chrisvoncsefalvay/vaers-outcomes huggingface dataset:
In the early evening after my second Covid vaccine I began to have moderate body aches, fatigue, injection site swelling and headaches. Some of my headaches developed into migraines. The body aches lasted about 14 hours but the headaches persisted for almost two weeks before resolving.
This infant had a diffuse homogenous erythematous rash on her trunk and face, with swelling of her nasal bridge and mouth as per her father. It occurred one hour post immunization. She was seen in the ER and treated with Prelone.
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine, Shingles vaccine and Shingles vaccine. In January 2021, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pruritus and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown and the outcome of the pruritus was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine. Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The reporter stated that, he/she had a Shingles shot and 2 booster shots over the years, which led to extra dose administered. The patient still got shingles on left arm and hand in January 2021 and still had itching. The patient stated that, it was a miserable disease. The follow-up would not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding the time to onset for shingles and laboratory test confirming shingles were unknown at the time of reporting.
Pt experienced local reaction site- had redness and warmth surrounding injection site. No fever or shortness of breath or any other symptoms.
This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 29-OCT-2015, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 single dose: 0.5 ml (lot # L013428, expiration date: 03-FEB-2017; dose and route were not provided). The vaccine underwent a temperature excursion of the lowest recorded temperature of 31 degrees Fahrenheit (-0.56 degrees Celsius) for 64 hours. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Subsequent to receiving one dose of varicella virus vaccine live in 1998, pt developed 7 vesicles with decreased appetite. Pt was afebrile.
started with generalized Headache and sob  5-6 days after vaccination with Janssen.  For pain she is being prescribed acetaminophen until labs have resulted.  A trial of albuterol nebulizer was given in office for spirometry showing  moderate airway obstruction.  Patient felt the same shortness of breath she is noted to have petechia at site of blood pressure cuff on the upper arms but states this always occurs.
Day two  after getting the vaccine, I started feeling vertigo and nauseous. I hydrated extensively, and  day three are started to feel a little bit better.  Day four I took a turn for the worse, and the vertigo and nausea intensified.   In the middle of the night, the vertigo was extreme.  I almost checked myself into the ER, but I decided to try to continue sleeping and hopefully feel better in the morning. In the morning, day five, I went to my primary care doctor.  I told her my symptoms, she said possibly due to the vaccine.  She prescribed me meclizine.  I took it in the evening, and did not feel any symptom relief.  In the middle of the night, extreme vertigo again, it was atrocious.   Day six (Saturday), I checked myself into the ER.  They upped my dose of meclizine (to 50 mg).  This new dose also had zero effect on my vertigo/nausea.  I felt vertigo/nausea all day. Speaking to some doctors in the family, they suggested to me that I had developed BPPV. Day seven, woke up again with vertigo/nausea, and it didn?t subside at all as the day went on.  I spoke with my father, and he told me that he had BPPV before apparently.  He drove to my house and did the Eply maneuver on me 10 times throughout the day.  Felt a little bit better.  Scheduled an appt with ENT for following day. Day eight, feeling a little bit better (after eply maneuvers, possibly related).  Visited ENT, he reassured me that the vestibular system is very efficient and I will eventually get better.  Scheduled appt for me for neurologist and MRI for later that day.  Went to see neuro, did MRI.   Day nine, feeling even more a little bit better. Day ten, which is today, feeling even more a little bit better.  Saw neurologist for follow-up, he told me MRI turned out fine, everything looks good with brain.  Just stay very hydrated and relax, I should get better in a week.  I really went through hell, it was atrocious.  My doctors said could be vaccine-related, impossible to prove one way or the other.  I figured I?d report it, just in case there might be others in the country who went through the same thing.
Significant injection site tenderness/fluctuance & erythema -> started on 7 day course of Doxycycline. Positive N/V, no headache first 2-3 days after injection. After antibiotics, (R) arm sx resolved.
I started having an aching pain in my L lower calf around 1/12/21- no redness or swelling noted. Was diagnosed with L lower extremity DVT in the peroneal vein by U/s on 1/15/21, ordered by my GYN Dr (I had a routine appointment with her that day). I had a follow up appointment with my family doctor Dr. on 1/20/21 and also had a follow up appointment with my hematologist Dr. on 2/5/21. I was treated with xarelto x 3months. Also treated with heat, elevation, and compression stockings.  I did stop taking my birth control pills the day after the DVT was discovered (I had already taken it the day of diagnosis). I am a nonsmoker. I missed work on Monday 1/18/21. I do not have a history of DVT or have had any DVT's since.  I have since recovered with no issues.
fatigue; her B12 was low; Last night she had suicidal ideation and she has never had that before. She has no plan. She has no desire to hurt others.; Depression; Crying; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 20Mar2021 15:00 (Lot number: EN6207, Expiration Date: 31Jul2021) at the age of 63 years as dose 1, single for covid-19 immunisation; fluoxetine hydrochloride (PROZAC), since 2020 (ongoing) (Batch/Lot number: unknown) at 40 mg 1x/day (40 mg, 1x/day in the morning) for bipolar i disorder, anxiety; lamotrigine (LAMOTRIGINE, manufacturer: Taro), since 2020 (ongoing) (Batch/Lot number: unknown) at 200 mg 1x/day (200 mg, 1x/day at bedime) for anxiety, bipolar i disorder; lorazepam (LORAZEPAM, manufacturer: Sun Watson Labs) (ongoing) (Batch/Lot number: unknown) at 2 mg 1x/day for anxiety. Relevant medical history included: "Bipolar 1 Disorder" (ongoing); "Anxiety" (ongoing); "Diabetic" (ongoing); "Thyroid" (ongoing); "Liver Problem" (ongoing), notes: bloodwork and MRI of abdomen every 4 weeks for monitoring. The patient took concomitant medications. The patient has diabetic medications to control her diabetes and thyroid medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Vaccination history included: Flu shot, administration date: 2019, for immunisation, reaction(s): "skin reaction"; Dtap, for immunisation. The patient reported that she had the worst week with depression and crying and felt like she was not taking her psych drugs/ her meds weren't working which started 24 hours after she got the vaccine, 21Mar2021 at 15:00. The patient honestly thought the fatigue was because her B12 was low. She had a doctor's appointment that day (as reported) and got a B12 shot, but that didn't help with the problem either. The depression and crying were ongoing. She has benzos, like Lorazepam and it took the edge off, but it did not keep her from crying. The vaccine was the only thing that she can thought of that was different. The night before the day of report on 29Mar2021, the patient had suicidal ideation and she has never had that before. She had no plan nor desire to hurt others. The patient confirmed that she was not currently having suicidal ideations on the day of report. The events did not result to emergency room nor physician office visit. The patient underwent the following laboratory tests and procedures: vitamin b12: low. The action taken for fluoxetine hydrochloride, lamotrigine and lorazepam was unknown. Therapeutic measures were taken as a result of vitamin b12 decreased which included B12 shot.  The patient has recovered from suicidal ideations but has not recovered from the rest of the events.   No follow-up attempts are possible. No further information is expected.
Stuttering and "trouble finding words" for 2 weeks after LAIV this year and last year.
15 YEAR OLD MALE PATIENT RECEIVED 1ST DOSE OF PFIZER. NO ADVERSE EVENTS HAVE BEEN REPORTED.
This literature marketed report has been received from the authors of the published article, and refers to an adult patient with a chronic autoimmune disease. The authors obtained data on varicella deaths for 2012-2016 using the Mortality Multiple Cause of Death public use records from the Center. A death from varicella was defined as one for which varicella diagnosis was listed on the death certificate. On an unknown date, the patient was vaccinated with a 1 dose of varicella virus vaccine live (Oka/Merck) (manufacturer unknown) injection (exact dose, vaccination site, route of administration, lot# and expiration date were not provided). On an unknown date, the patient died and varicella was listed as the underlying cause. The patient was vaccinated with varicella virus vaccine live (Oka/Merck) (manufacturer unknown) within 1 month prior to death. Varicella-zoster virus (VZV) specimens were unavailable for laboratory testing. It was unknown if an autopsy was performed. The authors considered varicella post vaccine to be related to varicella virus vaccine live (Oka/Merck) (manufacturer unknown). This is one of several reports derived from the same literature article (linked with MARRS # 1808USA000251 and 1402USA010964). Sender's Comments: US-009507513-1402USA010964: US-009507513-1808USA000251: Reported Cause(s) of Death: varicella listed as the underlying cause of death.
Fever 102.7 degrees, chills, body aches, swollen lymph glands, nausea, pain at injection, unable to lift/move arm, headache, backache, burning sensation in lungs, extreme fatigue.  Has been 72 hours since vaccine and still not completely back to normal.  Missed 2 1/2 days of work due to vaccine.
Patient monitored for 30 minutes until complaints subsided. Patient left facility in stable condition and stated his heart was not pounding and was not dizzy and I feel fine. Dizziness and Tachycardia
This spontaneous report was received from a Licensed Practical Nurse (LPN) concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with PROQUAD, lot # M022400, expiration date: 01-JUL-2017 (strength, dose and route of administration were unknown), which were improperly stored at -12.7 C for 15 hours. No adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
FLUVIRIN 0.5 ml admin on 10/10/09-pt states she had shoulder pain shortly thereafter, which prevents her from raising arm above shoulder level as of date of this form pain has not lessened over time.
Arthritis; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Fractured finger.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (Arthritis). At the time of the report, ARTHRITIS (Arthritis) outcome was unknown.            No concomitant medication details was provided. No treatment medication details was provided. The patient stated that the index finger on the right hand was froze, cannot bend it and stated that the doctors told him it was due to arthritis and he broke the fingers 3-4 times while playing sports.; Sender's Comments: This spontaneous case concerns a 68-year-old male patient with relevant medical history of broken fingers3-4 times while playing sports, who experienced non-serious unexpected event of special interest (AESI) arthritis. The event occurred unspecified time after the second dose of the Moderna COVID-19 Vaccine (mRNA-1273). Reportedly, the patient could not bend his fingers without pain and the index finger on the right hand was frozen without the ability to bend it. The doctor told him it was due to arthritis and prior history of broken fingers multiple times while playing sports. Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable.  Patient's advanced age and history of fractured fingers are possible confounders. The benefit-risk relationship of drug is not affected by this report.
After getting home from office, patient was very sleepy and clingy, didn't want to be put down when they got home.  About 30 minutes after getting home grandmother was holding her and she and the mother noticed patient was staring and unresponsive.  Lips turned blue, she was limp, very pale, but no jerking, no fever.  Paramedics called and she was transported via ambulance to hospital.  She was not responding normally, but was alert by the time she got to the hospital.  She was pale and not herself for the past 2 days.  Today she is acting normally, eating normally.
Immediate headache within 10-20 minutes. After a few days headache never went away. Started developing neck, arm, shoulder & upper back pain with pain also shooting down the left side of my chest. After dealing with this for over a week I contacted my doctor about the chronic headache because it was interrupting my daily life. My ears had also started popping and my lymph node behind my left ear was swollen. On Aug. 18th I was prescribed 800mg of ibuprofen for the headache and muscle pain as well as Clindamycin 300mg 3x a day for 5 days as well as start taking Zyrtec & Flonase.  She also wanted me to have a COVID test done. The COVID test was negative and I finished the antibiotic on Aug. 23rd but I?m still having the same problems with the headache & muscle pain. As of today, Aug. 25th I?ve started chiropractic care to see if I can get some relief but I will not be getting my 2nd shot!!
MUSCLE CRAMPS  IN LEGS, ARMS, FEET; COULD NOT MOVE ARM /HAVE DIFFICULTY MOVING ARM; DISRUPTING SLEEP; RIGHT ARM BEING  SORE EVERY OTHER DAY; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's past medical history included major surgery - aorta bypass, legs cramping prior to the surgery, and almost no blood circulating towards legs, and concurrent conditions included sulfa allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: 23-JUN-2021) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-JUN-2021, the subject experienced muscle cramps in legs, arms, feet. On 04-JUN-2021, the subject experienced could not move arm /have difficulty moving arm. On 04-JUN-2021, the subject experienced disrupting sleep. On 04-JUN-2021, the subject experienced right arm being sore every other day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle cramps in legs, arms, feet, right arm being sore every other day, disrupting sleep, and could not move arm /have difficulty moving arm. This report was non-serious.
experiencing Fluctuating blood pressure; blood pressure high; This is a spontaneous report from a contactable consumer or other non hcp via Pfizer-sponsored program. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration on 11Feb2021 as SINGLE DOSE for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing, but it is pretty well controlled with medication, product dose omission issue from an unknown date and unknown if ongoing. Reportedly, patient does have history of elevated blood pressure and missed his morning medication. The patient's concomitant medications were not reported. Vaccine history for dose 1 was not provided. He had no reaction to the 1st dose and really no reaction to the 2nd dose. It was reported that patient took second dose on Thursday, on 14Feb2021 (third day) after second dose indicated high and varying blood pressure. Patient received Second dose of Covid vaccine on Thursday- Last night patient was experiencing Fluctuating blood pressure back and forth between somewhat high and very high- wants to know if that s from the vaccine. The patient said that he took his blood pressure a couple of times and noticed that the numbers kept changing, which was abnormal. He stated that normally if he takes his blood pressure multiple times, it stayed pretty close in the same range, but that time when he retook it the first number was down and the second number was up, then he was able to get the second number down, but the first number was up again. He said that he even tried a second machine, but each time he took it, it was different and this all occurred over a number of hours. He said that on 15Feb2021 morning, it was little high, but not that bad. He had not called his doctor yet and was debating where to start but thought he would see if it was from the vaccine before he called the doctor. The patient underwent lab tests and procedures which included blood pressure measurement: high on 14Feb2021. The outcome for the events was unknown. Information on the lot/batch number has been requested.
Patient admitted for acute pulmonary embolism.  Patient does not have thrombocytopenia.
Around the 17th of June I started feeling facial ticks or spasms under my right eye.  The next few days it was beginning difficult to talk and my eye was not blinking completely.   I could not feel my face.  I went to the health department and they did some test.  The diagnosed it as bells palsy.  They prescribed me prednisone to take.  They wanted me to follow-up in three weeks.  I still have very little movement in my face.  I have been on the prednisone for about a week now.
super dizzy; really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (super dizzy) and HEADACHE (really bad headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Migraine since an unknown date. Concomitant products included SIMVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), FAMOTIDINE, PROBIOTIC 10, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), FLUOXETINE HYDROCHLORIDE (PROZAC), ALPRAZOLAM (XANAX) and DOCUSATE SODIUM for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced DIZZINESS (super dizzy) and HEADACHE (really bad headache). At the time of the report, DIZZINESS (super dizzy) and HEADACHE (really bad headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient developed really bad headache at 3 0'clock but 12 hours later was super dizzy ang her husband helped her to walk to the bathroom before going to bed. She was fine by next day.   Concomitant medications also include blood pressure medication, diuretic, water pills, blood thinner.  Treatment medication was not provided by the reporter.
an expired dose of quadracel was administered to a patient today with no reported adverse event; Initial information received on 11-Jul-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an unknown age and gender patient who was administered an expired dose of diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 11-Jul-2023, the patient received an expired dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine, suspension for injection (batch number: C5916AA; expiry date: 06-Jul-2023) via unknown route in unknown administration site for immunization with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event an expired dose of quadracel was administered to a patient today with no reported 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 the guidelines. 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.
On May 14th, 2021, the day of my 2nd Pfizer COVID-19 vaccine dose, I went to bed.  I sneezed 6 times, hayfever related.  I had a little too much sugar before bed and had a strong beating heart.  I woke at 3am on May 15th, 2021 felling cold. Definitely cold, NOT chills. I felt "off", meaning that I was not experiencing the usual COVID-19 symptoms listed on eligible sources.  I had a sore arm at the site of the vaccine.  I took a hot shower, layered up and went back to bed to sleep, or doze.  I had to get up at 5:30am.  I felt better by 11am.  Much improved by 3:00pm.   I had heart arrhythmia for seconds between 11:00am-1:00pm.  I had super and caffeine for breakfast.  I have been consuming sugar and coffee together for years.  No sugar and caffeine (coffee, chocolate) before bed on May 15th.  No heart arrhythmia.  Heart arrhythmia after combo M&Ms chocolate/peanuts.  Sugar and caffeine seems to be a developed sensitivity to the point of getting heart arrhythmia.
Child had shots 8/20/07; on 8/21, right arm (at shot areas were painful. Then 8/22 areas became itchy and somewhat reddened. Through that day swelled up and became quite red and swollen from elbow thru deltoid area. Mother gave Benadryl. 8/23/07 Mother says it's not as red.
no adverse event received pcv13 instead of 23 and doesn't meet criteria for requiring pcv13