chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 04-NOV-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot# and expiration date were not reported), as prescribed and/or administered by a healthcare provider at a military facility, for the long-term prevention of shingles and zoster-related conditions. Subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a healthcare provider at a healthcare center, for shingles. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Information has been received from a registered nurse referring to three patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 30-SEP-2015 the patients received doses of improperly exposed RECOMBIVAX HB (lot # L010595, expiration date 12-NOV-2016, route and dose were not reported). Concomitant drug was not reported. All of these vaccines had been improperly exposed to 47.5F for 2 hours and 28.9F for 11 hours on an unspecified date prior to 30-SEP-2015. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Pt reported feeling achy all over the day after his flu shot. The following day is legs started to hurt, and the day after that his arms and legs had muscle twitches which persisted. The following day pt had numbness and weakness which resolved later that evening. Pt finally called the office 5 days after the vaccine that he was still having muscle twitching and his legs were going numb again. Pt given appt 23 mins after initial phone call as the weakness persisted, from the office he was sent to the ER, and evaluated there.
Pt developed chest tightness approx 10-15 minutes post vaccination. Also c/o HA and dizziness.  BP 138/63 HR 66 SpO2 98% RA  Pt brought to ER
Pt gotten a bump around injection site. Pt gotten injected Ceftriaxone 400mg  in office today around 2:37pm.
Over a 24 hour period she noticed increased swelling, tenderness, and warmth at the area of the injection site.
Fluzone High Dose was administered to 3 patients after too long in transit, no AE; Initial information received on 13-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to cases 2019SA318341 and 2019SA318343 (same reporter).  This case involves a 77 years old female was administered with a 05. ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ307AB, expiry date: 29-Jun-2020, via intramuscular route in the right upper arm) after too long in transit on 11-Nov-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to incorrect product storage.  At the time of reporting the patient had no 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.
Following 1st dose of the Moderna vaccine, a few days later, felt moveable lump in center of throat around the thyroid area, with a gagging feeling present. There were no prior issues with thyroid or throat, and not feeling ill. Concerned, scheduled a visit with Primary Care for 8/17 and spoke with NP, who stated it could be lymph swelling from the vaccine. To ensure it was not something more concerning, to get more information, she authorized an ultrasound. Ultrasound took place on 8/19. Results showed a cystic nodule/thyroid isthmus mass had developed, suspended below the isthmus. Scheduled a visit with an ENT surgeon on 9/8 to review results. Decided to watch and wait. Mass did not go down in size and became increasingly more uncomfortable. Also, cancelled 9/8 2nd vaccine dose. 9/22 had follow-up visit with surgeon and scheduled surgery to have it removed. 9/30 reported for surgery and had the cyst/mass taken out.
Severe arm pain, fever ,myalgias and fatigue for about 36 hours.   No lasting adverse effects. Not looking forward to second dose!
15 hours after injection: 102 fever with chills  first day then low grade fever for two more days  body aches headache loss of appetite arm soreness and redness still 5 days after vaccine
I still  have extremely horrible muscular skeletal full body pain and have not been able to manage my normal duties at home after receiving 2nd dosage of the vaccine. I have gone for acupuncture, massage therapy, and water therapy; however, none of the treatments work. I was prescribed Tramadol and it just isn't working for my symptoms.
Day after I received the shot. Late last night, my arm hurt but I was expecting that. This morning I was in pain, and my eyes hurt and I had a headache. I had my regular medication plus Tylenol and breakfast (toast and orange juice) this morning. By 10 am, I was extremely dizzy, and did not feel safe to walk. I?m too weak to fill out this form myself
Information has been received from a medical office concerning a 49 year old male with *no known drug allergies and* a history of epilepsy, mitral valve proloapse and aortic insufficiency with aortic valve replacement, who on 8/27/02 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent in his right arm. In the early morning of 8/28/02 the pt developed rigors, a 104.9 degree fever (also reported as 105), injection site pain and swelling, cyanotic nail beds and was unable to move his right arm. On 8/29/02 the pt was seen in the doctor's office where IV fluids were administered and the pt was then sent to the ER. Blood cultures taken in the ER were negative for growth and the pt was released. As of 9/3/02 the pt's adverse experiences had not abated. As of 9/6/02 the nurse reported that his recovery status was unknown. *As of 11/26/02, the PT's recovery status was not known. It was also reported that the PT had right shoulder pain, numbness and tingling in both hands, and inject site redness.* The pt's experiences *of rigors, fever, inject site pain and swelling, cyanotic nail beds, and being unable to move his right arm* were considered to be disabling by the reporter. Additional info has been requested.  Follow up on 07/08/2003: "Follow up information was received from the RN. On 05/09/2003, the patient was seen and the "reaction to shot has resolved".  The patient's experiences of rigors, fever, injection site pain and swelling, cyantonic nail beds, and being unable to move his right arm were considered to be disabling by the reporter.  Additional information is not expected."
Information has been received from a physician concerning a female who was vaccinated with the second dose of Gardasil. Subsequently the patient has not had a period since her vaccination and has slight vaginal spotting and sore breasts. The physician did not perform a pregnancy test. Medical attention was sought. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a physician concerning a female who on an unspecified dates was vaccinated with the first and second dose of GARDASIL (lot number unknown). The physician reported the patient has not had a period since her second vaccination. The patient has slight vaginal spotting and sore breasts. The physician did not perform a pregnancy test. Medical attention was sought. Additional information is not provided. Further information is not available.
no adverse event; patient received improperly stored vaccine; This spontaneous report was received from a medical assistant regarding a patient of unknown demographics. Information on patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 25-APR-2019, the patient was vaccinated with improperly stored Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (lot # R021078, expiry date: 12-JUN-2021), dose details, route, strength of all the vaccines were unknown) for prophylaxis. The vaccine was stored at a temperature range of (52.5 degree fahrenheit) for time frame of 4 hour 40 minutes. No previous temperature excursion involved. The digital data logger was involved. No adverse effects reported.
Arm and shoulder swelling, rash down back congestion, fever lips swollen and struggling to breathe, possible viral illness
tested positive for Covid 12Feb2021; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (tested positive for Covid 12Feb2021) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced COVID-19 (tested positive for Covid 12Feb2021). At the time of the report, COVID-19 (tested positive for Covid 12Feb2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, SARS-CoV-2 antibody test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: No new information. Patient denied consent.
BACK PAIN; SIDE PAIN; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced back pain, and side pain. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from back pain, and side pain. This report was non-serious. This case, from the same reporter is linked to 20211009261.
0.3ml of the Covid vaccine was administered by the nurse instead of the 0.5ml.  A second injection of 0.2ml then had to be administered to make up the full dose.
Nurse Practitioner reported while she was administering a dose of MMR II to a patient on 7/7/2020, the patient moved and a "small amount" of MMR II "went into" Nurse Practitioner's eye; she is experiencing "slight" itching in the eye; Information has been received from a nurse practitioner referring to a 45 years old female patient. The patient had no pertinent medical history. The patient's concomitant medication included loratadine (CLARITIN). The patient's drug reactions/allergies included seasonal allgergies.  On 07-JUL-2020, while the nurse practitioner was administering a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) (lot # S015427  and expiration date 20-MAY-2021; strength and dose were unknown) to a patient, the patient moved and a small amount of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) went into the nurse practitioner's eye (occupational exposure to product). The vaccine was reconstituted with sterile diluent (manufacturer unknown) (lot # S022090 and expiration date 21-FEB-2022; strength, dose were unknown). The nurse practitioner immediately flushed unspecified eye with water. On the same day, the nurse practitioner was experiencing slight itching in the eye. The nurse practitioner reported itching was probably related to seasonal allergies. The outcome of the event slight itching in the eye was not recovered.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA003205:
This spontaneous report as received from a Registered Nurse refers to a 1 year old patient of unknown gender with no pertinent medical history/drug allergies or drug reactions reported. On 24-FEB-2015, the patient was vaccinated inadvertently and simultaneously with the first doses of PROQUAD (Merck) 0.5 ml, subcutaneous (lot # K007800, expiration date 29-NOV-2015) and VARIVAX (Merck) 0.5ml, subcutaneous (lot# K007785, expiration date 28-MAY-2016) which was considered to be an overdose. No adverse effects and product quality issue (PQC) reported. The outcome of overdose was unknown. Additional information has been requested.
Bell's Palsy; stroke; Minor injection site soreness; Extreme sleepiness (2 days); This is a spontaneous report received from a contactable consumer (patient). A 62-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6206), first dose via an unspecified route of administration, administered in right arm on 05Mar2021 07:30 as single dose for covid-19 immunisation. Medical history included high blood pressure (HBP) hypertension, Transient ischaemic attack (TIA) twice, pre-diabetic. Known allergies was none. Concomitant medications received within 2 weeks of vaccination included metformin, atorvastatin, losartan, amlodipine, Aspirin (acetylsalicylic acid). The most recent COVID-19 vaccine was administered at work location. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced bell's palsy (17 days after vaccination - confirmed via ER visit vice stroke) and stroke (seriousness crietria was medically significant), minor injection site soreness (2days) and extreme sleepiness (2 days); all events on 22Mar2021 17:30. The adverse event result in emergency room/department or urgent care. Treatment was received for all adverse events including Steroid/anti-viral medication 7 days by neurologist. The event outcome for all events was not recovered.  Follow-up attempts are needed. Information on batch/lot number was available.
Fever, muscle and joint aches, eyeball aches, loss of appetite, extreme fatigue. On the first day after the second dose (Tuesday, March 16, 2021), I slept 19 hours, sat up for 1 hour, and went back to bed and slept another 16 hours. Upon waking on the second day after the vaccination (Wednesday, March 17, 2021), the fever had broken and the aches were not as severe but still present. No food or drink were consumed as I slept the entire time. On the third day after the vaccination (Thursday, March 18, 2021), aches were gone, but I was so weak with little energy. In addition, I had lost 3.5 pounds since the day of the vaccination. I could not find a thermometer (as well as was too tired to look), so I cannot tell you what my temperature was, but my face/forehead was hot to the touch.
Pt vaccinated with DTP/OPV experienced seizure aprox 8-10 hrs post vaccine.
Fever, body aches, arm stiffness. Lasted approximately 12-15 hours.
Patient has what seems to have been a self-limiting syncopal episode after the shot was administered. Please see narrative: Patient came in and asked for a Flu Shot. Filled out questionnaire. No contraindications. I asked him if he had had a flu shot before. He had not. I asked him if he has ever had a reaction to any vaccinations that he is aware of. He had not. He did offer that he was anxious about needles. I reassured him and told him that it is a very thin needle, and most people don't even feel it. I gave him the injection. I inspected the site, and told him that there was no blood. I asked him if he wanted a Band-Aid. He responded that he would; that it would be good. I asked him if he felt OK- he responded that he did. I asked him to wait for the observation period, told him that I would go into the department to finish the paperwork, and told him that I would check back on him. He responded affirmatively. I returned to the department and had been there for less than a minute, when somebody called from out front saying that the person who just had a shot was having a reaction.  I went out to find him on the floor trying to sit up. As he was trying to sit up, his eyes rolled up and he fell back from a semi-sitting position, banging his head on the wall. I instructed my technician to call EMS. I adjusted him so that his head was flat on the floor and his knees were up, and he became responsive after about a minute (he was unresponsive for a short time). I asked him if he remembered what happened. He said yes, and that it had happened to him once before when he was giving blood. His color at this point was grey. His pulse was 64 bpm, and his blood pressure 106/60. EMS arrived and examined him. He was rapidly improving at this point. They spoke with him for about 20 minutes, he declined to be transported, signed their refusal of treatment and they left. He stayed for about 10 more minutes, then left.
This case was reported by a consumer via an other manufacturer and described the occurrence of nonspecific reaction in a male subject of unspecified age who was vaccinated with combined diphtheria, tetanus, pertussis (A or W not known) vaccine (DTP (A or W not known), manufacturer unspecified) for prophylaxis. On an unspecified date the subject received unspecified dose of DTP (A or W not known) (unknown). At an unspecified time after vaccination with DTP (A or W not known), the subject experienced a reaction to DTP (A or W not known) and was not able to receive additional pertussis vaccines. At the time of reporting the outcome of the event was unspecified.
Pt recvd TD 22MAY91 had achiness; On the 28th devel redness over upper arm w/extreme itching; Seen by MD;
Patient briefly slumped over and appeared to pass out shortly after receiving the vaccine.  This only lasted about 30 sec to a minute before she became responsive again.  Patient reported that this has happened multiple times before when she has received vaccines and was anxious (crying) prior to receiving the vaccine.  An initial blood pressure reading was 100/64 at 12:50.   She was then able to sit up in the chair and began feeling a little better, asking for water.  A second reading five minutes later was 94/54.  The patient then chose to drink some water and eat some candy she had brought and this seemed to make her feel better.  Lightheadness/weakness was the only symptom she complained of.  By 1:03, 15 minutes after the vaccine, she reported "feeing much better."  I continued to observe her, seated, for 15 more minutes and a final blood pressure reading at that time was 115/74.  Patient reported feeling normal again and went home.
Information has been received from a physician concerning a 12 year old female patient with asthma who on 28-SEP-2010 was vaccinated with a first dose of GARDASIL (Lot # not reported). Concomitant therapy given on the same day included a INFLUENZA vaccine (unspecified). The physician stated that the patient came to his office on 25-OCT-2010 with systemic right side pain down to her legs and was admitted to an unspecified hospital for three days, where upon discharge symptoms resided. It was also reported that on 28-OCT-2010 the patient recovered from all these symptoms and the sequence of GARDASIL was discontinued, after the first dose was administered. Additional information has been requested.
approx. 2.5 x 2.5 area of slight erythema warmness, slight induration on the (R) deltoid area, warm compress on the affected area ADVIL 200 mg cap 2 caps every 6 hours prn
Symptoms started almost exactly 12 hours to the minute after vaccine administration and lasted about 36 hours: Fever 103.5, chills, joint pain, body ache, nausea, headache, fatigue.
The patient fainted and stopped breathing. she started breathing on her own. 911 was called and EMT's evaluated her. She was then transported to the hospital by her mother. I followed up with her mother and primary MD on 11/10/09. She fainted due to anxiety and vagal synope. It was determined to not be vaccine related by the hospital.