chrisvoncsefalvay/vaers-outcomes huggingface dataset:
huge bruise; This case was reported by a pharmacist via call center representative and described the occurrence of contusion in a 83-year-old female patient who received Herpes zoster (Shingrix) (batch number M77B4, expiry date 8th February 2021) for prophylaxis.   On 13th August 2018, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced contusion. On an unknown date, the outcome of the contusion was unknown.   It was unknown if the reporter considered the contusion to be related to Shingrix.  Additional details were provided as follows: The patient experienced a huge bruise down her arm after receiving Shingrix vaccination. The reporter consented to follow up.
A nurse reported that a 12 month old male received Prevnar, MMRII and "Variox" vaccines on 02/28/02. "Almost immediately", the child developed swelling at the site of Prevnar administration. According to the nurse, the child's mother subsequently reported that the swelling extended from the child's thigh to his knee, and he also developed tenderness. The site of administration of the concomitant administered vaccines were not reported. No further information was available at the date of this report. MANUFACTURER'S comment: The lot number reported was 48317; however, this this not a valid Lederle lot number.
Information has been received from a school nurse concerning a teacher with a history of chickenpox and shingles who was vaccinated with a dose of varicella virus vaccine live. On approximately 24-Sep-2003, the patient developed breakthrough varicella. Subsequently, the patient recovered.  It was noted that the patient also had the disease at age three. The school nurse also reported breakthrough varicella in children after therapy with varicella virus vaccine live, a case of varicella in a teacher (WAES #0311USA01765), and a case of breakthrough varicella in a child which resulted in hospitalization (WAES #0311USA00972). It was noted that the Centers for Disease Control and Prevention and state health department were involved in surveillance. Additional information has been requested.
-Muscle pain 9/17 through 9/20 -Redness, itching, and skin sensitivity on upper arm 9/18 through 9/22 -Chills 9/18 -Migraine 9/18 -Fatigue 9/18 -Muscle aches 9/18  Took Tylenol and Ibuprofen alternately every six hours starting after the injection until afternoon of 9/18. Took Excedrin 9/18pm to treat migraine. Ice on right upper arm.
THE SHOT WAS GIVEN ON 4/21/23, THE MONOVALENT WAS DISCONTINUED ON 4/18/23
rt eye irritation, infection that showed up as white spot on cornea...sensitive to sun, mouth and eyes swelling
Patient had severe lower quadrant abdominal pain and fever to 38.2 C at home. Fever starting on 4/20, abdominal pain starting on 4/21. Presented to ED and was found to have bilateral ovarian vein thromboses. Was found to be septic with WBC 23.1, blood culture growing GPC in pairs and chains (anaerobic bottle) and GPC in chains (aerobic bottle). Further speciation pending.
Patient accidentally received the liquid portion of Menveo without reconstitution; Patient accidentally received the liquid portion of Menveo without reconstitution; the first vaccine being Menactra; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 44-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA912A, expiry date 01-MAR-2024) for prophylaxis.   Co-suspect products included MENACTRA for prophylaxis.   On 08-MAY-2023, the patient received the 2nd dose of Menveo. On an unknown date, the patient received MENACTRA. On 08-MAY-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Patient accidentally received the liquid portion of Menveo without reconstitution), inappropriate dose of vaccine administered (Verbatim: Patient accidentally received the liquid portion of Menveo without reconstitution) and interchange of vaccine products (Verbatim: the first vaccine being Menactra). The outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and interchange of vaccine products were unknown.   Additional Information: GSK Receipt Date: 09-MAY-2023  The reported wished to know how to proceed. They provided information about the vaccine, vaccination and patient. The vaccine administration facility was the same as primary reporter. The call was escalated to second line, but agent did not answer, thus the reporter consented to receiving a call back. The reporter consented to follow up. The patient accidentally received the liquid portion of Menveo without reconstitution with the first vaccine being Menactra, which led to inappropriate preparation of medication, inappropriate dose of vaccine administered and interchange of vaccine products. This case US2023066924 was identified as duplicate to case US2023066923, thus this case US2023066924 was deleted. All future correspondence will be submitted to case US2023066923.
Immediate pain post injection lasting until present. Limited range of motion in left shoulder, severe pain with ROM, unable to sleep at night, unable to dress without pain, unable to exercise, tenderness to touch.
This literature-study case was reported in a literature article and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis) in a 40-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.      Concurrent medical conditions included Asthma, Latex allergy and Drug allergy.    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, the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis) outcome was unknown. Possible    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Skin test: negative (Negative) Negative. On an unknown date, Tryptase: 3.8 ug/l 3.8 ug/L - post-2nd dose.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ANAPHYLACTIC REACTION (Anaphylaxis) to be possibly related.    Patient presented with Generalized hives, shortness of breath, chest tightness, tachycardia as symptoms of anaphylaxis.  Patient experienced Protracted symptoms (5 days).   She received received 2nd dose in high risk clinic; 20 min later developed cough (no other symptoms)  Company comment: This case concerns a 40-year-old patient of unknown with a relevant medical history of Asthma and Drug allergy, who experienced the expected serious event of Anaphylactic reaction after mRNA- 1273 Moderna vaccine (Moderna COVID-19 Vaccine). The event occurred approximately 5 days after the second dose of mRNA- 1273 vaccine, temporal relationship unknown. Clinical manifestations included cough 20 minutes after vaccination and generalized hives, dyspnoea, chest tightness and tachycardia 5 days later. The rechallenge is not applicable, since the event was reported exclusively after the second dose. Previous asthma and Drug allergy remain a confounder. The benefit-risk relationship of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine is not affected by this report   This case was linked to MOD-2021-372464, MOD-2021-372371, MOD-2021-372466 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Follow up received by safety on 04-Nov-2021. contains no new information. Updated address, phone number and laboratory test from initial report.; Sender's Comments: This case concerns a 40-year-old patient of unknown with a relevant medical history of Asthma and Drug allergy, who experienced the expected serious event of Anaphylactic reaction after mRNA- 1273 Moderna vaccine (Moderna COVID-19 Vaccine). The event occurred approximately 5 days after the second dose of mRNA- 1273 vaccine, temporal relationship unknown. Clinical manifestations included cough 20 minutes after vaccination and generalized hives, dyspnoea, chest tightness and tachycardia 5 days later. The rechallenge is not applicable, since the event was reported exclusively after the second dose. Previous asthma and Drug allergy remain a confounder. The benefit-risk relationship of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine is not affected by this report
pt devel sz 11 days p/vax in clinic; adm to hosp had full eval done; discharged home on Phenobarb; hx of ? febrile sz but not documented in chart;
They say that I suffered a CVA on 05/27/2021 around 8AM that morning. I had nausea, vomiting, my vision was distorted, and my heart rate was increased. I couldn't walk. I was taken to the ER and they did a CT of my head. They also did an MRI. That's when they told me that I had a stroke. They prescribed medications. I was in the hospital for 05/30/2021. On 05/31/2021, I had the same thing happen. I went to the ER and they said I had a TIA. They did a CT and MRI. I was released from the hospital on June 2nd. I have been doing home physical therapy and speech therapy. I have also been doing occupational therapy. I will be starting outpatient in July.
Started with nerve pain in jaw.  Within 24-36 hours, pain, numbness & tightness in right jaw. Beyond 36 hours, pain, numbness & tightness in both jaws, across both jaws up to temples (Mild Bell's Palsy)
Chills; Muscle ache; Fatigue; Has a temperature.(no exact temp. provided) a; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), MYALGIA (Muscle ache), FATIGUE (Fatigue) and PYREXIA (Has a temperature.(no exact temp. provided) a) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced CHILLS (Chills), MYALGIA (Muscle ache), FATIGUE (Fatigue) and PYREXIA (Has a temperature.(no exact temp. provided) a). At the time of the report, CHILLS (Chills), MYALGIA (Muscle ache), FATIGUE (Fatigue) and PYREXIA (Has a temperature.(no exact temp. provided) a) outcome was unknown. Not Provided          No concomitant medications were reported.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
At 1:20 pm got Flu vaccine, slept for ~ 3 hrs. Seemed tense approx every 30 sec the described as "limp" and this would last several seconds. This occured over 2 1/2 hr period then completely resolved. No further issue.
Patient's father did not mention that she had previously experienced dizziness with vaccination. Within 5 minutes of getting this vaccine on 9/30/2017, she complained of dizziness that lasted about 20 minutes. During this time, she had difficulty standing. After that time, she was fine and resumed normal activity. No lump, redness, or pain at injection site was observed or reported by patient.
A non-serious report of runny nose and nasal congestion has been received from a consumer, patient's parent, concerning a 12-year-old male subsequent to FLUMIST. The patient's medical history and concomitant medication were not provided. The patient received FLUMIST on 10-Sep-2009. He received a total of one dose of FLUMIST before the onset of the events given on 10-Sep-2009. On 11-Sep-2009, he experienced running nose and nasal congestion. Per reporter, these symptoms were progressively getting worse. Outcome of the event was not reported.
parent called to report pt had come home early from school on 20OCT98 w/T102, bad h/a  & sore arm;will call again if sx persist, will call Md if sx worsen;
Pt.'s Mother states that after receiving the 3rd dose of Phizer 01/07/2022, started experiencing symptoms 01/09/2022 of headache and cloudiness in the eyes. Emergency Room visit / Admitted to Hospital 01/30/2022 x2 days. Follow-Up Ophthalmologist appt. scheduled for 02/03/2022.
After the 2 month vaccinations my child became constipated. We have had this problem for over 3 weeks. She cries out in pain. Her bowel movements require assistance with laxatives and suppositories. We thought it was related to the formula but that has changed and she is still with the problem.
administration of a second dose of Menveo; Instead of receiving Bexsero/ HCP administrated Menveo; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amva467a, expiry date 31st March 2022) for prophylaxis.   Previously administered products included Menactra (1st dose received in 2015). Concomitant products included Men ACWY-CRM NVS (Menveo) and Men B NVS (Bexsero).   On 13th August 2021, the patient received the 2nd dose of Menveo. On 13th August 2021, unknown after receiving Menveo and an unknown time after receiving Menveo and Bexsero, the patient experienced extra dose administered and wrong vaccine administered. On an unknown date, the outcome of the extra dose administered and wrong vaccine administered were unknown.  Additional details were provided as follows: The reporter stated that, the patient received 2nd dose of menveo on the day of reporting instead of Bexsero, which led to extra dose administered and wrong vaccine administered. The health care professional had no further information, agreed to be contacted for follow-up
Client received the second Pfizer vaccine with lot number EW0161 exp. 7.31.21 at 11:26am. Client walked over to the EMT station from observation area and requested that his blood pressure be taken to EMT. Client stated that he was feeling "dizzy" but denied any pain throughout his body. Client appeared alert and tracking with his eyes, and in no apparent distress. Client stated that he had just finished his 15 minutes observation but began to feel dizzy after standing up prompting him to check in with the EMT station. This was the client's second dose of the Pfizer vaccine and he denied any significant reaction to the first dose. Client denied any underlying medical conditions, had no known allergies and is not on any medications. Client was negative for hives, redness, discoloration, severe sweating, shortness of breath or other signs of anaphylaxis. Client?s airway, breathing and circulation was intact and he was alert and oriented to person, place, date and event. Client stated that he did not eat breakfast or have very much water today. Vital signs at 1150 were: Blood pressure 120/88, Pulse - 72, O2 sat 97%, Respirations 16, eyes equal and reactive to light. Client consented to remaining an additional 30 minutes after his vital signs were measured. Client was provided with a snack and water to eat while completing his observation. Client's vitals remained stable and consistent throughout his observation. Vital signs at 1205 -blood pressure 124/88, heart rate 76, respiratory rate of 16, and oxygen saturation of 97% on room air. Vital signs at 1220 - blood pressure of 128/88, heart rate of 68, respiratory rate of 16, and oxygen saturation of 98% on room air. After the completion of his observation at 1220, client denied any further dizziness. No medications were indicated or administered and EMS was declined. Client was encouraged to seek medical care if their symptoms returned or increased later in the evening. Client departed  vaccination site at 1221 in confident disposition and stating he felt comfortable driving home.
5 days after immunization pt seen for right testicular pain and swelling. Onset of symptoms approximately 8/5.  Dr felt to be unilateral orchitis. Relation to vaccine unknown.
Atypical Steven's Johnson Syndrome ~15 days post vaccination. Recurrence of SJS (as noted previously, ~3 months ago had SJS secondary to influenza B). Developed mouth + eye + penis involvement (ulcerations, clear discharge, pain, photosensitivity) starting 14 days post vaccination.  Worsening over the next two days. History of preceding URI as well about 10 days prior to SJS symptom appearance. Patient admitted to the hospital on 5/25/2018 (15 days post vaccination) -- started on acyclovir, IVFs, clindamycin (secondary to concern of bacterial superinfection of extensive mouth lesions), tobradex drops, and IV steroids (3 days; 1mg/kg/day of Solumedrol). Improving 4 days into hospitalization. Patient received ophtho consult, peds ID consult, and peds GI (to evaluate for esophageal involvement). Dermatology consulted via phone over the weekend. Etiology of recurrent SJS believed secondary to recent URI versus receipt of influenza vaccine --- contacting VAERS for review and recommendation for receipt of influenza vaccine next year. At this time, tracking down lot/manufacturer of influenza vaccine received as well as DTaP.
After this patient's shot #1, at approximately 8 PM (same day), the patient reports a rash (red band, with white raised bumps) may be 10-12. This rash was on the right wrist, underneath the thumb area. The rash was itchy, and is still itchy today, but redness is not as bad and the white bumps have gone down. At approximately the same time (8 PM last night) right leg was numb from top of the right gluteal area all the way to the foot, the majority of numbness has lessened, however, the right knee and foot (ankle-inner area) are still numb, the knee is the worst. The patient also reports numbness in the right deltoid area and right elbow. (Feel as if the right side was in "icy hot".)
Severe arm swelling - blisters at injection site. Looks like allergy. Received IV therapy and oral antibiotics.
Client felt lightheaded and faint. Presyncopal. Had not eaten that day by mid afternoon. Given juice and a snack and felt better quickly.
shortness of breath; developed atrial fibrillation of the heart; Heart pounding; Screwing up my ability to work; This is a spontaneous report from a contactable consumer (patient).  A 71-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 12Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunization.  Medical history and concomitant medications were not reported.  The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 19Feb2021 (Batch/Lot number was not reported). He then had angiogram done the end of Feb2021 due to shortness of breath and COPD noted in 2021. It was stated that his cardiologist stated that his heart looked health like a 40 year old  (as his heart and arteries were in excellent shape). The patient then had the 2nd dose on 12Mar2021. He was then in the hospital in Apr2021 due to shortness of breath noted in 2021. In Apr2021, he developed atrial fibrillation of the heart. The patient stated that his cardiologist was a monkey and he does not check anything and just prescribes medication and it was really becoming a pain in the neck. The patient just wanted to know if it atrial fibrillation was a possible side effect or direct link to the vaccine. His doctor was not giving him information on the medication he was taking and its making him felt terrible and he wanted to see if we have any information that he can point his new cardiologist in the right direction when he finds one. It was also mentioned that the he was having 4-6 events of heart pounding a day and it was screwing up his ability to work. Outcome of the events were unknown.  Information regarding the batch/lot number has been requested.
I started getting rapid heart rates over 100 while just sitting down relaxing. She feels very foggy headed and unlike herself all the time. Very confused and can?t focus sometimes. Low blood pressure
Was given flu shot high on left arm. It became very sore & then I was unable to move it and it effected the deltoid muscle.
Information has been received from a physician concerning a 27 year old female patient with asthma who on 06-SEP-2007, was vaccinated with a third dose of GARDASIL (Lot# 658560/1062U). Concomitant therapy included SEREVENT, ADVAIR, NUVARING and CELEXA. About one hour after the vaccination, the patient experienced blurred vision and cold sweats. Unspecified medical attention was sought. That same day, the patient recovered. No product quality complaint was involved. Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 10/12/2007. Information has been received from a physician concerning a 27 year old female with asthma and depression who on 06-SEP-2007, was vaccinated IM into the left arm with a third dose of GARDASIL (Lot# 658560/1062U). On 06-MAR-2007 and 08-MAY-2007, the patient was vaccinated IM into the left arm with a first and second dose of GARDASIL (Lot # 654702/0011U), respectively. Concomitant therapy included SEREVENT, ADVAIR, NUVARING and CELEXA. On 06-SEP-2007 about one hour after the vaccination, the patient experienced blurred vision and cold sweats which lasted about 10 minutes. Unspecified medical attention was sought. That same day, the patient recovered. No product quality complaint was involved. Additional information is not expected.
Hospitalization for weakness and altered mental status due to COVID-19 on dates  8/29/2022-9/2/2022.  Treated with vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
experiencing mylagia Friday she has chest pain with deep inspiration the pain is sharp but also pressure like continue to have myalgia and headache  pt has taken tylenol with no help  she has difficulty breathing with activity no loss of taste or smell, no fever
muscle pain; nausea; muscle weakness/no muscles strength at all; completely lethargic no energy; she now has bone pain; joints are having pain in them comes sometimes and goes sometimes; pain; She has not been able to sleep; Flu-like Symptoms; Running a fever; hot Chills/cold chills; This is a spontaneous report from a non-contactable consumer. A 79-years-old female patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Strength: unknown, Batch/Lot Number: unknown), dose 2 intramuscular on 16Feb2021 as Dose 2 SINGLE for covid-19 immunization (Age at vaccination: 79-Years-old). The patient medical history and concomitant medications were not reported. On 16Feb2021, the patient had Running a fever, Chills/cold chills, on 17Feb2021, the patient had Flu-like Symptoms and on an unspecified date, the patient had muscle pain, nausea, bone pain and sleeplessness. Her mother said she had flu-like symptoms: the mother reported for the 1st week and a half she had hot chills, cold chills, nausea, muscle weakness, completely lethargic no energy, no nothing. Now she is reporting no muscles strength at all and muscle pain. Just reporting she now has bone pain, muscle pain. All her joints are having pain in them comes sometimes and goes sometimes. In some places it stays with her all the time. She had not been able to sleep and has pain for 6-8 weeks. Patient was asked to take Tylenol. The events were assessed as Non serious. Outcome of event sleeplessness and pain was not recovered, and other events was unknown.  No follow up attempts are possible. No further information is expected.