chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Seven days after vaccine was given patient experienced sudden unconsciousness, severe abdominal pain on the right side. Patient was also found to  have low blood pressure and severe hypoglycemia. Symptoms were treated in ambulance with IV fluids. Hospital and subsequent doctor visits diagnosed patient with ventricular tachycardia relating to the event. 7/11/08-records received- First Gardasil vaccination 7/9/07- 7/11/08-records received-5/21/07-C/O passing out from low blood sugar. Syncopal episode with nausea. DX:Dizziness and giddiness. Holter monitor 6/4/07-mild supraventricular tachycardia. Presented to ED with sore throat and fever. Acute exudative tonsillitis. First Gardasil vaccination 7/9/07 7/28/08-records received for DOS 5/16/07-presented to ED with C/O near syncope and abdominal pain times 3 days, diarrhea. Lightheadedness and pain when standing. Nausea times 3 days. Recent bronchitis. Migraine Headaches. Impression: syncope vasovagal, hypoglycemia, abdominal pain intestinal colic.
Administered 1ml of Boostrix to patient; 2 vaccines drawn up into one syrige and administered.; 2 Boostrix administered, Last tdap Mar 2021; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 37-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number B4C44, expiry date 10th November 2024) for prophylaxis.   Previously administered products included tdap vaccine (the patient received tdap vaccine in March 2021).   On 13th September 2022, the patient received Boostrix 1 ml. On 13th September 2022, unknown after receiving Boostrix, the patient experienced overdose, wrong technique in drug usage process and drug dose administration interval too short. On an unknown date, the outcome of the overdose, wrong technique in drug usage process and drug dose administration interval too short were unknown.   Additional Information: GSK Receipt Date: 13-SEP-2022 and 15-SEP-2022 Reporter's Comment: The reporter reported that, they had just injected 1ml of Boostrix vaccine to adult patient by error. The reporter stated that, the patient received 2 Boostrix vaccines drawn up into one syringe and administered.  The poison control was contacted and said patient would be fine.  The patient had no side effects. The reporter did not consent to follow-up.  Additional Supportive Information: The reporter stated that, the patient received 2 Boostrix vaccines drawn up into one syringe and administered and last dose of tdap was in March 2021, which led to overdose, wrong technique in drug usage process and drug dose administration interval too short.
Headache, Palpitations, flushing, elevated blood pressure (134) and Heart rate (90) Narrative:
headache; n/v; n/v; malaise; This case was reported by a physician and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced headache, nausea, vomiting and malaise. On an unknown date, the outcome of the headache, nausea, vomiting and malaise were unknown.   It was unknown if the reporter considered the headache, nausea, vomiting and malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had vomiting, nausea, headache and malaise.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020204699:SAME REPORTER
(L) upper arm - site where vaccine given - swollen, hard to the touch, red, and sore. Temp 100.1.
seizure; passed out; stopped breathing; blood pressure bottomed out.; This case was reported by a consumer and described the occurrence of seizure in a male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced seizure (serious criteria GSK medically significant), passed out (serious criteria GSK medically significant), breathing arrested (serious criteria GSK medically significant) and low blood pressure. On an unknown date, the outcome of the seizure, passed out, breathing arrested and low blood pressure were unknown.   It was unknown if the reporter considered the seizure, passed out, breathing arrested and low blood pressure to be related to Meningococcal B vaccine.  Additional details were provided as follows: The age at the vaccination was not reported. The case was reported by the parent of the patient. The reporter son received the vaccine. The patient passed out, had a seizure, stopped breathing and his blood pressure bottomed out. They had to be taken to emergency room by ambulance. The reporter was insanely running up and down the halls of the doctor's office. The reporter was absolutely terrified. His older 3 siblings got it and it did not effect them.
received vaccine 3/19/21 at 23:30 pm.  Woke up at 4:20 am 3/20/21 with extreme pain  and burning sensation at injection site.  swelling noticed at injection site 2 hours later.  iced area. Congestion and coughing began around this time.  Fatigue began  around 5 pm.  Kept falling asleep.  Arm still swollen and burning.  Iced again.  Went to bed at 8:30 pm.  Woke up at 10:30pm with diarrhea and heart racing.  Heart raced for 30 minutes.  Went back to bed and slept for 10 hours.  Woke up at 9 am with grogginess and some cough and congestion.
redness starting at the site of injection and moved to biceps, bubble on biceps, hot and cold sweats during the night, loss of appetite , clammy, malaise
After receiving the Flu Zone Vaccine, it has ruined my life. The following symptoms I suffer are a nightmare, heinous, torture, and horrific. The Flu Zone 5mg FP 19-20 I received has caused the following; severe visual disturbance, to the point that I can't use my eye sight, visual disturbance is so ongoing that it affect my eyes when they're open & closed,   sharp and fulling pain from head to feet, feel like attached to a machine because I often feel a buzzing on the lower left back,whenever I feel the buzzing, the objects within the visual disturbance changes, and suicidal. Prior to receiving the Flu Zone vaccine from Sanofi, I was very healthy, sure not suicidal. I have seen several doctors, which can't find anything wrong because I'm healthy, and these symptoms aren't natural cause. I have been suffering with these horrific  symptoms for 22 months, and getting worst.    I have more detailed description of these horrific symptoms, if you need more info.
32/89 pt failed  to maintain adequate titers 27mo post vax w/Rabies vax;
Major sweating, major headaches, stiff neck pain and ear pain (right ear only). Still experiencing symptoms.
This spontaneous report as received from a certified medical assistant refers to a male patient of unknown age. On an unknown date the patient was vaccinated with the first dose of GARDASIL (lot#, expiration, dose, route unspecified). On an unknown date when the patient came to the office for the second dose, he was inadvertently given CERVARIX (lot#, expiration, dose, route unspecified). No adverse effect reported. Additional information has been requested.
I felt general flu like symptoms. I had a fever, soreness, and swelling in my throat. I thought I had strep throat so I went to the clinic. I got tested for the flu, strep throat, and COVID-19 and all the tests were negative. The physician thought it was a virus that weren't any of the three I tested for so there wasn't specific treatment other than waiting for it to resolve. The doctor prescribed me Lidocaine for the pain I was experiencing in my throat. I waited a few more days and my symptoms resolved over time.
Soon after receiving GARDASIL and MENACTRA vaccines patient, per mother's report. Felt lightheaded, eyes rolled up in head, went stiff and mom helped her to the floor. Patient was conscious with 1 min of being on ground. Information has been received from a physician concerning a 17 year old female patient with no pertinent medical history and no known allergies who on 24-JUN-2008 at 15:31 was vaccinated with GARDASIL in the left arm. Secondary suspect therapy included MENACTRA (lot # U264OAA). Concomitant therapy included tuberculin purified derivative (Lot # C2907BA). There was no illness at the time of vaccination. On 24-JUN-2008 soon after receiving GARDASIL and MENACTRA the patient felt lightheaded, eyes rollwed up in head and went stiff. The patient's mom helped her to floorl. The patient was conscious with 1 minute of being on ground. At the time of reporting, the patient had recovered from the adverse events. The patient required emergency room/doctor visit. No further information is available.
she was not feeling good; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (RA).  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "she was not feeling good".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a nurse regarding a patient (age and gender not reported) who on 29-JAN-2007, was vaccinated with dose 1 of PNEUMOVAX 23 (Lot no. reported as "L008P") (site and route not reported). On 12-AUG-2008, the patient was vaccinated with dose 2 of PNEUMOVAX 23 (lot number, site and route not reported). On 08-OCT-2015, the patient was vaccinated with a dose of PREVNAR 13. No adverse event was reported. Additional information has been requested.
fell on the ice; broke hip, arm and her wrists; broke hip, arm and her wrists; broke hip, arm and her wrists; This is a spontaneous report from a contactable consumer report for self from a Pfizer Sponsored Program . This 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269) via an unspecified route of administration on 03Feb2021 at single dose for COVID-19 immunization. None medical history nor other products. The patient received the first vaccine on the 03Feb and she is scheduled to get the second one on 24Feb and about a week after the first dose she fell on the ice at her house and broke hip, arm and her wrists and had to have surgery. Her admission into the hospital was 09Feb2021. She had surgery on the 10Feb. She was discharged home 13Feb2021. She lost enough blood in surgery that she had to have 2 units of blood transfusion, she said the blood transfusions on 11Feb2021. She wanted to know is it safe to get the second vaccine after having those transfusions.
Woke up on day 1 post dose #2 (Jan 27) with hot flashes, anxiety, elevated HR (100's lying down; 140's when up) in addition to body aches, headache.  Have  lost 5 pounds over previous 2 weeks without trying.  HR has been steadily increasing over last month, along with increasing anxiety.  Was seen by endocrinologist on Jan 28 who drew lab work and confirmed on Jan 29 that all thyroid labs were elevated. Prescribed methimizole and metoprolol. Will follow up in 4 weeks.
After receiving vaccination my heart rate increased rapidly. I did not report it because I thought it would go away. This lasted for 24 hours. Heart rate was between 90-120 beats per minute.
pt received both the pneumovax 23 and flublok  vaccine in the left arm.  By the evening the patient experienced extreme pain and swelling as well as reporting a fever of 100.2. She called her son, who then advised she be transported by ambulance to the hospital.  She was treated for bursitis and hypertension.
Left armpit 7.5centimeter long x 4.5 centimeter tender mass; This is a spontaneous report from a contactable nurse (patient).  A 55-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH 9899), via an unspecified route of administration at left arm on 21Dec2020 15:15 at single dose for COVID-19 immunization at a hospital. The patient's medical history included arthritis, known allergies: Penicillin (Pcn) and COVID-19 (diagnosed prior to vaccination). Concomitant medication received within 2 weeks of vaccination included golimumab (SIMPONI), methotrexate and meloxicam (MOBIC). No other vaccines within 4 weeks prior to the COVID vaccine. It was reported that on 23Dec2020 09:00, the patient experienced "left armpit 7.5centimeter long x 4.5 centimeter tender mass". The event led to doctor or other healthcare professional office/clinic visit and patient consulted the event. The outcome of the events was unknown.
Broke out in hives after second shot; terribly itchy; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Broke out in hives after second shot) and RASH PRURITIC (terribly itchy) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 031M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE, LISINOPRIL, GLUCOSAMINE, OXYCODONE, COLECALCIFEROL (D3), ZINC, ISOSORBIDE MONONITRATE, LOVASTATIN, BUDESONIDE (NASOCORT), ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]), UBIDECARENONE (COQ10 [UBIDECARENONE]), FISH OIL (OMEGA 3 [FISH OIL]), NABUMETONE, CALCIUM, MAGNESIUM (CALCIUM + MAGNESIUM), ASPIRIN [ACETYLSALICYLIC ACID], OXYMETAZOLINE (AFRIN [OXYMETAZOLINE]) and ZEAXANTHIN for an unknown indication.   On 16-Mar-2021, the patient received second 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) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced URTICARIA (Broke out in hives after second shot) and RASH PRURITIC (terribly itchy). The patient was treated with DIPHENHYDRAMINE ongoing since an unknown date at an unspecified dose and frequency. On 20-Mar-2021, URTICARIA (Broke out in hives after second shot) had not resolved and RASH PRURITIC (terribly itchy) outcome was unknown.            Concomitant medications also included stool softener,phenyl fibrate,leutin. Treatment included Antihistamines were taken for itching.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: follow up document contains information about new event was added Treatment information was added.
Itchy thick and red rash. Rash turned into one large blob. Presently, the site is healing, flaky and dry a little sore.
Severe nerve pain; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (Severe nerve pain ) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEURALGIA (Severe nerve pain ). At the time of the report, NEURALGIA (Severe nerve pain ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment information was reported by reporter.
sl fussy than noticed screaming; pt started screaming devel sz, eyes rolled back, arms-legs began to stiffen & shake;
Diffuse hives, skin rash, with severe itching all over. Transferred to ACC.
Left side toes became red, warm to touch, and painful in the middle of the night. Ran cool water over them and tried to get back to sleep given the hour. By morning toes were stiff but redness, warmth, and pain were done.
Full Body Rash with blisters and hives. Rash is hot and itchy. Makes the body feel anxious in the chest area. Weakness, slight head fog, and heartburn. Went to the Emergency room. Was given Antacid. I had already taken Benadryl.  Topical application is Benadryl and hydrocortisone. No relief. Day 2 Used EMU oil on rash and it gave relief but rash came back after 7 hours. Plus vomiting of food and antihistamines.  Day 3 Using EMU oil, Benadryl topical and orally. Rash is not as severe but the burning in the limbs, hands and feet still present but not as visible. Pain in abdomen, and chest, but no vomiting. Stopped taking the acid reducer only the Benadryl. Omega vitamins with vitamin D seemed to help stop the burning under the skin on Day 2 but not Day 3 Throat is raspy and voice has a different sound; lower and breaking up. Sleeping a lot
mistakenly giving a patient the FLUZONE HD QUADRIVALENT vaccine who was not supposed to get it due to patient being under the age of 65  with no reported adverse event; Initial information received on 27-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 44 years old female patient who had been mistakenly given the influenza quadrival A-B high dose HD vaccine [fluzone high-dose quadrivalent] which was not supposed to get it due to patient being under the age of 65 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Sep-2022, the patient received a 0.75 ml dose of suspect (once) influenza quadrival A-B high dose HD vaccine (lot number: UJ918AAE) (Strength: high-dose) (form was unknown) (expiry date: 30-Jun-2023) via intramuscular route in the left arm for Immunization.  On 26-SEP-2022 the patient had been mistakenly given the influenza quadrival A-B high dose HD vaccine [fluzone high-dose quadrivalent] which was not supposed to get it due to patient being under the age of 65 with no reported adverse event (product use issue) (latency: same day).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
shortly p/vax given very sleepy; slept 4 hrs (unusual for this pt) then awoke crying; mostly unconsolable crying for 24 hrs; fever 105;
The pt developed redness, swelling, and a knot around the DTaP injection site (x2 days). Eight days later, the size decreased.
8/21/06- 8/23/06 pt complained of stomach ache and had low grade fever.  8/24/06 - 8/26/06 pt has rash covering body.  Rash began on chest and progressed to face and arms and legs.  Rash was absent on palms and soles of feet.  8/28/06 mom reports the rash is completely gone.  child acts tired.
This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age. On unknown dates patients were vaccinated with ZOSTAVAX (dose, lot no. and route unknown). No concomitant medication was reported. The patients were inadvertently administered vaccine that had been improperly stored. No adverse effects were reported. The outcome of events was unknown. This is one of several reports from the same reporter. Additional information has been requested.
Shots given on 10/21/19. Pt ran elevated temp and body aches 10/22/19. Redness and swelling 2" below the injection sites. Warm to the touch.
Sore left injection site arm; Body aches; Being very tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site arm), MYALGIA (Body aches) and FATIGUE (Being very tired) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 077C21B, 031A21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Nov-2021, the patient experienced VACCINATION SITE PAIN (Sore left injection site arm), MYALGIA (Body aches) and FATIGUE (Being very tired). At the time of the report, VACCINATION SITE PAIN (Sore left injection site arm), MYALGIA (Body aches) and FATIGUE (Being very tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Nov-2021, SARS-CoV-2 antibody test: positive (Positive) greater than 2500 U/ml.         Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-404697, MOD-2021-404698 (Patient Link).
Woke up with sever pain on my right arm. It was difficult to move my arm. Hive on my face, neck, and upper body. This lasted 2 hours. But happened twice on the next day. Fast heartbeat. Lymph nudes under arm being swollen. Sever body ache and tiredness for the next 24 hours.
Expected due date 12/6/2021. Experience unexpected heavy bleeding on 10/08/2021. Hospitalized for 4 days, cause of bleeding was unknown. Potentially placenta tear or blood vessel burst.  No issues with pregnancy up until this event.
This infant had muscle swelling at the injection site, tenderness, overlying redness, and a low grade fever.
Type of practice: Community Health Office Name of products involved: KINRIX, 0.5ml given to 11-month-old child for the second set of immunizations of DTaP, IPV and (should have been) HIB. Child should have been given PENTACEL. At 0905: 11-month-old child given KINRIX instead of PENTACEL. KINRIX is not licensed for this age group. Child monitored for 30 minutes with no signs of reaction. This error was identified at 0910, after administration of KINRIX vaccine. The nurse identified the error upon entering the lot number information onto the immunization record. At 0910: Family notified of error in person at community health office. Family gives verbal consent for error to be reported to child's doctor via telephone. At 0915: Family's doctor notified of error. At 1345: Doctor instructed community health nurse to contact the Department of Health for further instruction. CDC contacted for further guidance. (3 days after): CDC (nurse educator with the CDC) confirms that doses do NOT need to be repeated. At 1415 Left voicemail with family informing them doses do not need to be repeated and asked them to call office to schedule next set of immunizations. Plan to schedule next set of immunizations per policy (4 weeks from this set of immunizations given). Variables contributing to error: Vial was checked two times prior to administration, not three. PENTACEL and KINRIX baskets set near each other in the med fridge. Plan of correction: KINRIX and PENTACEL baskets moved to opposite shelves to create more distance between them. Color-coded labels placed on both KINRIX and PENTACEL better identifying their intended age group. Color-coded labels also placed on the front of the med fridge. Reviewed the policy and correct vaccine administration practices emphasizing verifying medications three times before administration.