chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 69 y.o. male patient of CNP with history of COPD, basal cell carcinoma, mantle cell lymphoma, GERD, presented to Hospital with cough fever shortness of breath.   COVID-19 infection Acute hypoxic acute respiratory failure probable atypical, most likely viral pneumonia, concern for superimposed bacterial infection. History of COPD; no clinical evidence of clinical exacerbation Immunocompromised, history of mantle cell lymphoma on chemotherapy. Presented with cough of 3 weeks duration, progressive shortness of breath worsening over the last 24 hours, fever. Vaccination status; vaccinated, and boosted. VBG; pH 7.37/45.5/29. COVID-19 positive, influenza A and B Undetected CRP 176 admission, CXR;Hazy interstitial opacities are present in the bilateral lung bases, left greater than right, suggestive of atypical infectious infiltrate/viral pneumonia. Urine Legionella, streptococcal antigen is ordered and is pending. Blood cultures X 2 is negative , urine culture is negative.  Started on vancomycin and Zosyn.  Discontinue 12/19 as cultures remain negative.  MRSA swab negative Continue supplemental oxygen currently on 2 L supplemental oxygen, titrate to keep saturation above 92. Given elevated CRP patient started on IV dexamethasone.  Patient successfully weaned off supplemental O2 on 12/20.  CRP downtrending on recheck 132.    History of Mantle cell lymphoma of lymph nodes of neck Diagnosed 10/21 Planning stem cell transplant was counseled about a month ago due to illness, has an upcoming PET scan next week Thursday. Does follows up with hematology oncologist. Completed 6 cycles of R-CHOP; C6 (last) on 2/16/2022.Currently On Q 2 monthly Rituximab last infusion was about 10 to 11 days ago.   H/O  Barrett's esophagus. Patient verbally reported planned EGD 12/20/22, however oncologist documented delay EGD until he is done with his treatment   Leukocytosis . Etiology unknown per documentation  was started filgrastim 10/28. Will monitor given possible ongoing infection.   Deconditioning weakness severe malnutrition related to chronic illness/injury
shingles; neuropathy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient (pt) of unknown age. Information of the pt's concurrent conditions, medical history or concomitant therapy was not reported.  In or about January 2014, the pt received zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), on an unknown date (reported as shortly after vaccination), the pt suffered from shingles and neuropathy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt symptoms had resulted in physical limitation and also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of zoster vaccine live (ZOSTAVAX), pt sustained severe and permanent personal injuries. He suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events was not recovered.  Causality assessment was related. Herpes zoster and neuropathy peripheral were considered disabling events.
covid test result positive; covid test result positive on 27Jan2021; arm is still sore where he got the shot; This is a spontaneous report from a contactable consumer (patient). A 70-years-old male patient received the first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3264), via an unspecified route of administration at arm left on 14Jan2021 11:00 am as SINGLE DOSE for covid-19 immunisation. Medical history included atrial fibrillation. Concomitant medications included atorvastatin calcium (ATORVASTATIN CALCIUM); metoprolol tartrate (METOPROLOL TARTRATE); apixaban (ELIQUIS). The patient experienced arm is still sore where he got the shot on 14Jan2021. It's a low-end, 1-2 on a pain scale. No other side effects from first shot. No side effects from second shot in right arm on 08Feb2021. The patient covid test (Nasal Swab) was positive on 27Jan2021. The patient underwent lab tests and procedures which included pain assessment: 1-2 on 14Jan2021, sars-cov-2 test: positive on 27Jan2021. The outcome of the events was unknown.
Pt. states that after receiving the 3rd dose of Phizer 12/02/2021, started experiencing symptoms 12/04/2021 of fever (102.0), fatigue, chills, numbness in the left arm (24hrs), dizziness, and nausea. No noted Primary visit/communications. Symptoms have subsided besides random tingling throughout the left arm.
This spontaneous report as received from a nurse refers to a 12 year old patient. No information regarding the patient's medical history, concurrent conditions or concomitant medications was reported. On 19-OCT-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (dose and route of administration were not reported), lot # L007560. No adverse reaction was reported at the time of the report. This is one of several reports received from the same reporter. Additional information has been requested.
His body was limp and pale rush to Hospital where his body was posturing and Cat scan showed swelling of the brain. Organs started to shut down and he died the next day.
Fever, erythema, swelling, induration, warmth, tenderness, that continues to spread to 8cm x 3cm area on thigh correlating to injection site.
Coagulopathy noted prior to scheduled thorocentesis. 02/16/10 syncope episode, GI bleed secondary to rupture of esophageal varices, INR increased to 2.4 swelling and hematoma beginning on left arm around vaccination site which grew over the course of approximately 5 days to entire arm, hand, shoulder and half of back. Left pleural effusion.
About a week after my second shot of Moderna I started having ringing in my ears. After I had the booster of Moderna  on 12/2/2021 the ringing in my ears got worse. It's so bad now that I can't hardly stand it.
Intermittent vomiting starting 12 hours post dose and continuing for 48 hours after
PT COMPLAINED OF PAIN AT INJECTION SITE AND ALSO OF PAIN IN L ARM AFTER ADMINISTRATION.
Rcv'd vaccines on 9/23, came in office 9/29 with fever of 103, which began on 9/26. Fever subsided the next day, none since. Rash noted on 9/28, dx'd by MD as erythematous morbilliform, maculopapular rash, over trunk, abdm & inguinal region
Seizures. DC DX: new onset seizures resolved and improved. Continues to have daily seizure activity.  Is being followed. Per 60 day follow up: Pt continues to have seizures which started the day after the vaccine. ? co-relation. Pt being followed by neurologist at this time for the problem.
within 4-5 hours fever spiked to 103; body was shaking, a sensation of pins and needles in arms and legs; abdominal cramping and vomiting. Fever reduced after administration of Tylenol to 102.3; fever persisted for 24hrs (@ 102.3); vomiting and cramping ceased after 12hrs.
A booster of Moderna (0.25 mL) was administered on 11/13/21 at 15:08 HRS. The patient's vaccine card showed she had only had 2 doses and she was in the appropriate time frame past 6 months from second dose. When I entered her booster into state vaccine tracking system on 11/14/21,  I discovered she had received a booster on 11/3/21 at Clinic. I contacted her legal guardian immediately and informed him of the error. He contacted her assisted living facility.  On 11/14 the patient was not having any symptoms or adverse reactions to the extra dose.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 77-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unknown date in 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles.  The outcome of the event shingles was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
I experienced a miscarriage a week after having the Pfizer to vaccine and I'm not being given much information from the vaccine facility they gave me a piece of paper with a phone number to vaers in this doesn't even look like a phone number or a fax number to their facility
stomach was dust a little sore; All around sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Jan2022 (Lot number: 330308D) as dose 1, single for covid-19 immunisation. Relevant medical history included: "paralyzed left diaphragm", start date: 2013 (ongoing), notes: Illness/AE: paralyzed left diaphragm, Stop date: Non repair above, Pertinent details: Last surgery. Family history included: "sleep apnea" (unspecified if ongoing), notes: Dad passed from sleep apnea; "Alzheimer" (unspecified if ongoing), notes: Mom was Alzheimer, dementia insomnia; "dementia" (unspecified if ongoing), notes: Mom was Alzheimer, dementia insomnia; "insomnia" (unspecified if ongoing), notes: Mom was Alzheimer, dementia insomnia. There were no concomitant medications. The following information was reported: ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomach was dust a little sore"; PAIN (non-serious) with onset 06Jan2022, outcome "unknown", described as "All around sore". Therapeutic measures were not taken as a result of pain.  Additional Information: The patient stated that just got the first pfizer vaccine. The patient had been procrastinating. The patient felt ok often, stomach was dust a little sore. Patient took second dose on 28Jan2022 in left arm with lot number: 330308D. Prior vaccination was none.  Follow-up attempts are completed. No further information is expected.
Chills; Fever; Heart racing; ached from head to toe/body soreness; FLU LIKE FEELING; Could not sleep and mind was racing; her mind was racing; Soreness at the injection site; Tension headache with pressure; This is a spontaneous report from a contactable consumer reported for herself. A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on left arm on 20Jan2021 12:30 at SINGLE DOSE for covid-19 immunisation. Medical history included none.  There were no concomitant medications. The patient received the vaccine on Wednesday, 20Jan2021. This was her first dose. She had the vaccine at 12:30 PM. Right after the vaccine she waited her 15-20 minutes and was fine. These things did not start till later. She was not sick prior to getting the vaccine. 8 hours after, around 8:30 PM she had a tension headache with pressure that went all through the night and let up around 21Jan2021 10 AM. Around 12 AM Thursday morning on 21Jan2021, she had chills, fever, and a racing heart. She ached from head to toe/body soreness. It was a flu like feeling. Then they all got better around the same time 21Jan2021 evening. The racing heart was not enough to need 911. It worried her but was not enough. She also could not sleep and her mind was racing. She thinks it was because what was going on with her racing heart. It was making her head pound. She finally was able to sleep last night on 21Jan2021 around 8:30 PM and slept until 4:30 AM this morning on 22Jan2021. The doctors said if she was not better by tomorrow they would work her in to see her. But she is much better today. She also had soreness at the injection site on 20Jan2021. She knew that was normal though. She is still sore but overall is better. It felt like there was an invasion in her body. She is a little scared now for the second dose. She is unsure if she wants to get it. She asks, do you recommend getting the second dose after she had all of these side effects? It worries her. The heart is the main thing. That worried her the most. Outcome of the event tension headache with pressure, chills, fever, heart racing, ached from head to toe/body soreness, flu like feeling was recovered on 21Jan2021, outcome of the event could not sleep and mind was racing was recovered on 22Jan2021, outcome of the event soreness at the injection site was not recovered.
Father noticed rash on lower lumbar spine on 11/21 on 11/22 rash has progressed up the spinal column in a line. Father states rash looks like hives and is painful to touch. No other symptoms noted. Child is going to see Primary Care Provider this afternoon for further evaluation.
administrated a third dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 88-year-old male patient who received Herpes zoster (Shingrix) (batch number zaa27, expiry date 31st January 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date).   On 5th November 2021, the patient received the 3rd dose of Shingrix. On 5th November 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The patient was inadvertently administrated a third dose of Shingrix, which led to extra dose administered. The reporter had not reported further events.  The reporter agreed to be contacted for follow-up. The case has been linked to US2022016975,reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022016975:same reporter
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 18-NOV-2021, the patient was vaccinated with improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) lot # U004366, expiration date 01-OCT-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of hepatitis A vaccine, inactivated (VAQTA) experienced temperature excursion of 0.7 degrees Celsius for 2 hours. There was no previous excursion reported. No additional adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments:  US-009507513-2112USA000817: US-009507513-2112USA000713: US-009507513-2112USA000819: US-009507513-2112USA000818: US-009507513-2112USA000821: US-009507513-2112USA000822: US-009507513-2112USA000823: US-009507513-2112USA000824: US-009507513-2112USA000825.
My arm began itching where the injection occurred (rear upper left arm)and shortly thereafter a large hard knot formed at the injection site. The knot measured 3 inches by 2 inches. The area was red, hot and very sensitive to the touch. Within the hour my arm began to swell. It was almost possible to sleep because of the sensitivity of the arm. By morning my arm was swollen from my shoulder to my elbow but the hard knot was gone. The sensitivity continued during the day and the following night. The swelling began to subside within 48 hours but the sensitivity continued for another 2 days. By the fourth day the arm was back to normal.
88 yr old male with PMH of arrhythmia, HTN, GERD, CAD, AFIb, HLD, LBBB and CHF presents fpr evaluation of dizziness. Patient states around 4 AM this morning he developed an onset of dizziness in which he states has been frequent and presistant. Patient is unsure if the room is spinning and feels geneally weak as well. Patient also had several episodes of vomitting . in er evaluation found to be in rapid afib and started on cardizem drip for rate control . pt also tested postive for covid . he has had J&j vaccine and pfizer booster
No adverse reaction; Improperly stored vaccines; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported.  On 11-APR-2019 the patient was vaccinated with improperly stored 1 dose of varicella virus vaccine live (oka/merck)(VARIVAX) (1 dose, 0.5 ml) (lot # R018933, expiry date: 02-JUN-2020) subcutaneously for prophylaxis. It was not known how the sterile diluent(DILUENT MRK INJ) (lot # and expiry date were not reported) used to reconstitute the administered vaccines was stored.  The varicella virus vaccine live (oka/merck)(VARIVAX) was stored in maximum temperature of -10.3 degree Celsius (C) for 16 hours 15 minutes. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved.  This is one of several reports received from the same reporter.
feeling poorly; diffuse rash on trunk, arms and legs; flu-like symptoms; myalgia; This case was reported by a physician via sales rep and described the occurrence of rash in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included gluten sensitivity.   On 28th June 2019, the patient received the 1st dose of Shingrix. On 29th June 2019, 1 days after receiving Shingrix, the patient experienced rash, influenza-like symptoms and myalgia. In July 2019, the patient experienced feeling unwell. The patient was treated with antihistamine and steroids nos (Steroids). On an unknown date, the outcome of the rash was not recovered/not resolved and the outcome of the influenza-like symptoms, myalgia and feeling unwell were unknown.   The reporter considered the rash, influenza-like symptoms, myalgia and feeling unwell to be related to Shingrix.  Additional details were provided as follows: On Friday 28th June 2019 at around 12 pm, the patient received vaccine. The patient did not received any other concomitant mediaction. By the Saturday, the patint developed diffused rash on trunk, legs and arms. On following Monday, the patient was seen by doctor and was feeling poorly and still had the rash. Patient was treated with antihistamines and offered steroids but turned the steroids down. Patient did not call back after taking antihistamines. The reporter agreed to follow up.
The patient was fine the day she received the zoster vaccine and she was fine the next day. On the third evening the site became firey red and hot. It became a big glob. It was not painful, but difficult to lay on. Today it is still a little red, but down in size.
ARM PAIN AND WEAKNESS WITH SUBQ PAIN OF RIGHT SHOULDER AND SUBJECTIVE MILD FEVER
Patient said that their right arm is still sore 6 weeks after vaccination. It has been getting worse in the last three weeks. Its tolerable during the day but very painful at night. MD office prescribed a muscle relaxer and augmentin as treatment.
The vaccination went as expected the day after with fever and chills. But the second day after the vaccine I woke up with welts on my arms and legs the grew until they encompassed my legs fully and inner arms full. It spread to my entire body in big parts. The third day is spread to everywhere it hadnt the first (chest, stomach, outer arms, feet and hands). But it swelled my hands to the point that I can't make a fist. The fourth day the welts and rash cleared up everywhere else but I woke up with it on my feet and they swelled to the point where I can't walk today. So day 3 it swelled my hands and day 4 is swelled my feet but its going away within a 24 hrs period. I am currently unable to use pens and small objects in my hands to hold due to the swelling. I am also unable to walk. The ER says to wait it out because its an allergic reaction and I intend to. But even the pharmacy said that out of their 9000 patients done i have been the only one thst has had a worse adverse effect on the second dose. Nothing occurred on the first dose, just the second. I hsvebeen taking benadryl and tylonol but they don't seem to do much ut just is taking time, but there has been no improvement on my hands or feet.
Immediately got a headache.  I get a headache every days since receiving the 2nd shot.  The day after I had to come home from work.  I have lightning of my chest and some pains about every other day.
The injection site was irritable; Achy arm, pain was from her elbowto the shoulder; Injection site was still sore, spot was all tender; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE IRRITATION (The injection site was irritable), PAIN IN EXTREMITY (Achy arm, pain was from her elbowto the shoulder) and VACCINATION SITE PAIN (Injection site was still sore, spot was all tender) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078C21A and 053E219 / 053E214 / 053E21A) for COVID-19 prophylaxis.     Patient did not have COVID + test or diagnosis.  No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.    On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION SITE IRRITATION (The injection site was irritable), PAIN IN EXTREMITY (Achy arm, pain was from her elbowto the shoulder) and VACCINATION SITE PAIN (Injection site was still sore, spot was all tender). At the time of the report, VACCINATION SITE IRRITATION (The injection site was irritable), PAIN IN EXTREMITY (Achy arm, pain was from her elbowto the shoulder) and VACCINATION SITE PAIN (Injection site was still sore, spot was all tender) had not resolved.            Patient was taking other medication.   The patient experienced achy arm since vaccination. Patient noticed in the past year and arm was achy. Patient stated it happened about 3 times. When the arm hurt, patient massaged the area. Then patient would feel better when massaged it. The arm was still achy where the shot was given. Once massaged it kind helped.
Thrush on tongue; This spontaneous case was reported by a consumer and describes the occurrence of ORAL CANDIDIASIS (Thrush on tongue) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ORAL CANDIDIASIS (Thrush on tongue). At the time of the report, ORAL CANDIDIASIS (Thrush on tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Concomitant medication was not provided.   Reporter did not allow further contact
11/14/03 SORE ARM.  BURNING AND ITCHING AT NIGHT.  FELT HARD AREA IN UPPER ARM 11/15/03  REDNESS AND SWELLING BELOW INJECTION SITE TO ELBOW.  CHILLS, HEADACHE.  NO FEVER.  CALLED ER.  WAS ADVISED TO APPLY ICE PACK AND TAKE TYLENOL. 11/16/03  REDNESS AND SWELLING DECREASED.  FELT BETTER. 11/17/03  CLIENT CALLED TO INFORM CLINIC OF REACTION.  STATED SYMPTOMS WERE STILL DECREASING.  TOLD SHE COULD DISCONTINUE TREATMENT. 11/18/03  CALLED CLIENT.  STATES ALL REDNESS AND SWELLING ARE GONE.  NO OTHER SYMPTOMS.
Injection site pain broadened to whole shoulder and became slightly raised. About 22 hours after booster, fever, chills, nausea set in. Responded for most part to NSAID. Continues through 28 hours post injection (current time).  The severity of reaction was much stronger than first two shots.