chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Two events of intussusception, each after given rotateq vaccine, the second episode was 7 days after the rotateq was administered.  Was life flighted both times.  03/25/09 Received hospital medical records of 2/15-2/17/09 & 3/21/2009. FINAL DX: Intussusception Records reveal patient experienced irritability, emesis, bloody stools.  Seen in outlying ER & transferred to higher leve of care.  Tx w/IVF, antibiotics.  Surgery consult done & PICU. Admitted overnight for observation s/p enema reduction of IS.  Radiology noted cecum abnormally positioned in LLQ.  Developed increased pain & repeat US (-) for IS.   3/21/09 records consist only of abdominal x-ray & US.  X-ray revealed distention of small bowel & possibly large bowel & could not exclude IS; however, US (-) for IS.  No further medical records available for this visit.
This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 18-APR-2013, the patient was vaccinated with a dose of GARDASIL (lot # H020002, expiry date 08-AUG-2015), with the same lot of improperly stored GARDASIL. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Shortness of breath, mild chest  pressure and tachycardia  began 28 hrs after 2nd  dose.
Client verbalized feeling tingling and numbness to right arm after receiving the vaccine. Assessment done by Fire Rescue Paramedics.  Client was released for home at 5:30 pm.  Per paramedics no further evaluation needed.  Symptoms resolved.
Warmth at the injection site; Hardness at the injection site; Itchiness at the injection site; Redness at the injection site; Soreness; A spontaneous report was received from a nurse (patient), concerning herself, a female patient of unknow age, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced soreness (pain in extremity), warmth at the injection site (injection site warmth), itchiness at the injection site (injection site pruritus), hardness at the injection site (injection site induration), and redness at the injection site (injection site erythema).  The patient's medical history was not provided. Concomitant product use was not provided.  On 29 Dec 2020, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19 infection.  A nurse who is the patient called to report that she received the Moderna COVID-19 vaccine on 29 Dec 2020. She stated that she had the typical soreness after receiving the vaccine. On 06 Jan 2021, the patient reported and experienced redness, itchiness, hardness and warmth at the injection site. Treatment information was not provided.   Action taken with second dose of mRNA-1273 in response to the events was not provided.   The outcome of the events, soreness, warmth at the injection site, itchiness at the injection site, hardness at the injection site, and redness at the injection site was considered not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and HEADACHE (Headache) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-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 CHILLS (chills) and HEADACHE (Headache). At the time of the report, CHILLS (chills) and HEADACHE (Headache) outcome was unknown.            No treatment details were reported.  No concomitant medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.
Patient walked over to  the post vaccine waiting area and fainted falling face forward hitting his head onto the concrete. Rph went to  to patient, he started to shake and open his eyes.  Paramedic was near and came over to aid patient.  Patient's head was bleeding. Medic radioed out to the ambulance and they came in with a stretcher. Patient was alert
Itching at right superior back for few days after injection and rash appeared 11/21/2009.  Patient evaluated 11/23/2009 and diagnosed with Herpes Zoster
This case was reported by a physician via call center representative and described the occurrence of muscle pain in a male patient who received FLUARIX QUADRIVALENT. On 29th September 2015, the patient received FLUARIX QUADRIVALENT. On an unknown date, 7 days after receiving FLUARIX QUADRIVALENT, the patient experienced muscle pain and joint pain. On an unknown date, the outcome of the muscle pain and joint pain were not recovered/not resolved. It was unknown if the reporter considered the muscle pain and joint pain to be related to FLUARIX QUADRIVALENT. Additional details provide were as follows: The patient experienced muscle aches and joint pain one week after receiving the vaccination in October 2015. The reporter did not provide any further details because he did not have time. He stated that someone can call him back and speak to one of his nurses regarding the adverse event.
suspected vaccination failure; I had them twice; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had them twice).   On an unknown date, the patient received Shingles vaccine and Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for himself/herself. The age at vaccination was not reported. The patient reported that, he/she had the Shingle shots even after the first outbreak of shingles, it did not help the patient. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation for shingles were not provided.
6/30/15 Adult dose Hep A administered in error. 7/3/15 Patient seen in sick call for 101.1 temp. 7/4/15 Patient seen by pediatrician for fever and URI symptoms. 7/6/15 Seen by pediatrician. No fever or rash noted. URI symptoms improving.
Itching to arms, legs and back of head; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching to arms, legs and back of head) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PRURITUS (Itching to arms, legs and back of head). The patient was treated with PARACETAMOL (TYLENOL) for Itching, at an unspecified dose and frequency. On 07-Mar-2021, PRURITUS (Itching to arms, legs and back of head) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Shortness of breath and tightness in her chest, feeling that her lip and tongue were swelling.
severe discomfort/pain from the shot area all the way up to the neck/head on the left side lasting several days. slight chest pain (2x). headache for 1-2 days.
This case was reported by a healthcare professional and described the occurrence of arm numbness in an adult male subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received 1st dose (unknown, right arm0, 2nd dose (unknown, left arm) and 3rd dose of TWINRIX (unknown, right arm). At an unspecified time after vaccination with TWINRIX, the subject experienced bilateral arm numbness and neuropathy arms. At the time of reporting the outcome of bilateral arm numbness and neuropathy were unspecified. A subject reported "he and his wife had the TWINRIX series last year on the traditional schedule, 0, 1 and 6 months. The subject states both he and his wife have had problems with numbness and neuropathy in their arms. Both arms were alternated for the series and it was right, left, right; he reported that both arms are bothering them. She (the wife) went to the clinic and the doctor told her they are seeing this with the hepatitis vaccines (subject was not sure if the doctor meant all hepatitis vaccines or just the TWINRIX). He also said another friend of theirs is experiencing the same thing." This is one of three cases reported; for the second case (wife) see case A0977598A; for the third case (friend) see case A0977599A. Follow-up information was received on 15 June 2012 via healthcare professional who reported the 67-year old male subject received 1st dose, 2nd dose and 3rd dose of TWINRIX (1ml) on 20 October 2010, 23 November 2010 and 2 May 2011 respectively. Concurrent medication included VALTREX. At the time of the report the events were unresolved.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions or concomitant medication. On unknown dates, the patient was vaccinated with the first and second dose of GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported) in first series, according to the recommended schedule. The patient did not received the third dose of GARDASIL 9. Because of this, the nurse re-started the vaccination at appropriate interval. On unknown dates, the patient was vaccinated with the first and second dose of GARDASIL 9 in a second series, for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On 08-AUG-2017, the patient was vaccinated with an expired third dose of GARDASIL 9 in a second series, for prophylaxis, lot # M014929 and expiration date 27-MAY-2017. No adverse events were reported.
Pt was exposed to an 8 year, old unvaccinated relative with chickenpox and two weeks later developed varicella. Pt had a fever of 104F for four days and an extremely itchy rash for five days.  Pt had lesions from head to toe, all over his face, and on his ears, eyelids and scalp.
Pfizer 2/3/21, 2/24/21, 9/30/21, 4/21/22. Positive on 7/22/22
arm started to hurt; shoulder started to hurt, It's hurting a lot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm started to hurt) and ARTHRALGIA (shoulder started to hurt, It's hurting a lot) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Parkinson's disease.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (arm started to hurt) and ARTHRALGIA (shoulder started to hurt, It's hurting a lot). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (arm started to hurt) outcome was unknown and ARTHRALGIA (shoulder started to hurt, It's hurting a lot) had not resolved.            The patient had 3 Moderna shots, but after the second one her shoulder started hurting, she had it in the same arm as the second. To this day her shoulder is still hurting her, she even is going to get an MRI. She was having minor issues with her shoulder before the shot and now she's having major issues. It was hurting a lot. She did not have any of this problems before the vaccine.  First dose was in January, second vaccine in February, third vaccine in August in a different arm. The patient Has a condition on the red blood cells, Parkinson's and myofibrosis.  She had antibody tesst to see how powerful Moderna was in her body.  Fist time was after having the two doses and antibodies read like 1 69.  Second time after the third dose, antibodies shooted to 1000 049.  Third time about a month after taking the third dose, on September, went down to 7 30.  NO concomitant medication details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Follow-up received on 27-Oct-2021. Patient demographics updated, historical condition updated, vaccine details updated.
I had little soreness after receiving the vaccine for about a day. I tested positive for COVID-19 on 01/13/2023. I had sore throat, muscle aches, runny nose and congestion. I went to an urgent care center and received the prescription for PAXLOVID. I tolerated the medication without any issues. As of today, I do not have any lingering symptoms.
Case number PHEH2014US021415 is an initial spontaneous report from the health care professional received on 22 OCT 2014. This report refers to a 56-year-old female patient. The patient was vaccinated with FLUVIRIN 2014/2015 (batch number: 14582P) from a prefilled syringe, intramuscularly on 21 OCT 2014. It was reported that the syringe used for vaccination was malfunctioned  and it caused the patient to not receive the full dose of FLUVIRIN. No adverse event reported following this medication error (under dose).
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who was administered dose of GARDASIL (dose and route unknown) on 30-MAY-2013, lot # H011350, Expiration Date: 21-FEB-2015). No adverse event was reported. This is one of the report from the same source, linked reports. Additional information is not expected.
Pt recvd 3 hep B vax as follows:20DEC89,24JAN90,16JUL90.Test results 21AUG90 showed pt did not seroconvert.Addt'l dose given & test results again neg for HBSAB.
Irregular periods following vaccination. Cycle is typically 28 days and it has been 24 days for two cycles post shot.
Severe pain when shot was given. Pain has gotten worse and never stopped over the months with limited use of arm. Have had accupunture with no relief from the pain.
Client seen by family physician on 10/18/05. Dr. reports pt. presented with localized reaction to immunization received in left thigh the prior day.  States left thigh warm, red, and swollen twice normal size from thigh to knee.  Prescribed Keflex and instructed to apply ice to affected leg.
shooting pain's in back at waist like someone is putting  knife in back.   Was sore in  back next 2 days.   Not sure how long  it lasted was there for over 45 min.
830 pm cold hands & muscle pain shoulders and neck and vacc site. 930 pm shivering/chills 934 pm 99.1 temp These items appear as known side effects on Mfg website.  As of 10PM, letting it run its course. Will monitor temp.
Exposed down to 28 F, administered; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 29-SEP-2022 Reporter's comment: The reporter reported that the patient received Shingrix vaccine. The pharmacist stated that the Shingrix vaccine was exposed down to 28 Fahrenheit for 8 hours, the reporter stated that there was no prior excursions. The reporter reported that the 8 patients were administered temperature exposed Shingrix vaccines. The reporter asked about Shingrix stability and wanted to know any recommendation on revaccination. The reporter was unable to provide patient details. The reporter did not consent to follow up. Additional supportive information: The Shingrix vaccine temperature was exposed upto 28 Fahrenheit for 8 hours, which led to incorrect storage of drug. This case was 1 of 8 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2022140240:Same reporter US-GSK-US2022140241:Same reporter US-GSK-US2022140239:Same reporter US-GSK-US2022140237:Same reporter US-GSK-US2022140235:Same reporter US-GSK-US2022140236:Same reporter US-GSK-US2022140234:Same reporter
Less than one day after my first dose, I experienced very uncomfortable and prolonged stomach cramps and fatigue. I felt them off and on for about day. Then when I was feeling better, I took the second dose as directed hoping it was a fluke. The day after my second dose, I experienced the worst pain I've ever felt. Severe stomach cramping, which cause my whole body to tense up badly. I couldn't do anything but cry and lie down. I also had diarrhea and fatigue, but it felt like my entire intestine was cramping. It hurt my whole lower torso and was really intense, sharp pain. I have never experienced this before. I was not able to finish taking the pills. The following day I was fatigued and my whole lower torso was sensitive to pressure and uncomfortable, but not nearly as bad as the previous day. Today I'm feeling fine but I still have diarrhea.
My ophthalmologist was suspecting that I may develop glaucoma before my booster but could not diagnose it as such until it got worse after my booster. This was discovered in 12/2021 because of loss of visual field in test. Was prescribed Timolol Maleate which I found was allergic to. Alphagan P was prescribed to replace it and I have been using it for two weeks.
Slurred speech, drooping left upper lip, feeling funny. One episode at @ 9:00 am, second episode @ 3:00 pm on the same day. Treatments at ER: Plavix, IV fluids
This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (cold sore) and FUNGAL INFECTION (yeast infection) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 29L20A) for COVID-19 vaccination. No Medical History information was reported.On 12-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, the patient experienced ORAL HERPES (cold sore). On 18-Nov-2021, the patient experienced FUNGAL INFECTION (yeast infection). The patient was treated with LYSINE for Cold sores, at an unspecified dose and frequency. On 13-Nov-2021, ORAL HERPES (cold sore) had resolved. On 18-Nov-2021, FUNGAL INFECTION (yeast infection) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):In October 2021, SARS-CoV-2 test: positive (Positive) Positive. Patient is not sexually active and has no allergies or maintenance medications No relevant concomitant medications were reported.Treatment medications include Monostat for Yeast infection. This case was linked to MOD-2021-395722, MOD-2021-395729 (Patient Link).
I received vaccine on 2/3/21 at 10:35 am. That evening I was tired and had arm tenderness.  The next morning (4:30 am), when I woke up for work, I was unable to walk without assistance due to dizziness.  If I do not move my head,  I am able to sit or walk slowly.
swelling at injection site; hive-like rash on chest/ hive-like rash on shoulder; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number 2Y9R4, expiry date 28th June 2021) for prophylaxis.   Co-suspect products included ciprofloxacin unknown for an unknown indication.   Previously administered products included Shingrix (1st dose received on 21st December 2018, without any adverse event).   On 20th June 2019, the patient received the 2nd dose of Shingrix and ciprofloxacin at an unknown dose and frequency. On 21st June 2019, 1 days after receiving Shingrix and ciprofloxacin and 1 day after starting Shingrix and ciprofloxacin, the patient experienced injection site swelling and rash urticaria-like. The action taken with ciprofloxacin was unknown. On an unknown date, the outcome of the injection site swelling and rash urticaria-like were unknown.   The reporter considered the injection site swelling and rash urticaria-like to be related to Shingrix. It was unknown if the reporter considered the injection site swelling and rash urticaria-like to be related to ciprofloxacin.  Additional details were provided as follows: The batch number of Shingrix was reported as 8Y9R4, which was corrected to 2Y9R4 as per sales data sheet.  The next day of vaccination, the patient experienced swelling at the injection site.   The patient also reported hive-like rash on the shoulder and on the chest. The reporter stated that, the patient never had a reaction to Ciprofloxicin before and he suspected these reactions were associated with the Shingrix. In Argus core additional event was given as injection site rash' which was deleted, since anatomical location was not reported in the case. Adverse events were coded as per narrative. The reporter consented to follow up.
This spontaneous report was received from a healthcare worker refers to an adult patient of unknown age and gender. Patient's medical history, concurrent conditions and drug reactions/allergies were not provided. On 04-NOV-2015 the patient was vaccinated with a pediatric dose of RECOMBIVAX HB, instead of an adult dose. No adverse effects were reported. Additional information has been requested.