chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nausea; extreme discomfort of gas; Chills in her hand; bright neon yellowurine / today was brown; congestion in her nose.; This case was reported by a consumer via call center representative and described the occurrence of nausea in a female patient who received Flu Seasonal QIV  (FluLaval Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th November 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. In November 2022, 5 days after receiving FluLaval Quadrivalent 2022-2023 season and an unknown time after starting Flulaval Tetra Pre-Filled Syringe Device, the patient experienced nausea, gas, cold hands, urine coloring yellow and nasal congestion. On an unknown date, the outcome of the nausea, gas, cold hands and nasal congestion were unknown and the outcome of the urine coloring yellow was not recovered/not resolved.   It was unknown if the reporter considered the nausea to be related to FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. The reporter considered the gas, cold hands, urine coloring yellow and nasal congestion to be unrelated to FluLaval Quadrivalent 2022-2023 season. It was unknown if the reporter considered the gas, cold hands, urine coloring yellow and nasal congestion to be related to Flulaval Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-NOV-2022 Reporter's Comment: Five days after vaccination in the left arm the patient experienced extreme discomfort of gas, chills in her hand, urine turned bright neon yellow, nausea, and congestion in her nose.  Today (on the day of reporting) when patient went to restroom and stated her urine was brown.  The reporter did not want to give any of her information as far as name, number, address, or date of birth.  The reporter consented to follow up.
pt recv vax MAY96 & 7MAY97 pt devel chickenpox consisting of rash w/many lesions, low grade fever, & a sore throat;pt was reported that pt was covered from head to toe;pt seen by MD @ which time pt was seropositive for varicella;
It kept getting worst; Fluid build up in underarm area; Underarm area with discomfort / When she puts her arm down, it is uncomfortable; It looks like a balloon; Discomfort insider her bra; Lightheadedness; Arm sore; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheadedness), PAIN IN EXTREMITY (Arm sore), BREAST DISCOMFORT (Discomfort insider her bra ), CONDITION AGGRAVATED (It kept getting worst) and FLUID RETENTION (Fluid build up in underarm area) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE/HYDROCHLOROTHIAZIDE) for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 06-Apr-2021, the patient experienced DIZZINESS (Lightheadedness) and PAIN IN EXTREMITY (Arm sore). On 10-Apr-2021, the patient experienced BREAST DISCOMFORT (Discomfort insider her bra ). On 12-Apr-2021, the patient experienced CONDITION AGGRAVATED (It kept getting worst), FLUID RETENTION (Fluid build up in underarm area), DISCOMFORT (Underarm area with discomfort / When she puts her arm down, it is uncomfortable) and SWELLING (It looks like a balloon). At the time of the report, DIZZINESS (Lightheadedness), PAIN IN EXTREMITY (Arm sore), BREAST DISCOMFORT (Discomfort insider her bra ), CONDITION AGGRAVATED (It kept getting worst), FLUID RETENTION (Fluid build up in underarm area), DISCOMFORT (Underarm area with discomfort / When she puts her arm down, it is uncomfortable) and SWELLING (It looks like a balloon) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included warm compress.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Follow up information was received on 12-APR-2021. Added dose unit details & Batch number, events durations, events outcome, and updated Treatment details.
Swollen lymph nodes in the arm pit; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes in the arm pit) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes in the arm pit). The patient was treated with PARACETAMOL (TYLENOL) for Swollen lymph nodes, at a dose of 1 dosage form. At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes in the arm pit) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided
Information has been received from a registered nurse concerning a 4 month old patient, who on 16-OCT-2008, was vaccinated with the first dose of ROTATEQ, orally; on 16-DEC-2008, with the second dose of ROTATEQ, orally, and on 26-DEC-2008 with the third dose of ROTATEQ, orally. No adverse symptoms reported. Additional information has been requested.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 25-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 06Dec2021 (Lot number: FJ1620) at the age of 25 years as dose 3, (booster) single for Covid-19 immunisation; influenza vaccine (FLU), administered in arm right, administration date 06Dec2021 (Batch/Lot number: unknown) as dose number unknown, single. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN; PEPTO BISMOL [BISMUTH SUBSALICYLATE]. Past drug history included: Corozine prochlorperazine, reaction(s): "Allergies: Corozine prochlorperazine". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ew0168, Location of injection: Arm Right), when the patient was 24 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Ew0172, Location of injection: Arm Right), when the patient was 24 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Booster"; URTICARIA (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Spontaneous urticaria/body is breaking out into hives/large welts"; PRURITUS (non-serious) with onset 18Dec2021, outcome "not recovered", described as "itchiness"; BURNING SENSATION (non-serious), PARAESTHESIA (non-serious) all with onset 18Dec2021, outcome "not recovered" and all described as "My hands burn and tingle"; SCRATCH (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Scratching at the skin"; PRODUCT USE ISSUE (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Other vaccine same date vaccine date 06Dec2021". Therapeutic measures were not taken as a result of immunisation, urticaria, pruritus, burning sensation, paraesthesia, scratch, product use issue. Additional information: Patient has not received other vaccine in four weeks. Adverse event: Spontaneous urticaria. Patient whole body was breaking out into hives with itchiness moving all over. My hands burn and tingle without any reaction to doing anything. Scratching at the skin causing large welts to form on my skin. Taking a Benadryl has helped, she takes 3 a day. Patient has not suffered from Covid prior vaccination and patient was not tested post vaccination. No known allergies were reported. No follow-up attempts are possible. No further information is expected.
Sore left injection site arm; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site arm) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore left injection site arm) outcome was unknown.        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 medication information was provided. No treatment medication were provided.   This case was linked to MOD-2022-539791 (Patient Link).
This is my first Covid shot.  I previously had COVID in July 2020.  Upon waking the day after my shot I felt fatigued and tired.  As the day went on, my symptoms became more severe.  I was severely exhausted, muscle aches, foggy brain, temperature of 101.5, and I lost my taste.  the symptoms felt like I did when I had COVID but more severe.  Day 2 waking up, I felt better but still foggy and slightly fatigued.
Information has been received from a registered nurse concerning a 7-year-old female with asthma and allergies to Zithromax, cyprohetador, beef, corn, soy, and milk, chronic gastric paresis, eosinophilic, and esophagitis who on 26-FEB-2007 at 4:30PM was vaccinated SC in the right arm with a second dose of Varivax (lot #656079/1306F). Concomitant therapy that day at 4:30PM included a forth dose of Fluzone (lot # U62271AA) administered in the right deltoid. Additional concomitant therapy included montelukas sodium, Flovent, Prevacid, Miralax and Vitamins (unspecified). On 26-FEB-2007 at 5:45PM, the patient's whole body became bright red, and the child became itchy and warm with hives. In additional, the patient's eyes started to swell. After talking to the doctor, 25mg Benadryl was given and was told to go to the ER. The patient began wheezing on the way to the ER. Epinephrine was given in the ER and the patient was discharged on prednisone. Subsequently, the patient recovered. There was no product quality complaint. The events were considered to be immediately life-threatening and other important medical events by the reporter. Additional information has been requested.
@ 130-2PM had an episode (w/babysitter) for about 2min-eyes rolled back, pt was limp;no tonic/clonic movements, no vomiting or fever;pt seen in office & eval;no tx necessary;
Sore arm and redness - Doctor considered just a mild muscular reaction -Skin is sensitive also.  - Warm compress - Tylenol, cannot take Advil.   Follow back as needed.  Confirmed with doctor that I was fine to receive booster on December 17th.
Local reaction, red circular macule, warm to touch 2 3/4 x 2 1/4 in on right shoulder. 10/24/17.
Following vaxs - son exp delayed growth, anorexia, constipation characterized by slow ht & wt gain. No wt gain 2 mos-4 mos. 1/20 pt delayed in devel, doesn't walk, talk, or eat by himself. Hosp for 15 days, feeding tubes.
got the flu after a flu shot/ suspected vaccination failure; got the flu; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 81-year-old male patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine. On an unknown date, an unknown time after receiving Influenza vaccine, the patient experienced vaccination failure (Verbatim: got the flu after a flu shot/ suspected vaccination failure) (serious criteria GSK medically significant) and influenza (Verbatim: got the flu).  The outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine.     It was unknown if the company considered the vaccination failure and influenza to be related to Influenza vaccine.   Additional Information: GSK Receipt Date: 05-OCT-2023 The reporter stated that her husband got the flu after a flu shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for flu and laboratory confirmation regarding flu were unknown at the time of reporting. The reporter did not consent to follow up. This case is linked with US2023137024, same reporter.; Sender's Comments:  US-GSK-US2023137024:Same reporter
fever, cough, fatigue, weakness, SOB, generalized body aches.  Tested positive 11/30
I started with itchiness at the injection site.  Prior to this I had a lump and soreness to the touch  but no redness or itchiness. When I got home from work  on 1.19.2021 I noticed a large red  patch which was hot to the touch.  During the day my arm where I received the injection became very itchy.  During the day I also was extremely tired and had developed a headache and felt like I may be getting a cold.  I also had a neckache.  I still have those symptoms.   I received my vaccine on 1.06.2021.
Rapid heart rate, achy, fever 101, flu like symptoms started about 7 hours after vaccine. She did have Covid on 11/1/2020. She is going to give it today and see how she feels and will let me know if she goes to the DR or ER.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date the patients were vaccinated with a dose of improperly stored GARDASIL 9 (incorrect product storage) (lot number and expiry date unknown) (dosing regimen and frequency unknown) for prophylaxis. No concomitant medications were reported. No adverse effects were reported. It was reported that the temperatures had reached below recommended temperatures. Specific temperature excursion details were unavailable at the time. This case is linked to case number 1610USA011174 and 1610USA011175 via same reporter link. All telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested. Narrative updated. Sender's Comments: US-009507513-1610USA011175: US-009507513-1610USA011174: MERCK 1610USA009568:Mfr number.
Died following his DTP; This case was reported by a consumer via interactive digital media and described the occurrence of death in a 20-month-old patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, less than 2 years after receiving DTPa vaccine, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the death to be related to DTPa vaccine.  Additional details were provided as follows; The age at vaccination was not reported, however the patient could be 20 months old or less than that at time of vaccination. The reporter friends son died following his DTP. The reporter stated that their lives are ruined forever. Th reporter stated that everyone needs to educate themselves beyond their pediatricians who receive a handsome bonus annually depending on the amount of vaccines administered. The number of vaccines children receive these days was completely ridiculous. Many at once and we were always told to give our babies Tylenol following the shots. Th reporter stated that Tylenol inhibits the liver's processing of these toxins further and everyone's quick to judge until their child loses his life or was vaccine injured.; Reported Cause(s) of Death: Unknown cause of death
Patient and patients father gave incorrect age of patient orally and on consent as 16 years old.  Nurse did not check math of birthday.  15 year old vaccinated with vaccine approved for 16+.  No known harm done to patient.  Waiting to hear from Risk department prior to contacting, second does will not be offered at this time.
crying for several hr on & off;went on for 2 days, would not eat & diff sleeping;
Patient called to report a clogging feeling in her left ear where she could barely hear out of it. She reported receiving her vaccine at 12p on 5/3/21 and started to experience these symptoms all of a sudden out of nowhere around 5:45p.  She reported these symptoms to the pharmacy at 6:15p on 5/3/21. She was also experiencing the usual pain in the left arm where she got the injection and a little cramp feeling in the muscle around her heart on the side of her body where she received the vaccine.
Information has been received from a medical assistant concerning a female patient with no known history who was vaccinated with pneumococcal 23v polysaccharide vaccine (Lot #658555/0964U). The patient developed redness and inflammation at the injection site> The symptoms appeared either one or two days after the vaccination. It was reported that three patients all received the same vaccination, two females and one male, all from the same lot number and they all developed redness and inflammation. Only one of the three patients recovered from the symptoms. The other two patients are either recovering or unknown. One patient received the flu vaccine along with pneumococcal 23v polysaccharide vaccine (Lot #658555/0964U) on a different arm. No further information is available. Additional information has been requested.
Information has been received from a RN concerning an adult white female (age unk), with no illnesses at the time of the vaccination or preexisting allergies, birth defects or medical conditions, who at 11:00AM on 12Dec05 was vaccinated IM with a first dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant medication. At 11:00AM, on 12Dec05 the pt experienced injection site redness and painful to touch. Subsequently, on 19Dec05 the pt recovered. There was no product quality complaint involved. Additional information is not expected.
After vaccine administration Patient and fiance stepped out to observation unit, fiance came back within 10 seconds to report dizziness, patient experienced syncopal event and head hit wooden floor- somewhat cushioned by fiance. Unresponsive to verbal and tactile stimulation. Fiance reports hx of seizure disorder. 911 called. Pulse not palpable by 2 nurses. Compressions started for less than one minute, patient rousable and oriented. Patient reports hx of syncopal events with medical situations. EMT staff take over. Patient left for eval at ED.
Felt similar to IV-DHE treatment...  at around 3am I woke up, felt my whole body  heat up really quickly - rapid flush - heart racing - chest constricted - difficult to breathe while laying down.  Sat up, grabbed washcloth with cool water, applied to face and neck, popped pillows so could sleep partially upright.  Whole episode lasted about 10 minutes and then I went back to sleep.   Frightening but not life-threatening.  would have been scarier had I not experienced something like this once before.
diffuse rash polyruptic & erythematous all over body-24hr post vax;this started as small papules & disappeared p/48hr;pt was fine except for this annular, polyruptic erythema;
Left leg swelling &  mild erythema within 2 days of vaccine.  PCP recommended Tylenol as needed  & Rx Amoxicillin
pt recvd vax 14DEC92, 17DEC92 mom called to say pt had t104; 18DEC92 parent instructed office pt devel a rash & was told to bring pt to office; 18DEC92 roseola infantum;
body aches; Fever of 101.8; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported), via an unspecified route of administration on 04Mar2021 as second dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 05Mar2021 morning the patient experienced little body aches then later in the day she started to have a fever. She said an hour before reporting it went up a whole degree and she is getting really hot. She said when she went to get the vaccine, the nurse who gave her the vaccine told her she couldn't have Ibuprofen, and then on info sheet it said she could. With a fever of 101.8, she wants to know if she can take some because she wants to. The outcome of the event fever was not recovered, while the outcome of  the event little body aches was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
CHILLS, FEVER, ACHY, FELT LIKE I GOT HIT BY A TRAIN
Pt is 56 yo female s/p full Moderna COVID vaccination: dose 1 on 12/30/20 and dose 2 on 1/27/2021. Pt is an employee of this institution. On 8/9, pt reports new onset sore throat and congestion/runny nose. She reports possible exposure to a COVID positive person. Rapid COVID test results back positive on 8/9. On 8/11 pt received casirivimab/imdevimab infusion.
Information has been received from a certified medical assistant concerning a 15 year old female pt with no past medical history and no allergies who on 02Sep95 was vaccinated with a dose of varicella virus vaccine live. On 09Feb2004 the pt developed chickenpox. The pt was seen with red papules and small vesicle points at the first visit to the physician's office. About 4 days later, the condition was a little improved. It was noted that the office did run tests which came out positive for chickenpox. The rash occurred on the facial body, and upper extremities. It was noted that the pt recovered. No product quality complaint was involved. Additional information has been requested.