chrisvoncsefalvay/vaers-outcomes huggingface dataset:
antibody test (IgG and IgM Immunoassay) negative 3 months after being fully vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of ANTIBODY TEST NEGATIVE (antibody test) negative 3 months after being fully vaccinated in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced ANTIBODY TEST NEGATIVE (antibody test negative 3 months after being fully vaccinated. At the time of the report, ANTIBODY TEST NEGATIVE (antibody test negative 3 months after being fully vaccinated, outcome was unknown. Not Provided.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, SARS-CoV-2 antibody test: Positive. In April 2021, SARS-CoV-2 antibody test: Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not reported. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above included, On 27-May-2021 Follow- up received on 27-May-21. January Lab Report Uploaded.
5 hours after vaccine, pounding headache followed by sever chills and shaking.  12 hours after vaccine vomiting and chills.  Loss of appetite  and  dizziness  for the next 48 hours.
Mother said pt started having symptoms of abdominal cramps, nausea and diarrhea on 7/5/05 while water skiing. Symptoms lasted for one hour. No further symptoms until 48 hours later. The pt had symptoms of a severe headache, dizziness and increased fever of 102F. An appointment with her private physician was completed on 7/12/05. According to mother, she was dx'd with illness of a viral infection.
I have a horrible headache, I had a fever last night, unsure how high, I was just shaking and freezing under blankets in bed during the middle of the night.  My arm is also very sore, which i expected.
had the shingles shot and just got shingles/ suspected vaccination failure; shingles / maybe a slighter case; pain is terrible; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult 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), shingles and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but selected as adult as per the vaccine indication. The patient had Shingles shot and just got shingles last month. The reporter mentioned that, this might be a slighter case but the pain was terrible and was getting better. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for shingles and laboratory test confirming shingles were unknown at the time of reporting. No further information was provided.
CHest pain radiating to Back and Jaw , nausea , lightheadedness , Admitted for 2 days to hospital for testing Diagnosed with Pericarditis-
No additional AE/PQC; VARIVAX was administered to patient with temperature excursion; This spontaneous report was received from a nurse prescriber and referred to a 13-year-old female patient. Concomitant vaccines on 09-FEB-2023 included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), polio vaccine and meningococcal vaccine a/c/y/w conj (crm197) (MENVEO). The patient had no significant past medical history no illness at time of vaccinnation. Information about drug reactions/allergies was not reported.  On 09-FEB-2023, the patient was vaccinated with first dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (0.5 milliliter, lot # w008712, expiration date 14-MAR-2024, administered for prophylaxis; anatomical location, strength and route were not provided) that exposed to a temperature excursion of 15.7 Fahrenheit degree for a time frame of 20 minutes (product storage error).  On 10-MAR-2023, the patient received second dose of varicella virus vaccine live (oka/merck) (VARIVAX). No adverse events related to vaccination.  This is one of six reports received from the same reporter.; Sender's Comments:  US-009507513-2304USA001247:
- Pt began to have fever 8 days after - Imm of MMR II fever was 104.5 rectal - irritable
Extreme onset of hives.  From mid chest down.  Welts the size of a quarter to some size.  Clustered in some areas or approx 6-9 inches apart.  Very random.  It was like all my skin in those areas was growing in intensity from 2pm? to about 2am (10/01) when it started to  finally calm.  I could not where my jeans because my skin was so irritated.  It was all I could do to not scratch through my skin.  I was unable to sleep as the tingling and itchiness was so intense.    I was shocked when I woke up at 6am and it had all gone away.  The only remnant we?re the few places that I had scratched and left a mark that had bled.  So far I have not experienced this again? something I am truly thankful for!
Information has been received from a registered nurse referring to a 18 year old patient. On 25-APR-2016 the patient was vaccinated with a dose of PROQUAD (Merck) (lot # L051101 with expiration date of 17-JUN-2017, strength, frequency, dose and route unspecified) (inappropriate schedule of drug administration). No adverse effects were reported. Additional information has been requested.
Information has been received from a nurse concerning unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with PROQUAD recombinant human albumin (rHA) (lot # M043310 with expiration date: 24-APR-2018, 1 dose also reported as 10 doses) (dose, strength, frequency, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature greater than -10°C but less than -14°C for 15 hours and 40 minutes with previous temperature excursion: temperature greater than -9°C but less than 8°C for 3 hours and 10 minutes; this information was registered in a digital data logger. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA014999.
Chills, body aches, fever, fatigue, headache.   Treatment: rest, ibuprofen. Outcome- resolved.
This spontaneous report was received from a health professional and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history and drug reactions or allergies were reported. On 28-JUL-2015, the patients were inadvertently administered RECOMBIVAX HB, lot # L001456, expiration date 22-OCT-2016 (dose, indication and route of administration were not reported), that had been improperly stored. Concomitant medications were not provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
NEXT DAY AND FOR THE NEXT 13 DAYS (TODAY) PATIENT HAS EXPERIENCED CHRONIC FATIGUE, SEVERE MUSCLE PAIN IN BACK (DESCRIBED AS FEELING LIKE A HEART ATTACK), PAIN IN THE LEFT KNEE CAUSING PATIENT TO LIMP. MINOR HEADACHE. NO FEVER
Vaccine administered to 7 patients beyond 30 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 7 patients beyond 30 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 7 patients beyond 30 days). On 17-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 7 patients beyond 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported.  No treatment medications was reported.
Patient called the office the afternoon of Thursday, 12/14/2017 to report the he "had a reaction to the shot" he was given in our clinic. Stated that "about an hour and a half after I got the shot I started having trouble breathing". "I started coughing and felt like I was having an asthma attack and I don't have asthma." "My mom wanted to call 911, but I told her not to because I was still able to get a little air." "It also felt like I lost sensation in all my limbs." Patient was instructed that calling 911 would have been the right thing to do under those circumstances. "I live in the country and it would have taken them 30 minutes to get here anyway and I was ok by that time (within 30 minutes). Patient states he developed significant hives from head to toe and it was still present. Patient stated he contacted his PCP following his reaction, but did not see her in person.
CHIEF COMPLAINT:   presents to ED with complaints of Right sided rib pain, cough and loss of taste and smell x 1 week   HISTORY OF PRESENT ILLNESS:     55-year-old female with history of obesity, asthma, comes to the ER for evaluation of chest pain and symptoms related to COVID-19.  Patient says for the past 2 to 3 weeks has had intermittent right-sided chest pain.  Take tamoxifen and therefore is more prone to having blood clots, but she has never had a DVT or PE in her lifetime.  She has had COVID-like symptoms for approximately 5 days, body aches fevers generalized weakness.  She was vaccinated for COVID-19 and she has been otherwise feeling well.  Because the chest pain has been persistent today she had to come in and be evaluated.  No other complaints.
got the two vaccines, they think it's shingles/suspected vaccination failure; shingles; stinging/ burning pain/ lots pain; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, couple of years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and stinging. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and stinging were recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles and stinging to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the 1st Shingles vaccination and then couple years later got the 2 Shingles vaccine and couple years later had stinging, burning pain and lots pain in the patient's left side. They thought it was Shingles on the inside been going on 3 months still there but lot better. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Rash across my stomach,  it itches and it's stinging pain across my lower back and my left side hip
mom states pt had inconsolable crying, started 2-3 hrs p/vax lasted 12 hrs; pt would not sleep, nurse, or eat; cried constantly & pulled @ clothing;
Rapid increase in body temp to 102 degrees; Uncontrollable shivering; Malaise; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 immunization. The following information was reported: BODY TEMPERATURE INCREASED (non-serious), 12 hrs after the suspect product(s) administration, outcome "recovered", described as "Rapid increase in body temp to 102 degrees"; CHILLS (non-serious), 12 hrs after the suspect product(s) administration, outcome "unknown", described as "Uncontrollable shivering"; MALAISE (non-serious), 12 hrs after the suspect product(s) administration, outcome "unknown"; FATIGUE (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: 12 hours after the bi-valent booster, patient experienced a rapid increase in body temperature to 102 degrees, uncontrollable shivering and malaise for approximately 4 hours. That was followed by a normalized body temperature, but continued malaise and fatigue for the next 12 hours.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Less than 2 days after vaccine Tinnitus has developed in both ears with a constant buzzing sensation and feeling of inflammation. Also feels like hearing ability is affected due to tinnitus sensation that is continuous 24/7. It has not diminished and is not getting better as of date of this report. I do not know if I should ghet another shot as do not want to lose my hearing. Will schedule an appointment with my ENT. I do not want to go deaf from this vaccine.
neck, chin, cheeks, bright red & getting hives, started breathing heavily; took pt to MD who administered DPH;
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare providers recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 02-MAY-2013, a pharmacist administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 08-SEP-2015, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
I got my shot at 745am and felt fine till 4pm that day. At 4pm I started to feel dizzy. Then started to get the chills. Then my whole body started to ache. By 5pm I was shaking from the chills and was very nauseous. By 6pm my entire body was in the worst pain I have ever felt. By 8pm it felt like all the bones in my legs were breaking. This all lasted through till Wednesday evening.
Case number PHHY2012US054673 is an initial literature report received on 25 Jun 2012. Authors presented the importance of clinicians alertness to possible influenza among children and young adults with neurologic and neurodevelopmental conditions, especially during influenza season. This case refers to a male patient (age not specified). The patient's medical history included of severe to profound neurologic and neurodevelopmental disabilities, including physical limitations. With his neurologic impairment, he was able to make sounds but unable to speak or move on his own volition. He had multiple prior admissions for aspiration pneumonia and a history of abnormalities noted on chest radiography. He was vaccinated with season influenza vaccine 2010/2011 (manufacturer and batch number: unknown) on an unspecified date during Oct 2010 to Nov 2010. On 19 Feb 2011, he had fever of 101.2 F (38.4 C), and his oxygen saturation was 88% on room air. Empiric treatment with ciprofloxacin was initiated. On illness day 2, he developed mild cough and wheezing and was given supplemental oxygen. On illness day 3, he became tachypneic and required increased respiratory suctioning. On illness day 5, he was hospitalized with fever of 101.3 F (38.5 C) and respiratory rate of 24 breaths-per-minute; empiric treatment with piperacillin/tazobactam and vancomycin was initiated. On illness day 6, he tested positive for influenza A by rapid influenza diagnostic test (RIDT) and was treated with oseltamivir (60 mg twice daily). On the same day, he developed both acute respiratory distress syndrome requiring mechanical ventilation and sepsis with hypotension requiring vasopressor support. On illness day 7, chest radiography showed diffuse lung opacities that progressed to complete opacity of both lungs. He died on illness day 8, Authors concluded that clinicians should be alert to possible influenza among children and young adults with neurologic and neurodevelopmental conditions, especially during influenza season. Prompt testing and early empiric antiviral treatment in residents with respiratory symptoms in residential or long-term care facilities is important. Influenza prevention efforts should include vaccination of residents, health-care personnel, and others who might transmit influenza to residents, use of infection control precautions, and appropriate use of antiviral medications.
Persisting muscle pain at left deltoid S/P flu shot approximately 3 weeks ago.
Vial was punctured on 3/17/2023,  but administered to the patient on 3/21/2023. The vial was expired when given to the patient.
I had a hive outbreak on the back of my thighs, on my elbows, on my arms. Sometimes my hands and feet would swell up.
About 5 minutes after vaccination child became pale, poorly responsive when I examined the child, eyes were closed, consider congestion noted, child remained pale, indigested fro several hours back to normal when seen the following day.
Patient had swelling and pain in right arm near injection site that began the evening of the vaccination (approximately 8 pm?).   The condition did not resolve by following morning and she went to urgent clinic for evaluation.    They determined that she had a local allergic reaction, probably to the pneumovax 23 which was administered in that arm.    She stopped by the pharmacy to inform us of the resolution this afternoon (8/2) and her treatment plan (benadryl + ranitidine).
This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 11-JUN-2015, the patient was vaccinated with a dose of improperly stored VAQTA lot number K008984, expiration date of 21-OCT-2015 (route of administration was not reported), which was stored 2 times with the following lowest recorded temperatures: 34F for 64 hours and 33 F for 16 hours. No highest recorded temperatures were reported. The type of storage was refrigerator. No concomitant therapies were reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to a 17 years old male patient. The patient was vaccinated intramuscularly in the left arm with the first 0.5 ml dose of GARDASIL on 20-DEC-2011. The second dose was administered on 08-AUG-2012 and the third dose (Lot # 0636AE, in validation, expiration date 09-JAN-2015) was given too early on 07-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
OLD SACROILIAC HIP INJURY AND SCIATICA FLARED UP IMMEDIATELY AFTER EACH INJECTION?INFLAMMATION.  THIS FADED AFTER FIRST VACCINE AFTER A COUPLE OF DAYS, AFTER SECOND IN A WEEK, WITH THIRD VACCINE I CAN BARELY WALK MOST DAYS. SERIOUS BRAIN FOG NEVER HAD BEFORE. ALMOST 3 MONTHS OF PAIN AND BRAIN FOG AFTER 3RD VACCINE. PAIN NOT DIMINISHING AT ALL AS OF 1-1-22.  CANNOT FUNCTION IN MY LIFE. DEFINITELY RELATED TO VACCINE. HAVE NOT HAD FLARE UPS IN THESE AREAS FOR YEARS -- SCIATICA FOR 11 YRS, AND SACROILIACITIS FOR 3 YRS. PAIN STARTED DAY OF EACH INJECTION! SERIOUS SIDE EFFECTS. EXERCISES AND DIET THAT HELPED IN THE PAST DO NOT WORK.  PLEASE NOTE I WAS 100% PRO-VACCINE PRIOR TO THIS EXPERIENCE.
After the first dose of the Pfizer vaccine I noticed some mild chest pain that mostly resolved with 325mg acetaminophen and 200mg ibuprofen. However, after the second dose, the chest pain was severe two to three days following the vaccination dose, so much so that it did not adequately resolve with acetaminophen or even with 800mg ibuprofen TID. At the point when I decided the pain was severe I determined that if it worsened, I would seek medical care. However the next morning, the pain was improving and I did not seek immediate care. By the next day the pain had resolved entirely.
presented to emergency room on 4/17/18 with sudden onset of numbness and weakness progressing over several hours