chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the swelling did seem to get worse; Right knee swelling; cyst; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administration date 26Apr2021 (Batch/Lot number: unknown) at the age of 60 years as dose 2,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization. The following information was reported: CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "unknown", described as "the swelling did seem to get worse"; JOINT SWELLING (non-serious) with onset 2021, outcome "unknown", described as "Right knee swelling"; CYST (non-serious) with onset 2021, outcome "unknown", described as "cyst". Relevant laboratory tests and procedures are available in the appropriate section.  additional information: patient stated he has one done without contrast in between first and second dose and it was something that he had previously.it was reported by the patient that cyst was on his right knee.  He did notice that after second dose, the swelling did seem to get worse for a short period of time. This MRI was prescheduled in between the first and second dose.Dates for Right knee swelling got worse after second dose was unspecified .Reporter seriousness for Right knee swelling got worse after second dose was Unspecified  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received vaccine 12 days too soon. Patient reported no adverse reaction after 15 minute wait time.
Patient reported that his arm hurt immediately after the vaccine but didn't start worring about it until 1 week had past. He claimed trouble moving his arm and mostly hurt when at work trying to lift heavy objects. He went to the doctor after 3 weeks, and was told it is normal and will go away on its own then was given an rx for Ibuprofen. He came to us after another week and told me he had an appointment with his regular dr and would let me know what they had to say. He called us this week saying it still hurts and the doctor told him again that it was normal and should go away on its own.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 22-JUN-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Extreme tinnitus ever since the week I received the shot. I have never experienced this and it still has not gone away but has gotten worse. It is very hard to sleep and extremely hard to focus during the day
Approx 5 hrs after getting shot, patient reported nausea, dizziness, body aches, fever, chills which lasted for approx 4 hrs then went away.
This spontaneous report was received from an unspecified reporter as part of a Market Research program, referring to multiple unspecified elderly patients. The patients' age, concurrent conditions and medical history were not provided. On an unknown date, the patients were vaccinated with PNEUMOVAX 23 (dose, administration route, anatomical site, lot number and expiry date were not reported). Concomitant therapies were not provided. The reporter stated that they have heard or seen in the last three months, that PNEUMOVAX 23 was "not as effective in elderly" (drug effect incomplete). At the time of this report, the outcome of drug effect incomplete was unknown. The original reporting source did not provide a causality assessment. Additional information is not expected, as the reporter did not wish to be contacted.
Swelling and pain in injection site,  fever, body aches, fatige; Started May 14 2021 @ 6:00 am
Received shot in back of left arm 7/22/09 - On 7/24 rash on left shoulder, then spread to chest and back of both arms, legs, and top of feet. Cont. to itch real bad like something crawling under my skin - the rash turned into hives very red and itchy - cont scratching - Went to ER received  6 prescriptions with no relief had appt 8/6/09 in bad shape. Adm. to hospital taken in ambulance, during admission I was placed in ICU with fever, high B/P, IV infusing, foley inserted. Blood sugar jumped up over 700 - started on insulin drip a series of other meds given, but heading up to this day cont and get worse after the dose finished. I became very weak, no strength, short of breath. I could barely get around after my first hospitalization, I was home for one week and the symptoms recurred I was put back in the hospital, My Dr said I had a second reaction from the vaccine - I was there for one week 5 specialists saw me, I was told that I had pneumonia, my blood count dropped 8.3 - I had to get 2 units of blood. From the reaction: 1. the rash - 2. hives - 3. bothered my body, ears, throat, my head, and my feet felt like I was walking on a rice bed, 4. my lips turned black, my nipples turned black and crusted - 5. my vagina and rectal area became very dry and itchy - almost four months later my skin is all scaly and blotchy - I lost layers of dry skin off my feet, my face is still very flaky, my body is left like I was in a fire very scared up, I have not been able to return to work yet - I have hopes I can go back Dec 1st 2009.  12/23/09 Clinic notes and hospital records received for 08/06/09- 11/12/09. Dx: Drug rash, acute bronchitis Patient presented with c/o diffuse itchy, erythematous rash, cough with brownish sputum, sore throat, SOB, night sweats, pain, feeling weak and ill.  On admission, patient hypertensive, anemic (thought due to CKD) and laboratory testing revealed hyperglycemia (thought secondary to starting pt. on prednisone), Cr elevated (thought secondary to hyperglycemia as well as allopurinol/colchicine toxicity) and hyperlipoproteinemia.  Rash initially developed around shingles vaccination injection site and was painful, red and bumpy. Unsuccessfully treated with prednisone (5 days). During hospitalization treated with benadryl, zantac, prednisone and triamcinolone cream. Rash improved and patient discharged home. 10/29/09 clinic note: No hives, no erythema.
Information has been received from a physician concerning a 7 month old male who on 02-DEC-2008, 02-FEB-2009 and 09-MAR-2009 was vaccinated orally with first dose (lot number 660682/0574X), second dose (lot number 661736/0690X) and third dose (lot number 663260/1794X) respectively of ROTATEQ. The physician reported that the patient came into the office on 09-APR-2009 for a follow up visit regarding the patient's unspecified congestion; the physician reported that it was unknown if the patient was congested after received any of the ROTATEQ doses. The patient's mother reported to the physician that her son had been experiencing diarrhea. The physician then did a rotavirus test on the patient and the test came positive for rotavirus. The physician reported that the patient's mother was given hydration information and he changed the patient's formula. The physician report that he had not heard back from the mother, so he does not know how the patient is doing. Additional information has been requested.
Information has been received from a pharmacist referring to three patients of unknown age and gender. Concurrent or medical conditions were not reported. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 (lot # L003188, expiration date 06-JUL-2016) (dose, strength, frequency were not reported). Secondary suspects and concomitant therapies were not reported. The pharmacist reported that upon administration of PNEUMOVAX 23 to the patients, they experienced injection site reaction described as swollen, red and raised area with blisters. No treatment was received for the events. It was reported that the patients sought medical attention by telling the pharmacist about the events. The outcome of events was not reported. The reporting pharmacist required a lot check of PNEUMOVAX 23. The events did not required intervention to prevent serious criteria, did not produce significant disability or incapacity, did not required hospitalization and were not life threatening for the patients. No product quality complaint was reported. Follow-up information has been received during phone call on 26-MAY-2015. The physician was unavailable at the time of the call. The call was transferred to the nurses' station where a voice mail was left requesting patient identification and a returned phone call. Follow-up information was received on 17-JUN-2015 from a physician's office via a registered nurse. The nurse reported that there were four patients who received a dose of PNEUMOVAX (lot # K008419, previously reported as lot # L003188 with events for three patients) and upon follow up from physician the lot number was corrected to K008409 and information was provided for 3 additional patients (MARRS # 1506USA012350, 1506USA012351, 1504USA009855). This patient is a 77 year old female who on 08-APR-2015 at 11:28 AM received a dose of PNEUMOVAX 23 in the left deltoid muscle. This was her first dose. There were no previous illnesses at time of vaccine administration and she had an allergy to sulfa. On approximately 08-APR-2015 the patient experienced pain, swelling, redness, fluid and heat at the injection site. The patient recovered on an unknown date. No other information was provided. The event of injection site vesicles was removed as physician did not report this reaction on questionnaires. Additional information is not expected. Narrative was updated. New cases were created for the 3 additional patients (MARRS # 1506USA012350, 1506USA012351, 1506USA012352. Initial case 1504USA009855).
About a week before my mom got the shot she had a leg wound that was healing and not infected. Two days after the shot she was weak, dehydrated, and the leg wound was severely infected. Took her to the emergency room and had IVs, tests and was put on antibiotics for two weeks.
Decrease Heart Rate; Increase pulse; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE DECREASED (Decrease Heart Rate) and HEART RATE INCREASED (Increase pulse) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced HEART RATE DECREASED (Decrease Heart Rate) and HEART RATE INCREASED (Increase pulse). On 30-Jan-2021, HEART RATE DECREASED (Decrease Heart Rate) and HEART RATE INCREASED (Increase pulse) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was not given.   No laboratory was not given.   No treatment information was not given.   This case was linked to MOD-2021-026680 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received no new significant information.
Suspected vaccination failure; Shingles; This case was reported by a consumer via (Shingrix GSK) 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 suspected vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the suspected vaccination failure and shingles were unknown.   It was unknown if the reporter considered the suspected vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient wanted to know who to report about getting shingles after taking GlaxoSmithKline vaccine. The follow-up would not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Patient came in on 3/19/2018 complaining of rash on lower abdomen, groin, and thighs. Patient was prescribed Prednisolone 15mg/5mL (2mL daily).
Information has been received from a physician concerning a 17 year old male who on 10/10/2001 was vaccinated with the first dose of varicella. Concomitant vaccination that same day included the first dose of hep B vaccine. At the time of vaccination, the pt had an upper respiratory infection. The pt was not on any chronic medicaitons. On 11/10/2001, the pt reported to the ER with right facial paralysis. He was diagnosed with Bell's palsy and was started on oral steroids and eye drops and was sent home. The pt was seen the next day by a primary care physician and later by a neurologist. No cause for the Bell's Palsy was found. It was noted that the mother of the pt alerted the physician that the package insert for lists Bell's Palsy as an adverse experience to varicella vaccine. It was reported that the pt was physically doing better but he was not back to his baseline status. The physician stated that the pt was not doing well emotionally because of the Bell's Palsy. The pt was seen again on 11/23/201 and he seemed to be slowly improving; however, he was at a very difficult age and was depressed over his physical appearance. The pt was scheduled to follow-up with a neurologist on 12/11/2001. On 11/28/2001, the physician reported that the pt should have completed the steroids at this time and he was using the eye drops as much, "as much as a 16 year old could be expected to use them." Upon internal review, the pt's Bell's Palsy was considered to be an other important medical event. Additional info has been requested.
This case was reported by a nurse via call center representative and described the occurrence of arm discomfort in a 19-year-old male patient who received BEXSERO (batch number 148901B, date 30th September 2016). Previously administered products included BEXSERO (1st dose received on an unknown date). On an unknown date, the patient received the 2nd dose of BEXSERO .5 ml. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced arm discomfort and swelling arm. On an unknown date, the outcome of the arm discomfort and swelling arm were recovering/resolving. It was unknown if the reporter considered the arm discomfort and swelling to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced arm discomfort and swelling. No further information was reported regarding the event.
THE VACCINATION SITE WAS WARM TO THE TOUCH; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, high cholesterol, thyroid problems, non alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies and not allergic to medication. The patient was not pregnant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAY-2021, the subject experienced the vaccination site was warm to the touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination site was warm to the touch was not reported. This report was non-serious.
Trigeminal neuralgia right side of face. Sensitive to touch, wind. Started a few days after second dose, lasted 3 months. Seems to have gone away now
GOT THE COVID-19 PFIZER VACCINE ON 12/4/2021. ON SUNDAY SHE GOT DIZZINESS, THROW UP AFTER EATING, FAINTED.  FAMILY RUSHED HER TO EMERGENCY.  SCAN AT HOSPITAL SHOWS STROKE, BLEEDING IN THE BRAIN
A report has been received from a Health Professional concerning a 6 year old, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (Intranasal) started on 12-Dec-2013. The reporter stated inadvertently gave expired FLUMIST QUADRIVALENT which started on 12-Dec-2013. The outcome of the event of gave expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by the reporter.
Accidentally received 3rd dose of covid vaccine twice. Pt came in with dad for flu shot but gave the nurse a consent form for flu and covid. Nurse asked if supposed to be getting covid too and dad said yes. Nurse checked EMR and it said "dose due" however patient had already received dose with mom and wcc on 9/2/23. We identified a glitch in our EMR where the new covid vaccines are not populating  into the vaccine schedule page even though they are charted on the vaccine history page. This was brought to tech support's attention and they are working on fixing it.
Client received vaccine, where Health Center was holding a vaccine clinic for staff needing the vaccine. Client came in for his first dose of the Pfizer vaccine. He was nervous prior to receiving the vaccine. Stated that he didn't like getting vaccines. He stated that he had seasonal allergies and was on zyrtec or claritin. He did not have any other allergies or history of a serious allergic reaction to food, medications or vaccine components/vaccines. I vaccinated patient, and he went into the observation room with two APRN's for his 15 minute observation. He stayed in the room for 20 minutes per APRN. When he got up to leave, he walked 20 feet and fainted per APRN note. She stated, "he was cold, clammy pale, bradycardic and was difficult to rouse but spoke less than 2 words or none at a time. Blood pressure at 6:10 pm was 90/50, pulse 40, shallow respirations at 10/min. At 6:15 pm blood pressure was 120/60, pulse 70, and respirations at 10/min. At this time EMS arrived and put patient onto the gurney and transported him to Hospital.
2nd Dose of Maderna Vaccine, Adverse effects: Pain,swelling and redness at injection site. Pain in the chest and breast area. Chills, headache, nausea, Diarrea, Body aching all over.
Tested positive after getting the first dose of covi-19 vaccine.; Tested positive after getting the first dose of covi-19 vaccine.; This is a spontaneous report from a Pfizer-sponsored program. A contactable male consumer ( patient) of unspecified age received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive after getting the first dose on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Injection site reaction 8 days post. Localized itchy rash with raised plaques and warm to the touch. Treated with oral Allegra and topically with alternating Triamcinolone and Benadryl creams. Rash continued for 5 days before resolving. Area remains hyperpigmented.
This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. Medical history and concomitant medications were unknown. On an unknown date, an unspecified number of patients were vaccinated with improperly stored doses of VARIVAX (Merck) Lot # L031065, expiration date 18-AUG-2017; Lot # L029467, expiration date 06-AUG-2017; Lot #, reported as L035127, expiration date 14-SEP-2017; Lot # L002217, expiration date 21-JAN-2017; Lot # L031065 expiration date 18-AUG-2017 and Lot # L034372 expiration date 08-SEP-2017, (route, dose and anatomical location were not reported), which were exposed to 5.7 degrees F temperature, outside of the recommended range during a time frame of 30 minutes. There was not a previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Normally expected soreness did not go away. Pain became progressively worse, and limited range of motion (left shoulder) developed over next several weeks. Orthopedist diagnosed "frozen shoulder" also known as adhesive capsulitis.
This spontaneous report received from a consumer concerned a White female of an unspecified age and ethnicity. Initial information was processed along with the additional information received on 11-OCT-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: 21-SEP-2021) dose was not reported, 1 total, administered on an unspecified date in SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient had laboratory tests done which resulted as positive for Covid-19 PCR test (confirmed covid-19 infection) and experienced the loss of taste, congestion and cough (suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a regulatory authority: 90000196853.; Sender's Comments: V0: 20211018360-Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
pt recvd vax;next am arms & legs shaking for 30 secs;to er 11jan95 in pm;blood count found to be anemia;juice given by MD;had CT of head,EEG - all neg;
Patient did not experience a true  allergic reactions they had a panic attack.   Panic attack symptoms experienced by patient  : vomiting, sweating, dizziness, redness develop on the back of neck and parts of face, increased heart rate  Patient had a panic attack after receiving vaccine they where nervous of switching to Pfizer from Moderna. Patient stated they want Pfizer but have a fear of needles. After about 10 minutes patient had dizziness and vomiting.   We were about to administer Epi pen but patient stopped and stated no its not an allergic reaction. We called 911 and they asked about symptoms while we where on the phone. Patient started to return back to normal within a few minutes and canceled emergency vehicle.  Injection site was also checked and patient injection site was clear with not redness or signs or rash  Patient was monitored for an additional 30 minutes and patient was back to normal with no symptoms present.
The patient has 2 blisters to the right upper arm. She received BEXSERO and MENVEO yesterday. She took off the Band Aids at 1:00 pm today and noticed the blisters. She has not felt pain at the site.  There is erythema and mild swelling. She denies fever. She states that she has not had shortness of breath or wheezing. She denies facial swelling. No other concerns. Patient was given BACTROBAN ointment, BENADRYL, and TYLENOL. Cephalexin tablet.