chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red rash; Itchiness; Injection site induration; Swelling of lymph nodes; Swelling; Injection site has pain; Injection site tenderness; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash), VACCINATION SITE PRURITUS (Itchiness), INJECTION SITE INDURATION (Injection site induration), LYMPHADENOPATHY (Swelling of lymph nodes) and VACCINATION SITE SWELLING (Swelling) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Red rash), VACCINATION SITE PRURITUS (Itchiness), INJECTION SITE INDURATION (Injection site induration), LYMPHADENOPATHY (Swelling of lymph nodes), VACCINATION SITE SWELLING (Swelling), VACCINATION SITE PAIN (Injection site has pain) and VACCINATION SITE PAIN (Injection site tenderness). At the time of the report, RASH ERYTHEMATOUS (Red rash), VACCINATION SITE PRURITUS (Itchiness), INJECTION SITE INDURATION (Injection site induration), LYMPHADENOPATHY (Swelling of lymph nodes), VACCINATION SITE SWELLING (Swelling), VACCINATION SITE PAIN (Injection site has pain) and VACCINATION SITE PAIN (Injection site tenderness) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications reported by investigator  No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Follow up received on 02MAY2021, does not contain no new information and patient stated that she is fine.
Fever 102 degrees for 6 hours Sore Arm 1 week Ibuprofen taken to lessen fever  Extreme exhaustion 18 hours Pancreas pain day 2 and day 3 No medical care sought as symptoms went away on there own.
Almost passed out; not feeling good; eyes start getting blurry and glassy; tingling sensation, in my chest; I was real slow; weak; hurting in my neck; could not move my neck, like my lymph nodes swell up in my neck; ribs hurt like when I cough; body hurt; my body felt like somebody beat the hell out of me and I was in so much pain; back is hurting; hurting in my neck; could not move my neck, like my lymph nodes swell up in my neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): -PFIZER INC-202200175283 (Pfizer).  A 44 year-old female patient received bnt162b2 (COMIRNATY), administration date 28Jan2022 (Lot number: FJ6369, Expiration Date: 31May2022) at the age of 44 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "Almost passed out"; MALAISE (non-serious), outcome "unknown", described as "not feeling good"; VISION BLURRED (non-serious), outcome "unknown", described as "eyes start getting blurry and glassy"; PARAESTHESIA (non-serious), outcome "unknown", described as "tingling sensation, in my chest"; ASTHENIA (non-serious), outcome "unknown", described as "I was real slow; weak"; LYMPHADENOPATHY (non-serious), NECK PAIN (non-serious), outcome "unknown" and all described as "hurting in my neck; could not move my neck, like my lymph nodes swell up in my neck"; MUSCULOSKELETAL CHEST PAIN (non-serious), outcome "unknown", described as "ribs hurt like when I cough"; PAIN (non-serious), outcome "unknown", described as "body hurt; my body felt like somebody beat the hell out of me and I was in so much pain"; BACK PAIN (non-serious), outcome "unknown", described as "back is hurting".
This was a Pfizer booster shot after I received the J&J one shot vaccine in May of 2021.  I now have intense pain in my hips and legs.  I received the shot four days ago. I immediately had pain at the injection site.  I felt fine for about 12 hours and then experienced expected fatigue and  minor body aches.  By the end of the second day I felt fine.  However, on the evening of the third day following the vaccine I started to have a lot of intense, shooting pains in my legs. It is now the fourth day and my legs and hips are in excruciating pain.  I haven?t done anything outside my normal activities and routine that could explain the leg pain.
This spontaneous report as received from a pharmacist via a company representative refers to two unspecified patients. The patients' medical history and drug allergies were not reported. On an unknown date, the patients were vaccinated with ZOSTAVAX (dose, frequency, route, lot# and expired date were not reported). Concomitant therapy was not reported. On an unknown date the patients developed shingles after receiving ZOSTAVAX. The outcome of the adverse event was not reported. This is one of several reports from the same source. Additional information has been requested.
Left arm pain and swelling ongoing since 2nd vaccination. Began right after vaccination. Reports that arm was not cleaned prior to injection
REACTION TO 2010-2011 SEASONAL INFLUENZA VACCINE; Per MR - Developed sudden disequilibrium while waking around 5PM. Symptoms were mild so pt ignored them. @ night, pt tried to go to the bathroom, he had difficulty getting out of bed due to diffuse weakness. Morning of 9/27, went to ER since unable to walk due to severe diffuse weakness. Upon admission on 9/27, patient unable to ambulate. Pt stated that he has had chronic numbness in L pinky and lately R mid finger but was told he had pinched nerve in neck.  Pt dx with GBS. IVIG 5x days but paralysis progressed and intubated & ICU on 10/4. Put on continuous infusion of high dose IVIG.  Will most likely be switched to plasmapheresis (written in prog note on 10/5).  As of 10/7, still hospitalized.  NOTE: Difficulty having BM while admitted and mention of preceding hx of UTI but no other details of UTI.  Mention in MR that GBS is secondary to influenza vaccine.
urticaria, fever, arthralgia, h/a (serum sickness synd) sick for 2 wk;
This spontaneous report as received from a pharmacist and refers to a female patient of unknown age. The patient had no concomitant medications, pertinent medical history, drug reactions or allergies.  On 09-MAY-2018 (2 days ago), the patient was vaccinated with PNEUMOVAX 23 in the left arm (lot#, expiration date, frequency, dose and route of administration were not provided) for prophylaxis. On 09-MAY-2018 (reported as later that day), the patient's left arm was swollen and warm to touch below the injection site. The pharmacist reported, that on 11-MAY-2018, the swelling has increased and moved towards elbow, was red, hot to touch, and very painful. The patient had no laboratory studies performed. The outcome of the events was reported as not recovered/not resolved. The causal relationship between the events and suspected vaccine was not provided by the reporter.
persistent screaming >3 hrs beginning 1/2 hrs p/inject w/some swelling of lt leg;
Feet sick-couldn't sleep-28 hrs later I broke out in large hives. My Dr gave me large dose of vitamin C to stop the reaction. Two weeks later, I still have redness from the hives.
Sick for 3 days each; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (Sick for 3 days each) in a  patient of an unknown age and 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick for 3 days each). At the time of the report, ILLNESS (Sick for 3 days each) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2022-437432 (Patient Link).
NEXT DAY HAD HIVES ON ARM THAT SPREAD TO BACK AND SIDE OF BODY, UPSET STOMACH, LOSS OF APPETITE, VOMITING. SHE CONTACTED AN ADVISE NURSE ON THE PHONE NOT SURE ON WHAT DAY. 08/19 STILL HAS STOMACH UPSET AND LOSS OF APPETITE WITH POTENTIAL WEIGHT LOSS THE HIVES ARE GOING AWAY.
5 hours after injection, chills, rigors, temp 103.8, increased B/P, HR level 3.
Patient is one year old. Given adult dose FLUZONE QIV 0.5ml.
Chills, sore throat, dizziness, fever, headache, and sore arm at injection sight
On 4/29 noticed at 8 am that began to feel muscle pain on back (let and right side) as morning progressed muscle soreness on rib cage started. In afternoon, developed lightheadedness and stomach problems. Symptoms similar to flu. Has not called doctor yet.
Exhaustion Severe muscle fatigue & soreness (day after) Joint pain (day after) Nausea, vomiting (day after) Random chest pain jabs  Severe head ache (for 3 days now)
heart flutters; muscle twitching in my calves/mild muscle twitching/muscle twitching in my left arm; high blood pressure spikes; stabbing pains in various areas throughout my body; The fatigues became extreme; unable to do normal daily activities; pins and needles; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FC3182), dose 2 via an unspecified route of administration, administered in Arm Left on 27Aug2021 10:30 (at the age of 58years) as dose 2, single for Covid-19 immunization. Medical history included hypothyroid. Concomitant medications included levothyroxine, liothyronine (NP THYROID); vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); vitamin d3 (VITAMIN D3); cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]); and magnesium (MAGNESIUM); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her first dose of Comirnaty (Batch/Lot No: FA7485) on 05Aug2021 (at the age of 58years) for Covid-19 immunization. The patient reported that after her first dose, she had cold symptoms, a sore arm, sneezing, runny nose, cough, headache, and low energy. Between the first and second dose she started having extreme fatigue and becoming easily out of breath. She also noticed some vision problems and brain fog. On 27Aug2021 12:00, the patient experienced heart flutters, muscle twitching in my calves/mild muscle twitching/muscle twitching in my left arm, high blood pressure spikes, stabbing pains in various areas throughout my body, the fatigues became extreme, unable to do normal daily, pins and needles. The patient clarified that after her second dose, she immediately started having vibrations in her left foot as if she was standing on the phone that was vibrating that went into pretty constant pins and needles and muscle twitching in her calves that intensified and she started having the muscle twitching in my left arm as well as high blood pressure spikes, heart flutters, pins and needles, stabbing pains in various areas throughout her body. The fatigues became extreme, and she was unable to do normal daily activities. It went on for 6 weeks and now she has her energy back, but mild muscle twitching and pins and needles continue. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for the events. There was no treatment received for the adverse event. The outcome of events was recovering.  Follow-up attempts are completed. No further information is expected.
Pt reported the day after receiving the first dose of the Moderna vaccine, she awoke with a very sore arm that was also accompanied by extremely swollen lymph nodes on the same side she received her vaccine in her neck, underarm area, and into her breast that were all very sensitive. She also said her posterior shoulder muscles were extremely sore. Even after 8 days, lymph nodes are still palpably swollen. She went to urgent care on 5/4/21 and was given some prednisone to try and relieve some of the swelling and discomfort.
Pt got shingles 2 weeks after receiving ZOSTAVAX vaccine. Physician diagnosed with shingles on face. Pt was having pain on shoulder as well.
COVID arm: My arm is warm to the touch and has a raised red rash about 2.5 inches x 2 inches.
31 hours after the vaccination I woke up at 11:00 p.m. and had two and a half hours of alternating sweats and chills that went away with 1000 mg of acetaminophen and 600 mg of ibuprofen. I did not have a fever, my temperature was 98.8, and I did not have diffuse muscle lakes. this was similar to but much shorter lived in milder than my reaction with shingrix earlier in the year.
Patient reports that she starting having side effects the night of 3-17-2021. She reports side effects of nausea, headache, body aches. Woke up in the morning of 3-18-2021 and had trouble seeing, felt dizzy. Blood pressure was lower at 115/54 pulse 80.  This did resolve over the next few hours.
Red  swollen skin, itchy and painful, started on about day 2. Currently still present on day 7. Darkened area in center, appears bruised
Initial misuse report received from a Healthcare professional on 27 January 2014. The case was received on 21 March 2014 at GPV. This is an invalid case as individual patient identifiers are not reported. A TYPHIM VI was given subcutaneously. (No information was provided regarding the patients). No adverse event was reported. List of documents held by sender: none.
UNDERAGED CHILD.  DATE OF BIRTH ON CONSENT CLAIMS TO BE OLDER THAN ACTUAL AGE.  DOB IN DATABASE IS SHOWS ACTUAL DOB.
Information was received on 03-JUL-2017 from a pharmacist who was reporting on a patient of unknown age and gender. No medical history or concomitant medications were reported. On 29-JUN-2017, the patient was administered a dose of ZOSTAVAX (lot M032650, expiration 15-JUN-2017) (dose and site not reported) for prophylaxis that was expired. It was reconstituted with non-expired sterile diluent (unknown lot and expiration). No adverse effects were reported. No further information provided. Additional information has been requested.
DIFFICULTY SLEEPING; NAUSEA; HEADACHE; RASH; ITCHING; PAIN; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol use, and nonsmoker, and other pre-existing medical conditions included the patient had drug allergies and had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with amoxicillin, and hydromorphone hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced rash. On 05-APR-2021, the subject experienced itching. On 05-APR-2021, the subject experienced pain. On 10-APR-2021, the subject experienced headache. On 14-APR-2021, the subject experienced nausea. On an unspecified date, the subject experienced difficulty sleeping. Treatment medications (dates unspecified) included: cortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching, headache, rash, pain, and difficulty sleeping, and the outcome of nausea was not reported. This report was non-serious.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with ZOSTAVAX at a pharmacy for routine adult health maintenance and the intended purpose 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, the very virus the ZOSTAVAX vaccine is intended to prevent. Later in 2015, the patient was treated by a physician for symptoms of a blistering vesicular outbreak, 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.
examined by NP on 6/22/23. No adverse side effects. Medication administrator error.
Fever (103.6) generalized clonic seizure (x10 seconds).  Full sepsis work up.  IV Ceftriaxione given.
This spontaneous report as received from a healthcare worker (certified medical assistant) refers to a patient of unknown age. On 30-JUL-2014, the patient was vaccinated with a dose of (Merck) VARIVAX (lot#, expiration date, dose and route not reported) which was exposed to unknown out of range temperatures since 25-JUL-2014. No adverse symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
felt like he was hit by a truck; stiffnes after second shot; covid-19 positive; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt like he was hit by a truck), LIMB DISCOMFORT (stiffnes after second shot) and COVID-19 (covid-19 positive) in a male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (felt like he was hit by a truck), LIMB DISCOMFORT (stiffnes after second shot) and COVID-19 (covid-19 positive). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, ILLNESS (felt like he was hit by a truck), LIMB DISCOMFORT (stiffnes after second shot) and COVID-19 (covid-19 positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         No Concomitant medications were provided    This case was linked to MOD-2021-029810 (Patient Link).
Large splotchy itchy painful rash on arm that keeps getting bigger despite taking Benidril.. It is below the injection site and is not connected to the rash that developed around the injection site.   I have also been experiencing palpitations on and off over the last couple of days. I went to the ER and all the tests were normal.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 05-OCT-2010 the patient received an expired dose of PNEUMOVAX23 25/0.5 (lot # 662747/1086X, exp date 06-JUN-2010), 0.5 ml (route unspecified). Concomitant medications were not reported. No adverse effect reported. This case is linked to case 1307USA013390, 1307USA015839, 1307USA015841, 1307USA015842 via same reporter link. Additional information has been requested.
Information has been received from a physician concerning numerous female patients (ages not reported) who on unspecified dates were vaccinated with a dose of Gardasil vaccine. Concomitant medication was not reported. Subsequently on unspecified dates, the patients complained of pain after receiving the Gardasil vaccination. Unspecified medical attention was sought. The outcome of the events were not reported. No product quality complaint was involved. No further information is available.
INJECTION SITE NODULE. Information has been received from a registered nurse concerning an "otherwise healthy" 50 year old black male who on 18JUN2003 and 23JUL2003 was vaccinated with a first and second dose of hepatitis B virus vaccine rHBsAg (yeast)(1st dose lot #644099/0835M; 2nd dose lot #1018N), respectively. After receipt of the second vaccination in his right arm, the patient developed a nodule at the injection site. It was not red, inflammed or painful for the patient. It was reported that this was discovered upon the patient's return for a third vaccination. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Left Leg (Dtap) local urticaria and redness to injection site within seconds of administration.  Patient immediately crying and complaining of itchineses and pain to leg. After 20 minutes of observation Patient had a 6x6cm area of redness with 3x3 cm blanching urticaria.  Her vitals were within normal limits and she was able to walk without limp.
This is to express our concern about the MODERNA and PHIZER vaccines and their possible SIDE EFFECTS, others than those already known. I had MODERNA 1st doses on February 14 and my wife had the 1st dose of PFIZER 1ST of March 1. After the vaccination, we both, have experienced a SIGNIFICANT increase in our blood pressure, issue that I explain below.   My wife is 75 years old, weight 128 pounds and goes to the gym six(6) days a week. She has blood Pressure condition, but has been under control due to the medication she takes for few years. I monitor her blood pressure once a week and it have been ok.
Patient came to the pharmacy with a rash (roughly baseball sized) around the injection site of her Shingrix vaccine, she reported no other symptoms and only reported mild discomfort/itchiness. Given the delayed onset and degree of symptoms I directed her to purchase and take some Benadryl for the itchiness and irritability. I also informed her that if the rash worsens or new symptoms develop to contact a doctor immediately.
Very sore arm, moderate body aches, moderate fatigue, minor headache, and sharp pains in left abdominal when eating.
Chills; Bodyache; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), MYALGIA (Bodyache), HEADACHE (Headache) and NAUSEA (Nausea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), MYALGIA (Bodyache), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, CHILLS (Chills), MYALGIA (Bodyache), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. Concomitant drugs were  not reported. Treatment medication was not reported.
One day post vax, the pt experienced tiredness, dizziness, and nausea. A doctor visit was required. No treatment was given. All lab tests which were done were negative. The most recent information received reports the condition of the pt is recovered.