chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A few weeks after my second Pfizer dose I began experiencing menstrual irregularities. At first, my period would come a week early which is notable given I was on birth control pills. Then, during the summer, my periods started becoming longer in duration, lasting 8-12 days. In September, I got my period/had breakthrough bleeding 3 times in the month for a total of 16 days that month. In October I got my period once, but it lasted for 12 days. In November, I got my period twice: 11/3-11/7 and then 11/9. I have not stopped bleeding since the 11/9 and today, 12/15 my bleeding has become heavier. I have been seen by an OB/Gyn, had a CBC (normal), my thyroid values checked (normal), and also had an ultrasound which found no polyps, cysts or fibroids. I have also seen a rheumatologist and had a complete autoimmune panel run which shows I am positive for ANA and Lupus Anticoagulant. I am a nationally ranked distance runner and am becoming anemic due to the blood loss which has an extreme negative impact on my performance and caused me to faint at my cross country meet.
100° fever; This is a spontaneous report received from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (COMIRNATY; Lot number: EW0161) via an unspecified route of administration in the left arm on 16Apr2021(at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes mellitus. The patient previously took amoxicillin(MANUFACTURER UNKNOWN) on an unknown date and experienced drug allergy. The patient has taken unspecified concomitant medications. Prior to 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 vaccination. On 16Apr2021 at 19:45, the patient had 100 degree fever. Therapeutic measures were not taken as a result of  the adverse event. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event 100 degree fever was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Severe pain throughout muscle of injection site (12 hours), Insomnia (48 hours - sleep aid required)
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 02-AUG-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 "23-10pk-0.5ml-SD PFS LLok w Tip" which had a lot number of M005287 and expiration date on 08-OCT-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified date, the PNEUMOVAX 23 had two temperature excursions; one for 32 hours with lowest recorded temperature of 34 F (1.1 celsius) and other one for 24 hours with lowest recorded temperature of 32 F (0 Celsius). The lowest recorded temperature was 32 F (0 Celsius) and the highest recorded temperature was not mentioned. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
Headache, body ache, 102.3 temperature, took 1000 mg ibuprofen
This spontaneous report was received from a consumer concerning her 11 year old daughter who was vaccinated with GARDASIL (dose, route and lot not reported) 6 months ago approximately in August 2012 and the date of the report on 19-FEB-2013 was going to get the second shot on 19-feb-2013. No adverse reactions were reported. The outcome of the event was unknown. The reporter considered the event to be not related to GARDASIL. Additional information is not expected.
Information has been received from a 65 year old female with no allergies or medical history who on 19-Dec-2006 was vaccinated with a 0.5 ml dose of varicella-zoster virus vaccine live. Concomitant therapy included cetirizine hydrochloride (ZYRTEC). On 19-Dec-2006, the patient experienced a headache after vaccination and was hospitalized. The patient recovered on 20-Dec-2006. No diagnostic laboratory test were performed. A product quality complaint was not involved. No further information is available.
Flu Like Symptoms; Chills; Body ache; Headache; Fever; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th January 2020, the patient received the 1st dose of Shingrix (intramuscular). In January 2020, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, chills, general body pain, headache and fever. In January 2020, the outcome of the influenza-like symptoms, chills, general body pain, headache and fever were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, chills, general body pain, headache and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. In the night of vaccination, the patient started experiencing flu like symptoms, chills, body ache, headache and fever that lasted for total of 3 days.  The reporter consented to follow up. No other details were provided.
felt like he was coming down with a cold or the flu; out of work today due to his current symptoms.; feeling cold; soreness in left arm / pain in the arm; fever; cramping in stomach; nausea; exhausted; trouble sleeping; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 17th October 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, fever, stomach cramps, nausea, exhaustion and difficulty sleeping. On 19th October 2020, the patient experienced influenza like illness, activities of daily living impaired and feeling cold. The patient was treated with naproxen (Aleve). On 18th October 2020, the outcome of the pain in arm, fever, stomach cramps and nausea were recovered/resolved. On an unknown date, the outcome of the exhaustion, difficulty sleeping, influenza like illness and feeling cold were recovered/resolved and the outcome of the activities of daily living impaired was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, fever, stomach cramps, nausea, exhaustion, difficulty sleeping, influenza like illness, activities of daily living impaired and feeling cold to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix (intramuscular), pain in arm, fever, stomach cramps, nausea, exhaustion, difficulty sleeping, influenza and activities of daily living impaired feeling cold. The patient reported that took Aleve and put an ice pack on the left arm Saturday evening. The patient reported within 3 hours after receiving vaccine was exhausted and this is still ongoing at till the time of reporting.  The patient reported trouble sleeping Saturday night due to the pain in the arm and this has resolved at till the time of reporting. The reporter consented to follow up. No further information was available.
hives on legs (close to plevic area) severe rash under right arm. Body aches and tired on 04/30 - more concerned about the rash
developed sx of sore throat, stuffy head 10/20, tested negative on binax rapid antigen 10/21, tested positive on binax rapid antigen 10/24
Tingling on lips and tongue within 5 minutes of vaccine. Then progressed to minor swelling of mouth area and increased tingling. Felt like numbness around entire bottom portion of face.
Skin Rash and/or Hives, swollen feet, hands, face and entire body. Extremely itchy. went to the Emergency room on 4/20/09 and was kept overnight for observation, I was released but the systoms were getting worst, and I returned to the ER on 4/23/09 my whole body was swollen and with an axiety attack and was admitted to the hospital and released on 4/25/09. I can't remember the name of the medicine given but I believe it was Predisone, Benadryl.  5/26/09 Hospital records received DOS 4/23/09 to 4/25/09. FINAL DIAGNOSIS: Allergic reaction, erythema multiforme, anxiety. Post vaccination erythema multiforme, rash and hives, shortness of breath, feels like throat is closing, biliary colic, anxious and jittery. ICD-9 Codes: 7080 allergic urticaria, 7821 rash / nonspecific skin eruption, 78605 shortness of breath, 27800 obesity unspecified, 5718 other chronic nonalcoholic liver diseas, 57420 calcu gallbladder w/o mention of cholecyst/obst, 69510 erythema multiforme unsepcified, 30000 anxiety state unspecified, 28860 leukocytosis unspecified, V5865 long-term use of steroids.
This spontaneous report as received from a licensed vocational nurse refers to a 16 year old female patient. The patient had no illness at time of vaccination. No information on patient's medical history or concomitant medications was provided. On 01-SEP-2015 at 08:40 AM., the patient was vaccinated with the second dose (reported as #1 given elsewhere) of VARIVAX (Merck) injection, lot # L010145, subcutaneously in the right arm (dose and expiration date were not provided) that was improperly stored. The patient's concomitant medications given on the same date and time included IPOL (manufacturer reported as Sanofi, intramuscularly in the right arm, fifth dose (4 doses given elsewhere)) and HAVRIX (intramuscularly in the right arm). No adverse effects reported. This is one of the several reports from the same source. Additional information is not expected as all correspondence was received.
High fever, lethargic, ashen skin coloring. The fever was treated with Tylenol (maxing out the appropriate 24 dosage).
Rash Narrative: dose 1: day 2 sore & red arm; 2-day 2: sore & red arm; welts day 2-6 wks
Information has been received from a physician concerning an infant who was vaccinated with a second dose of ROTATEQ. The infant developed blood in their stool within one week post vaccination. The mother took the infant to the emergency room (ER), given that "the office" was closed. They were met in the ER by the physician. The infant underwent an x-ray, the results of which were negative. The physician diagnosed the condition as hematochezia, etiology unknown. It was noted that although the condition did not resolve, the infant did complete the series. There was no product quality complaint. Upon internal review the event of hematochezia was considered to be a other medically important event (OME). Additional information has been requested.
7cm red, non-warm, hard area on R hip area. 24 hr after given vaccine. Use Tylenol and cool compresses. Temp. 96.9F.
Patient is a 69 y.o. male here after an episode of seizure like activity last night.  Patient got up to go the bathroom and fill the toilet and on to the for and has seizure-like activity that lasted about 30-40 seconds.  Witnessed by wife.  She described seeing his eyes stay open, arms clenched, legs extended, and unresponsive, no tremors.  He hit his head on the ground.  Patient did vomit and was incontinent.  This morning patient feels tired.  Patient declined going to the ER last night.  Denies having seizures in the past however he does have history of syncopal episodes due to low blood glucose.  He is not on any diabetic medications. HPI Patient came in and got influenza vaccination. Three to four hours later, he did not feel quite right. His wife told him that the flu vaccine always makes a person feel achy. He says he had right shoulder burning and felt like pins and needles. He says around 11 AM, he went to pee. His wife asked him to sit down. He then began vomiting. After this, he had sweats and felt hot. He then passed away. She did not bite tongue. He did urinate but on the other hand, it occurred when he was planning to use the restroom to pee. He was unconscious for less than 1 minute.
ADMINISTRATION ERROR: 17-YEAR-OLD FEMALE PATIENT RECEIVES SECOND DOSE OF MODERNA
First noticed tenderness & redness on left upper arm.  Condition worsen through the day to: area hot & hard to touch, redness increased and pain. Spoke with M.D. office. Advised to monitor & go to E.R. if condition worsens.  No treatment received.
FEVER; VOMITING; HEADACHE; CHILLS; This spontaneous report received from a consumer 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, intramuscular, batch number: Unknown) dose was not reported, administered on 06-MAR-2021 to Right Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-MAR-2021 (about 5 hours post vaccination), the patient experienced chills. On 07-MAR-2021, the patient experienced fever, vomiting and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, vomiting and headache was not reported. This report was non-serious.
has two autoimmune diseases; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (has two autoimmune diseases) 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.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 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 AUTOIMMUNE DISORDER (has two autoimmune diseases) (seriousness criterion medically significant). At the time of the report, AUTOIMMUNE DISORDER (has two autoimmune diseases) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: 0.02 (Low) level was 0.02, 5 months after the first dose.         The patient was tested by the physician a couple of days ago to see how effective the two doses of COVID shots were.  Concomitant products were not provided.   Treatment medication was not reported. Very limited information regarding this event has been provided at this time. Additional information required.; Sender's Comments: Very limited information regarding this event has been provided at this time. Additional information required.
This case was reported by a pharmacist via call center representative and described the occurrence of general malaise in a 60-year-old female patient who received SHINGRIX for prophylaxis. On 20th August 2018, the patient received the 2nd dose of SHINGRIX. In August 2018, less than a day after receiving SHINGRIX, the patient experienced general malaise and fever. On an unknown date, the outcome of the general malaise and fever were unknown. It was unknown if the reporter considered the general malaise and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX a day prior to reporting date, and overnight experienced general malaise and a possible low grade fever. The reporter did not have access to lot number or expiration date.
Fever, aching, cough, sore throat, have had numerous flu shots throughout years. Never any problems (last shot 11-11-11 (dr's office).
Initial information received on 18-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a female patient (reported as 41or 43 years) who was vaccinated with a suspect dose of FLUZONE QUADRIVALENT lot UT6290KA (Expiry date: 30-Jun-2019) via intramuscular route in the deltoid on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is an actual medication error case due to wrong injection technique. It was reported that the nurse attempted without the needle for the injection and all the liquid ran down on her arm. It was also a case of exposure via skin contact and a case of needle issue. It was reported that order arrived without the needles attached. 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 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. List of documents held by sender: none.
Vaccinated on 12/28/20.   1/4/21- Pt had swelling  and pain of the LEFT breast and under arm lymph nodes. This subsided on 1/07/21.  1/07/21- Large, red, raised rash appeared on LEFT deltoid. Measuring 4in. x 4in.  Itchy but not painful. Doctor was consulted. Patient given Benadryl and Zyrtec. Rash began to shrink in size and became lighter in color. Rash still present but is slowly resolving as of today.(1/12/21).
Fever of 100 degrees F. Chills and body soreness.   No treatments. Fever broke the next day, Continued soreness at the injection site.
Pt experienced a large local skin reaction described as erythema, edema, pain & induration at the site of injection after receiving Typhoid vaccine.
started to get ulcers in mouth. It was some kind of sore and taste changed, it was not oozing. It was inside of lower lip and into the corner of mouth. It was very painful. Tongue burns; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (1st Booster, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (2nd Booster, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: MOUTH ULCERATION (non-serious), 4 days after the suspect product(s) administration, outcome "unknown", described as "started to get ulcers in mouth. It was some kind of sore and taste changed, it was not oozing. It was inside of lower lip and into the corner of mouth. It was very painful. Tongue burns". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient enquired for information regarding a potential adverse effect she was experiencing. She referred that 4 days after getting her third booster, the adult Pfizer BioNTech COVID-19 bivalent vaccine, she started to get ulcers in her mouth. It was some kind of sore and her taste changed, it was not oozing. It was inside of her lower lip and into the corner of her mouth. It was very painful. Her tongue burns. Some days it goes away and some days it comes back. The patient have not gotten COVID-19 so she discarded that, and all her bloodwork came back normal. Her dentist said she saw other patients coming with the same issue. She was not the only one. She also saw online some people complaining about the same issue. She havent changed her diet, she take the same 5 pills that she have been taking for 15 years so she thought she could call Pfizer to get some information, but she see that it has been a waste of time.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Severe increased pain and quantity of blood loss during period. The already strong menstrual symptoms were heightened further impacting daily activities.
Patient admitted on 5/5/21 for suspected acute ischemic CVA after presenting with altered speech for a day (last known well on 5/4/21 PM). No CT evidence of an acute intracranial process. Her pacemaker precluded MRI evaluation.  Pacer interrogated on 5/6/21 with AT/AF burden <0.1%. She was seen in consultation by neurology.  Evaluation and clinical deficits were suggestive of acute ischemic CVA. Risk factors for CVA include age, HTN, Afib. Patient recently received her first COVID-19 vaccine (Pfizer) on 4/26/21. Patient?s symptoms improving with antiplatelet and statin therapies along with blood pressure management. Per Neurology consult, possible etiologies include cardioembolic versus atheroembolic versus thrombotic versus inflammatory related to recent COVID-19 vaccine. The neurologist specifically stated that ?The COVID vaccine was temporally close to this event. I have seen transient CNS inflammation from the vaccine--probability low but still possibility.?
Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 24-Jan-2022; Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 24-Jan-2022; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 24-Jan-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 24-Jan-2022) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2022 at 5:13 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 24-Jan-2022 at 5:13 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 24-Jan-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 24-Jan-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 24-Jan-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 24-Jan-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  The patient received Moderna vaccine past its 30 day of expiry date. Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021, this vaccine was administered up until its manufacturing expiry date of 4 April 2022.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-542869 (Patient Link).