chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 59-year-old female patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020). On 17th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, less than a week after receiving SHINGRIX, the patient experienced pain and fever. In April 2018, the outcome of the pain and fever were recovered/resolved. The reporter considered the pain and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The physician stated the patient's symptoms were severe but not disabling, and the patient almost stayed home from work due to the symptoms. The patient did not require a doctor visit, emergency room visit or hospitalization.
Redness and swelling at the injection site. Warm to the touch, spread down the arm to the elbow of inside of left arm.
2 days after the vaccination, I experienced extreme fatigue and heart palpitations.  After 2 days in bed, I experienced impaired balance, poor coordination, and migrating pains in my legs.  I had some difficulty with hearing and reading.  The extreme fatigue and heart palpitations lasted 2 days.  The loss of balance and coordination, visual and hearing problems began to diminish slowly after 4 weeks.  During this time, I felt that my entire nervous system was slowed down.  When I stood, I had to pause and wait for a sense of balance.  When reading, I read each word individually and felt that I was waiting for recognition of each word.  These problems have improved slowly over the past 2 months.  I have some lingering fatigue and irritability.
Hives and rashes all over the body, occurring randomly in all places on body, including face and near genitals but never on. Has never appeared on scalp, and in extreme episodes. Often soothed by a Benadryl tablet and hydrocortisone cream on the flare up sites. Both treatments help slightly, but the itching is still pretty severe. Occurs randomly throughout the day with no rhyme or reason, not directly linked to movement or outside exposure. Skin first turns very red, then soon after hives will show up. The skin becomes textured (bumpy) in all surrounding areas that isn't the hive itself. The skin itself, while red, is never sore to the touch or when pressure applied. Itching only.
Patient was found sitting in his driveway around 4pm, dizzy with incontinent stool and vomiting. He was brought to ED where he was found to have skull fracture and SAH. Patient was admitted to the hospital .  Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine. This hospitalization does not appear to be related to the vaccine.
Patient signed up for booster of vaccine.  His last Janssen COVID vaccine was on 11/5/21 (the only one listed in our system).  After completing the vaccine, I went to fill in his COVID vaccine record card and saw he received a dose on 5/3/21 at the local health district, which was his first dose.  This means the 11/5/21 dose was the booster, and this dose was not needed or recommended.
I am a physician with a decade long hx of post-viral autoimmune disorder, working halftime due to this.  This typically flares with infections.  I Had J&J shots x 2 , no problem.   Did ok with Moderna shot for a couple weeks, then joints, fatigue and neuropathy flared badly, followed by overwhelming fatigue, persistent bigeminy and trigeminy, cognitive problems.  I had to stop clinical work with patients due to concerns about cognition, and have dropped down to 3-5 hours work weekly.  My immunologist thinks I had a big IgG surge a few weeks after the vaccine, which set off the problem.     My neurologists think I have post-vaccination hypersomnia due to specific effects of inflammatory mediators on specific parts of the brain.  They say I may or may not get better.   My cardiologists think the physiologic stress of the inflammatory surge caused cortisol and adrenaline surge which kicked off arrhythmia.
Narrative: Vaccinated, not boosted pt admitted for symptomatic covid. Ultimately discharged to rehab facility
Fainted; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer reported for a male patient (reporter's nephew).   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was fainted. The reporter wanted to know more about the vaccine. he was very scared to get it. Read ISI and he still wanted more info. In conversation he said his nephew got the vaccine and fainted. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
epigastric burning; warm inside; BP elevated to 224/93; This is a spontaneous report from a non-contactable pharmacist. A 64-years-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in Arm Right on 24Feb2021 (Batch/Lot Number: en6200) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The adverse events resulted in Emergency room/department or urgent care unit. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive other medications in two weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. On 24Feb2021 the patient experienced epigastric burning, warm inside, bp elevated to 224/93 on 24Feb2021. The patient underwent lab tests and procedures which included blood pressure measurement: elevated to 224/93, elevated to 224/93. Therapeutic measures were taken as a result of events. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
I had the injection at 1000 am. At 8pm, I had chills, fever (Tmax 101), body aches, bone pain, fatigue, and swollen lymph node under my right arm. For about 4 hours, I could barely move because I was in so much pain. These symptoms continued, but after the four hours, was a little better. I still had significant symptoms for another day and a half. The symptoms slowly decreased until gone. I was off of work for 3 days. No treatment outside of OTC Tylenol, Aleve, ice pack, and rest.
PREVNAR 13 was given in (L) leg - immediately after vaccine given the (L) leg turned red -> then purple, swelling at the site. Nl pulses. About 1 min later the leg was starting to look normal again.
The first two weeks after I got the second dose of the Covid-19 vaccine I had pain in my knuckle of my left hand and I could not bend my left middle finger. After the two weeks, I had discomfort in the same area for one or two weeks.  On February 20th, my right hand started shaking and I lost strength in both of my hands and arms. I went to the doctor and did an EMG, and the test results came back as normal.  On March 31st, I had sharp shooting pain in my right thumb.  On April 27th, the pain in my left hand middle finger knuckle came back and it hurts when I touch it and bend the finger.   Aside from these symptoms, I still continue to have chills which I started having after I was infected with Covid in late November.
Patient had Covid.  Had side effects with 2nd dose also.  Had the booster on 12/3/2021.  Symptoms started 3 AM 12/4/2021.  Chills, fever, diarrehea, general weakness. Could not eat or sit upright in the bed.  Much worse that with 1st shot.  Administered Tylenol, and kept hydrated on the Saturday.  Still ill on Sunday-even weaker.  Started with energy shots and pedialyte.  Could not eat.  Patient has asthma and could not take medication essential to his breathing.  Complained around 5 PM Sunday that he couldn't breathe.  Call emergency.  EMS took him to Medical Center.  Released but was not able to return to work or resume normal eating patterns until Tuesday.  No problem with the 1st shot, ill with the 2nd shot and sickest with the booster.  Lost 10 pounds
Head ache, fatigue, left arm soreness (injection site),  some congestion and occasional cough.
Broke out in shingles on right side of my nose, head, face, eyelid, eye socket, and eyeball.  Excruciating pain for six weeks, blisters, lesions, scabs resulting in deep scars and marred skin. Cleared up for a week. Reemerged on my left side of face with the  same results. I was in chronic pain for three months and sick tired and unable to do daily routines. The scars left on my face hindered my well-being, self-esteem, and mood, becoming more depressed and hiding in shame.
This spontaneous report as received from a nurse refers to a 16 year old male patient. The reporter stated that the patient was administered with 3 doses of GARDASIL (all were 0.5 ml, and all via intramuscular route) on dates (17-FEB-14, 29-APR-14, 02-JUL-14) that were outside the product insert recommends. Pertinent medical history and concomitant medications were not reported. No adverse effects reported. The outcome of the events was unknown. No further AE information was available. Additional information has been requested.
Patient received an expired dose of covid Pfizer Monovalent vaccine , patient was informed and reached out in regards this incident.
I started with a sore throat that went to a cough, fever, shortness of breath, and the symptoms lasted 12 days. The shortness of breath and coughing is still going on. My doctor gave me the Z-PAK and 40mg of prednisone. I took the Z-PAK for 5 days and prednisone for 7. I went to the ER and got the monoclonal antibody treatment, TORADOL injection, breathing treatment, MEDROL pack for 5 days. My Pulmonologist added a steroid inhaler.
Within minutes (less than 5), patient began to faint and become extremely diaphoretic. Patient also lost control of her bladder and urinated while sitting in the chair. We immediately called 911 who stated not to move her our of the chair. Patient went in and out of consciousness several times (2-3) for short intervals (15-30 seconds). EMS arrived within 10 minutes of symptom onset and took her to the local hospital. While EMS was evaluating the patient in the pharmacy, she stated that she was beginning to have trouble breathing; but those symptoms quickly resolved without the administration of epinephrine. We received a phone call from the patient within 2 hours stating that she was being discharged from the hospital and was feeling much better.
blastomycosis/fungus in lung; This spontaneous case was reported by a patient and describes the occurrence of BLASTOMYCOSIS (blastomycosis/fungus in lung) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 043L20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced BLASTOMYCOSIS (blastomycosis/fungus in lung) (seriousness criterion medically significant). The patient was treated with ITRACONAZOLE at an unspecified dose and frequency. At the time of the report, BLASTOMYCOSIS (blastomycosis/fungus in lung) outcome was unknown.            Concomitant medication details were not reported by the reporter. Reporter asked if it was safe to get second booster with reported medication (itraconazole) because diagnosed with the blastomycosis - fungus in lung on April 2022.  Company comment: This spontaneous case reported by a patient, concerns a 73 year old female patient, with no relevant medical history reported, who experienced the unexpected, serious (medically significant) event of Blastomycosis about 5 months after receiving the 3 dose of mRNA1273 vaccine in the covid 19 vaccination series. Patient previously had received the 2 primary doses of Moderna vaccine at an interval of 25 days, with the 2 dose taken about 9 months prior to the 3 dose. Patient was treated with Itraconazole for the event. No information was provided about the comorbidities, risk factors, labs, diagnostic tests, symptoms, clinical course and concomitant medications. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case reported by a patient, concerns a 73 year old female patient, with no relevant medical history reported, who experienced the unexpected, serious (medically significant) event of Blastomycosis about 5 months after receiving the 3 dose of mRNA1273 vaccine in the covid 19 vaccination series. Patient previously had received the 2 primary doses of Moderna vaccine at an interval of 25 days, with the 2 dose taken about 9 months prior to the 3 dose. Patient was treated with Itraconazole for the event. No information was provided about the comorbidities, risk factors, labs, diagnostic tests, symptoms, clinical course and concomitant medications. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
rash on face, hives all over body, was given 4 shots, 2 in each arm, unsure of which arm except tetnus
The pt called the clinic at 4:00 PM on 1/6/00 to report that he experienced sweating, shaking, chills and dizziness at 3:45 PM. The pt denied having breathing problems, nausea and hives or rash. He was advised to have someone take him to an ER or Physician for evaluation of symptoms. He was alone at his employment site when symptoms started. When he called don 1/7/00 he reported that he didn't go to any medical facility for evaluation and the symptoms were gone.
7 days post vaccination, vaccination site and most of body is very itchy, and rashy. Injection site is sore, red and swollen. Feels like I have a urinary tract infection. Symptons have lasted for 7 days.
I delivered one baby in 1999 and one in 2002. Two miscarriages in between.   I woke up 4/6/21 with a strange pain in my left leg. It felt circulatory, not muscular or skeletal. Swelling behind knee. I went to ER for ultrasound and they found a blood clot. Cat scan revealed pulmonary embolism. The nurses at the hospital confirmed that this was happening frequently. They said it wasn?t rare. My PA at the clinic told me it was 1 in 5000 like me. Why doesn?t the hospital report?  I?m on bed rest for 10 days, compression stockings and Eliquis to thin my blood. I have halted all HRT, but have been  told by my dr that it?s clearly not related since i e been on them for over 6 years and never had a blood clots.
About 20 hours after vaccine administration, patient had lip swelling and felt like there was a ball in her throat. No respiratory involvement. Went to ER and received EPIPEN, IV BENADRYL, IV steroids. Vital signs and respiratory status all remained normal. Admitted for observation overnight and had no further allergic reaction symptoms.
Very heavy period days after vaccine; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 01Apr2021 at 15:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and allergy to a couple antibiotics. The patient did not receive any other medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 05Apr2021, the patient experienced very heavy period days after vaccine. The patient did not receive any treatment for the event. The clinical outcome of the event very heavy period days after vaccine was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
On march 4,2023, I started to get a sore throat. It went on for a few days, worse at night. On march 12,2023, my throat had an excessive amount of white patches on it. My glands were really swollen. I was prescribed amoxicillin for 7 days by a doctor while on vacation.  Within a couple of days, My throat felt better but glands were still swollen. When I returned home, I was prescribed an extended amount of amoxicillin. On March 21, 2023, I went to see my doctor and he did a strep culture and a EBD test, which the EBD test came back positive.  I was prescribed a medication for it and it eventually cleared up.
ST on 04Jan2023 and positive AG test; ST on 04Jan2023 and positive AG test; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 44-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Nov2022 as dose 4 (booster), single (Lot number: CJ6742) at the age of 44 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Jan2023, outcome "not recovered" and all described as "ST on 04Jan2023 and positive AG test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jan2023) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: Patient had not received any other vaccines within 4 weeks of COVID-19 vaccine. ST on 04Jan2023 and positive AG test after large football event on 01Jan2023.; Sender's Comments: As per the available information the causality of the events drug ineffective and covid-19 with the suspect can not be ruled out completely.
pt devel red, bumpy vesicular eruption on trunk 2 wk p/vax, pruritic, low grade fever of 101;
Appx. 12h after vaccination patient was experiencing sweating, nausea, hallucinations, high fever. Patient thought those were symptoms of hypoglycemia so he took glucose. Sugar went up but patient still had uncontrollable chills and nausea. Patient went to doctor's office appx. 12h after the episode, still had fever and high pulse. Doctor said it was a delayed reaction to SHINGRIX which caused hypoglycemia. Patient didn't receive any treatment because the symptoms started to normalize. He didn't require Glucagon. Patient received a flu vaccine (AFLURIA QUAD PF on 10/04/2018 with no adverse reactions.
About 3 weeks to a month at most, I started getting a strong smell.  Similar to smoke or burning.   Still get it on and off.    Several months after that I started to get a bad case of tinnitus.  Pulsating tinnitus as well.  Still have it.  On and off where it is very bad at times and other times milder but does not completely stop.   Along with the tinnitus came a racing heartbeat which started around the same time as the tinnitus.  Never had anything like that. Not from anxiety although it causes a great deal of anxiety.  Fast heartbeat at the slightest movement when it first started.  Mostly in the morning.
My flu shot was given in the left arm. The vaccine was actually injected above the deltoid and into the shoulder causing now weeks of pain with movement.
Infant less than 4 years received on April 2021 a Kinrix / at 8 months of age; Infant less than 4 years received on April 2021 a Kinrix / at 8 months of age; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-month-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pentacel (1st dose received at 2 months of age) and Pentacel (2nd dose received at 4 months of age).   In April 2021, the patient received the 3rd dose of Kinrix and Kinrix Pre-Filled Syringe Device. In April 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: The reporter stated that, since the office was out of Pentacel, the staff gave Kinrix as dose 3 to 8 months old patient, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. The patient's initials and lot number not provided on call (not asked as reporter became frustrated with questions but did consent to follow up via email).  The reporter added that, there might be more patients this occurred with; the staff was currently auditing patient charts to see if there were additional patients impacted.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021131693:FU deleted
MUSCLE/STOMACH CRAMPS, VOMITING, UPSET STOMACH, HEADACHE, TIRED.
It started with appetite loss, longer napping, and runny nose.  At night, he had a fever (100.4F). Next morning (Friday), the fever subsided then returned around noon (102F).  He was also showing loss of appetite, malaise, nose congestion.  The fever persist until next morning (Saturday).  The fever came back Saturday night (100.5F), but subsided next morning (Sunday).  Since then, he had no fever, but still has very bad nose congestion as of today (10/16, Wednesday).
Initially I just had arm pain. Around 4:30pm, I started feeling tired. At 8:00PM I had extreme arm pain, so much it hurt to lift items and take off my sweatshirt. Around 11pm, I started feeling like I had a fever. I was going from hot to cold throughout the night. At 2:30am I woke up with chills that lasted for 20-30 minutes. I continued to have a fever throughout the night. When I woke up around 8am, I felt extremely sore, my body, head and stomach hurt. My symptoms have been improving throughout the day but I still feel tired. I?ve also had diarrhea throughout the entire day.
fever of 99.5; tired; arm pain; This is a spontaneous report from Pfizer-sponsored program. A contactable consumer(patient) reported that a male patient of an unknown age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on 14Apr2021 for Covid-19 immunization. Medical history and concomitant drug were not provided. Patient had a fever of 99.5 along with being tired and arm pain in Apr2021.  Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
(L) leg: at site of injection has 1 cm nodule, subdermal, at 2 cm distal to injection site has 1 cm erythematous scaling patch.
Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 16-APR-2015, the patient was vaccinated with a dose of RECOMBIVAX HB 0.5 ml, lot # K010535, (expiration date, route and site of administration were not reported) that underwent 72 hours temperature excursion outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.