chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives on right thigh, left side of middle belly, left armpit about 7 days after vaccine. Hives resolved after about one day. Left armpit remains discolored. as of today. Numbness, swelling, and itching on bottom right lower lip 14 days after injection. Hives on right and left side of middle back, right shoulder, and upper belly 16 days after vaccine. Hives on left eyelid, numbness, swelling and itching on outside and inside bottom left lower lip, joining right side 16 days after injection.
Patient called me over and began feeling light headed and nauseous.  We came to the immunization booth where she removed her mask.  We took her blood pressure, applied a cold pack to her neck and got some ice water.  Timeline below 1:15 pm-nauseous, ice pack applied 1:17 pm-Pt lay head down, BP error 1:20 pm-ice water gotten for pt, able to drink a few sips 1: 23 pm-BP 77/57 1:25 pm BP 80/59 1:27 pm BP 95/66 1:30 pm BP 100/63.  Patient states that this is her normal BP.  She felt much better and was able to leave the pharmacy on her own.  I contacted her later in the day and she was feeling fine.
This spontaneous report as received from a pharmacist refers to two unspecified patients. On an unknown date the two unspecified patients received ZOSTAVAX at two separate unspecified pharmacies and developed a "baseball sized knot' at the injection site at an unspecified time. The pharmacist reported that the one patient was unable to move the arm that they received the ZOSTAVAX (captured in MARRS # 1306USA007036). The outcome of event was unknown. Lot number 000444 is an invalid lot number for ZOSTAVAX. This is one of two reports received from the same source. Additional information has been requested.
21AUG fever 103, swelling @ site 2x3cm;22AUG no fever, swelling, induration, erythema 3 1/2 inch x 3 1/2 inches, mild anorexia, otherwise well;23AUG dec erythema & edema, resolved anorexia;
Patient registered at the mass vaccination clinic while outside of the acceptable age requirement for vaccination.  We were alerted afterwards to this error due to age of the patient.
1ST DOSE: EXTREMEM FATIGUE 6 HRS. AFTER DOSE GIVEN. NEXT DAY. SEVER NAUSEA X1 WHICH QUICKLY WENT AWAY. BUT, INTERMITTENT DIZZINESS STAYED FOR 1 WEEK.  2ND DOSE: 7 HOURS AFTER SHOT GIVEN BEGAN FEVER AND CHILLS; SEVERE ACHINESS. ALL MY JOINTS HURT & MUSCLES WERE SORE. MY ARM DID NOT HURT AT INJECTION SITE AS MUCH AS THE REST OF MY BODY. NEXT DAY (SATURDAY)-ALL DAY IN BED WITH SEVERE CHILLS, ELEVATED TEMP (ABOVE 99.9-101); SEVERE ACHINESS & HEADACHE. --FEVER BROKE AT 3 AM ON 1-24-21; HEADACHE & ACHINESS DISAPATED. SLIGHT FEVER RETURNED AROUND 6PM (99.8)ON 1-24-21; SMALL AMOUNT OF ACHINESS & HEADACHE. NEXT DAY-TODAY 1-25-21-JUST ACHY.
Information has been received from a Physician Assistant concerning a 12 year old female patient with pertinent medical history reported as none and drug reactions or allergies reported as none who on 15-JUL-2008 was vaccinated with a first dose of GARDASIL (lot # 660387/1967U) 0.5ml (also reported mg) intramuscularly. Concomitant therapy included prednisone and PRILOSEC. In March 2009 the patient experienced difficulty breathing. She was taken to the hospital and "as per mom she was given an adult dose of morphine and went into respiratory failure". She later was unable to smile or move her face. Her cranial nerves were affected and she was seen by neurology. Later she was sent to a hospital for myasthenia gravis crisis. She had been hospitalized 3-4 times and she had received rehabilitation therapy. Most recently approximately on 16-JUN-2009, she had a "thymomectomy", secondary to myasthenia. The Physician Assistant and Physician did not feel the events were connected with GARDASIL. At the time of the report on 07-JUL-2009 the patient was recovering. There were many unspecified laboratories and diagnostics tests performed results not reported. She had not received any additional doses of GARDASIL. Difficulty breathing, respiratory failure, cranial nerves affected, given adult dose of morphine, and myasthenia gravis crisis were considered to be immediately life-threatening, disabling and other important medical events. "Given adult dose of morphine" was considered to be an overdose. Additional information has been requested.  Medical records received DOS 7/15/08 to 7/7/09. Assessment: Myasthenia Gravis. Patient presents with continued fainting. Can't raise arms, not able to cough, laugh, very weak. Falls, drops things. Redness and inflammation where spinal tap was done. Facial weakness.  PMH: \ksk
A bad rash; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and RASH (A bad rash) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced DIARRHOEA (Diarrhea). On an unknown date, the patient experienced RASH (A bad rash). At the time of the report, DIARRHOEA (Diarrhea) and RASH (A bad rash) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: bad (abnormal) Bad. Concomitant medication was not provided. The patient experienced diarrhea from last week, last Thursday after received the second booster dose of the Moderna COVID-19. On an unknown date, the patient had a bad rash and a bad heart rate. Treatment medication was not provided.
Patient received an expired dose of the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was not provided by the reporter.
Reported feeling sleepy and appeared slightly pale within approx. 5 minutes of receiving vaccines; assisted to lie supine x 20 minutes; BP and HR unchanged from baseline; recovered to feeling well; left clinic in stable condition similar to baseline.
No adverse effects; received expired dose of VARIVAX; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. Concomitant therapies included sterile diluent. The medical assistant was reported that on 01-OCT-2019, patient was vaccinated expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5ml,once(expired product administered), lot # N017700 and expiry date 09-JUN-2019, (strength, route were not reported) for prophylaxis. varicella virus vaccine live (oka/merck)(VARIVAX) was reconstituted with properly stored sterile diluent (lot # and expiry date was unknown). No adverse effects were reported. There was no product quality complaint.
Intranasal administered at approx 10:40 a.m., about 20 min later she complained of desire to vomit Epipen junior was administered by school nurse.
COVID 19 Treatment; COVID 19 Treatment; Moderna:dose 1-2/ Pfizer / BioNTech: dose 3; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Nov2021 as dose 3 (booster), single (Lot number: EW0173) at the age of 39 years, in left arm for covid-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 28Jan2020 as dose 1, single (Lot number: 011J20A), in left arm and on 25Jan2021 as dose 2, single (Lot number: 042L2OA), in left arm for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Nov2021, outcome "unknown", described as "Moderna:dose 1-2/ Pfizer / BioNTech: dose 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course: The patient was not taking other medications within 2 weeks of starting COVID-19 treatment.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Pt recvd vax 28JAN91 & on 4th day, had fever to 104; next 2 wks temp was intermittant & ranged from 100-104; Pt also had dec appetite & was irritable for about 2 wks; Mom did not report event to the MD until 15 mo visit;
Itching with tightness and slight swelling. My arm looks very similar to when I am bitten by a mosquito. Also, there is a soreness in my armpit adjacent to the injection site. I think it may be my lymph node.
Vaccines were administered, right after he stated he felt dizzy and threw up and turned very pale.
Side effects post vaccination; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Side effects post vaccination) 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 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   In February 2021, the patient experienced ADVERSE EVENT (Side effects post vaccination). At the time of the report, ADVERSE EVENT (Side effects post vaccination) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment information was not provided. Concomitant medication was not provided.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Joint Pain-Medium
Day of the vaccine, she started feeling pain in the injection site and legs within 2-3 hrs when she got home. Sensitive to touch, soreness etc.. The pain got worse as days passed, the pain got stronger on left leg, abdomen, on 3rd day, she started seeing red dots. and a big blister on left side of the abdomen. The pain increased daily, as did the red rashes, all around the left side of the  abdomen, keeping her up at night due to sharp shooting pain on her sides. Daly 11, the pain is felt all the way up to her upper chest area including breast and neck, again keeping her up all night with pain. Today is day 22. The pain is at worst to date.
A physician reported that a 26 month old pt received Prevnar on 5/10/2000. On 5/12/2000, the pt developed an injection site reaction characterized by an area of redness and warmth "the size of a fist".
ARM AND LEG PAIN; This spontaneous report received from a patient concerned a female of unspecified age. 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: 1805022, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced arm and leg pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm and leg pain. This report was non-serious.
Vomiting with nausea beginning evening of 4/3/18  (4-5X ), fever (undocumented), redness at site and spreading down arm, pain radiating to shoulder and back.
Vaccination at 2pm. By midnight, entire right arm painful and throbbing. By 2:30am, developed fever. Lethargy, malaise, headache for the following 24 hours.
On 4/13, I started having diarrhea and vomiting that lasted until about 4/15. On 4/16, I started having a fever about 100.8 with flu symptoms that evening. On the 4/18, I did a COVID-19 test which was negative. On 4/20, my fever broke.  on 4/23, I tested again and it was positive.
I got an exceptionally heavy period with extreme cramps a week and a half after the 2nd dose of COVID vaccination on April 22nd - Day 25 of my cycle.   My cycle is typically 27-29 days.   But then on May 5th (day 14) I got an unexpected period, again heavier than i've ever experienced in my life and lasting 7 days.  I got my period yet again on May 20th.  So two heavy, painful 7 day periods in one month following the vaccine.  My next period occurred on Day 20 of my cycle.  It didn't return to normal until July.
All symptoms last for about 1.5 hours. Lightheaded, foggy vision and weakness in the legs: felt like going to faint.=> washed face and hands with cold water and these feelings disappeared.  Then periodic palpitations started, each serious was weaker until they disappeared after about  an hour. During the palpitations, felt weakness/ numbness in the low jaw and low lip with difficulties to talk but it lasted only for number of seconds. The last symptom during that 1.5 hour was some warm feeling in the inner part of the leg (thigh and calf) and the outer side of the legs filled just as normal. I di have some tightness in the chest with difficulties to have a deep breath but it was't significant while I was driving home
27 years old received a Havrix pediatric dose; 27 years old received a Havrix pediatric dose; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 27-year-old male patient who received HAV (Havrix pediatric) (batch number B23EA, expiry date 15th May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th May 2021, the patient received Havrix pediatric and Havrix Pre-Filled Syringe Device. On 20th May 2021, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: A 27 years old patient received a Havrix pediatric dose which led to underdose and adult use of a child product. The reporter informed that, till the reporting, the patient was in the clinic and asked how to proceed in this scenario. The reporter consented to follow up.
Patient received 12 and up dose of Pfizer instead of 5-11 year old dose of pfizer. Child is 11 years old at this time and will be 12 years old 4/18/22 (approx 4 months)  This information was found during clerical process of scanning.  Agency was contacted and Mother was notified of event.  Mom states child has no complaints at all and is doing well.
The patient developed lightheadedness, tightness in his chest, and tingling of his hands about two minutes after receiving the vaccination.  He said that he felt anxious that something was happening.  He was hyperventilating.  During the event, his heart rate was normal (in the 70s-80s), his blood pressure was normal (SBP in the 130s to 140s), and his oxygen saturation was 100%.  He was able to communicate without difficulty, he did not have any weakness, chest pain, diplopia, dysarthria, dysphagia, trouble with walking/balance, bowel/bladder dysfunction, or pain elsewhere in his body.   He had a bottle of water.  His symptoms lasted about 30 minutes, and then resolved completely.
Sore Throat; Body muscle sore; This is a spontaneous report from a non-contactable consumer, the patient. A 17-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 17-years-old) as dose number unknown single for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced sore throat and body muscle sore. The clinical outcome of the events sore throat and body muscle sore was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Added vaccination Facility Country.
Received vaccine in (L) arm. Could not lift arm subsequently. Reports deep pain & hyperesthesias. Shoulder exam normal. Neuro exam hyperreflexic & increased/hyper sensory exam.
Patient was only 11 at time of vaccine. Mother was not truthful on scheduling site, consent form or screening form. She marked over age of 12 on the question "I am 12 years and older". She also put on all three forms that her child was born on a different date than the date her child was actually born.  When I went to enter information the patient could not be found. I did a name search and the date of birth was different. I then call patients pediatrician and asked them to  verify information. Address and guardian matched up. Patient did not have an adverse reaction but was 2 months short of being at age for Pfizer vaccine.  Patient pediatrician is aware the mom was not truthful on vaccine consent. Our facility is a pop up vaccine clinic and does not have records for this patient.
Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patient's concurrent condition and medical history was not reported. On unknown dates the patients were vaccinated with PROQUAD (strength, dose, route and lot # not reported) which was improperly stored. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
The vaccine did not prevent shingles as intended; Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 17-APR-2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine was intended to prevent. On 18-FEB-2016, the patient was treated by a physician for a vesicular outbreak which was diagnosed as herpes zoster.  The patient was prescribed famiciclovir for management of her painful symptoms and chronic pain.  On or about 29-FEB-2016, the patient sought subsequent treatment from a physician for pain in the facial region, which was diagnosed as postherpetic trigeminal neuralgia.  The patient was prescribed gabapentin for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
TENDER ARM; LETHARGIC; MODERATE FEVER; This spontaneous report received from a consumer concerned a female of unspecified age. 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: Unknown) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 03-APR-2021, the subject experienced tender arm. On 04-APR-2021, the subject experienced moderate fever. On 05-APR-2021, the subject experienced lethargic. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from moderate fever on 05-APR-2021, and the outcome of tender arm and lethargic was not reported. This report was non-serious.
fainted; seizure; lost consciousness; pain around injection site; Cold sweat; Dizziness; everything was blurry; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route in left arm single dose for covid-19 immunization at 32-year-old on 18Oct2021. Medical history included seasonal allergy. No seizure, no epilepsy no history of that whatsoever. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in left arm for covid-19 immunization at 32-year-old on 27Sep2021 and had fainted. The patient had seizure, so essentially it started as pretty typical, pain around the injection site but then cold sweats, dizziness and then he lost consciousness essentially and it was like sensation of not being in control, everything was blurry, he had no control of any of his bodily functions essentially and then after he didn't know a minute or so, he regained consciousness. The patient reported didn't just faint he had a full long seizure. No treatment or lab test. Outcome of events was resolving.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101407923 same patient and drug, different event separated in time
About 8 hours after getting Shingrix at a pharmacy started developing Shingles.  Seen in doctors office 2 days later and diagnosis made.  Placed on antiviral.  Spoke to him a week later--severe pain went away fairly quickly after a few days and the rash was also significantly improved at one week.
Redness, swelling, itchiness, pain and heat at the injection site still occurring nine days after the administration of the vaccine.  PA diagnosed cellulitis, prescribed ibuprofin, Amox-clav 875 mg  one tablet BID, cold compress
Vaccinator gave Booster 7 days early. Client was not notified as she had already left by the time error was caught
Within a few hours, headache and body aches started, fever increased. By 1am the morning of 8/15 (14 hours after injection, fever was over 102 with nausea. By 8am on the morning of 8/15, the fever was over 103, breaking with Tylenol but spiking by the four hour mark after Tylenol. Body aches and headache continued through the day with no appetite and onset of diarrhea. Nausea off and on through the day. Sunday, 8/16, almost fainted after a shower, lightheaded and dizzy. Start of red spots at bra line under breasts first noted. Fever spiked over 104 overnight the morning of 8/17. Red spots increased all over torso, up neck and face, breathing started to feel restricted, chest tight.  Took Benedryl at 4:30pm and again at 9:30pm to help control the red spots. Fever, severe diarrhea and nausea continue at the time of completing this form.