chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shoulder got swollen; Clear fluids started leaking out of the swelling area,Clear fluids leaked out from blisters; huge blister on shoulder; not feeling well; face (cheek on left side) and chest broke out with viral-looking blisters,rash-type thing; blisters were itching; top of my shoulder hurt in the muscle; fever; shoulder hurts; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (shoulder got swollen), DISCHARGE (Clear fluids started leaking out of the swelling area,Clear fluids leaked out from blisters), BLISTER (huge blister on shoulder), MALAISE (not feeling well) and RASH VESICULAR (face (cheek on left side) and chest broke out with viral-looking blisters,rash-type thing) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-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 experienced SWELLING (shoulder got swollen), DISCHARGE (Clear fluids started leaking out of the swelling area,Clear fluids leaked out from blisters), BLISTER (huge blister on shoulder), MALAISE (not feeling well), RASH VESICULAR (face (cheek on left side) and chest broke out with viral-looking blisters,rash-type thing), RASH PRURITIC (blisters were itching), MYALGIA (top of my shoulder hurt in the muscle), PYREXIA (fever) and ARTHRALGIA (shoulder hurts). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash vesicular, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Pyrexia, at an unspecified dose and frequency. At the time of the report, SWELLING (shoulder got swollen), DISCHARGE (Clear fluids started leaking out of the swelling area,Clear fluids leaked out from blisters), BLISTER (huge blister on shoulder), MALAISE (not feeling well), RASH VESICULAR (face (cheek on left side) and chest broke out with viral-looking blisters,rash-type thing), RASH PRURITIC (blisters were itching), MYALGIA (top of my shoulder hurt in the muscle), PYREXIA (fever) and ARTHRALGIA (shoulder hurts) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Reportedly, clear fluids leaked out of the viral looking blisters and they bled.
NOT ENOUGH PROTECTION (SUSPECTED VACCINATION FAILURE); This spontaneous report received from a physician via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included breast cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 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.   On an unspecified date, after five or six weeks of vaccine, it still looked like the old one from last time for the patient. According to her physician there was just not enough protection (suspected vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of not enough protection (suspected vaccination failure) was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210556690-COVID-19 VACCINE AD26.COV2.S- not enough protection (suspected vaccination failure). This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Hep B injection given 8:15am - called to Health Department at 10:15 with 90 heart racing, headache, blurred vision, face flushed - hot feeling. H.R. at time was 88 per another nurse that was with pt - Pt. was able to talk to me - denies Resp. problems - had eaten this am - I referred her to family MD - gave her his phone # to call today.
Immediately following injection, patient notes "clogged feeling" in right ear, along with blurry vision. Arrived to observation unit at 4:48pm. Blurry vision resolved. EOMI. No nystagmus. Hears snapping in ears bilaterally upon testing. 4:57, denies all symptoms. Lungs CTA bilaterally. Negative romberg.
Frozen shoulder  SIRVA Cannot move my arm Hurts to extend fingers Pain from forearm all the way up my neck to my ear and the whole back of my left shoulder I cannot move my arm outwards I cannot lift my arm above my head   A nursing student administered the vaccine. She administered it almost at the top of my shoulder
A serious report of Henoch-Schonlein purpura and intussusception, status post reduction was received from a study investigator concerning a four-year-old male, who is enrolled in a trial. The patient had a medical history that consisted of episodes of bright red blood in the stool which occurred on 18-Oct-2007; bilateral pedal edema and macular rash over the lower extremities and buttocks for which he was seen in the emergency room on 25-Nov-2007. Concomitant medications were not reported. The subject received FluMist intranasally on 10-Nov-2007 for influenza immunization. On 25-Nov-2007, the subject was seen in the emergency room for bilateral foot swelling/pain with a rash that spread from feet to groin. Physical examination confirmed bilateral pedal edema and macular rash over his lower extremities and buttocks. Laboratory evaluation which consisted of sedimentation rate, complete blood count (CBC) with differential, liver function enzymes, blood urea nitrogen (BUN), urine analysis were within normal values. Impression was that of hypersensitivity vasculitis. A diagnosis of Henoch-Schonlein purpura was made on 26-Nov-2007 when he was re-evaluated for his rash. From 01-Dec-2007 to 02-Dec-2007, he was hospitalized for abdominal pain and vomiting secondary to Henoch-Schonlein purpura. Ultrasound and gastrografin enema were negative for intussusception and other pathology. His laboratory results were normal except for his white blood cells (WBC) count of 13.7 and a 4+ ketones in his urine on admission. His discharge diagnoses were : Henoch-Schonlein purpura, and abdominal pain and dehydration. He was re-hospitalized from 08-Dec-2007 to 10-Dec-2007 because of blood in the stools, severe abdominal pain and bilious emesis. An air enema revealed intussusception in the upper part of the ascending colon which resolved during the procedure. Abnormal laboratory results include : WBC= 22.1; red blood cell (RBC) count = 6.01; hemoglobin = 14.9; hematocrit; platelet = 508; granulocyte = 851; lymphocyte; serum glucose = 140; serum creatinine = 0.11; serum sodium = 131; serum potassium = 5.6; serum albumin = 3.5; urinalysis showed protein = 30, 1+ blood. RBC = 3.9, ccasional mucous and amorphous crystals. He was observed for three days without complications except for one episode of painless bloody stool. His discharge diagnoses were Henoch-Schonlein purpura and intussusception, reduced. The subject was discharged home on prednisolone 15 mg twice daily for three days followed by a tapering regimen over six days, and lansoprazole 15 mg daily. The subject recovered from both events. The subject did not experience a rechallenge while receiving the study vaccine. The investigator assessed causality for the events as not related to FluMist.
Severe muscle aches, fatigue, cough, nausea, and  feeling generally unwell to the point of being bed bound.   Lasted 39-40 hours post-vaccine
Swollen lymph nodes on left side/breast identified in mammograms, ultrasound and MRI.  You need to warm women to delay mammograms until a month after second dose.   Anxiety, unnecessary tests and expense.
fever, chills, achy joints, left knee the worst on 2nd day. Third day right middle finger became swollen and achy. Bump at injection site and warm t otouch for 3 days.
Severely Archy throughout body, severely fatigued, nausea, vomiting,
Redness and induration to left deltoid post vaccine administration marked area as instructed by phone.
12/21/2021: 77-year-old female with a history of rheumatoid arthritis presents to our ED as a transfer.  Patient was found unresponsive today by family, taken to Hospital.  There she had a GCS of 6, was intubated for airway protection. She tested positive for COVID-19. Chest x-ray consistent with what could have possibly been a superimposed pneumonia
ACHES AND PAIN ALL OVER BODY; SORE ARM; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and alcohol user, and other pre-existing medical conditions included patient had no known allergies and had no drug abuse and illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. Batch Number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced aches and pain all over body. On 12-MAR-2021, the subject experienced sore arm. On 12-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, sore arm, and aches and pain all over body. The reporter causality between JNJ-78436735 and headache, sore arm, and aches and pain all over body was not related. Company causality between JNJ-78436735 and headache, sore arm, and aches and pain all over body was possible. This report was non-serious.
Hx given by mom relates rash starting on same day as injection. Continue to spread an swelling noted on ears and hands.
Livedo Reticularis (purple veins on legs/arms, rapid heartrate, shivering, teeth chattering, pain in legs & left chest); This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202)  via an unspecified route of administration in the arm left on 25Feb2021 at 15:00 (at the age of 36-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an  unspecified route of administration in the arm left on 18Mar2021 at 10:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. The patient medical history included multiple sclerosis. Concomitant medication included Gilenya 0.5mg (MANUFACTURER UNKNOWN), Lisinopril 10mg (MANUFACTURER UNKNOWN) and Amitriptyline 25mg (MANUFACTURER UNKNOWN) all for unknown indication. The patient had no allergies to medications, food or other products. The patient was not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since the  vaccination.  On 08 Mar2021, the patient experienced livedo reticularis (purple veins on legs/arms, rapid heartrate, shivering, teeth chattering, pain in legs & left chest). The patient  had no treatment for AEs. The clinical outcome of livedo reticularis was unknown. No follow-up attempts are needed. No further information is expected.
Reports redness to palms f both hands that went up each arm to chest. Also reports  headache and sensation of feeling very hot.
patient experienced pounding headache, severe body aches, nausea, chills, fever, burning on injection site   notable: patient has SEVERE rash all over front and back of her body - red, puffy, not itchy
Patient received AFLURIA and PNEUMOVAX at 12:30pm 9/21/13. It was roughly 2 minutes later she complained of dizziness, chest was heavy and throat was closing. Gave patient one dose of EPIPEN and her symptoms improved.
pt recv vax 5DEC96 & 16DEC96 pt devel a swollen lymph above testicle;f/u from a MD indicated that pt devel bilat inguinal lymphadenopathy, w/1 node measuring over 1cm;pt dx w/viral lymphadenopathy;
Lymph nodes inflation, under the right armpit.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on an unknown date in 2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 20Apr2021, the patient experienced lymph nodes inflation, under the right armpit. It was reported that it could be felt and seen from the outside. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event lymph nodes inflation, under the right armpit was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Information has been received from a nurse practitioner concerning a 20 year old female who on 07-MAR-2008 was vaccinated IM with the first dose of GARDASIL (659964/1978U). Per the reporter, the patient experienced extreme pain in her arm after receiving the first dose of GARDASIL. The pain was experienced in the same arm that the vaccine was administered and the patient noted that the pain made it difficult for her to move her arm. It was also noted that the patient nearly fainted at the office on the day of administration and that the patient had experienced vomiting in the evening of the date of administration. The patient sought unspecified medical attention in the physician's office. Subsequently, the patient recovered from her extreme pain, decreased mobility, near fainting and vomiting. No further information was provided. Additional information has been requested. Additional information received from B-form (03-JUN-2008). The nurse practitioner reports that the patient received the second dose of GARDASIL vaccine (lot # not reported) on 09-MAY-2008. No further information on patient's present status was provided. Additional information is not expected.
8x9 cm red warm indurated patch on (L) thigh - not painful - no treatment.
I have what look to be hives on my stomach. I received the shot on a Friday on the Sunday immediately following I started to see what I thought were bug bites on the left side of my stomach. Over the past few days a few more red itchy bumps show up and they are moving from left to right and bottom of my stomach to the top.
Achy, fever, redness and hot to touch. Swelling at site. Redness 13cm x 15cm.
Extreme arm aching, pain, and upper arm swelling - no relief with NSAIDS or heat or muscle rub. Unable to sleep or use arm normally.
3PM pt recv vax; 4PM mom noticed pt w/SOB & shivering; 420Pm pt brought to clinic w/sx of bronchial spasms of lungs, high pitch cry, SOB, irritability; inability to swallow, generalize cyanosis & t101; pt examined per MD; 420PM 02 started
Swollen sub maxillary glands, left arm pain, headache and chest pains with increased dizziness episodes started the day of the two concurrent immunizations (TDAP L arm and Zoster R arm) but, by the AM of 09/18/2017 I couldn't move my neck, difficult per the chest pain to take a deep breath. Left arm pain was severe. Headache and dry throat with swollen sub mandibular glands was worse.
This is a spontaneous report form a contactable physician. A female patient of an unknown age and race received PREVNAR 13 single dose for immunization in the arm, on 05Jul2017. Medical history and concomitant medication were not reported. On 09Jul2017 the patient experienced arm redness, swelling and itching and chills. The outcome of the events was unknown.
Second shot my arm barely hurt at all compared to the the first one; She was fine with the first dose, felt a little yucky; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "chronic leukopenia" (unspecified if ongoing); "COVID-19", start date: Dec2020 (unspecified if ongoing), notes: sick with Covid for 4 months, has "long haulers symptoms"; "chemotherapy" (unspecified if ongoing), notes: 33 months of chemo. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Second shot my arm barely hurt at all compared to the the first one"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "She was fine with the first dose, felt a little yucky".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Generalized as well as local muscle aches, fever (100.4), vomiting, headache, lethargy. Lasted two days.
Client states arm started bothering her on 6/2/06 with redness, swelling, itching, and warmth at injection site. States redness a little better today, but arm still feels hot. To see her MD.
pt recv vax & devel unspecified sx following vax w/Hep B vax; MD reported 3 pts; The pts were assigned WAES94030368 through 94030370; No further details were provided;
Pt. doesn't have lot # for Dose 2. On 04/23/2021 and 04/24/2021 at 10:00 am I felt like I had the flu. 4/25/2021 The next morning super bad chest pain and also sharp pain when I took a breath. Mostly in center chest area.
Cold; Congestion; Bad Cough; Body Aches; Headache; Joint Pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), NASAL CONGESTION (Congestion), COUGH (Bad Cough), PAIN (Body Aches) and HEADACHE (Headache) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced NASOPHARYNGITIS (Cold), NASAL CONGESTION (Congestion), COUGH (Bad Cough), PAIN (Body Aches), HEADACHE (Headache), ARTHRALGIA (Joint Pain) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CHLORPHENAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (ROBITUSSIN TOTAL COUGH, COLD & FLU EXTR.STR.N) at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (Cold), NASAL CONGESTION (Congestion), COUGH (Bad Cough), PAIN (Body Aches), HEADACHE (Headache), ARTHRALGIA (Joint Pain) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This is a non-serious spontaneous case from a physician in the USA who reports a patient experienced sore throat after receiving FluMist. The reporter causality was not provided.  This is a 14 year old female who experienced fever, sore throat and severely swollen lymph nodes after receiving FluMist vaccine on 12/11/04. On 12/25/04, the patient was taken to her family physician at an urgent care center and was diagnosed with mononucleosis. The patient has not yet recovered.
Received yellow fever vaccine on back right arm, subq, on 3/17/2014.  On Tuesday and Wednesday (3/18 and 3/19) developed a red rectangle, shaped area on R upper arm (back).  Area was approximately 4" x 3".  Went to pharmacy on 3/19, was directed to ice area which patient did. The ice improved the situation.  Much smaller area by 3/21 but called Health Department to report it.
Information has been received from a healthcare worker referring to a child patient of unknown age and gender. The patient's medical history was not reported. On 04-MAY-2015 the patient was received improperly stored VARIVAX (Merck) (lot # K026385, expiration date 15-DEC-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
she was not feeling well/she just has not felt good, just have felt blah; just can't taste anything; pain in her arm; Injection site did have a little pain; Tiredness; Muscle pain; This is a spontaneous report from a contactable consumer (patient herself). An 83-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9262), via an unspecified route of administration, on 28Jan2021, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) on 08Jan2021 for covid-19 immunization and experienced couldn't taste anything. The patient called about the vaccine as she was having some effects. She stated she got the first shot on 08Jan2021 and, last 28Jan2021 she got the second shot. She informed she was given a "paper" to tell her of the effects that one might possibly have when getting the shot, and then she checked all of those. On 30Jan2021, 2 days after the shot, she was not feeling well. She stated her injection site did have a little pain on Jan2021, but it was okay, it went away the next day. She also had on Jan2021 some tiredness and muscle pain which was on there; other than that, she just has not felt good, just have felt blah. She informed that her lymph nodes were not swollen, and she has not been nauseated or have had any of these things written on the paper. She also informed having read on the paper that "the people with Covid-19 and it gave the symptoms of people with COVID 19 and one of them was loss of taste, and smell was okay". She then added that after she got her first shot, she noticed once in a while she couldn't taste anything but that wasn't all the time. But now, since she got the second shot, it seemed like all day yesterday, 30Jan2021, and this morning also, that she just can't taste anything. Then she stated "So, my problem is, would that be a result of the shot?" She stated she was feeling a little bit better today other than that, her mouth - she can't taste anything. Also, yesterday, she took an extra strength Tylenol every 4 hours to try to help with the pain in her arm on Jan2021; but she has not taken any today. She was just trying to help her arm feel better. The outcome of the event injection site did have a little pain was recovered on Jan2021. The outcome of the event she was not feeling well/she just has not felt good, just have felt blah was recovering. The outcome of the event just can't taste anything was not recovered. While the outcome of all other remaining events was unknown.