chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Found on unconscious on the floor, I have no memory of coming of bathroom; I felt weak and hot; I felt shaking extremely cold; I felt weak and hot; I felt shaking extremely cold; Nausea; Headaches; Soreness to left arm; A spontaneous report  was received from a consumer who was also a 82-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who was found on unconscious on the floor/loss of consciousness, hit me like a ton of bricks, soreness to left arm/pain in extremity/, I felt shaking extremely cold/feeling cold, I felt weak and hot/feeling hot; asthenia, I felt shaking extremely cold/tremor, nausea and headaches.   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included levothyroxine, vitamin D, calcium and senior vitamin not specified.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 030M20A) on 06 Feb 2021 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 06 Feb 2021, patient experienced sore arms which was resolved on 08 Feb 2021.  On 06 Mar 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 013M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 08 Mar 2021 the patient experienced headaches, nausea, felt shaking extremely cold, hot and weak, the patient was found unconscious, hitting patient with a ton of bricks and was taken to emergency room on an ambulance.  Treatment for the event included hydration fluids, tylenol and aspirin.  The action taken with the drug in response to the events was not applicable.  The all events were recovered except tiredness which was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Information has been received from a nurse concerning an unspecified age female patient who in January 2011, was vaccinated with the first dose of MMR II 0.5 ml (lot # and route not reported). it was reported that the patient was seen in the emergency room of an unspecified hospital for "croup" at an unspecified date. The hospital administered epinephrine (dose unspecified) and dexamethasone (manufacturer unknown) (dose and manufacturer unspecified). It was unspecified if the patient sought medical attention. At the time of the report, the patient's outcome was unknown. Upon internal review "croup" was considered to be an other important medical event due to treatment with epinephrine. Additional information has been requested.
pt recv vax 16SEP96 & 26SEP96 pt exp a gen rash;
FEELING MISERABLE; UNSPECIFIED ADVERSE EVENT; NAUSEA; SEVERE HEADACHE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced feeling miserable, unspecified adverse event, nausea, and severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling miserable, unspecified adverse event, nausea, and severe headache. This report was non-serious.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant information was reported. The date of placed in refrigerator was on 29-Jan-2022 and vaccine did not undergone any temperature excursion. No other adverse events were reported for patient. No Treatment information was reported.
Rebound Covid. Positive13Aug (1st Positive test 14Aug). Neg on 20Aug and symptom resolved by 21Aug. Recurrence and positive test 25Aug2022; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Lot number: EJ1685), on 14Jan2021 as dose 2, single (Lot number: EL3246) and on 30Sep2021 as dose 3 (booster), single (Lot number: EW0217) at the age of 36 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Aug2022, outcome "not recovered" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant) with onset 25Aug2022, outcome "not recovered", described as "Rebound Covid. Positive13Aug (1st Positive test 14Aug). Neg on 20Aug and symptom resolved by 21Aug. Recurrence and positive test 25Aug2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Aug2022) Positive, notes: first positive antigen test 14Aug; (20Aug2022) Negative, notes: negative antigen test 20Aug; (25Aug2022) Positive, notes: recurrence of symptoms and positive antigen test 25Aug2022; (13Aug2022) Positive, notes: positive PCR 13Aug known exposure 10Aug and onset of symptoms 13Aug. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of disease recurrence. Clinical course: Rebound COVID. Positive PCR 13Aug2022 (known exposure 10Aug2022 and onset of symptoms 13Aug2022), first positive antigen test 14Aug2022. Patient was given anti-viral Paxlovid from14Aug2022 to 18Aug2022 for treatment of COVID-19. Negative antigen test 20Aug2022 and resolution of symptoms by 21Aug2022. Recurrence of symptoms and positive antigen test 25Aug2022.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19, vaccination failure , disease recurrence cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19, vaccination failure, disease recurrence  is : expected. The case will be reassessed further upon receipt of additional information.
Pt recvd 3 doses of Engerix-B vax 8JUL90, 22AUG90 & 17JAN91 & was found to be a non-responder;
This case was reported by a other health professional via sales rep and described the occurrence of cold sores in a 57-year-old female patient who received SHINGRIX for prophylaxis. On 11th October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced cold sores. On an unknown date, the outcome of the cold sores was unknown. It was unknown if the reporter considered the cold sores to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. At the date of reporting, the patient came into the office with 5 to 6 cold sores around her mouth. The reporter agreed to be followed up.
Contracted COVID after taking the vaccine; Couldn't remember things/some short-term memory loss; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Contracted COVID after taking the vaccine), AMNESIA (Couldn't remember things/some short-term memory loss) and HEADACHE (Headaches) 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 COVID-19 (Contracted COVID after taking the vaccine), AMNESIA (Couldn't remember things/some short-term memory loss) and HEADACHE (Headaches). At the time of the report, COVID-19 (Contracted COVID after taking the vaccine), AMNESIA (Couldn't remember things/some short-term memory loss) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were provided. Treatment information was not provided.  Patient's husband believed that his wife had taken Moderna vaccine if he was not mistaken. His wife worked in the healthcare field and had to take the vaccine through her job. He had to quarantine for 2 weeks after his wife contracted COVID. He confirmed that he had no NDC, lot or expiry date for the Moderna vaccine his wife had taken. He stated that she was doing fine. However; he mentioned that his wife still had headaches but had returned to work. He reported that after contracting COVID, his wife had some kind of memory loss. If she made plans for today, she would not remember.
get vaccine / got shingles 6 days later; This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 6 days after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provide are as follows: The case was reported by patient for himself/herself. The age at vaccination was not reported. The patient never had shingles doctor insisted to get vaccine. The patient received Shingles vaccine and got shingles 6 days later. The patient get them yearly in the same spot on his/her back on the side. The follow up would not be possible as no contact details were available. The case has been linked with case US2021AMR170524 reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR170524:Same reporter
abdominal rash/rash on arm; shingles outbreak; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in May 2018).   In September 2018, the patient received the 2nd dose of Shingrix. On 19th June 2019, less than a year after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced rash. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  The reporting pharmacist was the patient. The patient developed a rash on her arm that she initially thought was poison oak, but she later developed a rash on her abdomen. She has never had a rash on her abdomen before. The reporter consented to follow up.  Call transferred to MI.
This case was reported by a physician via call center representative and described the occurrence of corneal lesion in a 69-year-old female patient who received SHINGRIX. Concomitant products included Vitamin C, DELZICOL, ELIQUIS, fish oil, and Salt Tablets. In March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced corneal lesion and herpes simplex. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced corneal lesion and herpes simplex. On an unknown date, the outcome of the corneal lesion was not recovered/not resolved and the outcome of the herpes simplex was unknown. The reporter considered the corneal lesion and herpes simplex to be possibly related to SHINGRIX. Additional details were provided as follows: This case was previously reported to physician. The patient also received Vitamin B as concomitant drug. The age at vaccination was not reported, but could be 68 or 69 years. The patient was seen by her eye physician and was diagnosed with corneal lesions that could be related to herpes simplex infection. The patient did not know which pharmacy where the patient had received the SHINGRIX dose.
Received expired vaccine beyond manufacturer's expiration date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond manufacturer's expiration date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond manufacturer's expiration date). On 27-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond manufacturer's expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were reported No Treatment Medications were reported.
pt said after getting the shingrix he had stomach aches weakness feeling aweful for a few days and finally got better today. He did not have to go to the doctor or er but just tough it out and he is ok now.
3 year old child received H1N1 nasal vaccine on 1/20/10 (second dose) and at 6 PM  had a 101.5 fever, was irritable and  was sleepy. Mom was concerned because he did not eat dinner and she does not have a pediatrician.  His  fever lasted 5 days ,  he developed a rash over his entire body.  He was  diagnosed  with scarlett fever by physician  at the emergency room where they took him the evening of 1/20/2010.  The entire family developed the illness , all are recovered now .   They took him to the ER because they do not have a private doctor or pediatrician.   Symptomatic and supporitve care was recomended by the emregency room.  Mom was reluctant to give further information ie name of hospital.
Pt received her moderna booster vaccine on 12/17/2021. She was previously vaccinated with moderna vaccines on 3/19/21 and 4/17/21 without incident. On 12/30/2021 she suddenly developed a diffuse, pruritic body rash that has persisted since. She was seen in the office for documentation of this rash on 1/4/2021. The rash involves her trunk, chest, arms and face/neck. It involves multiple, small, papular lesions without crusting, drainage. they are blanchable and non tender but are pruritic. she has no fever. She has never has a rash before. No hx of allergies.  No change in medications, soaps, no recent illness. No other cause to attribute this rash  other than recent vaccination. pt using benadryl and hydrocortisone cream to treat symptoms.
Patient went to the bathroom and when she got back to the couch, she fainted and could not get back up. Patient called her husband and he came home and helped her to lay down on the couch. Patient reports she was very weak. Patient has not told her doctor.
Immediately after receiving the vaccine the pt displayed seizure like activity for 3-5 seconds. We had the pt elevate his feet and monitored him for about 30 min, checking vitals frequently. We gave the pt a glucose tablet (no history of diabetes or hypoglycemia) and water.
Patient had no reaction to first vaccine, then after the second dose, she quickly had shortness of breath and trouble breathing. Patient's tongue and throat were closing up. I stuck the patient with an EpiPen and she started to do better. Waiting on the EMS to arrive the patient started having rebound anaphylaxis so I stuck her with another EpiPen. Patient was then put into EMS and left for the hospital
4-9-21 The morning of I tested negative for COVID, took vaccine that afternoon. Following morning, 4-9-21 woke up with 101 fever. Took Tylenol at 4 am.  Did not take anything else since.  Fever subsided in low  99's throughout that day. No other symptoms.  4-10-21 Woke up fine, no fever. Went to work at 7 am.  Toward end of work day, vaccination site became sore and I felt out of sorts.  4-11-21 Woke up fine, no fever. Went to work at 7 am. By noon, feeling foggy. Very sore throughout my body, especially upper body and vaccination site. 4-12-21 Woke up ok, no fever but not quite myself. Went to work 7 am. At about 8 am began to feel a bit foggy , dizzy and almost past out. Blood pressure taken by medics was normal but high for me, after resting  for 15 minutes it had gone done to my normal.  Went back to work station sitting  down but the foggy & dizziness continued off and on. Went back to my hotel to rest at 1 pm. While resting felt better but when moving out of bed sensations would come back. Some pain in left side vaccination and shoulder/neck pain but that may be related to chronic issues. 4-13-21 Stayed home to rest, fogginess continues, pain in vaccination site down arm.
mom states localized rxn to MMR in lt deltoid began w/in 10min of vax;skin red & splotchy @ site of shot;does not have any other c/o;pt remained approx 35min w/no further problems-redness of skin faded considerably-advised to call PMD
This case was reported by a healthcare professional and described the occurrence of injection site redness in a 46 year old female subject who was vaccinated with Flulaval for prophylaxis. On 27 December 2006 at 12:00 the subject received 1st dose of Flulaval (.5ml, subcutaneous) instead of a tuberculin skin test. She experienced injection site redness, wrong drug administered and wrong route of administration. The subjec had already received an influenza vaccination this year. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Flulaval.
Patient received PNEUMOVAX 23 on 09/04/18 and started having pain in the night. The next day he noticed the pain was so bad that he couldn't lay on it. It started to feel hard and it was burning. It was red and swollen. Today 09/06/18 he came to the pharmacy to report the incident. He said the redness and swelling has spread even further. He says he doesn't feel burning today.
Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves four patients (age and gender was not reported) who were vaccinated with a dose of FLUZONE QUADRIVALENT (lot number and expiry date was not reported) on an unknown date. 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 to incorrect product storage. It was not reported whether the patient experienced any adverse events following the vaccination. 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 party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
feel heavy, like brain fog; felt terrible/still feels very not good/feels crappy; felt like would vomit again; really very sleepy; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feel heavy, like brain fog), SOMNOLENCE (really very sleepy), MALAISE (felt terrible/still feels very not good/feels crappy), NAUSEA (felt like would vomit again) and VOMITING (vomiting) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RIMEGEPANT SULFATE (NURTEC ODT) tablet for Migraine.    Concurrent medical conditions included Thyroid disorder and Migraine since 1963.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021 at 7:00 AM, the patient started RIMEGEPANT SULFATE (NURTEC ODT) (Sublingual) 75 milligram. On 18-Feb-2021 at 8:30 AM, the patient experienced VOMITING (vomiting). On 18-Feb-2021 at 9:15 AM, the patient experienced SOMNOLENCE (really very sleepy). On 18-Feb-2021 at 9:35 AM, the patient experienced NAUSEA (felt like would vomit again). On 18-Feb-2021 at 9:45 AM, the patient experienced FEELING ABNORMAL (feel heavy, like brain fog) and MALAISE (felt terrible/still feels very not good/feels crappy). At the time of the report, FEELING ABNORMAL (feel heavy, like brain fog), SOMNOLENCE (really very sleepy), MALAISE (felt terrible/still feels very not good/feels crappy), NAUSEA (felt like would vomit again) and VOMITING (vomiting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.
Employee requested and received Hepatitis B vaccine 1st dose. Returned to Employee Health approximately 30 minutes later with c/o shortness of breath. Taken to ER. Exam and treatment of Benadryl, Solu Medrol and Ativan given. Not admitted.
Initial unsolicited report received from a consumer via social media on 10 Oct 2016. This case is linked with 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851 (Same reporter source, same vaccine). This case involves a male patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Flu shot) (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, patient got sick. The patient's laboratory data and corrective treatment was not reported. On unspecified date, patient recovered from the event. List of documents held by sender: none.
varicella-approx 20 spots 1 day prior to breakout;sl fever;pt recv vax 10JUN98;