chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a 63-year-old male patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The patient experienced adverse reaction after receiving 1st dose of SHINGRIX. The patient was late for 2nd dose of SHINGRIX due to an ongoing adverse reaction from the 1st dose of SHINGRIX. The reporter did not consent to follow-up.
Patient already received Fluad vaccine 9/19/23 and got another one on 10/10/23.
flu; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 03-Dec-2020.  This case involves a patient of an unknown demographics who experienced flu (influenza), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, past vaccinations, family history and concomitant medications were not provided.   On an unknown date in 1991, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced flu (influenza), (unknown latency) following the shot of INFLUENZA VACCINE. Also reported this was happened two weeks after got the last flu shot.  No laboratory data reported.  It was not reported if the patient received a 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.
Patient received his vaccinations on 1/18/10, and presented to the hospital with a 2-day history of fussiness and decreased appetite on 2/2/10. Patient had developed Idiopathic thrombocytopenia (ITP).
Felt nausea's 5 minutes after administration. Patient vomited and felt dizzy. Monitored for 25 minutes.
This case was reported by a physician via sales rep and described the occurrence of erythema of extremities in a 54-year-old female patient who received Shingrix for prophylaxis. On 3rd October 2018, the patient received the 1st dose of Shingrix. In October 2018, less than a week after receiving Shingrix, the patient experienced erythema of extremities and fever. In October 2018, the outcome of the erythema of extremities and fever were recovered/resolved. It was unknown if the reporter considered the erythema of extremities and fever to be related to Shingrix. Additional details were provided as follows: The patient experienced local redness of entire arm from shoulder to elbow and fever in 101 degree F range for 5 days from the vaccination date. In October 2018, the patient's body temperature was recorded as 101 degree F. The reporter did agree to follow up from GlaxoSmithKline and stated that she would like to talk about it.
Severe fatigue, headache, joint pain, fever. Started around 0700 next day of injection and these symptoms lasted 24 hours.  Took Tylenol, Ibuprofen for fever.  Even with these two onboard, continued low grade temp.
Dystonia of left upper extremity. MRI brain on 11/22/2009 reveals multiple areas of demyelination. Concern for ADEM. Patient has had no prior symptoms. Patient does not meet criteria for multiple sclerosis.  11/25/09 Hospital neurological consultation received. Service date: 11/22/09. Assessment: Left upper extremity tonic activity. Patient presented with frequent intermittent left extremity stiffening spells. 5-10 second duration, tonic-like activity. Left upper and lower extremity weakness.  12/17/09 Hospital records, discharge summary received. Service dates 11/22/09 to 11/25/09. Assessment: Acute disseminated encephalomyelitis. Patient presented with frequent intermittent left extremity stiffening spells. Oral contraceptives.
"w/in 4 to 7 days p/vax pt exp 3 to 4 cycles of drenching noc sweats, bilateral swelling of the lymph nodes, low grade fever between 99 & 101, hot flashes, diarrhea, diff eating, weight loss;hemorrhagic cyst that burst;dx EBV & staph"
Initial problem  2/8/21 pericarditis. Hospitalized 2 days. Started on colchicine, metoprolol and rosuvastatin, pain medications. EC 4/12/21 for DVT; Admit 4/16/21 for worsening DVT in right leg.
Server pain at the injection site to the point it is hard to move the arm, and it woke me up when I rolled onto it. Migraine headache with visual pain and nausea. I have taken Tylenol and ibuprofen for the pain and discomfort and I have also been icing the injection site. I missed work today because of the migraine
A pharmacist reported that a female in her 30's received an injection of Tetanus and Diphtheria Toxoids Adsorbed, Purogenated and subsequently developed a localized injection site reaction and an elevated temperature. No further information was available at the date of this report.
ON 09/4/2019 PATIENT STARTED COMPLAINING OF VERY SEVERE UNEXPLAINED HEADACHE THAT IS GETTING WORSE AND WORSE, WAS SEEN BY SPECIALIST ON 09/08/2019 HAD CT SCAN DOSNE SAME DAY AND WAS ALL NORMAL. HIS SPECIALST THOUGHT IT MIGHT BE AN ADVERSE EFFECT TO FLUARIX.
Within 24hours of being vaccinated with the mmr, a rash developed on the left and right buttocks and on right facial cheek.  6 days after the mmr, he developed a fever of 101 in the evening.  On 4-23-04, 7 days after shot, his fever was around 102.  Around 6:30 that evening, he started to stare into space and I couldnt get him to react to me.  Called 911, when we got to the emergency room he started to shake.  They thought his seizure was about an hour, (he had never had a seizure pryor to this).  They gave him 4.5 mg of ativan and a big dose of dilantin to stop the seizure.  While in his 5 day hospital stay, he had chest xray, eeg, and mri.  He also developed and ear infection, on the chest xray they thought it look like slight pneumonia.  They redid the xray and it came back ok, but that was after the fact, he was given antibiotics.  His eeg and mri showed damage to the white matter of the brain.  The doctors said that they don't know what kind of damage it has done, it may turn out to be nothing, we just have to wait and see.  Some of the side affects to the MMR shot were rash, fever, ear infection, pneumonia, seizures (staring & jerking), and brain damage.  He has all the signs.  For treatment he has to go to a neurologist clinic once a month and stay on phenobarbital for the unknown future.  Nurse follow up on 08/23/04 states: "Discharge summary states diagnoses of status epilepticus, postictal encephalopathy, and fever."
Tinnitus moderate to severe onset about 24 hours after vaccination.  High pitched ringing both ears. Occurred with a low grade fever, chills, and muscle aches.  One alleve (naproxen sodium) pill to address symptoms did not impact tinnitus.
Patient called call center number to reach provider to cancel appointment for second dose of MMR vaccine. Patient reports that on day 18 after receiving vaccine at the Clinic she developed right sided facial swelling with an enlarged and tender lymph node on that side, making it difficult to chew. Patient followed up with PCP and PCP reports that it may have been an adverse reaction to the vaccination and advised patient to not get second dose of vaccine. Patient reports symptoms have improved but have not gone away completely.
Treatment of COVID-19; Treatment of COVID-19; Dose 1/Dose 2/Dose 3: Pfizer / BioNTech; Dose 4: Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Apr2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 24Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 20Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 26 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Idiopathic intracranial hypertension" (unspecified if ongoing). Concomitant medication(s) included: ACETAZOLAMIDE, start date: 01Sep2020. Past drug history included: Sulfa drugs, reaction(s): "Allergy". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Sep2022, outcome "not recovered", described as "Dose 1/Dose 2/Dose 3: Pfizer / BioNTech; Dose 4: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300182880 same reporter/patient, different drug/AE;
Pt reported ringing in ears since 7:30 PM on 7-19-13. Rated ringing as a "10" at onset. Ringing today (7-17-13) equals "3". Denies h/o ringing in ears. Referred to PMD since package insert did not list this as an adverse reaction. Pt. saw Dr who does not feel this is related to the Rabivert vaccine. Pt states that Dr said it is a "coincidence". Dr gave pt a Rx for Augmentin, 'steroids" and Zyrtec. PMH: Hypothyroidism. Takes Synthroid and multivitamins. Allergies: Bactrim, Pseudoephedrine. No ENT consult ordered. Pt is receiving pre-exposure rabies vaccinations. To receive last dose 7-30-13. Pt states that PMD said it is ok to receive next dose.
28Jan98 pt recv vax. 13Feb98 pt exp fever & slight rash. lab eval revealed positive IgM testing for varicella.
c/o temp/emesis/shaking referred to MACC dx sz rx blood cult/urine cult;transferred to another hosp spinal tap/Rocephin & advil;observed for a couple of hours until sx were resolved & sent home;did not stay overnoc;
hives, within 15 minutes of receiving vaccine.  vomited once, within 30 minutes.  notified physician, who said to give benedryl.  gave and then took to physician office and was seen by nurse pract.  gavin was better by time arrived at physician office.  still increased respiration.  NP stated no way to know if reaction to vaccine.
ulcerated ankles bled into her shoe/ bled more; ulcerated ankles bled into her shoe/ bled more; bleeding disorder; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8732), first dose via an unspecified route of administration, administered in Arm Right on 01Apr2021 (at 67 years old), single dose for covid-19 immunisation. Medical history included ongoing ulcerated ankles, joint bleeding diagnosed prior to the vaccine in her 40s. The patient had no concomitant medications. On 04Apr2021,  3 days post-vaccination her ulcerated ankles bled.  She explained this bleeding has happened before, but she bled more, and it reached into her shoes which is "unusual". Patient came home from shopping three days after the vaccine and her shoes were saturated with blood, states this lasted for about a day and resolved two days later around 06Apr2021. She was reading through the paperwork and it said to let them know if you have a bleeding disorder. She is scared. Her ankles have bled like this before, wants to know if this is considered a bleeding disorder, does the vaccine make you bleed more. The outcome of the events was recovered on 06Apr2021.
At seven days after getting the Moderna vaccine, my left arm started to get red, itchy, swollen and uncomfortable just below the injection site. In addition, my skin all over my body started to feel kind of "rashy." I had to take a Benadryl to sleep because my skin, overall, felt so warm. This has persisted and I'm onto to day 3. The swelling has lessened, but it's more itchy. I will not be taking the second Moderna dose. This is way too strong of an allergic reaction, to put my body through this again.   I realize that many people have had much more serious adverse reactions. But, my Dr. encouraged me to fill out the form, so I am.  I'm also making this report because I'm tired of reading in the news that this happens very rarely, but my Dr. told me it was fairly common. Moderna needs to fix their vaccine, or I need to switch to Pfizer.
Was prescribed Paxlovid / Can this drug, Paxlovid, reduce the benefits of getting the Pfizer COVID-19 vaccine; was prescribed Paxlovid / Can this drug, Paxlovid, reduce the benefits of getting the Pfizer COVID-19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, 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: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Was prescribed Paxlovid / Can this drug, Paxlovid, reduce the benefits of getting the Pfizer COVID-19 vaccine"; COVID-19 (medically significant), outcome "unknown", described as "was prescribed Paxlovid / Can this drug, Paxlovid, reduce the benefits of getting the Pfizer COVID-19 vaccine". Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient asked if PAXLOVID could reduce the benefits of getting the Pfizer COVID-19 vaccine reported it was administered it 8 or 10 days ago.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
flu like symptoms; flushed in her face; body aches; nausea; A really bad headache; This is a spontaneous report from a contactable consumer or other non hcp. An 81-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 15Feb2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The medical history and concomitant medications were not reported. On an unknown date the patient experienced flu like symptoms, flushed in her face, body aches, nausea and a really bad headache. It was reported that the reporter asked if the symptoms her mother is experiencing were side effects of the vaccine. The reporter stated that her 81yo mother (name) had her second vaccine dose on 15Feb and yesterday she began having flu like symptoms including being flushed in her face, body aches, nausea and a really bad headache. She asks if this is from the vaccine and is that normal for symptoms to start so long after getting the vaccine, reporting that she didnt have any symptoms following her first dose. The outcome of all the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient reports intense pain after injection, went to friends home and was having intense pain in shoulder of the injected arm, she "passed out" when trying to stand up from sitting position. Friend called EMS and EMT came to assess. EMT took her to the hospital because her BP was very high. She thinks could be from excitement or getting vaccine or a previous heart condition. Had no issues with first dose. She was assessed at the hospital emergency room and discharged several hours later.
Received 2nd dose one week after receiving 1st dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose one week after receiving 1st dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose one week after receiving 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose one week after receiving 1st dose) had resolved.            Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
My problem started in November when I would get up to walk, when I would start to walk my right knee gave me a lot of pain. After a few weeks my left knee started to give me the same pain so I made an appointment to see the doctor they referred me to get some x-rays and after the x-rays I was referred to an Orthopedic doctor. The Orthopedic doctor gave me a cortisone shot in both knees and she prescribed the medication meloxicam and Diclofenac Sodium Topical. I was also sent to rehabilitative therapy and my condition improved.
Left upper arm red, swollen, feverish. Was seen in ER on 2/25/03 at 7:00 PM. Was told to give Benadryl and Tylenol every 4 hours and use cold cloths to area.
intense pain starting in deltoid muscle migrating to elbow in the first hour. Unable to raise arm due to pain.  Rash progressing to solid redden area that was inflames and emense swelling in the next 24 hours.  Temperature of 99.7.  Swelling began to decrease after 48 hours.
Continuous Headache that is not treatable with over the counter medication (Tylenol, ibuprofen, or alieve); mensural bleeding & spotting in between periods despite being on hormone pills to prevent it; Fatigue
From 11/22 to 11/26, High fever, chills, constant headache, nausea (nor vomiting or diarrhea).  Extreme fatigue, muscle aches, muscle fatigue, joint aches, esp. hips.  Temp range 100-104.  Muscles weak.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 05-FEB-2015, the patient was vaccinated with an improperly stored dose of VAQTA 50 U/ 1 ml (lot # K006604, expiration date 21-OCT-2015). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/ Celsius) and the type of excursion (R/F) for each time were 144, 31 and R; 216, 34 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Hot to touch skin around injection site; Red circle on injection site; Itchy injection site; Arm was swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm was swollen), INJECTION SITE WARMTH (Hot to touch skin around injection site), INJECTION SITE ERYTHEMA (Red circle on injection site) and INJECTION SITE PRURITUS (Itchy injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     no medical history was provided by reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PERIPHERAL SWELLING (Arm was swollen). On 02-Mar-2021, the patient experienced INJECTION SITE WARMTH (Hot to touch skin around injection site), INJECTION SITE ERYTHEMA (Red circle on injection site) and INJECTION SITE PRURITUS (Itchy injection site). At the time of the report, PERIPHERAL SWELLING (Arm was swollen), INJECTION SITE WARMTH (Hot to touch skin around injection site), INJECTION SITE ERYTHEMA (Red circle on injection site) and INJECTION SITE PRURITUS (Itchy injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided
on Jan 16th 2021 patient received first dose and never gets the second shot; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 16th January 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
pregnant: Yes; last menstrual date: 02May2021; Fever; chills; Diarrhea; vomiting; Shakes; shivers; Severe arm pain; Headache; dizziness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Sep2021 11:00 (Lot number: Fc3184) at the age of 29 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Date of last menstrual period: 02May2021. The patient was 16 weeks pregnant at the time of exposure to bnt162b2. The patient was 16 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 22Feb2022. Concomitant medication(s) included: SYNTHROID. Vaccination history included: Bnt162b2 (lot number Fc3181, lot unknown False, administration date 20Aug2021, dose number 1, vaccine location Left arm), administration date: 20Aug2021, when the patient was 29 years old, for COVID-19 immunization. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "pregnant: Yes; last menstrual date: 02May2021"; PYREXIA (non-serious) with onset 10Sep2021, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 10Sep2021, outcome "recovering", described as "chills"; DIARRHOEA (non-serious) with onset 10Sep2021, outcome "recovering", described as "Diarrhea"; VOMITING (non-serious) with onset 10Sep2021, outcome "recovering", described as "vomiting"; TREMOR (non-serious) with onset 10Sep2021, outcome "recovering", described as "Shakes"; CHILLS (non-serious) with onset 10Sep2021, outcome "recovering", described as "shivers"; PAIN IN EXTREMITY (non-serious) with onset 10Sep2021, outcome "recovering", described as "Severe arm pain"; HEADACHE (non-serious) with onset 10Sep2021, outcome "recovering", described as "Headache"; DIZZINESS (non-serious) with onset 10Sep2021, outcome "recovering", described as "dizziness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of maternal exposure during pregnancy, pyrexia, chills, diarrhoea, vomiting, tremor, chills, pain in extremity, headache, dizziness.  Additional information: Fever and chills over night. Diarrhea and vomiting (I haven't had vomiting in a few weeks from pregnancy). Shakes/shivers. Severe arm pain. Headache and dizziness right after vaccination. Patient did not receive other vaccine in four weeks. Patient did not receive treatment AE. Patient was not covid prior vaccination and covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.