chrisvoncsefalvay/vaers-outcomes huggingface dataset:
could not put weight on knee; could not walk on her knee that has a spacer in the knee joint; This non-serious case was reported by a consumer and described the occurrence of walking difficulty in a 69-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included knee operation.   On 10-OCT-2023, the patient received Arexvy. In OCT-2023, 1 hr after receiving Arexvy, the patient experienced walking difficulty (Verbatim: could not walk on her knee that has a spacer in the knee joint). On an unknown date, the patient experienced weight bearing difficulty (Verbatim: could not put weight on knee). The outcome of the walking difficulty and weight bearing difficulty were not resolved.   It was unknown if the reporter considered the walking difficulty and weight bearing difficulty to be related to Arexvy.     It was unknown if the company considered the walking difficulty and weight bearing difficulty to be related to Arexvy.   Additional Information: GSK receipt date: 06-NOV-2023 It was reported that patient was walking on her knee and was ok but after the vaccine she could not put weight on the it. She had a spacer in the knee. Within one hour she could not walk on her knee that had a spacer in the knee joint. It was reported that the symptoms were treated.
Wrong dose give, 0.25ml administered instead of recommended dose of 0.5ml.
CLOT BLOOD; DEEP VEIN THROMBOSIS (DVT) IN LEFT LEG; SHORTNESS OF BREATH; This spontaneous report received from a parent concerned a 37 year old male The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and other pre-existing medical conditions included: The patient had no known drug allergies. The patient did not had asthma and he was active at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown), (Dose Number in Series: 1), dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The reporter reported that patient got the vaccine some day in August or early September. 30 days later, both his leg swelled up (blew up) and he went to the hospital. He was hospitalized for the night and was told him that he is having a DVT (deep vein thrombosis) and blood clots. They gave him an unspecified intravenous (IV) injection and put him on anticoagulant (3 or 4 medications) and discharged him (duration of hospitalization was 1 day). He also developed shortness of breath at the same time as the DVT. As per reporter, 3 weeks later it seems that the clot resolved. He was going back and forth to the doctor. The reporter reported that patient could not walk well on his legs. Then after 45 days later he got another clot. Around 18-NOV-2021 or the 21-NOV-2021, patient woke up with severe extreme horrifying pain in his leg and left leg was Swollen. He went by ambulance to hospital. He was diagnosed with another DVT in the left leg. They treated him but didn't keep him in the hospital. They gave him unspecified intravenous (IV) injection and prescription and sent him home with a leg compression equipment to compress the leg due to the pain. The reporter mentioned that the clot was resistant to normal anticoagulants. As per reporter, patient was continuing to be unable to walk and he was not able to work. He need to lay down with his compression stocks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from deep vein thrombosis (dvt) in left leg, and clot blood, and the outcome of shortness of breath was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20211165859-Covid-19 vaccine ad26.CoV-2.s-Clot blood, Deep vein thrombosis in left leg. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Certain things taste off since vaccine/  ''I''ve eaten chicken 3 times since vaccine and each time tastes very off; Chicken tastes chemical and metallic sort of/ Certain fruits and veggies taste like dirt; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 16Apr2021 at 11:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included herniated disc L4-L5, bulged discs L1- L2, L2-L3, L3-L4, asthma, migraines. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), paracetamol (ACETAMINOPHEN), dexlansoprazole (DEXILANT), cannabis sativa (CBD/THC) and colla (MANUFACTURER UNKNOWN), all for an unknown indication from an unknown dates and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received sumatriptan (IMITREX), rizatriptan benzoate (MAXALT), naratriptan hydrochloride (AMERGE), tramadol hydrochloride (ULTRAM), caffeine/ergotamine (CAFERGOT) and butalbital/caffeine; paracetamol (ESGIC PLUS), for unknown indication from an unknown date and experienced drug allergy. On 20Apr2021 at 06:30, the patient experienced certain things tasted off since vaccine. Chicken tasted chemical and metallic sort of, certain fruits and veggies tasted like dirt. The patient could eat chicken soup and everything else tasted fine except the chunks of chicken. She had eaten chicken 3 times since vaccine and each time tasted very off. Different brands, from different sources, cooked by different people of the fruits and veggies that patient ate or smoothies she drank, since the vaccine, some of had tasted just like dirt mainly leafy greens and green juice blends. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were not taken as a result of reported events. The clinical outcome of the events certain things tasted off since vaccine, chicken tasted chemical and metallic sort of and certain fruits and veggies tasted like dirt, she had eaten chicken 3 times since vaccine and each time tasted very off was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt raised hand states that she feels lightheaded & she is nervous. VS obtained, O2 sat 99%, HR 96,  B/P 142/84 RR 20. Pt states that she has not eaten anything at all today & states she is startingto feel  better. As pt prepared to leave she stated the feeling was returning & she was so nervous. Pt & I  continued to chat while she snacked. 2nd set of VS obtained O2sat 99%, P 80, B/P 142/82, RR 18. Pt Pt states she is ready to go. Additional med attention offered, Pt refused, son who is 20 yrs is in car waiting.
Extreme redness, soreness, swelling, pain and brusing at injection site. Fever of 106.3 within 6 hours of injections
I had fatigue, post nasal drip, coughing, lost of taste and smell and I had a slight fever. I had been with our daughter who was visiting us and I went in and tested positive. I had an infusion after I tested and after 24 hours I felt better of receiving that infusion.
she has a bruise about the size of a quarter around the injection site.  It is red and hot to the touch that goes from the injection site down her left arm about 4 inches.  her arm was sore for about 3 days but now it is itching. Pt still has these symptoms today and are not improving.
Mild pain at injection site, followed by peripheral petechial rash with itching, which started approximately 3 days after inoculation and extends, in a circular fashion, with a diameter of approximately 7 1/2 cm. The area with the rash is still present, but subsiding, after 17 days. I took Benadryl 25mg once for the itching because it is not severe.
VACCINE HAS GOTTEN RID OF THEIR BLADDER INCONTIENCE / HELPED WITH NERVE DAMAGE; This case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic effect in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concurrent medical conditions included nerve damage (previous nerve damage from shingles) and bladder incontinence.   In December 2020, the patient received Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown.   It was unknown if the reporter considered the unexpected therapeutic effect to be related to Shingrix.  Additional information was provided as follows: This case was reported by patient herself. The patient wanted to provide positive feedback for Shingrix because the patient no longer experienced bladder incontinence and that previous never damage from shingles was going away. The reporter consented to follow up. This case had been linked with US2021AMR047706, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR047706:same reporter
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 11 years old child patient and unknown gender. On 18-JUL-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot H020901, expiration date 05-JUL-2015) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unkonwn. No product quality complaint was involved. this is one of several reports received from the same source. Additional information has been requested.
pt recvd vax 23AUG93 & 3SEP93 devel swelling on both sides of mandible, low grade fever & a runny nose; pt seen by MD who noted bilateral 3x3 submandibular nodes; rt mandibular angle was nontender to palpatation; parotitis &/or  adenopathy
Patient had all three HPV (GARDASIL) Quadrivalent shots at three different locations. 1. 05/06/2014 @ 2:30 pm in Left Arm HPV 4 Lot H020901 expired 7/05/2015. 2. 07/08/2014 Not sure of time in Left Arm HPV 4 Lot J006236 expired 02/25/2016 Department of Health. 3. 04/11/2016 @ 11 am in Left Arm HPV 9 Lot L044475 expired 5/12/2017. Prior to the two HPV vaccinations, patient was a very high functioning person. She was in advanced classes, cheerleader, tennis, babysitting, took her college entrance exam, highly social, etc.
PAIN; SKIN BURNING SENSATION; BURNING SENSATION IN JOINTS; CHILLS; FATIGUE; MUSCLE SORENESS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included type 1 diabetes, diabetes neuropathy, and lupus flare-up. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 07-APR-2021;10:00 for prophylactic vaccination. The batch number was not reported and has been requested.   No concomitant medications were reported. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced fatigue. On 07-APR-2021, the subject experienced muscle soreness. On 07-APR-2021 22:00, the subject experienced pain. On 07-APR-2021 22:00, the subject experienced skin burning sensation. On 07-APR-2021 22:00, the subject experienced burning sensation in joints. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, muscle soreness, chills, skin burning sensation, burning sensation in joints and pain was not reported. This report was non-serious.
pt recv vax & devel morbilliform rash w/confluent patches on the face, chest, groin;less devel on extremities;
After receiving the Prevnar-13 vaccine the patient reported feeling warm. The patient was given cold cloth for her forehead and stated she felt better initially. Her husband was called over and the patient leaned against him as she stated she was now dizzy. The patient coughed in a manner that implied she may vomit, and when asked the patient confirmed she was nauseous. EMS was called and arrived a few minutes later. At the time EMS arrived the patient stated she was feeling better. After being evaluated by EMS the patient declined further treatment. Approximately fifteen minutes had passed since the immunization at this time. The patient stated she had felt dizzy after a previous influenza immunization three years prior, but had successfully been vaccinated for influenza twice since then, so thought the previous reaction was a fluke.
Extreme soreness in all my muscles. Hurt all over. Flu-like symptoms for 2 days. Arm still very tender to touch on 3rd day.
The patient Received second dose of COVID-19 vaccine Pediatric Pfizer (LOT#: FK5618) exp: 2/21/22 on 12/26/21 and first dose COVID-19 Pediatric Pfizer was given on 12/07/21. Patient came in with siblings and mother. Mother brought children two days early from second dose due date. RN submitted a medical consult via text message to Vaccine Operations Leads, requesting to proceed with the COVID second dose Pediatric Pfizer. Per Dr., approval to proceed with COVID second dose Pediatric Pfizer vaccine was obtained from medical consult team via text message from RN, Vaccine Operations Lead. Client received COVID vaccine Pediatric Pfizer 2 days before due date. The patient did not report any symptoms during the 15 minute observation period. RN educated client on possible adverse reactions and when to seek medical care. Patient left vaccination site with her mom and siblings at 1545 unassisted and with a steady gait.
Experienced chills and was shaky from about 9:30 PM until Midnight the day of the vaccination.
Gastrointestinal issues began Spring 2021 (also due to loss of husband I do have this under control). I also had skin issues around my mouth and treated May 2021. February 2022 very intense loud pulsing in my ears that I couldn't ignore that keeps me from sleeping began. March 2021 had scare with bladder and diagnosed with Weak Pelvic Floor Syndrome.
SWELLING OCCURRING FROM TIME TO TIME IN LEFT FOOT/SWELLING OF LEFT FOOT AND RIGHT HAND/FINGER; BRUISE; TENDERNESS; BURNING SENSATION; VEINS ARE MORE PUFFED UP DISTENDED AND SWOLLEN; DISCOLORATION OF FOOT AND HAND/ FINGER; LESION/BLISTER ON FOOT; ITCHING ON LEFT FOOT; This spontaneous report received from a patient concerned a 75 year old female. The patient's weight was 200 pounds, and height was 65 inches. The patient's concurrent conditions included deep vein thrombosis, hypothyroidism, hypertension, penicillin allergy, nickel allergy, wasp sting, peanut allergy, alcohol user, and non smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and expiry: 20-MAY-2021) dose was not reported, administered on 11-MAR-2021 15:11 for prophylactic vaccination. Concomitant medications included epinephrine for anaphylaxis, cannabidiol for burning sensation on back of hand/are of foot or hand, acetylsalicylic acid for prevention of deep vein thrombosis, amlodipine for treatment of hypertension, and levothyroxine sodium for treatment of hypothyroidism.  On APR-2021, the subject experienced lesion/blister on foot. On APR-2021, the subject experienced itching on left foot. On 17-APR-2021, the subject experienced discoloration of foot and hand/ finger. On an unspecified date, the subject experienced swelling occurring from time to time in left foot/swelling of left foot and right hand/finger, bruise, tenderness, burning sensation, and veins are more puffed up distended and swollen. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Unknown, and X-ray (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lesion/blister on foot, had not recovered from itching on left foot, discoloration of foot and hand/ finger, swelling occurring from time to time in left foot/swelling of left foot and right hand/finger, and bruise, and the outcome of tenderness, burning sensation and veins are more puffed up distended and swollen was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
At site of ZOSTAVAX injection, patient stated the area looked as if it were a cellulitis infection. After a couple of days the swelling went down and no antibiotic treatment was necessary.
ringing in her ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "ringing in her ears".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swollen, red injection site. Fever of 102F with vomiting and fatigue.
After Moderna Vaccine did not get any noticeable reaction, just attributed feeling like crap to always feeling this way related to Crohn's Disease; This spontaneous case was reported by a physician and describes the occurrence of FEELING ABNORMAL (After Moderna Vaccine did not get any noticeable reaction, just attributed feeling like crap to always feeling this way related to Crohn's Disease) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohns disease aggravated.    No medical history was provided by the reporter.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced FEELING ABNORMAL (After Moderna Vaccine did not get any noticeable reaction, just attributed feeling like crap to always feeling this way related to Crohn's Disease). At the time of the report, FEELING ABNORMAL (After Moderna Vaccine did not get any noticeable reaction, just attributed feeling like crap to always feeling this way related to Crohn's Disease) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Treatment information was not provided.; Sender's Comments: Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the event(s) of AFTER MODERNA VACCINE DID NOT GET ANY NOTICEABLE REACTIONS, JUST  ATTRIBUTED FEELING LIKE CRAP TO ALWAYS FEELING THIS WAY RELATED TO CROHN'S was not provided
First dose on November 12 2019/second dose on November 22 2021.; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 12th November 2019).   On 22nd November 2021, the patient received the 2nd dose of Shingrix. On 22nd November 2021, 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 provided as follows: The age at vaccination was not reported. The patient received the 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. No demographics details were collected. The reporter did not consent to follow up.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Severe, Systemic: Weakness-Medium, Additional Details: Patient had same reaction with J&J vaccine. He has had flu shots with no issue in past. Patient fainted/body jerks within 1 minute of injection. Other Staff called 911. I held him in chair and supported him. Several minutes later he had another episode with much more severe body jerks, and rigid muscles. I supported him in chair as best I could, very strong muscle thrashing and jerking. Patient complained of being HOT. He was sweaty and pale. EMTs arrived and took him to ER.
developed "full blown chickenpox"; unable to receive the second dose in the Moderna series; diagnosed with chickenpox; This spontaneous case was reported by a pharmacist and describes the occurrence of VARICELLA (developed "full blown chickenpox"), PRODUCT DOSE OMISSION ISSUE (unable to receive the second dose in the Moderna series) and VARICELLA (diagnosed with chickenpox) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, the patient experienced VARICELLA (diagnosed with chickenpox). On 16-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (unable to receive the second dose in the Moderna series). On an unknown date, the patient experienced VARICELLA (developed "full blown chickenpox"). At the time of the report, VARICELLA (developed "full blown chickenpox"), PRODUCT DOSE OMISSION ISSUE (unable to receive the second dose in the Moderna series) and VARICELLA (diagnosed with chickenpox) outcome was unknown.        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 medication reported.  No treatment medication reported.
TIREDNESS,FATIGUE, BODYACHE RESOLVOED IN 48 HOURS Narrative:
The day after the vaccine I started having cramping - feels like period cramps. I still am cramping daily and have. been having irregular periods since the vaccine - have been regular for 7 years prior. With this, gradually over the next couple weeks I started having, vertigo/dizziness, terrible brain fog, confusion, forgetfulness, headaches, muscle weakness, tremors, twitching, numbness and tingling, vision issues, weird dreams, severe fatigue, stiffness - mostly around neck and shoulders, lethargy, would hear things that weren't said, depersonalization, increased sensitivity - mostly light, heart palpitations, chest pain, memory loss. These were all severe for a span of a couple weeks. I was not able to work all of July and August due to feeling sick/trying to recover. Currently I still experience headaches daily, cramping has not left - still daily, irregular periods, POTS symptoms - increased heart rate from standing (140bpm for me at times).