chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient went in for mamogram on Monday 10/28/19. and noticed swelling. By tuesday 11/29/19 it was hurting and swollen red. Went to urgent care of which sent her to ER. Patient was admitted, given IV antibiotics, blood work, check for clots. Discharged Thursday 10/31/19 - given oral antibiotics.
pt recvd vax & devel sore throats & rashes; No further details were provided;
If the patient received/ first dose over a year ago do they have to start the series over?; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on unknown date, over a year prior to reporting).   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 age at vaccination was not applicable for this report. Till the time of reporting, patients did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The Healthcare professional was later asked by medical information agent that what product the person received and the reporter answered that it was Shingrix. No more information was available.
I had diarrhea at night on Sep 22nd, 2012 and also got several cramp in stomach which I never experienced. Then, my baby has no heart beat in the next ob/gyn office visit.
This spontaneous report was received from a healthcare worker referring to a 17 week and 3 days old patient of unknown gender. Information about the patient's medical history and concurrent conditions was not provided. On 09-JUN-2016, the patient was vaccinated with the first dose of ROTATEQ, orally (dose, lot number and expiration date were not provided) at 17 week and 3 days of age, which is considered outside the recommended age range. No concomitant therapies were reported. No adverse effects were reported. Additional information has been requested.
fever-not measured; pain @ lt shoulder & chest, pain & inflammation of joints, severe h/a, dizziness;
Patient was given flublok at age of 13, this is restricted to 18+ years of age without specific documentation of need, patient at this time has not experienced any adverse events
Swelling with fluid buildup from left armpit down to left side of breast and upper side of torso.  At day 4 still present and seems to be working it's way downward. Red rash which appeared at day 2 after injection and subsided at day 3.
57 yo male patient received his first dose of the Moderna COVID-19 vaccine on 12/31 @0726. Patient called institution's vaccination line on 1/6 @1216 stating that the day after his vaccination he experienced arthralgia and myalgia. Three days after vaccination his hands, arms and legs were swollen and painful. He had severe hip pain and was unable to open or close his right hand. Patient went to the ER at an outside institution and was admitted where he was treated with 3 days of methylprednisolone 125 mg. He continued to experience migratory polyarthralgia including his knees, ankles, and hands.Patient diagnosed with and admitted for COVID-19 on 1/21 which was mild, no respiratory distress, some fevers, and some migratory arthralgia. Discharged on 1/22. Still experiencing diffuse joint pain and after consult with rheumatology was started on colchicine. Did not proceed with 2nd vaccine dose scheduled for 1/28 due to COVID-19 diagnosis and arthralgia reaction.
On the date listed, I began to have a mild amount of chest pain. Pain was persistent, did not have shortness of breath. Pain would occur thought out the day and at night. Pain was not relieved by any otc medication.
After 2 weeks got sick with Headache, nasua, dizzyness, neck pain, sleepness, Loss of smell & taste, Physicl Therapy
Patient was febrile at 104F.  Found passed out on floor at home.  SIRS from vaccine administration is the likely cause of this event
I am considering as side effects not adverse reactions. The day after vaccination I experienced: weakness, joint pain, dizziness, nausea, vomiting,  chills, headache, fever of 101.7. The symptoms were intense. On the second day after vaccination I felt better with temperature of 100.5 and headache. On the  third day I was back to normal.  Should I take the SECOND dose on 27th of January? Thank you.
Grandma noticed some redness and slight swelling in right deltoid. 7/21/05 per mom child much better. Follow up - Vaccine lot number received.
Treatment of COVID-19; Treatment of COVID-19; Moderna: dose#1-2 and Pfizer / BioNTech: dose#3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose 3 (booster), single (Lot number: GH9702) at the age of 43 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Mar2021 as dose 1, single (Lot number: 017B21A), in left arm and on 21Dec2021 as dose 2, single (Lot number: 029H21B), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 14Oct2022, outcome "unknown", described as "Moderna: dose#1-2 and Pfizer / BioNTech: dose#3"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Positive; (Sep2023) Negative; (Sep2023) Negative. Therapeutic measures were taken as a result of covid-19, drug ineffective. No follow-up attempts are possible. No further information is expected.
Client received vaccine at approx 530pm. at 551 client complained of itching. Benadryl 50 mg administered. Client then complained of seeing double. Client remained alert and responsive to staff during time. V/s -BP- 110/70 86 18 97% EMS called and arrived. client left facility at approx 615pm accompanied by two EMT technicians
Information has been received from a consumer referring his/her daughter, a female patient of unknown age. The patient's concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot #, dose and route were unknown). The patient's concomitant medication was not reported. On an unknown date, the patient was "a shadow of her former self". The outcome of the adverse event was unknown. The causality between the event and GARDASIL was not reported. Additional information is not expected.
Patient states she developed a painful lump at injection site.  It showed little improvement in the 28 days up to the second dose. After the second dose it became more painful and persists still. She has seen her PCP who has suggested doing an ultrasound on the injection site.
Patient complained of tongue feeling thick at back of mouth/throat.   Examined by MD in clinic.
No adverse effect; an unspecified number of patients may have been administered an improperly stored doses of MMRII; This spontaneous report was received from a physician referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and drug reaction/allergies were unknown. Concomitant therapies included sterile diluent. On an unknown dates, the patients may have been administered an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) of lot # S005249  with expiry date 20-FEB-2021 (dose, strength, dose number, route of administration unspecified) for prophylaxis (product storage error). On an unknown date, the vaccines were exposed to the temperature of 11.73 Celsius for 4 hours and 30 minutes. There was no previous temperature excursion and digital data logger was involved. No adverse effects were reported.   Follow up information was received from physician on 07-NOV-2019.     No vaccine adverse reaction were reported. The only had to recall patients because no data available for temperature excursion. On 23-OCT-2019, during office site visit temperature excursion were noted. 10, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) doses (Lot # R000550, expiry date: 08-JAN-2020) were stored to 24.08 degree Celsius. Since no data exists were (illegible doc) to revaccinate. No adverse reaction noted.    This is a non-valid case due to lack of patient identifiers.  Follow up information was received from the physician on 08-APR-2020.   This information refers to a 12-months-old female patient. On 19-JUN-2019, the patient was administered with an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) with Lot number R000550.  This is one of several cases received from the same reporter.  This case was previously considered non-valid, but upon receipt of follow-up it was determined that the case is now valid as the patient demographics were obtained.; Sender's Comments:  US-009507513-1910USA016114:
This case was reported by a consumer and described the occurrence of diarrhea in a male subject aged between 60 and 69 years old who was vaccinated with Engerix B for prophylaxis.  The reporter is the subject.  A physician or other health care professional has not verified this report.  The subject had no pre-existing medical conditions.  There were no concurrent medications.  On an unspecified date before 29 November 2006, the subject received the 2nd dose of Engerix B.  At an unspecified time after vaccination with the 2nd dose of Engerix B, on an unspecified date before 29 November 2006, the subject experienced diarrhea and stool color change from "brown to yellow."  On 29 November 2006, the subject received 3rd dose of Engerix B.  The subject was seen at a physician's office.  At the time of initial reporting, 19 February 2007, the subject reported that the diarrhea had improved and that he is "now having one firm stool in the morning and then diarrhea later in the day."  The outcome of the stool color change was not reported.  Follow-up information was received from the subject on 20 February 2007.  The subject reported that he was advised to have a liver function test.  He called to report that his liver function test was "fine".  He reported: "I have a good liver".
Patient was inadvertently given Johnson & Johnson booster shot when the requested booster was the Pfizer booster.
Period Bleeding/prolonged period blood that won't stop; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Period Bleeding/prolonged period blood that won't stop) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (Period Bleeding/prolonged period blood that won't stop). The patient was treated with PARACETAMOL (TYLENOL) for Prolonged periods, at an unspecified dose and frequency. At the time of the report, HEAVY MENSTRUAL BLEEDING (Period Bleeding/prolonged period blood that won't stop) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.
Information has been received from a consumer concerning her 15 year old daughter, with no pertinent medical history, who in January 2007, was vaccinated with a 0.5 ml dose of Gardasil. There was no concomitant medication. Subsequently the patient experienced "some dizziness while taking" Gardasil. It was reported that the patient did not seek medical attention. On an unspecified date, the patient recovered. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Information has been received from a physician and a consumer concerning her 15 year old daughter, with no pertinent medical history, who on 20-DEC-2006 was vaccinated intramuscularly, into the left deltoid, with a 0.5 ml second dose of GARDASIL (lot #653978/0955F). There was no concomitant medication. In late March it was reported by phone that the patient felt dizzy and lightheaded. It was reported that the patient did not seek medical attention. On an unspecified date, the patient recovered. No further information is available.
diarrhea; different taste on the tongue; numbness on the tongue; soreness of the deltoid muscle; sleepiness; This is spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not provided. The patient reported diarrhea the next day after receiving the vaccine as well as different taste on the tongue or numbness on the tongue that is foreign to her normal days. She also experienced soreness of the deltoid muscle and sleepiness. The outcome of the events was unknown.  Information on lot/batch number has been requested.
After the  vaccine for dose 1 on  5/21/2021. Swelling of lips, jaw and tongue on and off and then hives throughout my body. Presently I have constant post nasal drip and I cough so infected and sore throat. Was prescribed Levocetirizine and Fluticasone. Also had Amox- clav. I still have the allegies.
Sudden dizziness and then vomiting. Specifically within hours of food being eaten. Nausea the following 2 days, March 28, 29, specifically after eating. March 30th, woke up with chills, sore throat, headache, body aches lasting all day. Diarrhea. No longer nauseated. March 31st, all symptoms subsiding except for a minor headache and sore throat with mild cough and phlegm.
Patient witnessed another patient become syncopal and she herself had a syncopal episode. She was responsive within 10 seconds. Patient  was monitored for a longer period of time and fully recovered.  She was taken home by her mother.
Reported by MD achy joints, conjunctivitis, fever, h/a, macular rash on face, trunk, extremities.
This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A female patient received the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), Feb 2021; both single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced hypoacusis (harder for her to hear), with outcome of unknown. Additional information: Patient had both COVID-19 vaccinations back in February. She also lost her husband at that time. She thinks she may have thrown out her vaccination card. Her doctor has proof of the first shot, but not the second shot. She was directed back to the facility where she received vaccine from for vaccination history. It is harder for her to hear when not on speaker phone. About a week and a half ago they were testing people for COVID-19, she hasn't heard as to whether she was positive or not. Not clarified if she had hearing issues prior to vaccine. Not clarified what symptoms she had that encouraged her to get tested for COVID-19. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
1/15/2021 vaccination 1/17/2021 Evening, I had a dullish pain lower right abdominal area. I would have to hold that area when I was in pain. I saw my PCM on that Wed.  1/27 blood panel per PCM 2/1 ultra sound; collection of cells on R side, 'benign and normal' 2/16 CT scan  2/17 2nd vaccination; flu-like symptoms  3/1 blood panel repeated *lot# of vaccine not provided on card *pain still comes and goes, esp when I don't drink water; mild. This pain appeared 2 days after vaccination.
Pain swelling redness left arm neck pain, HA nausea fever treatment seen urgent care put on ZYRTEC 10mg. TYLENOL/ADVIL.
10/30/2009 Injection site is very hard, hot, swollen and burning. 11/1/09 went to urgent care clinic. Prescription given. Entire upper arm hard, swollen and burning hot.
Vaccine expired on 13-Oct-2021 and placed in refrigerator on 30-Oct-2021; Doses was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and placed in refrigerator on 30-Oct-2021) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and placed in refrigerator on 30-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and placed in refrigerator on 30-Oct-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that there was a confusion between the expiration date printed in the carton and the expiration date when the code was scanned. No adverse events were reported. Vial did not undergo any temperature excursion. Vial was placed in refrigerator on 30-Oct-2021.  No treatment medications were reported.
Severe stomach cramping and diarrhea. Severe muscle and bone pain  Swelling of arm
This spontaneous report was received from a nurse refers to a 6 month old male patient. No pertinent medical history was reported. On 15-OCT-2014, the patient started therapy with ROTATEQ VIAL (lot # K008139 and expiration date 15-APR-2016) dose 1, oral for routine vaccination. On 17-FEB-2015, the patient was vaccinated with dose 3, 2 ml, oral. On 17-FEB-2015, the patient coughed either during or after administration of his third 2 ml ROTATEQ, oral and as a result, a drop of rotavirus vaccine, inadvertently entered the eye of another nurse (refer MARRS # 1502USA009155). It was not clarified whether this may had resulted in a partial dose of ROTATEQ. Treatment was not given to the patient. Patient sought medical attention, still in office when event occurred. No Product Quality Complaint (PQC) was involved. Action taken with the therapy of ROTATEQ. On 17-FEB-2015, the outcome of events was reported as recovered/resolved. Causality was not assessed by the reporter. This is one of two reports from the same source. Additional information has been requested.
Signs and symptoms on-site: anxiety, lightheadedness/dizziness, shortness of breath, difficulty swallowing.   About 12 minutes after receiving a Rabies immunization, the donor reported experiencing difficult swallowing and difficulty breathing. 50 mg of Benadryl PO was administered, and paramedics were called.. Respiration rate 14 breaths per minutes. After about 5 minutes donor stated symptoms began to resolve.  Paramedics arrived and donor released to paramedics.  Donor transported to hospital in stable condition.  Follow-up with donor on 3/20/18: Donor stated she also experienced itching and had hives noted at the hospital. But, she felt fine and left hospital same day. Donor was not prescribed medications and denied taking anything for the reaction after leaving the plasm center. Per donor, all symptoms resolved by the next morning (after immunization).
About 4 weeks post vax pt was noted to have four raw scattered macular lesions about 1/2 -3/4 cm on back of neck; no vesicles. Pt was treated with Bactroban. Pt continues to develop scattered lesions on body.
fever (under 100 degrees) muscle aches, diarrhea, extreme fatigue and generally feeling terrible. This lasted 48 hours. Then I woke up with what felt like a head cold. I still have diarrhea.
High Heart Beat, severe dizziness, High Fever, unable to stay awake, this lasted for 36 hours
Chest pain began the evening of June 18th 2021. Chest pains continue to this day. I began having daily debilitating headaches that continue to this day. Difficulty breathing that comes and goes. Muscle spasms in legs, arms, and face.  Severe anxiety. GI issues such as bloating, cramping, blood and mucus in stool. Daily dizziness
She has COPD and other health conditions and went to the hospital for a few days after getting the vaccine; This is a spontaneous report from a contactable consumer (reported for her mother-in-law). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the COVID-19 vaccine on 07Jan2021. It was reported that on Jan2021, she has chronic obstructive pulmonary disease (COPD) and other health conditions and went to the hospital for a few days after getting the vaccine. The reporter was where she can get the second dose now, she thinks the date she was supposed to get it has passed. She needed to find out where the second dose can be attained and asked for the number to the local health department for their area. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Patient went in for a sports physical. She received Bexsero. Within 5 hours had such severe arm pain she can not lift her arm. Can not function due to pain/no comfortable position. Pain continues even when resting and not moving. Vaccine also caused headache and fever of 100%. None of the symptoms have resolved 24 hours later. Pain was intolerable. Unable to sleep overnight. Not just mild pain and swelling, but extreme pain.
pt recv vax & had an allerg rxn to vax;pt reported the same morning recv vax nose became stuffy w/diff breathing & gen achiness;to ER for observation;MD contacted by mom;pt has a cold & cough @ present time on amoxicillin;