chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diagnosed with cryptogenic posterior cerebellar CVA; severe dizziness; vomiting; arm pain; severe general back pain; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9261), via an unspecified route of administration, administered in left arm on 20Jan2021 13:30 (at the age of 57 years old) as single dose for COVID-19 immunisation, at a workplace clinic. Medical history included hypertension (HTN) and depression, both from an unknown date and unknown if ongoing. The patient has no history of COVID prior vaccination. The patient has no known allergies. Concomitant medications included sertraline hydrochloride (ZOLOFT); and benazepril hydrochloride, hydrochlorothiazide (BENAZEPRIL/HCTZ) both taken for an unspecified indication. On 22Jan2021 the patient experienced arm pain and severe general back pain. On 23Jan2021, the patient experienced severe dizziness and vomiting. She went to urgent care and symptoms were treated. The patient was advised to have follow-up with the patient's professional care provider; she had MRI and CT angio of head on an unknown date with unknown results. The patient was diagnosed with cryptogenic posterior cerebellar CVA on 23Jan2021. Due to the events, the patient was recommended to have full diagnostic working including cardiac and neuro workup as treatment. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization for three days. The patient underwent lab tests and procedures which included CT angio of head and magnetic resonance imaging (MRI): both with unknown results on an unknown date, and Nasal Swab: negative on 12Apr2021. The patient was recovering from the events.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that vaccine BNT162B2 contributed to the reported events; these are likely intercurrent medical conditions in this patient with underlying hypertension. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
After the first dose, mild dizziness and nausea followed by massive inflammation in joints and face, severe fatigue and loss of hearing in right ear.  Hearing returned in 3 days, general malaise until a week before 2nd shot when she started having severe bloody noses and EXTREMELY heavy period.  After the second dose, 45 minute nose bleed soaked through two wash cloths, so many blood clots it clogged the sink.
Whole left arm is painful without moving it. Pain med was sent (Norco) Recovered on 3/21/2017 in AM with no pain, arm felt normal.
16OCT95 parents stated felt hot & gave Tempra drops off & on last wk for fever-noticed rash 18OCT95 & began on chest-rash kept getting worse;went to hosp ordered cream for diaper rash only-measle like rash noted on body
Patient complains of chills, nausea, headache swollen shoulder she said she took advil and norco but no relief
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 05-JUN-2013 the patient was vaccinated with a second dose of GARDASIL, 0.5 ml, intramuscular injection (site of administration, lot number and exp. date were not reported0. The second dose of GARDASIL was expired. No adverse effects had been reported. Additional information has been requested.
Red warm area about 8 cm (L) leg worse than (R) at shot site. KEFLEX 500 TID x 10d. MOTRIN, BENADRYL prn.
This spontaneous report as received from a physician refers to a 60 year old female patient with no drug reactions or allergies. On 23-MAY-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot# and dose not reported). Concomitant medication included an unspecified blood pressure medication (dose and frequency unspecified). On 30-MAY-2014, the patient was experiencing the shingles virus after receiving ZOSTAVAX. No treatment was given for the event. No lab diagnostics studies was performed. The patient sought medical attention by visiting to the office. At the time of report, the outcome of the event was reported as not recovered. Additional information has been requested.
Patient received 2nd dose of influenza vaccine on 12/08/03.  The next morning he woke up with a red itchy rash.  That day he went to the doctor and was diagnosed with hives.  Benadryl was used as the course of treatment.  The next day the red itchy rash was accompanied with swelling, particularly around the face and hands.  The hives lasted through 12/13/03.
Pt has an area of cellulitis to medial aspect of left upper arm- 8 cm X 16 cm. with axillary adenopathy.  (+) fevers (101.6) and pain.
Information has been received from a licensed visiting nurse concerning a 19 week old male who on 09-JAN-2007 was vaccinated with an oral second dose of Rotateq. it was reported that the second dose was administered 11 weeks after the first dose. No problems were reported. Medical attention was not sought. There was no product quality complaint involved.
had the shot and still got the shingles/Suspected Vaccination Failure; shingles; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the Shingles shot and still got the shingles and had them really bad. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting.
Medical Assistant (Reporter) reconstituted the Menveo immunization with Sterile Diluent instead of reconstituting the immunization with the proper solution provided with the immunization.  Nurse notified medical assistant after discovering the medication count was off when medical assistant documented the count for vaccine.  Management was made aware, CDC was notified for proper administration recommendations for re-vaccination, an internal event report was made, patient's mother was notified of the error, patient was scheduled to come in for a repeat vaccination as recommended
Allergic reaction; Hives; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: ER8727, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 20Mar2021 (at the age of 52-years-old) as dose 1, single for COVID-19 immunisation. The patient has no relevant medical history. Concomitant medications included metformin taken for an unspecified indication, start and stop date were not reported. On an unspecified date in Mar2021, the patient experienced allergic reaction and hives. It was further reported that the approximately 8 hours after the vaccine, the patient had an allergic reaction and some hives. He contacted his primary physician and was told to take Benadryl as treatment which he did. He was recommended not to take the second dose but asked him to call in report the side effects. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
This was a clinic for Covid-19.  Janssen vaccine was used. Patient is 17 years old. RpH reviewed the information gave the vaccine to him. The vaccine is for 18 and over.  I spoke to mom who check and patient has no side effects thus far is doing fine. Employee at our store translated for mom. The information was given to this store for processing only.
patient states she was trying to read on Tuesday 9 days after vaccination and works became "jumpy" "black boxes" and confetti-like all over the page. She followed up with optometrist who did not note anything remarkable, thought perhaps ocular migraine. Later in the day she also had trouble finding words in her speech, had neurological work up which also did not produce any diagnosis, nothing remarkable such as stroke per patient.
At 1:28 pm, one minute after injection started to feel dizzy, lightheaded, weird feeling of being happy, happy gas, like at the dentist office after receiving Novocain, both lasted for 15 minutes.
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown ages and genders. On multiple unspecified dates, the patients were inadvertently administered with improperly stored M-M-R II, (lots and expirations were unspecified) (route: subcutaneous). The vaccine was stored at a temperature of 33 F for a time frame of 84 hours. There was no previous temperature excursion and data logger was not involved. No adverse effect reported. This is one of the four reports received from the same reporter. Additional information has been requested.
Information was received from a lawyer regarding a case in litigation. A female patient, age unspecified, was inoculated with ZOSTAVAX on 05-FEB-2014 at a pharmacy as recommended for routine adult health maintenance for prevention of shingles. It did not prevent shingles as intended and subsequently the patient contracted a persistent strain condition of herpes zoster. On or about 24-MAY-2016 the patient was treated by a physician at a medical group for a blistering vesicular outbreak which was then diagnosed as herpes zoster, shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
I started noticing vision changes a few days after receiving the vaccine and went to the eye doctor. I was told I had white blood cells in my aqueous fluid which appeared to be an inflammatory response to something.  The official diagnosis was uvetis.  There was not really any explanation for what could cause this. I do not have any history of eye problems or autoimmune conditions.  I was put on steroid drops and dilating drops. I have had two follow up appointments and have been improving.  I also noted a large lump and redness at the sight of injection one week post shot. That has since cleared.
Fever, Chills, nausea, extreme fatigue (12-72) hours after injection.  3 days post injection tender, hard, red markings at injection site. Swollen underarm lymph node on same arm as injection site. Still there at reporting time.
Fatigue, arm pain at injection site,  stuffy head, aches, difficulty concentrating, loss of appetite.
RASH ON ARM WHERE THE COVID BOOSTER INJECTION GIVEN; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (RASH ON ARM WHERE THE COVID BOOSTER INJECTION GIVEN) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for Chronic lymphocytic leukemia.    Previously administered products included for Drug use for unknown indication: LISINOPRIL. Past adverse reactions to the above products included Drug allergy with LISINOPRIL. Concurrent medical conditions included Drug allergy (LISINOPRIL ALLERGY).   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and (IMBRUVICA) (Oral) 420 milligram once a day. On an unknown date, the patient experienced VACCINATION SITE RASH (RASH ON ARM WHERE THE COVID BOOSTER INJECTION GIVEN). At the time of the report, VACCINATION SITE RASH (RASH ON ARM WHERE THE COVID BOOSTER INJECTION GIVEN) outcome was unknown.            No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event of vaccination site rash was not provided with IMBRUVICA  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Approximately 12 days after vaccination co began to have fatigue, weakness, Pancytopenia      Recent hospitalization which involved initial presentation at hospital on AK 12/29, and then again on 12/30, after eval on 12/30 was then transferred to another hospital, and later transferred where she later recovered and was discharged.      She was initially very ill and was thought to have sepsis due to fever/initial presentation/clinical picture, also had lab abnormalities including thrombocytopenia.  These things necessitated transfer.  While at hospital, hematology was consulted.  Decision was made to transfer due to concern for DIC/possibility of leukemia. Also there was concern for C Diff, treatment was given for this.  While in hospital, she underwent further testing on blood samples which revealed no evidence for malignancy, also bone marrow biopsy was performed.  While there, DIC labs were trended/began to improve.  Discharged on 1/5/21.  Had f/u with hematology @ hospital on 1/12/21.  No reason has been found as of yet as to why she became ill.  Per discharge note it's thought it could have been viral in nature, or possibly related to supplement use.  Will f/u with heme in early Feb.   Of note, she does report getting her first dose of pfizer covid vaccine on 12/17/20, she reports concern that this could have played a part in her illness.  She states this was the only new/out of the ordinary thing that she can remember recently, regarding her medical hx, prior to recent acute illness/hospitalization. Requests I reach out to inquire how she can file a report with Pfizer or CDC
I started developing chills a few hours after I was vaccinated. Later that night, I started vomiting for approximately two hours. The following morning I found that I had a fever of 102.3 degrees. This temperature went down after I took Ibuprofen. I also experienced fatigue and headaches.
swelling and tenderness in left underarm. patient came into clinic for assessment with provider. Patient left clinic in good condition with instruction to return if symptoms worsen as ultrasound may be needed. provider states it may be lymphadenopathy, axillary
On March 10, 2021, day after second dose of the Moderna vaccine, I started having low back spasms and low back pain  as well as pain at the injection site. The next day, I continued to have low back spasms, low back pain and pain at the injection site.  On March 12, 2021, my symptoms got worse with continued low back spasms and pain, pain at the injection site, my fibromyalgia flared up causing pretty much overall pain, as well as my sciatica flared up.  I also have a mild headache.  I used a heating pad on my lower back.  It helped some but the pain still exists.
Two days after the shot I developed large, raised, itchy welts all over my body. It was the worse in my groin area.
Initially (24 hours) I had fever 100.5, chills, aches.  These resolved by 3/20.  Arm was very sore for about 3 days, but took almost a week to completely feel better.     On 3/21 more concerning symptoms started to develop.  Brain fog, spacenesses, trouble looking at books, computer tv.  Very strange sensation.   This resolved by 3/25.     Other symptoms that developed beginning 3/21 were GI upset (diarrhea, stomach churning) as well as insomnia - very short and broken sleep all night with dreams and waking up each time after brief sleep with bad/sour taste in mouth.       The insomnia has gotten progressively worse and unlike anything I've had before.  I do not have a history of insomnia ( I sleep very well) .  For the last week, I do not sleep more than a hour or two at a time and have the broken sleep, with dreams, not a good deep sleep at all, and sour/bad taste in the mouth.  I also don't have  any history of GI problems.  I have been eating a bland diet to try and help with the stomach issues, which have improved somewhat but are still not resolved.     The insomnia is very troubling.    Also occurring is heat sensation in the right hand (this actually developed after my first shot which was 2/23)  that would occur a few times a day where my knuckles are.   In the last several days (starting 4/3)  my right forearm and bicep  have been feeling  of  weakness and numbness, almost like someone has been sitting on it.  Not pins and needles feeling, but weak and numb.  This is somewhat transient, and happens for a few hours each day.  It seems to have improved as of today 4/6.    My physician feels I could have had some kind of neurological response to the vaccine.  I would like to know if this could be the case, or if there is any data showing these symptoms will go away, as I am obviously upset by them.
shortness of breath; Chest pain/feels like sharp pains are stabbing her chest; a lot of dry coughing/dry cough; migraine headaches; flu- like symptoms; sneezing; the cough is bringing up a lot of phlegm; difficult to for to consume harder, more solid foods; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2022 (Lot number: FK9894) at the age of 23 years as dose 2 (booster), single for covid-19 immunisation. Relevant medical history included: "interchange of vaccine products" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Johnson and johnson covid-19 vaccine (Johnson and Johnson Covid-19 vaccine, Date received: 23May2021, Lot: 201A21A, NDC, EXP: unknown, Administered in Left arm; dose unknown), administration date: 23May2021, when the patient was 22 years old, for Covid-19 immunization. The following information was reported: DYSPNOEA (non-serious) with onset 05Mar2022, outcome "not recovered", described as "shortness of breath"; CHEST PAIN (non-serious) with onset 05Mar2022, outcome "not recovered", described as "Chest pain/feels like sharp pains are stabbing her chest"; COUGH (non-serious) with onset 05Mar2022, outcome "not recovered", described as "a lot of dry coughing/dry cough"; MIGRAINE (non-serious) with onset 04Mar2022, outcome "recovering", described as "migraine headaches"; INFLUENZA LIKE ILLNESS (non-serious) with onset 04Mar2022, outcome "not recovered", described as "flu- like symptoms"; SNEEZING (non-serious) with onset Mar2022, outcome "not recovered", described as "sneezing"; PRODUCTIVE COUGH (non-serious) with onset Mar2022, outcome "not recovered", described as "the cough is bringing up a lot of phlegm"; DYSPHAGIA (non-serious) with onset Mar2022, outcome "not recovered", described as "difficult to for to consume harder, more solid foods". Therapeutic measures were taken as a result of dyspnoea, chest pain, cough, migraine, influenza like illness, sneezing, productive cough, dysphagia.  Additional information: Received the Covid-19 vaccine booster on Friday and is still experiencing side effects today. She reached out to report side effects to the vaccine. Shortness of breath: Started in the evening. Outcome: She explains it fluctuates. Sometimes feels like its getting better, but then it gets worse after she thinks its getting better. Chest pain: When she is not coughing, it feels okay, but when she is coughing it feels like sharp pains are stabbing her chest. She thinks the chest pain coincided with the dry cough which is also ongoing as well.   No follow-up attempts are possible. No further information is expected.
Fatigue; Ringing of the ears; Fever; Vomiting; Headache; Rash; Weakness; This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd March 2019, the patient received the 1st dose of Shingrix. On 22nd March 2019, 10 hrs after receiving Shingrix, the patient experienced fever, vomiting, headache, rash, weakness, fatigue and ringing in ears. On an unknown date, the outcome of the fever, vomiting, headache, rash and weakness were recovered/resolved and the outcome of the fatigue and ringing in ears were not recovered/not resolved.   It was unknown if the reporter considered the fever, vomiting, headache, rash, weakness, fatigue and ringing in ears to be related to Shingrix.  Additional details were provided as follows: The reporter was patient. On 22nd March 2019, about 10 hours later post vaccination in the left arm, in the evening, the patient experienced fever, vomiting, headache, rash, weakness, fatigue and ringing in the ears. All adverse events lasted for about 1 to 2 days, except fatigue and ringing of the ears which were still ongoing at the time of reporting. The patient had been to the doctor twice and also had seen the nurse at the county health department where he received the vaccine. He had scheduled an appointment with an Ear, Nose, Throat (ENT) doctor at the end of this month. The reporter consented to follow up. No further details were provided. The caller did not have doctor's information handy.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients received improperly stored doses of VAQTA lot # M017982 with an expiration date of 13-SEP-2017 (doses and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine underwent the temperature excursion of 9 degrees Celsius for 30 minutes which was detected by a data logger. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments:  US-009507513-1701USA014067: US-009507513-1701USA014062: US-009507513-1701USA003654.
I was walking around my house trying to fix my printer and I started to feel funny. My heart started pumping SO hard all of a sudden. I sat down and called my daughter in law and she told me to call 911, so I did. By the time they arrived my heart rate had slowed down but my blood pressure was really high so they took me to the ER. They wanted to keep me overnight and did about every test they could with my heart but didn't really find anything. I had to wear a Holter monitor when I went home and was still having some episodes. They then discovered that my hypothyroidism was turning even worse and so they changed my thyroid medication, and I haven't had any issues since. They amount has been adjusted a few times but since starting the new medication I feel better, my heart doesn't "feel funny".