chrisvoncsefalvay/vaers-outcomes huggingface dataset:
it makes me very sick, got shots only 2 times; Initial information regarding this unsolicited valid non-serious social media case received from a consumer (patient) and transmitted to Sanofi on 15-Dec-2020.  This case involved a 75-year-old patient who reported it makes me very sick (Illness), got shots only 2 times, after receiving vaccine INFLUENZA VACCINE.  Relevant medical history, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient reported a non-serious, got shots only 2 times and made the patient very sick (Illness) , unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  Final diagnosis was  illness.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
Initial unsolicited misuse report received from a nurse on 06 May 2016. This case involves a 19-year-old male patient who was vaccinated with a 0.1 ml dose of Meningococcal vaccine (frequency once) intradermally in right forearm on 06 May 2016 believing it to be TUBERSOL for a tuberculosis skin test. It was a wrong vaccine administered case. It was unknown whether the patient had some adverse event related to vaccination. Documents held by sender: none.
Client received first dose on 2/13/21, reported 2 hrs after vaccine he experienced facial dropping, evaluated by PCP, unsure if stroke or Bell's Palsy. Only right facial paralysis unresolved at the present.
Patient was asymptomatic to COVID and presented to the hospital for other health conditions.  While in the hospital, patient was tested for COVID (standard protocol) left nasal swab via SARS-CoV-2 Test (T2 Biosystem/ T2SARS-CoV-2 Panel) and the result came back positive.  This is on 2/8, roughly 2 weeks after first dose of Pfizer vaccination.  Per physician, "Patient was COVID positive, but  asymptomatic, no leucocytosis, no fever, CXR showed no signs of PNA, and pt SaO2 above 95% on RA".  Patient was continue to be monitored and isolated.  Patient was discharged once stable for his admitting condition other than COVID
Headache & NauseaVomiting related to nausea that developed about 5 hours after the vaccination. Nausea resolved same day as the injection. Also experienced a headache that was alleviated with acetaminophen. No other adverse effects noted.
OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient via company representative via social media concerned a patient of an unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. On an unspecified date, the patient was vaccinated with covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (Dose number in series 1) (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, 01 total administered for covid-19 prophylaxis.  It was unknown whether the patient experienced any adverse events following vaccination with first dose of covid-19 vaccine (unspecified manufacturer) (Dose number in series 1) On an unspecified date, the patient was vaccinated with covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (Dose number in series 2) (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, 01 total administered for covid-19 prophylaxis.  It was unknown whether the patient experienced any adverse events following vaccination with second dose of covid-19 vaccine (unspecified manufacturer) (Dose number in series 2) The patient additionally received covid-19 vaccine ad26.cov2.s (Dose number in series 3) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 01 total administered for covid-19 prophylaxis. The product was associated with Off label use related to dosing frequency (Dose number in series 3). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. As per the patient, "I got the J and J at the first opportunity, which made it so I could feel at ease attending my mother's funeral. I have had 3 boosters, and I did have a breakthrough infection exactly 11 days before our family reunion last July. I am so grateful for medical advances." The outcome of off label dosing frequency was not reported. This report was non-serious. This case, involving the same patient is linked to 20221162023 (dose number in series 4).
Nausea, diarrhea, stomach cramping, injection site pain 24 hours after vaccination.
bad reaction; couldn't move; fever; real tired; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (bad reaction), MOBILITY DECREASED (couldn't move), PYREXIA (fever) and FATIGUE (real tired) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 031A21A) for COVID-19 prophylaxis.     Concomitant products included CYANOCOBALAMIN (B 12) for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced IMMUNISATION REACTION (bad reaction), MOBILITY DECREASED (couldn't move), PYREXIA (fever) and FATIGUE (real tired). On 16-Apr-2021, IMMUNISATION REACTION (bad reaction), MOBILITY DECREASED (couldn't move), PYREXIA (fever) and FATIGUE (real tired) had resolved.            No medical history was reported by reporter. Concomitant medication included Men's Vitamin. No treatment information was provided.   This case was linked to MOD-2022-609219, MOD-2022-609018 (Patient Link).
Patient advised she took COVID-19 Vaccine and formed blood clots in leg; This is a solicited report from a non-Pfizer sponsored program: -CW2891702, received from a contactable consumer, based on information received by Pfizer from manufacturer (manufacturer control number: BMS-2021-032881), license party for apixaban.  This 86-year-old female patient was involved in a patient support program. The patient (patient ID: (ID)) received APIXABAN. The report describes a case of THROMBOSIS (Patient advised she took COVID-19 Vaccine and formed blood clots in leg). Co-suspect products included Covid-19 Vaccine for an unknown indication. On an unknown date, the patient started APIXABAN (unknown route), (unspecified dose and frequency). On an unknown date, the patient experienced THROMBOSIS (seriousness criterion medically significant). The action taken with APIXABAN (Unknown) was unknown. At the time of the report, THROMBOSIS outcome was unknown. For APIXABAN (Unknown), the reporter did not provide any causality assessments. This report was received from consumer. The patient received therapy with apixaban and COVID-19 Vaccine for unknown indication. Follow-up is unable to be performed. Medical evaluation comment: This patient had blood clots in the leg after apixaban therapy. Based on the limited information regarding medical history, event details, treatment details, it cannot be ascertained that the suspect drug contributed to the reported event.  The reporter's assessment of the causal relationship of the event Thrombosis leg with the suspect products was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Amgen's assessment: the event, Thrombosis leg, was assessed as unrelated to apixaban.  No follow-up attempts are possible; information about batch number cannot be obtained.; Sender's Comments: As there is limited information in the case provided, the causal association between the event of thrombosis and the suspect vaccine BNT162B2 cannot be excluded. Based on known mechanism of action of the drug, the event of thrombosis is assessed as not related to Apixaban.  The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
This spontaneous report was received from a licensed practical nurse and refers to an unknown number of patients of unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The reporter mentioned that on an unknown date, this indeterminate number of patients received a dose of ROTATEQ (strength, anatomical location, dose, frequency, route of administration, lot number, and expiration date were not provided) for prophylaxis; which had been exposed to excursion temperatures of 8.6 Celsius degrees on two different occasions (one for 15 minutes and the other for 3 hours). No adverse effects were reported. There was no product quality complaint involved. This is one of four reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001795: US-009507513-1704USA014013: US-009507513-1704USA014012:
Pt phoned HD 3MAY91 stated childs face & eyes were swollen; rash on abd & stomach went to private MD 3MAY91, t99.6;
PATIENT HAD REDNESS AROUNG THE SITE IN THE EVENING, THE REDNESS SPREAD DOWN THE ARM OVER THE NEXT TWO DAYS.
Developed Bell?s Palsy. 6/3/21: Ear ache (right side) 6/4/21: Lost sense of taste in 3/4 of mouth (front and right side) 6/5/21: Right eye paralysis (not blinking) 6/6/21: Right side facial and weakness (little to no movement)
Complaints of shortness of breath and throat tightness at 1305.   Pt evaluated by Express care.  Given Epinephrine and symptoms got better.
Throat tightness and difficulty swallowing. Pt had no objective abnormality on physical exam.  She was observed in the ED and given Benadryl and Pepcid and Solu-medrol.  Symptoms did not progress.  Pt discharged home.
I developed a rash - both of my hands; raised, red and very itchy and around both of my eyes as well. I had the rash until June when I finally got on something that took care of it. I started the medication (1st treatment in the middle of March 0 Hydrocortisone 2% cream and a dose of Prednisone 60 mg a day for 5 days and then 40 mg a day for three days and tapered down etc and that did not help). Dupixent medication - cost thought was $2500 to me and I didn't take it but then I got on a program that paid for it and got on the medication finally in June and around the 20th it (the symptoms) was getting better. I am still on the Dupixent - a shot in the abdomen twice a month -I am not sure how long I will be on it. It's not apparent anymore. In middle of February, I started having chest pain. It is on the left side and right on the upper chest. Right where the PMI area on the heart is. Between 3rd and 5th rib on the left hand side. I have had arrhythmia in the past that was fixed with a procedure in the past. That pain started hurting. I went to the ER in April. It wasn't the heart that was hurting me. June visit initially on 22nd - and further testing in July. Cardiologist - Echocardiogram; stress test; bloodwork labwork, etc. nothing was found. But I am still having this pain. I never had this pain before I had the vaccine. Nitroglycerin was given at first but that didn't help because it wasn't my heart. I have to follow up in there months. Lipitor - 10 mg - that is what he put me on but that was for cholesterol. I am still having pain.
Complaining dizziness, nausea, blurry vision, sweating, for 15 minutes, then her condition improved without treatment.
Patient was present in the clinic for her booster dose, Pfizer pediatric lot number FL0007. The dose was administered to her LD at 1331, however the vaccinator, RN, reported that an unknown quantity of the vaccine leaked before and during administration. The client and her guardian were made aware and informed of guidelines that re-vaccination is indicated without minimum interval. The client?s guardian declined revaccination at this time despite education and encouragement, reporting that she?d prefer to speak to her child?s physician before proceeding. She verbalized understanding of the education provided and was made aware of possible side effects and how to treat them.    The vaccinator reports that the needle/syringe was a 5/8th inch VanishPoint (a type of needle that does not have a luerlock, but instead is a complete syringe/needle combination). The vaccinator reports that she is not sure what led to the occurrence. She believes that she may have seen a small amount of vaccine exiting the needle before puncture, but that she definitely saw a significant amount of the vaccine leak out during the administration, followed by more after withdrawal of the needle. The possibility of equipment failure cannot be ruled out at this time, although the issue may lie with vaccination technique.   The vaccinator?s technique was evaluated by on-site leadership and found to be appropriate with no concerns. She was educated to be sure to inspect the syringe for any visible defects and not proceed if she notices any vaccine leakage prior to vaccination; she verbalized understanding.
Pt recv 1 dose vax & devel erythema inj site. Tx w/Benadryl. Within 30 min pt recovered
A legal complaint was received from an attorney alleging that a child received series of Tetramune and hep B vaccines as well as doses of HibTITER, DTP, Engerix B, and DT vaccines from January 1995 through at least August 2000 and subsequently "developed severe neurodevelopmental disorders with associated high mercury exposure levels as a result of the vaccinations he received, and has suffered serious permanent injury." It is alleged that "As a result of the mercury in the Thimerosal-containing vaccinations that Minor Child received, Minor Child now suffers, and in the future will continue to suffer, from the toxic neurological effects of mercury poisoning." According to the legal complaint, "the Minor Child has sustained mental, intellectual, developmental and neurological incapacity and associated learning disabilities, affect disorders and impairments." No further info was available at the date of this report.
Cellulitis lt thigh x 3 days, 0 fever; Rx w/PCN 375mg TID;
Very painful. States on 7/2 her Lt. arm (deltoid) was twice as large as other arm, very red, very itchy. Came to Employee Health 7/3 - we were closed, took Ibuprofen. States pain, swelling and itching lasted for 2 weeks. Today 8/5 states her left shoulder/deltoid is fine no problems. States with 1st dose Hep B had had some itching and redness, nothing with 2nd dose.
rash / spreading rash for 2 weeks; This case was reported by a physician via call center representative and described the occurrence of vesicular rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th June 2020, the patient received Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was recovered/resolved.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving 1st dose of Shingrix, the patient developed a shingles like rash (2 spots and spread over 4 weeks) noted to 6th cervical nerve area on the side of her neck down to her clavicle.   The patient continued to observe a spreading rash for 2 weeks after on her face and down the arm.  The reporter was consented to follow up.
hearing loss; zoster; ill defined disorder; This spontaneous report was received from a lawyer referring to a patient of unknown age and gender.  The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported.  In 2012, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (strength, route, dosage schedule, lot number and expiration date were not reported).         On an unknown date, was treated for hearing loss and other zoster-related conditions. As a direct and proximate result the patient had and will continue to 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.   Upon internal review, hearing loss was considered medically significant.
Began w/pain in arm at injection site which turned into severe pain lasting 30 hours, low-grade temperature, temporary loss of mobility in arm, fever, severe flu symptoms, lethargy & swelling and heat in affected arm.
pt recv vax;c/o tenderness at site per mom;hives noted 28jul95 in am on neck,torso & legs;fever of 100.1;on 30jul rash disappearing;denies breathing diff;tx w/ dph & apap;
Information has been received from a physician concerning an approximately 11 year old female or older who in approximately May 2007, was vaccinated with Gardasil (lot number unknown) 0.5 mL IM. In approximately May 2007, the patient complained of pain in the arm where she received the injection for over a month. Medical attention was sought. An MRI was performed on an unspecified date and the results showed a "8mm fluid sac". It was reported that it was not known if the fluid sac was the injection site. At the time of reporting the patient has not recovered. Additional information has been requested.
Redness, warmth, pain and swelling from shoulder to elbow. Currently improving with ice and ibuprofen.
Patient came for second Covid vaccine.  She stated that she was here for her Moderna. .  Her fist covid vaccine was a Pifizer .I gave Moderna and did not note it was given in error until after vaccine given. Charge nurse and pharmacist and patient notified.  Patient counseled on normal side effect and adverse side effects. Her adult son is coming to stay with her as this was prearranged.
Collarbone off to side of neck is swollen; felt like back of neck was sore; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6205, expiration date: 30Jul2021) via intramuscular route, in right arm, on 18Mar2021 10:00 (at the age of 56-years-old), at dose 1, single for covid-19 immunization from clinic through hospital system. Family medical history included mother allergic to iodine dyes for MRI's and CT scans. Concomitant medications included ibuprofen, vitamins. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient experienced felt like back of neck was sore on 18Mar2021, collarbone off to side of neck is swollen on 19Mar2021 08:00. There were no relevant test results. The outcome of the events was not recovered.  Follow-up (31May2021): Follow-up attempts completed. No further information expected.
This patient had sudden episodes of severe weakness to the point of total paralysis, being unable to use his extremities or able to sit up on her own lasting 1 1/2 - 2 hours. These started approx 2 weeks post-vaccination and continued through early to mid February 2001.
developed a large welt on her arm at the injection site with small amount of pain, redness and swelling; She started out having a small red area where the vaccine was given/developed a large welt on her arm at the injection site with small amount of pain, redness and swelling; painful/developed a large welt on her arm at the injection site with small amount of pain, redness and swelling; developed a large welt on her arm at the injection site with small amount of pain, redness and swelling; This is a spontaneous report from a contactable consumer or other non hcp. A 47-year-old female patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot Number: EW0168) as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's husband is reporting in regards to his wife. He states that she received the first dose of the Pfizer COVID 19 vaccine two days ago. She started out having a small red area where the vaccine was given. He reports that it has continued to get larger and is now about 2.5 inches around. He described the area as a welt and relays that it is somewhat painful. He states that they are concerned because it continues to get larger. He states that he had the Moderna vaccine and that he had bad side effects of fever and couldn't use his arm for 3 days because it hurt. He states that he hadn't heard about side effects with Pfizer so he was worried. With regards to Treatment, Consumer stated, "No, not yet because we just noticed it today it got bigger from last night to today it got little bigger so that's why I called and they said that was one of the side effect of the Pfizer. So you know, she said to let it go another day and its getting any bigger or anything hurts some more to take her either to her doctor or to the emergency.". The event welts was assessed as serious-medically significant. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Chills, fever, fatigue, muscle aches, nausea, headache, lasting approximately 36 hours.
Lethargy, congestion, runny nose, vomiting, severe cough, loss of appetite. Treatment: fluids, sleep/rest
Recurrent severe mouth ulcers lasting for weeks . they began as a small mouth ulcer which grows to encompass entire inside of cheek, lips and roof of mouth. very painful and impact quality of life.
Swollen hand starting on 3/26/2021, his hand and fingers were swollen with decreased ROM to extremity. 4/8/2021 presented with persistant elbow pain/swelling with continued limited ROM and ADLs.
Right deltoid area swollen, red, painful, hot to touch, no drainage, no fever 11/01/2006.  Patient advised to use ice packs locally, increase water intake and observe, report changes 11/1/06, return if worse.
Information has been received from a physician concerning a 10-week-old female who on 15-APR-2008 was vaccinated orally with a first dose of ROTATEQ (lot # 660288/1828U). On 15-APR-2008 the patient experienced a distended stomach, pain and was screaming post vaccination. On an unspecified date the patient was hospitalized but no treatments were given. The patient sought unspecified medical attention via a phone call to the physician's office. On an unspecified date, the patient recovered. A product quality complaint was not involved. Additional information has been requested.