chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had FLUARIX administered on 9/21/2016. Patient called pharmacy on 9/27/16 complaining of soreness and lack of range of motion in arm.
PATIENT AND HER MOTHER COMPLAINED OF PATIENT EITH LOW GRADE FEVERS AND FLU LIKE SYMPTOMS AFTER GETTING THE FIRST TWO INJECTIONS. ALSO COMPLAINED OF NUMBNESS IN HER ARM
Had slight cough when vaccines administered 1/11/07. That night, temp increase 103 and stayed 103 through 1/16 alternating Tylenol and Motrin. Large 5cm raised red area left deltoid (Dtap) 1/13, to ER to Dr 1/16. Has petechiae on chest and small blisters also cough. 1/17 mother said arm and chest fading.
Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves Elderly patient (age and gender was not reported) and reported that vaccinated with FLUBLOK QUAD instead of FLUZONE HD, while he/she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number, expiry date, dose, dose in series, route and site of administration was not reported). It was a case of actual medication error due to Wrong vaccine administered. It was unknown if the patient had any adverse event. 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. List of documents held by sender: none.
New and unprecedented occurrance of irregular heart beats that are still ongoing regardless of state of rest or level of activity.  ZIO heart monitor worn for 13 days.  Cardiologists' analysis: runs of PAC,s, PVCs, and  SVTs.
Patient, developed a fever the same night as the vaccination which was May 31st, 2017. At his wellness check u where I was advised he was due for shots. Note: he was not sick at this appointment. Patient attended daycare Friday, June 2nd, 2017. At dismissal time his father and I were informed that he felt warm and did not appear to well. He was brought home and given tylenol to bring down his fever of 100.3. Patient appeared to be wheezing so I administered his asthma medication to him that night through his nebulizer, trying to help his discomfort. I monitored him throughout the night. His breathing eased up, only to become worse the following day, which was June, 3rd, 2017. He started to breath at a rapid pace, his entire chest at the base of his neck would sink in only to pop back out, he, was very irritated, high fever, diarrhea, would not eat or drink, and cried hysterically non-stop. At this point I phoned his doctor to inform her what was taking place and was advised to go to the emergency room where, I had begin to proceed anyway. Patient was checked into hospital at approximately 7:00. I was advised he would have to be admitted because he was in no condition to be released from the hospital due to his difficulty breathing and very rapid heart rate.
Received the shot about 1:15 pm on 10-03-2012. By 5:30pm my eyes were bloodshot. By 8:30 pm I couldn't breathe from my nose. Clogged nasal passages, sniffles, red-runny eyes, head-achy. A little coughing & sneezing. Took 2 CORICIDIN'S HBP, drank orange juice (a cup) & a cup of water. Ate & went to bed.
Mother phoned to say the child has broken out in a rash all over body. Questioned in regard to anaphylactic shock and denies any other problems at this time. Referred to physician.
increased heart rate, out of breath, couldn't lay flat on his back and couldn't sleep, went to the clinic and they said he had fluid on his lungs. Got admitted to hospital and he had a stroke and  a blood clot on his brain and his leg
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 64-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020) for prophylaxis. Concomitant products included citalopram and lisinopril. On 7th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 12th June 2018, 5 days after receiving SHINGRIX, the patient experienced shingles, itchy rash and pain. In June 2018, the patient experienced sleep decreased. On an unknown date, the outcome of the shingles, pain and sleep decreased were unknown and the outcome of the itchy rash was not recovered/not resolved. It was unknown if the reporter considered the shingles, itchy rash, pain and sleep decreased to be related to SHINGRIX. Additional details were provided as follows: The patient  was the technician who works at the facility of administration. The concomitant medications were not new. The patient received SHINGRIX in the right upper arm (right deltoid). The patient experienced the itching and burning painful rash started on the right side of her back. On 13th June 2018, the patient went to a doctor's appointment because of the symptoms, after another pharmacist at the pharmacy suggested that she go ahead and go to see the doctor about the symptoms. On the same day the doctor diagnosed the symptoms as being shingles. when asked to the reporter that if the symptoms were disabling, the reporter responded that the patient had missed 45 minutes of work due to the doctor's appointment. The itchiness and pain of the rash keeps her awake. The doctor gave her a medication which did not seem to help, but the rash was still itching and was spreading to different spots. On the day of reporting, the patient said the rash was on the right side of her back from below her braline all the way down further to below her waistline. At the time of reporting there were total ten patches of rash in that area. She had about eight spots of the rash at the time of the doctor's appointment and at the reporting the patient had about one or two new areas since her Wednesday doctor office visit. The reporter agreed to contact for further follow up.
Migraine, Pain/immobility of left arm, Fever and drop in body temperature, chills, nausea, body ache, dizziness, fatigue
Had hives on his legs, that progress from his nipple to his kness; Being itchy. on his belly and legs, no visible rash at that time; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 5 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in leg right, administration date 24Nov2021 18:00 (Lot number: FK5618) at the age of 5 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "Non pertaining to hives" (unspecified if ongoing), notes: had hives in the past and been worked up by allergy with no known etiologies.; "Allergies" (unspecified if ongoing); "Reflux" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC taken for hypersensitivity (ongoing); FLOVENT HFA taken for hypersensitivity (ongoing); OMEPRAZOLE taken for gastrooesophageal reflux disease (ongoing). Past drug history included: Benadryl, reaction(s): "Allergic to benadryl", notes: Allergic to benadryl. The following information was reported: PRURITUS (non-serious) with onset 24Nov2021 18:30, outcome "recovered" (Nov2021), described as "Being itchy. on his belly and legs, no visible rash at that time"; URTICARIA (non-serious) with onset 24Nov2021 19:00, outcome "recovered" (26Nov2021), described as "Had hives on his legs, that progress from his nipple to his kness". Therapeutic measures were taken as a result of pruritus, urticaria.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. His mother gave zyrtec (4ml instead of his normal 2.5 ml nightly dose) and gave an oatmeal bath.   No follow-up attempts are possible. No further information is expected.
Shortly following the initial vaccine, I felt slightly queasy and my arm had a stinging sensation radiating from the injection site.  The next day I had a headache that lasted for several days, and my arm was extremely painful (for several weeks.)  Following the second vaccine I also felt particularly queasy (stomach unease) and a headache.  In about 24 hours post second dose I felt extremely ill.  I had severe chills, fever, and loss of appetite.  I could not control my body temperature and my body ached all over.  The following morning I felt well enough to go to work but exhausted, headache and muscle aches.  My arm was painful for a few weeks. I have never experienced a vaccine reaction such as this with any previous vaccines in the past. It has been about 2 month since my last covid-19 vaccine. Since then I have felt sluggish, foggy and "just not myself."  I feel like I just cannot recharge my "battery" completely.  Simple tasks take much longer to complete and I have difficulty with short term memory or thinking of the names of items I use on a daily basis or names of people I see regularly.  This has given me a great deal of anxiety because I do not completely trust myself to do my job appropriately without second guessing myself or having someone else check my work. I intend to follow up with my physician about this but as of yet have not consulted with anyone.
Cellulitis redness and swelling of right upper arm with warmth to touch around vaccine site. Possibly unrelated however of note patient also developed fever, fatigue and body aches,
This spontaneous case reported by a consumer, describes the occurrence of sleep disorder (wakes out of deep sleep), palpitations (pounding heart) and vomiting in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 091D21A) for COVID-19 immunization. The patient's past medical history included a tumor. Concurrent medical conditions included celiac disease. On Jul 27, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced sleep disorder (wakes out of deep sleep), palpitations (pounding heart) and vomiting. At the time of the report, sleep disorder (wakes out of deep sleep), palpitations (pounding heart) and vomiting outcome: unknown.  Concomitant medication and treatment information not provided. This case linked to MOD-2021-328145 (patient link).
Arm was sore day after shot and remained so....then last night it started itching and there was a slight rash above.  It is now aching enough that I have tried putting ice on it and taking Tylenol and Advil.  It is somewhat swollen and red with slight rash.  Red at the spot of injection.  It did bleed when shot was given.  I would have thought by now it should be clear.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer the vaccine on the 22Aug2022 and 23Aug2022 after the use by date 21Aug2022, to two pediatric patients), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 22-Jul-2022 and administered on the 22-Aug-2022 and 23-Aug-2022) and NO ADVERSE EVENT (No Adverse Event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis. No Medical History information was reported. In August 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer the vaccine on the 22Aug2022 and 23Aug2022 after the use by date 21Aug2022, to two pediatric patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 22-Jul-2022 and administered on the 22-Aug-2022 and 23-Aug-2022) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer the vaccine on the 22Aug2022 and 23Aug2022 after the use by date 21Aug2022, to two pediatric patients), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 22-Jul-2022 and administered on the 22-Aug-2022 and 23-Aug-2022) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (administer the vaccine on the 22Aug2022 and 23Aug2022 after the use  by date 21Aug2022, to two pediatric patients) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 22-Jul-2022 and administered on the 22-Aug-2022 and 23-Aug-2022). This case contains information for the 1st of the 2 pediatric patients who received the vaccine on 22-AUG-2022 and 23-AUG-2022 as described by the reporter. No concomitant medications was reported. The vial was initially stored in the refrigerator on 22-July-2022. The vial did not undergo any temperature excursions. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2022-632635 (E2B Linked Report). Sender's Comments: US-MODERNATX, INC.-MOD-2022-632635: Patient- 2 from two pediatric patients.
It was just noted that patient received 0.5ml rather than 0.25ml for a booster dose; Patient had no symptoms or reactions since the time of the vaccine administration until 1-2 weeks later she developed urticaria; was seen at urgent care and given a dose of steroids IM and Benadryl but continues with urticaria
Vomiting, nausea, dry heaving, general sense of not feeling well, heaviness in body.
Redness, swelling, induration x 3 days. Afebrile. BENADRYL given day 2.
Pleurisy in her left lung; Brain fog; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8729), via an unspecified route of administration, administered in the left arm on 15Apr2021 (at the age of 26-years-old) as 1st dose, single for COVID-19 immunization. Medical history included acid reflux and allergy to honey. The patient was not pregnant at the time of vaccination. Concomitant medications received within 2 weeks of vaccination included ibuprofen (ADVIL 12 HOUR) and cetirizine hydrochloride (ZYRTEC). The patient previously took sulfamethoxazole/trimethoprim (BACTRIUM DS). The patient reported that after receiving the shot, she started to have brain fog for a couple of days and she knows that she have pleurisy in her since - both on 21Apr2021. It has been a month and it hasn't gone away. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events were treated with prescription ibuprofen so far. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. On 18May2021, the patient has been tested for COVID-19 with pending results. The outcome of the events was not recovered.  Follow-up attempts are needed. Further information is expected.
Bell's Palsy diagnosis.  Paralysis on left side of face.  Severe headache behind left ear.  Numbness in feet/toes.
funny feeling in her lips/lips; felt funny; funny feeling in her; tongue/tongue; felt funny; funny feeling in her; throat/throat felt funny; lips; swollen; tongue; swollen; throat; swollen; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration on 06Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient informed that she received her first dose of Covid vaccine yesterday (06Jan2021) between 7:30 and 8:00. In Jan2021, the patient had a slight reaction. The patient experienced funny feeling in her lips, tongue and throat and swollen/lips, tongue, and throat felt funny and swollen. The patient didn't tell anyone because she was embarrassed. The patient left and went home. It lasted for two hours and then she felt ok. Wants to know if she should take the second dose, which she was due for on 27Jan2021. The patient informed that her doctor told her to take a Benadryl before taking the second dose and see him after the vaccine. The outcome of the events funny feeling in her lips, tongue and throat and swollen/lips, tongue, and throat felt funny and swollen was recovered  Follow-up activities are possible, information on the batch number has been requested.
Myalgia; aches and pains all over; headache; arthralgia; This case was reported by a physician via call center representative and described the occurrence of myalgia in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced myalgia, general body pain, headache and arthralgia. On an unknown date, the outcome of the myalgia, general body pain, headache and arthralgia were unknown.   It was unknown if the reporter considered the myalgia, general body pain, headache and arthralgia to be related to Shingrix.  Additional information received were as follows: No batch number or expiry date was reported. The patient experienced aches and pains all over. The events were not subsided. The reporter consented to follow up.
saline to reconstitute SHINGRIX; saline to reconstitute SHINGRIX; This case was reported by a consumer via call center representative and described the occurrence of wrong solution used in drug reconstitution in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 25-APR-2022 Reporter's comments: Reporter was the patient. She stated that her Nurse Practitioner (NP) said she used saline to reconstitute the Shingrix Vaccine. The reporter did not consent to follow up. The reporter did not wish to provide details regarding the Nurse Practitioner contact information The reporter provided limited information. Additional Supportive Information: The saline was used to reconstitute the Shingrix vaccine, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This case has been linked with case US2022AMR070691 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR070691:Same reporter
GOT DOUBLE VACCINE; VACCINE BROKE INTO MY MUSCLE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported, per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced got double vaccine, and vaccine broke into my muscle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the got double vaccine and vaccine broke into my muscle was not reported. This report was non-serious.
Fever up to 100.9, body aches, chills, soreness of body and site of injection, tickle in throat
mom noticed sx of SOB, extreme drowsinss excessive crying, (diarrhea started Saturday); no elevated temp;
12 hours after shot developed high fever. It was 102.5 after taking a max strength Tylenol. Took another Tylenol and lowered it to 101. Fever has been on and off for the last four days and seems to rapidly come on. Having headaches and a rapid heartbeat, very tired. Still feeling extremely tired Thursday pm, had shot Monday morning. Fever of 99 currently.
redness  with swelling at the injection site. painful. pain and swelling resolving on evaluation today.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Medium
CHIEF COMPLAINT:   Pt presents tonight from a group home w low oxygen saturation in the low 80s, cough, generlal ill feeling for 2 days   HISTORY OF PRESENT ILLNESS:     Patient presenting to the emergency department with low oxygen.  Patient has been generally feeling ill for the last 2 days.  Patient not having any fevers at home.  Per EMS patient was saturating in the mid 80s on arrival.  Patient is not vaccinated against Covid secondary to severe allergic reactions.  Patient otherwise nonverbal.  Patient seen during the Covid pandemic.  Nursing note reviewed.
Patient had already received the moderna series on 3/31/21 and 04/29/21 from the  Dept of health
This spontaneous report as received from a registered nurse refers to a patient of unknown age (gender was unknown). On 11-JUL-2013 the patient was vaccinated with an expired dose of VARIVAX (Merck) (lot # 671126/1062AA, exp. date: 05-JUL-2013). No symptoms reported. Additional information has been requested.
Dizziness, fainting, brain fog, hands shaking, internal vibration, tinnitus right ear, pressure in chest, feeling disconnected from self to such a degree felt suicidal (one day only). On all days to date, doing smallest things like writing a simple email for 10 minutes, or any kind of focus-- talking on phone, etc , will suddenly make me feel panic and I feel lightheaded and start to pass out (note this side effect is ongoing in week 6 but to lesser degree). Feel very rundown--this is ongoing.  All side effects are ongoing in week six except chest tightness.
Achy joint pain on both sides; Mild Fever of 100.9; Mild chills but not shaking; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ARTHRALGIA (Achy joint pain on both sides), PYREXIA (Mild Fever of 100.9) and CHILLS (Mild chills but not shaking) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced ARTHRALGIA (Achy joint pain on both sides), PYREXIA (Mild Fever of 100.9) and CHILLS (Mild chills but not shaking). At the time of the report, ARTHRALGIA (Achy joint pain on both sides), PYREXIA (Mild Fever of 100.9) and CHILLS (Mild chills but not shaking) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, Body temperature: 100.9 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Patients Physician suggested Tylenol but she did not report taking it as yet.
Melanoma went aggressively: lesions started to grow enormously, targeted  therapy stoped working  Alk the same had happened back in March ,2021 when i was sick with Covid -19. All the same symptoms: lesions were growing vert fast