chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At injection site, there was swelling, warm to touch, erythema and pain, all the time, 4 days, post injection.
The physician is reporting that the patient received improperly stored vaccine; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concurrent conditions, past medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with one dose of an improperly stored vaccine of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD)  lot # S009757 and expiration date 27-SEP-2020 (dose, frecuency and route were not provided) for prophylaxis (product storage error). The administered dose of the vaccine was stored with a temperature of 32.5 degrees Fahrenheit for 8 hours. There was a digital data logger involved, but there was no previous temperature excursion.
R arm felt weak, pt had trouble moving arm, pt couldn't raise arm. Pt tried taking acetaminophen to ease pain, but it did not help.
Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 03-APR-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Possible incorrect dose was administered to the patient. The undiluted vial of Pfizer vaccine was mixed with possibly 1.3ml of diluent and only 5 doses were obtained from mixed vial. Patient was contacted immediately upon discovery of the possible mistake, and reported no side effects/adverse events (within 24 hours of administration). Patient was counseled on watching any further complications and will be followed up in next 48 hours and 72 hours.
This case was reported by a physician and described the occurrence of severe upper arm pain in a 56-year-old female subject who was vaccinated with Boostrix, (GlaxoSmithKline). Concurrent medical conditions included celiac disease and reflux (nos). Concurrent vaccination included Twinrix (GlaxoSmithKline) given on 22 March 2011. There were no concurrent medications. On 22 March 2011 the subject received a dose of Boostrix in the left arm. On 22 March 2011, at an unspecified time after vaccination with Boostrix, the subject experienced severe upper arm pain. At the time of reporting the event was unresolved. The physician considered the event was possibly related to vaccination with Boostrix. Follow-up information was received on 06 May 2011 from the reporting physician. Celiac disease was removed as relevant medical history. The subject used alcohol occasionally and did not use tobacco. On 22 March 2011, the subject experienced left upper arm pain secondary to Boostrix administration. Outcome of the event was unknown. 19 April 2011, x-ray of left humerus was negative. The subject decided not to finish the Twinrix series.
30 y/o AD SM receives rabies vaccinations on 5/21/2007 and 5/29/2007. He began to develop symptoms after the second shot on 5/29 including headache, malaise, fatigue, progressive whole body swelling, and acute renal failure over the next several days. Symptoms: Headache, general Start: 05/29/2007 End: 05/30/2007 Comment: Mild HA started the same evening of the vaccination. Symptom: Fatigue Start: 05/30/2007 End: 06/12/2007 Comment: Noted the day after the headache. Described as 'just feeling tired all of the time'. Symptoms: Swelling Start: 06/02/2007 End: 06/12/2007 Comment: Swelling noted in the legs, feet, and hips first and then continued to migrate upwards to involve his back, hands, and face. This swelling is best described as an edema. Symptom: Anorexia Start: 05/30/2007 End: 06/01/2007 Comment: Decreased appetite reports for 1-2 days after 2nd shot. 8/22/07-records received for DOS 6/7-8/20/07-DX: Acute renal failure. Rabies vaccine causing adverse effects in therapuetic use. Injury or poisoning occurring at/in other specified places. Evaluation of edema and possible kidney failure. Noted increasing edema over past 2-3 days and fatigue. Patient is a body builder and uses supplements extensively. Stopped about 10 days ago. Noted swelling 2 days after rabies vaccination. Swelling involved entire legs up to hips. Some swelling in sacral area of back. Dryness in mouth. On 6/4/07-swelling included puffiness around eyes, toson and tightness in hands.  Renal biopsy consistent with FSGS which developed immediately after Rabies Vaccines #2. Patient had antrax vaccine booster 15 days prior to Rabies vaccine.  Per 60 day follow up: The servicemember continues to have decreased renal function since the incident. His overall status has progressively improved but he is still not back to his prevaccination baseline. He continues on medication for control of blood pressure and lipids. Member continues under the care of a nephrologist at medical center. 1/11/2010 The member still exhibits abnormal serum creatinine levels. This reflects the now chronically impaired state of his kidneys.
Having a compromised immune system (no spleen, ulcerative colitis), my immune system,  while working to figure out what to do with the Moderna vaccine, allowed CMV virus (cytomegalovirus), a dormant virus in most people,  to come to the forefront.  I was not familiar with this virus at the time. I began having symptoms of CMV virus on January 31,2021, with fever, chills, night sweats, fatigue, and then on February 9, 2021 I began itching and chicken pox like sores came up on my torso, back, arms, and legs.  Prior to the appearance of the sores, I thought these reactions were related to the Moderna Vaccine.
Broke out in hives. I have never had an allergy so wasn't quite sure what to do.  After some soaking baths and lotion ,which didn't work, I finally thought to take an Allegra about 5:30 Monday morn. (10-18).  I could sleep then and when I woke, itching had stopped.  I still hav some welts, but hopefully it's over. I am going to e-mail my Doctor later.
2 x 3 cm, raised, warm, hot local reaction (was looked at 1 week after inj.).
Phone call from pt on 07/14/04. Was seen in our Family Planning Medical Clinic the day before and received her 3rd HBV (the 1st of the adult formulation). Felt tired when she left the clinic about 14:30 or 15:00. Went home and had lunch. Went over to visit friends and chatted outside in the sun. Felt hot and went to porch to continue visit, felt weak and "passed out and seizured". This occurred about 18:30. Friends put her into their truck and were driving to the hospital when her eyes rolled back and she started to have more seizure activity. They became apprehensive and called 911 for assistance. Remembers waking up as the paramedics arrived and that she had a severe headache. At the hospital, continued IV and had testing done. MD interviewed friends, reviewed test results and told pt the test results were all fine and the seizure was from the shot.  07/15/04, spoke with pt midday, stated she still did not feel well. PMD had advised to seek follow up prior to leaving hospital. Reminded of options of care. Plans to go to hospital today. 15:20 spoke to a friend, states on the way to the hospital fainted twice. The hospital has requested the records from her last ER visit and they are waiting for the information now at the Medical Center.
pt recvd vax 18AUG95 & 10SEP95 devel a rash all over body;pt's mom described it as a chickenpox-like rash;pt had no other sxs;No further details were provided;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 32 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EL9267), in left arm, on 16Mar2021 as dose 2, single (Lot number: EP7534), in left arm and on 13Nov2021 as dose 3 (booster), single (Lot number: FF2593), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Reactive airway disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 from 12Jan2023 to 16Jan2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever 105; Pale Skin; Chills; Rocking Back and forth; Staring off into Space; Shaking of hands and body; cognitively "not with it"; Vomiting.
Itching from head to tops of feet, this includes neck, back arms, buttocks, and other areas of the body, stiff neck, tingly tongue
Information has been received from a Medical Assistant (M.A.) concerning a 66 year old male patient with osteoarthritis, emphysema, bronchitis chronic, rhinitis allergic, atrial fibrillation, sinusitis, hypertension and otitis external fungal who on 12-JAN-2009 was vaccinated with the first dose of PNEUMOVAX 23. On 10-AUG-2009 the patient was vaccinated with the second dose of PNEUMOVAX 23 (Lot # 662746/0625Y). It was reported that the patient developed left arm pain and injection site redness after his second vaccination with PNEUMOVAX 23. He was seen in the office on 12-AUG-2009 and treated with KEFLEX and a MEDROL dose pack. The outcome of the patient was not reported. Follow-up information has been received from a Medical Assistant (M.A.) who mentioned that the Doctor handled everything and the patient is doing well. Also was reported that the Doctor had asked for the case to be closed. No further information is available.
Patient came in today (9/11/23)  stating that the day after vaccination (8/30/2023) she felt a slight burning sensation in her legs. As time progressed, patient states that it has now spread to most of her body (arms, legs, stomach). As of today (9/11/23) she is still experiencing these symptoms. Patient called her primary care physician and they did not provide any treatment.
This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 28-NOV-2018, the patient was administered improperly stored GARDASIL 9 for prophylaxis lot #1586751 and expiration date 16-FEB-2021 (strength, dose, frequency and route of administration were not reported). No adverse effects were reported. The lowest temperature of excursion was below 36°F / 2°C (34.9°F) for 28 minutes including below 32°F for 15 minutes. There was no previous temperature excursion. There was no digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-09507513-1901USA007858.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 23-DEC-2014, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml (lot#J010613, expiration date 11-JUN-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 72, unknown and R; 48, 1 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Subsequent to vax, this child developed a severe location reaction. His leg became red and swollen at the injection site. Mother states that this reaction occurred a couple of months prior, post another vax. She noticed that the only common ingredient in both vaxs is hydrolyzed gelatin.
negative titres with serologic tested for measles, mumps, rubella and varicella; negative titres with serologic tested for measles, mumps, rubella and varicella; negative titres with serologic tested for measles, mumps, rubella and varicella; negative titres with serologic tested for measles, mumps, rubella and varicella; Vaccine adminisred intramuscularly; received one dose of PROQUAD at age 22 years old; This spontaneous report was received from a physician refers to a 22-year-old female patient. The patient's medical history, current conditions and concomitant medications were not reported.  On two separate unspecified dates, the patient was immunized as a child with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot number and expiration date unknown) for measles, mumps, rubella and varicella immunity.  On an unspecified date, the patient was also immunized as a child with varicella virus vaccine live (oka/merck) (VARIVAX) (lot number and expiration date unknown) for measles, mumps, rubella and varicella immunity. On 14-MAY-2019, at 22 years of age the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot number and expiration date unknown by reporter) (Product administered to patient of inappropriate age). On an unspecified date, the patient showed negative titers with serologic tested for measles, mumps, rubella and varicella. The vaccines were administered intramuscularly (Incorrect route of product administration). Blood work for measles, mumps, rubella and varicella was done. Outcome of the events were unknown. Causality of events were not reported. No PQC (product quality complaint) was filed.
Extreme High Fever 105 to 106. Baby on constant Tylenol and Motrin for 2 weeks before fever broke. Racing heart, heavy breathing, and constant crying.
Medication was injected subcutaneously and not intramuscularly.  Arm is discolored at present.  Remained very warm to touch, irritated, inflamed, red, and very large (tennis ball sized)raised circular area was present for weeks following injection.
Serious rash on neck, arms, chest and back.  Worse on neck.  Itchy and red.  Given Allegra, Aveno Bath and Cortizone Cream.  If symptoms do not appear to be getting better, another doctor visit will be necessary and a possible steroid shot will be given on or about 8.23.05.
Flushed cheeks and upper shoulders during 15-minute waiting period. History of this in the past. Benadryl given with improvement.
This spontaneous report was received from a physician and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot # M034189, expiration date 23-MAY-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 35.2 degrees Fahrenheit for 3 hours 30 minutes. Data logger was used to capture temperature excursions. There were no previous excursions. No Product Quality Complaint (PQC)was involved. Additional information has been requested.
7-19-11 - approximately 2 weeks ago mom noticed bumps appear on trunk, arms, neck, legs, head; pt occasionally scratched at them; no fever; increased amt of stools since switching to milk; 16 pox were counted over the surface of the body.
Information has been received from a woman at the department of health concerning a 6 year old female who on 27-JUL-2000 was vaccinated with Varivax (Oka/Merck) (lot 634842/1867J). Subsequently the patient experienced "suspect vaccine failure". It was unknown if medical attention was sought. No further information was provided. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of localized skin reaction in a patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced localized skin reaction. On an unknown date, the outcome of the localized skin reaction was unknown. It was unknown if the reporter considered the localized skin reaction to be related to Influenza vaccine Quadrivalent unspecified season. Additional information was received were as follows: The age at vaccination was not reported. The physician's office called pharmacist reporting that the patient got a severe localized skin reaction with the flu vaccine. The reporter did not know which flu vaccine was administered to the patient. The reporter did not had any patient information or any other details.
Extreme headache/migraine starting around 4:30 am on 4/3/21 lasting until 10:30 am (6hrs), took an Aleve at 7am, persistent nausea throughout the day (4/3/21)  improved as day went on,  also woke on 4/3/21 with the chills, took temperature at 7am (before the Aleve) and it was 99.9.   Took temperature again at 10 am on 4/3/21 and it was 97.8
Systemic: Dizziness / Lightheadness-Mild, Additional Details: Pt. felt lightheaded 5 minutes after receiving the vaccine and recovered within 25 minutes. Pt reported that he did not experience this side effect after receiving his first Pfizer shot.
6 - 7 inch rash around injection site and streaking. Itches. She states she was sore the first night then it started to feel better.
10 days post vax the pts father noticed several spots on her abdomen and back and by the next day the pt had numerous additional generalized varicella like lesions. Two days later the pt had approximately 195 generalized lesions. In addition the pt experienced itching.
2nd shot received 5/24/2021.  About the second week in June noticed 4 round res spots about the size of a pea on left dorsal foot. Over the next few weeks multiple areas on bilateral arms, legs, thigh and hip with Red blotches all over. Still persist as if this date.
Neck painful adenopathy that started on right side of neck and now progressing to left.; no SOB or difficulty swallowing.  Narrative:   Other Relevant History:
After injection patient stated she has a histamine intolerance and was concerned she may have a reaction.  While under observation at 2:13pm patient told us her tongue was getting thick and breathing difficult.  We gave her 50mg oral Benadryl and called 911.  EMS arrived at 2:21 and examined patient.  By then her breathing was returning to normal and tongue swelling going down and she did not want to go to the hospital.
Patient had blurry vision and dizziness initially. Patient's BP was stable throughout. Patient continued wtih dizziness and also developed nausea, nausea, and pain at the shot site for 3-4 hours after shot given. Patient reported no symptoms after that time.
15 minutes after vaccine received, patient reports feeling hot and dizzy. Patient denies respiratory distress. Patient advised to follow up with primary care provider and to call 911 if symptoms persist or experience respiratory distress. Patient instructed to take Acetaminophen/Ibuprofen, to have food/fluid, and to rest. Pt able to hydrate with water. Patient ambulatory and reports symptoms resolved after 30 minutes. Patient reports able to return to work. Patient declined transportation to hospital for further evaluation. BP 118/78, HR 64.
Information has been received from a registered nurse concerning a 15 year old female who on 20-MAY-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (Lot # 659964/1978U) at approximately 4:15 pm. On 21-MAY-2008, the patient developed a 102F fever after vaccination and a sore throat. On 22-MAY-2008, patient sought medical attention at the physician's office where a rapid strep test was negative. Treatment was acetaminophen (TYLENOL) and ibuprofen. On an unknown date, the patient recovered. Additional information has been requested. 10/08/08 This is in follow-up to report(s) previously submitted on 8/14/2008. Additional information was received from the registered nurse. At the time of vaccination, the patient had fatigue. No further information is available.
cough, dizziness, chest pain, cerumen impaction, earache, generalized body aches, back pain and fatigue.
Tongue has been swollen; Scalloped in appearance; No taste; Mouth sores; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWOLLEN TONGUE (Tongue has been swollen), SCALLOPED TONGUE (Scalloped in appearance), AGEUSIA (No taste) and ORAL PAIN (Mouth sores) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced SWOLLEN TONGUE (Tongue has been swollen), SCALLOPED TONGUE (Scalloped in appearance), AGEUSIA (No taste) and ORAL PAIN (Mouth sores). The patient was treated with GABAPENTIN at an unspecified dose and frequency; NYSTATIN at an unspecified dose and frequency; PREDNISONE at an unspecified dose and frequency and LIDOCAINE at an unspecified dose and frequency. At the time of the report, SWOLLEN TONGUE (Tongue has been swollen), SCALLOPED TONGUE (Scalloped in appearance), AGEUSIA (No taste) and ORAL PAIN (Mouth sores) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications included magic mouth wash, yogurt.
02/04/ 2021 the day of the vaccination, within the hour, so dizzy and weak I couldn't sit in the chair. I felt  I  had to lie down. I couldn't keep myself upright. The doctor thought it was inner ear disturbance and sent me to an ENT.  ENT did not find anything abnormal. I had to get my potassium on the 3rd of March. I saw the ENT on the 4th of March. The vertigo persisted for a while, and every now and then I feel weakness and I need to sit down.
felt really tired; felt with no energy; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt really tired) and ASTHENIA (felt with no energy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.  On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced FATIGUE (felt really tired). In February 2021, the patient experienced ASTHENIA (felt with no energy). On 06-Feb-2021, FATIGUE (felt really tired) had resolved. At the time of the report, ASTHENIA (felt with no energy) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Pfizer Bivalent was given as dose 1 primary vaccine.  No s/sx occured.
Temperature >102F tympanic X 4 days (Temp. max 104.9F tymp. on 9/6/00 at 02:00 hours) days 6-10. Red, splotchy, rash covering entire body days 10-12. Red bumps w/white centers on knees (localized) days 7-12.
Mom called and brought daughter to office red area 10x12cm warm to touch right thigh able to walk. no c/o pain.
The patient is 12 years old but was inadvertently given the 5-11 year old dose (10 mcg) of the Covid vaccine. No adverse effects have been reported by the family thus far.