chrisvoncsefalvay/vaers-outcomes huggingface dataset:
While patient was waiting in the waiting area after the vaccine, patient started to experience breathing issue, along with neck congestion and tingling in the mouth. Called 911. After 15 min of evaluation still didn't get better, so started IV diphenhydramine and Epi-pen and then take her to ER for further observation.
Joint pain in neck, mid to lower spine, hips, knees, ankles and feet. Started 2 days after vaccination and is still on-going. Reported to my nephrologist at regular visit on 4/13/2021. Pain ebbs (doesn't go away) and flares. Affects my mobility primarily.
Began with light throat ache and coughing. Around 8 pm, started vomiting. Vomited twice through the night. Also diarrhea. Next day and the following few days, stomach still was upset. First day after I got the shots, felt extremely weak and had to be careful not to fall down. Weakness and stomach upset gradually diminished and as of today, Nov 4, effects are almost gone. Had a similar vomiting reaction each time I had eaten mussels or shrimp, even small amounts, in the past.
No other AE; temperature excursion; This spontaneous report was received from a medical assistant concerning a 6-month-old patient. No concurrent condition, medical history, or concomitant therapy was reported.  On 17-SEP-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength was unknown; 1 time dose, lot # 1741377 has been verified to be a valid lot number, expiration date reported and confirm upon internal validation as 07-MAR-2022) orally for prophylaxis following a temperature excursion (product storage error). Temperature were 35.02 Fahrenheit (F). The time frame was reported as 19 hours. There was no previous temperature excursion. No signs or symptoms were reported. There was no adverse event.
Information has been received from a licensed practical nurse (L.P.N.) concerning a 12 years old female who on 13-JUL-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot number 665516/1271Y) (expiration date: 03-MAR-2011). The nurse stated that on 13-JUL-2010, the patient inadvertently received a dose of ZOSTAVAX (Merck) instead of her second dose of VARIVAX (Merck) (Human error, no PQC). The patient received her first dose of VARIVAX (Merck) at the age of 12 months. No adverse effects reported. The patient did not seek medical attention. All telephone attempts to obtain follow-up information have been successful. Additional information has been requested.
almost passed out; Ear infection; Pneumonia; Arm hurt like crazy and couldnt lift up; This spontaneous case was reported by a health care professional and describes the occurrence of PNEUMONIA (Pneumonia) and PRESYNCOPE (almost passed out) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pulmonary embolism (Blood clot disorder) and Clotting disorder (Blood clot in leg).    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt like crazy and couldnt lift up ). On 03-Apr-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant) and EAR INFECTION (Ear infection). On an unknown date, the patient experienced PRESYNCOPE (almost passed out) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (Pneumonia), PRESYNCOPE (almost passed out), EAR INFECTION (Ear infection) and PAIN IN EXTREMITY (Arm hurt like crazy and couldnt lift up ) 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.   The patient reports receiving a steroid shot on Saturday and almost passing out  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
1 1/2hr p/vax had a h/a, sl nausea, very tired;
pt recvd vax; c/o inconsolable crying approx 4 hrs post immun;
Patient reports feeling cold, hot, headache, and has a fever. Patient has been taking apap to help with symptoms.
a 17 years old female patient received Fluzone High-Dose by mistake/ NO AE; a 17 years old female patient received Fluzone High-Dose by mistake/ NO AE; Initial information received on 03-Sep-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 17-years-old female patient who received once 0.7 mL dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number: UJ450AB, expiry date: 30-Jun-2021, via an intramuscular route in left deltoid) (product administered to patient of inappropriate age) on 01-Sep-2020 for prophylactic vaccination from nurse by mistake.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for prophylactic vaccination.  It was an actual medication error case due to inappropriate age at vaccine administration and it was also a case of  overdose (latency: same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Tiredness on the date of shot (March 31, 2021), then chronic throbbing pain on right side of my body from the base of the skull to the top of my right foot. On Oct. 30, 2021, I noticed a tremor on my right hand, which continued through November 1, 2021 (2 a.m.)  I am feeling this strange sensation, especially in my right index finger.
Swelling, redness, warm to touch on Rt arm where meningococcus vaccine was given.
Soreness in the left arm, 2 inch ribbon of rash a few inches below the injection site, (headache/migraine occurred 24 hours after the vaccine for a few days)
on 07/28/09 patient was brought in my mother with lower extremities on left thigh with palpable mass with 1.5 cm erythema on the higher injection site; with 2 injection sites. Treatment given was Hydroxyzine susp (10 mg/5ml), and Cutivate cream 0.05%
My right face, around the cheek/mouth area had a feeling like when you get Novacaine and lasted about an hour.
Right deltoid where vaccine was administered turned red next day and began to swell up. Traveled down to elbow and is still red and swollen. Advised patient to seek urgent medical care earlier in the day today but had to leave clinic she went to due to long wait time. I called her this evening to see how she was doing and advised her to try and go back to the urgent care clinic to get taken care of.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date during 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Information has been received from a health professional concerning a 16 week old patient who on 24-OCT-2006 was vaccinated with a first 2 ml oral dose of ROTATEQ (lot # 654247/0600F). It was reported that the patient was not experiencing any known symptoms. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Problems raising my arm up past level. Constant sharp pain in area of injection (upper arm and shoulder) loss of strength in arm. Have problems lifting. Have problems with everyday grooming (combing hair and anything that requires arm up.) Physical therapy didn't help.
Started with a low grade fever, clouded thoughts, and fatigue. Low grade fever continues to climb over the course of the next day. Arm soreness and redness
Severe itchy eyes, cough with blood in phlegm, rapid heartbeat, trouble breathing.
Pt developed redness and swelling at injection site that spread down arm (started at injection site and is travelling down the arm). Other than pain at injection site, pt does not have any discomfort in arm.
shoulder pain in the joint space causing paresthesia in the hand and arm with intermittent pain in the forearm.  loss of full range of mobility in the shoulder. this has been ongoing x 1 week.
pt recv vax 25JUN97 11AM, rxn occurred @ 9-10PM;raised 5cm x 7cm area, itchy, rash local;mom applied cortisone cream which relieved itching, area still appears bruised;
One week from  the date of receiving  my first Moderna Covid-19 vaccine shot I developed a minor reaction.  I had no signs or symptoms of a reaction prior to this day.  My arm turned red at the sight of injection and it was slightly itchy.  It lasted 2 days.  It was odd that it took a week to develop and thought I should report it in case it was an important piece of information.
Information has been received from a pharmacist concerning a postpartum female who was vaccinated with a dose of MMR II. The patient developed a rash after receiving the vaccine. The patient sought unspecified medical attention. The outcome of the patient was not reported. Additional information has been requested.
Chills; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and FATIGUE (Extreme fatigue) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced CHILLS (Chills) and FATIGUE (Extreme fatigue). At the time of the report, CHILLS (Chills) and FATIGUE (Extreme fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Concomitant product use was unknown by the reporter
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 38 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included: azithromycin (rash), alcohol user (consumes beer or wine once or twice a week), and non smoker, and other pre-existing medical conditions included: There was no drug abuse or illicit drug usage. The patient was previously received covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 043A21A, expiry date: unknown) dose was not reported, 1 total, administered on 06-APR-2021 for a prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient additionally received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822809, expiry date: 04-AUG-2022) dose was not reported, 1 total, administered in left arm on 26-OCT-2021 for prophylactic vaccination. Age at time of vaccination 38 years old. No concomitant medications were reported.  On 06-JAN-2022, the patient experienced flu-like symptoms (confirmed covid-19 infection) (dose number in series 2). On 07-JAN-2022, covid-19 polymerase chain reaction (PCR) test was performed. On 08-JAN-2022, the result came back as positive (confirmed clinical vaccination failure) (dose number in series 2). Reporter stated that, she had flu like symptoms for two days before she got tested positive for Covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000231351.; Sender's Comments: V0-20220532722-Covid-19 vaccine ad26.CoV-2.s-Confirmed clinical vaccination failure. 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. Therefore, this event(s) is considered not related.
Patient had an intrauterine fetal demise at 40 5/7 weeks. Most likely unrelated but wanted it reported that she had vaccine during pregnancy.
Administration of an expired vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-month-old female patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10-JUN-2023) for prophylaxis.   On an unknown date, the patient received Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Administration of an expired vaccine). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 28-Jul-2023 The HCP asked if the expired dose was valid. The health care professional reported the administration of an expired Infanrix dose to a patient, which led expired vaccine used. The reporter consented to follow up.
tested positive with Covid-19/experienced a cough and a raspy voice as her symptoms; tested positive with Covid-19/experienced a cough and a raspy voice as her symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CKD" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "dyslipidemia" (unspecified if ongoing); "5-favor blood disorder" (unspecified if ongoing); "has a pacemaker" (unspecified if ongoing). Concomitant medication(s) included: COUMADIN; AMIODARONE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14Jul2022, outcome "unknown" and all described as "tested positive with Covid-19/experienced a cough and a raspy voice as her symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jul2022) Positive, notes: tested positive with Covid-19 on 14Jul2022. Therapeutic measures were taken as a result of drug ineffective, covid-19 treated with monoclonal antibody infusion on 14Jul, and is doing all right.  Clinical course: She was on Coumadin and Amiodarone and numerous other medications for her co-morbid conditions. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200986996 same reporter/product/event, different patient;
From e-mail correspondence received at manufacturer on 8/20/02, was reported by the pt's husband, a MD, that his 53 year old wife received Imogam and Imovax vaccines after exposure to bats on 8/10/02. Pt received 1300 IU of Imogam divided in four IM injections in the buttocks and one cc of Imovax in the left deltoid muscle without reactions. About 15 minutes after receiving the second one cc dose of Imovax IM on 8/14/02, pt developed tightness in the chest, fuzzy feeling in the head, phlegm in throat, slight itch on scalp and nose, and tachycardia. Later her pulse was slow ~60 and not very strong, no treatment given and within one hour later all symptoms had disappeared. "In the view of the allergists, she had an anaphylactic reaction, albeit mild." He suggests that pt should get her blood drawn for rabies antibody titer and repeat it in two or three weeks. IF antibodies are rising, then probably stop the series. If the titer is low or not rising, then perform skin test on pt with the vaccine and desensitize, if necessary, so she could received the three remaining doses, perhaps divided, following antibody titers.
24 hrs after first dose child developed difficulty breathing. 48 hrs later child had insomnia and chest pains x 30 mins.
Arm pain and swelling; swelling; feeling of Malaise; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in an elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Nucala with an associated reaction of pain (for tolerance, refer case US2020AMR057319). Concurrent medical conditions included asthma.   On 15th November 2019, the patient received Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced pain in arm, swelling and malaise. On an unknown date, the outcome of the pain in arm and malaise were recovered/resolved and the outcome of the swelling was unknown.   It was unknown if the reporter considered the pain in arm, swelling and malaise to be related to Shingrix.  Additional details were provided as follows: The age at event onset was not reported but it could be 64 years or 65 years. The patient experienced arm pain and swelling and a feeling of malaise. The patient consented to follow up.
11 November 2008 I got the flu shot in my left arm. About 6 to 8 hours following the shot I started getting muscle ache in my left shoulder. I took ibuprofen to try to releive the pain. After almost a week with the pain I went to a chiropractor who said that he could no cause for the pain except possibly the flu shot. He gave me a treatment but it had no effect. Today I went back to the doctors office where I got the flu shot and they are prescribing a pain medication and a muscle relaxant which I have not yet picked up from the drugest. The person who gave me the shot said that I should call the CDC and they told me to fill out this form. If others have reported this same side effect please let me know.
Loss of balance, numbness in arms and legs.  Brain fog, inability to concentrate, feeling like being in a movie, very confused.  Episode lasted one week.  Saw primary doctor as well as shrink.  Anti-anxiety drugs were prescribed but did not help.  Multiple similar episodes occuring.  Patient unable to complete school year.
On 6/1/2020 patient experienced injection site pain and joint pain. 6/2/2020 {inj. site pain/joint pain/swelling @ site of injection, body aches, headache, fever the symptoms were resolved on 6/3/2020
FEVER, CHILLS, BODY ACHE, HEADACHE, SORE ARM, SINUS DRAINAGE, RUNNY NOSE, ARM REDNESS AROUND SHOT AREA, REST, TYLENOL TAKEN TO REDUCE FEVER, SLEEP, FLUIDS, STAYED HYDRATED, KEPT WARM, LAST ABNORMAL TEMPERATURE OCCURRED AT 9:30 PM 11/19/05.
Patient presented to ER on 3/27/2021 with c/o right side numbness and facial paralysis, right side.  Dr. attending ER physician, diagnosed him with Bell's palsy.   Patient states he received 2nd dose of Covid-19 vaccine (Moderna) on 3-25-21, and woke up the next morning with numbness, weakness of right side of forehead, eye, and mouth. went to ER around 11:00am the next morning (03-27-21).  No other significant paralysis or problems with limbs or other mobility problems are noted in ER record.  Patient history significant for:  Diabetes Mellitus (uncontrolled), and Hypertension (controlled).  Was given Clonidine and labs, CT scan was ordered.   Labs were signficiant for elevated blood glucose, 321 and elevated HgA1c (10.5).  patient was given insulin in the ER.  Results of CT (w/o contrast) scan was negative-"no hemorrhage, no mass-effect, no extra-axial fluid collection."  "subtle right-sided basal ganglia calcifications."
I had a high fever of about 103.3 later on that same day. My arm is still bruised today from the shot. I had body aches, hot and cold chills. I had taken Tylenol and started to throw up. I than called a constant nurse to make sure I could take some more Tylenol that would not interfere with your other medications. I also have a swollen lymph node under my left arm that is still swollen today. I still have a fever today as well.
patient stated that one eye started swelling on 7/31/21, thought he may have gotten something in it, then he noticed 8/5 that his other eye was beginning to swell as well. this vaccine was the only thing new he has had; instructed pt to seek medical attention
COMPLAINING OF SORENESS LEFT UPPER ARM WITH LIMITED RANGE OF MOTION BECOMING INCREASINGLY MORE PAINFUL OVER THE WEEK BEFORE SHE REPORTED THE REACTION TO FACILITY.
On 10/4/2011 @ 9:30 PM, I began feeling nausea. On 10/5/2011, I had symptoms including: severely sore throat, nausea, loss of appetite, runny nose. 10/6/2011, symptoms: all of above plus coughing, sneezing & fatigue. 10/7/2011 symptoms: all of above plus body aches. Saw doctor 10/7/11, who prescribed " Tamiflu" capsules and "Phenergan" cough syrup.
4/26/21 - Chills, Muscle Aches, night Sweats, severe sore arm 4/27/21 - Chills, Muscle Aches, severe sore arm 4/28/21 - and still current as of the date of this application - Poor muscle movement in right eye and face, inability to open right eye upon awakening from sleeping,  sensitivity to light, headache - diagnosed as Unspecified Ptosis of the right eye / Bell's Palsey. I have an appointment with a Neurologist.
Vaccine was diluted with 0.8mL instead of 1.8mL.  Error was found approximately 1 hour after dose was given.  Patient was called and notified of error.