chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt had no reaction to her first HPV vaccine. She had no past medical problems or complaints until  January 2020 after she had her second HPV vaccine.  In the immediate days post her 2nd dose of the HPV vaccine given on 1/20/2020 pt began experiencing trouble sleeping, fatigue, poor appetite, stomach pains. Symptoms were initially thought to be temporary side effects that would go away but unfortunately pt continued to have symptoms of abdominal pain. She was not a patient of our practice at the time of vaccination of immediately after however old records from her previous pcp document no medical problems, childhood illnesses or concerns at her visits. She established care with us in april 2020 where she noted weight loss and was seen on 6/9/2020 c/o of continued abdominal complaints and severe constipation. thyroid testing was done along with an abdominal x ray. thyroid testing showing autoimmune thyroiditis and abdominal imaging revealed significant constipation. she was referred to pediatric GI for her continued abdominal complaints and was seen june 25, 2020. She was also referred to pediatric endocrinology. She was ultimately diagnosed with crohn's disease after undergoing GI work up, testing and MRI. She is now on lifelong treatment including thyroid surveillance, intermittent steroids and humira.  She continues to follow with pediatric endocrinology for autoimmune thyroiditis.
Patient received the vaccine on 1/21 she presented for her first OB US on 2/4 and pregnancy was found to be nonviable;  Patient has D&C scheduled for next week and more information will be available at that time
Swelling, redness and itching at the site of the shot. Significant swelling in the left armpit.
She had a reaction for the first dose; Headache; does not feel well; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Feb2021 (Batch/Lot Number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient reported that she had a reaction to the first dose on an unspecified date, the event was serious and caused hospitalization, the patient experienced also headache and "does not feel well", both on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
2/17 in the evening I noticed a redness on my arm. I drew a circle around it and it surpassed the circle. it is around my injections site and is 5 inches long by 5 inches wide and getting bigger. it is swollen as well. its a little warm and itchy. I took 2 benadryl.
I woke up from sleeping around 2:00 am on 8/5 (approx 12 hours after my vaccine) to difficulty breathing and a sore throat. I felt like there was pressure on my chest and although I could still take deep breaths, it was difficult.
First had fever, body aches, then neck pain, shoulder/arm pain; left side of back  stabbing pain, diarrhea, stomach pain; then later left leg pain traveling down her  leg. SOB and chest pain that same night, but chest pain went away by next day.  Seen in community Urgent Care the night of the vaccine; placed on  prednisone pack. All symptoms resolved, except for left arm at injection site and  shoulder pain
Diffuse urticarial rash, fevers, tachycardia, transient hypotension, body aches
1:50 pm patient complained of HA, dizziness, nausea. Provided water, elevated legs, observed x 5 minutes. Patient's color became very pale. EMS notified. Placed on O2 at 3L NP. SATS on RA 95%; after O2 improved to 98%. Initial VS 182/110 (2:05 pm); p 78; R. 30 - irregular. Glucose - 100dl BP 212/113; p 78. R 30. Nausea better. Sipping water. Refused food. 1415hrs. Fire/rescue arrives at 1420. Assessed patient. She initially refused transport, but later gave her consent. 1438 Transported to ER.
From telephone contact received at manufacturer on 10/01/2002, it was reported that a 43-year-old female pt (DOB 12/17/1958) was administered the 4th dose of Imovax Rabies (lot #U0961-2) on 09/28/2002 for post-exposure prophylaxis. Sometime after vaccination (date unspecified), she experienced a fever of 102 degrees F and headache. She was prescribed acetominophen by her physician. The symptoms resolved as per reporter.
Diarrhea; Tiredness; Fever of 100.2 F; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), FATIGUE (Tiredness), PYREXIA (Fever of 100.2 F) and MYALGIA (Body aches) 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 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), FATIGUE (Tiredness), PYREXIA (Fever of 100.2 F) and MYALGIA (Body aches). At the time of the report, DIARRHOEA (Diarrhea), FATIGUE (Tiredness), PYREXIA (Fever of 100.2 F) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-039255 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up received on 04-MAY-2021, contains no new information; Sender's Comments:  MOD-2021-039255:same reporter (daughter case)
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 5:02 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 5:02 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 70.64.  Concomitant products were not provided.  On 11-Jan-2021, At excursion time 09:00 AM, temperature was 34, total doses given for the day was 98 and at 02:00 PM, temperature was 35, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 08-Jan-2021, vial was moved to clinic on 11-Jan-2021. 9 vials were sent to clinic. Vaccine BUD date was 07-Feb-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
3-4 days after vaccination: Dizziness - I felt as though I was unable to keep my balance On day 5, I woke up in the morning with severe allergic reaction all over my hands, the palms of my feet, and inflammation the inside of my mouth (palate and toung). The dizziness continued for many more days.  I also had on and off chest pains.  I had a chest x-ray done in the emergency room which indicated inflammation in the lower area of my lungs.  I was given a prescription for Prednisone (steroids) which helped reduce all of the above.
immediate persisting Metal Taste from the throat and front lower teeth leg cramps later 6 hrs later
Headache; Sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date 07Mar2021 14:45 (Batch/Lot number: unknown) at the age of 69 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "Headache"; OROPHARYNGEAL PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "Sore throat". Therapeutic measures were not taken as a result of headache, oropharyngeal pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Noticed a baseball sized red, warm, sensitive area around vaccination site.  In addition, an upper body rash, headache, elevated blood pressure developed.  She sought medical care.  Took some Benadryl on Sunday; noticed an improvement.
Site where Prevnar was given was swollen red and painful approximately 2-3 hrs after injection.
Pt: Redness, swelling, pain in both areas, fever, flu symptoms, date of visit 9/20/10. Provider: erythema, induration (left deltoid 11 x 7 cm, right deltoid 15 x 10 cm, date of visit 9/20/10.
liver ache/believed it could have been due to ginseng; liver ache/believed it could have been due to ginseng; Fatigue; lethargic; Felt a little achy; Dizzy; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6201), intramuscularly in left arm on 23Feb2021 (at the age of 69-years-old) at a single dose for COVID-19 immunization. The patient also took ginseng, via an unspecified route of administration from an unspecified date to 04Mar2021 at one pill, twice a day for an unspecified indication. Medical history included hepatitis A from 1975, moderate drinking and liver ache. Concomitant medications included L-arginine taken to "keep the veins permeable"; aspartate zinc, magnesium aspartate, pyridoxine hydrochloride (ZMA) taken to help after exercise, help rebuild muscle tissue, keep up the blood flow; and lepidium meyenii (MACA). The patient reported he was slightly dizzy on 25Feb2021, just a little bit, couple of days after. Then on Saturday, 27Feb2021, he was the most fatigued he was. He really was lethargic to sit there. He did not have a temperature but felt a little achy. He felt it was just minor, not serious at all, nothing to be debilitated. He was not debilitated at all. The patient further stated that he maybe experienced a very strange side effect. He mentioned that he had hepatitis A in 1975 and did not drink for a couple of years to get his system better and to keep his liver from becoming scarred. This happened when he was 25-26 years old; though he enjoyed life of a moderate drinking with eating. Earlier on, maybe a few years after he had hepatitis, he would feel his liver ache a little. After the first shot, on 28Feb2021, he felt an ache in his liver and did not know what it was. It lasted 3-4 days on and off. He used Ginseng and changed the kind of what he used to take. He had to take it twice a day, each pill with 7% of ginsenosides so he got 14% in a day. He researched to see if there was any effect that his liver would have because he noticed that it happened a couple of hours after the ginseng. He had read about it on the internet, there were insights of ginseng interacting with medication and can possibly cause some form of liver damage. He stopped using ginseng and felt fine. The liver ache stopped after 4 days on 04Mar2021. That was when he stopped using the ginseng. It was only an ache nothing really a damage at all. It was an unusual may be a coincidental happening. He had the hepatitis A in 1975 then felt the liver ache most recently. He believed it could have been due to ginseng as COVID-19 vaccine was flowing through his body. The action taken in response to ginseng was permanently withdrawn in 04Mar2021. Outcome of the event liver ache was recovered on 04Mar2021, and of the remaining events was unknown.
1 day post vaccines complex generalized seizure with fever 103 lasting 30 minutes requiring intubation and ICU admission to Med Ctr
Vomiting, fever, achy, loss of appetite, stomach pain. Given IV's. The discharge summary states weakness, dehydration, vertigo and nausea.
I started getting symptoms of sore throat, cough, and chills. I thought it was a cold. I took an at home COVID-19 test that was positive. I have cough, congestion, difficulty breathing, and body aches and pains that have progressed.
Red rash that extended the length of inside upper left thigh, itched, began approximately 4:45 pm and resolved by 9:30 pm
Patient complained of tingling in neck and throat area.  We administer 50mg of diphenhydramine orally.  Patient then complained of a lump in her throat that did not go away .  We check her blood pressure it was 201/102.  We then called 911.  Patient was assessed and transported to hospital.
Client returned with spouse, stated "I have this feeling of tachycardia, sl. nausea, and a urge to defecate."States" anxious anxiety." Assisted to lay down flat with feet elevated, called 911. Cold/wet compress to head/neck. Radial pulse 96. Resp even/unlabored, skin dry, color, good. No complaints of itch. States having "bronchitis chronic": heavy thick cough, no note of emesis or phlegm c/o weakness in legs. Asked if diabetic denied. Asked if taking any meds at this time for cardiac - Pt denied. Patient asked when last time ate: states "this morning I had an Activia YoguA and some mashed potatoes". All I ate for dinner last night was mashed potatoes." States not having much of an appetite for the last week, eating only jello. Asked again about bronchitis, pt states "I have had it of/on for the past few days, but felt good yesterday." States taking MUCINEX for congestion. Denies taking antibodies antihistamine. At time of influenza injection, patient was asked how she was feeling, weather she had a flu shot before, patient denied any illness at this time, no mention of having bronchitis. States having flu vaccine in the past with any incidence. Advise patients to stay at vaccine site for 10-15minutes. EMS arrived at the clinic at 1020AM. At this time allowed paramedics to take over. Patient verbal, no s/s of distress noted at this time - 1045 patient transported in ambulance to hospital.
Numbness beginning in the nose and spreading to the jaw and rest of face, arms and hands. Numbness  and weakness in the hands and lower arms lasted for 3 days before gradually resolving
Per pt, the "massive" diarrhea started the next evening after the vaccine, she also had some nausea. After 4-5 days, she took imodium and this improved her symptoms. She has been keeping in contact with her gastroenterologist and states she has already done stool testing, lab tests, colonoscopy, and US and they have been all been normal.    Even now about 3 weeks later, when she doesn't take Imodium, the "runs" come back. When she takes Imodium, she only needs to pass stools 1-2 times per day. She doesn't want to take Imodium everyday, which she discussed with her GI doctor. He recommended that she try metamucil. She has also stopped her tumeric supplement. She has not start the metamucil yet.
pt admitted to hospital positive for COVID. He received 3 doses of Moderna on 1/8/21, 2/5/21, 11/24/21. Unfortunately he passed on 12/14/21
The pt experienced a 2 cm red raised painful area on the left thigh where 2 shots were given. Nothing on the right thigh where shots were given.
Pt was vaccinated with two doses of varicella virus vaccine live.  Subsequently the pt experienced a lack of seroconversion. Additional information has been requested.
EKG showed minor heart Block; Dizzy; Cannot walk; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIOVENTRICULAR BLOCK (EKG showed minor heart Block) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hip replacement. Concurrent medical conditions included Diabetes. Concomitant products included CALCIUM CARBONATE (FORTIFY) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced ATRIOVENTRICULAR BLOCK (EKG showed minor heart Block) (seriousness criterion medically significant), DIZZINESS (Dizzy) and GAIT INABILITY (Cannot walk). At the time of the report, ATRIOVENTRICULAR BLOCK (EKG showed minor heart Block) had not resolved and DIZZINESS (Dizzy) and GAIT INABILITY (Cannot walk) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Blood glucose: 140 140. On 06-Mar-2021, Electrocardiogram: abnormal showed minor Heart block.. On 06-Mar-2021, Heart rate: 42 42.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was temporarily withheld on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the events 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 events a causal relationship cannot be excluded.
Nurse reports no other AE; administration of an expired dose of MMR II to a patient; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.     On 28-JUN-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) 0.5 milliliter, lot number S015962, expiration date 23-MAY-2021 (route of administration not provided) for prophylaxis. No adverse event was reported.
Reports waking up on 1/25/07 with feeling of liquid in his throat and chest - causing him to cough. Had minimal nasal drainage and states his chest felt tight making him unable to take a deep breath. Additional symptoms started around 630-7pm that night included body aches, headache, dizziness, dry cough, periods of chills and diaphoresis - lasting throughout the night with fever increase to. Denies taking medication states all signs/symptoms resolved by afternoon on 1/27/07.
lump appeared near the injection site; extreme fatigue; it is sore at the injection site; This spontaneous report was received from a male patient, age reported as 55 (units not provided), reporting on himself. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant therapies were not reported.    On 15-OCT-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), intramuscular, for prophylaxis (strength, dose, lot number, and expiration date were not reported).   On an unknown date in 2020, the patient experienced injection site pain and extreme fatigue. The patient reported that on approximately 05-NOV-2020 (reported as 3 weeks after the injection), a lump appeared near the injection site (injection site mass).   At the time of reporting, the outcome of injection site pain, fatigue and injection site mass was unknown.
Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves five-month-old female patient for whom medication error was reported, while she received vaccine PENTACEL. batch number: C5516AA, expiration date: 15-Sep-2019, (dose, was not reported for both vaccines) via intramuscular route in the left vastus lateralis on 25-Sep-2018. The patient's medical history was not reported. Concomitant medications included PNEUMOCOCCAL VACCINE 13V and ROTAVIRUS VACCINE. It was an actual medication error due to product preparation error. (It was reported that Medical Assistants gave a patient the PENTACEL without using the proper diluent provided and used sterile water for injection that we had out at room temperature instead here in the office by accident). The patient didn't get the solution part of the vaccine, only got powdered form. The patient didn't have an adverse event to anything. It was unknown whether the patient had any adverse event. 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. List of documents held by sender: none.
No additional information provided; Patient was administered an expired dose of ROTATEQ; This spontaneous report was received from a pharmacist referring to a 3-month-old patient. The patient's medical and drug history, current conditions, and concomitant medications were not provided.       On 27-DEC-2021, the 3-month-old patient was vaccinated with expired first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis (expired product administered) (dose, vaccination scheme, route of administration, anatomical location of vaccination, and lot number were not reported). The dose expired on 25-DEC-2021.  No product quality compliant and no additional information provided (no adverse event) were reported.
Step-mom states that pt had a rash after she got home from receiving H1N1. Rash now resolved.
Received MENACTRA vaccine on Thursday and he felt fine on Thursday and Friday. Then Saturday felt like lungs were sore, 100.0 Temp alternately cold and hot, and felt drained. Had intermittent off balance. Currently in exam room without fever, VSS, Pulse Ox 98% room air.
c/o of feeling faint;extreme diaphoresis;mild dyspnea;chest pressure;tightness in throat;BP 98/60, pulse 48-60;
PT. DEVELOPED SOB, NAUSEA, VOMITING, FEVER   ADMITTED TO HOSPITAL 6/12/2021 REPORTS FAMILY ALL VACCINATED BUT TESTED POSITIVE ALSO STILL INPATIENT