chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient complained of lethargy, headache, pain in arms, swelling in arm where shingrix had been administered.
Rec'd flu shot at 5:15 PM. At 9 PM had chills, fever of 101 and aches.  By midnight face, lips and tongue swollen, throat sore and tight, tightness in chest.  Was given Benadryl at ER and told to take for a few days.  As of 10/16/2013 my lips are still swollen and numb.  Was told to go back to ER today if still numb this evening. Never had ANY reaction (including chills and aches) from a flu shot before.
During my first dose of Covid vaccination on 5/18, the vaccine leaked to my hand and the floor.  The amount successfully injected is unknown. The pharmacist apparently didn?t know what to do, and asked me what I?d like to do. I told her I don?t know. She then told me it?s up to me or she could give me another 1/3 dose if I am ok with it. Because there was a good amount of liquid NOT injected, I agreed to her suggestion. She then did it on the same left arm.  Then I found out today 5/19 that she didn't follow the CDC interim recommendation: If less than half of the dose was administered or the proportion of the dose cannot be estimated, administer the authorized dose immediately (no minimum interval) in the opposite arm   When I contacted CDC, the agent told me to report the incident and the wrong correction she performed on VAERS where I will know the precautions and the actions needed for me to be successfully vaccinated. Should I get an antibody test after my second dose in June?  Please advise.
pt stated after she got her vaccine she had to use the bathroom right away.  she went home and went to straight to the bathroom.  When she urinated it was dark gold color.  She thinks the vax medicine went straight to her kidneys.  She has urinated since this episode and said her urine was back to normal.  Pt has not contacted her PCP at this time since he urine returned to normal color.
Patient experienced itchy throat and took a diphenhydramine tablet quick melt. several minutes later patient's throat felt numb.  Epipen was administered to right leg and 911 called.  Patient did not feel relief in 5-10 minutes of administration.  A second one was given in left leg.  At this time EMTs arrived.
Headache, fever but most concerning, intense pain in right arm. I can't lift it over my head, my hand shakes when I try to grab items and it literally brings me to tears. I have had swelling from vaccines before but nothing this intense.
Dose received: 3; Heart palpitations; This is a spontaneous report received from contactable reporter (Nurse).  A male patient received bnt162b2 (BNT162B2), administration date an unknown date in 2021 (Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine manufacture unknown (DOSE 1, SINGLE, Lot Number: UNKNOWN), for COVID-19 immunisation and Covid-19 vaccine manufacture unknown (DOSE 2, SINGLE, Lot Number: UNKNOWN), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset an unknown date in 2021, outcome "unknown", described as "Dose received: 3"; PALPITATIONS (non-serious) with onset an unknown date in 2021, outcome "unknown", described as "Heart palpitations". The event "Heart palpitations" was evaluated at the emergency room visit. It was unknown whether any therapeutic measures were taken as a result of the event PALPITATIONS.  Additional Information: Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was reported that while on a vendor call one of the vendors mentioned in passing that he had received the Pfizer booster and had to go to the ER for heart palpitations, but no further information was provided.  The lot number for BNT162b2 was not provided and will be requested during follow up.
feel like she wants to vomit; on and off headaches; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (feel like she wants to vomit) and HEADACHE (on and off headaches) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 026B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 04-Apr-2021, the patient experienced VOMITING (feel like she wants to vomit) and HEADACHE (on and off headaches). At the time of the report, VOMITING (feel like she wants to vomit) and HEADACHE (on and off headaches) outcome was unknown.            Concomitant included Prenatal.   Treatment Tx: Tylenol.   Reporter did not allow further contact
blotches appeared on abdo & back & forehead; described by mom as red, raised areas size of head of pencil, seem to come & go; denies any resp distress or illness sx;
Got COVID positive test result on 14Oct2021; Got COVID positive test result on 14Oct2021; This is a spontaneous report from a contactable consumer. This consumer reported for a 16-year-old female patient that:  A 16-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP6955), intramuscular, administered in Arm Right on 12Apr2021 (At the age of 16 Years) as DOSE 2, SINGLE for covid-19 immunisation. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP6955), intramuscular, administered in Arm Right on 22Mar2021 (At the age of 16 Years) as DOSE 1, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 13Oct2021 Nasal Swab. The patient got covid positive test result and vaccination failure on 14oct2021. No, treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Yes, patient covid tested post vaccination. The outcome of the events were recovering.  Follow-up attempts completed. No further information is expected.
Whelp appeared on her arm after flu vaccine given 10:00 am 9/6/17.
This spontaneous report as received from a healthcare worker refers to a 6 month old patient of unknown gender. Concurrent conditions and medical history were not reported. On 18-JUN-2015, the patient was vaccinated with improperly stored dose of oral, ROTATEQ (lot # K009900 and expiration date 04-MAY-2016 (dose was not provided). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
3 dialysis pt each recv 1 dose of Engerix-B for prophylaxis;post vax each pt exp a hematoma on the arm (inj site);
On 10/9/19 Pt. reported continued shoulder soreness without swelling, redness or increased warmth.
This spontaneous prospective pregnancy report as received from 27 year old female medical assistant refers to herself. The medical assistant confirmed that she had chicken pox during her childhood and she discontinued use of HUMIRA pen for psoriasis "three weeks ago" (on 13-AUG-2014). On 03-SEP-2014 the medical assistant was inadvertently stuck in left fifth finger with VARIVAX (Merck) (lot#, dose, route not reported) needle prior to administration to patient. Concomitant medications included iron (unspecified), minerals (unspecified), vitamins (unspecified) (prenatal vitamins). Medical assistant was seven weeks pregnant at that time. She cleansed area and applied band aid. The physician at practice was made aware. The Last Menstrual Period (LMP) was estimated on 16-JUL-2014. The Estimated date of delivery (EDD) was estimated on 22-APR-2015. No treatment was given. The outcome of the pregnancy was unknown. Additional information is not expected because the reporter did not want to be contacted.
Got shot at 10:00 am had a rash head to toe by 9:00 pm. His back arms, legs, stomach covered with rash.
Information has been received from a mother concerning her daughter who on unspecified dates was vaccinated with first and second doses of Gardasil. Her daughter only took 2 doses of the vaccine and had to stop. Subsequently, it was reported that the patient's body had rejected the vaccine. Unspecified medical attention was sought. The patient was seen by a neurologist. The patient's outcome was unknown. No further information is available.
Head ache, body ache, waves of pain. Then turned to urethral hemorrhage on day 3. Event happened 2 times that day but not since.
I want to thank you so much for creating the vaccines and boosters. As I write this note I had tested positive for covid and have hardly any symptoms; I want to thank you so much for creating the vaccines and boosters. As I write this note I had tested positive for covid and have hardly any symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I want to thank you so much for creating the vaccines and boosters. As I write this note I had tested positive for covid and have hardly any symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Right after eating scallops the inside of my upper lip swelled. I took an  antihistamine and the swelling subsided.  The next morning there was still a little swelling but it cleared soon after.
Had to visit the doctor about a week later with strep throat symptoms but strep test was negative. Symptoms continued a few days and was prescribed antibiotics.
The patient received 0.2 mL of an undiluted vaccine. No adverse events or treatments have occurred. Patient is currently experiencing no adverse effects.
Pt states she started having multiple body aches since yesterday but started having left eyelid swelling and itching this morning.
The symptoms began about 6 hours after administration.  Fever, muscle aches, fatigue, headache and nausea.  Patient used Tylenol. Symptoms were resolved in about 12 hours
Folliculitis; This is a spontaneous report based on information received by a contactable consumer or other non hcp.    A 38-years-old female patient received BNT 162b2 (COVID-19 VACCINE, Solution for injection, Lot No number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced folliculitis on an unspecified date. As you may be aware, the FDA Guidelines for Post marketing Reporting of Adverse Drug Reactions (Docket No. 85D-0249) dated March 1992 (Part VI, I), require that reports of ADEs in which the initial reporter identifies the suspect drug as one marketed by another applicant should be promptly forwarded to that applicant. Additionally, per 21 CFR 314.80, Post-marketing Reporting of Adverse Drug Experiences, updated 01Apr2016, the requirements of paragraphs (c)(1)(i) and (c)(1)(ii) of this section, concerning the submission of post-marketing 15-day Alert reports, also apply to any person other than the applicant whose name appears on the label of an approved drug product as a manufacturer, packer, or distributor (non-applicant). To avoid unnecessary duplication in the submission to FDA of reports required by paragraphs (c)(1)(i) and (c)(1)(ii) of this section, obligations of a non-applicant may be met by submission of all reports of serious adverse drug experiences to the applicant. If a non-applicant elects to submit adverse drug experience reports to the applicant rather than to FDA, the non-applicant must submit, by any appropriate means, each report to the applicant within 5 calendar days of initial receipt of the information by the non-applicant, and the applicant must then comply with the requirements of this section. We are, therefore, forwarding the information below relating to your product which was obtained by one of our employees during the normal course of business. Outcome of the event was unknown.    Information about lot/batch number has been requested.
Severe stiffness in entire arm starting about an hour after vaccine. Swollen nearly all around entire arm and up into the shoulder. Red, hot, and itchy.  Hive like area on the edge. Cold packs for 7 hours. During the night woke with chills. Swelling decreasing as today progresses and mobility increasing.
COVID following COVID vaccine series 02/09 COVID vaccine dose #1 03/02 COVID vaccine dose #2 05/04 tested for COVID due to travel, COVID negative 09/09 evaluated in ED w/ c/o fevers, chills, body aches and nasal congestion x 3 days, COVID positive 09/11 c/o cough, rhinorrhea, flu like symptoms 09/13 reports improving cough, ongoing rhinorrhea 09/14 improved cough, fever resolved 09/27 COVID vaccine dose #3, influenza vaccine 09/30 pt requests repeat COVID test to find out if still positive, asymptomatic; COVID positive
Information has been received from a physician concerning a patient who was vaccinated with a dose of MMR. The patient currently showed no immunity. The reporter was considering revaccinating the patient. A product quality complaint was not involved. No further information is available.
Pt had sz 3 hrs p/vax recvd; paramedics were called & pt was transported to local ER; pt was unresponsive then ambulance arrived; t100.5 @ ER: pt states pt had a hot flash a/sz;
a little tongue swelling; itching was so bad "she wanted to dig it out".; spot on her arm increased in size and was 3.5in x 2.5in; Burning tongue syndrome; tingling; arm was sore, I couldn't raise it for three days; it looked blotchy and red; swollen, raised up; numbness on tongue; hot to the touch; red welt; red; rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (it looked blotchy and red), PERIPHERAL SWELLING (swollen, raised up), PAIN IN EXTREMITY (arm was sore, I couldn't raise it for three days), VACCINATION SITE SWELLING (spot on her arm increased in size and was 3.5in x 2.5in) and BURNING MOUTH SYNDROME (Burning tongue syndrome) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy and Allergy (Poison Ivy, Wasps and some pain medications). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LIOTHYRONINE, CALCIUM, GARLIC [ALLIUM SATIVUM], COLECALCIFEROL (VITAMIN D 3) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced RASH MACULAR (it looked blotchy and red), PERIPHERAL SWELLING (swollen, raised up), HYPOAESTHESIA ORAL (numbness on tongue), FEELING HOT (hot to the touch), URTICARIA (red welt), ERYTHEMA (red) and VACCINATION SITE RASH (rash at the injection site). On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was sore, I couldn't raise it for three days). On 31-Jan-2021, the patient experienced VACCINATION SITE SWELLING (spot on her arm increased in size and was 3.5in x 2.5in), BURNING MOUTH SYNDROME (Burning tongue syndrome), PARAESTHESIA (tingling) and PRURITUS (itching was so bad "she wanted to dig it out".). On an unknown date, the patient experienced SWOLLEN TONGUE (a little tongue swelling). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH MACULAR (it looked blotchy and red), PERIPHERAL SWELLING (swollen, raised up), VACCINATION SITE SWELLING (spot on her arm increased in size and was 3.5in x 2.5in), BURNING MOUTH SYNDROME (Burning tongue syndrome), PARAESTHESIA (tingling), HYPOAESTHESIA ORAL (numbness on tongue), SWOLLEN TONGUE (a little tongue swelling), PRURITUS (itching was so bad "she wanted to dig it out".), FEELING HOT (hot to the touch), URTICARIA (red welt), ERYTHEMA (red) and VACCINATION SITE RASH (rash at the injection site) had resolved and PAIN IN EXTREMITY (arm was sore, I couldn't raise it for three days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included cold compresses, hydrocortisone cream and Benadryl at night.
This case was reported by a pharmacist via call center representative and described the occurrence of hepatitis in a 28-year-old male patient who received TWINRIX  adult (batch number A4XD4, expiry date 7th October 2017). Concomitant products included  TWINRIX adult. On 25th April 2016, the patient received the 2nd dose of TWINRIX  adult. On an unknown date, less than a year after receiving TWINRIX  adult and an unknown time after receiving TWINRIX  adult, the patient experienced hepatitis (serious criteria GSK medically significant and other: as per reporter). On an unknown date, the outcome of the hepatitis was unknown. the reporter considered the hepatitis to be unlikely related to TWINRIX  adult. Additional details were provided as follows: the reporter was not sure if this is an adverse event due to the fact that the patient did not finish the series. On 23rd March 2016, the patient received the 1st dose of TWINRIX  adult. The patient was given 2 doses of TWINRIX  adult. The patient was waiting for the 3rd dose. The patient called healthcare professional and said he was tested positive for hepatitis. The healthcare professional was not sure which hepatitis. the patient was concerned that TWINRIX  adult gave him the hepatitis. The patient also said he had elevation in "ALC" levels of the liver. the patient visited the emergency room. the reported lot number (A4X04) for TWINRIX  adult did not exist and was updated to A4XD4, according to sales database.
It started out the evening I got the shot with chills, headache and fatigue that developed into a body aches and fever throughout the night along with light sensitivity. That lasted for 2 days with the fever going up 101.5 that went back to normal after 2 days. The lymph nodes in my neck and underarms became very painful and swollen and still had a headache and fatigue. The lymph nodes were swollen until May 7th and my neck is still very stiff and sore. A very red and swollen upper arm for 5 days after shot.  The whole time the fatigue has been intense and unbearable. even after large amounts of sleep. On may 7th I tried to sweep my floor and I was too fatigued and had to lay down after.  On May8th the fatigue is so intense I can't stay awake so I went to urgent care to be checked and they only checked my vitals and said it could be lasting effects from the shot.   Took tylenol and ibuprofen periodically for several after shot.
Patient received Hepatitis A, PCV-13, & VARIVAX immunization ~ 10 AM 5/18/10. He was fussy that evening & vomited part of a G-tube feeding that night. On 5/19/10 at 8:20 AM he had a focal seizure without fever no LOC, (+) post-ictal somnolence. He also had seizures on 5/20 & 5/21/10.
After first vaccination on April 1st, patient was limping several days later (thought to be claudication by patient).  After second vaccination on April 27th, patient was diagnosed on May 26th as having had a miscarriage.  She subsequently developed uveitis in her left eye on May 26th.  It did not respond to prednisolone eye drops and was treated with an extended course of prednisone.  She had continual headaches for several weeks and was diagnosed with Behcet's disease on August 12th.
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitants were reported.  No treatment drugs  were reported.
6/26/2008 1pm Pt states was walking to her room and doesn't remember anything and woke up on the floor.  6/28/2008 Also, complains of right arm red, swollen, sore, tingling on and off, blotchy white rash around injection site, lightheaded on and off and nausea on and off.  Saw doctor on 6/30/2008 mom states doctor says it was a local reaction. Ice the area, take benadryl and motrin.
Sore arm developed about 3-5 hours after injection and resolved around 40-48 hours. Soreness/stiffness was significant enough during about first 24 hours after onset to inhibit common daily acitivities like putting on clothes, wiping with toilet paper, raising arm straight out or above head, but later could be accomplished with slower, careful stretching movements.  About 12 hours after injection (around 2-3 AM), possible low fever (? actual temperature was not taken) or at least a subjective feeling of being too hot/unable to properly regulate body temperature began, with some sweating, that interrupted sleep for about 4-5 hours. I was stiff and sore the next day which might have been also related to poor sleep (and not being able to tolerate lying on my left side as I often do).
I got 2nd shot on 10 am  04/13/2021 I feel o.k during date time. I am getting tire a little around 6pm. I cam back take later dinner around 9 pm. I feel like  have a cold after 10:30pm  I drink a lot and went to bed almost midnight. While I was sleeping, my body aches and hurts. I almost wake up 9:30 am. then I felt some strange I can not hear well from my left ear. Even I could not take phone using my left ear because I can not hear well what they said. I thought it will be better because it might by vaccine and i am tire However, this Symptom did not got away. I heard some noise from my ear and I can only heard sound around 10% comparing with normal hearing I reported my medical doctor on Wed night and I communicate with him by phone 2:30 pm 04/14/2021. He recorded my symptom. and I have schedule to check my hearing test on 2;20pm 04/22/2021
recvd vax;w/in 8 hrs of vax had grand mal sz & was unconscious for 20 mins;to er;given dilantin & eval by neurologist;observed in er & released; sz due to small brain tumor, not vax; tumor uncovered through neurological work-up & operable;