chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Friday evening, pt. was shaking so much that he could not even hold on to anything, had pain in his legs, hips, joints, knees to where he could not walk, and had a fever.  He had a hard time breathing as well so he went to the hospital.  They checked him out and ran tests but it was all in relation to the shot they thought.  Saturday he was very tired that he slept all day.  Sunday he was feeling better but had some issues with his vision and his peripheral vision went away for part of the day.
Pt broke out with chicken pox after brother exposure. Pt vaccinated 08/04/1997.
1030am: On 11/07/2006 administered FluMist intranasally 0.25mg both nostrils. 1145am: Patient c/o tingling of face, skin tightening and red blotches.  Noted erythema and swelling unilateral left side of face with hives to neck and upper chest.  Patient denied any shortness of breath or difficulty breathing. 1440pm: B/P 147/91, HR 63, RR 18. Administered Benadryl 50mg IM and Solumedrol 125mg IM. 1513pm: Symptoms subsided.  Patient recovered.  Skin complexion normal, no evidence of redness, swelling or hives.  Discharged home with PO Benadryl. 11/13/2006 0830am:  Patient returns to clinic with symptoms worsened.  Vital signs stable. Afebrile. Patient mentioned his eye had swollen shut over the weekend and he felt "bad".  Denies any decrease in vision, blurred vision, headache or dizziness. Noted erythema, urticaria, increased swelling especially left outer ear, unilateral left side facial edema with cracking of skin of left upper eye lid and left lymph node enlargement. Additional skin lesion noted to right shoulder annular, redness, cracking of skin and honey crusted.  Patient states it itches "like the dickens". Approximatley 1030am:  Patient evaluated and treated with Medrol dose pack and Azithromycin Z-pack.  MR received revealing 2 outpatient visits for c/o sudden onset of red blotches, skin tightening and facial itching initially beginning several hours after Flumist administration. Second visit 6 days later for continued facial redness, itching, and swelling, as well as rash on the right shoulder. Iniitially treated with Benadryl IM and Solumedrol with po Benadryl to continue at home. Medrol dose pak and azithromycin (Z-pak)  given at 2nd visit. DX: 11/07/2006 Allergy to drug serum/vaccines. BP isolated elevated. DX: 11/13/2006 Allergic reaction.  Impetigo
79yr old female presented to ED with son.  Patient is complaining of lower left back pain and increased shortness of breath.  Patient states that she is receiving chemo for ovarian cancer, however these are not side effects she has experienced.  Last chemo treatment was last Friday.  Patient had booster for covid on 10/15 and has not felt great since.  Patient rates pain in back a 7 on scale of 0-10 has taken ibuprofen for it this morning without much relief.  Patient states that has had chills last night and this morning, currently does not.  Did have 2 emesis this morning.    Son states that patient spouse is home with what appears to be the flu, he has been having emesis for 24-36 hours. ED admitted patient to hospital. In the hospital for 2 days.   Discharged on antibiotics for pyelonephritis.
No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous was received from a certified medical assistant (CMA) referring to an 18-month-old female patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 20-DEC-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S009943, expiration date: 26-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S009943; expirationdate: 26-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1910USA012749:
Patients did no experienced any symptoms; Unspecified number of patients received unspecified doses of PEDVAXHIB; This spontaneous report was received from medical assistant, concerning an unspecified number of patients. The patient's pertinent medical history, concomitant medications, concurrent conditions, and past drug allergies or reactions were not reported.   Since May 2019, the patients were vaccinated with unspecified doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) for prophylaxis (strength, dose, route of administration, and anatomical site of injection were not reported), lot number R0121083 with an expiration date on 13-JUL-2021 and lot number R014261 with expiration date on 25-MAR-2021. The patient did not experience any symptoms and nor product quality complain involved. The administrated doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature of 14 degrees Celsius for 12 hours with a previous temperature excursion of 17 degrees Celsius for 12.5 hours (product storage error).  Follow-up information was received from a medical assistant on 21-MAY-2020.  The reporter confirmed that no further information was available regarding the patient identifiers and the date of vaccination.  This case is non-valid due to the lack of patient identifiers.
patient presented to the ED on 5/29/2021 for a COVID test which was required in order for him to be able to undergo a sleep study at another facility.  Came back +.  Patient was asymptomatic on presentation to the ED.
On December 27,2022, I had a bad cough emerge, and within 48 hours I was congested and fatigued. On December 29, 2022, I had a tele visit with a nurse and she diagnosed me with viral pharyngitis. Those symptoms lasted two weeks. Then I flew on a five hour flight and had ear blockage. I went to an urgent care on January 30, 2023, and they prescribed me Flonase and Sudafed.  I went to my doctor in February who prescribed me stronger steroids and diagnosed me with eustachian tube dysfunction. My ears are better now, but I wouldn't say they are back to normal.
Sunday 4-11-21 my legs started feeling heavy and numb also my left armpit has a swollen lymph node
On 11/14/22 at 12PM, Pt. received second dose of Hepatitis A two weeks early. Pt.  last dose received on 06/02/2022. At 12:05PM, Pt. spoke with patient in person in the lobby area privately and informed of the situation. Pt. replied back and she understood the situation. At 1:09PM, followed up with the pt. in person in the vaccination room. Pt. is stable and no reactions to vaccine noted. Will continue to follow up with the pt. as needed. Pt. is aware.
Patient reports re-occurrence of Left arm pain, redness, swelling and warmth 10 days post vaccination.  States she had these same symptoms up to 3 days after vaccine but they resolved.  She is also reporting onset of headache, joint pain yesterday (9 days post vaccine) and low grade temp today (10 days post vaccine).
Aside from the soreness at the injection site, I developed chills, fever up to 101.9 degrees, fatigue and joint pain beginning about 12 hours after the injection.  The fever lasted about 30 hours.   I used Tylenol to keep it down. I haven't used Tylenol for the past 12 hours and feel fine, at the moment.
the vial stored post puncture in fridge; Expired Vaccine Administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Administered) and PRODUCT STORAGE ERROR (the vial stored post puncture in fridge) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 059A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2022 at 1:20 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial stored post puncture in fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Administered) and PRODUCT STORAGE ERROR (the vial stored post puncture in fridge) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. One dose was administered. The vial was initially stored in the refrigerator on 31-May-2022. The vial was first punctured on 08-Jun-2022 at 2:48 PM. The vial did not undergo any temperature excursions. The vial was exposed to room temperature range (8 degree Celsius to 25 degree Celsius = 46 degree Celsius to 77 degree Fahrenheit) for 15 minutes.
Patient had moderate fever and night sweats. But had a bad case of thrashing his body (almost like he's fighting) around in his crib, even when holding him. Stayed up for a straight 6 hours without any sleep . (both doses second and third)
Chills, body aches, painful/heavy arm, and worst headache. Took tylenol and ibuprofen with no relief.
No additional adverse events reported; PROQUAD that was administered after improperly stored; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 06-OCT-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot number: U002534, expiration date: 24-JUL-2022; route of administration not provided) 0.5 mL (product storage error). The vaccine was stored in temperatures 6 degrees Fahrenheit to 14 degrees Fahrenheit (8.5 degrees Fahrenheit) for 0 hours 18 minutes and 0 seconds; 6 degrees Fahrenheit to 14 degrees Fahrenheit (11.9 degrees Fahrenheit) for 1 hour 0 minutes and 0 seconds. There was no previous temperature excursion. No adverse event was reported.
felt like she would come down with a urinary tract infection; This is a spontaneous report received from a contactable consumer (Patient). A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 29May2021 (Batch/Lot number was not reported), as second dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received her second dose of the Pfizer COVID Vaccine a couple of hours ago before calling. She felt like she would come down with a urinary tract infection on an unspecified date and would want to know if it would affect the shot. She emphasized that she did not considered this as a side effect. Seriousness of the event was reported as non-serious. The outcome of the events was reported as unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Patient received flucelvax and covid pfizer bivalent booster around 1pm.  A few minutes after receiving the  vaccines patient was walking around store waiting his 15 minutes before leaving. Front end staff notified pharmacists that a patient had fainted. Patient reports becoming lightheaded and lightly fell into a display and slid down to the floor. Patient was with 2 family members and they reported that he didn't hit his head, but slid down to the ground. By the time the two pharmacists arrived to patient, he was sitting on floor leaning against pole. I asked patient questions to keep him talking. He said he felt warm, lightheaded, a bit nauseous, and hearing was a bit dull. I had patient clench and unclench fists to keep him from passing out again. A front end team member got patient a cold rag for his neck. Patient reported lightheadedness came back briefly, so patient sat on floor for 15 minutes, then moved to  chair for another 10 minutes before walking around the store with his family members before leaving. Patient says he doesn't have a primary provider and said he was feeling fine when he left. He said he has never had this reaction before.
Sudden onset of blurred vision and spike in BP, dizziness, and facial numbness... Went to local ER for treatment, results came back as Atypical Migraine. Symptoms onset within 1 hour of shot being administered
I was a Sales Representative who contracted Lyme and Babesia in June of 1999. I never saw a  tick but after my long recovery I remember a bite on the back of my scalp.  After receiving the Sanofi Paster Td vaccine on February 15, 2001 I came down with back pain and neck pain within 7 days. I have been on chronic pain medication ever since.  Initially I went to chiropractors and it was my chiropractor who referred me back to my Doctor for Xrays and MRI's and the like. I was rapidally deteriorating while the Medical System denied that I had Lyme Disease for 15 years until I finally tested positive in December of 2013 for Lyme and Babesia Duncani.
No adverse effect reported.; his son received the second dose of his GARDASIL 9 shot in June of 2019 (15 months after his first dose); This spontaneous report was received from a consumer referring to his son as a male patient of unknown age. Information about medical history, concurrent conditions and concomitant therapies was not provided.    In March 2018, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dosage detail, strength, route, lot # and expiration date were not reported) for prophylaxis. In June 2019 (reported as 15 months after his first dose), the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dosage detail, strength, route, lot # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration).  In December 2019 (reported as six months after his second dose), the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dosage detail, strength, route, lot # and expiration date were not reported) for prophylaxis.  No adverse effects were reported.
first night- severe headache, body aches and chills. second day - severe reaction to the sun. face, neck, and legs are swollen and red from being outside for about an hour and a half. nothing unusual for me as I normally spend time outside in the sun.
Joint pain  and swelling to lower extremities, both ankles, both knees and pain in hips at 12 hours after injection.  Pain still continues this month of February in right knee replacement  with intermittent swelling, and heat. Taking Motrin 600mg and Ultram100 mg prn.   I had a regular office visit with PCP on 2/25/21 and she advised to report this.
Right deltoid hot, red, swollen 3 x 3mm Benadryl/ Tylenol
Initial report received from a nurse on 19 September 2007. A 32 year old female patient (with no medical history) developed headache, body aches, stiff neck, nausea and flushed, within 24 hours after she received Adacel (lot number C2769AA) intramuscularly in the left deltoid on 13 September 2007. The patient did not have illness at the time of vaccination. It was reported the symptoms resolved in 24 hours and the patient recovered.
9JUL92 pt recvd 1st dose of Engerix-B & 10JUL92 devel abdo cramps, diarrhea, nausea, local swelling @ inject site, aches all over & vision problems;
Indication for use in the case: Treatment of COVID-19; Indication for use in the case: Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 29Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 10Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: SULFASALAZINE; LISINOPRIL; VITAMIN D NOS; COQ10 [UBIDECARENONE]; NORETHINDRONE [NORETHISTERONE]. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin", notes: known allergies: Amoxicillin.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Indication for use in the case: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: Patient took other medications in two weeks. Patient received Paxlovid for Covid-19 treatment. Treatment was started on 22Jun2022 stop date on 23Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
OB patient c/o diarrhea, nausea and vomiting since receiving vaccine. 11/20/09 Medical records recieved 11/03/09.  Prenatal clinic notes. EDD 5/24/2010. LMP 8/17/2009.  12 wks gestation.
"Flu shot yesterday - right after flu shot my toes started tingling, then the tingling increased - numbness started today.  I can't move my right arm or leg due to numbness".  no trouble breathing, "having trouble urinating", onset of syptoms was about 5 minutes after the flu shot according to the patient. Medical records state asthenia, urinary incontinence; apathy. msv I tried to follow up with this pt today, the phone number on her records has been diconnected.
Pfizer-BioNTech COVID-19 Vaccine EUA.    48 hours after I had 2nd vaccine I had  major swelling of mouth  and lips/gums; this gradually increased over night and diminished by end of next day. I have had delayed reactions before. Of note, I have significant hx of angioedema but no hx of anaphylaxis .  I had no  food, drink nor medication that would have caused this reaction; I'm sure it was a delayed reaction to the vaccine
sweating; lightheadedness/dizziness; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), DIZZINESS (lightheadedness/dizziness) and FATIGUE (tiredness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 032L20A) for COVID-19 vaccination.     No specific medical history was reported.  Concomitant products included NEBIVOLOL from 01-Jan-2007 to an unknown date and HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL + HIDROCLOROTIAZIDA) from 01-Jan-2007 to an unknown date for Blood pressure high, TAMOXIFEN from 01-Jan-2015 to an unknown date for Cancer (NOS).   On 26-Jan-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 23-Feb-2021, the patient experienced HYPERHIDROSIS (sweating), DIZZINESS (lightheadedness/dizziness) and FATIGUE (tiredness). On 01-Mar-2021, HYPERHIDROSIS (sweating) outcome was unknown and DIZZINESS (lightheadedness/dizziness) and FATIGUE (tiredness) had resolved.            No treatment details provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: concomitant medications have been added.
I experienced a breakthrough case of COVID-19 with tiredness,  body aches and coughing.
On 3/22/01, client states soreness in left upper arm laterally since receiving TD on 1/29/01. Complained of discomfort with raising arm above shoulder level and when sleeping on it. Client had not mentioned this soreness to mother until today when she presented in clinic for #3 Hep-B. No other history of injury. Advised warm compresses. Mom does not plan to seek doctor's care.
Severe tightness in chest, throat closed up, headache, back pain, nausea, pain in left arm and shoulder. Treated in ER with Toradol IM. Pt continued to experience symptoms several days after receiving the vax.
in Jan2022, the patient experienced tested positive for COVID-19; in Jan2022, the patient experienced tested positive for COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4362657-00 (Agency).  An 11-year-old female patient received BNT162b2 (BNT162B2), on 13Nov2021 as dose 1, single (Batch/Lot number: unknown) and on 14Dec2021 as dose 2, single (Batch/Lot number: unknown) at the age of 11 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Jan2022, outcome "recovered" (2022), VACCINATION FAILURE (medically significant) with onset Jan2022, outcome "recovered" and all described as "in Jan2022, the patient experienced tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2022) Positive. The action taken for adalimumab was unknown. The reporter considered "in jan2022, the patient experienced tested positive for covid-19" related to BNT162b2. Clinical course included In Nov2021, the patient experienced tested positive for covid-19. In Dec2021, the patient experienced COLD. In January 2022, the patient experienced tested positive for COVID-19. In 2022, the tested positive for COVID-19 resolved. On unknown dates, tested positive for COVID-19 and COLD resolved. Pfizer BioNTech COVID-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's assessment of the causal relationship of the [COVID-19 ] with the suspect product was provided possible at the time of this report. Since determination has been received, the case is managed based on the company causality assessment.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events vaccination failure and COVID-19 cannot be excluded.
This spontaneous report was received from a nurse and refers to unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On an unspecified day, the unspecified number of patients received improperly stored PROQUAD (Merck) (lot # L002419, expiration date 23-JUL-2016; lot # reported as L007248, expiration date 03-SEP-2016 (dose, frequency , route of administration and indication were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Lot number L007248 is an invalid lot number of PROQUAD (Merck). Additional information has been requested.
Nonfebrile seizure x 2 minutes. 5 Days after Adacel vaccination.