chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe to moderate epistaxis for 6 days.  Rhino rocket at onset of bleed and removed 36 hours later.  Various other packings attempted  for approximately 60 hours all of which failed to stop recurring bleeding.  Rhino rocket inserted and will remain inserted for  four days.  Scheduled to be removed by an Ear, Nose and Throat  specialist at the end of four day period.  Continuing treatment unknown at this time.
Patient was given vaccine at 21 days from the first dose NOT 28 days from the first dose.  Patient stated he has not had any adverse reactions. He stated he feels fine and is out doing chores and enjoying the nice weather.
This is a spontaneous report from a contactable pharmacist, received via a Pfizer sales representative. An elderly female patient of an unspecified ethnicity received PREVNAR 13 (Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The elderly female patient had a very small body frame, with very little muscle mass on the upper deltoid injection site. The pharmacist was unable to get the patient to relax the small amount of deltoid muscle. The patient called back to the retail pharmacy that she was still experiencing pain at the injection site a week after the injection. The pharmacist advised the patient that she should follow up with her primary care doctor. The outcome of the event was not recovered. No follow up attempts are possible. No further information is expected.
Caller received COVID vaccine on the 18th then tested positive on the 24th; Caller received COVID vaccine on the 18th then tested positive on the 24th; This is a spontaneous report from a contactable healthcare professional. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that the patient received COVID 'vaccine on the 18th then tested positive on the 24th'. The reporter mentioned that a friend who works for Pfizer told her to call and report. Clinical outcome of the events was unknown.  Information on batch/lot number was requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the short duration of 6 days since the vaccine first dose is given.
Pt went to ER day after vaccination with (L) arm pain and swelling. Dx in ER with cellulitis with BACTRIM.
After 2nd dose my tongue felt tingly, then the inside of my mouth was numb. It felt like I had novocaine. It numbness was in several areas in my mouth; After 2nd dose my tongue felt tingly, then the inside of my mouth was numb. It felt like I had novocaine. It numbness was in several areas in my mouth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 12:30 (Lot number: EP7534) at the age of 52 years as dose 2, single and (Batch/Lot number: unknown) for 1 day for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: FLONASE ALLERGY RELIEF; CLARITINE; LIPITOR; TYLENOL PM; CBD OIL. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer,, lot_number=EN6202,,, administration_time=12:30 PM,, dose_number=1,, vaccine_location=Left arm), administration date: 04Mar2021, when the patient was 52 years old, for COVID-19 immunization, reaction(s): "Metallic taste in mouth".  The following information was reported: PARAESTHESIA ORAL (non-serious), HYPOAESTHESIA ORAL (non-serious) all with onset 25Mar2021, outcome "recovered" (2021) and all described as "After 2nd dose my tongue felt tingly, then the inside of my mouth was numb. It felt like I had novocaine. It numbness was in several areas in my mouth". Therapeutic measures were not taken as a result of paraesthesia oral, hypoaesthesia oral.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Reported Event: After 1st dose there was a metallic taste in my mouth. After 2nd dose my tongue felt tingly, then the inside of my mouth was numb. It felt like I had novocaine. It numbness was in several areas in my mouth. It lasted several hours. My sister had the same reaction but her throat was closing and she had to go to the hospital. My throat did not close. Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
19FEB97 mom reported pt started rash on 4FEB98 forehead then entire body;mainly in groin;took to MD;rx w/amoxicillin;mom feels this is a vaccine rxn to MMR:no fever;
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # L016429, expiration date: August 2017, (exact doses, injection site and route of administration were not reported). There were no concomitant medications reported. It was stated that the vaccines were exposed to the temperature of 30 degrees Fahrenheit for 20 hours and to the temperature of 53 degrees Fahrenheit for 19 hours. No previous temperature excursion was reported. No adverse effects were reported. No PQC (product quality complaint) was involved. Follow-up information received on 29-MAR-2016 indicated that all telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 01-APR-2016 from the unspecified reporter concerning a patient of unknown age and gender who on 30-OCT-2015 was vaccinated with improperly stored dose of GARDASIL 9, lot number reported as L07560, expiration date: June 2017. The reporter also stated that thermometer was malfunctioning during the excursion and clarified that no COMVAX (as previously reported) only GARDASIL 9 was involved. This is one of several reports received from the same reporter. Additional information is not expected as all required information has been received. Reporters, patient details, suspect details, event details and narrative were updated.
Swelling (approx 2.5 inch diameter, redness, hot, lump).
Child was given a 2nd dose of FluMist and only should had received 1 dose, due to age. Child is 10 years of age. No treatment. Per mother, no signs or symptoms noted after adverse event. Adverse event was reported.
1st Night/2nd Day: extreme pain in arm, could not raise it, redness, extreme swelling 3rd Day: swelling, reduction in pain, reduction in redness 4 Day: Swelling, no pain, redness is a extremely light pink 5th Day/6th day: all symptoms gone 6th night/7th Day: swelling and redness returned, itchiness began 8th day: reduce in swelling, redness becoming larger, itchiness reduced 9th Day: redness becoming larger, swelling and itchiness gone 10th Day: Redness still becoming larger 11th Day: Redness is largest since shot, warm to the touch
Slight throat tightness a few minutes after injection Bright pink vaginal bleeding when wiping a couple of hours later Woke in middle of night with swollen hands and feet
11/22/2022 I tested positive for COVID-19 with a rapid and two at home kits as well. Mild symptoms runny nose, dry cough and postnasal drip. I talked to my doctor at the urgent care, and they told me to take over the counter medication to treat it. I am still currently dealing with the symptoms. I tested negative on 11/27/2022 put positive on the PCR. I went to my pomologists yesterday 12/01/2022 the
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 26-FEB-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not reported). The vaccine had an excursion of 27 degrees Fahrenheit (-2.77 degrees Celsius) (lowest recorded temperature) for 1380 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a physician via a company representative refers to a female patient of unknown age. Approximately in 2013 (also reported as about 2 years ago) the patient was vaccinated with first series shots of GARDASIL dose 1, 2 and 3 intramuscular injection (dose and lot # unspecified). No concomitant medications were reported. Approximately in 2013 the patient fainted (duration unspecified) and experienced a headache for two (2) weeks. The patient was referred to a neurologist, but no treatment was given, and the headache went away on its own on an unknown date. Action taken was not applicable also reported as the therapy was discontinued (date unspecified). The outcome of both the events was reported as resolved. Causality assessment was not reported. Additional information has been requested.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Additional Details: fainted 30 seconds after recieving both flu and pfizer shots. was unresponsive for about 1 min.  was then nauseous and dizzy.  was seen by emt and declined to go to hospital.  left with a friend
Within hours of vaccination, patient C/O pain, tingliness and weakness both upper extremities. This has improved but to date but periodically present. No fever, rash, GI or lung components.
FATIGUE; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 2021 for prophylactic vaccination. No follow up required as the case received from social media. No concomitant medications were reported. On an unspecified date, the subject experienced fatigue, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue and headache was not reported. This report was non-serious.
injection site got extremely swollen and inflamed. the swelling went down and 6 days later there is an itchy large red spot
Menactra was exposed to negetive  46 degree Celsius for about 14 hours with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a Physician via Global Medical Information (GMI) (Reference number- 00672178) and transmitted to Sanofi on 07-Jul-2021.  This case involves an 18 years old male patient who received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] that was exposed to negative 46 degree Celsius for about 14 hours (product storage error).  The patient's medical history, past medical treatment, past vaccinations and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE B (MENINGOCOCCAL VACCINE B) and HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation.  On 11-Jun-2021, the patient received a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6919AA and expiry date: 13-Apr-2021) via intramuscular route in the left deltoid for prophylactic vaccination that was exposed to negative 46 degree Celsius for about 14 hours (product storage error).  The reported called for guidance and confirm if revaccination is needed.  It was a potential medication error case due to product storage error temperature too low (latency: same day).  At the time of reporting, the patient experienced 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.
headache; chills; joint pain; 100.4 fever; injection site swelling; little bit of redness on the site/injection site redness; injection site redness, pain, and swelling; nauseated; pain in the arm/arm started hurting/his arm and all the way up to his jaw was hurting; It felt like he had the flu and he had body aches.; It felt like he had the flu and he had body aches; He felt like what he was experiencing was COVID symptoms.; tiredness; general feeling of unwell; This is a spontaneous report from a contactable consumer (patient's wife) via Medical Information Team. A 58-year-old male patient (Reporter's husband) received first dose of bnt162b2 (FIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0177), via an unspecified route of administration, administered in left arm on 14May2021 in the evening (at the age of 58-years-old) as single dose for covid-19 immunization in pharmacy. Medical history included covid-19 in 2020. Family history included COVID (They all had COVID last year). Concomitant medications included acetylsalicylic acid (ASPIRIN), oral at 81 mg, daily started a couple of months ago and ongoing rosuvastatin at 40 mg, daily, has been taking it for a couple of months; paracetamol (TYLENOL, Strength: 650mg, Lot: SEA002, Expiry: Mar2021) at 650 mg. No additional Vaccines were administered on same Date of the Pfizer Suspect. It was unknown if he had prior Vaccinations (within 4 weeks). When he goes to the doctor he goes by himself. It was reported that reporter's husband had the first dose of the Pfizer Friday and enquired some people say on the second dose the symptoms are worse, if it was true. He had tiredness and had general feeling of unwell on 14May2021; on 15May2021 he had headache, chills, joint pain, 100.4 fever, little bit of injection site redness, pain, and swelling/ injection site swelling, was nauseated. It felt like he had the flu and he had body aches. He went to sleep early on Friday night. She asked if he wanted Tylenol he said no. He mentioned in the middle of the night his arm started hurting. Then in the morning his arm and all the way up to his jaw was hurting. For the past two days their son has been sick and caller hasn't been able to talk to her husband much. He comes home from work and goes to bed. It is unknown if symptoms are ongoing. It was the 8 hour muscle ache and pain. He took Tylenol twice on Saturday. On Sunday, he was feeling better. He felt like what he was experiencing was COVID symptoms. Reporter asked if he could wait a couple of days for getting the second so he can be off work. The second vaccine was scheduled for 04Jun2021. That is a Tuesday and he prefers a Thursday so he could have Friday and Saturday off. A visit to emergency room or physician office was not required. Seriousness for the events was reported as unspecified. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Fever 101, injection site red and swollen- Right Thigh. Warm compresses and TYLENOL.
This spontaneous report was received from a physician refers to a 4 year old male patient without pertinent medical history and allergy to unspecified flu vaccine. Concurrent conditions were not reported. On 06-FEB-2015, the patient was vaccinated with a dose of PROQUAD (Merck), (strength, dose, frequency and anatomical location were not reported), intramuscular, (lot # K008868; expiration date: December 2015). Concomitant therapies included SYNTHROID, baclofen, KEPPRA, clonidine, unspecified growth hormone injection and PREVACID. The reporter indicated that 5 minutes after receiving PROQUAD (Merck), the patient developed a full body erythematous reaction which was described as "he was completely flushed from head to toe" and severe vomiting. The reporter stated that they gave to the patient BENADRYL as treatment while the patient was in their office, and then the patient was sent to emergency room for further medical attention. It was reported that the patient received SOLU-MEDROL and unspecified intravenous (IV) antihistamines in the emergency room. The patient was sent home later that day. Lab diagnostics studies were not performed. The physician reported that in the acute phase the events were life threatening and the patient was followed up a couple of days afterwards and the patient was completely recovered. The outcome of full body erythematous reaction and severe vomiting was reported as recovered/resolved on an unknown date in February 2015. The relatedness between full body erythematous reaction and severe vomiting and therapy with PROQUAD (Merck) was not reported. Additional information has been requested.
Information has been received from a physician concerning a patient who was vaccinated with the second dose of Rotateq. The patient developed bloody loose stools which have continued for six months. It was unknown whether medical attention was sought. The patient's recovery status was unknown. Upon internal review, bloody loose stools were determined to be an other important medical event. Additional information has been requested.
On 4/21/2021, 45-year-old male presents to urgent care for complaint of constant left lower extremity pain centralized in the calf area radiating to left posterior thigh area since April 12, 2021. He denies fevers, chills, chest pain, shortness of breath, palpitations, orthopnea, peripheral edema, claudication, nausea, vomiting or diarrhea. He reports that symptoms started after receiving the 1st dose of the Moderna Covid vaccine. Ultrasound of LLE completed 4/21/2021 results Acute deep vein thrombosis. Patient directed Hospital ED. Patient prescribed Eliquis 5mg.
received a Fluzone Quadrivalent after 2 days of shipping, vaccines were nonviable, no adverse event; received a Fluzone Quadrivalent after 2 days of shipping, vaccines were nonviable, no adverse event; Initial information regarding this unsolicited valid non-serious case received from a pharmacist on 05-Nov-2019.  This case is linked to 2019SA310489 and 2019SA310490.  This case involves a 40 year old female patient who received a dose of 0.5 ml of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ270AA, Expiration date 30-JUN-2020) via unknown route in the left deltoid in Nov-2019 after 2 days of shipping, vaccines were nonviable.  The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided.  No other vaccine was given.   It was a case of actual medication error due to product storage error and product distribution issue.  it was reported that patient received a Fluzone Quadrivalent after 2 days of shipping which were not viable.  At the time of report no adverse events were observed.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Disclaimer: 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 approx 30 mins post vaccine administration patient developed shortness of breath. No c/o cp, syncope or other symptoms. Patient ambulated from vehicle. Able to sit down. Received1 inhalation of albuterol MDI w/ immediate relief.  Also administered 25mg of PO liquid Benadryl  and a further 2 puffs of albuterol. Monitored for approx 30m with complete resolution of symptoms. Remained aA&Ox3 throughout w/o progression of sob, stridor, cp, MM  or soft tisse swelling. Patient d/ced in stable condition and remained with her older sister for an additional 15-30m on site in private vehicle. Discharged in stable condition with strict instructions to take  additional OTC benadryl. She was provided with albuterol MDI with instructions on use over the next 12h. Also instructed mum/older sister to call 911 should symptoms recur.
Eight days after receiving vaccination, I awoke with a baseball size rash oat the injection site.  It was itchy, warm and a bit hard.  Tolerable.
Client stood up and stated he felt lightheaded,I walked over and sat client down removed his mask and asked hi to take some breathes, as I called for RN client passed out and fell out of the chair  to the floor. Client was unresponsive for less than 30 seconds. Client then was A& O x 3. denies pain or discomfort. PERRLA, strength equal  on both sides. Vital signs BP 138/ 80 P 64 R 22 SP02 97% temp 36.9 C. EMS was called and @ nurses were present during event. Client ambulated without difficulty to stretcher and left with EMS for further evaluation.
mom gave pt APAP 1030AM prior to vax;pt recvd vax 11AM by 2PM pt became irritable w/t101;inj site was red, hot to touch w/a knot under the surface;cont w/APAP which would bring fever down temp;pt not eating;used warm compress @ the site;
pt recv vax & c/o vomit & hot flashes;02 via nasal cannula & IV was started;T102.3;pulse 133;resp 18;BP 100/52;taken to hosp where was treated & released;dx allerg react
Tongue tingling, no other sx : treated with PO Benadryl, sx resolved.  Observed 30' : no sequala
flu-like symptoms, fever ,chills, body aches ,swollen lymph nodes, hives around injection site
2nd Dose of Moderna Vaccine administered on 9/6/21 from Lot #011A21A expired 8/16/21.  *Site leadership consulted with the Moderna  and received the below confirmation: * If the dose given in error is the first dose, a second dose should be administered 28 days later. If this dose is the second dose, the series is complete and no additional doses are needed.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates, reported as since December 2013, the patients were possibly administered doses of ROTATEQ suspension 2 (units not provided), orally (dose and lot number were not reported) which were not stored properly. No adverse effects were noted. Concomitant medications were not specified. This is one of several reports received from the same reporter. Additional information has been requested.
I experienced extreme fatigue, muscle aches, headache, fever and upset stomach that lasted 2 days.
hospitalized 8/17/21 - only documented to have received 1 dose of Pfizer vaccine.
29M hx HTN who obtained his first COVID vaccine. Few minutes after receiving the vaccine, he reported to  provider that he felt warm and dizzy. He was immediately brought to the enclosed first responder area where he mentioned additional sx of nausea.   Vasovagal response, Dizziness, Hypotension, nausea