chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse concerning her approximately 30 years old female colleague, who on 30-JUL-2012 had VARIVAX (lot # not provided) splashed, in both eyes, due to staff error. The nurse stated that when her colleague went to administer a VARIVAX (merck) she thought the syringe came apart and vaccine splashed in her eyes, and were burning. Both eyes were flushed with water, but the reporter stated that maybe not long enough. The nurse stated they would flush patient's eyes with water again, and had her follow up with a health care provider. At the time of the report outcome of eyes burning was unknown. Nurse stated no adverse event occurred with the patient who was getting the vaccine. Additional information has been requested.
Pt recvd dose of Hep B vax on 3APR92 & on 5APR92 devel chills & weakness; pt went home & remained in bed most of day;
01/03/2022: Event occurred after 2nd vaccine. presents to the emergency department via EMS from home for weakness and shortness of breath.  Patient had Covid positive today as an outpatient.  He has been symptomatic for 3 days since 1/1/2022. Patient states his son with whom he lives is also Covid positive.  He denies any fevers at home, he is not on home oxygen.  He has minimal cough but his most prominent symptom is generalized weakness.  States he has been unable to walk for the last 3 days. aced on high flow nasal cannula and respirations increased to greater than 40 times per minute.  He is placed on BiPAP with increased patient comfort and improved oxygenation with decreased respiratory rate.  Due to continuous BiPAP, he will be placed in the ICU for further management.  01/03/2022: remains in ICU.
Fever - treated with Children's Motrin.  Last 72 hours.  On 06/09/17 at 5:00 PM, rash appeared on child's abdomen, chest, and back.
patient experienced yesterday (6/10/09)  on the body from face to upper thigh, fever. Mom gave Tylenol- steaspoonsful and applied Calamine lotion. Temp at visit today was 102.4- Tylenol  2&1/2 teaspoonsful was given to patient. Orders were to continue Tylenol 2&1/2 teapspoonsful q 6 hours, Calamin elotion if tiching and Benadryl 1 teaspoonful q 6 hours for itching.
Generalized muscle weakness (back, shoulder, less). On 07/21/1999, the patient received his first injection of Lymerix, with no untoward effects.  On 07/23/1999, he received the second dose, and in the fall-winter of 1999 he experienced generalized muscle weakness of his back, muscle exercises to strengthen his muscles. The information received on 03/30/2000 reported the symptoms were ongoing.
Donor called 3:40 PM 3-09-19 stating L-arm sore but is swollen worse than day after injection. States arm warm to touch - advised donor to seek medical evaluation with donor verbalizing he is going after our phone call. Advise to bring supporting doc of evaluation. Unable to reach donor after 3 attempts.
Around September 21, 2022 I started having the pain in my abdomen that I knew was pancreas. I have chronic pancreatitis, so I know the pain all too well. I called and made an appointment with my gastroenterologist. We discussed what I was experiencing, he decided not to run any test or change my medication and that together we would wait and watch what happens. I do not feel any better since September, I feel that this is an ongoing issue for me.
Pt. with fever 5 days post-administration, and developed multiple pox 6 days post-administration. Seen 7 days post administration.
p/vax pt c/o of rash; limbs covered w/large red, raised bumps; no itching; no head on bumps;
bloody nose; This is a spontaneous report from a contactable consumer (the patient). A 35-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number and expiration date was not reported), via an unspecified route of administration on 26Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 28Apr2021, the patient experienced bloody nose and would like to know if this was anything to worry about. Outcome of the event was unknown.   Response: Spoke from the FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION PFIZER-BIONTECH COVID-19 VACCINE Prescribing Information Section 6.1 (LAB-1457-7.0. Revised: 06 April 2021) to let caller know that while there were no reports of bloody nose with the clinical trial participants, the data only speaks to commonly reported side effects and does not include all possible side effects of the vaccine. Referred caller to HCP for further guidance.  Follow-up1 (28Apr2021): This is a spontaneous report from a Pfizer sponsored program COVAX US support. A contactable consumer female patient reported information related to the same event.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Swollen Lymph Node under left arm.  Currently causing muscle tenderness and tingling in left arm.  I had an Ultrasound, and no evidence of breast cancer was found.  I am currently scheduled to see a breast specialist on 2/23/2022 and may have to have a biopsy performed.
Large area of redness around dtap injection site. Slightly swollen. Warm to the touch.  Started within hours of injection.  Hasn?t went away within 48 hours, so I?m reporting.
shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was reported. On an unknown date in 2013, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported), as prescribed and/or administered by a healthcare provider at a physician's medical office for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider at the physician's medical office for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered/not resolved. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
No additional AE reported; Patient was accidently administered an expired dose of VAQTA on May 10, 2022.; indicate at which point in the process the medication error ocurred: Preparation for administration; This spontaneous report was received from a medical assistant referring to a 2-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  The patient was given a hepatitis vaccine, as the patient had medical insurance. Medical assistant pulled vaccine off designated box. Expiration and lot number were not checked before administration of vaccine (Product preparation error).   On 10-MAY-2022, the patient was accidently administered the second dose with an expired dose of hepatitis A vaccine, inactivated (VAQTA) intramuscular injection (lot #T037788, expiration date: 30-APR-2022), administered at left thigh for prophylaxis (strength, dose, and route of administration were not provided) (Expired product administered). After vaccine was given, the patient's parent asked to schedule next appointment. As medical assistant was scheduling appointment, lot number and expiration date were also being entered. Error in expired vaccine was not identified until the following day when coordinator was continuing and doing inventory for vaccines. The vaccine was not available for return. Product had no previous temperature excursion. No additional AE reported (No adverse event).
Patient received vaccine on 1/2 and had no immediate side effects. Approximately one week later  she developed a giant, red local reaction that lasted approximately 5-6 days. Once that cleared up she developed pain, tingling and numbness to radiating to fingertips in that arm, lasting approximately 1-2 weeks.  She had xrays to check for arthritis or anything else and they ruled out any injury or arthritis following xray. She did receive a course of tizanidine and naproxen as a result.  She has declined the second immunization of the series.
NECK PAIN; SICK ALL THE TIME; LEG CRAMPS; ARM PAIN; HIVES; This spontaneous report received from a parent via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced neck pain, sick all the time, leg cramps, arm pain, and hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the neck pain, sick all the time, hives, leg cramps and arm pain was not reported. This report was non-serious.
Information has been received from a registered nurse concerning a 35 year old, white, female psychiatric office specialist with thrombocytopenia and a history of hysterectomy, back injury, and two pregnancies, who during childhood may have been vaccinated with MMR. Concomitant therapy included conjugated estrogens, Premarin, dipyridamole, and unspecified therapy. Subsequently, on 4/22/05, laboratory data revealed that patient's titer was negative for rubella and titer was also negative for measles. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. Additional information is not expected.
Clostridium difficile (C-diff) infection; Acute colitis; This is a solicited report from a Non-Interventional Study based on the information received by Pfizer from AbbVie, manufacturer control number: 21K-163-4128768-00. A contactable 71-year-old male consumer (patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscular on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation; and adalimumab (HUMIRA, Solution for injection in pre-filled pen; citrate free), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unknown dose and frequency for psoriatic arthritis. It was unknown if patient was enrolled in a COVID-19 vaccine trial. Patient received 1st dose COVID-19 vaccine manufactured by Pfizer. There was no reported medical history. The patient's concomitant medications were not reported. On unknown dates, the patient experienced acute colitis due to covid vaccine and Clostridium difficile (C-diff) infection. Pfizer Biontech COVID-19 vaccine (tozinameran) was also considered suspect. Relevant laboratory & other diagnostic tests on unknown date included C-diff test and diagnostic test: both waiting for results. The outcome of the events was not recovered/not resolved.  The reporter's assessment of the causal relationship of the events with the PFIZER BIONTECH COVID-19 VACCINE was possible.  The reporter's causality for the events of acute colitis due to covid vaccine and C-diff with Humira (adalimumab) was no reasonable possibility.  No follow-up attempts are needed; information about Lot/Batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the serious events and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a consumer concerned a 39 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211132288, 20211132362, 20211132383 and 20211121650.
Very itchy and swollen rash inside both thighs. So far has lasted three days. Started nine days after vaccine.
rash on the sides of the injectio site; rash itch; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of   in an 81-year-old female elderly exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the parent received the product for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Cholesterol.    On 10-Jan-2021, the parent received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drugs provided. In general, she takes medication for her blood pressure and cholesterol, a daily baby aspirin and a water pill. 22Jan2021
02/23/2021 I began to experience vaginal bleeding. It was as if my cycle had started again. I had 3 different ultrasounds done and biopsies done with a full Gynaecology check up. From these tests, the doctors could not find anything remarkable to report. This had lasted about 2 weeks in duration until the bleeding stopped. I have not experienced any symptoms since this time. Covid-19 diagnosis on 16th of November, and was hospitalized for post covid pneumonia. I am now 03/02/2022 back in the hospital for coughing and will be seeing a pulmonologist as well shortly.
on 11/19 my left arm felt week and the muscles started periodically jumping. This continued until 11/22 when my fingers started seizing up twice that day and my left arm would start shaking when I made a fist. This continued until 11/23 when my left arm started shaking without clenching my fist. It doesnt do it all the time, mostly when I have it resting on a table, resting at my side stretched out in front of me or hanging on to something. . My arm still hurts today even weeks after my shot, it hurts when I move it certain ways or when the doctor poked on it today
1 week after receiving MENACTRA in right deltoid, the patient had about 3 cm rash with (R) arm pain. No burning sensation to rash; had fever 101.3 degrees on day of onset. Chest tightness and sore throat.
GETTING CHILLS; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced getting chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the getting chills and fever was not reported. This report was non-serious.
ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXIA 1/30/2023 &  1/28/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
COVID-19 symptoms started 06/12/22; tested positive on 06/14/22. It started with sore throat and on the night of the 13th I had a slight chill and a temperature of 98.4. 06/13/22 I had a headache. 06/14/22 I tested positive because of chills and I had a positive result within 2 minutes but at the same time I was testing I had what felt like a constricting band around the lower part of rib cage. I contacted my doctor that morning and he was listening to my symptoms and prescribed me PAXLOVID at that point. By 6:30 PM that night I felt much better but I had an extreme metallic taste from the PAXLOVID. I did 2 doses a day and 2 days I was on PAXLOVID the next morning I was very lightheaded and fuzzy so I called my doctor and they stopped the PAXLOVID because of the reaction. By 2 the next day the fuzzy headedness was gone so it was related to the vaccine. The sore throat continued through the 24th. I also had some fatigue but not extreme fatigue. All symptoms are gone.
No known adverse effects; a 17 year old patient received a dose of PROQUAD; This spontaneous report was received from a medical assistant referring to a 17-year-old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On 03-JAN-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant Human albumin (rHA), lot number S021617 with expiration date on 09-JAN-2021 (dosage schedule, route of administration and anatomical location were not reported), for prophylaxis (product administered to patient of inappropriate age). No adverse event was reported.
Itchy rash and hives- like lesions to ears, wrists, ankles and feet and mild swelling and pain of the ankles and feet.
Swelling and warmth at injection site next day after injection.  Worse 2nd day after injection.
4/16/18: (2:30pm)- received vaccine in the left arm. (8:30pm)- arm was sore. (11:30pm)- I went to bed but I was freezing/shivering, high fever, massive headache, nausea, neck pain/stiffness, a little soreness on left side of throat, muscles in my legs and body felt very weak to get up and go to the bathroom, slight heart palpitations lasting about 5 seconds. I was going to call 911 but it went away. I didn't get to sleep until about 3:30am after my husband gave me 2 ADVIL and put cool rag on my forehead. I am still very drained and weak the next day. I feel wiped out and still have a headache, back of the neck pain, and feel still cold but fever went away. Arm is still sore but no rash or swelling at site of injection.
Patient was given 2 HIB vaccines. One in the Pentacel vaccine and one separate HIB vaccine. Pt. was also given routine Prevnar vaccine.
Pt did not have any reaction to the vaccine he was just given a third menningitis vaccination.  Has received one every year since 2007.  I was instructed by the PA I was working with to give the vaccine.  she too was unaware he has received 2 prior.  Also, when pt's mother was asked if he had ever received vaccine she said no and had not brought an immunization record with her to his well child appt.  Pt received this and none of the vaccines have dropped into MCIR.  This vaccine was given on 9/2/09 and it is now 9/11/09 and it is still on in MCIR.
This  patient was admitted to Hospital on 1/29/222 for COVID related symptoms. This is considered a breakthrough case
16-year-old received the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year-old received the Moderna vaccine) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year-old received the Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year-old received the Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided by reporter.
chills; low grade fever to 38.4; body aches; felt very tired; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730), intramuscularly on left arm at 18:15 on 18Dec2020 at single dose for COVID-19 immunization. Medical history included COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19). There were no concomitant medications (No other vaccine in four weeks, no other medications in two weeks). The patient had chills, low grade fever to 38.4, body aches and felt very tired at 15:00 on 19Dec2020. All events were reported as non-serious. The patient did not receive any treatment for all events. The outcome of events was recovering. COVID was not tested post vaccination.
down and out straight; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (down and out straight) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (down and out straight). At the time of the report, ADVERSE EVENT (down and out straight) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-236647 (Patient Link).
Erythematous 9x7cm patch with centralized vesicles on left thigh.
Information has been received from a consumer concerning her son with no medical history or drug allergy who was vaccinated with a dose of MMR II on an unspecified date. It was unsure if other vaccine was given at the same time. Before the patient received MMR II he was a healthy smart child. A day after receiving MMR II, the patient did not talk, would not look at anyone and would not use his words. The reporter stated that after a couple months after receiving MMR II the patient was diagnosed with autism. No lab tests were performed. The patient was doing better with a lot of intervention treatment (conflicting information/also reported as the patient did not seek medical attention). Upon internal review, autism was determined to be an other important medical event. This is one of several reports received from the same source. Additional information has been requested.
Woke up with an extreme migraine. Lasted entire day. Woke up next day with a slight headache.
Headache, hives, indigestion, throat swelling and tightness, and heartburn