chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I noticed I was congested when I was in an airplane and my ears did not equalize the pressure. It progressed to more congestion, nose blowing, pressure, and inability to hear. I tested negative a few time and then I lost my sense of smell. I tested myself for COVID 19 and was positive on June 22. I continuously had dry mouth throughout this process. I contacted my doctors office. The prescribed Paxlovid which I got and then provided instruction for isolating. I took 5 days of Paxlovid. My symptoms improved after 2 days. I have completely recovered and my sense of smell is gradually coming back. Along with my sense of taste. I took a test 5 days later and it was negative. I would classify that a very mild case.
Abdominal- burning, cramps, pain, acid reflux (Tx), appetite loss, concentration- difficulty, trouble, confusion, cramps, depression (Tx), diarrhea, balance, endurance-loss, energy, fatigue, feeling sluggish, headaches, hearing, memory, neurological, mood, pain-legs, tachycardia, skin, suicide, sweats, thyroid, vision, weight problem.
SHINGLES BREAKOUT AFTER THE SHOT; This spontaneous report received from a consumer via social media via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced shingles breakout after the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shingles breakout after the shot was not reported. This report was non-serious.
a few hours later, thought I had a few bug bites on my Right leg. Ignored it, went through my day and went to bed. Woke up with hives on legs, hips, lower torso and stomach (not on arms or back though). PCP said to take Zyrtec, which I took at 12:30pm on 11/11/20 and started to itch less within an hour. New ones popping in slowed down and I am about to go to bed now, feeling fine.
sore arm; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunization, reaction(s): "sore arm"; Bnt162b2 (2nd dose), for Covid-19 immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: Patient stated "all of my shots including the 3 boosters I have had were all Pfizer. I had absolutely no complications and only a sore arm after each shot. That made me want to always use the same  company going forward".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300015071 same patient/event, different vaccine dose;US-PFIZER INC-202300035214 same patient/event, different vaccine dose;
Pain and swelling in the armpit and lymph nodes.  Took 2 (200mg) of Advil for pain relief beginning 3/04/05 through 03/07/2015.
Tested positive for Covid on 4/12.  Symptoms stared on 4/10. Scratchy throat, cough, phlegm.
Pt was administered Moderna vaccine second dose that was 13 hours past the BUD date.  The Moderna vaccine was removed from the freezer and placed into the fridge with an assigned BUD date of 9/18/2022.  The pharmacist administering the vaccine administered the vaccine on 9/19/2022 around 1 pm. The administration error was not noted until processing around 5 pm.  The manufacturer has been contacted and is doing a test on that lot for stability. So far no adverse reactions have been reported and results of the stability testing will determine the next steps to take.
Dizziness; Sweating; joint stiffness; fatigue; Severe Headache; Nausea; severe pain at vaccination sight; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150), in the right arm on 11Apr2021 at 12:30(at the age of 54-year-old), as a dose for COVID-19 immunisation followed by second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) in the left arm on 01May2021 at 12:30 (at the age of 54-year-old), as a dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. 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 an unknown date in 2021, the patient experienced dizziness, sweating, joint stiffness, fatigue, severe headache, nausea and severe pain at vaccination site. The clinical outcome of the events dizziness, sweating, joint stiffness, fatigue, severe headache, nausea and severe pain at vaccination sight was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Patient experienced dizziness, headache, and abdominal cramping after administration of Moderna COVID-19 vaccine. Observed for 1 hours. VS WNL. Advised to call PCP and to call 911 if S/S resume or worsen. Released to family.  VS: Initial @ 1215: BP 130/80; HR 72; RR 20; Temp 97.3; Abdominal Pain 8/10. 2nd @ 1220: BP 120/80; HR 80; RR 20; Abdominal Pain 6/10. 3rd @ 1240: BP 112/92; HR 74; RR 18; Abdominal Pain 3/10.  Disposition: S/S improved. RN deemed patient stable. Released to family.
This spontaneous report as received from a nurse refers to 3 patients of unknown age. On 05-AUG-2014 the patients was vaccinated with GARDASIL (lot# was not reported). The reporter reported that GARDASIL were improperly stored. No adverse symptoms reported. Additional information has been requested.
red arm; swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red arm) and VACCINATION SITE SWELLING (swollen arm) 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 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red arm) and VACCINATION SITE SWELLING (swollen arm). At the time of the report, VACCINATION SITE ERYTHEMA (red arm) and VACCINATION SITE SWELLING (swollen arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
throat on fire; Couldn't breathe very well; Couldn't stay awake; not hungry; No energy; three fingers on right hand were stiff swollen couldn't bend; three fingers on right hand were stiff swollen couldn't bend; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Apr2021 at 15:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 00:00, the patient experienced throat on fire, couldn't breathe very well, couldn't stay awake, not hungry, no energy, three fingers on right hand were stiff swollen couldn't bend and completely non coherent for the first 24 hours, The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events throat on fire, couldn't breathe very well, couldn't stay awake, not hungry, no energy and three fingers on right hand were stiff swollen couldn't bend was recovered with sequelae on an unknown in Apr2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
numbness/tingly sensation in forehead 65 yo male with PMH of glaucoma, afib, spinal stenosis, PTSD, SNHL, bilateral, chronic cough, chronic lbp, anxiety, depression, sleep apnea, gastritis, GERD, gout, and insomnia reported numbness/tingly sensation on his forehead with the first dose COVID19 vaccine Pfizer on 1/11/2021. It lasted for an hour and self-resolved. Vaccine administered without complications. The patient denied any prior severe reaction to this vaccine or its components or a severe allergic reaction such as anaphylaxis to any vaccine or any injectable therapy.
Extreme insomnia and frequent urination the night of vaccine; muscle aches, head ache, fatigue for about 36 hours
Mother of patient called HD today, 08-28-07, stating that patient c/o numbness in left ring and little finger on Friday, 08-24-07 which was the morning after the injections were given.  Numbness as described above is persisting, but has not gotten worse.  No other s/s of illness or distress at this time.  No treatment at this time.  Patient is at college now and mom is to contact him to advise him to seek medical care/treatment at the med center on the college campus.  He does not have a PCP to contact.
no problem w/the 1st capsule;  took 2nd capsule 17DEC92 & devel fever 100.5 & severe chills; pt states was deadly ill; diarrea;
No additional AE information provided.; the patient was administered an improperly stored dose of PEDVAXHIB; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. Information about the patient's past drug and medical history, as well as concomitant therapies and allergies were not reported.  On 13-DEC-2019, the patient was vaccinated with a dose of improperly stored Haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, with lot number S006471, which was confirmed to be a valid lot number for Haemophilus b conjugate vaccine (meningococcal protein conjugate) (therapy type: digital data logger), and expiration date reported and established as 22-JAN-2022 for prophylaxis (strength, exact dose, frequency, and anatomical location were not reported).  Temperature excursion (product storage error) was reported as follows: temperature of 48.5 degrees Fahrenheit for a timeframe of 1 hour. There was no previous temperature excursion and the product storage error was identified via a data logger. No additional adverse event information was provided. No product quality complaint was reported.
Patient Fell on the floor after getting the shot (pt waited in the vaccine room for a while, and he wanted to use to the restroom, he walked out and felt lightheadedness, then he fell on the floor outside the pharmacy).  (patient said he has history of felling lightheadedness from a blood draw, and he did not eat any food before the shot. the lightheadedness might be due to that) . We called 911, and I waited with the customers until paramedic comes. (patient was feeling fine during that period).
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Concurrent conditions, medical history and concomitant medications were not reported. On 26-MAR-2015, the patient was vaccinated with ZOSTAVAX, (lot #, expiration, dose, frequency, route of administration and indication were not provided). Patient did not receive an expired dose of ZOSTAVAX. On 26-MAR-2015, experienced itching at injection site immediately following the injection. On an unknown date in 2015, the outcome of itching at injection site was resolved without any treatment. Causality was not provided. No additional information was reported. This is one of two reports that received from the same reporter (linked with MARRS# 1504USA000724). Additional information has been requested.
low-grade fever; headache; nausea; This is a spontaneous report from a contactable consumer. A 19-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Jan2021 at single dose for covid-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for covid-19 immunisation. Yesterday (24Jan2021), the patient experienced a low-grade fever, headache, and nausea. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Stomach ache (Abdominal pain upper). Fever (Pyrexia). Sore throat (Oropharyngeal pain). Lethargic (Lethargy). A non-serious spontaneous report of lethargic, stomach ache, high fever, and sore throat has been received from a nurse concerning a 4-year-old female, subsequent to FluMist. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FluMist on 02-Sep-2009. The patient received a single dose before onset of the events. On 03-Sep-2009, the patient developed lethargy, stomach ache, high fever, and sore throat. The outcome and causality were not reported.
I am having pains in my chest in yet; This is a spontaneous report received from contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 21Apr2021 as dose number unknown, single for COVID-19 immunisation and ibuprofen (MOTRIN MIGRAINE PAIN), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date for chest pain. The patient medical history included on going, chest pain from an unknown date. The patient's concomitant medications were not reported. Consumer stated, "Okay, I had the Pfizer vaccine shot on "yesterday". Okay, prior to that I was at emergency room, and they put me on some Motrin's for, because I have pains in my chest, the walls of my chest it shows the report and I take the Motrin. So, after taking the shot yesterday and I am up today, and I am having pains in my chest in yet. So, I was wondering is it alright for me to take the Motrin after taking the Pfizer shot. Can I still take a Motrin because the Tylenol don't help my chest?". Consumer confirmed vaccine shot name as Pfizer COVID Vaccine. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Extreme itchiness; This case was reported by a nurse via sales rep and described the occurrence of pruritus in a 59-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 3A929, expiry date unknown) for prophylaxis.   On an unknown date, the patient received FluLaval Tetra 2019-2020 season .5 ml. On an unknown date, less than a day after receiving FluLaval Tetra 2019-2020 season, the patient experienced pruritus. The patient was treated with prednisone. On an unknown date, the outcome of the pruritus was recovered/resolved.   The reporter considered the pruritus to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. Approximately 4 to 5 hours after vaccination, in the the evening, the patient experienced extreme itchiness. The patient took Prednisone close to bedtime because the itchiness became intolerable. The itchiness lasted about 2 days and was intense. This case has been linked with US2019AMR199254, reported by the same reporter.
Client rec'd the 3 vaccines listed below @ 0935. Client went back out in the lobbly after vac. adm.-Reported that she was lightheaded-staff assisted her back to the clinic room and was placed in Trendellenburg position @ 0945 client pale & clammy, reporting nausea and seeing spots BP 110/60, P 90, R 20--0950 BP 122/70, P 90, R 20, cool cloth to forehead, still c/o symptoms persisting--1000 BP 120/70,P 100, R 24 Ammonia inhalant used--1008 BP 122/70, P 96, R 22 c/o symptoms of seeing spots, nausea & dizziness but sl. improving--1015 client offered apple juice-drank about 2 oz & stated it made her inc. nausea, client began to c/o min. shaking-covered with coat c/o SOB/chest tightness after asked by staff stated chest was "tight" from lower left abd to mid abd to epigastric area to mid chest- No respitory distress observed, color has much improved, no diaphoresis or clamminess assessed--1025 O2 mask 2L applied--Immediately after placing O2 she voiced that her breathing was better, but that other symptoms persist- Dr. called & notified--order to have 911 called and have client taken to ER via ambulance-client able to get onto amb. stretcher with min. assist- no ortho static changes--1035 client left via ambulance--IVF started by EMS-- ER reports client was d/c'd home after CXR and ECG completed, caretaker reported at 1400 that client was totally asymptomatic
shingles; Information has been received regarding a case in litigation. It referred to a patient (pt) of unknown age and gender. No information about the pt's pertinent medical history, concomitant medications and drug reactions or allergies was provided.      On an unknown date in 2015, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a healthcare provider, for the long-term prevention of shingles and/or zoster-related conditions (strength, route, frequency, lot/batch # and expiration date were not reported).         Subsequent to the zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider for shingles (herpes zoster) and was hospitalized due to it (dates not reported). It was reported that the pt would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.  The outcome of herpes zoster was not reported.   The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Rt anterior thigh with erythema & induration measuring 12cm x 13cm in diameter. Very warm & tender to touch. Discussed using ice 2-3 x a day, Ibuprofen 3 x a day & BENADRYL.
RASH, ITCHING UNKNOWN IF RELATED TO VACCINE OR HOTEL STAY.
uncommon rectal bleeding and extreme diahrrea; Heart palpitations; lightheaded; uncommon rectal bleeding and extreme diahrrea; vomiting; legs and arms rash; This is a spontaneous report from contactable consumer (patient). A 62-year-old non-pregnant female patient received the second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration, administered in the left arm (deltoid) on 19Apr2021 at 09:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing , hypertension from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included lisinopril for an unspecified indication, start and stop date were not reported; levothyroxine sodium for an unspecified indication, start and stop date were not reported; furosemide for an unspecified indication, start and stop date were not reported; valproate semisodium (DIVALPROEX) for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration, administered in the left arm (deltoid) on 22Mar2021 at 09:00  (at the age of 62-years-old) as a single dose for COVID-19 immunisation. On 06May2021 at 01 :00 AM, the patient experienced uncommon rectal bleeding (medically significant) and extreme diahrrea, heart palpitations, lightheaded, vomiting, and legs and arms rash. The events resulted in Emergency room/department or urgent care visit. The patient was given unspecified I.V. drip, and unspecified meds and underwent CAT scan, specimens, and EKG, no results provided. The outcome of the events, uncommon rectal bleeding and extreme diahrrea, heart palpitations, lightheaded, vomiting, and legs and arms rash was unknown.
Single non erythematous raised lesion 8mm in diameter at the right temple area. Asymptomatic( no pain, no itching). Started 2-3 days after Shingles vaccine but more noticed after a week.No trauma. No treatment given. We are  observing for resolution.
She has a slight headache; This is a spontaneous report from a Pfizer-sponsored program Pfizer  A 68-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient stated she has a slight headache on an unspecified date and to get rid of it she would like to take ibuprofen. At the time of reporting, the outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
on 6/6/8 child and mother came to clinic. Child had 10 inch by 7 inch swollen left leg, child c/o pain with ambulation, mom states "she can not walk". Lt thigh from the inguinal area to below knee significantly edematous, hot and some redness noted. VS T=37 (ear) RR = 32, HR 111.
This spontaneous report was received from office medical assistant refers to a 14 month old female patient. There was no pertinent medical history or drug reactions reported. On 28-MAY-2013, the patient was vaccinated with a dose of PROQUAD (Merck), (lot number J000140, expiry date 04-JUL-2013, route was not reported). No concomitant medications were reported. on 11-JUN-2013, the patient was diagnosed with varicella virus. The patient was given ibuprofen and tyelon. There were no laboratory diagnostics performed. The outcome of varicella virus was unknown. The patient sought medical attention. Additional information has been requested.