chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lost a lot of weight /weight loss; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (lost a lot of weight /weight loss) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WEIGHT DECREASED (lost a lot of weight /weight loss). At the time of the report, WEIGHT DECREASED (lost a lot of weight /weight loss) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for an unknown indication.     No Medical History information was reported.   On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not experience any adverse event.  No concomitant medication were reported.  No treatment medication were reported.   This case was linked to MOD-2021-395985 (Patient Link).
Left side of body weakness; This spontaneous case was reported by a consumer and describes the occurrence of HEMIPARESIS (Left side of body weakness) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Learning disability and Seizure.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced HEMIPARESIS (Left side of body weakness) (seriousness criterion medically significant). At the time of the report, HEMIPARESIS (Left side of body weakness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
erythematous macular papular rash over trunk 2 days after vaccine (3/4)
DTAP placed in left arm on 2/19/02. Pt returned with a local redness and swelling of left arm on 2/21/02. Had 11cm X 18cm of redness and warmth and 5cm X 4 1/2cm of induration. No fever.
25" after received flu vaccine; pt felt like throat closing, hives, wheezing + given epi pen, Benadryl + taken by ambulance ED + Rxed with IV Prednisone. Pt had similar but worse Rxn 4 week prior
Information has been received from a nurse practitioner concerning a 21 year old female patient with no drug reactions/allergies, smoker, exercise-induced asthma and a history of eczema, who in 11-OCT-2010 was vaccinated with the first dose of GARDASIL, 0.5ml, intramuscularly (lot number 665768/1377Y). On 10-JAN-2011, the patient was administered her second dose of GARDASIL (lot number 665768/1377Y). Concomitant therapy included KARIVA. On the evening of 10-JAN-2011 the patient developed chills. The next day, on 11-JAN-2011, the patient developed difficulty breathing, wheezing, fever, body aches, lightheadedness, fatigue and back pain. The symptoms resolved within 24-36 hours. No lab diagnostics studies were performed. No treatment was given for the experience. The patient sought medical attention by a telephone call to the nurse practitioner. At the time of the report, the patient had recovered. No further information is available.
Weakness, muscle aches, headache, nausea, Had same reaction after 1st dose. More severe after 2nd dose but improving.
Developed chicken pox. Injection 10/3/08.  Lesions started 10/6/08
had a chest cramp; This is a spontaneous report received from a contactable consumer (Patient's mother) reported for her son. A 15-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via an unspecified route of administration on 15Aug2021 (at the age of 15-year-old) (Batch/Lot number: Not provided) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that caller was calling on behalf her 15-year-old son who received the first dose of the Pfizer Covid-19 vaccine on Sunday. This morning he had a chest cramp on an Aug2021, and it disappeared, he does weights but since she had been told that the vaccine could cause heart disorders she would like to know if this may be related to the vaccine and she would like to know if people after receiving the vaccine should take care of themselves as patients in doing any activity or if it doesn't matter. No information found. Referred caller to their HCP. She also mentioned that before the vaccine she did a medical examination on her son and everything went perfectly, his heart was fine. The patient underwent lab tests and procedures which included investigation: normal on an unspecified date everything went perfectly, his heart was fine. Outcome of event was recovered on an unspecified date in Aug2021.  Follow-up attempts are completed. No further information is expected; information about lot/batch number cannot be obtained.
pain, tenderness at injection site in left deltoid; difficulty moving left arm two days after receiving injection
Per ED Note: Chest pain that began this morning.  Cannot describe the pain.  Rated as 8/10.  Also noting feeling more confused.  Called EMS.  Initial rhythm unremarkable.  Patient did have sudden change to wide-complex sinus rhythm while in route to the ED concerning for acute STEMI.  Patient received aspirin and 1 dose of nitroglycerin via EMS.  After receiving nitroglycerin dose EKG changes returned back to baseline.  Patient states that she is still having some chest pain.  Otherwise has no complaints.  She did receive both of her COVID-19 vaccines.  She is coughing but states that she has been coughing for a long time and this is gradually improving.  She does not smoke, drink alcohol, or recreational drugs.  Patient has had quadruple bypass in the past and has a history of heart failure.
slight shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (slight shortness of breath) 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.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced DYSPNOEA (slight shortness of breath). At the time of the report, DYSPNOEA (slight shortness of breath) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jul-2021, Heart rate: increased (High) faster than usual.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported. No treatment drug details was reported.
Note: Surgery 3/27/2021 - left shoulder replacement  and biceps tendon reattachment - that had been schedule prior. April 1 - Diarrhea started on that day. Nothing stopped it - nothing stopped it - even Imodium. Finally on the 4/5/2021, I went to ER for the first time. They said I was dehydrated and I got IV fluids but they didn't do anything to help me with the diarrhea. They did lab work which showed I was dehydrated. I can't remember if they did x-rays or scans. The diarrhea continued though and it was 4/12 - as the day progressed, it got to the point that I couldn't walk - I was so weak and sick an d the diarrhea was so bad - stool would just run all the way from bedroom to the bathroom - it just wouldn't stop. It was awful. I went to ER after doctor told me to go back again. I found out I was septic. I had septic shock and was so sick. I was in the hospital for  4 to 5 weeks.  I didn't go to Rehab from the hospital until mid May and I was there for two or three weeks.  They said it takes 6 months to a year to fully recover  Note: I had the third vaccine today for Pfizer. Last week, I had my first Shingrix and my flu vaccine on the 15th.
within 6 hrs of DTP admin. pt irritable & hives for 48 hrs /p immunization
pain at the injection site; fever; chills; muscle aches; joint paint; Changes in the way some things smell; Loss of appetite; A spontaneous report was received from a consumer a 43-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever/Pyrexia, pain at the injection site/Injection site pain, chills, muscle aches/Myalgia, joint paint/Arthralgia, Changes in the way some things smell/Parosmia, Loss of appetite/Decreased appetite. The patient's medical history was not provided by the reporter. Concomitant medications was not provided by the reporter.   On 1st Feb 2021 the patient received their first of two planned doses of mRNA-1273 intramuscularly in unknown location for prophylaxis of COVID-19 infection.  on 1st Feb prior to receiving mRNA-1273, patient experienced pain at the injection site, fever, chills, muscle aches, joint pains, loss of appetite and changes in the way some things smell. Treatment information is not provided. Action taken with mRNA-1273 in response to the events is not applicable.  The outcome of the event fever, pain at the injection site, chills, muscle aches, joint paint, Changes in the way some things smell, Loss of appetite was not reported.
he had a sore arm for a couple of days; This is a spontaneous report from a contactable consumer (patient). This male consumer reported for himself. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 08Mar2021 as DOSE 1, SINGLE for COVID-19 immunization. Medical history included skin ulcer from an unknown date and unknown if ongoing ulcer on his leg. Concomitant medication included valaciclovir hydrochloride (VALTREX) taken for skin ulcer (for an ulcer on his leg) start and stop date were not reported. The patient experienced a sore arm for a couple of days. Patient wanted to know, patient took Valtrex daily and prophylactically, for an ulcer on leg, and it will affect the efficacy of the vaccine. Response: no drug interactions listed in the fact sheet (Sect 10). Provided the two classes of medication that are contraindicated in the attached document. The outcome of the event was unknown.    Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
This spontaneous case, initially received (combinedly processed with follow-up) from a pharmacist on 15-Oct-2018, concerns a 51-year-old, adult, male patient. It was reported that, the vaccine reached the maximum temperature of 56 Fahrenheit and was out of the recommended storage conditions for 8 hours. It was the first excursion. On 14-Oct-2018, the patient was administered FLUCELVAX QIV [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252668 and expiry date: not reported] which underwent temperature excursion and administered the vaccine. The patient did not experience any adverse events after the vaccination. The reporter assessed this case as non-serious. This case 201804552 was cross-linked with the original case 201804533 due to the same reporter.
patient received a half dose as the second primary dose instead of a full one; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (patient received a half dose as the second primary dose instead of a full one) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (patient received a half dose as the second primary dose instead of a full one). At the time of the report, UNDERDOSE (patient received a half dose as the second primary dose instead of a full one) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
pt brought to ED from SNF for N/V, and decrease in BP; large right pleural effusion found with infection; O2 supplementation and antibiotics given; was to be transferred back to a SNF but was found to be positive for COVID; per SNF protocol, pt had to quarantine for 10days before could come into facility; pt quarantined in the hospital; pt's condition worsened and he passed away in the hospital
At 1712 on January 8th, three hours after the vaccination, patient presented to the Urgent Care with c/o dizziness, tachycardia and shortness of breath. Other symptoms included fatigue, foggy headed and poor appetite. As of today, January 10th, continues to complain of exhaustion, mild shortness of breath and body aches, but states that the tachycardia has resolved.
9/25/01 rec'd TD in R delt & MMR in L delt. 9/28/01 R shoulder is red, swollen, painful a little bit of rash, hot, itchy.
Mother reports left upper arm 5-6cm area of erythema and induration warm to touch and tender. She also reports child with complaint of headache, fever and lightheadedness. At this time 8/24/07 evening she took child to emergency room. Diagnosis as localized skin reaction - discharged to home in stable condition.
patient called and stated that later that day he had shooting nerve pain  traveling  up his arm to his  neck
It started on Monday 04/12 I had a back ache around 1 or 2pm I thought it was because I was sitting at the table for to long and around 6 it was really bad by the time I went to bed it was really painful I couldn't roll over I wasn't able to mover over from my left side to my right  04/13 when I woke up I couldn't get out of bed without support I had to roll off my bed and use the wall in order to get up to a standing position ( went to urgent care this day )  I couldn't sit down without a lot of pain and also couldn't get up without pain I went to urgent and they gave me a muscles relaxer and steroid and also Tylenol this was like this for about 5 days and it started to go down after the fifth day and over the course of 3 weeks it did get better but the whole process lasted for about 4 week I couldn't get out of bed without support for about 2 weeks   04/15 i went to see a doctor who agreed with the medication and there was no change to the prescriptions
Covid19 breakthrough. 1st Vaccine received on 02/15/2021. 49 y/o with PMHX of Sarcoidosis, Pulmonary HTN/Fibrosis, Asthma, HTN, chronic Bronchiectasis presents to ED with c/o cough and SOB after going to the movies 2 weeks ago. Patient tested positive at Urgent Care where had room air sat of 70%. Cough productive with purulent sputum-per ID had recent MDR achromobacter and received ABX. CXR-chronic reticulonodular dz. Immunocompromised on Humira.  Started on IV Abx/steroids and Remdesivir.
Symptoms started 5 minutes after injection, patient began to experience numbness in his left leg around the calf and hamstring area. Further description highlights the feeling sensation of patient's leg falling asleep. Subject requested physical examination 3 days later and upon being seen, muscle motor reflexes were checked with no abnormal indications, nor discoloration or swelling to rule our possible blood clotting. Patient was then told by Provider Care Manager (PCM) to continue monitoring conditions and emphasized if conditions change for the worse to seek medical care at nearest emergency room.
A few days after the 3rd shot (booster), I developed high-pitch tinnitus. It has persisted. Other than a sore arm, I had no other reaction to any of the 3 Pfizer shots.
Patient was not feeling well; Cough; Sore throat; Runny nose; Chest burning; Like the flu; Nausea; Headache; Sleepy; Was all day in bed; Low fever; Possible wrong vaccine schedule; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy), BEDRIDDEN (Was all day in bed), MALAISE (Patient was not feeling well), COUGH (Cough) and OROPHARYNGEAL PAIN (Sore throat) in an 80-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 Depression, Blood pressure high, Heart disease, unspecified and Urinary infection.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Possible wrong vaccine schedule). On 07-Apr-2021, the patient experienced SOMNOLENCE (Sleepy), BEDRIDDEN (Was all day in bed) and PYREXIA (Low fever). On an unknown date, the patient experienced MALAISE (Patient was not feeling well), COUGH (Cough), OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose), CHEST PAIN (Chest burning), INFLUENZA LIKE ILLNESS (Like the flu), NAUSEA (Nausea) and HEADACHE (Headache). On 04-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Possible wrong vaccine schedule) had resolved. On 08-Apr-2021, SOMNOLENCE (Sleepy), BEDRIDDEN (Was all day in bed) and PYREXIA (Low fever) had resolved. At the time of the report, MALAISE (Patient was not feeling well), COUGH (Cough), OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose), CHEST PAIN (Chest burning), INFLUENZA LIKE ILLNESS (Like the flu), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications includes unspecified drugs for depression, cholesterol, high blood pressure, something for the heart and chronic urine infection. Current condition also included Cholesterol. No Treatment information was reported.   This case was linked to MOD-2021-378173 (Patient Link).
Immediately after receiving Gardasil pain. Within the first hour pain and redness increased, also a headache started. Four hours after receiving the vaccine severe pain. Raised red bumped from shoulder to elbow. Severe headache. Nausea. Dizziness. Still on going side effects as of 11/22/2015. Which include, severe pain in site of the vaccine. Off and on swelling and heat. Headaches that were not present prior to the vaccine. Unusual tiredness. Weakness in left arm where vaccine was given.
Sharp pain in ear and head for head nose eyebrow  It started April 18,2021   time was !:30
Patient aged 62 y.o. with PMH of HTN who presents to the Emergency Department as a stroke alert for right facial droop and numbness of the right arm and leg numbness. He was seen immediatly on arrival.   Complains of pain in RUE, which is occasionally sharp and shooting up the shoulder on movement. Complained of chest tightness beginning this afternoon and has coughed up small 'pencil eraser' sized bits of colorless sputum a few times. Covid-19 positive test obtained today, patient describes that he has been treated for Covid-19 at Hospital, and was diagnosed initially about 3 weeks ago.   PULM: airways patent, mild chest tightness, mildly decreased breath sounds bl.   Disposition: Home Condition: Stable (s/sx potential problems absent or manageable)
TOOK TWO DOSES IN A ROW; This spontaneous case (PVX2019-824) was received from a consumer on 08-Apr-2019. It describes a female consumer who "took two doses in a row". The consumer was receiving Vivotif for typhoid prophylaxis.  Case report: The consumer took two doses in a row. The doses were taken on 07-Apr-2019 and 08-Apr-2019.   Action taken with Vivotif was not applicable.   The clinical outcome of the event "took two doses in a row" was unknown.  Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.
Vomited 2-3 times per hour and experienced diarrhea 3 times, no fever.
Redness and swollen to left arm. Mom was concerned and took her to emergency room. Patient was prescribed antibiotic.
Itching, redness, and swelling in left arm; 2x3 inches in diameter; warm to touch; No fever
From initial information received on 4/14/04 from the patient regarding an adverse event occurring in the USA, it was reported that a 32 year old female patient received a seventh dose post-exposure IMOVAX vaccination, lot number X0581, administered in the left deltoid on 4/8/04. An unspecified time later she complained of redness and pain in the left arm, a fever of 98.8 degrees F, difficulty sleeping, backache, and restlessness. The patient received the first four doses overseas and the rest of the doses at home (dose four lot # W1419 given on 1/22/04 and dose five lot number X0581 given on 3/22/04). The rabies series was given due to a dog bite she received while overseas. The redness has resolved, but the backache and other events persist. Additional information received 5/7/04: From the reporter's physician, report reviewed, no additional information is available at this time. No further information is anticipated, therefore, this case is closed.
Left deltoid injection site reddened and swollen. No fever. Apply ice to the area for 20 mins each hour for two consecutive hours. Call back if injection site starts to look infected.
She received the J and J vaccine on 3/19/21 at STM. She presented to Med center with a "viral syndrome" including fevers, rigors, muscle pain and SOB. She received a Z pack. Fever persisted for 1 day after ER visit but she continued to feel badly. The following day, 3/27 she was awakened with severe R>L jaw pain, post HA with standing, pain in the cartilage on the tip of her nose and SOB. SOB resolved by 3/31. HAS persisted as did jaw pain and pain behind her eyes. ON 3/30 she noted increasing bruising and periorbital petechiae which continued through 4/5 when she sought help from Dr , her PcP. When she saw DR she was noted to have bilateral leg swelling R>>L . She had labs and a Doppler US which we are trying to locate. She had a syncopal spell on 4/6 and was brought to ER at STM where she was diagnosed with sagittal vein  thrombosis, RLE DVT and thrombocytopenia.
Sore throat, nasal congestion, cough, headache, body aches 24 hours after vaccine.
Student nurse went to give a TB Skin Test to this student and accidentally gave Pfizer vaccine 0.1 cc intradermally instead.  The student has a 4x3 cm by 5x8 cm reddened area on the left forearm and is having swollen lymph nodes in the axilla area bilaterally as of today 3/23/2022.  We are continuing to monitor the area and for other side effects.