chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heart pounding. Could not sleep because of heart pounding as well. The next day, I played tennis, and for the first time, I felt shortness of breath and accelerated heart beat / tachycardia. These seem very unusual given I have no pre-existing condition or other health conditions/ illness
signifcant fatigue for 48 hours followed two days later by 19 hours of chills
Headache, NauseaVomiting, Chills, Fatigue Narrative:  Other Relevant History:
Pt states that a few weeks after having HD Flu vaccine, she was hospitalized from late Nov 2016 until mid-January 2017 due to the effects of Guillain-Barre Syndrome.
There were no known adverse events. However, the liquid form of Pentacel was only given (Dtap and Polio). The powder form (Hib) was never diluted with the liquid form (Dtap and Polio), so the Hib was never administered.
Headache, Pain in arm. Can barley move arm at all.  Stomach ache, nausea, diarrhea.
Vaccine administered 10/18.  On morning of 10/21 child would not wake up and respond to parents.  She would moan, then fall asleep.  Would not sit, stand, verbalize, or eat.  By about noon she began to respond, although still listless.  No fever, exam normal.  No treatment given, just observation at home.
Swollen Lymph Node extending down toward toward breast on right side (same side as vaccine injection). Initially believed it was a clogged duct as patient is breastfeeding. After following standard course of treatment for a clogged duct with no resolution as expected, patient determined likely cause of the issue was a swollen lymph node. Symptoms included a swollen, painful area starting at the outer armpit and extending to within 1" of the nipple. The area around the swollen hard tissue was red and felt warm to the touch. Symptoms lasted one week from onset then resolved.
Branch retinal artery occlusion (stroke); Branch retinal artery occlusion (stroke); This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0171 and expiration date not provided), via an unspecified route of administration, in left arm, on 25Apr2021 12:45 (at the age of 29-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history reported as "none". Patient had no known allergies. Patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. The patient experienced branch retinal artery occlusion (stroke) on 05May2021 16:15. Events resulted in doctor or other healthcare professional office/clinic visit emergency room/department or urgent care, disability or permanent damage. The patient underwent lab tests and procedures, which included COVID-19 test (Nasal Swab) was negative on 10May2021, and negative on 18May2021. Therapeutic measures were taken as a result of events and included treatment with acetylsalicylic acid (ASPIRIN), atorvastatin calcium (LIPITOR) and ongoing tests/consultations. The outcome of the events was not recovered.
Colon inflammation; Rectal bleeding; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (Not aplicable). The reporter is the patient. Other Case identifier(s): 22K-163-4276982-00 (Agency).  A 32 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 22Nov2021 (Batch/Lot number: unknown) at the age of 32 years as dose 3  (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous since Sep2020 (ongoing) (Batch/Lot number: unknown) at 40 mg (40 mg (citrate free 40 mg, 1 in 2 week)) for crohn's disease, colitis ulcerative. Relevant medical history included: "Alcohol use", start date: 2008 (unspecified if ongoing), notes: Alcohol use, weekends or two to three times a week, beer, drinking alcohol (started  2008); "Non smoker" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing), notes: Penicillin allergy Manifested by hives. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Route of administration: Intramuscular), administration date: 01Apr2021, when the patient was 31 years old, for COVID-19 Immunization; Bnt162b2 (Dose:2, Route of administration: Intramuscular), administration date: 22Apr2021, when the patient was 31 years old, for Covid-19 immunization. The following information was reported: RECTAL HAEMORRHAGE (medically significant) with onset Dec2021, outcome "not recovered", described as "Rectal bleeding"; COLITIS (non-serious) with onset Jan2022, outcome "not recovered", described as "Colon inflammation". The patient underwent the following laboratory tests and procedures: biopsy colon: (Jan2022) mild inflammation, no cancer nor any abnormal, notes: findings found; colonoscopy: (Jan2022) mild inflammation, no cancer nor any abnormal, notes: findings found. The action taken for adalimumab was dosage not changed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient was given a Havrix, manufactured by GlaxoSmithKline, on 6/20/2022. The expiration date for this vaccine was 6/18/2022. Patient is not having any adverse reaction or symptoms. I am required to report this immunization error. GSK and CDC were contacted to confirm that patient's  health is not in any danger. This was confirmed and GSK stated the potency/viability for this vaccine extends up to 30 days past expiration date. No further action needed.
Information has been received on 01-MAY-2017 from a registered nurse regarding an unspecified number of patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant therapy were not reported. The registered nurse reported that on unspecified dates, unspecified patients received doses of GARDASIL 9 (lot number, expiration, dose, route not reported), PNEUMOVAX23 )(lot number, expiration, dose, route not reported) and M-M-R II )(lot number, expiration, dose, route not reported) which were stored at -0.24 degrees Celsius for 124 hours. There were no previous temperature excursions. The call was made because of a data logger. The lot and expiration date for the sterile diluent used to reconstitute was unknown by the reporter. No side effects to report. No further information to report. Additional information has been requested.
This spontaneous report was received from a licensed practical nurse refers to a 4 year old unknown gender patient received an expired 0.5ml dose of VARIVAX (Merck) (lot # 670709/0820AA, expiration date: 02-JUN-2013) subcutaneous at unspecified location on 09-AUG-2013. No adverse effects reported. At the time of report, the outcome of the events was unknown. Additional information has been requested.
Second Hep A given 4 months early no other adverse event reported by parent/guardian.
Rash on left arm lasting about a week after vaccination. Around 1.5-2 inches in diameter. Itchy and blotchy/red. Resolved on its own after about a week with no intervention or medication.
Starting 11/06/2022, I had right sided pain. I ended up in the ER and they did a CT scan and ultrasound. They found a pelvic mass. They did a biopsy of it and determined it was a low grade serous carcinoma. On 12/27/2022, they ended up doing a total hysterectomy and during the surgery they saw that the large intestine had some of the tumor on it. So, they had to remove part of it and now I have a colostomy bag.
Dec 8, the morning after, woke up with nausea, cold sweat, almost fainted.   High fever first 24 hours Dec 9 By mid afternoon, tachycardia and irregular heart rate, at least one episode of atrial fib, elevated blood pressure.  Arrhythmias associated with cold sweats, nausea, loose bowel.  Dec 10 Fast, irregular heart rate all day, worse as the day progressed Dec 11-13  slow, gradual improvement but still feel some nausea.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 02-NOV-2017, the patient was vaccinated with improperly stored dose of ZOSTAVAX injection (lot # N019921 with expiration date on 05-JUL-2018; dose, route of administration were not reported) for prophylaxis. Concomitant therapy included sterile diluent (STERILE DILUENT). The doses of vaccine experienced a temperature excursion of 15 to 46 degrees Fahrenheit for 720 hours. No previous temperature excursion was reported. Data logger was not involved in recording the excursion details. No adverse effect was reported.
bump on her tongue and it looks like she has a "U" on tip of her tongue; 6-8 hours later her tongue began swelling and her nose and back of throat felt funny.; nose and throat felt funny; nose and throat felt funny; tongue became like misshapen, it has an extra point on it, that is like a blister or something, but it is not really a blister, but it is definitely not normal; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, (Batch/Lot number was not reported) via an unspecified route of administration in Arm Left on 24Feb2021 as 1st dose, single dose for COVID-19 immunization. The patient medical history was not reported. Patient has lots of medicine allergies years ago she took Advair discus inhaler. Patient had no other vaccines on the day of COVID vaccine. Concomitant medications included cetirizine hydrochloride (ZYRTEC) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication and diphenhydramine hydrochloride (BENADRYL), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication. Patient states she had an adverse event when she got her first dose of the product last Wednesday (24Feb2021). She is a little nervous about getting her second dose on 18Mar2021. On 24Feb2021 about 6-8 hours after first shot her tongue got swollen/began swelling, nose and throat felt funny. She took Benadryl and same symptoms occurred next day. She states that her tongue became like misshapen, it has an extra point on it like a blister or something but it is not really a blister but it is definitely not normal. She has a bump on her tongue and it looks like she has a "U" on tip of her tongue. She states that her niece is a Nurse Practitioner and she talked to her niece about it. She took Zyrtec D in the morning and her niece told her to also take regular Zyrtec at night. She has been doing that for a few days and it is about 80-85 % better. She states that the little blister thing is gone, but her tongue is still misshapen. The swelling went right away after her Benadryl and Zyrtec D, and no more swelling issues, but her tongue is still misshapen and tender. She would like to report her side effects but also wants to know if she needs to do anything special for the second dose, like should she get an Epi Pen. She also reports that in the past she had a reaction to the Advair Discus inhaler and experienced "tongue swelling". ER gave Benadryl shot and symptoms calmed down. She then got virus and had tongue thing for 8 months. She was given Benadryl and prednisone, saw an allergist, and stated no one knew what to do. It ended up worked itself out. She would like to know if there are any similar ingredients with that or if it plays a part in the vaccine. The clinical outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
On 10/17/2001 the patient experienced right upper quadrant pain and gas. On 10/18/2001 in the P.M. the patient developed hives and itching of the arms and legs. This continued occasionally through 10/21/2001.
Pt awoke with sudden onset shaking, chills, feeling febrile (temp not taken,) severe HA and fatigue. generalized body aches and fatigue. Felt better by 8 or 9 AM
I experienced severe stomach cramps, diarrhea, vomiting, turned bright red and had severe hives for about an hour all over my body, including my feet. Itching so bad I rubbed the skin off the back of my hand trying to get relief with a cold wet washcloth. I took my usual allergy pills, Sudafed, Singulair and doxepin, as well as two Benadryl. It took an hour for the itching to stop. The next day I had pain in the back of my neck and lower back and stomach cramps after eating. I took Naproxen for that. I didn't have anymore vomiting or hives though.
flu; Initial information received on 29-Jan-2022 regarding an unsolicited valid social media non-serious case was received from the patient.  This case involves an adult patient of unknown demographics, who experienced flu while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received influenza vaccine (produced by unknown manufacturer) (strength, formulation, dosage, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination. Information on batch number was requested.   On an unknown date, the patient developed flu (influenza) (unknown latency) following the administration of influenza vaccine. Reportedly, had the flu once in his life the year patient got the flu shot.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event of flu.
Immediately after vaccination pt had a syncopal episode while in vaccination chair. she did not fall, ammonia inhalant used & pt assisted to stretcher. vital signs stable and given hydration and food. Felt better and left clinic of her with friend. Pt did have 2nd vaccination on 05/29/2021 without incident.
No adverse symptoms reported.; the patient, who is pregnant, was vaccinated with a first dose of Gardasil 9; This spontaneous prospective pregnancy report was received from an administrator and refers to a 35-year-old female patient. Concomitant therapies included anti-rh gamma globulin (RHOGAM (ANTI-RH GAMMA GLOBULIN)) (also reported as ROGAM), iron (unspecified), minerals (unspecified), vitamins (unspecified) and acetaminophen (TYLENOL). The patient's Rh blood group was Rh negative. No information regarding the patient's pertinent medical history, drug reactions and allergies was provided.  On 22-JAN-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) dose 1, intramuscularly (exact dose, lot # and expiration date were not reported) for prophylaxis. The last menstrual period (LMP) was calculated as 11-JUL-2019 and date of delivery (EDD) was calculated as 16-APR-2020. Initial exposure to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was at 27 weeks. The pregnancy outcome was outcome pending.
2 weeks post vax pt experienced slight jaundice. Pt was diagnosed with viral illness.
Metal taste in the mouth, sweating, headache, palpitations and heavy legs few minutes after the shot.  Two hours after I was just feeling chills, low fever, headache, diarrhea, tiredness and pain in the local of the shot (mild to moderate).
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 21-AUG-2015 the patient was vaccinated with an improperly stored dose of oral, ROTATEQ (lot# K024700, expiration date 30-JUL-2016) (strength, dose and route were not reported) (Incorrect product storage). No adverse effect reported. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Patient was admitted for abdominal pain and for splenic infarct. Patient will dc on anticoagulation. Patient reports she received Johnson and Johnson COVID Vaccine. Confirmed with center on date and place of administration, Unknown lot #.
pain at the injection site / injection site started to hurt again; on his right leg only "painful cramps; swollen - leg / Heel and foot are still - swollen /; painful leg, foot and heel / inner thigh is starting to hurt again; Painful ankle; knee area was so swollen; patient could not walk; patient had fever; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date on right arm and experienced fever. For the tolerance of 1st dose, refer linked case US2020AMR176846).   On 26th February 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced injection site pain, leg cramps, swelling of legs, pain in extremity, pain ankle, swelling of knees, gait inability and fever. The patient was treated with analgesic, nos (Pain Killer). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, swelling of legs, pain in extremity and pain ankle were not recovered/not resolved and the outcome of the leg cramps, swelling of knees, gait inability and fever were unknown.   It was unknown if the reporter considered the injection site pain, leg cramps, swelling of legs, pain in extremity, pain ankle, swelling of knees, gait inability and fever to be related to Shingrix.  Additional details were provided as follows: The reporter was the spouse of the patient. The patient received Shingrix in the left arm.  After receiving Shingrix, the patient had pain at the injection site that last a couple of weeks.  Few days after the 2nd dose of Shingrix, the patient had on his right leg only painful cramps in the inside of his thigh, midway in between hip and knee.  The patient had swollen and painful leg, foot, ankle and heel.  The knee area was so swollen his kneecap wiggled around.  The patient could not walk.  Till the time of reporting, heel and foot were painful and swollen 6 months after vaccine. The patient took medications for pain. The patient's inner thigh was starting to hurt again and still had swelling in his leg at the time of reporting.  The patient's injection site started to hurt again when the patient recently started exercising the shoulder area. The patient had fever. The reporter consented to follow up. This case was linked with case US2020AMR176846, reported for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR176846:same patient
PT HAD A RXN TO THE FLU SHOT; RED, SWELLING, ITCH, AND WARM TO TOUCH. WENT DOWN HER ARM PAST THE ELBOW.
Lump in arm pit of left arm. Denies erythema or induration at shot site.
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild
This spontaneous report was received from a certified medical assistant concerning to a 16 years old female patient. On an unspecified date from 15-OCT-2014 through 27-OCT-2014, the patient was vaccinated with an improperly stored dose of GARDASIL (Lot # K009811, expiration date: 19-JUN-2016). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient had adverse reaction...a red, inflamed,. blotchy area 10X8 area on arm around inject site, one week post injection
Pericarditis - Hospitalization from May 17-21, 2021, symptoms: shoulder and back pain, rapid heart rate, fever, shortness of breath, body aches, chest pain, chills. Treatment 2 weeks round of colchicine and lasix, antibiotics. Re-occurring pericarditis symptoms starting on June  9, 2021
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX, (GlaxoSmithKline).  In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown).  In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint.  The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site.  At the time of reporting the outcome of the events were unspecified.  For the other 79 linked subjects please see cases : A0756483A - A0756508A, A0756510A - A0756562A.  The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A.  With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA).  On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA) : AFLUCA320, AFLUA320A, and AFLUA320B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA.  On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA) : AFLUCA350 and AFLUA350B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Blister. This case was reported by a pharmacist and described the occurrence of blisters in a 25 year old female patient who received hepatitis A vaccine inactivated (Havrix) for prophylaxis. The patient's medical history included allergies to codeine and clarithromycin (Biaxin), hepatitis B infection, and hepatitis C infection. There were no concurrent medications. On 30 July 2003 the patient received the 1st dose of Havrix. Two days post-immunization, on 1 August 2003, the patient experienced "two small" blisters near the injection site. The patient was seen by the physician. Additional information was received from a nurse at the facility on 11 September 2003. The nurse reported that the blisters were in the area where an adhesive bandage had been applied after immunization. The blisters resolved on 2 August 2003. The nurse considered the blisters to be possibly related to the adhesive bandage.