chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse, and refers to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date, the patient was vaccinated subcutaneously with an improperly dose of either PROQUAD lot # R015739, or VARIVAX lot # R010469, for prophylaxis. No adverse effect was reported. The temperature excursion was from -14°C to -10°C during 88 hours and 30 minutes. Digital data logger involved.
PT REDNESS, SORENESS, AND ERYTHEMA AROUND SITE OF VACCINATION ON LEFT ARM WITH A LARGE KNOT AT VACCINATION SITE. PT STATES SORENESS AT SITE AND STATES THAT REDNESS AND ERYTHEMA SPREAD THREE DAYS AGO. TODAY IS 7 DAYS FROM DATE VACCINE GIVEN ON 25 JULY 07. PT DENIES DENIES ANY ADDITIONAL SYMPTOMS AND DOES NOT NEED ANY TREATMENT AT THIS TIME. PT HAD ANTHRAX #1 AT 28 SEPT 05. THIS SHOT WAS #2 IN ANTHRAX SERIES.
pt recvd vax & 2 days later devel swelling of the legs & joint aches (except in the knees); on f/u it is noted that the pt sx were attributed to Rieters synd;
got severely sick; Initial information was received on 25-Jan-2021 regarding an unsolicited valid non-serious social media case from a consumer or non-health care professional (patient).  This case involves patient (unknown demography) who got severely sick (illness), while the patient received INFLUENZA VACCINE [Flu shot].  It is unknown if the patient had any medical history, concomitant disease or risk factor.  Medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got severely sick (illness) (non-serious) unknown latency following the administration of INFLUENZA VACCINE.  It was reported that, patient got flu shot got one 20 years, got severely sick. Never had one since, never had the flu. Will never get one again.  Details of laboratory data were not reported.   It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Blueness of lips, no breathing difficulties called MD, brought to pediatrician, no breathing issues after that, mild fluid in ear, thought to be mild upper respiratory infection prescribed amoxicillin. 7 days after vaccine had fever on/off for 3 days highest 104. 8 days after vaccine noticed small red bumps that have worsened. Currently 12 days post vaccine with worsening small red bumps over trunk, extremities and head.
Flu like symptoms 8 hours after injection, bad headache, body chills and shaking, felt both cold and hot, couldn't untense legs or relax, body aches. Lasted around 4 hours until falling asleep. Mild headache the next day.
Weak, sensitivity, whole body aches, incredible spine and shoulder pains, migraine-type aches, sore throat. Felt these symptoms from about 4:00 PM until about 11:00 PM when I went to sleep. The next morning, 24 hours after receiving the vaccine, my head still ached/throbbed, and my back still felt incredibly awful. My left shoulder was also still very sore. As of now, almost 60 hours after the vaccine, the only symptom still remaining is the very sore shoulder. I cannot extend it fully without immense pain, but it still hurts otherwise.
Headache within 15 minutes, turned into Constant Migraine within 2weeks, then fatigue, body aches, dizziness, nausea, diarrhea or constipation, either insomnia or I sleep for 16 to 20.
Rash on neck and upper chest. Slight itching Had MMR 07/17/1978
Large rash, swelling, pain approx 4? x 2? around site of injection. Skin is still discolored.
Diarrhea; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (Diarrhea) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.            Concomitant medication include Arthritis Medication, Blood Pressure medication and Prostrate Medication.  Patient reported his symptoms with CDC and he was told to call Moderna and find out if this is something related to the vaccination.  Treatment include probiotics but symptom persists.
Pt reported HA and Dizziness.  Pt denies nausea, blurry vision. Vitals: 119/77,67,16,100% Pt placed in Reverse Trendelenburg position, rest.  Pt given teaching regarding rest,hydration and seeking medical attention if symptoms return.  Pt stable and released from the vaccination site.
Box 17 - Shingrix  Box 22- Flu Went to a store immediately after vaccine and wasn't feeling well. Ended errands early and went home. Told by pharmacist that I could "feel like I'm getting a cold, but this is normal". By 10pm I felt worse and went to bed. Took Trazadone to help with sleep. Woke up around 3am, and had difficulty breathing. Throat narrowed, heart rate was 130. Husband got cold compress, Motrin, took temp at 103. Extreme sweating, headaches. Symptoms lasted for three days. I may see Dr. to follow-up. Not sure if I will seek medical attention.***People should not be alone after receiving this vaccine***
Swollen injection site, red and hot  Severe joint pain Chills Fatigue  Severe weakness
Patient presented to the emergency department for evaluation of lightheadedness after receiving second Moderna vaccine the previous day. Patient was eating breakfast when she started feeling lightheaded. Patient subsequently experienced some nausea. She does endorse a minor headache overnight, but none today. No visual changes no numbness or tingling extremity abnormal weakness in extremities. Patient received IVF and zofran with symptom improvement. Able to discharge home without further escalation of care
Fever, Joint Aches and pains, swollen glands or nodes, dizziness,  chills, headaches and fatigue for two + days. Swelling and hardness about the size of a racquetball,  under right arm  near injection.
Pt recv vax on 2/10/99; on 2/11/99 pt exp edema/ swelling/ erythema of LA & shoulder w/ blisters; tx=Rocephin & Losphizan antibiotic
Flu symptoms: migraine, chills, body aches and pains, fever, back pain
The lump in my arm grew from little to small over the past two weeks of the original injection date
This case was reported by a other health professional via sales rep and described the occurrence of malaise in a male patient who received FLUARIX QUADRIVALENT 2018-2019 season for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT 2018-2019 season at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced malaise and fatigue. On an unknown date, the outcome of the malaise and fatigue were unknown. It was unknown if the reporter considered the malaise and fatigue to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. The reporter denied permission for GlaxoSmithKline to follow-up.
This spontaneous report as received from a nurse refers to a 13 year old female patient. On 12-APR-2013 the patient should have received the second dose GARDASIL (dosing information and route were not provided). However the patient was inadvertently administered two doses of GARDASIL on the same day (12-APR-2013). The outcome of patient was inadvertently administered two doses of GARDASIL on the same day is unknown. Additional information has been assistant.
husband tested positive; husband tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose  1, single (Batch/Lot number: unknown), on 01Mar2021 as dose  2, single (Lot number: FE3590) and on 12Oct2021 as dose 3 (booster) , single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "husband tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: her husband tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient called a different location and spoke to pharmacist and complained of severe pain and stated she thought the shot was given too high.
while reconstitute the Diluent DTaP/IPV and the HIB of a Pentacel and the needle came off of the syringe. The pressure of the syringe splashed the Pentacel in the employees face; while reconstitute the Diluent DTaP/IPV and the HIB of a Pentacel and the needle came off of the syringe. The pressure of the syringe splashed the Pentacel in the employees face; Initial information received on 15-Jul-2019 regarding an unsolicited valid non-serious case received from a other health care professional.  This case involves a 33 years old female patient who was exposed to vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patients past medical history, concomitant medication and family history were not provided.   On 15-Jul-2019, the patient was exposed to 0.5ml  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE, Pentacel Box Lot: UJ097AAA, Exp. Date: 19-Sep-2020, DTaP/IPV Lot U6327AA, Exp. Date: 19-Sep-2020, HIB Lot UJ097AA, Exp. Date: 19-Sep-2020.  It was an actual medication error due to occupational exposure to product and syringe issue.  It was reported that Medical Office Assistant who tried to reconstitute the Diluent DTaP/IPV and the HIB of a Pentacel and the needle came off of the syringe. The pressure of the syringe splashed the Pentacel in the employees face.  It was unknown whether patient experienced any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Got Kinrix instead of Daptacel; Kinrix was dose #4 of DTaP and IPV; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 6-year-old female patient who received DTPa-IPV (Kinrix) (batch number G9N2M, expiry date 14-APR-2024) for prophylaxis.   On 01-MAY-2023, the patient received Kinrix. On 01-MAY-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: Got Kinrix instead of Daptacel) and inappropriate schedule of vaccine administered (Verbatim: Kinrix was dose #4 of DTaP and IPV). The outcome of the wrong vaccine administered and inappropriate schedule of vaccine administered were 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: 01-MAY-2023 The medical assistant reported that a patient received a dose of Kinrix instead of Daptacel inadvertently.  This was dose 4 of DTaP and IPV.  The reporter consented to follow up via email. The patient received Kinrix (4th dose)  instead of Daptacel, which led to wrong vaccine administered and inappropriate schedule of vaccine administered.
This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age and gender. Concurrent conditions and medical history were not reported. The healthcare worker reported that since 11-DEC-2015, the patients had been vaccinated with unspecified doses of oral, ROTATEQ (Lot# L013193, exp. date 20-JAN-2017) (Strength and route were not provided), which were exposed to temperatures outside of the recommended range. Concomitant medication was not reported. No adverse experience had been reported. This is one of several reports from the same source. Additional information has been requested.
5 hours post injection severe chills and severe shaking, numbing at ends of fingers and toes.  11 hours post injection feverish .   Fever resolved 24 hours post injection. Over the course of the following few days,  head and body aches and constipation . It is currently 3.5 days post injection and most side effects have resolved
nausea, vomiting, diarrhea, headaches  x 2 days. HA lasting 5 days
fever of 101,chills,nausea lasting 8hrs;this was 1st dose in series p/saliva contact to open wound;
pt states that her right arm is extremely sore, hot to touch and she has a rash up to her shoulder.  She has had a severe headache.    She says it took about 5 days for the rash to subside, the swelling is going down but she still has a severe headache.
Raised, well-demarcated, red skin on R arm, surrounding and radiating from injection site. Hot to the touch and itchy. Concurrent symptoms of mild headache, dizziness, and fatigue. All symptoms first noted one week after 1st dose of vaccine.
pt recv vax 30OCT95 & that day devel an inj site rxn characterized by redness  & swelling;pt also recv flu vax that day & had a local rxn in the lt arm;
This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient. A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 at 13:30 as dose 1, single (Lot number: EN5318) at the age of 60 years intramuscular, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Migraine headache" (unspecified if ongoing); "Hypertension intermittent" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DISTURBANCE IN ATTENTION (non-serious) with onset 05Feb2021 at 09:00, outcome "recovered with sequelae", described as "Difficulties focusing"; GUILLAIN-BARRE SYNDROME (medically significant), PYREXIA (non-serious) all with onset 05Feb2021 at 09:00, outcome "recovered with sequelae" and all described as "Guillain-Barre syndrome with fever"; MUSCULAR WEAKNESS (non-serious) with onset 05Feb2021 at 09:00, outcome "recovered with sequelae", described as "Severe muscle weakness"; SOMNOLENCE (non-serious) with onset 05Feb2021 at 09:00, outcome "recovered with sequelae". The patient underwent the following laboratory tests and procedures: Polymerase chain reaction: (13Dec2020) Negative, notes: Nasal Swab; (13Jan2022) Negative, notes: Nasal Swab; (07Mar2022) Negative, notes: Nasal Swab; (27Apr2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of Guillain-Barre syndrome, pyrexia, muscular weakness, somnolence, disturbance in attention. Clinical course: Patient experienced Guillain-Barre syndrome with fever, severe muscle weakness, somnolence, difficulties focusing and completing tasks for 2 and 3 weeks after 1st and 2nd vaccination respectively. It was reported that adverse events were treated with valacyclovir 1000 mg orally four times a day, Ibuprofen 400 mg orally three times a day and was said bed rest. It was said that the patient was recovered with lasting effects. It was reported that the patient never had Covid prior vaccination and was tested for Covid after vaccination. The patient had not taken other vaccine in four weeks and even no other medications within two weeks and other vaccine date was 06Feb2022. The patient had no known allergies. Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event GUILLAIN-BARRE SYNDROME 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.
9/27 patient reported muscle aches day after and for 7 days from having the influenza shot. 9/28/2010 - Dr says patient has a lung infection, waiting on rest of Lab result.
I have had two shots of Moderna and one shot of the Pfizer Covid 19 vaccine. Prior to the shots I didn't seem to have a blood clotting disorder but I was recently diagnosed with a blood clotting disorder. The disorder may not be related to the vaccines as I did have a TIA in February, but it seems like the blood work completed after the vaccines shows a significant increase in the blood clotting tests.
Patient experienced malaise, achiness, and had a rash around the injection site extending down to her elbow.
given a Shingrix expired dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number 252JX, expiry date 14-SEP-2023) for prophylaxis.   On 24-OCT-2023, the patient received the 1st dose of Shingrix (intramuscular). On 24-OCT-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: given a Shingrix expired dose). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 24-OCT-2023 It was reporter that patient was given Shingrix expired dose which led to expired vaccine used. The reporter consented to follow up.
raised red rash p/1st dose of vax; 7SEP93 bitten by a cat that was trying to remove from attic; no though to be high risk exposure; no cases in domestic animals in this area; was also given augmentin for wound infect; will not cont series;
Patient received Pfizer has his 1st dose on 9/23/21 and Moderna has his 2nd dose on 2/23/21.
Fatigue within 24 hrs.  Swelling in forearm tingling & coldness & color change in fingers within 7 days.  potential transient ischemic attack (TIA) or potential seizure 65 days after shot.
On 10/27/2000 or 10/25/2000 the patient presented with chickenpox. The nurse reported that the patient had a rash for 2 days consisting of 5-10 red itchy pustules/vesicular lesions with erythema at the base on his neck, back, face, and chest. It was reported that the physician expected more. The rash increased in number over 12-24 hours prior to the visit. Subsequently, the patient recovered from his experience. No further information is available.
Woke up the next morning and was so weak and dizzy that I  had difficulty walking to the bathroom. Made it to the bathroom but went back to bed and slept for 5 more hours. Still very weak so stayed in bed.  Was still weak the next morning, stayed in bed til 1 pm when I was feeling stronger.
This spontaneous report was received from a registered nurse and refers to an unspecified patient of unknown age and gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 09-AUG-2016, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX subcutaneous injection (subcutaneously; lot # M006726, expiration date 08-FEB-2018 (strength and dose number were not reported), which was exposed to temperature excursion of 11.5 degrees Fahrenheit for 1 hour and 52 minutes. On an unknown date, there was a previous temperature excursion of 13.1 degrees Fahrenheit for 48 hours. Data logger was involved. No adverse effects were reported. Healthcare professional called and reported there was no further information to provide for this adverse event. The reporter requested no further follow-up from the company. This is one of several reports received from the same reporter. Additional information is not expected as the reporter requested no further follow-up.
PATIENT RECEIVED PEDIATRIC VACCINE WITH NO ADVERSE REACTIONS EXCEPT SORENESS AT INJECTION SITE
Approximately 10 hours after vaccination, child in bed with blanket vomiting on blanket, grunting and  ?, non-responsive and lasted approximately 20 minutes.
Pt developed flu like symptoms. Five days post vax, pt presented to the ER with a fever of 104F and back pain.
suspected vaccination failure; Patient got HZ after getting shingrix series / Rash started / 1 month post his second dose / increased and worsened 2 months post second dose; Rash; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number FY5H2, expiry date 25th May 2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number NE49X, expiry date 23rd August 2022) for prophylaxis.   The patient's past medical history included herpes zoster.   On 9th October 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix and 1 month after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster and rash. On an unknown date, the outcome of the vaccination failure, herpes zoster and rash were unknown.   It was unknown if the reporter considered the vaccination failure, herpes zoster and rash to be related to Shingrix and Shingrix.  Additional details were reported as follows: The patient had previous history of Herpes zoster prior to receiving Shingrix series. The patient experienced Herpes zoster after getting Shingrix series. The patient reported no immediate side effects but stated a rash started to form 1 month post his second dose. The rash then increased and worsened 2 months post second dose. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown. The reporter consented to follow up.
Very tired; stayed in bed for a day; This spontaneous case was reported by a consumer and describes the occurrence of BED REST (stayed in bed for a day) and FATIGUE (Very tired) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced BED REST (stayed in bed for a day) and FATIGUE (Very tired). At the time of the report, BED REST (stayed in bed for a day) had resolved and FATIGUE (Very tired) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. It was reported that when the reporters supervisor at work received the first dose of primary series vaccine that patient became very tired and stayed in bed for a day. Treatment information was not provided.   Reporter did not allow further contact