chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # M044720, expiration date: 07-MAY-2018, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from another reporter concerning a 4 year old patient. On 10-OCT-2017, the patient vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # N019826, expiration date: 09-JAN-2019) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002186: US-009507513-1709USA002098.
received first dose in 2019 , now planning get second; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on October 2019, 0.5mL left deltoid intramuscularly, batch number: EE924 Expiry date: 16th October 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, till the time of reporting, the patient did not receive 2nd dose which led to incomplete course of vaccination. The patient now planning to get the second dose. The patient did not have an exact date when the first dose was given. The reporter gave a consent to reach her for follow-up.
Case number PHEH2012US025492 is an initial spontaneous report received from a pharmacist on 26 Dec 2012: This report refers to a 54-year-old female patient. She was vaccinated with MENVEO (batch number: M10051) intramuscularly in to the right arm on 12 Oct 2012. She developed a lump in the right arm where the vaccine was given. The onset time and date for the reaction was not reported. No further information about seriousness, outcome and causality was available.
This case was reported by a healthcare professional and described the occurrence of swelling injection site in a subject of unspecified age and gender who was vaccinated with Engerix B for prophylaxis. Concurrent medical conditions included crohn's disease. Concurrent medications included Flagyl, Remicade, Ascal, Clarinex, Xifaxan, and HCT. On 16 May 2007 and an unspecified date the subject received 2nd dose and 1st dose of Engerix B (unknown). At an unspecified time after 1st vaccination with Engerix B, the subject experienced mild pain at the injection site. Following the 2nd dose of Engerix B on 16 May 2007, the subject developed swelling about one inch across at the injection site and redness. The subject also reported injection site pain and swelling following the 2nd injection. At the time of reporting the outcome of the events were unspecified.
Pt seen in office for rash, was dx'd at this time with chickenpox. Had approximately 10 chickenpox. She was given the varicella vaccination on 4/9/97.
PT VACCINATED WITH DTP EXPERIENCED CRYING FOR 5 HRS UNCONSOLABLE SCREAMING.
Patient presented with septic shock of unclear source, also with septic cardiomyopathy.
Severe neck & back pain.  Entire surface of back felt black & blue.  Couldn't tolerate touch.  Only lasted 24 hours.
chills; body ache; sore arm after receiving the second dose of the vaccine; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chills"; PAIN (non-serious), outcome "unknown", described as "body ache"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm after receiving the second dose of the vaccine". Additional information: The events took place less than 24 hours after receiving the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
after receiving first Shingrix vaccine injection, developed herpes zoster blisters on abdomen with accompanying pain
The patient was in generally good health and physically very active until April, 2021. At that time, he received the 2nd of two shots of Pfizer vaccine and developed fever and chills. On the weekend prior to this he was able to complete a full game of tennis without any problems; however, when he tried to play on the weekend after the vaccine he had to quit early b/o severe dyspnea. Over the next months he gradually improved but not completely back to baseline. He did develop abdominal pain, however, and as part of his workup he had a CT of chest, abdomen and pelvis, with contrast, on 8/14/21. This revealed a "moderate to large volume pulmonary embolism," with lobar, segmental, and subsegmental emboli present bilaterally in the right middle, left upper and bilateral lower lobes," without evidence of right heart strain. Bilateral venous duplex ultrasound of lower extremities on the same day showed an acute DVT in the left popliteal vein. Echocardiogram showed only mild concentric left ventricular hypertrophy.
My right eye is red right now; Inappropriate schedule of vaccine administered; shivers; I had the tingling thing around my arm; difficult to open my right eye, because of crusty stuff around it/It felt like when you put a dirty contact in/it had crusty stuff around it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PARAESTHESIA (I had the tingling thing around my arm), OCULAR DISCOMFORT (difficult to open my right eye, because of crusty stuff around it/It felt like when you put a dirty contact in/it had crusty stuff around it), OCULAR HYPERAEMIA (My right eye is red right now), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and CHILLS (shivers) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer Biontech Covid-19 vaccine on 11-Mar-2021 and Pfizer Biontech Covid-19 vaccine on 01-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer Biontech Covid-19 vaccine and Pfizer Biontech Covid-19 vaccine.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced VACCINATION SITE PARAESTHESIA (I had the tingling thing around my arm), OCULAR DISCOMFORT (difficult to open my right eye, because of crusty stuff around it/It felt like when you put a dirty contact in/it had crusty stuff around it), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and CHILLS (shivers). On 30-Nov-2021, the patient experienced OCULAR HYPERAEMIA (My right eye is red right now). On 29-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, VACCINATION SITE PARAESTHESIA (I had the tingling thing around my arm), OCULAR DISCOMFORT (difficult to open my right eye, because of crusty stuff around it/It felt like when you put a dirty contact in/it had crusty stuff around it), OCULAR HYPERAEMIA (My right eye is red right now) and CHILLS (shivers) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
pain on the wrist; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain on the wrist) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Triangular fibrocartilage complex injury.  On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (pain on the wrist). At the time of the report, ARTHRALGIA (pain on the wrist) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication information was provided.  Patient was scheduled to received his second dose today but he cancel the appointment. His surgeon did not asked him if he had been vaccinated. Patient received a steroid injection last Friday 10Sep2021 because of a pain he was having on his wrist and now he had concerned because he read in Moderna's website that he should have not received steroids less than 2 weeks after the first dose.
Patient seen 2 days after TDAP.  Pt complained of left lymph node swelling over left collar bone, tender to touch.  Symptomatic treatment given, ECG and labs
Case number PHEH2014US025018, is an initial spontaneous report received from a nurse on 09 Dec 2014. This report refers to a 63 year old male patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 12 Nov 2014. The nurse reported that before administration, the FLUVIRIN had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperatures were in between 46 to 49 degree F. No adverse event was reported following this mal administration.
After receiving her vaccine, client stated that she has a stuffy nose.  Vital signs obtained by EMS  BP 173/83, HR 69, O2 sat 98%. Client stated she is feeling better.  Discharged home by EMS.
large rash on the leg, high fevers, high blood pressure, palpitations, chills, nausua,
Hives for 7 months; This case was reported by a consumer via call center representative and described the occurrence of hives in a adult female patient who received Herpes zoster (Shingrix) (batch number ZM3D2, expiry date 3rd April 2022) for prophylaxis.   On 7th May 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In May 2020, 2 days after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was recovered/resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. This case was reported by the patient herself The patient had received Shingrix and 2 days later had hives, the hives lasted for 7 months then resolved (hives, resolved). The reporter initially provided some demographic information, then asked for it all to be deleted and would ask her pharmacy to file an adverse event report. The reporter did not consent to follow-up.
BUG-BITE LIKE ABOUT 10-20 ITCHY SPOTS ON ARM,LEGS AND STOMACH THAT APPEARS LIKE MOSQUITO AND INSECT BITE; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, treatment medications included: diphenhydramine hydrochloride. On 03-APR-2021, the subject experienced bug-bite like about 10-20 itchy spots on arm, legs and stomach that appears like mosquito and insect bite. On MAY-2021, treatment medications included: permethrin. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from bug-bite like about 10-20 itchy spots on arm, legs and stomach that appears like mosquito and insect bite. This report was non-serious.
Patient indicated that her arm/bone are painful from her immunization; she believes that the pain has lasted longer than it should. She indicated that at her regular medical appointment Dr. did check the imz. site. Patient indicates that the MD observed that she can lift her arm and that the site is not red.
patient described symptoms came on around 24 hours after the vaccines such as shivers, muscle ache, pain, headache,  tired just like flu -like symptoms, erythema around the injection site on her left arm and warm to touch. She took tylenol for shiver and pain. She confirmed that she is OK and will be fine. The redness on the arm has stay at the same
Headache, Fever, Nausea Vomiting, chills, body aches Narrative:
I received the vaccine on 4/28/2021 at 10:45am. No adverse effects that day, except for minor tenderness at the injection site. On the morning of 4/29/2021, about 7:30, I woke with a fever of 102. I had no appetite, and felt general flu-like symptoms--dizziness, etc. When I took Advil, my fever lessened. At about 1 pm I ate lunch as usual, and took more Advil in the afternoon for fever. At about 5 pm, I suffered a bout of severe muscle weakness, to the extent that I could not get myself to the bathroom unassisted, and required the help of 2 people to get me out of the bathroom and back to a chair in the living room. At the same time I had dry heaves, severe sweating, and physical exhaustion. I immediately fell asleep in the chair, and slept for 2 hours. When I woke, about 7:30pm, I felt a little better. I was able to take some fluids and a little food. I was also able to stand and walk with just a little support. By 9:30 that night I could stand and walk fairly steadily by myself. I slept well, and when I woke up the morning of 4/30, at about 7 am, I felt pretty much normal. I was steady on my feet, and my fever was down. I had a little dizziness on exertion, but fairly minor, and it passed quickly.
This non-serious spontaneous report (initial receipt 01-Dec-2014) concerns a 42 year-old patient who had received the flu vaccination before and did not have any problems. She had no history of shoulder injury and did not take chronic medications. Concomitant medication included an unspecified allergy medication taken on an as required basis. On 04-Nov-2014, the patient received AFLURIA (batch number not provided) 0.5mL in her right arm. On the same day, the patient also received PPD tuberculosis skin test. On 04-Nov-2014, the patient stated that the injection was very painful. Later that evening, the patient experienced a decreased range of motion in her right arm. She felt the arm pain, which was coming from "inside of her". Her arm felt heavy and numb that was hard to move. She thought it was muscle stiffness from the injection and had been using a heating pad, which helped. However, the symptoms bothered her for more than one week. She was unable to visit her primary care provider because of scheduling conflicts. Therefore, she visited a prompt care center where an x-ray was done and was diagnosed with bursitis in her right shoulder. She was referred to an ortho specialist for follow-up. She was not sure if she previously had AFLURIA, however, this was the first time she had problems following her annual flu vaccinations. Outcome was not yet recovered.
Severe vertigo and nausea x 5 days. Continued slight vertigo and nausea x3 more days after
Cellulitis L arm. Rx Cephaloxin tid x 10 days. Warm, moist packs.
Redness, warmth, discomfort approximately 3-4 hrs post administration. DX as cellulitis. DX lymphedema - on 10-26-2016.
Severe joint pain lasting several days then effecting a different joint several days later. Symptoms continue intermittently as of 4/24/21.
On 11/7/2022, I had a routine mammogram. An anomaly was found in the right breast, so I was scheduled for a follow-up mammogram on 11/14/2022. The presence of an anomaly in the right breast was confirmed, and I underwent a biopsy of the right breast on 11/21/2022. On 11/22/2022, I was informed that I had stage I breast cancer. On 12/8/2022, I underwent an MRI of both breasts. On 12/15/2022, I underwent a SAVI SCOUT procedure. I then underwent a lumpectomy on 12/29/2022. Between 3/6/2023 and 3/27/2023, I underwent radiation treatment. Sometime in mid-April 2023, I began undergoing letrozole treatment, which I ended on 5/17/2023. The letrozole treatment was ended, because I didn't like the side effects. I plan to take a break from any breast cancer therapies for a month, and then I plan to start taking anastrozole on 6/16/2023.
Joint pain, mainly in elbows but also wrists and hands/fingers.  Elbow pain is debilitating. Fatigue increased from baseline since vaccination as well as shortness of breath with moderate exertion(climbing stairs).
PATIENT WAS GIVEN IMMUNIZATION 2 DAYS PAST 10 WEEK LIMIT FROM REMOVING FROM FREEZER.
The second shot had me resting had a headache and some small side effects. But the ringing in my ears I thought was from the headache. My ringing in my ears hasn?t   stopped
pt rcvd vax; approx 2-4 wks later pt devel arthritis & arthralgia; was decided that pt would not continue the vax;
Reg. Symptoms then rapid heartbeat and body pulsing for 20-30 minutes.  Chest pain on left side on and off since, shortness of breath, have upper chest pain if talk more than couple of minutes.  Bending over makes me feel faint.
Vaccine given on 9/16/13. On 9/23/13 patient had 3 pox appear, left shoulder blade (2 pox), left calf (1 pox) and also on 9/23/13 at injection site pt had 3 elevated red spots at injection site. All spots intensly itchy and red but no pus/exudate.
Vaccine records not received before immunizations given. Patient was given extra quadracel and proquad.
Broke out in hives an hour after vaccination, went back to the pharmacist where I was given two Benadryl, and told to stay there on watch. After Benadryl kicked in, pharmacist sent me home with an Epi pen to be on the safe side.
pt went to MD for flu vax & got a pneumococcal vax by mistake;pt devel fever, red rash from shoulder area to top of head;cont for several hr;instructed to have pt assessed by MD & to discuss;
Breakthrough case admission after 2 vaccines Moderna 4/14/21 lot# 044B21A;  Moderna 5/12/21 lot# 034C21A
WELT BEGAN TO FORM IN PATIENTS ARM RIGHT AS VACCINE WAS ADMINISTERED. PATIEN DECLINED ANY PAIN INWELT OR SURROUNDING AREAS
I developed a moderate headache 3-4 hours after receiving the vaccine that became more painful over time. At 8 PM, I developed a rash on the left side of my face, neck and chest that lasted through the night and into the morning (about 12 hours). The rash did not look like hives, but it was itchy and blotchy red patches. I also spiked a 101 degree fever that lasted until the morning (about 12 hours).
Same day as shots developed fever, chills, body aches, swelling at sit of pneumovax.
Expiration date on Hib vaccine was misread as 03/15/23 instead of 03/05/23. Pt was given the vaccine on his LT on 03/14/23 (9 days after expiration). Pt is not experiencing any adverse side effects at this time.
Wheal noticed at site of injection, then muscle ache in left deltoid.  At 1230 AM awoke with rash upper Left arm, and deltoid swelling.  2:30 AM severe pain under arm and Left arm pain.  5 AM pain large joints, primarily hips and knees, but also hands hurt to open and close fist.  1030 AM shakiness, dizziness, left sided HA, hands shaking, difficulty focusing, muscle weakness legs. Pupil size on left larger than right. Blood pressure and heart rate elevated.
Infant developed a large lump with redness and yellow center. Mother had taken infant to MD for antibiotic treatment. Lump developed 2 months after immunization was given in left thigh.
Site of the subcutaneous varicella #2 injection was inflamed red and itched a little, 24 hours after receiving the vaccine. At 48 hours post-vaccination, the indurated area was increasing so we prescribed antibiotics for presumed cellulitis on 8/14/13.
Information has been received from a 71 year old male with type 2 diabetes and high blood pressure, who on 31-AUG-2010 was vaccinated with one time dose of ZOSTAVAX (Merck), SC. Concomitant medication included diabetes medicine. On 12-SEP-2010 the patient had a red bump the size of a nickel on his right shoulder which eventually spread to his muscle and was now the size of a half-dollar. When he was going to the physician's office he was told by the physician's assistant that it appeared to be shingles and was prescribed a medication to help cure it. The patient said he is not sure that it was in fact shingles because he did not feel confident in the physician assistant's answers, but his shoulder itched like mad. Until he was assured by his physician that he did have shingles he would not get the prescription filled. At time of reporting, the patient had not recovered. Additional information has been requested.
pt recv vax 10JUL95 & 19JUN97 pt devel chickenpox which was described as scattered pruritus & papules over the trunk & arms & one vesicle;
ARM PAIN, COUGHING, LETHARGIC, CHEST PAIN, CLAMMY,
Patient reports his left arm is very stiff with initially no mobility. However, at his time of reporting he has limited mobility. He reports shoulder joint and arm pain. He reports no redness, warmth, or swelling at the injection site. Patient reports he has full mobility of his left hand.
This spontaneous report has been received from pharmacist referring to a patient of unreported age and gender. No information was provided about the patient's concurrent conditions, pertinent medical history, concomitant therapies, drug and/or allergies reactions. On 27-DEC-2021, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(rHA) (M-M-R II), 0.5 milliliters, subcutaneously (SQ) (Expired product administered) (lot number # S035355 has been verified to be a valid lot number, expiration date reported and established as 05-NOV-2021; vaccination schemes, frequencies, and anatomical site of vaccination were not reported) for prophylaxis. No additional adverse events reported.
On days 2 and 3 post vaccination I was achy and sore in my joints more than usual. I assumed it was just two bad arthritis days until on day 4 I felt back to normal level of more tolerable pain.
I just got super sick. Ran a fever. My body felt horrible. And my arm felt like I got shot with a gun. After that I started getting allergies I've never had before. It all lasted about a week and a half of not doing good at all and over the next six months the allergies got worse and have continued to get worse since then. I have never had allergy issues before receiving the vaccine.