chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning an 11 year old white male with no pre-existing allergies, birth defects, or medical conditions who on 08/16/1996 was vaccinated subcutaneously in the left thigh with a first dose of varicella virus vaccine live.  There was no illness at the time of vaccination.  There was no concomitant medication.  Subsequently the patient developed approximately 20-30 apparent pox lesions per telephone report from the mother.  There were no relevant diagnostic tests or laboratory data.  There were no adverse events following prior vaccination.  The outcome was reported as recovered.  It was also noted that the patient's brother developed varicella after vaccination with varicella virus vaccine live.  No additional information is expected.
Patient passed out right after getting vaccine, started shaking and fell to floor and hit her head on table.
Pt recvd 3 doses of Engerix-B & when titer was checked it indicated non response;
Pt went to ED for fatigue, weight loss, chest pain, and fatigue.  Fatigue started about 3 weeks before hospitalization after recieving Bexsero vaccine at doctor's office.  Pt was transferred to another hospital for further work-up.
Arm feels like being hit it with a bat; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of arm discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 25-APR-2023, the patient received the 1st dose of Shingles vaccine. In APR-2023, an unknown time after receiving Shingles vaccine, the patient experienced arm discomfort (Verbatim: Arm feels like being hit it with a bat). The outcome of the arm discomfort was not reported.   It was unknown if the reporter considered the arm discomfort to be related to Shingles vaccine.     It was unknown if the company considered the arm discomfort to be related to Shingles vaccine.   Additional Information: GSK receipt date: 26-Apr-2023 This case was reported by a patient via interactive digital media. The patient received the first shot of Shingles vaccine on the day before reporting. The patient's arm  was felt like somebody hit it with a baseball bat. The follow up would not possible, as no contact, details were available.
I had typical initially nausea chills exhaustion but then woke up early sun 2am with heart palpitations, I get this allergic reaction to codeine. It didn?t seem as intense as the response I get from codeine but it lasted a few hours.  I was going to see clinic when opened but it stopped about 5 am.
Patient received Vaxelis instead of Pentacel due to mishearing the doctor's order. There was no obvious adverse event after vaccine administration. Physician notified immedietly.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 18 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Dec2021 15:30 (Lot number: FJ5787) at the age of 18 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administered in arm right, administration date 03Dec2021 (Batch/Lot number: unknown) as single for immunisation. Relevant medical history included: "Pneumonia", start date: 2015 (unspecified if ongoing), notes: hospitalized for pneumonia in 2015; "Asthma" (unspecified if ongoing), notes: Mild asthma. There were no concomitant medications. Past drug history included: Rocephin, reaction(s): "Drug allergy", notes: known allergies: Rocephin. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE; Lot number: EW0182; Anatomical site: right arm; Route of administration: Unspecified), administration date: 10May2021, when the patient was 17 years old, for COVID-19 immunisation; Bnt162b2 (DOSE 1, SINGLE; Lot number: EN9581; Anatomical site: unspecified; Route of administration: Unspecified), administration date: 18Apr2021, when the patient was 17 years old, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 03Dec2021 15:30, outcome "unknown" and all described as "Flu shot received on 03Dec2021 and also received BNT162B2 on 03Dec2021"; IMMUNISATION (non-serious) with onset 03Dec2021 15:30, outcome "unknown", described as "Dose received: 3"; LYMPHADENOPATHY (non-serious) with onset 04Dec2021, outcome "not recovered", described as "Swollen lymph nodes in neck and armpit"; URTICARIA (non-serious) with onset 04Dec2021, outcome "not recovered", described as "Itchy hives on forehead, neck, legs"; NIGHT SWEATS (non-serious) with onset 04Dec2021, outcome "not recovered", described as "Night sweats". Therapeutic measures were taken as a result of lymphadenopathy, urticaria, night sweats. Additional information: The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment included unspecified oral Antihistamine, Ibuprofen and topical Cortisol. The patient also received FLU SHOT, administered in right arm, administration date: 03Dec2021 for immunization.
severe pain and soreness in her shoulder going down to her hips; hard time lifting her hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 11Oct2021 (Batch/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: Bnt162b2 (1st Dose), for COVID-19 immunization; Bnt162b2 (2nd Dose), for COVID-19 immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "severe pain and soreness in her shoulder going down to her hips"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset 2021, outcome "unknown", described as "hard time lifting her hand".  Additional Information: Patient received the third dose of Pfizer Covid-19 Vaccine 11Oct2021. Patient was concerned because she had severe pain and soreness in her shoulder going down to her hips. Patient was also having a hard time lifting her hand. Patient just called to ask if those symptoms were normal after the third dose of Pfizer Covid-19 Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
herpes reaction spt  4 getting severe by spt 10.  tool valcyclovir 4 days.  second reaction spt 22 with tremors
Initial misuse report received from a healthcare professional on 13 June 2013. A patient (No information was provided regarding the patient) had received MENACTRA vaccine exposed to 33 degree Fahrenheit. No adverse event was reported. Documents held by sender: None.
During the post-vaccine monitoring period , a bout 5-10 minutes after  the first dose injection of Moderna Covid Vaccine, pt felt  nausea and had seizure episode for about 2-3 minutes.  Pharmacist noticed rolling eye balls and body shake with brief unconsciousness.   Pt  was alerted 2-3 min after with sweats and slight confusion.  Meanwhile, 911 was called and paramedics came and checked patient. out .   Pt was pale but all vitals were normal and returned  to stable condition.   Pt was released and his wife accompanied back home.  Pharmacist is planning to l follow up with patient .
Patient stated she had intense lower back pain that spread to her legs.  She then noticed her left leg started tingling and became numb.  This then spread to her right leg and she became unable to walk.  This lasted until the next day and then began improving.  She did not seek any medical attention.  By 48 hours all symptoms had improved.  By 96 hours she said she was back to 100%.
(On 02/14/2020, After receiving vaccine Father states patient legs became sore and patient did not want to walk. Father states child had fever of 102 F after vaccine w/ cough . Per: Provider patients fever has been improving. Provider diagnosed child with acute URI and Impacted Cerumen on Right ear; Medical Assistant attempted to perform an ear lavage on child with no success. Therefore, provider prescribed patient with Ofloxacin, Amoxicillin and  Guaifenesin and advised father to bring child in 2 weeks for follow up.
Lymph node swelling under left arm where vaccine given. Swelling noted morning after injection and continued for x 7 days.
Administration of expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 76-year-old male patient who received HAB (Twinrix) (batch number x239d, expiry date 7th August 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th August 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 24th August 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-AUG-2022 Reporter's Comments: The pharmacist reported that male patient received a dose of Twinrix and was expired on 7th Aug 2022.  The vaccine administration facility was the same as primary reporter The reporter consent to follow up. Additional Supportive Information: The patient received an expired dose of Twinrix, which led to expired vaccine used.
Probable secondary transmission of vaccinia: Patient is not vaccinee. VAERS filed on vaccinee. 26 year old female patient whose boyfriend received his SPV on 16 April (patient said he received the SPV at Air Force Reserve Base; had lab work drawn on 23 April). Patient noted painful, perineal lesions on 30 April. Pt also developed a lesion on her right thumb and lesions on her upper left thigh. She experienced a fever (max temp of 101) without significant systemic symptoms. She sought evaluation and was treated initially for herpes with VALTREX and pain medication. HSV culture came back negative. Currently afebrile and under the care of Dr. . PCR war sent of state lab for vaccinia PCR and cultures. Precautions to avoid spread of vaccinia reviewed with patient.  6/4/09 ER records received DOS 5/5/09. FINAL DIAGNOSIS: Herpes genitalis. Post vaccination presents with left neck soreness, bilateral inguinal adenopathy, rash left genitalia, thighs. Ulcerative and vesicular. Was previously thought to have herpes zoster and prescribed Valtrex. Progressive pain, fever. Vaginal discharge.  6/9/09 PCP medical records received DOS 5/4/09 to 5/8/09. FINAL DIAGNOSIS: "vaccinia reaction small pox vaccine reaction" Patient presented with right and left inquinal adenopathy, low grade fever, fatigue, malaise, joint aches. Rash on back of left thigh extends to genital region and L lower introitus. Boyfriend vaccinated with smallpox. Pt later presents with pustule on R thumb. Vesicular pustular rash to perineum extending into labia. Older lesions begining to scab.
Weakness and pain in ankles and feet. Ankles are giving out while walking.  Still hurt and are weak today.
Systemic: Dizziness / Lightheadness-Medium, Systemic: anxiety, said throat felt tight, tingly all over, very nervous-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ROTATEQ (Lot # not reported) (2 ml, oral route) that was exposed to a low temperature of 34 degrees Fahrenheit for an unspecified number of times over a period of 7 days (168 hours). Concomitant therapy was not reported. No adverse event reported. Additional information has been requested.
Receive the shot on 10/7/2021 at 1 pm and on 10/8/2020 around 9 pm, I began experiencing chest pain.  I went to urgent care where they did my vitals and an EKG. My blood pressure was 170/96 and the EKG was abnormal with Left Ventircal Overload vs. Ischemia.  My heart rate is usually 110/65.
felt really cold; Shivering; This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th January 2020 18:30, the patient received the 1st dose of Shingrix. In January 2020, less than a day after receiving Shingrix, the patient experienced feeling cold and shivering. On an unknown date, the outcome of the feeling cold was recovering/resolving and the outcome of the shivering was recovered/resolved.   It was unknown if the reporter considered the feeling cold and shivering to be related to Shingrix.  Additional details were reported as follows: The reporter was the patient's wife. The patient received of Shingrix on the day before reporting at around 6:30 PM in his right arm. On 16th January 2020 in morning the patient felt really cold and then began shivering for approximately 20 minutes. No other information was provided.
Pt recvd OPV/HIB TITER on 15OCT91 & later that day t102-103 gave APAP; would scream 1/2 hr, then would sleep, then scream again; 16OCT91 @ 830AM t104.5; t99.8 in office now mildly irritable;
Approximately 2 minutes after vaccine was given patient became pale, diaphoretic, dazed, not responding to name and then was observed to start having full body jerking movements for 30-45 seconds while sitting in chair. Tonic clonic seizure activity stopped, pupils dilated and patient slow to respond after shaking stopped. No loss of bladder or bowel but patient reports he felt like he "fell asleep" and does not know what happened.    BP and HR low, 80/36 and 40, no difficulty breathing. 911 called due to seizure and unstable vitals after episode. Patient awake and oriented, transferred to nurse treatment room to await paramedics.
Pt was given an expired vaccination, no adverse reactions noted. Expiration date on Vaccination dated 5/20/18 pt was given vaccine on 5/30/18. This was discovered on 6/25/18. No adverse reaction noted.
Patient received Vaccinia vaccine in his left upper arm. Within 2 days, patient developed significant left shoulder pain. Pain intensity was rated as 6-7/10 using pain scale of 0 (=no pain) to 10 (=worst pain ever experienced). Patient self treated with Ibuprofen 1200 mg without significant improvement. He later treated with Hydrocodone with minimal relief. Patient denied fever, but had experience brief episode of "chills". He denied chest pain, palpitations, shortness of breath, and pedal edema. He also denied significant fatigue, headaches, rashes, nausea/vomiting, and generalized body aches. Patient denied significant reaction surrounding vaccination site. He denied weakness and numbness/tingling of left upper extremity. Patient denied recent trauma to left upper extremity. He had left shoulder surgery (rotator cuff repair) in 2010. By 2200, patient was not able to go to sleep due to pain. After speaking to DHA Immunization Healthcare Support Center, he sought evaluation at local emergency room, where he was given Toradol injection. According to the ER physician, patient's exam was unremarkable. Patient's pain significantly decreased after Toradol, but returned the following morning. No additional symptoms reported, just continued, constant left shoulder pain. Patient called IHB Immunization Healthcare Support Center and was advised to seek evaluation with local PCM or urgent care. Patient self treated with Ibuprofen until he started experiencing symptoms of gastritis. He sought evaluation at St. Luke's on 20 Aug 2016. The pain continued and interfered with his sleep and limited his range of motion and function. The vaccination site had a robust take several days after pain started. Differential per MD was Brachial Plexus Neuritis. He was treated with oral steroids and narcotics with improvement over the next 24-48 hours.  By 24 Aug 2016, pain had completely resolved.
This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE IRRITATION (Injection site is irritated) and INJECTION SITE ERYTHEMA (Injection site is red) in a patient of an unknown age and gender 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 INJECTION SITE IRRITATION (Injection site is irritated) and INJECTION SITE ERYTHEMA (Injection site is red). At the time of the report, INJECTION SITE IRRITATION (Injection site is irritated) and INJECTION SITE ERYTHEMA (Injection site is red) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. Treatment medications were not provided by the reporter.
Pt stated that she began to feel light headed after receiving vaccination  VSS, she rested on cot for 30 min and left
pt devel intussusception of small bowel 6 days p/vax;intussusception did not reduce w/enema & pt required surgery;
patient got the second dose  from a vial  that was punctured and out of storage conditions for 17 hours; patient got the second dose  from a vial  that was punctured and out of storage conditions for 17 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient got the second dose  from a vial  that was punctured and out of storage conditions for 17 hours) and PRODUCT STORAGE ERROR (patient got the second dose  from a vial  that was punctured and out of storage conditions for 17 hours) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient got the second dose  from a vial  that was punctured and out of storage conditions for 17 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patient got the second dose  from a vial  that was punctured and out of storage conditions for 17 hours). On 05-Jun-2021, EXPIRED PRODUCT ADMINISTERED (patient got the second dose  from a vial  that was punctured and out of storage conditions for 17 hours) had resolved. At the time of the report, PRODUCT STORAGE ERROR (patient got the second dose  from a vial  that was punctured and out of storage conditions for 17 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided.  Reportedly, the patient reported no side effects up to the time of reporting.
Patient began to complain of dizziness and nausea upon standing and loss of ability to concentrate at school or on homework. General fatigue and exhaustion.
COVID-19 Vaccine EUA  Approximately 12 hours after injection woke up in middle of night with fever and chills. The next morning a moderate headache and minor muscle soreness presented. Ibuprofen reduced headache and soreness.
7 patients ages 6mo-5yr were given Moderna Bivalent Pink cap/yellow label 0.2ml/10ug for dose 1 and/or dose 2. The correct dose should have been Moderna Bivalent Blue cap/gray label 0.25ml/25ug.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (7 patients ages 6mo-5yr were given Moderna Bivalent Pink cap/yellow label 0.2ml/10ug for dose 1 and/or dose 2. The correct dose should have been Moderna Bivalent Blue cap/gray label 0.25ml/25ug.) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (7 patients ages 6mo-5yr were given Moderna Bivalent Pink cap/yellow label 0.2ml/10ug for dose 1 and/or dose 2. The correct dose should have been Moderna Bivalent Blue cap/gray label 0.25ml/25ug.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (7 patients ages 6mo-5yr were given Moderna Bivalent Pink cap/yellow label 0.2ml/10ug for dose 1 and/or dose 2. The correct dose should have been Moderna Bivalent Blue cap/gray label 0.25ml/25ug.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (7 patients ages 6mo-5yr were given Moderna Bivalent Pink cap/yellow label 0.2ml/10ug for dose 1 and/or dose 2. The correct dose should have been Moderna Bivalent Blue cap/gray label 0.25ml/25ug.).    Concomitant drugs were not reported. It was reported that patients were of age 6 months to 5 years. It was unknown that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment medications were not provided. This case was reported for patient 6th out of 7.   This case was linked to DE-MODERNATX, INC.-MOD-2023-724290 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2023: Follow up received contains updated reporter country, country of incidence and  suspect product coding. On 11-May-2023: Follow up received contains No New Information. On 12-May-2023: Live Significant Follow-up received contains updated age group and route of administration On 16-May-2023: Follow up received contains No New Information. On 16-May-2023: Follow up received contains No New Information.; Sender's Comments:  DE-MODERNATX, INC.-MOD-2023-724290:Patient 1
This spontaneous report as received from a registered nurse, refers to an unknown number of patients of unknown age and gender. Patient's pertinent medical history, drug reactions/allergies were not provided. On an unknown date, the nurse reported that vaccines of VAQTA (Lot # and expiry date were not provided); vaccines of "Tetanus" (therapy unspecified) and "Diphtheria", were exposed to temperature excursion and were administered to unknown number of patients. The vaccines were exposed to 50F for 1 hour and 5 minutes, and were administered to unspecified number of patients since the temperature excursion. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Pfizer Dose 1 1/7/21 (EL0142) Pfizer Dose 2 1/28/21 (EL0142) Pfizer Does 3 10/13/21 (FD0809) COVID Positive 3/28/22 Hospitalized 3/23/22-3/30/22
Excruciation pain during and after injection at the injection site late spreading to whole arm within minutes followed by inability to lift and move the left arm for more than 5 weeks. Was prescribed tylenol Codeine for the pain but no relief. Unable to lie down on my left side, unable to lift wight to move my left arm.