chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHHY2011US69628 is an initial spontaneous report received from health care professional on 29 Jul 2011. This case refers to 11 year old male patient. He was vaccinated with MENVEO (batch number: M10034) 0.5ml intramuscularly on 28 Jul 2011. But, he was given only Men A conjugate conjugated vaccine reconstituted with a sterile diluent instead of Men CYW-135 liquid conjugate. No adverse reaction had occurred following this drug administration error.
Employee complained of discomfort at time of IM injection of 2nd Hepatitis B vaccine. States pain has persisited since vaccinated. Dull ache in deltoid area at the beginning. Dull ache has continued to progress and involve whole deltoid muscle and symptoms of numbness developed. Numbness is down arm, but is concentrated above and below the elbow. Denies numbness and stingling in hand. States there has been a developing decrease range of motion of the shoulder area and feels pain when trying to reach behind. ROM pain noticed with dressing. After the IM injection, states she has been taking a total of 800 mg ibuprophen 2 (200 mg) once in am and once in pm. Has tappered ibuprophen to 2 (200 mg) in evening. If ibuprophen not taking, pain comes back. When taking ibuprophen pain is relieved.
Pt woke up 2 days later with excruciating pain in the knee throughout the day that has been semi relieved by ibuprofen 600mg TID. His knee buckled twice  while walking. 1st time the knee collapse and he fell backwards.  The 2nd time his knee froze with excruciating pain and had to fall over because it locked.  Tonight, he is resting with his knee elevated and will schedule an appointment with his primary for further evaluation. (Only on the right knee.) (Today is day 2 of the symptoms of the knee buckling and pain. Day 1 was the arm pain, slight headache, weakness.)
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild
Systemic: patient fainted after injection regained conciousness in few seconds-Mild, Additional Details: faintedafter injection
Patient had fainting and blackout post vaccination. Patient has lied on the floor immediately and ambulance was called. Upon arrival of ambulance it was found patient had low BP 56/36 mm Hg.  So, patient was advised to be hospitalised by the ambulance team.
Information has been received from a registered nurse concerning a 58 year old female with asthma and cardiac arrhythmia who the morning of 9/7/05 was vaccinated in the left deltoid with an IM 0.5ml first dose of Pneumococcal 23v polysaccharide vaccine (lot 650457/0973P). Concomitant vaccination that morning included a SC first dose of meningococcal ACYW polysaccharide vaccine (Menomune AlClYlW-135) (lot UE4804A) in the left arm. There was no illness at the time of vaccination. On 9/14/05 the patient called the office complaining of a headache and tingling in her fingers. Unspecified medical attention was sought. No lab test were performed. There was no product quality complaint involved. Follow up information indicated that the patient complained of a headache several hours after vaccination which persisted for three days. On 9/13/05 profuse sweating began which lasted three days. The patient stated that she had to get up during the night several times to change gowns. The patients temp was not taken. It was reported that all complaints ended by 9/17/05, the pt was considered to be recovered. Neither the pt nor her sibling had an adverse event following prior vaccination. Additional information is not expected.
3-4 days of sore throat, aches, cough fever 102-103 degrees  x 2 days
Became tachycardic approx 30 post vaccination Began running fever 103.0 approx 1 am  on 10/30/21. Fever remained above 102 with rotating doses of Tylenol 1000mg and Ibuprofen 800mg
Initial non-serious report received from a consumer on 22 September 2011 under the local reference number 11-0609. A 70-year-old female with a medical history of fibromyalgia, diabetes and sleep apnea had received an intramuscular dose of FLUZONE HIGH-DOSE (batch number unknown) in the left arm in early September 2011 at 2:00 p.m. The patient was under concomitant treatment with VICTOSA and "FORDm". The patient had no illness at time of vaccination and no known allergies. 7 hours after vaccination, the patient had her left deltoid sore and warmth at injection site. She also experienced nausea and "night sweats" all night. According to the reporter, symptoms resolved except arm which was reported as "a little sure". The patient treated herself with TYLENOL. At the time of the report, the patient's outcome was unknown. Follow-up information was received from a health care professional on 03 January 2012. The lot number for FLUZONE HIGH-DOSE was reported as UH439AA. No further information was available at the time of the report. The patient's outcome was not reported. Follow-up information was received from a health care professional on 02 March 2012 reported that the patient recovered. Documents held by sender: none.
hair loss became more prominent, mother is basically bald now; she has been having diarrhea off and on; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair loss became more prominent, mother is basically bald now) and DIARRHOEA (she has been having diarrhea off and on) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ALOPECIA (hair loss became more prominent, mother is basically bald now) and DIARRHOEA (she has been having diarrhea off and on). The patient was treated with BISMUTH SUBSALICYLATE (KAOPECTATE [BISMUTH SUBSALICYLATE]) for Diarrhea, at a dose of 1 dosage form. At the time of the report, ALOPECIA (hair loss became more prominent, mother is basically bald now) and DIARRHOEA (she has been having diarrhea off and on) had not resolved.            Concomitant medication included unspecified medication for blood pressure.  It was reported that the patient experienced diarrhea once or twice every week, or every other week. It was also reported that when the patient was taking medicine for diarrhea, it was going away but was coming back after sometime.   This case was linked to MOD-2021-419573 (Patient Link).
Rabavert given on 9/14/01. Telephone call on 9/17/01, reporting itching and rash. Pt seen on 9/17/01. Rash was over face and neck and itching had started on 9/16/01. No difficulty in swallowing or breathing. Left eye swollen. Medrol dose-pack ordered and Benadryl cream for itching.
PFIZER COVID BOOSTER GIVEN 01/11/2022, LOT #999; pt to ED on 2/11/22, states he did an at home COVID test on 2/3/22 and it was positive; found to be positive in ED for COVID; increasing  SOB; hypotensive with hypoxia; given fluids; placed on NRB mask; given Dexamethasone; Tocilizumab; Pneumonia secondary to COVID; pt requested DNI, but is ok to receive cardiac meds and CPR if needed; respiratory status worsened requiring BiPAP; pt kept removing BiPAP; placed on Vapotherm and 100% NRB; grave prognosis; wife made pt a DNR/comfort care; pt expired in the hospital
Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to an approximately 67-year-old female patient (pt). No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 26-JAN-2012, the pt was administered the zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not specified) at clinic for prophylaxis. On an unknown date in 2015, the pt was caused to suffer shingles, including any and all of its sequelae. As a result of her receipt of zoster vaccine live (ZOSTAVAX), the pt had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. She was caused to suffer serious, dangerous side effects including shingles, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. The pt required or would require more health care and services and did incur medical, health, she would in the future be required to obtain further medical and/ or hospital care, attention, and services. In addition, she suffered and would continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. Her direct medical losses and costs included physician care, monitoring, and treatment. She incurred and would continue to incur mental and physical pain and suffering. The outcome of the event of shingles was considered to be not recovered. The lawyer considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).   The event of shingles was considered to be disabling.
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Additional Details: Pt apeared to have HTN crisis / seizure like aftivity 3 min after injection. Airway and then consiousness was lost with no breathing.  EMS was called pt was assisted to floor and after opening airway and stimulation regained consiousness.
In approx 24 hrs, area itched and evident of redness that progressively enlarged in size to max of 3" by 2" and lasted over 2 wks.  Now has sign of dry, flaky skin at inj site.  Discomfort to area last 2-4 day.  I feel administration of inj was the problem.  Not S.Q. felt like rough IM.
This case was considered medically important (OMIC). Information was received from a published literature article concerning vaccinating health care workers against smallpox in an isolated primary care facility. The article describes the authors' experience implementing a smallpox vaccination program and its effect on routine operations in an isolated hospital and its nine satellite clinics. Their program included an extensive educational component provided to each person, whether or not they were to receive vaccine. A child of one of the vaccinated healthcare workers developed skin lesions suggestive of secondary vaccinia. Relevant medical history was not provided. Indication for smallpox vaccination was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. A child developed skin lesions suggestive of secondary vaccinia following exposure to the parent, who was a healthcare worker who received the smallpox vaccination through the vaccination program. The child was kept isolated from a daycare center for five days. The authors noted that the healthcare worker did not miss any time from work, and insurance covered all diagnostic testing. The authors concluded that it is as important to address a potential recipient's perception of vaccination, as it is to inform them of scientific fact. They credit an aggressive preliminary education campaign for the compliance in their smallpox vaccination program. Polymerase chain reaction (results: testing for herpes and vaccinia virus was negative) was done on an unspecified date. This is one of three siblings who developed skin lesions suggestive of secondary vaccinia following exposure to a parent who had received the smallpox vaccination. No additional information was available at the date of this report.
This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the parent. A 6-year-old female patient received BNT162b2 (BNT162B2), on 18Aug2022 as dose number unknown (orange cap), single (Lot number: FL2757) at the age of 6 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 18Aug2022, outcome "unknown", described as "excruciating pain in her right leg, it was administered in her left arm/ extreme pain in her right leg/ it was the worst pain"; CRYING (non-serious) with onset 18Aug2022, outcome "unknown", described as "she was just crying really bad". Therapeutic measures were taken as a result of pain in extremity, crying. Additional information: It was reported that, it had been like 4 hours ago (as reported). It was 7 or the reporter thought it was administered somewhere around 7 in the morning and everything was fine. She had put her in the bed, she was about little bit late and she just came downstairs about 10 minutes ago and all of sudden have excruciating pain in her right leg, it was administered in her left arm. She was complaining about extreme pain in her right leg and like she even stopped at a point and said she could not take it anymore, she had rather died, she cannot feel this, it was the worst pain she ever had in her life and she was just crying really bad. It was eased up a little bit, the nurse gave her some Ibuprofen. The patient concomitantly received vitamins probiotics. The patient did not had any prior vaccinations.
Patient is not feeling well right now; weak; dizzy; having a reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (having a reaction), MALAISE (Patient is not feeling well right now), ASTHENIA (weak) and DIZZINESS (dizzy) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2022, the patient experienced MALAISE (Patient is not feeling well right now). In January 2022, the patient experienced VACCINATION COMPLICATION (having a reaction), ASTHENIA (weak) and DIZZINESS (dizzy). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (having a reaction), MALAISE (Patient is not feeling well right now), ASTHENIA (weak) and DIZZINESS (dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by reporter.
one episode of pre-term contractions; Got vaccinated during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Got vaccinated during pregnancy) and PREMATURE LABOUR (one episode of pre-term contractions) in a 34-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L20A) for COVID-19 immunisation.     The patient's past medical history included Alcohol use (1 drink/day) from 03-Aug-2006 to 02-Oct-2020, Cigarette smoker (1 pack cigarettes/week) from 03-Aug-2003 to 06-Sep-2018, Pregnancy (live, full-term  birth) on 09-Jun-2018 and Pregnancy (live, full-term  birth) on 09-Sep-2014. Concurrent medical conditions included Depression and Anxiety. Concomitant products included CELEXA for Anxiety, VITAMIN D and PRENATAL VITAMINS for Pregnancy.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 21-Sep-2020 and the estimated date of delivery was 28-Jun-2021. On 29-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Got vaccinated during pregnancy). On 27-Mar-2021, the patient experienced PREMATURE LABOUR (one episode of pre-term contractions). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourteenth week of the pregnancy. The delivery occurred on an unknown date.  At the time of the report, EXPOSURE DURING PREGNANCY (Got vaccinated during pregnancy) had resolved and PREMATURE LABOUR (one episode of pre-term contractions) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, Ultrasound scan: normal (normal) normal findings.     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.   Treatment for pre-term contractions included unspecified medication.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: The patient information including medical history and lab tests, pregnancy information and vaccine information were provided.
redness/swelling /irritation  to upper arm- MD treating with ABT Levaquin x 7 days
Large rash around injection site, itchy, hot, and a lump at injection site.  First showed signs one week after injection, started as a lump and small red circle, grew and covered most of upper arm over the next 4 days.  Mostly gone one week later.
Sudden calm feeling of euphoria; Relaxed feeling; Slept better; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of EUPHORIC MOOD (Sudden calm feeling of euphoria), FEELING OF RELAXATION (Relaxed feeling), SOMNOLENCE (Slept better) and PAIN (Soreness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced EUPHORIC MOOD (Sudden calm feeling of euphoria), FEELING OF RELAXATION (Relaxed feeling), SOMNOLENCE (Slept better) and PAIN (Soreness). On 08-Feb-2021, PAIN (Soreness) had resolved. At the time of the report, EUPHORIC MOOD (Sudden calm feeling of euphoria), FEELING OF RELAXATION (Relaxed feeling) and SOMNOLENCE (Slept better) outcome was unknown.      No treatment information was reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report as received from a healthcare worker refers to 2 patients of unknown age and gender. On 12-AUG-2015 the first patient was vaccinated with a dose of PNEUMOVAX 23 (lot # K009876, exp. date 19-MAR-2016) (dose and route were not reported) and on 17-AUG-2015 the second patient was vaccinated with a dose of PNEUMOVAX 23 (lot # K009876, exp. date 19-MAR-2016) (dose and route were not reported). Both of doses were improperly stored. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Her upper left arm swelled and was hard .. about the size of a baseball.  It was about 3 1/2in. in length about 2 in in width.  I gave 1 1/2 tsp of Benadryl and 2tsp Motrin that night. on Nov. 9 it is still pretty swollen .. gave another round of Benadryl and Motrin. Still waiting on it to go down.
Incorrect amount of diluent used. Used 0.5 ml instead of 1.8 ml. Administered 0.3ml dose from the incorrect concentration.
onset of self-described 'sinusitis' a week after vaccine administration, and then 2 days after that developed severe tinnitus
This spontaneous report as received from a certified medical assistant refers to 3 patients of unknown age and genders. No patients' demographics, medical histories, concurrent conditions or concomitant medications were reported. On an unknown dates in August 2014 (also reported as "the week of 04-AUG-2015, she is unsure of the exact dates") the patients were vaccinated with doses of PNEUMOVAX23, 0.5 ml, intramuscularly, lot # J015868, expiration date 25-FEB-2015. It was reported that all three patients received PNEUMOVAX23 from the same lot. On approximately 07-AUG-2014 (reported as "around 07-AUG-2014, but she is unsure of exact dates") all patients reported the same reactions to the PNEUMOVAX23 vaccine. In August 2014 all three patients experienced pain in the entire injection arm, upper arm redness and swelling, measuring 20cm x 11 cm, which was hot to the touch. All three patients were feverish as well. The patients sought medical attention. The outcomes of the adverse reactions were unknown. Relatedness between use of PNEUMOVAX23 and the adverse events was not reported. Additional information has been requested.
Large bruise at injection site. At first, swollen and red skin. No itching or pain associated in that area. Skin on both arms up to neck exhibited red splotches. Hot to touch and at night before going to bed. Patient has had issues sleeping at night. Advised patient to see physician for further treatment and to let me know the outcome.