chrisvoncsefalvay/vaers-outcomes huggingface dataset:
when fever broke, I was in a pool of water in bed; developed tenderness and sores in mouth; feels like I have COVID again; both arms were bad; achiness; chills; felt the injection; injection site became red; high fever; very tired; warm to touch; miserable; no appetite; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE WARMTH (warm to touch), FEELING ABNORMAL (miserable), DECREASED APPETITE (no appetite), HYPERHIDROSIS (when fever broke, I was in a pool of water in bed) and ORAL PAIN (developed tenderness and sores in mouth) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN, HYDROCHLOROTHIAZIDE, ASCORBIC ACID (VIT C), ZINC, COLECALCIFEROL (VITAMIN D3) and LOTEPREDNOL ETABONATE (LOTEMAX) for an unknown indication.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch), FEELING ABNORMAL (miserable), ORAL PAIN (developed tenderness and sores in mouth), PAIN IN EXTREMITY (both arms were bad), VACCINATION SITE PAIN (felt the injection), VACCINATION SITE ERYTHEMA (injection site became red) and FATIGUE (very tired). 13-May-2021, the patient experienced DECREASED APPETITE (no appetite), PAIN (achiness), CHILLS (chills) and PYREXIA (high fever). 13-May-2021, the patient experienced COVID-19 (feels like I have COVID again). On 14-May-2021, the patient experienced HYPERHIDROSIS (when fever broke, I was in a pool of water in bed). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 14-May-2021, PYREXIA (high fever) had resolved. At the time of the report, VACCINATION SITE WARMTH (warm to touch), FEELING ABNORMAL (miserable), DECREASED APPETITE (no appetite), HYPERHIDROSIS (when fever broke, I was in a pool of water in bed), ORAL PAIN (developed tenderness and sores in mouth), COVID-19 (feels like I have COVID again), PAIN IN EXTREMITY (both arms were bad), PAIN (achiness), VACCINATION SITE PAIN (felt the injection), VACCINATION SITE ERYTHEMA (injection site became red) and FATIGUE (very tired) outcome was unknown and CHILLS (chills) had resolved.            This case was linked to MOD-2021-142492 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow-up received contains no new information.
This spontaneous report as received from a pharmacist refers to a 59 year old female patient with no pertinent medical history or known drug reactions or allergies. On 24-OCT-2015, the patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX injection (lot# L021610; expiry date 10-SEP-2016). Concomitant therapies included lisinopril (manufacturer unknown). On 25-OCT-2015, the patient experienced soreness, redness, warmth, pain, and a lump at the injection site. It was reported that the lump was initially "the size of a 50 cent piece" on 25-OCT-2015, and the size increased to "approximately the size of three to four 50 cent pieces" on 26-OCT-2015. The patient sought medical attention- she saw a pharmacist and the events were treated with BENADRYL. No diagnostic lab studies were performed. The outcome of the events was not reported. The relatedness between ZOSTAVAX and the events was not provided. Additional information has been requested.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment details were provided.    Reporter did not allow further contact
PATIENT ABOUT 24 HOURS AFTER INJECTION DEVELOPED A FEVER (102-104 DEGREES F). THIS PERSISTED FOR ABOUT 1 DAY. THEN HE ALSO DEVELOPED A RASH ON HIS LEFT ARM AROUND THE SITE OF INJECTION AND SURROUNDING AREAS. OTC PAIN/ALLERGY MEDICATIONS RECOMMENDED. PATIENT WAS TOLD IF RASH DOES NOT BEGIN TO RESOLVE, IF IT WORSENS, OR OTHER SYMPTOMS DEVELOP TO SEEK MEDICAL ATTENTION.
Had a large red, raised, warm skin reaction at injection starting day after vaccine was administered. 3 days after administration blisters formed on back of each thigh.
COUGH; CHILLS; INJECTION SITE PAIN; FATIGUE; GENERAL BODY ACHES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-APR-2021, the subject experienced general body aches. On an unspecified date, the subject experienced cough, chills, injection site pain, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site pain, general body aches, fatigue, chills and cough was not reported. This report was non-serious.
pt recv vax & later that day pt devel a cough productive for dark sputum, dry throat, nasal congestion &  a feverish feeling (actual temp unk);self-tx w/a multivitamin & was feeling better @ the date of this report;
Reported lightheadedness, brought via wheelchair to medical screening for evaluation by medics. Pale, diaphoretic. Initial : Pulse: 40     B.P. 70/35 Repeat: Pulse: 60     B.P. 104/66 Left in stable condition at 16:35 p.m. Recorded by medical proffesional
Mild dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Mild dizziness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced DIZZINESS (Mild dizziness). At the time of the report, DIZZINESS (Mild dizziness) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
Another employee that he works with got fully vaccinated in January, and then got covid a few months later.; Another employee that he works with got fully vaccinated in January, and then got covid a few months later; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE, and dose 2 via an unspecified route of administration, administered in Arm Left on Jan2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that another employee that he works with got fully vaccinated in January, and then got Covid a few months later on an unspecified date. The outcome of the event was unknown.   Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021614562 same drug, different patient/event
chills, fever, nausea, anorexia, head ache, joint aches, swelling and redness at injection site 2 inches by 2 inches
Syncopal event  without associated trauma, no seizure.   No associated fever, vomiting, changes in vision, balance or coordination. Neurologically back to baseline 1-2 minutes after the event.  Normal on examination 4 hours after the event.   Significant history of anxiety, current medication list including clonidine and Lexapro.
About 9 hours post vaccine, started to get extreme fat. 12 hours post vaccine, started getting chills and body aches. About 15 hours post vaccine, woke up with worsening body aches, headache, chills, nausea and a fever of 101.4. Took 600mg Ibuprofen at this time. 22 hours post vaccine, still having body aches, headache, nausea and temp 100.2. Took another 600mg Ibuprofen. 23 hours post vaccine, I feel exactly how I felt when I was infected with Covid-19 a few weeks ago. Temp 100.5.
Right arm hurt at Vax site and surrounding upper arm gradually worsening. By 48hrs, arm was tingling, intermittent numbness distally. Intermittently, pain would shoot down the arm to the wrist or up over the shoulder. This was intermittent with the arm feeling tired. At one week, phoned Health Center because it was not improving. Since 10/10/21,  upper right arm pain. Intermittently the forearm has pain. On going, at present.
Three hours after getting TDAP, Varicella, MENACTRA & HPV patient began having jerking of right arm. Went to ER & had CT & labs all normal. Was seen in my office 2 days later.
patient called pharmacy  on 11-3-22 claiming her arm has been sore since she got her flu shot on 11-20-22. she said it was sore for 2 days and then the pain came back a week later and is still there
The day following the second Moderna imz, pt went to ER due to high fever, weakness and exacerbation of COPD with wheezing and difficulty breathing
Headache Pericarditis Narrative:  Diagnosed as idiopathic pericarditis.
Swollen glands  Friday night had blister rash on rib cage with pain and burning. Monday went to clinic, diagnosed with Shingles. Reflex sympathetic dystrophy is considered an autoimmune disorder.
breakout spread more and keeps breaking out on her body; rash break out in different parts of her whole body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (rash break out in different parts of her whole body) and RASH (breakout spread more and keeps breaking out on her body) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced RASH (rash break out in different parts of her whole body). On an unknown date, the patient experienced RASH (breakout spread more and keeps breaking out on her body). At the time of the report, RASH (rash break out in different parts of her whole body) and RASH (breakout spread more and keeps breaking out on her body) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Products known to have been used by the patient, within two weeks prior to the event were probiotics which was stopped upon occurence of adverse events.  No laboratory investigations were provided. The Treatment information included Antihistamine (loratadine) 10 mg twice daily
chills; got a cold on the top of her mouth; sweating in between her thighs; she had a rapid heart rate of 99 beats per minute for almost whole night; spend a night miserable; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for a female patient (coworker). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE DOSE for covid-19 immunisation. Medical history included injury, Caller also mentioned having friend of the friend who used to be her coworker (female, age 60 -65 caller not sure) that many years ago she had a car crash injury, food allergy (Stated that her coworker had a food allergies as well, that a food has to be natural without additives (caller thought that it was because her coworker overused Ibuprofen (caused her to be allergic to all sorts of stuff) in the past)). The patient's concomitant medications were not reported. On an unknown date, the patient (coworker) got a Covid shot she got chills, caller stated "she (coworker) got a cold on the top of her mouth" and sweating in between her thighs and she had a rapid heart rate of 99 beats per minute for almost whole night. Caller stated that coworker is allergic to a lot of foods now because she overused the Ibuprofen (took too much of it) in the past. Caller stated that her coworker could not take Ibuprofen to take down any fever she had, stated that she (coworker spend a night miserable and this is why she decided to call us and ask because she is on Tikosyn and knows that it regulates her heart. Stated that her coworker had a food allergies as well, that a food has to be natural without additives (caller thought that it was because her coworker overused Ibuprofen in the past) caller stated that PA told her (the caller) that what caused a rapid pulse is a fever. Caller stated that she heard that before you get a shot you have to sign a disclaimer because it is an experimental drug. The patient underwent lab tests and procedures which included heart rate: had a rapid heart rate of 99 beats per minute on an unknown date, she had a rapid heart rate of 99 beats per minute for almost whole night. The Outcome of all the events was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
PT presents with fever/chills and fatigue x 1900 reports received JJ vaccine 0945 yesterday. Patient is a 25 year old male who presents to ED with fever, weakness, nausea and body aches 12 hours after receiving the J&J vaccine. He has not taken any OTC medications. He is able to drink however. He denies any vomiting, no rash, no productive cough.
Vaccine error; A second dose of Janssen vaccine was received by the patient failure to check prior immunization record: Pt consented having receiving no prior COVID-19 vaccines before.
I was given my first moderna vaccination on April 26,2021 . on April 28 my hands were shaking making it very difficult to eat . I had difficulty walking . I became very weak . My hands stopped shaking in about one week . I am still very weak . I still use a cane or walker . I did my receive a second moderna vaccination . The second vaccination made no difference .
Reports that he has had a cough with some production.  Also notes some chest congestion.  His initial symptom was sore throat, that persists.  He has not felt short of breath
Patient was seen in clinic for 2nd dose of COVID vaccine. Had experienced lightheadedness and nausea with 1st dose. May have been secondary to vasovagal response. No signs of allergic or anaphylactic reactions. Today after admin of 2nd COVID dose while in observation area the patient began to again experience lightheadedness/nausea with some wrenching, no emesis, diaphoresis and weakness. Patient was taken back to nurses area for further evaluation. Vital signs were normal, no signs of allergic/anaphylactic reaction. Placed into an area to rest in supine position. Given water and cold compress. Serial vitals were taken all within normal limits. Patient felt better after 20 minutes. Escorted by wheel chair, accompanied by family home.
3 oral angioedema attacks since approximately Nov. 2021, the 2nd and 3rd treated in ER and admitted to hospital.
Information has been received from a registered nurse concerning a currently 23 year old female who on an unspecified date was vaccinated with a dose of MMR II (lot# not reported). Concomitant therapy included DTaP (unspecified). It was reported that patient had febrile seizures after receiving MMR II and DTaP (unspecified) as a child. At the time of this report, the patient had recovered. Upon internal review, febrile seizure was considered to be an important medical event. No further information is available.
Information has been received from a physician via a company representative referring to a female patient (reported as "the patient's wife") of unknown age. Concurrent conditions and medical history of the patient were not reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose and route unspecified). Two days after receiving ZOSTAVAX, the patient experienced retinopathy in an unspecified eye. The outcome of the event was unknown. Additional information has been requested.
Period supposed to start on May 03, but it is 2 weeks late starting today on May 16.
redness and itching around the injection site; additional redness and swelling.; hand pain; redness and itching around the injection site; little rash and itching at the injection site.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (hand pain), VACCINATION SITE PRURITUS (redness and itching around the injection site), VACCINATION SITE ERYTHEMA (redness and itching around the injection site), VACCINATION SITE RASH (little rash and itching at the injection site.) and VACCINATION SITE SWELLING (additional redness and swelling.) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (redness and itching around the injection site) and VACCINATION SITE RASH (little rash and itching at the injection site.). On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (hand pain). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (redness and itching around the injection site) and VACCINATION SITE SWELLING (additional redness and swelling.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at a dose of 1 dosage form and IBUPROFEN for Pain relief, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (hand pain), VACCINATION SITE PRURITUS (redness and itching around the injection site), VACCINATION SITE ERYTHEMA (redness and itching around the injection site), VACCINATION SITE RASH (little rash and itching at the injection site.) and VACCINATION SITE SWELLING (additional redness and swelling.) 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 medications were reported.
Swelling in left ear, red eyes with discharge, hearing loss during  early morning of 4/1/2021. Went to primary care physician on morning of 4/2/2021 and was diagnosed with allergies - prescribed flonase.  Serious dizziness, couldn't walk, vomiting on afternoon of 4/2/2021. Taken to ER and admitted to hospital. Cat scan normal. Diagnosed with Labyrinthitis. Referred to ENT.  Saw ENT at 2pm on 4/7/2021. She prescribed anti-viral and steroid for hearing loss. Had 2nd dose of Moderna vaccine after Dr appointment.  After no improvement in hearing sought further help from Dr
Information has been received from a pharmacy technician concerning a patient who was vaccinated with a dose of MUMPSVAX instead of MMR II. No other information was reported. A product quality complaint was not reported. Further information is not expected.
Information has been received on 09-FEB-2017 from a nurse regarding an unknown number of unspecified patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant medications were not provided. On unspecified dates, an unknown number of unspecified patients received doses of RECOMBIVAX HB lot # M020926, expiration 11-AUG-2018, "single dose", intramuscular for prophylaxis that had been improperly stored. The vaccine doses were stored at 35F for 8 hours and there was no previous temperature excursion. No adverse effects reported. No further information was reported. Additional information is not expected because the reporter refused consent to follow up.
Rash/redness around injection site, swollen lymph nodes, fatigue.   Going to urgent care on advice of vaccination staff
wrung out; nauseous; strange headache; I noticed my leg felt strange. When I touched it I found my left thigh felt numb; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9267), via an unspecified route of administration, on 12Feb2021, 13:15PM (age at vaccination: 62), in left arm as dose 2, single for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history reported as high cholestrol, acid reflux, & high blood pressure. Patient reported other medicines in two weeks includes Other medications in two weeks: Omeprazole, Atorvastatin, Lisinopril, Calcium and other vaccine in four weeks reported as no. Patient known allergies reported as unknown. Historical vaccination included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982), via an unspecified route of administration, on 12Jan2021, 10:30 AM (age at vaccination: 62), in left arm as dose 1, single for COVID-19 immunization. Patient reported that COVID prior vaccine and post vaccination was no. On 12Feb2021, 14:30PM patient had strange headache, about 4 hours patient noticed that leg felt strange When touched it found my left thigh felt numb, feeling nauseous and on 15Feb2021 patient experienced feel wrung out but no headache, nausea, or numbness. Treatment was not taken. The outcome of all events was recovering.  Follow-up attempts are completed. No further information is expected.
Severe swelling in hand with very painful joints in fingers and difficult movement. Some pain in knee also.