chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A patient received an early dose of Adacel yesterday with no reported AE; Initial information was received on 04-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 28 years old female patient who experienced a patient received an early dose of adacel yesterday with no reported ae while receiving vaccine diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 03-Apr-2023, the patient received a dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection at dose of 0.5 ml lot U7657AA ( route, strength, expiry date; unknown) in the left deltoid for Immunization.  On 03-Apr-2023 the patient developed a non-serious event of a patient received an early dose of adacel yesterday with no reported ae (inappropriate schedule of product administration) following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine.  It was reported "A patient received an early dose of Adacel yesterday, 03Apr2021. The dose was administered in the left deltoid. A factor in the error is that the administering nurse looked at the Td vaccine in the system and saw that the last date of the Td vaccine for the patient was in 2007. The nurse did not see that the patient received a Tdap on 22Jun2021. She went by the last dose of Td and incorrectly thought the patient was due for Tdap".  Action taken with DIPHTHERIA, TETANUS and acellular pertussis vaccine (Adacel) was not applicable.  At time of reporting, the outcome was Unknown for the event a patient received an early dose of adacel yesterday with no reported ae.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This child had Prevnar administered to her on 02/13/01. On 02/17/01, the patient had a rash on her face, trunk and legs. She was seen in the ER 02/17/01 and given Atarax syrup, and advised to use warm compresses to the injection site. Discharged from ER.
Jansen COVID-19 Vaccine EUA. Weight gain of 8 pounds overnight (water retention), glucose levels over 300 for several hours, elevated blood pressure (160/111). Doctor prescribed water pills for weight gain. Patient continues to monitor glucose levels.
one had a headache and maybe a fever; one had a headache and maybe a fever; This is a spontaneous report from a non-contactable consumer via medical information team. A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the reporter who was a frontline worker, received his first dose of the Pfizer Covid vaccine on 17Jan2021. He had no side effects except for a very sore arm at the injection site which he never had with a vaccine before. Some of his work colleagues complained of fatigue and one had a headache and maybe a fever on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible.; information about lot/batch number cannot be obtained. No further information is expected.
Patient received 2nd dose of Pfizer vaccine on 01/19/2021. Symptoms of cough, sore throat, and runny nose started on 08/26/2021. Positive for Covid-19 on 08/26/202.
Vaccines PEDIARIX and PREVNAR administered in arm on 9-29-08. Parent reports low grade temp through night of 9-29-08. High fever started 9-3o AM on 9-30-08 max temp 103 degrees. Rash on left thigh around injection site.
One week after receiving the shot I started with a small rash on my left hand. Over the next three days the rash spread rapidly, now over my hands, arms, neck, face, legs, back and buttocks.
24 hours after vaccines administered both knees began to swell. After 5 days R. knee swelling subsided but L. knee worsened to include L. thigh, calf and ankle/foot. SynviscOne Injections both knees 8-19-2010. Eight days before vaccines. These injections were done by orthopedic surgeon. Both knees were still inflamed from these injections when vaccines administered 8-27-2010. Left knee was drained by doctor on 9-1-2010 and knee fluid sent for testing. Informed by doctor on 9-7-2010 (while in hospital) that tests were negative and there is no infection. Must be vaccines. Went to ER on 9-4-2010 and admitted due to high white blood cell count, +18,000. Antibiotics administered by IV until 9-7-2010 when it was determined there was no infection. Began Colchicine meds (in case of gout) and VOLTAREN Gel 9-7-2010, per doctor. Released from hospital 9-8-2010. Left knee drained and joint fluid tested on 9-7-2010 and 9-13-2010 by doctor (rheumatologist). Currently under his care. Tests have shown no gout or pseudo-gout. As of 9-15-2010 swelling in left thigh, calf and ankle/foot has subsided. Left knee is still somewhat swollen and cannot bend knee more than 90 degrees. Currently taking 600 mg. Ibuprofen and PROPOXYPHEN-APAP. Left arm muscle where pneumococcal vaccine was administered is still sore.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 26-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were Reported. No Treatments were Reported.  Moderna vaccine was pulled from the freezer on 13-Oct-2021 with a "use by date" of 12-Nov-2021 (30 days storage viability in the fridge).   This case was linked to MOD-2021-364614, MOD-2021-367363, MOD-2021-367372, MOD-2021-367376 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow-up received contains no new information
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2011, the patient was inoculated with ZOSTAVAX at a healthcare facility/office for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 15-JUL-2016, the patient was treated (by an unspecified healthcare professional) at a healthcare facility/office for a persistent and severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
R09.02 HYPOXIA 8/12/2022 HTN (HYPERTENSION) R09.02 HYPOXIA 8/12/2022 METABOLIC ENCEPHALOPATHY R09.02 HYPOXIA 8/12/2022 HTN (HYPERTENSION) R09.02 HYPOXIA 8/12/2022 HEMATOMA, INIT R09.02 HYPOXIA 8/12/2022 LEFT HIP DISLOCATION, INIT
loss of hearing, patient has hx of wearing hearing aids, hearing worsened after vaccination.  Patient went to ENT doctor today, was advised to call CDC per ENT doctor. Spoke to pt's daughter because mom has lost 80% of her hearing and she is taking all of her calls. They went to audiologist for hearing test, then to ENT who prescribed Prednisone for 10days but was unsure about her situation and told her to call the CDC. Their main concern is does she take her 2nd shot and risk loosing more or all of her hearing if it was a result of the vaccine. The daughter said that they received new hearing aids a week before the vaccine. I told her that we will follow up with her in about a week to see if the steroids are helping and to find out the results from her ENT follow up appt.
Vaccine was administrated without dilution, resulting in a higher than indicated dose to the patient.  No adverse effects noted at time of injection
Hives/Welts; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives/Welts) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported. .  Concomitant products included EPINEPHRINE (EPIPEN) for an unknown indication.   In July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced URTICARIA (Hives/Welts). At the time of the report, URTICARIA (Hives/Welts) outcome was unknown.            Treatment information was not provided.   This case was linked to MOD-2021-304952 (Patient Link).
Pt had injection on 11-13-11 and pain started 11-14-11. Injection site felt a little hot but no real swelling. Pain radiating into hand. Took Ibuprofen for several days then went to doctor. Dr gave antibiotics and to rule out infection. Did not help. Dr took x-rays (came out normal). Pt told to make appt with hand surgeon. Was told he had infection in joint and got steroid shot. Also starting physical therapy for a few weeks.
Rheumatoid arthritis flare up; slight inflammation; Fatigue; This is a solicited report based on the information received by Pfizer. (Manufacturer control number: 21K-163-3986159-00).  A contactable consumer (patient) reported that a 55-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via intramuscular on an unspecified date (Batch/Lot number was not reported), as single dose for Covid-19 vaccination; upadacitinib (RINVOQ), orally from an unspecified date (Batch/Lot number was not reported) and ongoing, at unspecified dose for Moderate to severe Rheumatoid arthritis. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via intramuscular on an unspecified date as single dose for Covid-19 vaccination. Medical history included ongoing Moderate to severe Rheumatoid arthritis. The patient's concomitant medications were not reported. Solicited report by a consumer of an adult female with events of non-serious fatigue and rheumatoid arthritis flare up with RINVOQ (UPADACITINIB). On unknown date, patient received 1st dose Covid-19 vaccine manufactured by Pfizer. On unknown date, patient received 2nd dose Covid-19 vaccine manufactured by Pfizer. On unknown dates, the patient experienced Fatigue and Rheumatoid arthritis flare up. PFIZER BIONTECH COVID-19 VACCINE was also considered suspect. The patient had slight inflammation. She had Covid-19 vaccine Pfizer brand. She had a reaction on second dose of fatigue. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken in response to the events for upadacitinib was dose not changed. The outcome of the event fatigue and slight inflammation was unknown, of the event Rheumatoid arthritis flare up was Not recovered.  The reporter's causality for the events of fatigue with Rinvoq (Upadacitinib) was no reasonable possibility. The reporter's causality for the events of Rheumatoid arthritis flare up with Rinvoq (Upadacitinib) was no reasonable possibility. The reporter's assessment of the causal relationship of the events with the suspect product BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the event Rheumatoid arthritis (Rheumatoid arthritis flare up) and the suspect drug BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Since 7/24, I?ve experienced the following symptoms sporadically, in waves. They are all present to some degree at all times, with small brief exceptions. I?ve had maybe 2-3 days where symptoms briefly paused then resumed the following day.  Whole Body: Poor circulation (pins and needles, burning feelings),  sometimes minimal pressure on arms and legs can aggravate the feeling, increased sweating  Head: Intense brain fog (to the point of nearly fainting),  brain ?zaps? (feels electric),  mild confusion,  increasingly intensifying depression/anxiety/frustration due to declining health   Chest: Tightness, not painful, but frustrating ? pounding heart despite pulse and blood pressure at relatively normal levels? pulse can jump up or down by 20 beats by switching between sitting/standing/lying down  I?ve taken minimal amounts of Tylenol, ibuprofen, and a little aspiring but nothing has helped much so I avoid medicine for the most part? for the last few months I?ve entirely given up coffee and alcohol, which I wasn?t even consuming much of to begin with but I don?t want to aggravate Symptoms?
Neck pain, leg weakness, (R) arm pain, ataxic gait, worsening over 2 days. -> Bell's palsy.  11/17/09 ED, hospital records, hospital and rehab discharge summaries received service dates 9/24/09 to 10/26/09. Assessment: Guillain-Barre Syndrome Patient with URI symptoms onset 1 week ago, seen by PCP for otitis, followed by malaise, cough, nausea, vomiting. Lower extremity ataxia and numbness, right upper arm pain. Ataxic gait, right sided facial droop and ptosis. Weak patellar reflexes bilaterally. Pain with downward gaze. Headache. Generalized back pain over spine on palpation. Unable to walk. IVIG administration. Discharged - to continue outpatient OT/PT.
Client was vaccinated and observed for 15 minutes.  Upon departure client reported feeling  dizzy. Client was reseated and  vitals were as follows: BP 172/112, SpO2 99%, HR 74 Client was treated with ice pack, water and cool gel pack while being observed. Client requested to be moved to private area, upon attempt to stand, client experienced dizziness and continued to feel ill. Client able to ask questions and then reported PMH. PMH was not reported to clinical staff prior to vaccination. 911 was called and  client was transported to hospital.
Swelling and band of redness around injection site; itching; burning. Warm to touch.
After 15-20 minutes of receiving the vaccine I began to have tingling in my lips that felt almost numbing but not quite. This progressed into my mouth with the slight swelling of my tongue and lips. I had incredibly dry mouth as well. Felt very thirsty.  I was given a Zyrtec (10mg I think). Swelling and numbness never progressed into anything serious, could swallow and speak fine. Did develop a small rash on my forehead that went away about an hour after the Zyrtec. 30 minutes after taking the Zyrtec the tingling and swelling in my mouth and lips subsided.  Around 7pm my cheeks and face felt tingly so as recommended I took a benadryl. In the morning all symptoms were non existent.
Started 2 days prior to appointment visit.  Crops of different stages of serious from papular to papule - vesicular, to vesicular to crusts noted on chin, around neck, crust on left nostril.  Went to the fall carnival 1 week before getting sick and had face painted.  His 1st Varivax was given on 12/21/04.
Breakthrough COVID 19. Patient was fully vaccinated on Apr 6, 2021. Patient tested positive on Sep 5 2021.
Initial report received on 02 November 2007 from a health care professional.  A 38-year-old female patient, who was pregnant at the time of vaccination, had received a first dose, left deltoid, intramuscular injection of FLUZONE SV 2007-2008, lot number U2526AA, on 30 October 2007.  Two days post-vaccination, the patient experienced a sore throat, and it was uncomfortable to swallow.  The event did not require medical examination.  The patient experienced no fever or chills and slept well.  Last menstrual period and estimated date of delivery were not provided.  Other medications included prenatal vitamins.  The patient recovered from the event.  Follow-up information received on 26 November 2007 from the patient.  The patient's primary care provider, OBGYN, and Maternal Fetal Medicine Center contact information was provided.  The patient has no known allergies but could possibly have a history of environmental allergies.  The patient experienced symptoms of coughing and headache two days post-vaccination (02/Nov/2007), in addition to the previously reported adverse events of sore throat, and "it was uncomfortable to swallow."  The date of the patient's last menstrual period was reported as "unknown"; but the expected date of delivery was reported as 13 March 2008.  Prenatal testing so far includes: ultrasound (routine), completed on 08 August 2007 (within normal limits); ultrasound for high risk age, completed on 30 August 2007 (results not reported); and ultrasound for high risk age, completed on 31 October 2007 (results not reported).  The patient is scheduled to see her OBGYN on 03 December 2007, and her next ultrasound is scheduled for 04 January 2007.  The recovery status of the coughing and headache was not reported.  At the time of this report, the recovery status was amended to "not recovered."  Follow-up information received on 24 June 2008 from a health care professional.  Per the reporter, the patient's obstetrical history included two previous pregnancies that resulted in one live birth and one spontaneous abortion prior to 20 weeks of gestation.  The patient did not use alcohol, tobacco or recreational drugs during her current pregnancy.  Ultrasound completed on 08 August 2007 confirmed the patient's pregnancy at eight weeks six days gestation.  Another ultrasound completed on 31 October 2007 showed a normal appearing fetus at 20 weeks four days gestation.  An Alpha feto protein test (date not reported) showed an increased level of "hcg").  The patient did not see the physician for any complaints regarding her pregnancy following her FLUZONE vaccination on 30 October 2007.  However, the patient did have complication of pregnancy identified as complete placenta previa requiring primary cesarean section on 21 February 2008.  The patient did not experience any complications of labor and/or delivery.  She did not experience any post operation or post partum sequelae.  The patient delivered one, live male child who's Apgar scores were eight at one minute, and nine at five minutes.  The baby weighed six pounds one ounce (3 kilogram), and he had no congenital anomalies.  Due to this new information, the case was upgraded to serious.
Rash on right and left lateral thigh. Mother states baby very restless and started with screaming type cry in the evening of 10-17-16 which lasted approximately 3 hrs. States fever of 100 degrees axillary, gave TYLENOL at 4:30pm, fever cont, so used MOTRIN cont. with fussiness.
THE COVID 19 SECOND SHOT, MY THROID WAS DISFUNCTION. WHICH IS, MY THYROID GLAD WAS PRODUCED A LOT OF THYROID HORMONE. I WAS SICK FOR WHILE.
this is 1 of 2 pt from this site to devel bulging fontanels p/vax w/lot# 441102;
The client did not experience any adverse events following vaccination but did receive the Live Attenuated Intranasal H1N1 vaccine (FluMist) which is not indicated for his age group or for those with pre-existing conditions.
stiffer; He states that he was only able to sleep 2 hours after; weak; soreness; dizziness; dehydration; Pain injection site; headache; stiffness in his joints; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 55-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution of injection, Lot Number: EN6204), via an unspecified route of administration, administered in Arm Left on 06Mar2021 (at the age of 55 years old) as dose 1, single for COVID-19 immunization. The patient's medical history included Deep venous insufficiency and Male pattern baldness from an unknown date and unknown if ongoing. The patient's concomitant medication included Celebrex (CELECOXIB), acetaminophen, vitamin C, and Vitamin D. The reporter reported that the patient stopped taking them 2 days prior to the vaccine. The patient had not received anything prior to the vaccine. On an unspecified date the patient experienced stiffer, he states that he was only able to sleep 2 hours after, weak, soreness, dizziness and dehydration while on 06Mar2021 the patient experienced stiffness in his joints, headache, Pain injection site. The patient reported that feeling the stiffness in joints, specifically ankles, knees, and hand. Patient stated that patient was only able to sleep 2 hours after, reporting feeling a little weak and everything. The next day the patient reported taking a 3 hours nap and feeling a little bit better after but still feeling very, very stiff in his shoulder to where he could not lift his arm. patient reported that this stiffness improved with some stretching and went away. The reporter reported that patient initially experienced pain with touch at the injection site but reports that that has now gone away as well. Patient also complains of stiffness in his neck and a headache between the temple region and the earlobe on the left side which Patient said feels like pain or soreness, feels like a stroke. Patient reported that this headache has now moved to the opposite side of his head, the right side and that it will go away when patient rest my head. Patient reported feeling dehydrated and states that patient felt better when the patient laid down. Patient reported that except for the stiffness, these symptoms were pretty mild. Patient reported that the patient normally takes a couple thousand mg of omega-3 fish oils and a shot 3 to 4 times a day of extra virgin olive oil to act as blood thinners. Facility of vaccine administration: Patient reported that it was also at the sae place at (institute name) in (address), the same place where he see's his PCP. It was suppose to be in Clinic A but patient had injection in Doctor (name withheld) office, which also calmed him down and took away his anxiety, because the place in line was to step into the office. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.