019) (additional dosage regimen information was not reported) for prophylaxis on 03-APR-2019 and 01-MAY-2019 respectively.  On 20-JUN-2019, the patient was tested for serology, which resulted negative for measles disease, but positive for the mumps and rubella disease. The serology test was under 25 (units were not specified) for measles immunity.  At the time of the report, the outcome of measles antibody negative was reported as not recovered. No causality assessment was provided.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1906USA011008:
4 cm blood clot in suclavian vein ,  resulting in TOD surgery, and multiple cysts in left breast
Pt. presented to Urgent Care with "allergic reaction-redness" Started with red patches over abd, legs, left face and left wrist,coming and going since am,arrived at Urgent Care 7:39 pm 9/15/07.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. The pharmacist reported that on 05-OCT-2016, the patient was administered a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). The patient was inadvertently administered a second dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported) on 09-JAN-2017. No adverse effects were reported. Additional information has been requested.
father says leg was red right p/vax; father says no cold packs applied as instructions not read; took pt to ball game in eve aprpox 8PM noted rash thighs to knees & underneath side of wrists; rash was tender; took pt to ER:
shoulder pain at injection site.; She was unable to lift her right shoulder four about 4 weeks.; nausea; vomiting; shoulder pain at injection site.; This spontaneous report has been received from the patient's husband concerning her wife, a 67 year old female patient. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On approximately 21-SEP-2020 (reported as "about 4 weeks ago"), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) single dose administered intramuscularly as standard vaccine for prevention of pneumonia (dose, anatomical location, lot number and expiration date were not provided). On the same date, 2 hours later after having the vaccine, the patient suffered from nausea, vomiting and shoulder pain at injection site (musculoskeletal pain) (injection site pain). She was unable to lift her right shoulder four about 4 weeks (injected limb mobility decreased). The patient did seek medical attention at the site where she received the vaccine and they told her to take naproxen sodium (ALEVE)/acetaminophen (TYLENOL).   At the time of reporting, the patient's husband stated that she still had pain at injection site. The outcome of all the events was reported as recovering.  The causal relationship between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events was unknown.
At 1:00 am on 10/26/2022 a series of diarrea events losing lots of water started. After 12 episodes at 3 Imodium tablets I vomited a couple of times. As of today I feel very tire but I have been able to eat my meals, Sometimes I feel dizzy but mostly tired. I consider myself an old person that do lots of exercises (gym/walk).
This spontaneous case, was received from other health professional (pharmacist) on 26-Sep-2017, concerning a male patient of an unspecified age. The patient's medical history was not reported. The patient's concomitant medications included CYMBALTA, folic acid, LIPITOR, LOPRESSOR, PAMELOR, PAXIL, PLAVIX, PARLODEL, PROTONIX; vitamin C; ULTRAM, VALIUM and ZOFRAN. It was reported that, the patient was already in hospital for an unspecified reason. On 26-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: subcutaneous, batch number: 00144621A (as reported), expiry date: Jun-2018 and anatomical location: not reported). The nurse intended to do PPD (purified protein derivative) test on the patient, but given him the vaccine subcutaneously, which was considered as inappropriate route of vaccination. The reporter assessed the event as non-serious. Significant case correction received 26-Sep-2017: The event verbatim was corrected. the event 'wrong vaccine administered' was added.
Information has been received from a 19 year old female patient referring to herself. There was no concurrent concomitant therapy, medical history or concomitant therapy. In July 2015, the patient was vaccinated with the first dose of GARDASIL intramuscular injection (dose and lot number unknown) for prevention of HPV. On 07-APR-2016 the patient was vaccinated with the second intramuscular dose of GARDASIL, late in the series of 3 injections. On the day after the second dose, the patient developed pink eye, low blood pressure, dizziness and nausea. The patient sought medical attention via online "teledoc" from her insurance for the pink eye and was advised to use OTC eye drops "COM A". No lab diagnostics studies were performed. On 09-APR-2016, two days after the second injection received, her blood pressure and the dizziness resolved and pink eye was getting better. The outcome of nausea was not reported. The causality between the events and GARDASIL was not provided. Additional information has been requested.
arm is swollen; red; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm is swollen) and ERYTHEMA (red) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 33H21A, 044A21A and 013?20A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]), AMITRIPTYLINE, ATORVASTATIN, VITAMIN D NOS, LISINOPRIL, METOPROLOL and UBIDECARENONE (COQ-10) for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (arm is swollen) and ERYTHEMA (red). At the time of the report, PERIPHERAL SWELLING (arm is swollen) and ERYTHEMA (red) outcome was unknown.            No treatment medications were reported.
pt recv vax JUN95 & 14OCT97 pt devel a rash & mom reported other child (WAES97110067) had a similar exp p/vax;
Pt developed a reaction to Tdap vaccine site of im injection on Rt deltoid. Pt was given BENADRYL and TYLENOL.
Inpatient admission for the treatment of sepsis (peptostreptococcus suspected) source of the infection unknown.
The patient did not return to complete the series. The patient was now 24 year old.; No additional AE reported; This spontaneous report was received from a pharmacist, referring to a 24 year old female patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On an unknown date, the 14 year old patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not reported). The patient did not return to complete the series. The patient was now 24 year old. No additional AE reported.
Patient had LOC for approx 1 minute, fell forward onto tile floor, brief tonic contraction followed by mild limb shaking, then regained consciousness.
Symptoms were getting progressively worse; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Symptoms were getting progressively worse) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M208) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced ADVERSE EVENT (Symptoms were getting progressively worse). At the time of the report, ADVERSE EVENT (Symptoms were getting progressively worse) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.
10/25 - 6 pm - normal coughing, 8-9 pm albuterol neb given at home. 11 pm pt having difficulty breathing, cough so hard pt vomited. Went to ER at hospital - croupy cough noted, final diagnosis - croup, TYLENOL/MOTRIN recommended. DECADRON given at hospital 9 mg.
Generalized macular-papular rash over whole body, itchy.  starting 3 days after Moderna Vaccine #2