chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; the patient was vaccinated with an improperly stored dose of PROQUAD; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.  On 18-MAR-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant Human albumin (rHA) (PROQUAD) lot number R024015, expiration date on 19-FEB-2020 for prophylaxis (strength, dose number, anatomical location and route of administration was not reported). The sterile diluent used to reconstitute Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant Human albumin (rHA) (PROQUAD) was properly stored.  The temperatures were from 6  degrees Fahrenheit (°F) to 14°F for a timeframe of 10 hours and 35 minutes with a previous temperature excursion of 6°F to 14 °F for 9 hours and 5 minutes and from 15°F to 46°F for two hours and 30 minutes.  The temperature excursion was called because of a data logger and no adverse effects were reported.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA002419: US-009507513-1903USA011545:
Had MMR 9/10/02-presents today 9/20/02 with scattered macular red rash.
At 1040A patient received 7 vaccines then started to feel dizzy. PHN had patient lie flat on exam table, VS checked frequently and water given. Patient did not eat breakfast.
Left side facial paralysis: lips numb and droopy, left eye doesn?t blink but can close during sleeping
Arrived to the hospital with questionable stroke, 2 seizures in route to hospital (witnessed by EMS personnel) approximately 8 hours after injection.
Information has been received from a healthcare administrator referring to a patient of unknown age and gender. On 23-JUN-2016 the patient was vaccinated with improperly stored oral ROTATEQ (lot# L048854, expiration date 31-AUG-2017, dose not reported) orally. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
FLUZONE HIGH DOSE was given instead of FLUZONE. Patient was doing ok no problem at the time.
I have been having really bad dry cotton mouth. when I received the first shot I had a horrible burning in my mouth three hours after shot. then the second shot I have chronic dry mouth on and off not consistent
pt recv vax 23SEP96 & on 24OCT97 pt devel a full blown varicella infect;
Error storage for Engerix-B  given to a patient; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a male patient who received HBV (Engerix B) (batch number N4GA4, expiry date 2nd January 2023) for prophylaxis.   On 4th November 2021, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The practice manager called to report that Engerix-B  was administered to patient after a temperature excursion, which led to incorrect storage of drug. This lot number was exposed to a lowest temperature of 18 degree Fahrenheit for more than 30 days, vaccines are not longer viable. The reporter consented to follow up. This case was linked with case US2021237518, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021237518:Same reporter. Pt 2/2
On June 3 he developed a sore throat. His voice sounded like he had a frog in it. Early on June 4 he had to urinate about 10 - 15 times overnight in about a 6 hour timeframe. Later on Friday he left home and a short time later called 911 saying he couldn?t breath. When the paramedics arrived they couldn?t revive him and he died.
Pt developed redness and itchy around site of injection 24-48 hours later. Recommended PO BENADRYL Q 4-6 hours. No resp. distress.
Sudden onset of lip and face tingling, redness and rash to chest, flushed face and increased heart rate
I came home from work on the 14th and I was freezing cold. I laid on my bed and bundled up in 5 0r 6 blankets even though it was 110 degrees outside. I got up and took a couple of Tylenol and went to sleep. Got up the next day and went to work and worked through my day and took my grandchildren somewhere and I got home and I was freezing and miserable. I took a couple Tylenol. On Wednesday, my husband said "This isn't normal" and he took me  to Urgent Care - and they tested for COVID it came back positive for COVID. Gave me a cough medicine prescription - but it was starting to upset my stomach. Had my husband to give me bananas and applesauce and when I eat that then I take the medication so it won't upset my stomach. And I can't breathe, I cough and have fevers and pain. I am pretty sure right now I have blood clots in my legs. I get up every once in a while to get something to eat and I'm really light headed and dizzy. Have to hold on to walls - don't feel stable in walking. And then I lay down in bed again.  I did get my doctor to call in a large dose of Zofran. I've got Zofran now and two different cough medicines.  Other than the cough medicine (which makes me dizzy when I call back) - it does prevent me from coughing.  Symptoms ongoing. I've tried to  force myself to get up more today and move around more to do a few things. I have had to take my work in small portions to fold three or four pieces of clothing and then rest a while. I don't have the energy to hardly do anything. I'm nervous to going back to work. I'm in the process of  recovery.
Redness, Tenderness, Swelling all around left bicep on inside of arm.
I tested positive for COVID-19 on 11/22/2022. I had a headache, fever, sore throat, chest discomfort, and body aches. The headache was the worst symptom. I contacted my doctor and was prescribed 5 days' worth of PAXLOVID. I started feeling better after taking PAXLOVID, but that only lasted for 2 days and then I started feeling worse than I did originally. I am feeling better now, but still have quite a bit of fatigue.
Headache, Myalgia, Diarrhea, insomnia, chills, injection site pain Narrative:
Information has been received from a advanced registered nurse practitioner concerning a 16 years old female who on 01-JUL-2009 was vaccinated with the first dose of GARDASIL. On 06-JUL-2009 the patient developed swollen glands, was aching all over and nausea feeling for a few days. On 10-JUL-2009 the patient was feeling better. At the time of the report, the patient's outcome was unknown. Follow-up information has been received from a nurse concerning that the date of onset of symptoms was incorrect in the original report. The nurse told the representative originally the symptoms began on 06-JUL-2009, but after speaking with the father again determined the symptoms actually started the day of vaccination 01-JUL-2009. Additional information has been requested.
Case number PHEH2014US020066, is an initial spontaneous report from a health care professional received on 02 OCT 2014. This report refers to a patient under 4 years of age. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN 2014/2015 (batch number: not reported) intramuscularly sometime in the last week. No adverse reaction reported following the maladministration (inappropriate age at vaccine administration).
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Jan2021 at 14:00 as dose 1, single (Lot number: EL0140), in left arm, on 26Jan2021 at 13:00 as dose 2, single (Lot number: EL3302), in left arm, on 27Sep2021 at 14:00 as dose 3 (booster), single (Lot number: 301358A), in left arm and on 06Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Pcn" (unspecified if ongoing), notes: known allergies: Pcn. Concomitant medication(s) included: SYNTHROID, start date: 15Aug2012; PRESERVISION AREDS 2, start date: 15Sep2016. Past drug history included: Sonata, reaction(s): "drug allergy", notes: known allergies: sonata. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Negative; (Aug2022) Negative; (Aug2022) Negative; (Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: other medication details: other medication in 2weeks brand=Synthroid. other medication in 2weeks brand=PreserVision Areds2. Yes patient taking  other medications/products within 2 weeks of starting COVID-19 treatment. Yes patient previously receive a COVID-19 Vaccine. Reported Event: Recurrent covid symptoms after taking Paxlovid with positive covid test after 3 negative tests. Anti viral details: product=COVID-19 Treatment. brand=Paxlovid. treatment start date=17Aug2022. treatment stop date=22Aug2022. Indication=Treatment of COVID-19; Sender's Comments: Based on the available information, there is reasonable possibility of causal association between the events vaccination failure and COVID 19 and the suspect vaccine BNT162B2
expired vaccine was administered with no 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 1 years old male patient to whom administered expired Hib (PRP/T) Vaccine [Act-Hib] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles Vaccine, Mumps Vaccine, Rubella Vaccine (Mmr); Varicella Zoster Vaccine (Varicella Vaccine); Hepatitis A Vaccine (Hepatitis A); And Pneumococcal Vaccine (Pneumococcal Vaccine) for Prophylactic vaccination.  On 18-Aug-2023, the patient received expired dose of 0.5 ml of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection (strength: standard, frequency: once, expiry date: 12-Aug-2023 and lot UJ796AA) via intramuscular route in left vastus lateralis for immunization (expired product administered) (latency: same day).  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.
Within 5 minutes of receiving a Pfizer vaccine, the patient began to vomit. She did receive one J&J shot previously but had not had Pfizer.   Vitals completed and patient stating she felt much better after episode. She denied any SOB, chest pain, or dizziness.   (BP 177/86, Pulse 72, Resp 18, SpO2 99%).  Patient then placed in wheelchair and brought into nurse room for further evaluation by PCP. PCP was updated on the series of events. Patient symptoms resolved before exiting the building.
rash all over her body; red bumps; dose 2 was given on january 12, 2020. Three days later; This case was reported by a consumer via call center representative and described the occurrence of generalized rash in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received in July 2019).   On 12th January 2020, the patient received the 2nd dose of Shingrix. On 12th January 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 15th January 2020, the patient experienced generalized rash and red rash. On an unknown date, the outcome of the generalized rash, red rash and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the generalized rash and red rash to be related to Shingrix.  Additional details were provided as follows: On 12th January 2020, the patient received the 2nd dose of Shingrix late, which led to lengthening of the vaccination schedule.  Three day later patient reports she was experiencing a rash all over body, except for her face. The reporter consented to follow up.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concomitant medications, drug reactions or allergies was reported. On an unknown date, the patient was vaccinated with a dose of M-M-R II injection in the right deltoid (dose, route of administration lot number and expiration date were not reported). Within 24 hours, the patient was vaccinated with another dose of M-M-R II in the right arm. The doses of the vaccine were reconstituted with sterile diluent (MERCK) (dose, route of administration, lot number and expiration date were not reported). Both doses were given while the patient was an inpatient at the Labor and Delivery unit at the hospital. No adverse events were reported.
It started with extreme cramping in my stomach and then broke out in a rash with white little bumps in the rash on the inside of both legs and private area that is blood red and feels like it's on fire. I also experienced 3 bumps around the vaccine area and it itches badly.
I noticed really small, streak of blood, a spot or 2 or red blood when I wiped myself after urination; my left arm was super sore; This spontaneous case was reported by a patient and describes the occurrence of HAEMATURIA (I noticed really small, streak of blood, a spot or 2 or red blood when I wiped myself after urination) and PAIN IN EXTREMITY (my left arm was super sore) in a 72-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) .5 milliliter. On 07-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced PAIN IN EXTREMITY (my left arm was super sore). On 09-Oct-2023, the patient experienced HAEMATURIA (I noticed really small, streak of blood, a spot or 2 or red blood when I wiped myself after urination). At the time of the report, HAEMATURIA (I noticed really small, streak of blood, a spot or 2 or red blood when I wiped myself after urination) had not resolved and PAIN IN EXTREMITY (my left arm was super sore) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter considered HAEMATURIA (I noticed really small, streak of blood, a spot or 2 or red blood when I wiped myself after urination) to be related. No further causality assessment was provided for PAIN IN EXTREMITY (my left arm was super sore).    No relevant concomitant medications were reported. On the night of 09 Oct 2023, she noticed really small, streak of blood, a spot or 2 or red blood when she wiped herself after urination. It was like when a needle was pricked and see a small blood. On 10 Oct 2023 she saw small dots. It was not getting worse and patient has not spoken with doctor. She went online and saw that this was a side effect of Covid vaccine, Spikevax. No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-745140 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-Oct-2023: Follow up included non-significant information and references updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745140:Monovalent Dose
pt arrived @ hosp 8APR98 w/T105 & appeared to have febrile sz;pt also dx OM;pt given med for fever & augmentin for ear;ear infect seems to be the considered course for the high fever;
About 24hours after receiving Moderna booster redness at injection site occurred and has lasted 4 days now. In addition, I have diabetes, my blood sugar has been difficult to keep down despite following my routine regimen.
Goose egg on right arm. Pain down to elbow, tenderness, restricted arm movement from side of body.
Patient experienced pain in the joints and muscles of the right arm the day after the FLUAD was administered.
Hypertension urgency DBP: 110 with current treatment with Hydrochlorothiazide 25 mg 1 tab PO, QD; Amlodipine  5 mg 1 tab PO, BID; Propranolol 160 mg and Propranolol 60 mg total dose 220 mg,  Worsened Parkinson's
R arm is red and swollen down to elbow, was instructed by health dept to ice arm and use TYLENOL.
Less than 24 hours after vaccine started stomach cramps, diarrhea and sore arm, next day ocular migraine(never had before) with flashing lights and severe headache, extreme fatigue, sore throat, felt terrible      Had vaccine on Friday and by Monday, I felt recovered
9/21/2021 woke up at 1am with severe heart burn (which I never have)  Pain in chest and neck.  Took Ibuprofen and Papaya.  subsided some and I went to work.  9/22/2021 woke up 2am with severe pain in neck and chest difficult breathing.  2:30 pm drove to Rapid Care thinking it was heart burn but breathing getting much worse.  They sent me to ER across the street, by the time I walked over I was in breathing distress and chest pain. EKG showed heart attack symptoms
A few hours after my vaccine my arm became itchy around the vaccine site. The it turn red and hot, it started to spread down and up my arm. The next day I had itchiness, redness, swelling and two big welts, one where the vaccine was given the other was lower down my arm. My arm itched for 4 days after my vaccine until it went away.
chills; nausea; vomiting; stomach cramping; muscle aches; headache; fever; chest pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (stomach cramping), CHEST PAIN (chest pain), CHILLS (chills), NAUSEA (nausea) and MYALGIA (muscle aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced ABDOMINAL PAIN (stomach cramping), CHEST PAIN (chest pain), CHILLS (chills), NAUSEA (nausea), MYALGIA (muscle aches), HEADACHE (headache), PYREXIA (fever) and VOMITING (vomiting). At the time of the report, ABDOMINAL PAIN (stomach cramping), CHEST PAIN (chest pain), CHILLS (chills), NAUSEA (nausea), MYALGIA (muscle aches), HEADACHE (headache), PYREXIA (fever) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Approximately 5 1/2 hours after receiving my second dose of the shingles vaccine I began to experience aching and soreness in the injection arm. Approximately 8 PM I began to experience chills. I took two doses of MOTRIN prior to midnight, and around 2 AM I took two EXCEDRIN. I was on able to sleep most of the night and was very uncomfortable. I had to take the following day off of work and could do no more than just lying in bed and wait for it to subside. I'm on day two and I still have aching and some chills. I have also developed a slight headache. The injection site was swollen in the evening but seems to be subsiding a little bit. I did not apply ice.
Lot of pain on the neck/ it hurts a lot; Constrain muscle on the shoulder; Pain close to her neck; Pain in the arm; Difficulties moving her neck; The injection site is bruised, a little green in the injection site; This spontaneous case was received on 16-Oct-2020 from other health professional via Health Authority (reference number: SEQW20-03809) and concerned a 51-year-old female patient.  The patient had no relevant medical history. The patient's concomitant medications were not reported.  On 10-Oct-2020, the patient was vaccinated with Flucelvax QIV  (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml; route of administration: intramuscular; anatomical location: left arm) for influenza prophylaxis. The batch number reported was 279844 and expiry date: 30-Jun-2021.  On the same day, one hour after receiving Flucelvax QIV, the patient felt pain on the arm.    On 11-Oct-2020, one day after receiving Flucelvax QIV, patient felt constrain muscle on the shoulder and by afternoon she felt pain close to her neck.   On 12-Oct-2020, two days after receiving Flucelvax QIV, the patient felt a lot of pain on the neck.   On 13-Oct-2020, the patient waited 3 days, as advised by the pharmacy and symptoms got worse.  On an unknown date in Oct-2020, the patient had difficulties moving her neck, since it hurt a lot, also the injection site was bruised, a little green in the injection site. The patient took ibuprofen and Tylenol (paracetamol) as a treatment and also put heat cream for pain relief in the neck area. The patient scheduled an appointment for the doctor next Monday.   At the time of initial reporting on 16-Oct-2020, patient had not recovered from events and was getting worse, without improvement.   The reporter did not provide a causality assessment.  The reporter assessed the event as non-serious.  Company comment:The patient developed pain in extremity, musculoskeletal stiffness, pain and neck pain within two days after vaccination with the suspect product, Flucelvax QIV. The events of movement disorder and injection site bruising occurred on an unknown date within same month. According to narrative, chronology seems plausible. No information regarding medical history and concomitant medications was provided. Considering all above mentioned, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed pain in extremity, musculoskeletal stiffness, pain and neck pain within two days after vaccination with the suspect product, Flucelvax QIV. The events of movement disorder and injection site bruising occurred on an unknown date within same month. According to narrative, chronology seems plausible. No information regarding medical history and concomitant medications was provided. Considering all above mentioned, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).
Patient states "On Tuesday 1/5/21 around 11:30 a.m. I started feeling sick like I had the flu. I had muscle aches, fatigue, shortness of breath, headache, nausea and diarrhea. The only thing I didn't have is the fever."   Patient seen her primary health provider on Wednesday 1/6/21 who listened to her lungs and just told her to take it easy. Patient is currently working from home