chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Syringe leaked and the patient did not receive full dose; Vaccine leaked on patient or nurse's skin; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, the syringe leaked and the patient did not receive full dose, and the vaccine leaked on the patient or nurse's skin.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 30 Dec 2020, the pharmacist called to report that when they vaccinated the patient, the syringe leaked and the patient did not receive the full dose. The pharmacist stated that they are not sure if the vaccine leaked on the patient or on the nurse's skin. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The events, the syringe leaked and the patient did not receive full dose and the vaccine leaked on the patient or nurse's skin, were considered resolved on 30 Dec 2020.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Incorrect dose administered and Exposure via skin contact without any associated adverse events.
I got COVID-19. I was exposed sometime and I tested positive; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6203 and Expiration date was not reported), via an unknown route of administration on 03Mar2021 at 15:45 in left arm, as UNKNOWN, SINGLE DOSE for COVID-19 immunization. The patient did not receive any other vaccine in four weeks of vaccination. The patient had no known allergies. The patient medical history included prediabetes and hypertension. The patient received Metformin, Lisinopril, levothyroxine sodium (SYNTHROID), metroprol, colecalciferol (D3), cyanocobalamin (B12), within two weeks of vaccination. Patient was not diagnosed with covid prior vaccination. Post vaccination patient tested positive for COVID. The patient reported that she got COVID-19. She was exposed sometime, and she tested positive on 09Mar21. She was now Covid positive and hopefully recovering. The patient had Covid test post vaccination: covid test type post vaccination (nasal swab), underwent Covid test date on 09Mar2021, test result was positive. Treatment was not received for the reported events. The outcome of the event was reported as recovering.
A serious report of dehydration and constipation has been received from a study investigator concerning a four-year-old female (subject number 03402040) participating in a post marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The subject's medical history included iron deficiency anemia. No concomitant medications were reported. On 14-Sep-2009, the subject received FLUMIST 0.25 ml per nostril. She received a total of one dose of FLUMIST before onset of the event given on 14-Sep-2009. The subject's mother reported that one week prior to hospitalization, the subject had cough and runny nose with intermittent fever of low grade. On 14-Sep-2009, the subject was diagnosed with otitis media and began taking AMOXICILLIN orally. One day prior to the hospital presentation, on 16-Sep-2009, the subject had nausea and began vomiting while febrile and could not keep down water. She was brought to emergency room, The subject was given three normal saline boluses for a total of 60 ml/kg in the emergency department, and she received ondansetron orally and intravenously. She continued to vomit and failed two oral challenges. Her white blood cell count had left shift, and urinalysis was positive for ketone. Other laboratory test results (electrolyte count, glucose and complete blood count) were normal. On 17-Sep-2009, the subject was admitted to the hospital for hydration. Due to intermittent discomfort and protracted vomiting as well as the report of low grade fevers, a KUB was done and showed no sign of obstruction but was significant for constipation. An abdominal ultrasound was obtained to rule out intussusception or an abnormal appendicitis and was normal. She continued to vomit and a non-contrast head computerised tomogram was performed, and the results ruled out intracranial abnormality as a potential cause of acute onset vomiting. The subject had fleets enema x 2 with stool output for constipation. She had persistent vomiting the day of admission which ceased overnight with return of bowel sounds. She was able to tolerate clear liquids as Jell-O and crackers with no pain or nausea, and intravenous fluids were discontinued. Follow-up electrolytes and complete blood count were normal. At discharge, the subject was tolerating diet described above with no intravenous fluid requirement, alert and active playing in the playroom. She was afebrile with normal vital signs. The events of dehydration and constipation were resolved on 18-Sep-2009. The investigator assessed the causality for the events of dehydration and constipation to FLUMIST as none. The severity of the event was mild. The alternative etiology was natural causes. The sponsor assessed the causality for the event of dehydration and constipation as not related to FLUMIST.
redness, itching & wheal @ site-no fever;DPH prescribed by phone;
NO ADVERSE EFFECTS.  EMPLOYEE TOOK VACCINE ON 05-16-2008 AND FOUND OUT ON 05-20-2008 THAT SHE WAS PREGNANT
got vaccinated and still have gotten shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the vaccinated with Shingles and still had got shingles 4 times. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Eight days post injection a rash started at the injection site.  Rash was about 4 inches in circumfurance, warm, itching, and sensitive.
Patient presented on 4/22 with gross hematuria for 3-4 days.
Patient received a dose of the Jassen covid vaccine and was sitting in the waiting room for his 15 minutes of observation. After about 10 minutes he passed out and fell out of his chair bumping his head on the way down.
Employee got 2nd dose of pfizer vaccine on 1/12/21 and on 1/13/21 she started having tachycardia resting 120, walking 150. she did not have this at the time of her first dose. She also feels warm, chills and fatigue but those are improving. She was urged to go to urgent care to get evaluated.
My initial symptoms described below started within hours (sore arm and swollen lymph) and continued 7-10.  Joint, muscle aches; diarrhea, extreme fatigue, headache, sharp  pain in head, brain fog/confusion, flu like symptoms, chills.  Today experiencing many of those same symptoms and unknown if it?s related. I?ve had good days in this last month as well. I postponed 2nd shot.  Herpes outbreak as well which I have Very seldom. Immune system definitely fighting hard!
Head bobbing (fully alert) frequently since 1 week post shots. 1st set given at two secondary to sick at 2 months. Immediate reaction was 5 minutes of not being able to catch her breath to cry, wanting to cry, whining, no deep distress, every time she awoke for 24 hours. Temperature 103 24  hours later. Then decreased muscle tone. Stopped rolling - just started again. No cooing since that time. Still not cooing.
Headache  Chills Fever Diarrhea  Nausea Abdominal pain Retching for  6 hours
the pneumonia vaccine left her arm sore; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (reported as fall; Batch/Lot number was not reported) as Dose number unknown, single for immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 27Mar2021 11:40 for COVID-19 immunization and experienced Coughing, feeling dizzy and Lightheadedness, Weakness and Trouble Walking. It was reported that the patient got both flu and pneumonia vaccines in the fall and the pneumonia vaccine left her arm sore for a few days. The outcome of the event was unknown.  No follow-up attempts are needed. No further information expected.
Sore throat; difficulty breathing/harder to breath/hard in breathing; Chest pain; chest tightness; This is a spontaneous report from a contactable consumer (patient, self-reported). A 35-year-old female patient (age at vaccination: 35 years) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0181 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 14Jun2021 at 11:45 AM, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient took Pfizer COVID 19 vaccine because she wanted to be a part of the solution not the problem. The patient did not receive any vaccine within 4 weeks prior vaccinations. There were no adverse events following prior vaccinations. There was no family medical history relevant to adverse events. The patient explained after vaccination on 14Jun2021, she experienced "chest tightness and difficulty breathing", but that has resolved. She asked if her symptoms were normal after vaccination. The patient added her colleague said her symptoms were linked to a heart conditions and she should have a chest X-ray. She said she was nervous about her symptoms and asked for what to do. The report was related to a study or program. The patient mentioned after getting the vaccine Monday after 2 hours, on 14Jun2021 at 12:00, she had chest pain almost immediately and hard in breathing. Now sore throat today. She had the vaccination and sat and hung out for 15 minutes; and after that when she started to walk around her chest felt tight; she was unloading the groceries, and it was a little harder to breath than normal; told her mother her chest hurts a little. Added she goes grocery shopping often and loading the eggs and cheese was normal for her. Yesterday she felt fine. Today, she noticed at about 03:00 AM or 04:00 AM on 16Jun2021, she had sore throat. The chest tightness was gone by the end of the first day; about 15:00. She was asking was this normal. Her second dose was scheduled for 05Jul2021. She took amoxicillin, she had extra, so she took one because she thought she might be getting strep. She couldn't remember if it would help or not. She had a baby and has not been sick since she had the baby. She was unsure if she didn't have a baby, would she just be in bed getting better. A girl at work told her the chest pain might be a sign of heart condition and that freaked her out. She mentioned she called (withheld) to see if they had the COVID test. She wanted an over-the-counter test, and she found a place that has one but it was hard for her to get out with the baby. She decided she would call the number on the vaccination paper first, so she called Pfizer. The adverse events did not require a visit to emergency room or physician office. Therapeutic measures were taken as a result of sore throat. Outcome of the event chest tightness was recovered on 14Jan2021 at 15:00 and the events difficulty breathing/harder to breath/hard in breathing was and chest pain was recovered on 14Jan2021. Outcome of the event sore throat was not recovered.
Systemic side effect started next day, fever, myalgia, ache all over the body, chills, couldn't get out bed, weak, lethargic. Had a kind of knot at the site of injection, Started improving after 2 days
PATIENT REPORTED TO CLINIC 30 MAY 2014 C/O MULTIPLE LESIONS TO SMALLPOX SITE TO RT DELTOID AREA AFTER RECEIVING TATTOO TO AREA ON 23MAY2014 AGAINST MEDICAL ADVICE. PATIENT SEEN BY PROVIDER AND TREATED WITH BENDARYL AND IBUPROFEN. INSTRUCTED ON HOW TO TAKE CARE OF LESIONS AND TO F/U EVERY 2 DAYS.
When I caught COVID-19 I had excessive coughing. I had  a runny nose and a headache. I felt generally lethargic and feverish. One time when I checked my temperature it was normal but I still felt a little feverish. I have been tired. I have had to take a nap everyday. I called my doctor, and I was prescribed PAXLOVID.
This spontaneous report as received from a health care worker refers to an unknown number of patients with unknown demographics. Approximately on an unknown date in the year 2014, unknown number of PNEUMOVAX 23 vaccines undergone temperature excursion and improperly stored had been administered to an unknown number of patients. No adverse effects were reported. No additional information was provided. No product quality complaint was involved. Additional information has been requested.
Left arm very swollen, red, itchy, swelling large hot erythema small flat papules measuring 20cm in length and 5cm wide. No lymph node swelling. Painful to patient.
This spontaneous report as received from a medical assistant refers to two unspecified patients of unknown age and gender. On 11-MAY-2015, the patient was vaccinated with a dose of VARIVAX (Merck) that had been improperly stored. On 13-MAY-2015, another unspecified patient received a dose of VARIVAX (Merck) which had been improperly stored too. Dosing, routes of administration, lot numbers were not provided. No adverse effect was reported. Additional information has been requested.
Sudden onset of dizziness, clammy, headache, hoarseness, swelled eyes, soreness in my joints.  No fever or stomach upset. Mostly dizzy, felt like I was in a fog and missed a day of work.
Severe vomiting one hour after injection. Vomited 7 times over the next 12 hours.
Plaque Psoriasis flare up; A spontaneous report was received from a Healthcare Professional concerning about his son in law a 37-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events as plaque psoriasis flare up.  The patient's medical history was not provided.   Concomitant medications reported were Otezla oral solid, Prednisolone oral solid for drug use for unknown indication.  On 12 FEB 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient experienced the events plaque psoriasis flare up.  Treatment details included Prescription Medications:, Otzela-chronic psoriasis, Prednisolone 15mg daily.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, plaque psoriasis flare up was not reported.
the patient was administered improperly stored VARlVAX; This spontaneous report as received from a medical assistant and refers to a 3-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 10-AUG-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, route of administration, anatomical location were not reported; lot number S025608 was confirmed to be valid, expiration date 18-AUG-2021) which was reconstituted with properly stored sterile diluent for prophylaxis. Administered dose of vaccine experienced multiple temperature excursions. It was stored in a temperature of -12.5 degrees Celsius for 1 minute and second time in temperature of -14 degrees Celsius for another1 minute. Data logger was involved. There were no previous excursions reported.
At 9:00 PM yesterday I had full body chills, body aches, and nausea. At 11:00 PM a fever of 100.4. About 20 minutes later my fever went up to 101.6. At this time I took Tylenol. With the fever came a head ache. My injection sight is very painful. I did not sleep very well. When I woke up at 7:00AM my fever was 100 degrees. It has stayed at 100 degrees until this point (1:30 PM). My headache became painful enough that I took 2 excedrin that have relieved most of the headache. My symptoms are improving as the day progresses. My injection site is still very painful. With the normal flu vaccine I get yearly I have never had any problems.
4 days after receiving FLUVIRIN and PNEUMOVAX vaccines he developed fever to 101, myalgias, headache, fatigue.
Fever, chills, headache, body aches, skin very sensitive, nausea. Naturally my digital thermometer battery had died.
A PENTACEL was given on the same day as PEDIARIX instead of an ACTHIB. A PREVNAR was also given in the same visit.
Strong shivering from 1 a.m. until 6 a.m., preventing sound sleep.
Only sore arm after the first two doses of Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Only sore arm after the first two doses of Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Only sore arm after the first two doses of Moderna vaccine). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, MYALGIA (Only sore arm after the first two doses of Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant informations were reported.   This case was linked to MOD-2021-402682, MOD-2021-402739 (Patient Link).
1/2hr p/vax pt became ill, dizzy & nauseated;felt funny, muscle weakness, fatigue, fever lasting 48hr;arm was very sore immediately;
I had an RA flare a sciatica flare, and the pain got intense on my left shoulder. I'm getting an MRI for it tonight. The perezone and araba have been prescribed to help me with this issue.
pt recvd vax & was limp, pale & grey, & looked very ashen; This episode lasted approx 10-15 mins a/spontaneously resolving; poss collapse reaction; MD felt pt should only have DT & be declared pertussis allergic;
Pt recvd 3 doses of Engerix-B 30OCT90, 30NOV90 & 2MAY91 & 11SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
About a week after the 2nd dose, I started feeling like my heartbeat was racing. I ignored it at first. I started to feel dizzy. I was getting body aches and pains. I finally made an appt 2 weeks later at our urgent care center. They told me that my blood pressure was higher laying down than when I was sitting up. They told me to go to the ER. They did blood work, EKG, and a chest x-ray. I was sent home on prescribed lisinopril. Then I went to primary care. Now she has sent me for blood work that I just had done and an echocardiogram because I am still feeling chest discomfort. My right leg is also hurting. It's a dull pain in my lower right leg and it's been there for 3 days. I am waiting to get my echocardiogram done. My appointment is for December 7th. For right now, I have to deal with all my symptoms. I was diagnosed with hypertension and put on medication. I have never had this before. I am still waiting on my blood test results. It all of a sudden happened right after I got my vaccine. It's hard for me to walk because I feel like someone is sitting on my chest and my leg is still hurting.
Several fever, several hours after the Prevnar (Prevnar 20); developed a fever 99.3 to 100.3 up until last night though I received Prevnar (Prevnar 20); Several illness; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 70-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 02Jun2023 as dose number unknown, 0.5ml single (Batch/Lot number: unknown) at the age of 70 years intramuscular, in left deltoid for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 02Jun2023, outcome "recovered" (05Jun2023), described as "Several fever, several hours after the Prevnar (Prevnar 20); developed a fever 99.3 to 100.3 up until last night though I received Prevnar (Prevnar 20)"; ILLNESS (non-serious) with onset 02Jun2023, outcome "unknown", described as "Several illness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, illness. Additional information: Reporter stated, "Several illness, several hours after the administration of Prevnar 20." Paraphrased the concern: Reporter stated, "Several fever, several hours after the Prevnar (Prevnar 20). I developed a fever 99.3 to 100.3 up until last night though I received Prevnar (Prevnar 20) on Friday, 02Jun2023, as of last night I had a fever of 100.3." The patient went to the urgent care and was given Tylenol, 650 milligrams, PRN, as needed. The patient's condition improved today. The patient's fever stopped on 05Jun2023.   The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
after receiving my third dose of the covid vaccine in my left arm, the glands in my left armpit got swollen; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 13Oct2021 at 18:30 as dose 3 (booster), single (Lot number: FH8020) at the age of 51 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Vaccine administration date: 14Mar2021, time: 02:30 PM, lot number: EN6206, dose number: 2, location: Left arm,), administration date: 14Mar2021, when the patient was 50-year-old, for COVID-19 immunization; BNT162b2 (Vaccine administration date: 21Feb2021, time: 03:30 PM, lot number: EN6198, dose number: 1, location: Left arm), administration date: 21Feb2021, when the patient was 50-year-old, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 15Oct2021, outcome "unknown", described as "after receiving my third dose of the covid vaccine in my left arm, the glands in my left armpit got swollen".  Additional information: within 48 hours after receiving third dose of the covid Vaccine in left arm, the glands in left armpit got swollen and did not go down for at least a month. patients believe they remained slightly swollen for months.   No follow-up attempts are possible. No further information is expected.