chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from health care professional on 24 October 2013. A patient (age and gender unknown) whose medical history and concomitant medications were not reported received  FLUZONE ID (lot number: UT4719AA and expiration date unknown) intradermal (site and dose number not reported) on 18 September 2013. On an unknown date, the patient experienced a BB size hard knot and red area at injection site which continues to today, 24 September 2013). Laboratory investigation and corrective treatment were not reported. As of 24 September 2013, outcome of events were not recovered. Documents held by sender: none
c/o itching after leaving the clinic on 11/2/07. Right arm. Area about 3 1/2 inches x 2 1/2 inches, swollen, painful shivering Friday night. Per patient. Staff did not observe reaction.
Fever runny nose congestion Narrative:  T 100 on 12/29, allergy like sx on 12/31
20 yo male unknown history transferred with AMS. Pt experienced a seizure in the field. Brought to ED with temp 102.3. Intubated. Seized during sedation with etomidate . Given Decadron and Dilantin. Admitted. Vented overnight.
Patient had an injection of the R deltoid. he had injection site soreness and continued fevers. eventually he was diagnosed with myositis with abscess of the R deltoid as well as R shoulder septic joint with MRSA with bacteremia. He had previous rotator cuff tears and atrophy of the muscles in the shoulder and it is postulated that poor injection practices may have led to the muscle and the shoulder being inoculated with MRSA from the skin. given atrophy of the muscles he may have gotten a deeper that what was though injection.
After the first dose FN6206 in my left arm, I got a quarter size hive near my left wrist and some red spots on my right wrist.  The large hive would come and go between my wrist and elbow on my left arm.  There were small random red spots on my right arm. Second dose ER8732 was on 3-24-21.  I showed the nurse the photos of my first dose and she asked me to stay for 30-45 minutes to be sure I was OK. We decided to do this one in the right arm.  After the 2nd dose, the large hive went away, didn't return.  But then I got a rash on both arms between my wrist and elbow.  Smallish red dots with a few pinhead sized clusters like I had with Covid.   The sores during covid (Nov 7, 2020, positive test Nov 12) were on my fingers/hand. I had what I would say is a mild version of covid with about a week of illness, one symptom at a time, no respiratory. Teeny headache, minor throat irritation, 1 day of body aches, 24 hour fever 99.5, couple days of fatigue, couple weeks of queasiness, loss of taste/smell for about 75 days and the little hand/finger breakouts plus a rash on my lower legs that looked like razor burn or tiny blister-like things.  I have been keeping a diary since March 1,2020.
Large local reaction with erythema, edema, severe pruritus from shoulder to elbow.
They think I may have Scleroderma; heart skipped beats less; swelling in my legs; my heart and lungs affected; My skin was thick and tight; my heart and lungs affected; This is a spontaneous report received from a contactable consumer or other non hcp. A patient of unspecified age and gender received 1st dose of bnt162b2 (COMIRNATY,Batch/Lot number was not reported), via an unspecified route of administration on Aug2021 as Dose 1,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced may have scleroderma on 2021, heart skipped beats less, swelling in my legs,heart and lungs affected, my skin was thick and tight on 2021.The outcome of the events was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient who was seen in office on 4/26/21 with FNP for a Well Child Exam. Patient was due for immunizations at time of his appointment. At his appointment the patient was given the Kinrix vaccine. The patient is 5months old and this is a 4-6 year vaccine. Patient had no reactions when in office or when leaving office. Mother was notified of incident and states the patient is still doing well no reactions has taken place.
Two minutes after administration of the vaccine, patient complaint of lightheaded. Legs elevated. Patient had a syncopal episode and regained consciousness in few seconds. Patient speaking coherently. VS taken. Ice pack applied, water provided. Patient verbalized of feeling better. Patient was observed for 30 minutes and left the site on stable condition
4/13/2023  I felt like I was getting a cold. On 4/14/23 I tested positive with an at home COVID test. I felt like I had a really bad cold. I had an appointment with the doctor.  The doctor took my vitals. They did not do another COVID test. I was given a prescription for Paxlovid. I began taking it the next day. I have been on it now for four days.   I feel better. My head is not as congested, my energy level is returning and generally feel better. I am sleeping much better.
Started with nausea and racing heart rate on 12/21/20 then lymph node under left arm became swollen, warm and tender on 12/23/20 and continued through 12/28/20
Joint pain /felt like it was worsening joint pain; just severe pain to where she couldn't walk; This is a spontaneous report from a contactable Other HCP. A 70-year-old female patient received BNT162B2(Lot Number: ET1685), via an unspecified route of administration at Deltoid Left on 23Dec2020 08:00 at the 70 years old at single dose for COVID-19 immunization.  The medical history included rheumatoid arthritis. The concomitant medications were none.  The patient received the shot on 23Dec2020 and experienced Joint pain afterward on 02Jan2021. The patient did have rheumatoid arthritis so there was that. The patient felt like it was worsening joint pain on 02Jan2021. She has had no fever, just severe pain to where she couldn't walk on 02Jan2021. The joint pain has gotten worse and it has gotten to where she is going to advise her not to take the second shot. The Reporter assessed the seriousness for the events was Disabling. The events did not require a visit to Emergency Room but required a Physician Office visit on 06Jan2021. The patient received a steroid injection on 06Jan2021. There was none History of all previous immunization with the Pfizer vaccine considered as suspect. There was none Additional Vaccines Administered on Same Date of the Pfizer Suspect. There was no Prior Vaccinations within 4 weeks. The patient underwent lab tests and procedures, which included x-rays on 06Jan2021: unknown results (they were awaiting the X-rays). The outcome of the events was not recovered.  The information on the batch number has been requested.; Sender's Comments: Based on the available information the events worsening joint pain and walking difficulty are attributed to underlying Rheumatoid arthritis; however, based on a compatible temporal association, contributory role of BNT162B2 vaccine to events occurrence 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.
Within one hour R arm became very painful. It radiated up into shoulder and down to wrist. Injection site was painful to touch for 2 full days. On second day, R arm was weak with numbness to wrist.
developed a fever in the evening that lasted all night. the next day still had some fever which progressed to chills and extreme tiredness. didn't feel "normal" until the 2nd morning afterwards. of course the injection site hurt just like any other shot.
Intense pain, numbness in hands, was referred to an Orthopedic on 12/10/2021. Tears were found in rotator cuff.
Diarrhea; This is a spontaneous report from a non-contactable consumer (patient) via the Pfizer- sponsored program COVAX US Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. As reported, patient wanted to reschedule second dose of COVID Vaccine due to diarrhea. The outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient received flu shot on 9/9, the next morning she states that she started to notice her arm becoming red, swollen, and hurting. The patient came to the pharmacy on 9/12 to report the reaction. By 9/12 when the patient came into the pharmacy the entire upper arm below the point of injection was red to the elbow, her arm was thickest at the elbow where it swelled the most, and she said it was tender to the touch. I instructed the patient to go to her PCP or an urgent care to get checked. By 8 PM on 9/12 the patient called to report that urgent care stated they were not worried and said that the swelling/redness has decreased since she was at the pharmacy earlier.
Pt received ppd right forearm, the vzv vaccine right upper deltoid. Pt c/o of feeling like fainting. Pt then syncopized in chair for few seconds. Had an episode of seizure like activity without incontinence. FS was 107. Oxygen was administered via NRB @ 6L. Pt was diaphoretic and HR 52 then 60 bp 107/60. Pt denied hx of epilepsy. Pt vomited 1x, EMS activated for new onset convulsive activity and arrived on the scene. Pt airway was not edematous, pt was not wheezy, no rash manifested.
Within 10 minutes of receiving flu vaccine, pt reported itching and redness at injection site. Redness 3" diameter around injection site. No systemic symptoms reported at that time. After cool pack applied, she stood up and unsteadily walked towards me, looking highly anxious. She stated "I feel terrible" and "I'm going to faint" after being assisted to lie down, she stated she had difficulty breathing 3 times. Stated "I cannot feel my arms." BP not heard on left arm. Continued to tell us she had a "hard time breathing". Never lost consciousness. Tx: Cool gel pack to injection site. Close observation. Assisted to floor in safe manner. BP attempted without success. 911 called as she was going down. Epinephrine .4cc subcu. of 1:1000 solution given in right arm. She stated "I can breathe easier now" about <1 minute after epinephrine injection - right deltoid. BP 110/88 right arm. Pulse, respirations attempted as paramedics arrived. (O2 by nasal canula, heart monitor, BP 110/58. revealed PVC's and HR = 46. Tx by emergency personnel) Transported to hospital at 9:45 AM.
Loss of strength, numbness, loss of motion. Began with pain. Pt then started complaining of inability to lift arm over head and lift self out of chair.
Adverse events:  fever, chills, headache, muscle pain, disturbed sleep, fatigue for 2-3 days Treatment: cold pack Outcome: Subsided after 3 days
Pt. devel hives and injection site warmth, redness and swelling, twenty-four hour post-vaccination.
pt recvd vax & exp sore arm/pain & mobile restriction; pt's sx are resolving;
Erythematous rash on lateral aspect of upper arm with swelling where vaccines were administered.
migraine h/a, aches in neck, shoulder, aches in joints (knee, ankle bilat lt), numbness & tingling in arm lt;arthralgias, myalgias, malaise, nausea, back pain x 24hr
Inappropriate schedule of vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (1st dose was received in 24th March 2019).   In September 2019, the patient received the 2nd dose of Shingrix. In September 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were received as follows: The pharmacist reports a patient was supposed to come in tomorrow to get their second dose of Shingrix vaccine, which was late, which led to lengthening of vaccination schedule. The reporter consented to follow up.
came out positive; came out positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "thyroid" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "came out positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Because I was tested positive for COVID I have been vaccinated (Unspecified Vaccine) twice with Pfizer; Negative, notes: I took a test for the one in the little box and it came out negative; Positive, notes: I did again the test. It came out positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Because patient was tested positive for COVID she had been vaccinated, twice with Pfizer. She got a mild cold and she was thinking it was just a flu and that was on Thursday and then she thought it was just a flu and Friday she took a test for the one in the little box and it came out negative. So she was thinking it is only the flu and then she became more sick and Friday, Saturday, Sunday  she did again the test. It came out positive. Then she was very, very sick from COVID. But yesterday her cough had diminished a little a lot and her body ache had diminished too. But her Doctor called her concerned that she had COVID and he said to her, they were going to send you something that was going to make you feel a lot better. They send her Paxlovid but she thought that was like poison.  It almost killed me. Consumer stated, no medication. She was only taking the medication for her thyroid but she told her doctor she was not going to take her thyroid medication while she was taking these Pfizer thing because she did not know if it was going to do a bad reaction so he say it was you can choose take not a problem. But she still did not take the medication. Treatment she mentioned she just took Pedialyte.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
existing idiopathic peripheral neuropathy spread from extremities to my entire body and has increased in intensity from a level 1 to a level 3 and has not receded.
RN states, " Patients R-arm cleaned first-upon admin previously drawn up vaccine was leaking from syringe during admin. After admin. was complete, needle removed from arm + detached syringe from needle. Needle was not broken. Pharm. made aware. Pt. then received full 0.5 ml dose in opposite arm per  staff recommendation per Moderna guidelines.
15-20 hot flashes per day started a couple of days after the vaccine and stopped completely after 2 1/2 months.  Skipped period for 4 months also, last period was September 6.  Didn't have another period until January 3
Starting 12/30/20 she was tired and achy, That night she experienced fever and full body aches that improved after Motrin.
pt recvd vax & w/in 24hrs p/vax exp a rash on arm & chest;these sx were not treated;they are improving,but still persist;
Pain in left arm after receiving flu shot. Shot was given high on the left arm, Pain with ROM.
Sore Arm, Fever for 3 days, Then at day four a full body rash developed. Sought medical attention from my primary physician, then went to a dermatologist for a second opinion. They both agreed the rash was pityriasis rosea and couldn't confirm whether it was from the vaccine or just a coincidence.
This spontaneous report as received from a medical assistant refers to a 19 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 01-JUL-2014 the patient was vaccinated with second dose of GARDASIL (dose, frequency and route of administration were not reported) (lot # K005083, expiry date: 04-NOV-216) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for GARDASIL. This case is linked to 1407USA010956, 1407USA01902, 1407USA012903, 1407USA012904, 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927,  1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013, and 1407USA013014 (same reporter link). Additional information has been requested.
Vasovagal response after immunizations given.  Child was ashen, diaphoretic and fell to floor.  Minor abrasion to face due to fall on carpet. Given juice, cookies. Child responsive. Pulse 60bpm.  Assisted to sitting position after 5 minutes. Child ambulatory and alert upon discharge at 12:22 PM.
the legs hurt too; the whole body hurt; fell and hit her foot and knee; fell and hit her foot and knee; is not able to walk very well; felt very bad; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt very bad), PAIN IN EXTREMITY (the legs hurt too), JOINT INJURY (fell and hit her foot and knee), LIMB INJURY (fell and hit her foot and knee) and GAIT INABILITY (is not able to walk very well) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Cholesterol.    On 23-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, the patient experienced FEELING ABNORMAL (felt very bad). On 14-Jun-2021, the patient experienced JOINT INJURY (fell and hit her foot and knee), LIMB INJURY (fell and hit her foot and knee) and GAIT INABILITY (is not able to walk very well). On an unknown date, the patient experienced PAIN IN EXTREMITY (the legs hurt too) and MYALGIA (the whole body hurt). On 27-May-2021, FEELING ABNORMAL (felt very bad) had resolved. At the time of the report, PAIN IN EXTREMITY (the legs hurt too), JOINT INJURY (fell and hit her foot and knee), LIMB INJURY (fell and hit her foot and knee), GAIT INABILITY (is not able to walk very well) and MYALGIA (the whole body hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications included, medications for diabetes, cholesterol and burning/tingling feet associated to diabetes.  Treatment information was not provided.
Urticaria starting on 3/27/07 immunizations on 3/23/07.
Developed hives; This is a spontaneous case, initially received from a pharmacist on 22-Oct-2018, concerning a 63-year-old, adult female patient.  On an unspecified date in 2017 (reported as some time last year), the patient was administered Afluria Quadrivalent [influenza vaccine, dose, route of administration, anatomical location, batch number and expiry date: not reported] for active immunization against influenza.  On an unspecified date after vaccination, the patient developed hives. The patient did not administered any treatment for the event.  On an unspecified date, the hives went away on their own (recovered).  The reporter assessed this case non-serious.  Follow up received from the reporter on 20-Dec-2018: The pharmacist was contacted but no information was obtained. Info number (SEQ18-06670) was added in the additional information tab.; Reporter's Comments: A 63-year-old, female patient developed hives on an unspecified date after vaccination with Afluria Quadrivalent. The company assessed the causality of the event with the suspect vaccine as unassessable due to lack of information regarding the onset latency of the event.
cancer; Neck was stiff; headache; This is a solicited report based on information received by Pfizer from Johnson & Johnson (Manufacturer control number: 20211019864(0.0)), from an adult female via #: Jansen Database for XARELTO, reporting herself.   A contactable consumer (patient) reported that an adult female patient received bnt162b2 (BNT162B2, reported as "Covid-19 vaccine"), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation; rivaroxaban (RIVAROXABAN, film-coated tablet, oral), via oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for product used for unknown indication. The patient medical history and concomitant medications were not reported. Patient reported that, on an unknown date, she was diagnosed with cancer and also stated that she got a covid shot and her neck was stiff and she had a headache. She was not sure if it was from the shot or not though. The action taken in response to the events for rivaroxaban was unknown. The patient recovered from neck was stiff, and headache, and the outcome of cancer was not reported.  The reporter considered the causality between rivaroxaban and cancer as not related. The reporter did not provide a causality assessment between rivaroxaban and neck was stiff and headache. Company causality between rivaroxaban and cancer, neck was stiff was not related and between rivaroxaban and headache was related. This report was serious (Life Threatening).  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: As there is limited information in the case provided, the causal association between the event (neck was stiff, headache, cancer) and the suspect vaccine BNT162B2 cannot be 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.