chrisvoncsefalvay/vaers-outcomes huggingface dataset:
her spinal stenosis "hit me again"; started "acting up"; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), administration date 20Feb2021 (Lot number: EL9267, Expiration Date: May2021) at the age of 78 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "spinal stenosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Steroid injections, start date: 2018. The following information was reported: SPINAL STENOSIS (non-serious) with onset 22Feb2021, outcome "not recovered", described as "her spinal stenosis "hit me again"; PAIN (non-serious) with onset 22Feb2021, outcome "unknown", described as "started "acting up"". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of spinal stenosis, pain.  Additional information: The patient was wondering, had spinal stenosis. The patient usually gets steroid shots but the last steroid shot she got was 3 years ago, patient had been fine this whole time until 20Feb2021, her doctor had told to ge t the COVID shot and on 20Feb2021 she got the first shot which was on a Saturday and then Monday her spinal stenosis hit her again, it was the same problem, full time and patient has seen the doctor 2 times since then. Her doctor put her on Hydrocodone and Gabapentin and that didn't do much and then changed it and put her on Oxycodone 3 per day and 2 Lyrica per day which has helped some but he told her make sure to get the second shot on 16Mar.  No follow-up attempts are possible. No further information is expected.
brain bleed; Initial information received on 07-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves a patient of unknown demographics whose brain bleed while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE, injection (strength, dose, route, frequency: unknown) produced by unknown manufacturer lot number not reported in unknown administration site as prophylactic vaccination.  On an unknown date the patient had brain bleed (cerebral haemorrhage) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  The patient haven't had the flue sense 1990.   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (brain bleed).  At time of reporting, the outcome was Unknown for the event brain bleed.; Sender's Comments: Sanofi Company Comment dated 13-Jan-2022. This case involves a patient of unknown demographics whose brain bleed while receiving vaccine INFLUENZA VACCINE. Based upon the reported information, the role of a vaccine cannot be assessed  Further information regarding therapy details, time to onset, concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case.
Fatigue and Brain Fog February 2022 Dizziness April 2022  February 2022 Heart Ultrasound shows widened right atrium April 2022 Doctor doubles blood pressure meds for high blood pressure May 2022 Hospitalized for 3 nights for dizziness.  New heart ultrasound shows widened right atrium and mild regurgitation of both mitral and tricuspid valves.
Migraine; Felt tired; Notice red bumps that were warm and itchy on the same site as the injection site; Notice red bumps that were warm and itchy on the same site as the injection site; Notice red bumps that were warm and itchy on the same site as the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Notice red bumps that were warm and itchy on the same site as the injection site), MIGRAINE (Migraine), VACCINATION SITE PRURITUS (Notice red bumps that were warm and itchy on the same site as the injection site), FATIGUE (Felt tired) and VACCINATION SITE ERYTHEMA (Notice red bumps that were warm and itchy on the same site as the injection site) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  .  Concomitant products included APIXABAN (ELIQUIS), METOPROLOL and PARACETAMOL (TYLENOL) for an unknown indication.    On 03-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Notice red bumps that were warm and itchy on the same site as the injection site), VACCINATION SITE PRURITUS (Notice red bumps that were warm and itchy on the same site as the injection site) and VACCINATION SITE ERYTHEMA (Notice red bumps that were warm and itchy on the same site as the injection site). On an unknown date, the patient experienced MIGRAINE (Migraine) and FATIGUE (Felt tired). At the time of the report, VACCINATION SITE WARMTH (Notice red bumps that were warm and itchy on the same site as the injection site), MIGRAINE (Migraine), VACCINATION SITE PRURITUS (Notice red bumps that were warm and itchy on the same site as the injection site), FATIGUE (Felt tired) and VACCINATION SITE ERYTHEMA (Notice red bumps that were warm and itchy on the same site as the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
05/07/04 client calls to report injection site is swollen, red and warm to touch. Fever at 99 and c/o dizziness since evening of 5/6/04. Rec: she apply cool compress to control fever, force fluids, and see medical provider. Client seen by Dr-given cortisone ointment, he felt dizziness was unrelated. 5/10/04 Client reports less swelling and redness
about 6 days later I started getting bad headaches, on and off. Leg pain, joint pain, dizzyness on and off and overall tiredness. 9 days later I started noticing odd bruises on my legs and arms. I am overall tired and achy. The headache comes and goes and I need to take tylenol.
covid vaccine has made me sick for 7 months; This is a spontaneous report received from a contactable reporter for a Pfizer sponsored program (005570). The reporter is the patient. A patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: illness, outcome unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient selected on our consent form that she will faint with vaccines sometimes, gave the patient the vaccine, she said she felt fine so she went to sit in our waiting area. I came out to give the next patient a vaccine, I checked on the patient and she was fine. Once I was completing the other patient's vaccine I noticed that she looked slightly pale so I went over to the patient to see if she was okay. She sat down on the floor, as we got her to the floor she passed out in my arms, she regained consciousness about a minute later. The patient waited around for another 20-30 minutes then left once she felt better. We gave her a cold glass of water while she waited as well.
A report was received from a health care professional on 08Nov02, concerning a female vaccinee who inadvertently received Fluvirin SC on 07Nov02. On 07Nov02 the vaccinee received 0.5ml Fluvirin SC. No adverse reaction was reported in relation to the incident. There was insufficient information to determine the reporter's causality assessment. Cross reference with: PJP-2002-00731, PJP200200729, PJP200200749, PJP200200744, PJP200200741, PJP200200720, PJP200200745, PJP200200690, PJP200200743.
arm itchy; arm splotchy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (arm itchy) and RASH (arm splotchy) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced PRURITUS (arm itchy) and RASH (arm splotchy). At the time of the report, PRURITUS (arm itchy) and RASH (arm splotchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.
This case was reported by a healthcare professional and described the occurrence of low grade temperature in a male subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medical conditions included sarcoidosis. On 20 June 2008, the subject received 1st dose of TWINRIX (1 ml, unknown). On 24 June 2008, four days after vaccination with TWINRIX, the subject returned to the medical office and reported a low grade temperature and sore throat. The reporting healthcare professional was unsure if the events were related to the TWINRIX vaccination or some other illness. At the time of reporting, the sore throat was worse, and the outcome of the fever was unknown. Follow-up information was received on 21 July 2008 via a healthcare professional, who reported that the subject was a 45-year-old male. In addition to the previously reported adverse events to be serious nor related to vaccine with TWINRIX. The related professional stated that several patients reported similar symptoms, all of which resolved within 24 hours. However, none of the other patients with these symptoms received a TWINRIX vaccination.
Pt. received both vaccines in left deltoid 2/15/2022.  Beginning  2/16/2022 pt. experiencing pain in left arm and left shoulder, generalized body aches and fever.  Called clinic 2/18/2022, reports symptoms are still occurring, "but it's a little better today."  Advised pt. to apply warm moist compresses to vaccine administration site, and to take OTC pain medications for fever and body aches.  Pt. agrees to rest today, present to UC or ER if needed over the weekend if worse at all.
Child given expired dose oral ROTATEQ 5 (12-8-10) per Dr., parent to be contacted to bring child for redose 4 wks after invalid dose was given.
Nausea 2/1/2010 5:00am 2/2/10 complaining of leg pain/achiness
After patient received the vaccine, patient was informed to stay in the waiting area for 15 minutes. After about 5 minutes of giving the vaccine, patient started feeling dizzy and requested to be given water. Patient became a little pale. 911 was called and the paramedics arrived less than 10 minutes and took patient's vital signs. Patient was asked if she wants to go to the hospital but she declined. Patient left the pharmacy with her husband after she was evaluated by  the paramedics
On 06/23/16, 73 yo F presented to clinic for an annual wellness visit. During this appointment, pt was ordered to receive Pneumococcal polysaccharide vaccine 23-valent greater than or equal to 2yo SQ/IM (PNEUMOVAX-23) . Per immunization record, 0.5 mL was injected into left deltoid (NDC #0006-4943-00, lot #M003027, exp: 6/21/2017). Pt was then discharged home. On 06/24/16, pt returned to clinic with complains of itching, redness and warmth at the injection site. Pt examination by RN found an ~2x6 inch area of erythema on pt's left upper arm, ventral aspect. Although injection site had been documented as IM, clinical findings suggested that site selection was more likely in subQ tissue in the back of pt's upper arm. MD made aware and recommended supportive care with topical hydrocortisone cream, oral diphenhydramine and localized application of ice/cold compresses. Pt was also instructed to report to ED for any symptom worsening. Pt verbalized understanding and was discharged home.
3 days after receiving the flu shot, patient presented to clinic (10/1/18) with hives. She was then put on prednisone and VISTARIL. She also complained of high blood pressure at same visit and was prescribed lisinopril, clonazepam, and atenolol. On 10/4/18, patient presented to same clinic and was prescribed a ZPAK, CLARITIN D, and ondansetron. She did not purchase the CLARITIN D and she claimed to have a reaction to the ondansetron. On 10/11/2018 she returned to same clinic and was prescribed to amlodipine. Patient presented to a different clinic (Urgent Care) on 10/15/18 and was prescribed BROMFED DM and doxycycline. She claimed to have blurred vision from the doxycyline and quit taking medicine after one dose. She returned to Urgent Care on 10/16/18 and was prescribed meclizine for dizziness and Cefdinir. She is allergic to Cefdinir and doctor is looking into a different medicine at this time.
This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 16-MAY-2013, the patient was vaccinated with a dose of VAQTA, (lot # H010659, expiry date MAR-2015), which was exposed to 31 degree Fahrenheit. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient given vaccinations morning of 9/15/09. At 8 PM following day patient starte vomiting. This continued through the next day. Parents called clinic where vaccinations given. Family instructed to go immediately to urgent care.
CLIENT HAD A BREAKTHROUGH INFECTION AFTER RECEIVING BOTH DOSES OF PFIZER. FIRST VACCINATION 2/19/21, SECOND DOSE 3/12/2021.  CASE MANAGER WAS NOT ABLE TO LOCATE CLIENT.
This infant had a fever and generalized swelling all over his body. The patient was seen in the local emergency room.
Gums and under the tongue swelling - gums were extremely painful and under tongue was swollen to a flat surface and it was gradually getting tougher to swallow
I started to have weakness on my left side around 9 hours after receiving the vaccine. I went to the hospital and was told I had a stroke in the right side of my brain from a clot in my brain,  which they took the clot out using a catheter through my leg. I am currently undergoing rehabilitation at a rehab hospital.
Red and slightly raised. Warm to the touch and covering an area from above the elbow to the upper arm. Improving per the patient.
Patient is a 66-year-old female here for evaluation of right shoulder pain.  She states that she received her Covid vaccine in the left deltoid, and her flu vaccine in the right deltoid at pharmacy on 9/24/2021.  Her left side feels fine.  She states that the few days after the vaccine her right arm became increasingly painful and stiff, and she has joint pain that has made it difficult to continue swimming or doing activities with overhead motions.  Her left side feels completely fine.  She is concerned that she possibly had a complication from the vaccine as she is never had real shoulder issues before.  She denies any numbness or tingling down the arm, just some joint achiness.
Nausea, vomiting 3 times over an hour.  Then, 1.5 hour nap + 1 hr rest, then more vomiting.  Extreme chills but no fever.  Very pale.  Difficulty walking - knees buckling, stumbling, lack of balance.  Racing heart rate.  Checked into ER.  IV was administered with anti-nausea drugs.    Lot:  500822b mist
Sore Left Arm, slight muscle aches and lightheadedness that lasted 24 hours after the day the vaccine was given.
pt recv 2 doses of vax 8JUN95 & 12JUL95 & an ELISA test on 15APR96 revealed a lack of immunity;no further details were provided;
Erythema of both legs, pain and tenderness 4 hours after shots. Left to right. Responded to Tylenol.
Presented to the ER on 12/18/2020 with abdominal pain. Was diagnosed with cecal volvulus and underwent exploratory laparotomy with right colectomy on 12/19/2021.
This case was reported by a consumer via call center representative and described the occurrence of fall in a 81-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included Flu unspecified (Flu vaccine). On 28th September 2018 15:00, the patient received the 2nd dose of SHINGRIX (intramuscular). On 29th September 2018, 1 days after receiving SHINGRIX, the patient experienced fall (serious criteria hospitalization), feeling dazed (serious criteria hospitalization), increased blood pressure (serious criteria hospitalization), obtundation (serious criteria hospitalization and GSK medically significant), sleepiness (serious criteria hospitalization), tiredness (serious criteria hospitalization), confusion (serious criteria hospitalization) and memory impairment. On an unknown date, the outcome of the fall and increased blood pressure were recovered/resolved and the outcome of the feeling dazed, obtundation, sleepiness, tiredness and confusion were not recovered/not resolved and the outcome of the memory impairment was unknown. It was unknown if the reporter considered the fall, feeling dazed, increased blood pressure, obtundation, sleepiness, tiredness, confusion and memory impairment to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband. The age at vaccination was not reported but the patient could be 80 or 81 years old. The patient received the dose of the SHINGRIX in the left deltoid and also received the flu shot simultaneously. The next morning, the patient collapsed on the floor while trying to go to the bathroom. She fell again that morning but was not hurt. The patient was very tired and was also dazed and confused. The reporter did report to the emergency room where her blood pressure was elevated to 210/110 when it usually runs around 120/80. The patient was hospitalized and her blood pressure did not go down to a more normal range until a day before date of reporting, after the doctors were able to adjust her blood pressure medications. The patient remained confused and had difficulty identifying her name and of her husband. She also was obtunded and wanted to sleep. The patient was doing several tests to determine a cause and would also be having a lumbar puncture performed. The patient had denied permission to contact their physician. The reporter was called back in attempts to gather the initials for the patient but the reporter stated that he could not talk at that moment. This case was linked with US2018179237, reported by the same reporter.
Had my J&J Covid-19 vaccine on Tues. Aug. 10th. I was recommended by my OB to get the vaccine while pregnant. I am around 5 weeks pregnant. Estimated birth date is April 2, 2022. That evening of the vaccine, I had 2 fevers that I controlled with Tylenol (one 500mg rapid release capsule at time of fever)as instructed by my OB. Along with the fevers, I had headache, muscle/joint ache and pains, nausea and extreme fatigue. I only got out of bed to use the restroom. Next day, Aug. 11th I had one fever and took one dose of Tylenol. After that most of my symptoms seemed to subside. I then went to the restroom at 11am to find a nickel to quarter size bright blood spot on my underwear. I then passed a nickel size blood clot while urinating. It was not painful but the blood scared me to call the OB in case I was having a miscarriage. I continued to have another spotting incident before I saw my OB's NP at 2pm for the abnormal bleeding. Prior to the vaccine I had small implantation bleeding (light pink discharge occasionally), but had not had as much blood as I saw after getting the vaccine which made me call my doctor's office. As of today Aug. 13th, I am still having light pink discharge, very little spotting. It is not as frequent as it was and not as much as it was day after getting the vaccine.
I got the vaccine on December 29, 2020 at work. I started to have muscle soreness that night and right arm soreness at the injection site. Wednesday I had right arm soreness. Thursday I was fine. But Friday (January 1) and Saturday (January 2)  I started to have diarrhea, nausea, extreme fatigue, headache, chills and stomach cramping and one welt on my abdomen. Sunday (January 3) I would have waves of intermittent nausea , Monday (January 4) I felt better, and Tuesday (January 5) I felt better. Wednesday (January 6) I have  one small welt on my abdomen but otherwise feel fine. My work did make me stay out of work one day on to get tested for Covid-19 and Flu A/Flu B which all came back negative.
Had vesicular lesions on face arms, trunk and back.  Pruritis, headache-emesis x1.
took 1st capsule & 6 hrs later had vomiting & dehydration; stomache cramps also; went in to ER had fever of 100; seen by MD & gastrologist; given anti-nausea;
around 12 hours post Moderna Covid vaccine Patient had a possible delayed anaphylactic reaction,  called an ambulance and was brought to hospital with Hypoxia and Hypotensive. He was transferred to hospital and is being treated by Dr.
SERVICE MEMBER HAD SYNCOPE EPISODE DUE TO MMR VACCINE ADMINSTERED AT FACILITY, HIT HIS NOSE NO BLEEDING. LOT S023656 EXP DATE 30 JUL 2021 LEFT ARM
Injection site pain; tiredness; chills; feeling unwell; administration date=02Feb2021, dose number=2/ administration date=16Jan2021, dose number=1; This is a spontaneous report from a contactable consumer (patient himself). A 81-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: unknown, Expiration date: unknown), via an unspecified route of administration in left arm on 02Feb2021 at 14:30 at 14:00 at single dose for covid-19 immunization. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number unknown, Expiration date unknown), via an unspecified route of administration in left arm on 16Jan2021 at 14:00 as a single dose for covid-19 immunization. Patient's concomitant medications were not reported. Patient was not performed lab test. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. On 02Feb2021, the patient experienced On 02Feb2021, the patient experienced administration date: 02Feb2021, dose number:2/ administration date:16Jan2021, dose number:1 on 02Feb2021 14:00. Also, he had injection site pain, tiredness, chills, and feeling unwell on 03Feb2021. The outcome of event injection site pain, tiredness, chills, and feeling unwell was recovered on an unspecified date while for another event it was unknown.   Information on the lot/batch number has been requested.
Severe muscle pain, severe joint pain, extremely hot skin, chills, headache, severe fatigue, loss of appetite. Could not go to work the following day. It crossed my mind to go to the ER but I knew I was not actually sick, I just felt like I had the worst flu ever.