chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After receiving the shot, I had an initial burning sensation that went away within 30-45 seconds. After about 1.5 to 2 hours after the shot, I noticed a small, hard bump at the injection site. By the next morning (2/17), the bump was larger and warm to the touch, and painful, but tolerable. By mid morning, I had aches in my upper back/neck. By noon, all of my joints were aching and I had muscle pain all over my body. By early that evening, I had a mild fever (100.3), significant increase in pain with the muscle/joint aches, and very tired. By midnight that night, my fever had broken and the majority of the achiness had subsided.  By morning of 2/18, there was little to no more aches/pains, however, the lump on my arm at the injection site is still hard, warm to the touch, but significantly less painful. By mid afternoon, the bump has spread out but softened, skin is still warm to the touch.
Information has been received from a pharmacist concerning his 72 year old wife who on 05-JUN-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included LIPITOR, DIAZIDE and INDERAL.  It was reported that on 05-JUN-2007 the patient developed a little bump which was described as 4x1 inches.  Bump was red in color warm to touch and tender.  The patient also had headache for which she took TYLENOL.  The patient had been applying ice and steroid cream to injection site.  No medical attention was sought.  At the time of report the patient was not recovered.  A product quality complaint was not involved.  Additional information has been requested.
Vomiting bad, urticaria within one hour of receiving DTaP, IPV, MMR. Sent to ER. Given Benadryl and Tylenol
Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022; No adverse reaction; Dose administered after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No adverse reaction) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A, 031H21A, 026C21A and 041B21A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 and Kidney transplant. Concurrent medical conditions included Blood pressure high (HBP), Diabetes and Asthma (Asma). Concomitant products included EMPAGLIFLOZIN (JARDIANCE), PREDNISONE, DOXAZOSIN MESILATE (CARDURA), INSULIN LISPRO (HUMALOG) and CLONIDINE (CATAPRESS) for an unknown indication.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 26-May-2022 at 8:33 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 26-May-2022 at 8:33 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No adverse reaction). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related and EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) to have an unknown relationship. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022).    Patient race was reported as other.  Event did not cause the patient to seek medical care.  It was unknown if there were any other potential causes and if patient experience similar events in the past.  The used vials were placed refrigerator on the same day of administration (26-May-2022) and vials did not undergo any  temperature excursions. Treatment medication was provided by the reporter.
6 week old received a Fluzone Quadrivalent 0.25ml vaccine, no AE; Initial information received on 13-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a six weeks old male patient who received 0.25ml dose vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot UT6709LA and expiry date: 30-Jun-2020) via intramuscular route in the right thigh, on 05-Dec-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due Inappropriate age at vaccine administration. It was reported that 6 week old male patient received a Fluzone Quadrivalent 0.25ml vaccine on 05-Dec-2019.  At the time of report no adverse event was reported.  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 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.
Knots at injection site; Fever in spot of injection; Welts; Itching; Swollen arms; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (Knots at injection site), INJECTION SITE JOINT WARMTH (Fever in spot of injection), URTICARIA (Welts), PRURITUS (Itching) and PERIPHERAL SWELLING (Swollen arms) 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 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced INJECTION SITE MASS (Knots at injection site), INJECTION SITE JOINT WARMTH (Fever in spot of injection), URTICARIA (Welts), PRURITUS (Itching) and PERIPHERAL SWELLING (Swollen arms). At the time of the report, INJECTION SITE MASS (Knots at injection site), INJECTION SITE JOINT WARMTH (Fever in spot of injection), URTICARIA (Welts), PRURITUS (Itching) and PERIPHERAL SWELLING (Swollen arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Approximately 1-2 minutes after vaccination, patient pitched forward off of exam table and hit his knees and then his head on the clinic floor. Patient appeared to convulse on floor for approximately 3 seconds, and then regained consciousness. Mother and nurse protected patient's head, and then lowered his head to the ground after convulsions ceased. There was a small cut (approximately 3 mm) above his right eye and below his eyebrow. Patient was alert and oriented and able to answer questions. Gave patient ice pack to place on eye and a Coke to drink. Patient drank entire Coke and after approximately 10 minutes sat up and then stood and was able to walk into waiting room. Patient reported having not eaten breakfast before arriving, had only had a Sunny-D to drink that morning. Mother reported that this had happened once before when patient had blood drawn.
Fever, chills, nausea, headache, diarrhea, fatigue, body aches, headache, pain/swelling at injection site.
Immunizations given in clinic on 11/7/12. Mother called office 11/9/12 reporting that daughter could not move her legs, unable to bear wt to (R) extrem while standing & had to sleep sitting up b/c child "screams" if laying down. Inj sites x3 had dot where inj given, no rash, redness, streaking. Fever first 24 hours, resolved. Mother admin. MOTRIN. Recommended TYL. Appt for eval. scheduled, no show. Unable to reach mother by phone.
Information has been received from a physician concerning a 42 day old white male who on 09-Jan-2008 was vaccinated with hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (Lot# 656509/0016U). Concomitant therapy included rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (Lot # reported as 1193U). Other concomitant therapy included hepatitis B virus vaccine (unspecified), diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, poliovirus vaccine, (PREVNAR) vaccine (CRM197) and Hib conj vaccine (unspecified carrier). On approximately 15-DEC-2007 the patient experienced a rash on his face that had spread over his head. He was not bothered by it, no illness or fevers were reported. The rash was described as a macular rash on his right cheek that went over his right ear and over the top of his head. Both of his cheeks were dry and scaly. The physician's assessment was seborrheic dermatitis on his face. He was treated with (LOTRIMIN) twice a day and another cream to be used daily. It was also reported, that the infant had newborn screening done 2 days after his birth which resulted as normal. At the time of this report, the infant's outcome was unknown. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 6-month-old female patient who received BOOSTRIX (batch number 4L972, expiry date 11th May 2018). On 7th February 2018, the patient received BOOSTRIX. On 7th February 2018, less than a day after receiving BOOSTRIX, the patient experienced fever, fuzzy, insomnia, behavior abnormal, vomiting, diarrhea, accidental underdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the fever, fuzzy, insomnia, behavior abnormal, vomiting and diarrhea were recovering/resolving and the outcome of the accidental underdose and inappropriate age at vaccine administration were unknown. The reporter considered the fever, fuzzy, insomnia, behavior abnormal, vomiting and diarrhea to be related to BOOSTRIX. Additional details were provided as follows: The patient's father reported that his daughter (patient) was administered a dose of BOOSTRIX at an age of 6 months by mistake, which led to accidental underdose and inappropriate age at vaccine administration. The nurse gave the shot to the patient. On 7th February 2018 (on the same day), the patient received several vaccines, but reporter did not have the name of the other vaccines at the time of reporting. On 7th February 2018 (on the same day), the patient had experienced several symptoms received the vaccine. The patient was feeling better at the time of reporting. This case was an accidental medication error associated with adverse events.
blood pressure which has been under control for quite some time began to spike/blood pressure climbed to 188/119; My potassium was low; feeling tingling in left arm; nausea; Fever; Aches; very swollen lymp nodes; I was not feeling well; This spontaneous case was reported by a pharmacist and describes the occurrence of BLOOD PRESSURE INCREASED (blood pressure which has been under control for quite some time began to spike/blood pressure climbed to 188/119), BLOOD POTASSIUM DECREASED (My potassium was low), PARAESTHESIA (feeling tingling in left arm), NAUSEA (nausea) and PYREXIA (Fever) in a 47-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypertension since an unknown date.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (blood pressure which has been under control for quite some time began to spike/blood pressure climbed to 188/119), BLOOD POTASSIUM DECREASED (My potassium was low), PARAESTHESIA (feeling tingling in left arm), NAUSEA (nausea), PYREXIA (Fever), MYALGIA (Aches), LYMPHADENOPATHY (very swollen lymp nodes) and MALAISE (I was not feeling well). At the time of the report, BLOOD PRESSURE INCREASED (blood pressure which has been under control for quite some time began to spike/blood pressure climbed to 188/119), PARAESTHESIA (feeling tingling in left arm), NAUSEA (nausea), PYREXIA (Fever) and MALAISE (I was not feeling well) had resolved and BLOOD POTASSIUM DECREASED (My potassium was low), MYALGIA (Aches) and LYMPHADENOPATHY (very swollen lymp nodes) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Lab test EKG normal. Cardiac enzymes normal.  potassium  low.ultrasounds and CT's abnormal Treatment medication  Chlorthalidone 25
symptoms include SOB, chest pressure, tachycardia  for 3-4 days, tested positive for covid on 1/17/2022
area / hot to touch; hives at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 2232K, expiry date 13th November 2022) for prophylaxis.   Concurrent medical conditions included shingles (patient has had shingles 3 to 4 times throughout her lifetime).   On 28th July 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced injection site warmth and injection site hives. On an unknown date, the outcome of the injection site warmth and injection site hives were unknown.   It was unknown if the reporter considered the injection site warmth and injection site hives to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix and experienced large area of hives at injection site, the affected area was about 6 inches in diameter and was hot to touch. The reporter consented to follow up.
Light dizziness that increased after 2 hours, extreme fatigue, inability to move limbs, extreme pain after several more hours, difficulty breathing in without any diverge pain in my lower back, difficulty moving neck, fever,  injection sight started having hives surround it, felt hot, shooting pain on the left arm and shoulder, pain on left side of entire body, sharp pain and heat moving up left shoulder, by day two, difficulty swallowing, difficulty swallowing and breathing in, difficulty moving, feverish pain kept moving up shoulder, by day 3 swollen lymph node, hives, painful body aches, slightly swollen left side of the neck and throat, painful swelling and hive lymph node area swollen hot to touch, feverish, day 4 injection sight was itchy with hives and warm to the touch but not unbearably painful, sharp pain in shoulder and lymph node, feverish hot pain on left side of throat, day 5 hives, feverish pain on shoulder, lymph node and left side of throat, day 6 injection sight has hives, difficulty swallowing, painful shoulder and lymph node hot to touch, difficulty turning neck, lifting arm.
April 20 2021: suffered a fainting/blackout episode where I collapsed onto my apartment building's outside entry stair.  I hit the deck causing contusions to my knees and upper back.  I regained consciousness after _about 10 seconds, was helped up another flight of stairs by a friend and neighbor where I - again -  blacked out falling to the hallway floor.  I regained consciousness in another 10 seconds.
This patient has red, hard swollen area with warmness approximately size of soft ball according to the mother. The site of MMR 12/10/00 - 12/11/00.
Sore arm; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 31Mar2021 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included was not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no allergies to any medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, the patient experienced sore arm. The patient did not receive any treatment for the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event of pain in arm was recovered on an unknown date in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient was given vaccine that he did not need. He had had Hep A #1 on 08/03/2021 and should come back in Feb 2022 for his second dose. I failed to recognize this and have him his second hep A 11/22/21. Patient was given Proquad 11/22/21. He had his 2nd MMR 08/03/2021 and did not need this. He did need his second varicella today-11/22/21. Quadracel was given. He had Quadracel 08/23/2021 for his 5th dtap and 4th polio. He did not need quadracel today.  I explained to mom afterward that I made  a mistake and that he should come back in Feb 2022 for his second Hep A. Mom was given a credit for his vaccines as she paid today. I had already told her side effects and symptoms with the assistance of the interpreter as well as what to watch for with an allergic reaction. I informed mom that these extra vaccines should not cause harm but to watch for side effects.
This spontaneous report as received from a Licensed practical nurse refers to unspecified number of patients. On unknown dates, the patients might have received doses of PEDVAXHIB (Lot # not reported) and GARDASIL (Lot # not reported) that were exposed to an unsupported temperature excursion. No adverse effect was reported. Additional information has been requested.
WITHIN 24 HRS AFTER VAX, PT EXP AND INJECTION SITE REACTION INCLUDING SWELLING(LG AREA), TENDERNESS AND HOT TO TOUCH.
Administered vaccine given on 10/3/2022 had a manufactures expiration date of 9/30/2022
This spontaneous report as received from a pharmacist refers to an unspecified patients of unknown age and unknown gender. On an unknown date, the unspecified patients were vaccinated with doses of improperly stored M-M-R II. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
short loss of consciousness, weak pulse, cold, clammy skin, BP decreased, unresponsive;
she is having colds.; This is a spontaneous report received from a contactable reporter (Consumer) for a sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER COVID-19 VACCINE) (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: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "she is having colds.".  Additional Information: The patient won't be able to get her scheduled second dose of vaccine today (26Apr2021) because she was having colds. She could not recall when was her first dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about August 2012, the patient was inoculated with ZOSTAVAX by a healthcare provider to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). In or about 2013, the patient was treated by a physician and various healthcare providers for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's shingles and other zoster-related injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to mental and physical pain. The outcome of the events was unknown. Causality assessment was related.
Covid until my wife caught in in the Covid until my wife caught in in the  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 76-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), 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 (Primary Immunization series complete), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Covid until my wife caught in in the". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results.  Clinical information: I am 69 years old, my wife is 76. Covid changed our lives. We were first in line for your vaccine and all boosters. We avoided Covid until my wife caught in. I have yet to have any symptoms. I wanted to tell all of your executives and scientists thank you for saving our lives.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.