chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sunday, the 17th, because of my sensitive skin, when I walk at night and it's very cold out when I come back into the house, I will get a mild case of hives on face and neck. That happened Sunday night. I take an antihistamine and it goes away. The next morning those hives on face and neck were gone but I had large red hives on my left arm by my injection site  in the deltoid area- swollen, red . I contacted my Dr. and she and I spoke about it and I wasn't having any other symptoms besides that and she recommended I continue to take an antihistamine and to contact Nurse Line. I transitioned from Benadryl to Claritin. Tuesday, I spoke with a nurse on line and she said that if I wasn't having any other symptoms continue with antihistamine but watch it. She had me measure it: it was 2 inches by 4 inches in size.  I continued with Claritin through that week and progressively improved. Redness went away but there was still a feeling a heaviness and achiness in that arm. It felt a little larger still in that arm. left arm felt different than my right arm. January 25, I decided to stop taking Claritin to see what would happen and didn't take a dose. The next morning, the 26th, I woke up with a slight amount of face swelling and an achy and heaviness feeling there as well. I contacted my Dr and my arm still didn't feel right either. We discussed what to do and she had me go back to Claritin and started taking more supplements Vitamin C and other immune supportive supplements for a few more days to a week. It progressively improved throughout that week. The week before my second dose, I was doing more Vit C and added Turmeric and other immune boosting things. The symptoms before the second dose. The second dose was received 2/7/2021. I did take photos of the rashes and can provide them.
bone very painful for 24 hours; Extreme fatigue; weakness; muscle and bone very painful for 24 hours; swelling at the entry of the injection; knot at the entry of the injection; just feeling unwell; Night sweats; lethargic; This is a spontaneous report from a contactable consumer(patient). A 77-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9246), via an unspecified route of administration, administered in left arm on 02Feb2021 23:15 as SINGLE DOSE for covid-19 immunization. The patient's  medical history included knee replacement, 3 times pneumonia, surgery for mitral valve repair ablation and atrial fibrillation, all from an unknown date and unknown if ongoing. On 25Jan2021 at 2:00 pm patient received first dose of Bnt162b2 (Lot no: EL3249) in left arm. On 11Feb2021 10:30 pm patient experienced bone very painful for 24 hours, extreme fatigue, weakness, muscle and bone very painful for 24 hours, swelling, knot at the entry of the injection, just feeling unwell, night sweats and lethargic. Outcome of the events was not recovered.
swelling in both thighs; swelling in both ankles; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (swelling in both thighs) and SWELLING (swelling in both ankles) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced PERIPHERAL SWELLING (swelling in both thighs) and SWELLING (swelling in both ankles). At the time of the report, PERIPHERAL SWELLING (swelling in both thighs) and SWELLING (swelling in both ankles) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Painful Heart Palpation 04/28/2021 & 05/01/2021, aspirin low dose, and persisted until.
vaccine administered 5 DAYS after 1st punctured; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered 5 DAYS after 1st punctured) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered 5 DAYS after 1st punctured). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (vaccine administered 5 DAYS after 1st punctured) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Source document contains no new information.
Feeling very nauseous and she threw up; Feeling very nauseous and she threw up; feeling dizzy and tired; feeling dizzy and tired; Headache; Blood pressure was higher than normal; This is a spontaneous report from a contactable pharmacist. A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), intramuscular in the left arm, on 08Sep2021 16:15 (Lot number: FE3592), at age 17 years old, as dose 1, single, for COVID-19 immunisation, at a pharmacy or drug store. It was unknown if the patient was pregnant at the time of vaccination. Relevant medical history was not reported. The patient has no known allergies. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination and if she has been tested for COVID-19 since the vaccination. Concomitant medication included prazosin, trazodone and lithium all taken for unknown indications, start and stop dates were not reported. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. On 08Sep2021, the patient had a headache. On 09Sep2021 00:00 (also reported as 12:00 AM), the patient was feeling dizzy and tired. On 10Sep2021, the patient started feeling very nauseous and she threw up. Over the next few days, the vomiting intensified. It was also reported that in Sep2021, after the vaccine, her blood pressure was higher than normal. The patient ended up going to the hospital on 13Sep2021 and was discharged on 18Sep2021. It was unknown if the patient received treatment for the events. The patient recovered from the headache on 18Sep2021. The patient was recovering from the remaining events.
On 7/15/03 client received Td-awoke 7/16/03 with severe and progressive total body muscle aches/soreness-feels flu-like. States was fine previous to Td.
lt deltoid w/ a large red area about the size or orange;area very warm to touch & sl swollen began 20AUG97;
Swelling, rednees, numb at the site, but also sore to the touch.  Injection site is hot to the touch.  Was prescriped Naproxin (anti-inflamitory medication).  Also warm compresses to the site.
Patient called pharmacy late on 10/12/17 and reported to pharmacist swelling, redness, warm to touch on left arm. He sent picture of arm to pharmacist and then came in to pharmacy on 10/13 morning to show arm to pharmacist. Left arm was red, swollen, and warm to touch from injection site to above elbow. He reported he could not move arm above his shoulder. He also reported flu symptoms on 10/12 with fever and body ache, lethargic and didn't feel like he could work. His arm was very warm to touch. I instructed patient to take ibuprofen for swelling and inflammation. Also told him to use cold compress twice daily. Pharmacist will call him this evening on 10/13 to see if arm is better.
I had the vaccine...I still get them/Suspect vaccination failure; I had the vaccine...I still get them....; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult 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 age group was not reported but it was captured as an adult as per vaccine indication. The patient had the Shingles vaccine ahd still get the shingles. 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. The follow up would not possible as no contact details were available.
Severe headache 12-15 hours post injection  Almost daily headaches since injection  Extreme fatigue most days post injection with slow recovery (even now?day 10) Nausea  Diarrhea  Residual soreness from injection (day 10) Some shortness of breath/trouble breathing
Dizziness Patient complaints of shakiness, dizzy, and SOB after injection. Coherent and able to talk. Narrative:  Patient transfered with assist of 2 to wheelchair and in attend of x1 RN to the ER. Patient stable and talking with evident shaking and SOB however, able to answer and talk to staff present.
20 minutes after the injection of COVID -19 vaccine, patient reports a itchy throat, administered patient own dose 0.3mf EpiPen into right thigh and Benadryl 50mg IM right deltoid, patient taken by EMS to hospital
No discomfort at all until a little soreness in the evening.  5 days later on 5-2-21 experienced much itching left arm at vaccination site which had become a red patch about 3" w x 5"l.
Tingling swelling above top lip just after shot.  Next day  in am cold shivers, body aches, Eyes swelling. 17:00 Head itching and hives  over top half of body, top lip swelling. Glands hurt under arm and near collar bone. Benadryl.
Severe breakout into hives. Severe itching. It happened after the second Moderna shot as well (this was the booster).
SOB & hives when 10-15min p/inj;saw PMD-DPH given & advised not to cont Hep B series
This spontaneous report was received from a medical assistant, regarding an unspecified number of patient of unknown age and gender. The patients' medical history, concurrent conditions, drug allergies, or concomitant therapies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX subcutaneous injection as a single dose (strength was not reported) (lot # M025870, expiration date 24-MAY-2018; lot #: M032493, expiration date: 06-JUL-2018) for prophylaxis. The patients were also administered sterile diluent (strength, lot number and expiration date were not reported). According to the reporter, VARIVAX doses had been exposed the following temperatures excursions: 22 degrees Fahrenheit (F) for 1 hour daily, during defrost cycle. No adverse effects were reported. A digital data logger was involved. This is one of two reports from the same reporter. Additional information is not expected as the reporter refused additional contact.; Sender's Comments: US-009507513-1703USA013063:
Fainting episode .  I was standing by a friend ,I fainted and hit my head on the floor .  Regained consciousness right away and had no other subsequent events.
LEAKED OUT VACCINE; INCOMPLETE COURSE OF VACCINATION; SUSPECTED PRODUCT TAMPERING; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 03-MAY-2021, the subject experienced leaked out vaccine, incomplete course of vaccination, and suspected product tampering. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the leaked out vaccine, incomplete course of vaccination and suspected product tampering was not reported. This report was non-serious.
Do not know that this is a reaction to the Vaccination but, approximately 2 weeks after the second dose of the Pfizer vaccine, I was admitted to the hospital with Bilateral and saddle pulmonary embolism with acute cor pulmonale, repeated syncope, elevated troponin and BNP and RV strain by CT as well as EKG.   1. Ultrasound-guided right common femoral venous access. 2. Pulmonary angiogram. 3. Pulmonary artery pressure measurement. 4. Bilateral selective pulmonary angiogram. 5. Flowtreiver thrombectomy of bilateral pulmonary arteries with extraction of large thrombus burden.
On the 9th day after receiving the 1st Moderna injection, a 2.5" in diameter rash with redness, hardness, and warmth presents on left deltoid.  In addition, a 1" in diameter swollen lymph node in the left armpit presents at the same time.
Tongue and left part of face become stiff and droopy. Called 911 and was treated for possible allergic reaction or stroke.  Treated with steroids for bells palsy. Taken for CT scan to eliminate a stroke. Outcome was the diagnosis of Bells palsy and to treat with medications.
The packaging on BayRab 2ml and 10ml vials look identical. We recently had a near miss in dispensing what we thought were 5 x 2ml vials but were actually 4 x 2ml and 1 x 10ml vial. They needed 10ml which would have been 5 x 2ml vials or 1 x 10ml. What happened was 4 x 2ml and 1 x 10ml was sent and the nurse started pulling up from all vials before realizing one was a different amount. Unfortunately the nurses drew up the excess and discarded it. It was a very expensive waste and this eliminated the only stock we had in our pharmacy had there been a second exposure we would not have been able to respond in a timely fashion.  The pt that the BayRab was ordered for did received the correct dose.  Package labeling was certainly the root cause of this error. Secondary causes included: not reading the labels closely, storage of the two different size vials in the same bin in the same drawer of the refrigerator (there was a divider in the bin to separate the two vial sizes but this obviously  was not enough of a distinction), not drawing up the dose and labeling it in the pharmacy. We completed education of all pharmacy staff at a staff meeting (show and tell), we separated the different vial sizes into two separate bins with different colored labels on the outside of each bin to visualized that there is a difference, we will now ask for a pt weight and draw up doses and label and send them to the ER when we received an order for this drug as opposed to just sending the vials. Please take a look at this and ask Bayer to do a better job distinguishing these two different size vials.
5/4/08 - 4 PM - swelling and redness around injection site.  Felt calling (like to mother of patient).  5 cm diameter.  5/5/08 - less red, but swollen, arm pain with reaction.  Some swelling.
This non-serious spontaneous case, was initially received on 18-Oct-2017 from other health professional (nurse), concerns a patient of unspecified age and gender. This was 23rd out of 31 reports. On 09-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: full dose (as reported), batch number: 195128, expiry date: 30-Apr-2018, route of administration, anatomical location: not reported). On 09-Oct-2017, this employee was given vaccine from a vial that leaked. It was reported that, after piercing the vial, when it was turned upside down and upon injecting air, vial was dripping from the rubber seal. The nurse could withdraw only 7 doses from the vial. The patient was administered with full doses. There were 2 defective units, but the package was not damaged or wet. The nurse used 23 needle gauge of size 3 cc. The PTC (product technical complaint) number provided for was 1025066. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the vial or stopper components, and no trends were identified for the batch. However, a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause can be attributed to improper handling by the user. Follow-up received on 21-Nov-2017: Added PTC number and the QA (quality assurance) report results. Narrative amended accordingly. Non-significant case correction received with IRD 18-Oct-2017: The verbatim of the event 'product leakage' was corrected and the lead sentence in narrative was amended.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 INFECTION; This spontaneous report received from a patient concerned a 6 decade old male. Initial information was processed along with the additional information received from a regulatory authority on 30-DEC-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 (patient age at the time of vaccination was 57 years) (dose number in series: 1) (suspension for injection, route of admin not reported,  batch number: 201A21A and expiry: 21-SEP-2021) dose was not reported, 1 total, administered on 12-APR-2021 to the left arm for prophylactic vaccination. No concomitant medications were reported. The patient stated that he had not performed covid 19 test but was symptomatic and he had symptoms of diarrhea, vomiting, body aches, joints hurt, feverish and chills at the time of reporting. The patient also stated that body aches may be from exertion from throwing up (coded as suspected covid 19 infection and suspected clinical vaccination failure) (dose number in series:1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid 19 infection and suspected clinical vaccination failure was not reported. The patient received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series: 2) (suspension for injection, route of admin not reported,  batch number: 213D21A and expiry: UNKNOWN) dose was not reported, 1 total, administered on 22-NOV-2021 to the left arm for prophylactic vaccination. It was unknown whether the patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series: 2). This report was serious (Other Medically Important Condition). This report was associated with a regulatory authority This case is a duplicate of 20211258611. The suspected regulatory authority has been confirmed to be voided (did not meet a regulatory authorities criteria)(this complaint does not describe a product quality issue and the patient was exhibiting symptoms of an infection there was no confirmatory test to confirm if this was covid-19, hence was confirmed as voided) based on the regulatory authority (product quality complaint) evaluation/investigation performed.; Sender's Comments: V0: 20211258571-COVID-19 VACCINE AD26.COV2.S-Suspeceted clinical vaccination failure. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS
Information has been received from a 79 year old female with no medical history or allergies who in July 2007 was vaccinated with a dose of Zostavax.  There was no concomitant  medication.  On 26-Sep-2007 the patient developed a black and blue mark and soreness at injection site.  The patient had contacted her physician but no medical attention was sought.  A product quality complaint was not involved.  No further information is expected.
16jan90 pt vax hepta B. 14 hrs after vax pt devel wheezing, diarrhea, nausea, dyspepsia, tinnitus, fever chills, neck pain, abdo discomfort, & dysuria which persisted for 3 days. pt treated w/ imodium. 16feb90 pt vax 2nd hepta B. see worm..
I need to share a few things about the Covid Johnson & Johnson vaccine. I took the Johnson & Johnson vaccine on September 22 and initially felt a discomfort in my left arm for about 15 minutes; it disappeared shortly after. But since September 22 that feeling has resurfaced especially in the evening. On November 1, I began a strange week of daily constipation that continues to this day Saturday, November the 6. I feel that my body is fighting the Johnson & Johnson vaccine or some active ingredient in the vaccine. So far, there?s constipation, a faint chemical smell in my system, and a feeling that my body is trying to discard a foreign substance that it doesn?t recognize. I need to talk to someone about this experience.
Information was received from a lawyer regarding a case in litigation. During 2013, a female patient, age unspecified, was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles. On or about 12-MAY-2016 the patient was treated (by an unspecified health care professional) at an urgent care facility for blistering vesicular outbreaks that were diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term 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 had a tickle in my throat. I didn't feel right, and I tested myself and, I was positive. I had a runny nose for a few days. I was tired but I didn't feel really bad at all. I developed high blood pressure. I had shortness of breath. The doctor wanted me to take a low dose of blood pressure medicine, but it didn't make a difference.
Pt recvd vax & mom stated pt felt faint & eyes then rolled & arms flexed when the pt fainted; pt was pale;