chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extremely sore arm and shoulder where injection was given (4 days); Nausea, vomiting, dizziness/fainting (24 hrs); Severe cramping/spasms of leg and lower back muscles (12 hrs); Fever (36 hrs); Generalized aching (72 hrs); Severe headache (36 hrs); Swelling of face and hands (36 hrs); All symptoms began approx. 6 hrs. after receiving vaccine.
might have received the Menveo /reconstituted with sterile water.; might have received the Menveo /reconstituted with sterile water.; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA548A, expiry date 28th February 2022) for prophylaxis.   On 26th July 2021, the patient received Menveo. On 26th July 2021, unknown after receiving Menveo, 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 details were provided as follows: The age at vaccination was not reported. It was reported that the patient might had received the Menveo vaccine reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter stated might, because she was not sure if it was this patient or another that received the improperly reconstituted vaccine. No further events were reported at the time of reporting. The reporter consented to follow up. This case has been linked with the case US2021163836 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021163836:same reporter
Information has been received from a physician concerning a female (age not reported) who was vaccinated with the first dose of Gardasil (lot# not reported). Subsequently the patient fainted. The patient recovered. There was no product quality control involved. Additional information has been requested.
FEVER CHILLS; SORE THROATE; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (FEVER CHILLS) and OROPHARYNGEAL PAIN (SORE THROATE) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PYREXIA (FEVER CHILLS) and OROPHARYNGEAL PAIN (SORE THROATE). At the time of the report, PYREXIA (FEVER CHILLS) and OROPHARYNGEAL PAIN (SORE THROATE) 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.
Patient reports the following: Within 10-15 minutes after the shot was given pain began that progressed through the day and increased. Next day, felt like he had been punched. Pain continued for next 2 weeks and was not able to lay down and slept in a chair. Saw doctor who prescribed 800 mg Ibuprofen. Worse at night. After 2 - 3 weeks pain subsided and weakness increased. Saw neurologist and was given diagnosis of Parsonage Turner. Could not lift arm and began physical therapy, which improved strength. Had more testing witch indicated nerve damage. Last Dr. was about 2 months ago and Dr. said there was improvement in one nerve and deterioration in the other. He reports now that he he has permanent nerve damage in left arm, ring  and pinky fingers.  Said that he has numbness and desensitization in fingers and arm. Every couple days he has pain in the region the shot was given and near the crease of the elbow. Says he has burning, sharp pain like a lit cigarette is touching his harm.
patients that were administered the expired Fluzone with no AE; Initial information was received on 15-Oct-2021 regarding an unsolicited valid non-serious case from consumer/non-healthcare professional via call center via Agency (Reference number- 00814619).  This case is linked to case 2021SA345109(CLUSTER).  This case involves a 26-year-old female patient who received the expired dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (expired product administered).  The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  On 03-Sep-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: QFAA2017 and expiry date: 30-Jun-2021) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  It was reported "they gave 15 patients expired Flublok vaccine, and wants to know what to do. There were 16 patients that were administered the expired Fluzone."  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.
Employee thinks may have developed ocular respiratory syndrome. Took vaccine in am on 10/25. Around 2pm throat felt a little tight, nose was slightly runny and felt slight muscle aches. When stood up felt BP drop, but later thought that may have been coincidental since was also having hot flash. States when has hot flashes, BP always goes down. Went home, drank fluids and went to bed, When woke up at 7pm eyes were matted shut. "Looked like peanut butter on my eyelashes". No ocular redness. Face may also have been slightly puffy. Also experienced another drop in BP, but again associated with hot flash. When woke up next am felt fine.
Patient received a COVID-19 vaccine on 05MAR21 @ 1600 at our onsite clinic.  He became light-headed, he was seeing "spots" and had cold sweats.  He laid down on a cot.  His blood pressure was 126/82, heart rate 64, respirations 14 and oxygen saturation 95% at 1615.  He slowly sat up, drank some water and was monitored an additional 30 minutes by our onsite nurse.  He was instructed to follow-up with our onsite nurse with any additional concerns.
Fever, body aches, chills, nausea, light sensitivity, weakness/fatigue/exhaustion, lethargy for 3-4 days starting from day of vaccination
I received the first Pfizer vaccine shot and within hours, I felt dizzy, fatigued and short winded. For several weeks afterwards, I was having chest pains, shortness of breath and fluttering in my chest when I tried to exercise. I was experiencing the symptoms of myocarditis.
I broke out in hives all over about 10 days after. I have never broken out before or been allergic to anything.  My doctor prescribed a steroid but it didn?t not go away after I finished the pack. I take Zyrtec each night which helps keep the hives very manageable but if I forget to take it then I am very itchy.
Monovalent vaccine given as booster; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Monovalent vaccine given as booster) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (Monovalent vaccine given as booster).    No concomitant medications were provided.  It was reported that reporter found out that they could not gave the Moderna as a booster starting 31-Aug-2022, but administered monovalent doses as boosters. She was told that booster that they received did not cover omicron, so the patients would need to be revaccinated with the bivalent later.   No treatment medications were provided.
Patient had hives and rash approximately 2 hours after receiving injection. Mother states he had a possible reaction 2 years prior but last year he had the flu shot and did fine. He received Benadryl in the office and a script for prednisolone.
Morbiliform rash began on face -> spread to trunk, was GU area LE spared non-pruritic, afebrile, mother gave BENADRYL x3 doses thinking it was as an allergic reaction. Rash resolved within one week. No further complaints.
Hives on chest, left arm, and stomach; Some itchiness on the arm; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 06Apr2021 at 16:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and high blood pressure. The patient was not allergic to medications, food, or other products. Concomitant medications included insulin (MANUFACTURER UNKNOWN) taken for unknown indication from unspecified date, unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 20:00, the patient experienced hives on chest, left arm and stomach, with some itchiness on the arm. These events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with application of cooling ointment on skin. The clinical outcome of the events hives and itchiness were resolved on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
High fever, 100 degrees, and severe uncontrollable shakes, severe headache.  No vomiting or diarrhea.  Paramedics called but vitals were all good except high fever.  Took OTC Tylenol PM or Tylenol every 4 hours and lots of sleep.
Itchiness; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itchiness) and INJECTION SITE PAIN (Pain at injection site) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M2014) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PRURITUS (Itchiness) and INJECTION SITE PAIN (Pain at injection site). At the time of the report, INJECTION SITE PRURITUS (Itchiness) and INJECTION SITE PAIN (Pain at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
diarrhea; stomach pains; vomiting; nausea; muscle ache/body ache; joints pains; chills; fatigue and tiredness; itching at the site of the injection,; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach pains), VOMITING (vomiting), VACCINATION SITE PRURITUS (itching at the site of the injection,) and NAUSEA (nausea) in an 86-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.     The patient's past medical history included Diverticulitis. Concurrent medical conditions included COPD. Concomitant products included TIOTROPIUM BROMIDE (SPIRIVA), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and ALPRAZOLAM (XANAX) for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the site of the injection,). On 20-Mar-2021, the patient experienced DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach pains), VOMITING (vomiting), NAUSEA (nausea), MYALGIA (muscle ache/body ache), ARTHRALGIA (joints pains), CHILLS (chills) and FATIGUE (fatigue and tiredness). At the time of the report, DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach pains), VOMITING (vomiting), VACCINATION SITE PRURITUS (itching at the site of the injection,), NAUSEA (nausea), MYALGIA (muscle ache/body ache), ARTHRALGIA (joints pains), CHILLS (chills) and FATIGUE (fatigue and tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included other psychotropic agents(not specified).The patient did not take any treatment medication.
Patient called today (09/02/2015 @ 9:30am) and reported that she has rash on her stomach and back and the rash or stomach looks like a scab. Called manufacturer and manf. did advise that rash should be on the area of injection.
Pt was given OPV/DTP/HIB p/shot pt cried then made some sounds poss secondary to laryngospasm; Did not stop breathing but became cyanotic for 1-2 sec; HR 120-130 min; Lungs positive air exchange but shortened breaths which was transient;
Rash swelling primarily to arm injected.; Rash swelling primarily to arm injected.; Chills; fatigue; mild nausea; This is a spontaneous report from a contactable nurse. A 50-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EH9899), Intramuscularly on 17Dec2020 08:15 AM in left arm at single dose for COVID-19 immunization. The COVID-19 vaccine was administered at hospital. Medical history was not reported. The patient had unknown allergies. Concomitant drugs in two weeks included Glucosamine, curcuma longa rhizome (TURMERIC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced rash swelling primarily to arm injected, chills, fatigue, mild nausea on 18Dec2020 08:00 AM. No treatment received for the events. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of events was recovering.  No follow up attempts are possible. No further information is expected.
This is a spontaneous report from a contactable consumer or other non hcp via a Pfizer sponsored program COVAX US Support. A male patient (reported for himself) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 15Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced soreness in the arm/ pain in one side of the hip radiating towards the other side in 2021, fever, chills, then the whole body as well on 16Feb2021, he could not move in 2021. He experienced soreness in the arm which he could not move. The next morning, he experienced fever (103'F), chills (needing 4 blankets just to get by), and pain in one side of the hip radiating towards the other side and then the whole body as well. Second dose will be on 08Mar2021, but he is kind of hesitant to take it and needs to talk to someone about it. The patient underwent lab tests and procedures which included body temperature: 103'f fahrenheit on 16Feb2021. The outcome of the events was unknown. No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
Nausea, headache, dizziness and visual problems on 6-19-06 referred to hospital er.
Patient presented to facility with fever, cough, nausea, decreased appetite. Patient has previous medical history of hypertension, chronic kidney disease, and pre-diabetic. onset of symptoms was three days before admittance. Patient reported to have COVID test done before being admitted, but no record from health department is showing that test was done.
sensorineural hearing loss with tinnitus I had a headache the day after the vaccine and the 2nd day after vaccine I had fullness in my ears and felt like a bubble was in left ear.  I kept yawning and swallowing all day trying to "pop" it (similar to what happens at altitude in an airplane). At 6pm I suddenly had loud tinnitus in left ear that was exceptionally upsetting.  Could not get away from loud ringing and echoing in my left ear. I realized sometime later that I had a hearing loss in left ear. Saw MD the following day and hearing loss documented with audiogram.  Started Prednisone 60mg/day and hearing returned to normal the next morning 4/17/2021. Tinnitus, however, is still continuous although it's severity fluctuates. Can be difficult to talk to several people inside due to echoing and the fullness in the ear is very annoying.
Vaccine administered 12/31/20.  SCAD heart attack on 01/21/21.
Patient turned pale about 2 min. post first HPV-9 vaccine. He became a little dizzy but no syncope, pt. still alert and oriented. Pt vomited x1 then started to feel better - color returned within 5 min. Monitored Pt's vitals, and Pt for another 20 min. Pt doing well today (7-25-17).
This spontaneous report was received from a registered nurse and refers to a 3 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 30-SEP-2016, the patient was vaccinated with an improperly stored PROQUAD lot # M022402 with expiration date of 01-NOV-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 3 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1705USA013888:
Vaccine was given on 2/27/23- vaccine use by date was 2/12/23.  No harm, no reports of negative side effects.  Contacted Moderna and given the following information: "Analysis of the vials associated with your storage excursion is complete. The vaccine administered on February 27, 2023 from lot number 015B22A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration"
Patient presented to the ED on 5/2/2021 for left ankle swelling. Patient presented to the ED on 5/10/2021 for diabetic ulcer of right midfoot and pneumonia and was subsequently hospitalized. These visits are within 6 weeks of receiving COVID vaccination.
Patient received vaccination for influenza today and within 45 minutes began vomiting in the restroom. The patient doesn't feel good. The patient does not have any hives, shortness of breath, or signs of allergic reaction. The patient does not feel light headed.
Injection site turned red and hot to touch 31/2" x 21/2" instructed to take BENADRYL as directed and put cold compress on it.
Vaccine given on 6/5/01. On 6/15/01, hives began on right foot. She presented with redness, swelling, pain, itching and heat. Preceded to spread throughout body (hands, feet, arms, legs, torso, neck and head). Seen by MD in ER and was given prednisone and Allegra. Seen again in ER and was given a higher dose of prednisone, Cimetidine and Benadryl. Seen by another MD for asthma and allergies and was Allegra 180mg; Cimetidine 400mg and Zyrtec 10mgs. These medicines finally brought the hive under control. None of the previous medicines had provided much relief. The ER doctor as well as the other doctor provided a dx of urticaria.
Woke up several time the following night. When I officially woke up the next morning I had cold chills with clammy skin. I felt so hazy walking, almost like vertigo.
Information has been received from an emergency room physician concerning a female patient who on an unknown date was vaccinated with GARDASIL.  The emergency room physician stated that she received a call from the patient's primary physician who stated that the patient will be sent to the ER because she experienced weakness symptoms.  At the time of reporting the patient had not recovered.  The patient sought medical attention, contacted the physician.  No further information is available.
BlurredVision, Headache, Sedation, Myalgia, Arthralgia, Fever, NauseaVomiting, Paint at injection site, Sore throat, Swelling/itching of right eye Narrative:
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving expired doses) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. No Medical History information was reported. On 24-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving expired doses) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications details were not reported by the reporter. Reportedly, 12 doses or vials were initially stored in the refrigerator on 31-Aug-2021. The vials did not undergo any temperature excursions. It was reported that doses were administered after 30-day use by date or after manufacturer date of expiry. Reporter wanted to clarify that this information provided by email was from new patients different than previous patients reported by her colleague on 31-Mar-2022, and that some of these new patients belongs to different clinics but all of them pertained to the same community clinic. Treatment details were not reported by the reporter. This case was linked to MOD-2022-534284 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2022: Follow-up document contains additional information regarding patients on same community clinic.
pt recvd DTP/OPV on 7OCT92; only complaint p/vax was sore leg; on the morning of 8OCt was noted to be pale & felt faint; no loss of consciousness; was seen in MD office; mom had noted red splotchy rash on lt leg which resolved;
Pt recieved Fluzone HD and 2 hours later experienced chills, low temperature, and low pulse rate.  6 hours later pt was ok.
Pt was in vaccination chair and began to feel faint post vaccination. Pt states hx of feeling faint with blood draws and vaccinations. Pt was always fully conscious and talking. EMS called to Pt side and cared for Pt. Pt offered water and VSS per EMS. Pt discharged home with wife driving post 15 min observation per EMS.  VS 0841 BP 100/palp HR 62 RR 16 Temp 98.6F O2 sat 100% on RA