chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have had fever now for 12 days. High of 102.8 for first 2 days. Now it is @ 100 or less.
Symptoms began 12/16/2021 at 05:00. Symptoms still present as of 12/19/2021. Headache, nausea, loss of appetite, muscle weakness, body aches, extreme fatigue, chills and low-grade fever. Treatment: acetaminophen Q4H.
Got a terrible migraine 8 hours after getting my vaccine. The migraine lasted for a week until I could get a toridol shot. Hospitals didn't know what to do and neither did doctors. The migraines continue every day at this point. They were happening every 20 days and would only go away with a toridol shot. Now they continue daily and will not subside with toridol or any migraine medication. I have had two ER visits, 15-20 doctors visits and my life has been completely altered as I can barely get through the day. I've spent thousands of dollars to try to heal and get answers. I can not get any answers. I also had to get a cat scan to look for a blood clot. No blood clot found but the headaches will not stop, virtigo included. BEFORE I GOT THIS VACCINE, I'VE NEVER HAD A MIGRAINE IN MY Life.  They have gotten progressively worse over time.
Patient noted to have cough within 10 minutes of immunization, then became stuffy and very flushed. Patient had a normal exam except, diffuse flushing as told  ; few hives on trunk and arms. Significant nasal congestion.
looked like cellulitis; rash at 7 days at the injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE CELLULITIS (looked like cellulitis) and VACCINATION SITE RASH (rash at 7 days at the injection site) in a 34-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE CELLULITIS (looked like cellulitis) and VACCINATION SITE RASH (rash at 7 days at the injection site). At the time of the report, VACCINATION SITE CELLULITIS (looked like cellulitis) and VACCINATION SITE RASH (rash at 7 days at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Treatment for the events included oral prednisone for 5 days.   Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Headache, fatigue, inflammatory pain in hips, involuntary muscle contractions of legs, nausea and vomiting. Unable to keep down water for several hours. Pain to injection site.
Within 30 minutes of the administration, tingling, cold sensations and numbness in toes on both feet.  24 hours after vaccination it has only slightly improved.   We called the pharmacist who administered the vaccine and they stated this was not something they normally see, and was likely instead to be something circulation related and would check with me the next day.
gave expired Menactra to a patient and was expired 3 days; Initial information received on 28-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an 18 years old female patient who received an expired dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA]   The patient's medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   On 27-Aug-2019, the patient received a single 0.5 ml booster dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5986AA (expiry date: 24-Aug-2019) via intramuscular route in the left deltoid.  It was a case of actual medication error due to expired vaccine used.  It was unknown whether adverse event was experienced by the patient or not. .  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.
Information has been received from a registered nurse concerning a female nurse who 7 years ago, in approximately 2003, was vaccinated with the first dose of VARIVAX (Merck). The registered nurse reported that on 05-APR-2010, the nurse received a dose of VARIVAX (Merck). She needed to receive the vaccine because her varicella titer came back negative. On 06-APR-2010, the nurse developed one hive on the injection site. At the time of the report, the patient had not recovered from the hive on the injection site. The nurse sought medical attention. Additional information has been requested.
Onset. Received varicella on 7/17/13. TB skin was read the day prior to injection negative. . Reports small bump to (Lt) arm 7-21-13. Since this 6 addition red, raised bumps have appeared measuring pea size to quarter size. C/O pain and itching to site. Appt with doctor on 7-25-13 at 900 AM.
Vaccine injection hurt more than expected, more than previous vaccines. One hour after shot describes whole arm "pins and needles", that lasted a couple hours then changed to "numb feeling" in upper arm and right palm. Exam with normal strength, ROM
Rash; Had Migraines; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) and MIGRAINE (Had Migraines) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash) and MIGRAINE (Had Migraines). At the time of the report, RASH (Rash) and MIGRAINE (Had Migraines) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD21-087683, US-MODERNATX, INC.-MOD-2021-114269; Sender's Comments:  MOD21-087683: US-MODERNATX, INC.-MOD-2021-114269:
more than 6 months since I got the first dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in March 2020, in right deltoid by intramuscular route).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix due to financial constraints , which led to incomplete course of vaccination. The patient just tried to get the second dose at a pharmacy, but they would not give it to her without her calling Glaxosmithkline to find out if she needed to restart the series. The patient stated that, she was going to go back today to get the second dose. Gave medical disclaimer. The reporter consented to follow up.
pt reports itchy rashy some pain on arm following 2nd dose  getting better but would like incident reported
headache; chills; muscle ache; joint ache; fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), CHILLS (chills), MYALGIA (muscle ache), ARTHRALGIA (joint ache) and PYREXIA (fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 immunisation.     No medical history was reported.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced HEADACHE (headache), CHILLS (chills), MYALGIA (muscle ache), ARTHRALGIA (joint ache) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, HEADACHE (headache), CHILLS (chills), MYALGIA (muscle ache), ARTHRALGIA (joint ache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Information has been received from a health professional concerning a female who was vaccinated on an unspecified date with her first dose of GARDASIL (lot# not provided).  She received this dose at an office and the morning after receiving the vaccine she fainted.  At the end of October 2007, the patient was vaccinated with her second dose of GARDASIL (lot# 658558/1061U).  She experienced fatigue and felt generally weak.  She also received the third dose of GARDASIL (lot#658563/1063U) at the end of February or beginning of March 2008.  The patient had no adverse symptoms after this dose.  Her outcome was not reported.  Additional information has been requested.
Information has been received concerning a 10 year old female (previously reported by the resident as a 5 year old male), with no known medical history or allergies, who in 2002 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On approximately 9/12/04, the patient developed a non-vesicular papular rash isolated to his abdomen. It was reported that he was afebrile. As of 9/20/04 the patient still had lesions. Unspecified medical attention was sought and no treatment was required. There was no product quality complaint involved. Additional information has been requested.
positive test; positive test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: En6208), in left arm, on 07Apr2021 as dose 2, single (Lot number: Er8737), in left arm, on 25Oct2021 as dose 3 (booster), single (Lot number: Fd0809), in left arm and on 26Apr2022 as dose 4 (booster), single (Lot number: Fm9992) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "breast cancer surgery", start date: Dec2019, stop date: Dec2019, notes: Dec2019 breast cancer surgery; "Known allergies: Xray contrast dye", start date: 1992 (unspecified if ongoing), notes: known allergies Xray contrast dye (1992). Concomitant medication(s) included: ANASTROZOLE, start date: Dec2021; HYDROCHLOROTHIAZIDE, start date: Aug2021; ATORVASTATIN, start date: May2018. Past drug history included: Gabapentin, reaction(s): "Known allergies: gabapentin", notes: Known allergies: Erythromycin; Erythromycin, reaction(s): "Known allergies: Erythromycin", notes: Known allergies: Erythromycin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Aug2021) Negative, notes: starting two days after a negative test; (19Aug2021) Positive, notes: following a positive test two days prior, and two days .after finishing a course of Paxlovid; (23Aug2022) Positive, notes: following a positive test two days prior, and two days. after finishing a course of Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical courser. Rebound case of COVID, starting two days after a negative test (following a positive test two days prior, and two days after finishing a course of Paxlovid). patient is not recovered and no treatment for a received, Known allergies: Xray contrast dye (1992), gabapentin, Euthromycin. Patient received other medication in 2weeks, Anastrozole, Hydrochlorothiazide, Atorvastatin.
Red spot bigger than a quarter size on L thigh. 5/12/06 17:45 PM, spoke with pt's mother. Doing okay.
Information received from RN post vaccine pt experienced laryngitis. F/U update was box 24, pt name, date of vaccine, date of report.
Pt received 4 vaccines at 9:13 AM on 10/23/2020 (see above). Pt states that he feels weak, had to lay down @ 9:21 AM.  Pt responding to questions appropriately, just says that he feels weak. Allowed him to lay down for as long at he needed. Pt states that he was feeling better around 9:35, BP checked 120/68, pulse ox 96%, pulse 80. States he had some apple juice this morning. Pt states he feels completely better and was allowed to leave with father.
Redness at the injection site; Swelling at the injection site; Soreness at injection site; Itchiness at injection site; Left side neck (muscle) pain; This is a spontaneous report received from a contactable consumer, the patient. A 68-years-old adult non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration in left arm on 11Mar2021, at 14:30 (at the age of 68-years-old) as a single dose, for COVID-19 immunisation. Medical history included breast cancer survivor and rheumatoid arthritis. Concomitant medications included letrazole (MANUFACTURER UNKNOWN), methotrexate (MANUFACTURER UNKNOWN) and losartan (MANUFACTURER UNKNOWN), all for an unknown indication and taken within two weeks of vaccination and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200), via an unspecified route of administration in left arm on 18Feb2021 at 14:30 (at the age of 67-year-old) as a single dose, for COVID-19 immunisation. The patient had no known allergies to medications, food, or other products. The patient had not received any other vaccines within 4 weeks prior to COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 12Mar2021 at 9:00, the patient experienced redness, swelling, hot to touch, itchiness, soreness at injection site and left side neck (muscle) pain which resulted in doctor or other healthcare professional office or clinic visit. Therapeutic measures taken as a result of the events included Zyrtec tablet. The clinical outcome of events redness, swelling, hot to touch, itchiness, soreness at injection site and left side neck (muscle) pain was recovered on an unknown date.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not provided. On multiple unknown dates, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB injection (lot number: L025738, expiration date: 14-AUG-2017; dose and route of administration were not provided). The reporter stated that the administered doses of RECOMBIVAX HB of lot number: L025738 were stored at temperature of 17.6 degrees Celsius (C) for 1 hour 38 minutes on an unknown date. Previous temperature excursions included storage at the temperature of 13 degrees C for 72 hours 30 minutes. Digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA014784: US-009507513-1704USA014783.
Pt began having difficulty breathing 15 minutes after injection Vitals monitored, Oxygen 15 liters NRB applied. EMS alerted and gave EPI pen via Auto injector. Transported to local hospital by EMS ambulance.
Heart Palpitations; This is a spontaneous report from a non contactable pharmacist, the patient. A 32-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. 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 COVID vaccine. On 24May2021, the patient experienced heart palpitations. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of reported event. The clinical outcome of the event heart palpitations was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt recvd vax & exp severe disabling joint sx; addtl details are being requested;
This spontaneous report as received from a nurse regarding unspecified number of patients of unknown age. Concurrent conditions and medical history were not reported. On an unknown dates, the unspecified number of patients were vaccinated with PNEUMOVAX23 (dosage regimen, lot # and expiry date were not reported) that was stored improperly  (inappropriate product storage). No adverse events were reported No further information was provided. This case is one of several reports from same reporter. Additional information has been requested.
Information has been received via a representative, from a nurse concerning her 13 year old daughter, a "special needs child" (unspecified disability), who in June 2007 ("last week"), was vaccinated IM with the first dose of Gardasil (Lot # not provided). The nurse reported that the nurse who administered the vaccine "bent the needle," then removed it and restuck her daughter with the same needle. The next day, the nurse reported that her daughter had developed two black bruises "about the size of a pencil eraser." At the time of this report, it was not specified if the patient had recovered. Follow up information from a physician, revealed that he had no communication with the patient nor direct knowledge of the event. He added that he "suspects bruise from shot." The patient sought unspecified medical attention. No further information is expected.
A physician reported that he received an injection of Typhoid vaccine on 4/27/00 and subsequently developed a 4-5 cm area of induration at the injection site. The pt's wife had an adverse event as well.
Right elbow swelling; about 25cc of fluid was withdrawn form the swelling; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Right elbow swelling) and ASPIRATION JOINT (about 25cc of fluid was withdrawn form the swelling) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (Right elbow swelling) and ASPIRATION JOINT (about 25cc of fluid was withdrawn form the swelling). At the time of the report, JOINT SWELLING (Right elbow swelling) and ASPIRATION JOINT (about 25cc of fluid was withdrawn form the swelling) outcome was unknown.            patient has visited his MD 5 times. No concomitant information was provided No treatment information was provided.
This case was reported by a consumer via call center representative and described the occurrence of prosthesis related infection in a 77-year-old male patient who received SHINGRIX for prophylaxis.  The patient had a Family History of bacterial meningitis (bacterial meningitis type b  for his 55-year-old son in law). Concurrent medical conditions included shoulder replacement and exposure to communicable disease (bacterial meningitis type b). On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced prosthesis related infection (serious criteria GSK medically significant). The patient was treated with sulphamethoxazole, trimethoprim (Bactrim). On an unknown date, the outcome of the prosthesis related infection was unknown. It was unknown if the reporter considered the prosthesis related infection to be related to SHINGRIX. Additional details were provided as follows: The patient called to ask questions about BEXSERO. The patient was concerned about being able to contract bacterial meningitis type B from his 55-year-old male son in law. The age at vaccination was not reported. The patient had received other vaccines, including SHINGRIX in the past and was particularly concerned because he was subject to infection. The patient at the time of reporting had an extremely bad infection on his artificial replacement in his shoulder and was being treated with Bactrim. The patient reported that if it did not clear up, he might need surgery. The patient was referred to healthcare professional. This was all the information that was captured. The patient did not consent to follow-up.