chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received vaccine around 5:30 pm, by 2:30 am I awakened with aches all over my body.  I went back to sleep and when I awakened i had a low grade fever 99+ and was very fatigued and had a headache and slight pains in my head.  I slept all day except to eat and go to the rest room.  Same reactions the next 2 days but second day the fever went as high as 101.2 for a period of time, 3rd day the fever was low grade again.  Arm was red and raised below injection site and about half of my upper arm.  Had sinus pressure and mild headache and swollen lymph nodes (glands) in throat for the next 2 weeks.  Did not report to doctor as gradually improved.
Pt was seen in the office on 4/14/00 with a case of the chicken pox.
Pt received KINRIX on 05/07/14 to left thigh having a reaction of an erythema measurements of a 22 cm long and 15 cm wide. Area warm to touch and hard.
Initial report was received 01 March 2013 from a health care professional. A 45-year-old female patient (medical history not reported), had received an intramuscular left deltoid injection of ADACEL, lot number C4196AA on 22 February 2013 and six days later, she developed cellulitis, redness and swelling at the left deltoid, and an increase in the diameter of the swelling and redness that was warm to touch. She was seen in an urgent care center and prescribed antibiotics (not specified) for 10 days. Laboratory and diagnostic testing was reported as "none". According to the reporter, the patient showed some improvement however outcome was not recovered. Documents held by sender: None.
Loss of consciousness, diarrhea, vomiting, and dehydration requiring hospitalization.
pt ran fever 103.6 yesterday; pt devel allerg type rash approx 4PM on 19AUG95; pt in to MD 5PM to look @ rash; sent to ER-ER stopped Motrin &  pediazole started; given DPh & Ceclor; found ear infect @ ER
Felt hot (did not take temp) then had shooting pains through muscles, mostly extremities.  This lasted approximately 6-8 hours, then abated. Afterwards felt weak for about 12 hours.
Numbness of the forearm and hand of both parts. It does not have a specific time, it occurs at any time but it happens more frequently when I'm sleeping.
48 hours after 2nd shot I had severe neck pain on the  right side. Doctor advised me to take motrin. That night when trying to sleep my nerves felt like they were vibrating in my upper spine area. The vibrations went down to my arms, my legs. Next morning the neck pain was much better but every single night since then my nerves vibrate all through out my body. I get toe pain and finger pain. Sometimes tingling feelings in my hands and feet and nose. I can't sleep at night due to the vibrations. Over the last 4 weeks I have frequent muscle spasms through out the day that last hours sometimes.
Big bruise on right arm; Shoulder and tendons very sore; Shoulder and tendons very sore; This is a spontaneous report from a contactable healthcare professional (patient). A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231, expiration date unknown), via an unspecified route of administration in the right arm on 05Jan2021 at 01:30 AM at a single dose for COVID-19 immunization.  The patient's medical history included allergies and patient had no COVID prior to vaccination.  Patient is not pregnant. The patient's concomitant medications were not reported. The patiently previously received the first dose of BNT162B2 on unspecified date for COVID-19 immunization. The patient has not had any other vaccine in four weeks and no other medications in two weeks. On 06Jan2021, the patient experienced big bruise on right arm. It was also reported that shoulder and tendons were very sore. The patient reported that it has been 10 days and it was not getting better. The patient had not been tested for COVID post vaccination. The outcome of the events was not recovered at the time of the report.
Information has been received from a hospital pharmacy technician via a pulmonogist concerning a 60 year old male who was vaccinated with a dose of PNEUMOVAX (Lot #658175/0856U).  Subsequently, he "got sick" and required bed rest.  He had chills over night and the arm was swollen and sore.  Treatment was not specified.  At the time of the report the patient's outcome was unknown.  Additional information has been requested.
Case number PHEH2015US026841, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 56 year old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 08 Oct 2015. It was reported that before administration the FLUVIRIN had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information provided. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
First pregnancy Weeks of brown bleeding prior to miscarriage Due 12/17/21  Miscarriage 05/22/21 at 1pm
Acute pericarditis onset 10 Dec 07, Direct hyperbilirubinema with transaminitis onset 20 Dec 07 (appx)- failed Motrin, responding to colchicine and Dilaudid. 2/14/08 Reviewed medical records which reveal patient experienced substernal chest pain radiating to bilateral arms & abdomen, nausea, sleep disturbance. Admitted 12/10-12/12/2007.   FINAL DX: Pericarditis. Exam revealed pleuritis & HA.  Dx w/pericarditis.  Tx w/antiinflammatories & improved.  D/C to cardio clinic f/u.   4/11/08 Reviewed hospital medical records of 12/31/2007-1/7/2008. FINAL DX: acute pericarditis; mycoplasma pneumonia; epididymo-orchitis (resolved); allergic rhinitis; GERD; abdominal pain & diarrhea secondary to colchicine. Records reveal patient experienced recurrent chest pain increased w/cough or lying down, DOE, tenderness to chest wall.  Cardio, ID consults done.   Improved & d/c to home.
Pt states he had a sore arm, achy body, overnight had chills and felt body was on fire, eyes burning.
next day erythema, blotchy, blanching @ inject site sl tender lasted 48 hrs;
SARS-CoV-2 RdRp Resp Ql NAA+probe~COVID-19 rapid diagnostic test (nucleic acid amplification test NAAT) performed on 7/24/21. Test done at Store most likely. Came back positive. Case investigation interview with patient has not been conducted as of the time of this note.
after booster covid vaccine felt achy and flu like; after booster covid vaccine felt achy and flu like; had an infection behind his eardrum; had cough and he had been plugged up for a month; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (after booster covid vaccine felt achy and flu like), PAIN (after booster covid vaccine felt achy and flu like), LABYRINTHITIS (had an infection behind his eardrum) and COUGH (had cough and he had been plugged up for a month) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    The patient's past medical history included Ear tube insertion. Concurrent medical conditions included Nasal passage irritation (terrible nasal passages) and Crohn's disease (MODERATE TO SEVERE ADULT CROHN'S DISEASE).   On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (after booster covid vaccine felt achy and flu like), PAIN (after booster covid vaccine felt achy and flu like), LABYRINTHITIS (had an infection behind his eardrum) and COUGH (had cough and he had been plugged up for a month). At the time of the report, INFLUENZA LIKE ILLNESS (after booster covid vaccine felt achy and flu like), PAIN (after booster covid vaccine felt achy and flu like) and COUGH (had cough and he had been plugged up for a month) outcome was unknown and LABYRINTHITIS (had an infection behind his eardrum) had not resolved.            No concomitant drug was reported. Humira was used for the indication of moderate to severe adult crohn's disease. No treatment drug was reported. Causality for HUMIRA(Solution for injection in pre-filled pen): The reporter's causality for the event(s) of tubes in ear and cough was not provided. the reporter's causality for the event(s)of infection behind eardrum, after booster covid vaccine felt achy and flu like unknown onset and after booster covid vaccine felt achy and flu like unknown onset with humira(adalimumab) was no reasonable possibility. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
2-3 days after 2nd Shingrix vaccine, developed a few (2-3) pox that were itchy (left or right wrist and left leg near knee).  Developed a few more (2-3) during the following week.  I'm aware of the current monkey pox outbreak, but do not believe this to be related as there's no pain and no concentration of pox in genital areas.  Believe more of a chicken pox reaction related to Shingrix.  Noted medical article states that about 1 in 10,000 can develop chicken pox after Shingrix vaccine.  Again, itchy and skin irritation, but not painful.
Pt with large amount of redness from site down to his knee that then wrapped around the back of his leg, along with mild swelling and itchiness
Patient filled out the Vaccine Administration Consent Form and used the incorrect date of birth and received a 3rd COVID vaccine.
Information has been received on 09-MAR-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During 2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated at a medical center for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, 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.
COVID19 breakthrough case.   Symptoms:  Fever, aches, sinus pressure, loss of smell, coughing, sneezing Time course:  Began symptoms on Sept 11, 2021 - Worse symptoms were over by 9/15/2021 &  Remdesivir Injections, Steroid Injection, Tamiflu, & Antibiotic on Tuesday, 9/14/2021
This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a female patient who received SHINGRIX (batch number H547E, expiry date 22nd February 2021) for prophylaxis. On 1st October 2018, the patient received SHINGRIX. On 3rd October 2018, 2 days after receiving SHINGRIX, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was unknown. It was unknown if the reporter considered the erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The case was came in via chat. The age at vaccination was not reported. At 2:00 pm, the patient received the SHINGRIX. Her arm was red.
influenza & pnemovax given SQ L upper arm, 24hrs later felt sick, fatigued. Increased redness at site of SQ inj. C/o bad taste in mouth, pain 10/10
Significant increase in systolic BP from pre vax average 130 to post vax 165
Swelling of right thigh 7.5 inches in diameter indurated, warm to touch. Diagnosed as local reaction to immunization r/o cellulitis. Treated with Benadryl x 2 days and bid x 10 days.  Keflex suspension.
CoVid Like symptoms lasting 28 hours including fever to 101, chills, body aches, muscle pain and headache
CHILLS; FEVER; 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, 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 subject experienced chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever. This report was non-serious.
Presented with slight rash on immunized arm at wrist and along exterior arm...only areas.
This spontaneous report was received from a licensed practical nurse refers to a multiple unknown patients of unknown age and gender. No pertinent medical history, drug reactions/allergies and concomitant medications were reported. On an multiple unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot #M018625 and expiry date 11-AUG-2018) (dosing regimen was unknown by the reporter). The vaccine was exposed to temperature of 0.2 degree celsius for 4 hours and 51 minutes. No previous temperature excursion was reported. The call was due to digital data logger. No adverse effects were reported. No product quality complaint (PQC) was filed. This is one of several reports received from the same reporter. Additional information has been requested.
Pt developed whelps over legs, trunk and back. Had wheezing and severe itching, within 3-4 hours, post vax. This lasted 4 days. Symptoms relieved by oral Benadryl. Rash continued until 3/29/00 PM.
No adverse effects reported; the Patient received improperly stored VARN AX; This spontaneous report was received from a medical assessment and refers to a 13-year-old patient. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 13-AUG-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R023513, expiration date 16-AUG-2020 (strength, route of administration and dose were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot # S000130, expiration date 23-AUG-2021). No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of -14 Celsius degrees (C) to -10 C (also reported as -13.2 C) for 46 minutes. The digital data logger was involved in recording the temperature excursion details. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA007312: US-009507513-1909USA006939: US-009507513-1909USA007512: US-009507513-1909USA007118:
Breakthrough case admission after two vaccines Moderna 1/12/21 Lot# 012L20A;  Moderna 8/5/22 Lot# 055A22A
Red, itchy rash on left side of face and neck started about 2 days after injection.  Also developed redness and swelling around the injection site at same time of rash development.  Rash moved to other side of face after about 1 day.  Saw a doctor today, 8/15/20, who prescribed triamcinolone cream and OTC Zyrtec.
Received the second dose of the Moderna Covid 19 vaccine less than 25 days after receiving the first one.; Aching; Chills; High fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aching), CHILLS (Chills), PYREXIA (High fever) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second dose of the Moderna Covid 19 vaccine less than 25 days after receiving the first one.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Cholesterol and Penicillin allergy.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second dose of the Moderna Covid 19 vaccine less than 25 days after receiving the first one.). On an unknown date, the patient experienced PAIN (Aching), CHILLS (Chills) and PYREXIA (High fever). At the time of the report, PAIN (Aching), CHILLS (Chills) and PYREXIA (High fever) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second dose of the Moderna Covid 19 vaccine less than 25 days after receiving the first one.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products included High blood pressure medication and Cholesterol medication It was reported that Patient did not had COVID positive nor Diagnosis No treatments were reported.   This case was linked to MOD-2022-537569 (Patient Link).
Adverse events began on 10/15/2022 and are still present.  Adverse events include;  sever chills, severe fatigue, loss of appetite,  severe nasal congestion, severe sore throat, cough, severe laryngitis.  Most of the severe  adverse events began to subside on 10/20/2022.
Patient positive for Covid and was admitted. Patient stated he was vaccinated for Covid. Unable to obtain any more information than this.
Dizziness, sob, painful joints, headache. Tylenol 2-500 mg bid, on day one Day two, mild headache, sob, eye socket pain, dizziness, body aches. Treatment nebulizer treatment, Tylenol,  Hot and cold symptoms
Doctor reports his sister, who is 34 weeks pregnant, was inadvertently given a dose of Arexvy instead of Pfizers RSV vaccine.; Doctor reports his sister, who is 34 weeks pregnant, was inadvertently given a dose of Arexvy instead of Pfizers RSV vaccine.; Inappropriate age at vaccine administration; This non-serious prospective pregnancy case was reported by a physician via call center representative and described the occurrence of wrong vaccine administered in a 30-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In OCT-2023, the patient received Arexvy. In OCT-2023, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: Doctor reports his sister, who is 34 weeks pregnant, was inadvertently given a dose of Arexvy instead of Pfizers RSV vaccine.) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Doctor reports his sister, who is 34 weeks pregnant, was inadvertently given a dose of Arexvy instead of Pfizers RSV vaccine.). The outcome of the wrong vaccine administered, inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 09-NOV-2023 Physician reported his sister, who is 34 weeks pregnant, was inadvertently given a dose of Arexvy instead of Pfizers RSV vaccine, which led to wrong vaccine administration, which led to wrong vaccine administered.  The reporter consented to follow up.
My left arm was a little sore for a couple of days but not bad.  Then I noticed  an itchy feeling on the muscle below where I had the shot.  This was for a couple of days, Today  (six days after the vaccine) I have a little rash there.  Left arm, muscle.  I put calamine lotiin on it today.
Myalgia, Arthralgia, Fever & CoughWheeze Narrative:  Self care provided with lost work time
Moderna 2/13/21, 3/15/21, 10/29/21. Positive on 7/19/22
myocarditis; heart problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from legal division, Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious) with onset 2021, outcome "unknown", described as "heart problems"; MYOCARDITIS (medically significant) with onset 2021, outcome "unknown". The patient underwent the following laboratory tests and procedures: Cardiac stress test: Unknown; Echocardiogram: Unknown. Clinical course: Per reporter, "You people gave me myocarditis when I got the vaccine April/May2021. I have been having heart problems for the past 2 or 3 months. I don't know how you coded the nucleotides, which most people don't know about, but I understand ribonucleic acid, and how uracil and thime and adenine and guanine work, and how permutations of those compose amino acids, the building block of proteins. I'd love to know exactly how you coded it. I will sue you. I am having an echocardiogram and a stress test done."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Swollen, indurated, pruritic area in subcutaneous area of injection site measuring over 3cm in diameter 11 days after immunization
This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (on right buttock once monthly) and genital herpes. Previously administered products included valacyclovir. On 29th December 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved. The reporter considered the shingles to be unrelated to SHINGRIX. Additional details were provided as follows: The patient noted her history of shingles had been monthly every month for 4 years now. The patient received SHINGRIX in the left upper arm. The patient needed to see a new dermatologist, as her previous one left and she also needs a new prescription for the valacyclovir. The patient was not relating the events to SHINGRIX but did not it occurred after the shots, so this report being filed. She noted her history of shingles has been monthly every month for 4 years now.
Patient was given booster dose of pfizer-covid vaccine while the patient is  less than 18 years old. Patient was doing ok, she was experiencing   some fatigue and fever-feeling only.