chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ear pressure; ear blockage; dizziness; fatigue; tinnitus/got worse; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Apr2021 10:30 (Lot number: EW0161) at the age of 28 years as dose 1, single and administered in arm left, administration date 14May2021 01:15 (Lot number: EW0172) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: EAR DISCOMFORT (non-serious) with onset 24Apr2021, outcome "not recovered", described as "Ear pressure"; EAR DISCOMFORT (non-serious) with onset 24Apr2021, outcome "not recovered", described as "ear blockage"; DIZZINESS (non-serious) with onset 24Apr2021, outcome "not recovered", described as "dizziness"; FATIGUE (non-serious) with onset 24Apr2021, outcome "not recovered", described as "fatigue"; TINNITUS (non-serious) with onset 24Apr2021, outcome "not recovered", described as "tinnitus/got worse". The events "ear pressure", "ear blockage", "dizziness", "fatigue" and "tinnitus/got worse" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of ear discomfort, ear discomfort, dizziness, fatigue, tinnitus.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Health Clinic. Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: No. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19. No known allergies. It was reported that the patient experienced Ear pressure, ear blockage, dizziness, fatigue, and tinnitus began shortly after receiving first dose, got worse after second dose, and has not improved in over 6 months. The patient received Antibiotics, steroids, and allergy medication as treatment. No follow-up attempts are possible. No further information is expected.  No follow-up attempts are possible. No further information is expected.
1.Sore throat, congestion and coughing 2. Drank tea, throat spray, 3. Felt better four days later
I am currently Pregnant, due August 11, 2021. I woke from sleep with a sever muscle cramp in my right calf on 04/11/2021 at about 3am after vaccination. The following day I have noticed moderate muscle cramping in both legs and forearms.
Got the vaccine ant 8:30 am started getting fever at 4:00 pm same day.fever went to 101.6 at midnight same day Also had body aches
Allergic urticaria x 1 day. Zyrtec and Benadryl prescribed by MD.
pt accidentally given two HIBs. pedarix was supposed to be ordered, pentacel given by mistake. no signs or symptoms of adverse reaction noted at this time. parents notified.
Patient experienced syncope after getting her first Pfizer Covid shot - patient's husband was present and said that this had happened before after receiving a shot.
This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (got 0.25mls booster dose Moderna covid vax on 3rd Nov, but this was her first dose, should have been 0.5mls) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 03-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (got 0.25mls booster dose Moderna covid vax on 3rd Nov, but this was her first dose, should have been 0.5mls). On 03-Nov-2021, ACCIDENTAL UNDERDOSE (got 0.25mls booster dose Moderna covid vax on 3rd Nov, but this was her first dose, should have been 0.5mls) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
pt recvd vax;devel erythematous,hot area w/ some ecchymosis at inject site;took erythromicin ethylsuccinate for 4 days & condition resolved w/in 3 wks;
The reaction is so severe; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (The reaction is so severe) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (The reaction is so severe). At the time of the report, IMMUNISATION REACTION (The reaction is so severe) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The dosage text was reported as unknown. No treatment medication was reported.    Reporter did not allow further contact
shakes; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (shakes). At the time of the report, TREMOR (shakes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported Treatment medications was not provided
Blister in upper right corner of cheek inside the mouth; This is a spontaneous report from a non-contactable consumer, the patient. A 19-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735), via an unspecified route of administration in the left arm on 29Mar2021 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included norethisterone acetate; ethinylestradiol; ferrous fumarate (MICROGESTIN FE 1.5/30) taken for an unspecified indication from an unspecified date. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021, the patient had a blister in upper right corner of the cheek inside the mouth. The adverse event did not result in a doctor or other healthcare professional office/ clinic visit/ emergency room/ department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event blister in the upper right corner of cheek inside the mouth was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
1/31/2021 03:56 Nursing Note Note Text: Pt. c/o R Abd pain at the waist line. Pt. stated it felt like a muscle being pulled. Not constipated, bowel sounds active. Took VS and they are charted. Writer called on call and spoke to NP and she stated to give him Tylenol and check the above. Bowel sounds and such. So writer did give him Tylenol at 3:45am.  1/31/2021 12:53 Admit/Discharge/Transfer Note Note Text: at 1030 pt stated that he had been having RLQ pain for the past hour. VS retaken. Described pain as constant but "increases suddenly" to an 8 on a 10 point pain scale. worsens with movement, alleviates with rest. RLQ pain radiates to R shoulder and around to his R lower back. bowel sounds x4, tender abd in right lower quadrant and upper right quadrant. follow-up assessment at 1220 found rebound pain. pt states last bm was yesterday and it was brown, formed, easy to pass. Lower posterior R lung sounds diminished and lower posterior L lung fields contain crackles. at 742: temp 98F, 140/68, 02 saturation 96%, respiration 16. denies n&v. ate pancakes, sausage, and fruit for breakfast. gave morning pantoprazole, held morning am medications.  Called on call triage nurse and NP. on call NP suggested sending pt to hospital. transferred to hospital via ambulance and paramedics at 1240.
(L) upper arm cellulitis - (L) arm pain - down fingers & across chest - started on KEFLEX 500mg 1 QD x 7 days. ROCEPHIN 1 gm IM - ALEVE - ADVIL - heat/ice - VICODIN 5/500 1 po Q 4-6hrs. # 20 ER --> 600 mg CLEOCIN - BACTRIM also added.
Broke out in hives; This is a spontaneous case initially received from other non-health professional via Med Communications (reference number: SEQ20-00433) on 29-Jan-2020 concerning a 74-year-old, male patient.   The patient's medical history included heart surgery, triple bypass and arthritis.   The patient's concomitant medications included atorvastatin, metoprolol, lisinopril, aspirin (acetylsalicylic acid), loratadine, cimetidine, hydroxyzine, Humira (adalimumab) and vitamin D, all used for unknown indications.   On 19-Sep-2019, the patient was administered Fluad TIV [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, anatomical location: deltoid, route of administration: intramuscular, batch number and expiry date: not reported] for prevention of seasonal influenza.    On the same day, the patient broke out in hives and it had affected him ever since, as reported.   The patient had taken antihistamines and prednisolone as a treatment.   At the time of the reporting, the patient did not recover from the event.  The case is linked with 202001402 (same reporter).   Company comment: The event of hives is considered as related to Fluad TIV.; Sender's Comments: The event of hives is considered as related to Fluad TIV.
Broke out on 10/23/05. 10-12 papules with hint of vesicle, scattered on face (drying), legs, groin, abdomen, and arms.
COVID-19; COVID-19; Dose Number: 1 and Dose Number: 2: Moderna; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 29Oct2021 as dose 3 (booster), single (Lot number: 320308D) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Jan2021 as dose 1, single (Lot number: 013420A), on 09Feb2021 as dose 2, single (Lot number: 016M20A), on 08Apr2022 as dose 4 (booster), single (Lot number: 065K21A) and on 13Sep2022 as dose 5 (booster), single (Lot number: AS7144B), in left arm for covid-19 immunisation; elasomeran (SPIKEVAX), on 02Oct2023 at 10:00 as dose 6 (booster), single (Lot number: AU3832B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "Multinodular Goiter" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Oct2021, outcome "unknown", described as "Dose Number: 1 and Dose Number: 2: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19: the patient received treatment with Paxlovid from 26Oct2023 to 30Oct 2023 (lot number GJ7157).; Sender's Comments: The contributory role of the suspect product to the reported event drug ineffective cannot be excluded as the efficacy of a drug varies individually and may be affected by different factors including drug potency. Considering interchange of vaccine, the contributory role of company suspect drug BNT162b2 to all the reported events drug ineffective, covid-19 cannot be excluded completely.
No adverse event. Administered vaccine then when logging in Registry saw that patient had previously received Janssen vaccine on 3/8/21.
Dull, achy pain in the arm/shoulder 2-3 days post-injection.  Injection was administered IM in the left arm
Cough, congestion, shot of breath, fatigue started on 10/17/22
rash/ redness at site of injection and pain reported by phone to pharmacist .  Patient was instructed to use a cold compress to site and take tylenol extra strenght for pain. Patient stated that she would follow the instructions given.
Menorrhagia during period - abnormal and extremely heavy bleeding. Bleeding so heavy that I would fill an ultra tampon and overnight pad in 1 hour, for several days at a time. Heavy period days used to be 1 - 2 days, but heavy bleeding now lasted several days. I also started to pass tissue and large clots during my period. This was accompanied by a general feeling of being unwell/like I had the flu.
Within 5 minutes of being vaccinated patient let out high pitch screaming, followed by high pitch crying, then lips turned purple and gasping for breathe.
This spontaneous report was received from a Registered Nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. In May 2016, the patients were vaccinated with the improperly stored doses of M-M-R II lot number reported as L040961, expiration date on 19-OCT-2017 (dose was not reported). No adverse events were reported. Administered dose of vaccine experienced the temperature excursion of 48 degrees Fahrenheit for 50 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested.
expired dose of ACT HIB had be administered with no reported adverse event; 68 year old patient administred ACT-HIB with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician and pharmacist via Global Medical Information (Reference number- 00684494) and transmitted to Sanofi on 15-Jul-2021.  This case involved a 68 year old male patient who administered expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (product administered to patient of inappropriate age and expired product administered)   Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On 15-Jul-2021, the patient received 0.5ml dose of suspect HIB (PRP/T) VACCINE (lot: UJ328AB and expiry date: 30-Jun-2021) (Frequency = once) (Strength = standard) via intramuscular route in the right deltoid for prophylactic vaccination (product administered to patient of inappropriate age and expired product administered)  It was reported that, "the caller stated that an expired dose of ACT HIB had be administered. What are our recommendations"?  This case was an actual medication error (expired vaccine used and Inappropriate age at vaccine administration) (latency same day)  At the time of reporting, no adverse 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 15 minutes, post vax, client was driving back to work and experienced shortness of breath, dizziness, weakness and shaking of hands and feet. Client pulled into a gas station and had attendant call 911 and was taken to the hospital. She also experienced shortness of breath and dizziness on 12/09/00 and went to ER and was treated with IV fluids. She was released the same day but didn't state a dx from hospital or plan for further shots.
pt up 930-945am & mom noticed appeared dazed;walked to master bedroom to use facilities which never done a/;mom states looks weird & acts dazed;red dots, nauseated, sore neck, disoriented, vague memory;MD states poss allerg rxn; had hives
No adverse effects reported; The patient was vaccinated with an improperly stored dose of PEDVAXHIB; This spontaneous report was received from a licensed practical nurse referring to a 12 months patient of unknown gender. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies, nor concomitants medications were not reported.  On 18-NOV-2019, the patient was vaccinated for prophylaxis with an improperly stored dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (route of administration and dosage regimen were not reported; lot number R022223, expiration date: 12-JUL-2021).  The improperly stored of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) experienced a temperature of below 2 Celsius degrees; 0.3 Celsius degrees multiple for 45 minutes; without a previous temperature excursion and was call because a digital data logger. No adverse effects were reported. No further information provided.
Pain in my back; I have CYP proteins in my urine each time; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Kidney transplant" (unspecified if ongoing); "CYP proteins in urine" (unspecified if ongoing); "Laminectomy" (unspecified if ongoing); "Nerve problem" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "Pain in my back"; PROTEIN URINE PRESENT (non-serious), outcome "unknown", described as "I have CYP proteins in my urine each time". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of back pain.  Additional information: Codeine, another unspecified pain pill, and unspecified muscle relaxer was taken as treatment of the event.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Redness that is warm to the touch, itchiness around injection site. Side effects appeared 2 days after vaccine administration. Dime-sized bruising around injection site also noted.
Information has been received from a male with a penicillin allergy and very healthy at the time of vaccination, who on 09-OCT-2008 was vaccinated with ZOSTAVAX (Oka/Merck), dose, therapy route and lot # were not reported. Subsequently the patient had chest tightening for 4 days. The chest tightening went away at the time of the reporting but the patient had itching in the legs, back and arms along with a rash. The patient also experienced flu-like symptoms. The patient's physician gave him a cortisone injection, and the patient had prodizone medicine and took anti itching solution. The patient reported the pills helped greatly. At the time of this report, the patient was recovering but "not yet recovered". Follow up information was received from the patient: The patient reported on 12-OCT-2008 he experienced flu-like symptoms, itching in arms and legs, rash on arms and heaviness on chest which lasted 1 day. The patient had a flu shot on 30-SEP-2008. The patient still have itch on arms and legs one month later, but the patient felt much better. Additional information has been requested. Follow-up AE information was received on 01-DEC-2008. The caller reported that he was still experiencing itchiness and would go to see his physician regarding that. No further information provided. Additional information has been requested.
PATIENT DEVELOPED COVID-19 IMMEDIATELY AFTER RECEIVING THE J&J VACCINE, HE THEN DEVELOPED HYPOXIC RESPIRATORY FAILURE DUE TO COVID AND THEN 2.5 WEEKS LATER HAS DEVELOPED SEVERE HYPOXIC RESPIRATORY FAILURE DUE TO EXTENSIVE BILATERAL BACTERIAL PNEUMONIA WITH SEPSIS.
LOSS OF SMELL , sick for 2 weeks, severe pain in arm for2 weeks,
About 5 minutes after administering the BOOSTRIX Tdap shot, the patient fainted (syncope). The patient was able to recover in less than a minute.
Says she got her first dose on 03/5 and tested positive for covid on 03/27; Says she got her first dose on 03/5 and tested positive for covid on 03/27; This is a spontaneous report from a Pfizer-sponsored program, via a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Mar2021 at first dose, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient wanted to know if her covid vaccine was effective. Said she got her first dose on 05Mar2021and tested positive for covid on 27Mar2021; she rescheduled her second shot and got it on 27Apr2021. Outcome of the event was unknown.  Information on batch number has been request.
Mother found infant in crib, moaning with straight arms, looking to side. Placed infant in car and drove to hospital. She heard moaning as she was driving. Ride approx 15 minutes. Got to hospital where fever was 105 degrees.
On 05/23/2022  I went to pharmacy for a PCR test. On 05/27/2022 My result came out to be positive. My symptoms started with Sneezing; sore throat; fatigue;  and brain fog.  I did a tele health with my doctor on 05/27/2022  he  prescribed me with PAXLOVID for 5 days. As of today 08/18/2022   am  still experiencing  fatigue from COVID-19 symptoms which hasn't resolved yet but all the other symptoms are gone.
No Additional AE; Consumer reporting administration of improperly stored VAQTA and VARIVAX; Information has been received from a consumer regarding itself, a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 11-JAN-2021, the patient was vaccinated with an improperly stored hepatitis a vaccine, inactivated (VAQTA) lot # S037576 with expiration date 10-APR-2021 and varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number T020653 with expiration date reported as 12-JUN-2022, but upon internal validation 16-JUN-2022 (dose, route of administration, strength and anatomical location not reported). Both vaccines were administered as prophylaxis.  The varicella virus vaccine live (Oka/Merck) (VARIVAX) and hepatitis a vaccine, inactivated (VAQTA) were stored at a temperature of 14 degrees Fahrenheit (°F) for the time frame of 1 hour and at a temperature of 21.3°F for 1 hour (time frame also reported as 2 hours). There was no previous temperature excursion and the call was because of a data logger.   No adverse effects reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S037576; expirationdate: 10-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability