chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional (nurse) and described the occurrence of nodule injections site in a female subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). On approximately 6 February 2013 the subject received a dose of BOOSTRIX (.5 ml, subcutaneous, right deltoid) and experienced intramuscular formulation administered by other routed. On approximately 6 February 2013, within the same day as the vaccination with BOOSTRIX, the subject experienced medication leaking from injections site. The nurse reported that the BOOSTRIX was administered "possibly via the subcutaneous route. She noted some vaccine may have leaked out of the area." On approximately 7 February 2013, 1 to 2 days after vaccination with BOOSTRIX, the subject experienced nodule injection site ("knot at the site of injections"). The subject reported to the nurse that 1 to 2 days after administration (possibly administered on 6 February 2013) a knot appeared at the site of injections. At the time of reporting the outcome of the events were unspecified.
Was here for his vaccines 9 days ago, that day had sore arms, still having pain on his right arm that hasn't gone away - where he received MenB. Feeling is a little numb Went to restaurant after the appointment and he ate something separate from the family, otherwise family eats the same things Next day non-bloody diarrhea started, approx 4-5 times and is happening every time after he eats Is also nauseous, and is dry heaving or vomiting with workouts - is doing some school workouts daily and is sweaty and dizzy at this time Has still been eating, but not as much and has lost some appetite Hasn't had any solid stools since the appointment, had a stool today that a little more chunks in it than the days previously  No treatment needed except PRN zofran prescribed, just supportive care (reporting due to extended symptoms >9 days long), phone call check-in 8/1 - still having diarrhea, or vomiting, but ongoing nausea
This spontaneous report as received from a 52 year old nurse with allergic reaction to KEFLEX and no other pertinent medical history, reporting on herself. The patient stated that about a month ago, on approximately 17-JUL-2012, she received the first dose of GARDASIL (lot# not reported) and experienced isolated periods of pain in her knee and felt like she had stress fracture in her leg. Concomitant medications included: SYNTHROID. The patient was informed that she was outside the indicated age for the vaccine and she stated she thought the situation in the operating room where she was a nurse warranted it. She stated that on an unspecified date she was exposed to HPV from electrocautery smoke from a patient who had it in the operating room. On an unspecified date, reported as "three days", the patient experienced isolated periods of pain in her knee and felt like she had a stress fracture in her leg. She also mentioned she had symptoms like Guillain-Barre syndrome. The patient was not sure if she would get the second dose of GARDASIL and would be contact her physician to discuss. The symptoms she experienced come and go. No lab diagnostic tests were performed. At the time of the report the patient was recovering from the adverse events. Additional information has been requested.
not even sure hypertension episode was related to vaccine  could be related to eyedrops following cataract surgery  history of hypertension
Neuritis developed in arm, swollen, weak hand and arm; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09May2023 at 12:00 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 75 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hyperlipidemia" (unspecified if ongoing); "low back pain" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTUERER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 4; MANUFACTUERER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 5; MANUFACTUERER UNKNOWN), for Covid-19 immunization. The following information was reported: NEURITIS (non-serious) with onset 13May2023, outcome "recovered", described as "Neuritis developed in arm, swollen, weak hand and arm". The events "neuritis developed in arm, swollen, weak hand and arm" required physician office visit. Therapeutic measures were not taken as a result of neuritis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history was not reported. On 02-MAR-2015, the patient was inadvertently vaccinated with an expired dose of M-M-R II (albumin status and lot # were not reported), 0.5 ml, 01-MAR-2015, subcutaneously. No adverse effect was reported. Additional information has been requested.
Within 24 hours, patient reported uncontrolled blood glucose levels above 200. Patient previously had blood glucose within normal limits and was well controlled for some time. These elevated blood glucose levels lasted approximately one week. He had no other dietary/medication changes during this timeframe. The only change was that he received the vaccine.  He also experienced headache, fatigue and severe injection site pain, peaking at 24 hours post injection.
Chills 1/23 Swollen lymph nodes in axillary of arm vaccine was administered
Pt recvd vax & exp feverish feeling & enlarged ax & inguinal nodes; 7JUL92 exp delayed menstrual period (11 days); aching armpits & arthritis; shoulders numb; JAN93 shakes, heart pounding, hips & ribs ache; tachycardia, BP elevation;
Uncontrollable shaking (not chills) for 45-60 min., approximately 12 hrs post injection, very high fever of 104 at its peak between 14 and 20 hrs post injection, headache and blurred vision 20-24 post injection, very red and hot face 20-36 post injection.  48 hrs post injection just fleeting episodes of flushed face.
My husband and I had three doses of the Covid vaccine, and we contracted COVID anyway/I have no faith any longer that the Covid vaccine is effective; My husband and I had three doses of the Covid vaccine, and we contracted COVID anyway/I have no faith any longer that the Covid vaccine is effective; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "My husband and I had three doses of the Covid vaccine, and we contracted COVID anyway/I have no faith any longer that the Covid vaccine is effective".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200006399 same reporter/product/event, different patient;
This spontaneous report was received from a licensed practical nurse, referring to a 12 year old, male patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 14-JUL-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the right arm (reported as RD), lot # K026247 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. Medical history, drug reactions or allergies were not reported. On 21-NOV-2014 the reporter stated that the patient was vaccinated with an expired dose of PNEUMOVAX 23 (dose number was not reported) lot # J004332, expiration date 26-SEP-2014, 0.5 ml, intramuscular. Concomitant therapy was not reported. No adverse experience was reported. Additional information has been requested.
did not eat anything; She could barely walk; she started having rigors where her teeth were chattering; fever of 103.5; nausea; splitting headache; fatigue; lymph node swelling; disequilibrium; tinnitus in her ears; redness; swelling; warm to the touch in the arm where she received the vaccine.; lightheadedness; This spontaneous case was reported by a patient and describes the occurrence of FEEDING DISORDER (did not eat anything), GAIT INABILITY (She could barely walk), BALANCE DISORDER (disequilibrium), TINNITUS (tinnitus in her ears) and ERYTHEMA (redness) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in July 2022. Previously administered products included for Product used for unknown indication: Pfizer Vaccine in March 2021, Pfizer Vaccine in April 2021 and Pfizer Vaccine in December 2021; for COVID-19 prophylaxis: Moderna Covid-19 Vaccine in July 2021. Past adverse reactions to the above products included No adverse event with Moderna Covid-19 Vaccine, Pfizer Vaccine, Pfizer Vaccine and Pfizer Vaccine.    On 07-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 07-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced PYREXIA (fever of 103.5). On 07-Oct-2023 at 10:00 AM, the patient experienced CHILLS (she started having rigors where her teeth were chattering). On 08-Oct-2023, the patient experienced FEEDING DISORDER (did not eat anything) and GAIT INABILITY (She could barely walk). In October 2023, the patient experienced BALANCE DISORDER (disequilibrium), TINNITUS (tinnitus in her ears), ERYTHEMA (redness), SWELLING (swelling), INJECTION SITE WARMTH (warm to the touch in the arm where she received the vaccine.), DIZZINESS (lightheadedness), NAUSEA (nausea), HEADACHE (splitting headache), FATIGUE (fatigue) and LYMPHADENOPATHY (lymph node swelling). At the time of the report, FEEDING DISORDER (did not eat anything), GAIT INABILITY (She could barely walk), BALANCE DISORDER (disequilibrium), TINNITUS (tinnitus in her ears), ERYTHEMA (redness), SWELLING (swelling), DIZZINESS (lightheadedness), PYREXIA (fever of 103.5), CHILLS (she started having rigors where her teeth were chattering), NAUSEA (nausea), HEADACHE (splitting headache), FATIGUE (fatigue) and LYMPHADENOPATHY (lymph node swelling) had not resolved and INJECTION SITE WARMTH (warm to the touch in the arm where she received the vaccine.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.5.         The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.   No treatment information was reported.
Acute, painful occipital headache, right side within three hours of the vaccination. Treated with ibuprofen, but it became recurring (every day).  I went to my doctor June 23rd and she advised it would go away with time.  I went back on July 15th (for my physical) and it was still recurring but not as frequently (about four times/week).  Went back to her September 27th because it was continuing and she advised if it continued at the same rate to come back in three months for imaging.  By November 1st the frequency was about once a week so I decided not to have the imaging.  I still get a headache but it is down to about twice a month now.
Received Hep B #2 and Td on 4/14/03. L arm started swelling pm on 4/15/03 swelling and erythema (+) pruritis (+) warmth 3.5in x 2in-Benadryl and hydrocortisone treated.
Headache; Has improvement of bp on observation along with headache has subsided; This is a spontaneous report from a non-contactable healthcare professional. An 88-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration on an unknown date in 2021 as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date in 2021, 15 minutes after the vaccination, the patient experienced a headache and "Has improvement of bp on observation along with headache has subsided". The patient denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling, tongue swelling and weakness face, arms/legs. Therapeutic measures were taken as result of the event headache. It was reported that treatment for the patient included only water and follow up response to the treatment was excellent. The patient was discharged in stable condition to go home and was advised to follow up with a primary care physician. The differential diagnosis was reported as red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns). It was reported that the patient was monitored for approximately 30 minutes and there was an improvement of blood pressure on observation along with headache had subsided. The patient was encouraged to monitor her blood pressure at home and follow up with a primary-care physician if blood pressure stays above 140/90. The patient's granddaughter had requested the patient to be evaluated and was appreciative of this evaluation. The outcome of the events was resolving.  No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information:  1 New AE 'Has improvement of bp on observation along with headache has subsided' added. 2 Age at vaccination removed. 3 Biological product captured as vaccine.
about 1hr p/vax given pt c/o severe colicky abd pain;no n/v,diarrhea;brought to clinic;abd was soft,no bowel sounds;would cramp up intermittently but was fine between episodes;lasted about 4-5hr;given APAP,Bentyl,pt recovered;
mild case of shingles, had shingles shot/ suspected vaccination failure; mild case of shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced 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 provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated his/her physician told that, could get a mild case of the shingles even after had shingles shot. The patient could vouch for Shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Initial report was received from a health care professional on 11 January 2012. A female patient (age and date of birth not reported) had sustained a cut from a syringe of FLUZONE, lot number UT4176BA because the barrel of the syringe was cut. The patient had a minor scratch, no skin breakage/bleeding and no physician/medical intervention was needed. No further information was available at the time of the report. The patient's outcome was not reported. Follow-up information was received from a health care professional on 19 March 2012. The patient received a cut from the vaccine barrel being chipped. The vaccine was never given and the syringe was disposed of. The patient had recovered. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: None.
The day after the vaccine, pt felt tired, weak, achy, with a headache. Felt light headed, briefly lost consciousness. Registered low BP of 85/44 at MD appt same day.
about 12 days after injection I had episodic dizzy spells,  then on 4/29 I just wasn't feeling well. on 4/30 I had severe migrating muscle pain w/ occ. pain in knee and hip joints.  nex day I ache all aver w/ most severe pain in lt lateral thigh, ? fever, malaise.
pt. recieved vaccine past 12 hours expiration. No adverse events. MD contacted pt. Pt. finished 2 dose in primary series.
21OCT94  cough, runny nose, fever, chills hot @ noc; to ER weekend following immun had xray @ that time; 25OCT94 f/u feeling much better-on Biaxin;
Blotchy arms and itchy legs within 10 minutes, no breathing issues.  At night severe chills (legs, arms, seizure like chills), severe body aches and exhaustion.  During the night fever of 100.2.  Took Tylenol every 4-6 hours after that, it helped.  No appetite and stayed in bed the next day.  Day 2 (today) fever has subsided, feeling exhaustion and slight back and neck pain.  Taking tylenol still, feeling more alert.  Still cannot go out of house or drive.
After second dose of SHINGRIX, experienced mild fever and shivering as well as muscle pain.
I started having extreme joint pain and pain all over my skin. I felt like I wanted to crawl out of my skin. I was also shivering and hyperventilating. It was really bad overnight and the next day, the symptoms were gone by the third day. I am unable to look it up, but I think I didn't go to the ER because I have had a reaction to immunization once before when I had a flu and a T-dap on the same day. I am a nurse, so I thought I would deal with it myself if I can. I took some Norco or Percocet, Valium, Benadryl for sure... maybe some NSAIDs. I sat in a bath for hours, that seemed to sooth my skin... eventually, the symptoms subsided a bit, but I was weak and beaten for another day or two.
This spontaneous report as received from a physician refers to a 12 months old female patient. The patient's medical history was unknown. On 06-JUN-2013, the patient was by mistake administered ZOSTAVAX instead of the first dose of VARIVAX (Merck). No other suspected medications or co-suspected medications were reported. No adverse events were reported. Additional information has been requested.
Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were unknown. On unspecified dates, the patients were vaccinated with improperly stored VARIVAX (dose, route, lot and expiration date unknown) for prophylaxis. The details of the storage were two occurrences when the temperature of the freezer reached 29 Fahrenheit degree for 30 minutes on each of the two occasions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted. Sender's Comments: US-009507513-1701USA001058: US-009507513-1701USA001057.
Swelling, redness, bruising, red line in the middle of the bruise. Left thigh redness and bruising spread in two days to a little larger than a quarter. ER doctor prescribed antibiotics for possible infection.
The vaccine vial was not diluted prior to administration. Patient did not experience any side effects or adverse reaction.
This spontaneous report was received from the registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (dose, route and lot were not reported). On an unknown date, the patients received improperly stored   RECOMBIVAX HB. No adverse symptoms reported. At the time of the report the action was not reported. All telephone attempts to obtain follow-up information have been unsuccessful.  Additional information was received from a registered nurse concerning a 1 day male patient. Patient's birth weight was 7 lb 15 oz with 0 siblings. Patient was vaccinated with RECOMBIVAX HB the same day that he was born (16-MAY-2014) at 14:00 PM. Lot number J012520; Exp. Date: 30-JAN-2016.  The vaccine storage temp dropped to 0-1 degrees on 18 different episodes between May 14th and July 21st (unspecified year) according to min/max. All recorded temps are within 2-8 degrees. Additional information is not expected since all follow ups requested to complete the case were received.
pt recv vax 8MAY97 4wk p/last menstrual period & pt became pregnant & underwent an elective termination of the pregnancy (date unk);
Throat was closing; Tongue swelled up; Heavy sweating; Fogging brain; Feeling of passing out; Lips swelled up; Weak; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8733) via an unspecified route of administration in the left arm on 01Apr2021 at 13:45 (at the age of 18-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any concomitant medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 19:30, the patient felt that the throat was closing, lips and tongue swelled up, heavy sweating, fogging brain, feeling of passing out and weak. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measure taken as a result of the events experienced included benadryl (MANUFACTURER UNKNOWN). The clinical outcome of the events throat was closing, lips and tongue swelled up, heavy sweating, fogging brain, feeling of passing out and weak were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient vomited approx a few minutes after vaccine was given. Patient slowly fell onto the ground from the standing position.  No injuries occured.