chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen Arm; "hyper" since the injection; Felt great, felt amazing, best she has ever felt, slept wellest she has ever felt; had "extra energy"; red arm; Haven't had a hot flash since my second shot; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen Arm), PSYCHOMOTOR HYPERACTIVITY ("hyper" since the injection), EUPHORIC MOOD (Felt great, felt amazing, best she has ever felt, slept wellest she has ever felt), had "extra energy" and ERYTHEMA (red arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Menopause. Concomitant products included RHEUM RHAPONTICUM ROOT (ESTROVERA) for Menopause, BIOTIN for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swollen Arm), PSYCHOMOTOR HYPERACTIVITY ("hyper" since the injection), EUPHORIC MOOD (Felt great, felt amazing, best she has ever felt, slept wellest she has ever felt), had "extra energy", ERYTHEMA (red arm) and THERAPEUTIC RESPONSE UNEXPECTED (Haven't had a hot flash since my second shot). At the time of the report, PERIPHERAL SWELLING (Swollen Arm), PSYCHOMOTOR HYPERACTIVITY ("hyper" since the injection), EUPHORIC MOOD (Felt great, felt amazing, best she has ever felt, slept wellest she has ever felt), had "extra energy", ERYTHEMA (red arm) and THERAPEUTIC RESPONSE UNEXPECTED (Haven't had a hot flash since my second shot) outcome was unknown.            At the time of reporting, the pause in hot flashes continued, and the patient's energy was still above their baseline normal.   Treatment medications were not provided by the reporter.   This case was linked to MOD-2021-09   This case was linked to MOD-2021-090463 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: No new significant information
LOST CONTROL OF THEIR BOWELS; METALLIC TASTE; VERTIGO; LOST THEIR APPETITE; FATIGUE; SEVERE MIGRAINE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: autoimmune disease, and other pre-existing medical conditions included: The patient had inner inner ear disease, osteoporosis, vitamin b complex deficiency, unspecified allergy and anxiety. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1802072, and  expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. On unspecified date the patient experienced severe migraine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. outcome of severe migraine was not reported. Non-company suspect vaccine included: mrna 1273 (dose number in series 2) ( batch number: 034F21A expiry: UNKNOWN, form of admin, route of admin, and were not reported) dose was not reported, administered on 08-NOV-2021 for prophylactic vaccination.  Concomitant medications included pregabalin for chronic migraine, citalopram for drug used for anxiety, ergocalciferol for drug used for unknown indication, vitamin b nos for for a deficiency, calcium/colecalciferol for osteoporosis, and cetirizine hydrochloride for year round allergies.  On 08-NOV-2021, the patient experienced severe migraine, metallic taste, vertigo, lost their appetite and fatigue.  On 09-NOV-2021, the patient experienced lost control of their bowels. The action taken with mrna 1273, was not applicable The patient recovered from metallic taste and lost control of their bowels on 09-NOV-2021 and severe migraine, vertigo, lost their appetite, and fatigue on 10-NOV-2021. This report was non-serious.
Heat and swelling in joints. Knees, hands, feet most prevalent. Both right and left sides.
Skin plaque; Pain in arm; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of SKIN PLAQUE (Skin plaque), PAIN IN EXTREMITY (Pain in arm) and ARTHRALGIA (Joint pain) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced SKIN PLAQUE (Skin plaque), PAIN IN EXTREMITY (Pain in arm) and ARTHRALGIA (Joint pain). At the time of the report, SKIN PLAQUE (Skin plaque) had not resolved, PAIN IN EXTREMITY (Pain in arm) had resolved and ARTHRALGIA (Joint pain) outcome was unknown.            No concomitant medication was reported.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The patient received Moderna as Booster dose.  The reporter's causality for the events of plaque build up on hands and legs, pinching in arm painful to turn rotator cuff and synovial pain with Humira (adalimumab) was no reasonable possibility and with Pfizer Biontech Covid-19 Vaccine (Tozinameran) was reasonable possibility.  No treatment medication was reported.
Approximately 3 inch area redness, pain, comma, swelling at site of vaccination. Right Deltoid.
While administering 2nd vaccine (IMOVAX) pt: stated her eyes were "going black", turned a pale color, and proceeded to pass out in the chair. We elevated her feet and moved her to a reclined position. Pt. came to within 1 minute, Pt appeared to have seizure-like movements for a few seconds before passing out. Pt rested for 15-20 minutes and felt well enough to leave with mom. Pt only received only 1/4 vaccine b4 passing out. I removed needle as patient passed out.
Information has been received from a 73 year old female consumer with asthma (diagnosed in 1971), gout (for the past four years since approximately 2003) and a history of shingles who on 22-NOV-2006 was vaccinated with a dose of Varivax. It was reported that the patient's initial bout with shingles "two years ago" was "very painful and unnerving for her." The patient had a few less painful rounds with it since that initial one, with small blisters on her hip and thigh. In October 2006 the patient "had another bad case" and was treated with acyclovir. The patient reported that she was back in the office on 22-NOV-2006 for a follow up and prescription refill. The nurse practitioner reportedly told the patient about this new wonder drug that would wipe out her shingles. The patient stated that the nurse practitioner "convinced her" by assuring her that she had both of her parents inoculated against shingles the week before. The patient allowed the nurse practitioner to give her the shot that day. The following morning, on 23-NOV-2006, the patient woke with what she thought was the flu, so sick that she wanted to die. In the next few days she really thought that she was "was going to die." The patient reported that she has had shingles since that day and that they settled on her spine next to her tailbone and that she had blisters under the skin that constantly itch. The patient developed small, scaly, itchy patches on her legs and arms that "will not go away.". The patient was using triamcinolone Acetonide USP 0.1% ointment which would dry them partially but they would return the next day. At the time of reporting the patient was on Sulfam + Tri Tab O.Bs, and prednisone 10 mg daily from what her physician diagnosed s viral pneumonia caused by the shingles. The patient reported that she was bedridden for 10 days (considered disabling). The patient states that she "cannot take this any longer" and that her doctor tells her that her nerve endings are damaged along her spine. Her doctor has prescribed her Cymbalta but she states that she is "afraid to take any more meds from this doctor." She is "afraid of the side effects." The patient states that the vaccine "nearly killed me, and I'm not sure it won't before I'm cured of it - or rather IF I'm ever cured." Additional information has been requested.
At about 1:30 PM the next day, I began to have strong chills and had a fever that broke at 2:00 AM, with headache, joint pain (hips, elbows). On day 2, still had fever, headache, pains, feeling unwell, pain and swelling at injection site. Day 3 had abdominal pain and nausea/vomiting/low grade fever. Day 4 visited my Doctor, with a 99 temp, pain in abdomen/nausea. Day 5 slightly better, still 99 temp and abdominal pain.  Please note that I am a fairly healthy person who missed two days of work, and still on day 6 do not feel totally well.
NEUROPATHY PAIN; PINS NEEDLES IN LEFT HAND; LARGE LUMP IN LEFT ARM/ PAIN IN LEFT ARM/ LUMP THAT WAS 9" NOW DOWN TO 3 (EXTENDING FROM SITE OF INJECTION TOWARD ELBOW, NOT SWELLING BUT AN INTERNAL LUMP); DROPPING THINGS/ AFFECTING ABILITY TO WORK; HAND IS COLD; This spontaneous report received from a patient via a company representative concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included brachial plexus break on right side of body, lyme disease, and brain injury, and concurrent conditions included downgraded brain tumor to brain cyst, neurontin and opiod allergy, and severe reaction to tramadol.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: 25/MAY/2021) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination at left arm. Concomitant medications included naproxen for drug used for unknown indication. On 13-MAR-2021, the subject experienced neuropathy pain. On 13-MAR-2021, the subject experienced pins needles in left hand. On 13-MAR-2021, the subject experienced large lump in left arm/ pain in left arm/ lump that was 9" now down to 3 (extending from site of injection toward elbow, not swelling but an internal lump). On 13-MAR-2021, the subject experienced dropping things/ affecting ability to work. On 13-MAR-2021, the subject experienced hand is cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from large lump in left arm/ pain in left arm/ lump that was 9" now down to 3 (extending from site of injection toward elbow, not swelling but an internal lump), and had not recovered from neuropathy pain, dropping things/ affecting ability to work, hand is cold, and pins needles in left hand. This report was non-serious.  Additional information received from patient on 31-march-2021 The following information was updated and incorporated :The reporter details were added, patients sex, race and ethnic origin was added, past and concomitant conditions were added. the events neuropathy, pain, dropping things, lump in the arm, hand is cold were subsumed under already presented events, Concomitant medication: naproxen was added, labelling and causality was added, seriousness criteria was updated from non-serious to serious and outcome, also updated from recovering/resolving to not recovered/not resolved, Vaccine facility address and city were added.; Sender's Comments: V1:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Chest pressure, muscle aches, chills, fever, headache and joint aches were initial symptoms About 12 hours later, restless legs took Benadryl 25mg X1 po result: sedation, restless legs relieved.  Initial symptoms resolved
The same night if second injection I started to feel dizzy and tired. General malaise also started to set in before bed. At with teaching the next day I felt sore, exhausted and nauseated but finished my work day at five. By the time I was hone, I was so exhausted and sick with flu like symptoms that ignored my children for two days and slept in bed in a very deep sleep. This was scary for the whole family.
injection given approx 2:25pm-at 3:15, pt went into resp distress, O2 sat 71, swelling to face and throat, SOB, eyes rolled back, pale, diaphoretic with blue lips 10/25/07-records received for DOS-10/20/07-DC DX: Anaphylaxis. Quadraplegia. UTI. Presented to ER with C/O shortness of breath. Developed immediate anaphylatic reaction after receipt of flu shot. Became cyanotic and hypotensive. Observed in ICU overnight.
Patient received immunization and approximately 7 or 8 minutes later, patient starting feeling light headed. Patient reported that he was having a hard time hearing for a few moments. Patients father requested we called an ambulance. Patient was checked by EMT. Patient was not taken to hospital. EMT told patient they did not believe the adverse reaction was due to the covid-19 immunization itself but rather from the patient becoming tense after he received the shot. Patient reported that a similar reaction occurred with other shots he had received in the past.  After being checked by EMT patient returned to pharmacy to report that he was feeling fine about 20 minutes after this event started.
Admission for Adenoviral bronchitis. empiric ceftriaxone/doxycycline started, By the following day he was feeling much better and is requesting discharge. He will discharge on cefpodoxime to complete a 7 days empiric course for pneumonia. ED visit and hospital admission were within 6 weeks of receiving the COVID vaccine.
Patient had HEP A, TDAP & TYPHOID vaccines on 8/25/08.  She reports minimal soreness only on 8/26 & 8/27 then pain went away.  Patient reports falling asleep in a recliner in the am of 8/30/08 and waking up with right arm swollen and warm to the touch in right deltoid area with whole arm feeling numb.  States she was sleeping on right arm.
received Adjuvant of Shingrix only(without the Lyophilized Antigen Component); received Adjuvant of Shingrix only(without the Lyophilized Antigen Component); This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number B7FL2, expiry date 17th April 2023) for prophylaxis.   On 11th February 2022, the patient received Shingrix. On 11th February 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received adjuvant of Shingrix only without the lyophilized antigen component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter. The reporter mentioned that did not care being contacting by safety.
This spontaneous report was received from a physician via company representative referring to a patient of unknown age and gender. The patient's medical history, drugs reactions or allergies, concurrent conditions and concomitant therapies were not reported. On 13-FEB-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB. "10 PK 0.5 mcg/0.5ml SDLLolCap Ped" and lot number L023387 with expiration date of 22-JUN-2017 (route and anatomical location of administration were not reported). The vaccine had two temperature excursions one of 16 hours with a lowest recorded temperature of 49 Fahrenheit (F) (9.444444444 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reports as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
FEELS LIKE EYES ARE BULGING; EYE PAIN FROM THE HEADACHE; WAS DRIFTING OFF; CALF PAIN/CALVES ARE ACHING A BIT BUT THAT MIGHT BE FROM LOW ENERGY; A FEW EPISODES DIARRHEA; FATIGUE/FEELING PRETTY DRAINED; LOW ENERGY/DOES NOT HAVE ENOUGH ENERGY TO GET OUT OF BED; HEADACHE; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, no alcohol, and non smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: UNKNOWN) dose was not reported, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-AUG-2021, the subject experienced feels like eyes are bulging. On 03-AUG-2021, the subject experienced eye pain from the headache. On 03-AUG-2021, the subject experienced was drifting off. On 03-AUG-2021, the subject experienced calf pain/calves are aching a bit but that might be from low energy. On 03-AUG-2021, the subject experienced a few episodes diarrhea. On 03-AUG-2021, the subject experienced headache. On 03-AUG-2021, the subject experienced fatigue/feeling pretty drained. On 03-AUG-2021, the subject experienced low energy/does not have enough energy to get out of bed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue/feeling pretty drained, had not recovered from a few episodes diarrhea, headache, low energy/does not have enough energy to get out of bed, eye pain from the headache, calf pain/calves are aching a bit but that might be from low energy, and feels like eyes are bulging, and the outcome of was drifting off was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
Numbness and tingling throughout the body; Had an uneasy night and fidgeting too much; Nausea on and off; Fever; Joint and muscle pain; Joint and muscle pain; Fatigue; Experiencing parasthesias; Vertigo; Elevated heart rate; Numbness and tingling throughout the body; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), HEART RATE INCREASED (Elevated heart rate), HYPOAESTHESIA (Numbness and tingling throughout the body), PARAESTHESIA (Numbness and tingling throughout the body) and PARAESTHESIA (Experiencing parasthesias) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included NAPROXEN for an unknown indication.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced VERTIGO (Vertigo), HEART RATE INCREASED (Elevated heart rate), HYPOAESTHESIA (Numbness and tingling throughout the body), PARAESTHESIA (Experiencing parasthesias), NAUSEA (Nausea on and off), PYREXIA (Fever), ARTHRALGIA (Joint and muscle pain), MYALGIA (Joint and muscle pain) and FATIGUE (Fatigue). On an unknown date, the patient experienced PARAESTHESIA (Numbness and tingling throughout the body) and RESTLESSNESS (Had an uneasy night and fidgeting too much). At the time of the report, VERTIGO (Vertigo), HEART RATE INCREASED (Elevated heart rate), HYPOAESTHESIA (Numbness and tingling throughout the body), PARAESTHESIA (Numbness and tingling throughout the body), PARAESTHESIA (Experiencing parasthesias), RESTLESSNESS (Had an uneasy night and fidgeting too much), NAUSEA (Nausea on and off), PYREXIA (Fever), ARTHRALGIA (Joint and muscle pain), MYALGIA (Joint and muscle pain) and FATIGUE (Fatigue) outcome was unknown.            Concomitant medication Naproxen (as needed), Hormones. Treatment information was not provided.
Pt experienced a fever and a rash on 2/16/00.  On 2/18/00 temperature was 105.3 at a clinic.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 18-JUL-2016 the patient received an improperly stored dose of PROQUAD (lot # L040412, expiry date: 13-APR-2017). No adverse effect reported. the outcome was unknown. No product quality complaint was involved. This is one of several report received from the same reporter. Additional information has been requested.
21APR94 the noc pt had shot had 2 epidoses of swallowing air loudly-seemed to have trouble breathing; no fever or color change; had 1 more epidose @ babysitters on 22APR94; fever 22APR94; cough & hoarsened; seen in ER: dx pneumonia;
13 minutes after receiving her vaccination, she reported feeling itchy nose in her throat as well as left swelling. She was taken to a private section of the arena monitored. She was given one tablet of fexofenadine 60 mg times one.
He felt odd on 6/22/23. Patient had a seizure on 06/22/2023.  Seen and evaluated in ER. No prior seizure history, nor family history or any other new or inciting events.  Saw me today.  Will refer to neurology.
About 24 hours after shot symptoms were; headache, fatigue, body aches, slight cough
I received my vaccine on 05/01/2021, my menstrual cycle was supposed to start on 05/02/2021. It did not arrive, so I took a pregnancy that came back negative. I called my doctor, and we discussed what could have caused this issue. We both agreed that it was stress. It did not arrive in June, I went to the doctor and had a hormone test to check my hormone levels, the test came back normal. My menstrual cycle did show back up in July, but it has not been regular since. There are cycles that are heavy, there are cycles that are light, I miss monthly cycles all together.
Woke up crying with fever and complaining of intense headache. He had a hard time moving because movement was painful. On 03/17/2016 his fever ranged from 101-104 degrees. The majority of the day it hovered around 102 with it reaching its peak the evening of 03/17/2016. He was unable to eat any food without vomiting until dinner last night. His continued symptoms were him being lethargic, having a fever, and his movement being painful. He still has a low fever today and has spent his day on the couch with a runny nose and complaining of a head ache.