chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Around 10am, my son complained of being very tired and laid on the couch. About 30 minutes later, he asked me to feel his chest and back. He was convulsing which I thought was a seizure. I took him across the street to ER where his BP was high. I believe 196/92. Then he started vomiting in the triage area. They moved us to a room. In that time, his BP dropped significantly and his fever rose to 103.7. After and IV of fluids and BENADRYL (i believe that was all that was given) he began to feel better and his symptoms subsided. His right arm was sore for a week. He is a basketball player and complained all week.
This spontaneous report as received from a Licensed Practical Nurse refers to an unknown number of patients of unknown age and gender. Medical history, current conditions and concomitant medications were not reported. Nurse reported that on an unknown date unspecified patients received improperly stored PEDVAXHIB (lot number and expiration date were not reported). No adverse effects were reported. The outcome of event was unknown. This is one of several cases received from the same reporter. Additional information has been requested.
slight pain in upper left arm; more pain in lower left arm; intense pain and swelling in left palm and left thumb
Approx 2 weeks after my second shot my right ankle swelled up. About 2 weeks later I noticed a lump on the side of my lower leg between shin and calf. A cyst formed on a blood clot. My surgeon who has 55 years of medical experience stated that he had never seen this happen before. I had it surgically removed and unfortunately contracted a staph infection. Ongoing recover.
Pfizer covid 19 vaccine lot # FJ6369 administered beyond use date on 03/25/2022, administered on 04/05/2022
12 hours after the vaccine administration, temperature started going up. At 22:00, temperature was 100.6F. Took 1tablet of acetaminophen 325mg and 25mg diphenhydramine. At 01:00, Fever went up to 101.8 F. Body started aching, persistent pain at right and left ribs that come and goes. Headache especially behind the right ear that also comes and goes (felt like a stabbing pain). Pulse was consistently over 100.  The next day, temperature went down to 99F. The sharp, stabbing pain that comes and goes behind the right ear is still there for the next 2 days. Relieved by taking ibuprofen. The pain comes very sudden, it makes me flinch and unable to hold anything still on the right hand. 2/26/21, woke up at 06:00 with a sharp, throbbing pain on the right ear. Relieved by ibuprofen.
Fever, chills, thunder clap headaches, dizziness, severe fatigue,  muscle aches, body aches, severe bone pain, numbness and tingling to both hands, tinnitus in left ear, back pain. Severe injection pain and unable to raise arm that received the vaccine above shoulder. Symptoms lasted 7 days.
Nothing at all for 12 hours.  Then normal soreness around site followed by achiness all over body by hour 15.  Fevers up to 101.9 on day 2 with horrible pain all over especially in ribs/trunk of body.  Day 4 began having swelling under right arm and in right breast.  Multiple lymph nodes swollen.   Gradually got better with no fever after 5 days, acches gone after 7 to 10 days but even today i still have nodes and a little soreness in my right armpit and lateral side of my right breast.(2/16/21).
Numbness, tingling to mouth, hands and feet progressing to weakness and difficulty swallowing. Admitted to hospital with diagnosis of Guillain Barre syndrome.
This spontaneous report received from a patient concerned a 34 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: fibromyalgia, penicillin allergy, and autoimmune disorder (Human leukocyte antigen B27 (HLAB-27)), and other pre-existing medical conditions included: The patient was not pregnant at the time of reporting. The patient was O negative. The patient experienced drug allergy when treated with amoxicillin. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 11-AUG-2021 13:00 for Covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 33 years old. Concomitant medications included levofloxacin, prednisone, and salbutamol. On 03-JUL-2022 20:00, the patient experienced suspected Covid-19 infection, blurred vision, confusion, itchy, extreme abdominal pain, loss of appetite, dizziness, joint pain, and nausea. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected Covid-19 infection, joint pain, blurred vision, confusion, itchy, extreme abdominal pain, loss of appetite, nausea, and dizziness. This report was non-serious.
Swollen lymph nodes on left breast. Underwent surgery and began radiation on 01/25/2022.
Right side parotitis started on 1/25/2015 PM, went to ED, diagnosed with sialadenitis. Patient came to see me the next morning, with increasing swelling. No testing done at that office visit, but swelling increased in size over the next 24 hours, she visited my office again on 1/27/2015, at which time I took a saliva sample for mumps PCR. At that same office visit, I admitted her to the hospital for concern of possible abscess/cellulitis in the submandibular region, which was subsequently drained and found to contain staph aureus. Since discharge from the hospital, swelling has significantly subsided (last office visit with me was on 2/5/2015).
Diffuse red rash, flat, does not itch, mostly on trunk and upper arms. No fever, no cough, but body aches. Does feel more fatigued than normal. (Hx flu like symptoms in 1970's after flu vaccines.)
Pt recvd vax on 29JUN92 & 10 mins later face became very warm & tight; flushing lasted for approx 5 mins; also exp discomfort, inability to take a deep breath, odd feeling in both feet; facial heat, weakness, thyroid soreness;
Joint pain swelling abdominal pain severe constipation, temporary obstipation, joint heat, chest pain,  peripheral vascular prominence  fatigue unilateral muscle cramp.back pain exacerbation and return of migraine headaches resolved after hysterectomy.
Rash to sore rash to upper chest , and bloating and diarrhea, swollen eyes where vision was like looking through a glass of water.
T/C from mother- client developed fever on 5/24 101 degrees, came down with Tylenol, but continues to run low grade fever (99) with Tylenol. Today noticed 4-5 pink raised spots on Left deltoid
Severe red and swollen arm, her pcp recommended for her to not get the second shot.
Vaccine given at 1409, 1410 passed out and came to within 30 seconds.  1413 physician notice tonic clonic seizure like movements to right arm for about 30 seconds.  Following this patient complained of complete loss of vision, loss of feeling in hands and feet for 10 minutes.  Transported to ER via ambulance
This spontaneous report as received from a consumer friend refers to approximately 55 years old female patient with no pertinent medical history and no drug allergies. On 05-FEB-2013, the patient was vaccinated with a single dose of ZOSTAVAX, 0.65 milliliter (ml), subcutaneously. Concomitant medications were none. On 06-FEB-2013, the patient experienced redness, swelling and a rash around the injection site. No laboratory test was performed. The pharmacists name and location of the pharmacy was not provided. The patient sought no medical attention and no treatment was given. The outcome of redness, swelling and a rash around the injection site was unknown. Additional information is not expected.
Headache, Myalgia, Fever, CHILLS; SORE ARM Narrative:
During a review of the local Health's internal records, it was found that there might have been a possible temperature excursion with how the vaccine was stored with our mobile vendor.
Started with severe constipation in a breastfed baby. Sever enough he would have fevers until passing it with assistance (stimulation, suppository, etc). From then on he got worse with every injection. Diagnosed with GERD and eventually suggested to put him on Zyrtec for allergies. Had severe protective vomiting several times per day and some weight loss. Eczema. Has been in the ER mulitple times due to breathing issues, has now (5yrs) been diagnosed with mild to severe persistent asthma.
After receiving vaccine within two hours became very tired and tightness in throat. Went home laid down. By evening nausea started. Went to bed woke up an vomited a few time through night. Nausea and vomiting continued for about 3-4 days along with lethargy. Was in bed for about 5 days. Completely out of it for about two weeks. Noticed a bruise at injection site within a few days. White ara abpout the size of a softball around that and pinkish-red rash around outside of that. Numbness developed at site of injection. Pain in joints developed within about a week and loss of mobility of L arm as well. Intermittant diahrrea and vomiting and constant nausea for a few weeks then intermittant nausea after. Continued pain
Palpitations, Arrhythmias, Tunnel Vision, Weakness, Dizzyness, and the onset of Cardiac Arrest.
about 0.1cc of the vaccine leaked out; during administration/vaccine leaked out of patient's arm; vaccine leaked out of patient's arm; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th August 2021, the patient received Shingrix. On 9th August 2021, unknown after receiving Shingrix, the patient experienced incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that, the Shingrix needle leaked during administration of vaccine and the reporter estimated about 0.1cc of the vaccine leaked out of patient's arm, creating a potential underdose, which led to incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact. The reporter consented to follow up.
my right arm had tingling effect feeling; was really wired I couldn't get the sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Apr2021 (Lot number: EW0150) at the age of 55 years as dose 1,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious) with onset Apr2021, outcome "unknown", described as "my right arm had tingling effect feeling"; INSOMNIA (non-serious) with onset Apr2021, outcome "unknown", described as "was really wired I couldn't get the sleep".  Additional information:Patient got first she already got second shot but when she got the first one the lady that gave me first shot and told me that if you had like after effect so call and let you know this about you know. The side effect this side effect she never heard with anybody say anything people say they got  got chills, fatigue or may be flu symptoms but  the side effect she had was Okay she got the shot both the shot she got in left arm but the side effect she had both the time first shot and second shot that my right arm had tingling effect feeling  and wired she couldn't get the sleep, the first time tingling feeling first she think  just laying on her arm how she thought fall asleep she felt like just laying wrong side she felt sleep. Treatment in response to event:  consumer stated, " First time she didn't did anything but the second time  she put some oil on her arm; Just Tylenol."  No follow-up attempts are possible. No further information is expected.
Mild fever 101.4 along with pain in left arm that continued for several days until I was hospitalized on 10/13/2011 to 10/15/2011.  I went to the Doctor's office 10/11 and 10/12 and received oral antibiotics that weren't working.  Diagnosed with cellulitis and given intravenous antibiotics that worked to bring down the infection.
SORE THROAT; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Mar2021 at 09:15 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included RT hip replacement and heart surgery. Patient reported unspecified allergies to food, medications and other products. Patient received unspecified medications within 2 weeks of vaccination. Prior to the vaccination, it was unknown if the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 05Apr2021, the patient experienced sore throat. The patient did not receive any treatment for the event. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event sore throat was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
34 year old military man presented to our urgent care 04/16/04 with complaints of right shoulder and right sided neck pains and nausea.
This case was reported by a healthcare professional (also the subject) and described the occurrence of not responding to therapy in a female subject of unspecified age who was vaccinated with RECOMBIVAX HB, (manufacturer unspecified) for prophylaxis. In 1989 the subject received 1st and 2nd dose of RECOMBIVAX HB. She received a 3rd dose of RECOMBIVAX HB in 1994. Titers were tested on an unspecified date and the subject was found to be non-responsive. The outcome of the events was not reported.
This is a self report:  two days after the vaccine I developed severe heart burn ( something I have never experienced). Several over the counter medication were used without relief. . The heart burn was followed by a horrible gastric disturbance.   I experienced abdominal pain, cramping and rectal pain.  During this time my temperature remand between 100.0 - 101.0 with fatigue and malaise. I have also noticed several welts on my body.   I?m typically a very health person and have never experienced any of these experiences before.
Mom reports that the patient developed a rash (bumps)  at injection site on Tuesday 08/11/20.  Mom had been giving Benadryl for the rash, but it continued to spread down the arms.  On Friday 08/14/20, mom noticed that the rash spread to patient left thigh.  Patient brought into clinic on 08/15/20.  Papular urticaria concentrated at injection site with spread over arms and left thigh.
Information has been received from a laboratory technician concerning a 16 year old patient who on approximately 14-JUN-2007 was vaccinated with a dose of Gardasil. On approximately 14-JUN-2007, while still in the physician's office the patient fainted and vomited. Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. From 01-JAN-2017 to 15-MAY-2017, the patients were vaccinated with improperly stored doses of VARIVAX lot # M037643 with an expiration date of 01-SEP-2018 (doses, route of administration and anatomical location were not reported). The reporter stated that sterile diluent (MRK) lot# M019201 with expiration date of 24-OCT-2018 was not improperly stored. Administered doses of vaccine underwent a temperature excursion (temperature and time frame were not provided). No adverse reactions were reported. There was no previous temperature excursions reported. A digital data logger was not involved. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA009026.
Patient had an allergic type reaction (dermatitis type reaction) after being vaccinated with Prevnar 20; This is a spontaneous report received from contactable reporter (Pharmacist) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DERMATITIS ALLERGIC (non-serious), outcome "unknown", described as "Patient had an allergic type reaction (dermatitis type reaction) after being vaccinated with Prevnar 20". The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Paralyzed on the right side down to her foot; Numbness in her hands and feet; Slurred speech; Felt really heavy in her face area, hurt really bad; Shooting pain; Feels tingly; Felt really heavy in her neck, hurt really bad; unable to walk; A spontaneous report was received from a consumer who was also a 25-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed heaviness in her face and neck, numbness in hands and feet, slurred speech, completely paralyzed on her right side, right fingers tingly, unable to walk and shooting pain feelings.   The patient's medical history was not provided. Concomitant product use was not provided.  On 21 Jan 2021, approximately two hours prior to the start of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 032L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   Approximately two hours after receiving the vaccine at 12:30 pm, the patient experienced heavy feeling in her neck and face area that hurt really bad. Later, she noticed numbness in her hands and feet. Slurred speech was reported from a bystander. By 3:30pm, the patient was completely paralyzed on her right side. She was taken to the hospital, and a code stroke was initiated; however, all labs were normal.   On 26 Jan 2021, the patient was still paralyzed on her right side, unable to walk, had shooting pain feeling, and two fingers on her right hand were able to move but still felt tingly. The doctors planned to discharge her on the next day to a rehab center because she could not function alone.  Treatment for the event included pain medication and hospitalization.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, developed heaviness in her face and neck, numbness in hands and feet, slurred speech, completely paralyzed on her right side, right fingers tingly, unable to walk and shooting pain feelings were considered unknown.; Reporter's Comments: A spontaneous report concerns a 25-year-old, female, patient, who experienced heaviness in her face and neck, numbness in hands and feet, slurred speech, completely paralyzed on her right side, right fingers tingly and shooting pain feelings. The events of heavy feeling in her neck and face area, numbness in her hands and feet, slurred speech, completely paralyzed on her right side occurred on the same day after the administration of the first dose of mRNA-1273 (Lot number 032L20A, expiration date unknown). The events of inability to walk, had shooting pain feeling and two fingers on her right hand were able to move but still felt tingly occurred the following day after the vaccine administration. Treatment included pain medication and outcome is unknown. Based on the information provided, which indicates a strong temporal association between the reported events and administration of mRNA-1273 vaccine (onset latency of 2 hours), a causal association cannot be excluded.
Information has been received from a RN concerning 4 or 5 pts who in July of 1999 were vaccinated with MMR and 7 to 10 days, post vax, the pts developed low-grade fevers and an "unusual rash consisting of discrete, fine, raised lesions a little bigger than scarletina lesions." Additional information has been requested.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 03-NOV-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (VLs 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 40 and 72 hours, the lowest recorded temperature was 28F (-2.222 Celsius) and the highest was 47F (8.333 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Got the shot, shingles in less than a year/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a elderly patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Additional patient notes included The patient had no shingles for 70 plus years.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the shot, shingles in less than a year/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2023 This case was reported by a patient via interactive digital media. The patient got the shingles shot and got shingles in less than a year. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
about 2 hours after vaccine administration, patient developed headache, bloodshot eyes, muscle pain, chest congestion that began to resolve the next morning
tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19), via an unspecified route of administration on 02Mar2021 as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had the first dose of the Pfizer Covid 19 on 02Mar2021, then experienced what she thought were side effects of the shot, but then she was tested positive for Covid. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
1. visual disturbances- unable to see clearly -3 or 4 occurances over 10 day period. Was seen by ophthalmologist and retina specialist and flouracin angiogram done. Diagnosis- ophthalmic migraine. 2. rash- line of 4-5 small blisters center of back and 1 on shoulder.