chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I'm experiencing a brain fog. I have trouble concentrating. It could be the medication that I take. They started me on a full dose of Clonazepam and this could be the cause to my brain fog, but it's hard to tell. Too much happened at this time.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, injection site swelling and injection site cellulitis. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site swelling and injection site cellulitis were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site pain, injection site swelling and injection site cellulitis to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. After vaccination, the patient experienced injection site reactions consistent with cellulitis, such as pain, redness and swelling. The reporter was not certain that this case confirmed with cellulitis, but the events were resolved spontaneously.The pharmacist reported the all events to VAERs. The call center representative advised to reporter, called to GlaxoSmithKline if had any future events. This is one of the 13 cases reported by same reporter.
ONSET OF SYMPTOMS AROUND 5 PM; VIOLENT SHAKES, FEVER, CHILLS, LACK OF FLUENCY IN SPEECH, TRIED TO GET OUT OF BED, FELL TO FLOOR AND COULDN'T MOVE; STILL VIOLENTLY SHAKING; EMT SHOWED UP TO HOUSE AND TRANSPORT PT TO THE LOCAL ER DEPT WHERE PT WAS MONITORED OVERNIGHT. PT HIMSELF SELF-DISCHARGED AT 10 AM THE NEXT DAY FEELING FINE BACK TO HIS NORMAL SELF.
One year my wife got the shot and days later had the flu.; Initial information received on 26-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves female patient of unknown age got the shot and days later had the flu (influenza) while she received influenza vaccine .  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect vaccine at an unknown dose produced by unknown manufacturer lot number not reported via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date (latency unknown) after the suspect vaccine initiation the patient got the shot and days later had the flu (influenza).  Laboratory details were not reported. Action taken was not applicable.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown.  There will be no information available on the batch number for this case.
Patient got rash on elbows and some tiredness after first  dose of vaccine 8/7/03  Rash is still present after 4 weeks. Took my otherwise healthy daughter for her  second dosewhich  was administered on 9/8/03 at approx. 4:45 pm.  Within 15 minutes after 2nd dose patient came down with extreme fatigue (could not stay awake on the way home in the car) and complained of a sore throat.  Went to sleep immediately and I(mother) had to shake her to wake her up to see if she was ok.  approx. 9:00 pm I woke her to get her to eat and drink.  She said she could not taste anything and her hands were sore and felt "tight".  Afraid she was having an anaphalatic reaction (tongue swelling) I gave her bennadryl.  Continued to sleep through the night and into the next afternoon.  I called Dr.  who told me to take her to the emergency room.  She was complaining of extreme fatigue, legs, hands, both arms, neck and shoulder aches, ear ache, sore throat.  Arm which injection was given was "throbbing".  Emergency room physician was of no help, although he could see swelling in her throat.  Took her home and 9/10/03 she showed no improvement.  Had been sleeping conntiniously for 36 hours, I again called Dr. office and the receptionist made an appointment for 9/11/03 at 10:30 am. Still sleeping continiously at 10:00 am on 9/11/03.  now it has been approx 50 hours of continious sleep.  Dr. drew blood to check for mononucleosis.  Tests came back negative for mono. Took her to another physician on 9/16/03 who confirmed adverse reaction which I had suspected.  It is now 11 days later and my daughter has shown hardly any improvement - although she isn't sleeping continiously.  She is extremely fatigued, been in bed 11 days, arm that vaccine was given in is throbbing, all of her joints ache, muscles ache, ears and throat ache, hurts when she walks up 6 stairs, has not been back to school. She has shown hardly any improvement for 11 days now.  I called CDC in atlanta as well as Dept. of Public Health - they offered no help.
I had a J&J vaccine back in April (there was nowhere to list that on this form), and then the Modern booster on November 28. Since getting the booster I have had a horrible headache every day for almost two weeks now. I feel the pain the most right in my forehead. It's the same level of pain every day and no OTC medicine makes it better. My PCP prescribed me Indomethacin yesterday and I started taking it but it's not helping at all. My doctor's recommendation is that I go to a neurologist, but I called multiple neurologists today and they can't see me for until March.  I'm very concerned that this isn't going away. I do not have any history of headaches and did not have a headache before getting the booster.
Information has been received from a physician concerning 2 or 3 patients who on unknown dates were vaccinated with ROTATEQ (lot # not reported). Patients had a small amount of blood in their stool after vaccination with ROTATEQ. At the time of reporting, the outcomes of the patients were unknown. It was unknown if patients sought medical attention. Upon internal review, a small amount of blood in their stool was determined to be an other important medical event. This is one of several reports received from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Pain at and surrounding injection site and the pain has not resolved after 2 weeks. No swelling, redness, fever. Patient claimed ice pack and tylenol have not helped.
Information has been received from a health professional concerning a 5 year old female who on 02/19/1999 was vaccinated with the first dose of varicella vaccine administered SC in the right thigh. On 05/21/2001 the pt developed 20-25 red spots that turned to fluid filed blisters. The blisters dried after 3-4 days and cleared in 7-9 days. The pt recovered on 05/27/2001. No further info is expected.
Red, hot rash at injection site followed by rash like bumps popping up all over body and at injection site, itching.
Patient presents to the ED with fever, chills, cough. He was admitted for further covid evaluation and treated with remdesivir.
Woke up night of vaccination with a sharp pain in lower back, pinpointed in L5 S1 area which lasted no matter how I moved/slept.  I woke with the same pain which went away that morning but since have had lower back pain in the whole region including directly on the spine (same area) everyday continuously.  It is not sharp but a concerning level.  I have not had sharp back pain for almost 25 years and have not seen a doctor as was not needed.  I had a car accident in my 20's that caused an issue there, but through physical therapy/yoga had healed it in my 20s.  I am so concerned that I cancelled my 2nd vaccination and will not take it.  I am disappointed and hope this pain goes away soon.  The pain is definitely from the vaccine.  I've had ZERO/NO PAIN since my 20's and I'm 51. I do not have a doctor that I see regularly as I've not needed one.  I only have a gynecologist for yearly exams.  I am monitoring the situation daily and if it does not go away soon, will see a doctor.
Acute sensory neural hearing loss of hearing in left ear starting about 8 weeks after vaccination.  Started approximately 2/24/21 and became progressively worse.  Audiogram demonstrated marked change.  Subjectively lost about 50%.  Treated with 10 days prednisone 60 mg/day with improvement to about 15% loss.  MRI scheduled but not completed.  COVID PCR negative.  COVID Ab negative.  Assessed relationship to vaccine--possible but not probable.
LP Rash, itching, Skin Inflammation topical Cortisone, Oral Prednisone Ultra violet light
Had red blotches on left upper thigh and both left and right ankle. They were raised and warm and also itchy. Also flared up my psoriatic arthritis into a full blown attack where I was on prednisone  for almost a month and was out of work for a month.
Patient was given the following vaccines: Hep B, HIB, Rotateq, DT/DTAP, IPV, Pneumococcal Conj. on Monday March 3rd, 2008 around 1:45pm.  He was fussy after and was given Tylenol at the dr's instructions and slept most of Monday evening other than waking to eat.  Tuesday he was still taking deap breaths as if he just finished crying and was very quiet.  Although I still was able to have him coo with me he was very calm and relaxed.  Monday morning I got him ready for daycare and dropped him off around 7:30 along with his sister and received a phone call at 4:45 that my baby was lot breathing.  Daycare performed CPR until the EMS arrived, then the EMS took over and transferred him to the hospital.  At the hospital they tried to revive him for an hour and had to pronounce him dead. 3/31/08-records received from ED for DOS 3/5/08-Presented in cardiopulmonary arrest. Found nonresponsive at daycare. Intubated. No blood pressure, no pulse, asystolic pulse. Patient expired. DX: Cardiopulmonary arrest.
About 10 minutes after the injection I felt something in my throat like when I have a sore throat.  I was checked by the nurse and she said my pulse is beating a little faster.  My breathing was fine. I was brought to Er and my blood pressure was elevated than usual. About almost an hour after the vaccine my forehead started itching  and but I was given  benandryl so my hives didn?t  continue to develop..
No physical adverse reaction, documenting for vaccine error that PedvaxHib administered when it was not due.
Information has been received from a pharmacist referring to a 64 year old female patient. Concurrent conditions and medical history of the patient were not reported. On 12-FEB-2016, the patient was vaccinated with a dose of FLUZONE, then administered both a dose of ZOSTAVAX (lot # L034726, expiry date 09-DEC-2016) subcutaneously (dose, frequency unspecified) and a dose of Tdap (lot#, expiry date, dose, frequency, route unspecified) on 15-FEB-2016. Patient also started therapy with AUGMENTIN 875 mg twice daily (which she had been prescribed for an unspecified reason prior to receiving ZOSTAVAX) in the evening after receiving ZOSTAVAX, on 15-FEB-2016. Concomitant therapy included EPIPEN. The patient became "violently ill to her stomach," clarified as "extreme" nausea and vomiting after taking one dose of AUGMENTIN on 15-FEB-2016. The nausea and vomiting resolved on the following day 16-FEB-2016 and patient would continue therapy with AUGMENTIN. The patient called pharmacist for medical attention. No treatment was given for the event and no lab diagnostics studies performed. Additional information has been requested.
Chest pain / tightness; nausea; extreme fatigue; pain in left / right rib cages; headache; 48 hours to date
Unable to lift arm, sharp stabbing pains. Pressure started into chest, and pain in chest. Was consistent, getting worse. Tried muscle rub cream, several aspirins, tried itch arthritis pills, hot wrap. Still unable to lift arm without stabbing pain. Not sure of if it is permanent disability, has eased up a little, but pain still there, so I am unsure what is wrong, and if it will take time to heal, so marking permanent, but unsure of future.
pt recv vax 3NOV98 & the next day pt devel an inj site rxn characterized by a 3cm by 4cm area of swelling, induration & numbness;the rxn occurred sl distal to site of needle insertion;
11.5 hrs after vaccine patient c/o chest pain, SOB, tachycardia, fever. Also c/o 5 second "shocks"to right hand (opposite side from vaccine site). Chest pain improves with ibuprofen and reproducible with palpation - consistent with chest wall pain.
pt recv vax 12FEB96 & six mont p/vax lab eval was positive for hep b B core antibody;MD retested & found pt to be negative for hep b core antigen antibody & positive for hep b surface antibody;MD indicated believed a false positive test don
Patient was given the wrong dose of the Pfizer Covid 19 vaccine by an MA. She was given the 12 year old and older dose and she is 11 years old.
Prostate-Specific Antigen (PSA), had increased; This case was reported by a consumer via call center representative and described the occurrence of psa increased in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 14th August 2020, 3 days after receiving Shingrix, the patient experienced psa increased. On an unknown date, the outcome of the psa increased was not recovered/not resolved.   It was unknown if the reporter considered the psa increased to be related to Shingrix.  Additional details were provided as follows: The patient reported that he received the first dose of shingrix and got his blood work drawn on 14th August 2020 and his Prostate-Specific Antigen (PSA), had increased.  The patient stated that his PSA levels was the same for the last five years, and they only increased after receiving the vaccine. The health care professional did not provide a diagnosis or change his plan of care, but he would be get his PSA checked again in 6 weeks.  The health care professional informed patient to call back with new results. The patient consented to follow up.
Date of death 2/28/22. Admitted 2/7/22 with acute ischemic stroke. Tested negative for Covid 2/7/22 and 2/9/22 and + 2/11/22.
27SEP93 pt had vax & wk later 7OCT93 woke up w/red marks on face-next morning when woke up face was more red, swollen, red going down neck, achy & uncomfortable; was red & blotchy;
Noticed pink eye in the morning. Around 1 or 2, I noticed the body aches, sore throat, sneezing, and runny nose. On 03/11/2022, I started running a fever. Lasted about a week.
Menstrual symptoms drastically worsened. 3 weeks after my second shot, I started experiencing extremely increased cramping, intensified pain with every day, a much heavier menstruation, and extreme fatigue which normally does not accompany my menses. Treatment is ibuprofen but it does not help the pain at all.
Sore (L) arm, 8cm length, 9.5cm width, discolored, no nausea or fever. Only mild systematic symptoms.
Information has been received from a registered nurse concerning a 41 year old female who on 17-JUL-2007 was vaccinated subcutaneously with a dose of Zostavax (Oka/Merck) instead of a dose of Varivax (Oka/Merck) due to medical error.  The patient sought unspecified medical attention.  The patient did not experience any known symptoms.  There was no product quality complaint involved.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 09/24/07. Follow up information from the nurse indicated that on 17-JUL-2007 the patient also received an IM second dose of diphtheria toxoid + tetanus toxoid (manufacturer unknown) (Lot#U1704BA) in the left deltoid. On 19-JUL-2007 the patient developed soreness at the injection site and joint pain. On 23-JUL-2007 the patient had recovered. No further information was provided. Additional information is not expected.
pt was inadvertently reimmunized 25NOV91 p/receiving a pneumococcal vax (MFR UNK) approx 2 wks earlier; pt exp an injection site reaction;
Initial report was received from a health care professional on 21 August 2012. A female patient (age and date of birth not reported) had received a dose one injection of PENTACEL (lot number, route, site and date not reported) and an unspecified amount of time later experienced a seizure. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: None.
pain on initial injection (felt like many needle pricks rather than the one), persistent pain in left upper arm and shoulder starting with injection and continuing thru to current, very limited movement and use of left arm, not able to sleep on left side. Also, 3 months after injection, diagnosed and treated for pneumonia in right lung at Medical Center Emergency Room, no prior diagnosis of pneumonia ever.
This spontaneous report as received from a licensed practical nurse refers to 3 patients of unknown age. The patients were subcutaneously vaccinated with 0.65 ml ZOSTAVAX (Lot# reported as H009779, Exp date: March 2013). No other co-suspects were reported. No concomitant medications were reported. Subsequently, all 3 patients had "heated, raised swelling with redness in the entire upper arm" on an unknown date. The patients had sought unspecified medical attention. No treatment information was reported. The outcome was unknown. Lot check has been requested for Lot#H009779. This is one report of several reports received from the same source. Additional information has been requested.
Myalgia, Arthralgia, Fever, SkinRash, Rash & UrticariaPruritis Narrative:  Limited movement in arm that shot was given. Rash at injection site. Fever/chills. Treated with steroid shot and antibiotic.  Other Relevant History:
On April 21, 2021, this patient received their first dose of vaccinations during medical in-processing. On April 27, 2021, the patient received their first dose of the Moderna COVID-19 vaccine. The patient answered ?yES? to receiving any vaccine in the past 14 days on the immunization screening form. Patient was discharged without complications and tolerated vaccine well prior to discharge.
had surgery on my ear 09Jan2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Oct2021 at 16:00 as dose 2, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "CRPS" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Single, Batch/Lot No: Unknown. NA, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 16Nov2021, when the patient was 50-year-old, for COVID-19 immunization. The following information was reported: TYMPANIC MEMBRANE PERFORATION (medically significant) with onset 09Jan2022, outcome "recovered", described as "had surgery on my ear 09Jan2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Aug2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of ear operation.  Clinical Information: The reporter (Patient) stated, Not too long after the shot I had a metallic taste that lasted 7 days. I was told that was rare but would go Away. 08Nov2021 I went to the ENT because my right ear ruptured a week later. I just had surgery on my ear 09Jan2022 so hopefully the surgery is a success. I was in perfectly good health was forced by employer (withheld). The patient received thyroid medication in two weeks. No any other vaccine received in four weeks.Other medications in two weeks Thyroid medication. no other vaccine in four weeks.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
3/2/2021 go vaccine - 3/5/2021 had visual issue, bright spinning colorful lights, dizzy. 3/12 had grand mal seizure after same issue. taken away in ambulance. 1st time in my life having a seizure.
Information has been received from a physician through a company representative concerning a 15 year old male patient with a history of vaccination subcutaneously with 2 doses, 0.5ml, of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live, as a child.  On 03/02/2005 the patient came into the office with a case of the mumps.  Concomitant is unknown.  The patient outcome is unknown.  There was no product quality complaint involved.  Additional information has bee requested.
Left arm began to swell and become red and painful within a few minutes. The swelling eventually reached below the elbow and the patient had trouble moving the arm. The patient also developed headache, nausea and low-grade fever, but the time course is unclear.
Excessive fatigue and narcolepsy/cateplexy started mid October after receiving 3rd HPV vaccine and have continued since then.
Patient received COVID-19 vaccination (Moderna) on 04/30/2021 from a store pharmacy. Patient presented to the Emergency Department on 05/04/2021 with a chief complaint of chest pain. Patient informed the care team that he began feeling intermittent, non-exertional chest discomfort on 05/01/2021.  Patient was then evaluated by the inpatient cardiologist due to concern for a myocardial infarction. The patient had a troponin of 8.9 ng/mL that climbed to 19.9 ng/mL the next day. Patient was ultimately diagnosed with  Myopericarditis and initiated on treatment with carvedilol and colchicine.
I noticed a large red area at the injection site (upper arm).  Within 3 or 4 hours, there was considerable redness and swelling in the area which continued to increase. By evening, the redness covered most of the back side of the upper arm with a very hot, hard center about 2.5 inches in diameter with an irregular shape. I used Benadryl cream, hydrocortisone cream and cold pack on the site.  By evening, I was developing a slight headache and the shoulder joint and elbow were aching.  The following day, the swelling was about the same, and by evening I had a raging headache.  At this time, 3/29/2010, the redness and swelling has subsided some, but is still there with some discomfort.  There has been NO respiratory problems or anything that I would consider life threatening.
Woke up an 4:00 AM the morning after receiving shot with random pain across back and shoulders.  Throughout the day felt extreme muscle weakness and fatigue.  The second day symptoms   were even worse, could not walk up stairs, stayed in bed over half of the day.  Fatigue is accompanied with inability to concentrate and general malaise.
Horrible headache with a very sore arm.  Arm felt like a wet noodle and ached terribly
medication was given 7 hours and 3 minutes after dilution outside of the 6 hour window
12 hours after getting the third dose she could not walk, she didn't know where she was (very confused)
Onset of strong aches in knees and shoulders where I have arthritis. I was quite sore and spent the rest of the day relaxing. After a good nights sleep, I was back to normal.