chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash all over my extremities, started on lower legs and moved up and was very itchy; Rash with some pus; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 17Mar2021 at 13:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient was not allergic to medications, food, or other products. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 24Feb2021 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021, two and a half weeks following the second shot, the patient experienced rash all over his extremities. It started on his lower legs and moved up. The event rash was very itchy with some pus. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events rash all over extremities started on lower legs and moved up, very itchy with some pus were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Fully vaccinated with J&J.  Boosted 11/9/21, do not know lot number of vaccine.   COVID infection breakthrough with inpatient hospital stay in ICU.   Kidney transplant patient on immunosuppressive drugs
patient informed temperature hot at injection site, and little bruise at injection site,  patient take ibuprofen and also recommend naproxen and heat pad, after followup with patient patient informed her bruise is getting better, advised to continue applying hot compress and take naproxen or ibuprofen
CHILLS; FEVER; This spontaneous report received from a parent concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and chills. This report was non-serious.
headache body chills body aches eye throbbing All symptoms were a milder version of what I experienced when I had Covid -19  in NOvmeber 2020. I also had slight injection site pain that radiated to the left side of my neck
Information has been received from a nurse concerning an 18 year old female patient who on an unspecified date was vaccinated in the arm with a second dose of GARDASIL (lot number not provided). The nurse reported that on 23-JUL-2010 the patient passed out and suffered a chronic seizure. On an unspecified date the patient recovered. The patient sought unspecified medical attention. The reporting physician considered the chronic seizure to be an other important medical event. Additional information has been requested.
Fatigue, brain fog, headaches, migraines, insomnia, shoulder pain, neck pain, joint pain, pain in arms and hands.
pt states had rxn to vax fifty cent size area redness-warmth;pt fine now
Initial report received from a healthcare professional on 08 OCTOBER 2013.  A 05-year-old male patient had received a dose of FLUZONE (batch number, dose number and site of administration was not reported on 27 SEPTEMBER 2013.  The patient had sore throat at the time of vaccination and had medical history of Autism, allergy to PCN and Suprex and concomitant medication was not reported. On 2 October 2013, five day after vaccination, the patient developed itching and on an unspecified date after 8 days of vaccination the patient developed rash.  Laboratory tests were not reported and the patient had received Benadryl mg Q 4 hr as corrective treatments.  On an unspecified ate, the patient had recovered. List of documents held by sender: None. Follow up information received from the healthcare profession on 28 January 2014. The case was medically confirmed in follow up. The patient date of birth was 20 December 1996. The patient had no illness at time of vaccination. On an unspecified date, after 6 days of vaccination the patient had developed rash on neck (previously the event rash was reported). The patient had received an intramuscular dose of FLUZONE vaccine (batch number: UH904AA) in the left arm on 17 September 2013. The patient had received an intramuscular dose of Hepatitis A vaccine.  (manufacturer other, batch number: 5J5HT) in the left arm on an unspecified date. No laboratory investigations were done. The number of brothers and sisters was reported as 2. The patient was vaccination in private doctor office/hospital. The patient did not receive any other vaccination prior within 4 weeks prior to 27 September 2013.
started out as pins and needles in arch of foot, progressed to pins and needles, body parts falling nunb for hours at time, pins and needles in arms, legs, feet, hands, nerve pain in hands , feet, around mouth, burning sensation for days on end, morphed into extreme joint pain in hands ,fingers, knees, elbows, weakness in arms- hard to raise hands over head for more then a few seconds.
The patient made an appointment for the 3rd moderna shot booster online and filled out a vaccine consent form. On that form, he attested to that he had previously had this shot before but we had no record of his previous vaccination status. He also attested to being immunosuppressed which made him eligible for the 3rd dose (0.5 ml) of Moderna. The patient reported not having his vaccine card and was unsure of its location so I went ahead and proceeded with vaccination administration.  After a few hours had passed, the patient came back with his card and it revealed he had J&J. The patient misled his vaccination status resulting in the wrong vaccine administered. I went ahead and put the moderna shot on his vaccine card.
Woke during the night with body aches. Morning: continued body aches, head ache, muscle soreness at injection, lethargy, chills, light headed
Girl in office with sister who was getting her one year vaccines.  Mom mentioned that chicken pox was going around preschool.  She showed me patient's shot card and only one chicken pox vaccine was recorded on the record, while two MMR were recorded.  We gave the patient a chicken pox vaccine on 3-26-07.  Today she has  9cm of pale redness and swelling and 4.5 cm of intense redness and swelling at the site of the shot.  She has a palpable femoral node, but full ROM of the joins, no fever, and is walking fine.  Mom says the swelling is less today than it was last night.  Now I have her chart, and on 9-12-06 she received a MMRV, but it was not recorded on moms shot card that way.  So, the 3028-07 vaccine was her third chicken pox vaccine.
Patient experienced a rash and swelling that started from the injection site on the deltoid muscle that extended down and anterior to the biceps area. The are was raised, red and warm to the touch. The rash was not tender but was pruritic from time to time. I offered to assist the patient with medical care but she declined and did not want to see a doctor about this issue. I advised her to use cold compresses and apply hydrocortisone cream to the affected areas and take benadryl orally. I also advised her to keep an eye out for signs of infection and to monitor her temperature for fever.
Possible late 2nd dose of Shingrix; This non-serious case was reported by a physician via sales rep and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Possible late 2nd dose of Shingrix).  The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 23-Aug-2023 The reporter reported on behalf of sales representative regarding possible late 2nd dose of Shingrix on an unknown date which led to drug dose administration interval too long. The vaccine administration facility was the same as primary reporter. No other adverse event information made available Safety team emailed contact information. The reporter consented to follow up.
Fever of 103.5 Fatigue  Headache  Dehydration  Diarrhea  Foggy brain Itchiness
I experienced fatigued and headaches after my 2nd dose injection.  I tested positive for Covid 12-30-2020.
Information has been received from a certified medical assistant concerning a 73 year old female patient with hyperlipidaemia, hypertension and AVELOX hypersensitivity, coronary heart disease and diverticulitis, who on 09-SEP-2008 was vaccinated intramuscularly with one dose of PNEUMOVAX 23 (Lot # 660717/0224X). Subsequently, the patient experienced an injection site reaction. The area was swollen, red and painful. The patient sought medical attention. On an unspecified date, the patient had recovered. Follow up information has been received from a physician on 17-FEB-2009. It was reported that th e73 year old female patient was vaccinated into the right deltoid with a first dose of PNEUMOVAX 23 (Lot # 655766/0038U, previously reported as Lot # 660717/0224X) at 12:50. On 10-SEP-2008, the patient experienced pain, redness, oedema and injection site reaction. On an unspecified date, the patient had recovered. This is one of two cases from the same source. Additional information is not expected.
Numbness tingling and moderate paralysis and loss of motor function in left pinky, left thumb, left index, left forearm, left shoulder, left neck, left jawline, bottom lip of mouth, right shoulder
Fever of 100.2F around 5:30 am March 14, 2021. Lips and lower extremities were hot and felt like they were burning the most. Additional symptoms: chills and headache. Chills were mild. Headache felt like an 8/10, pain irradiated throughout my entire head. I took a total of 1500mg of acetaminophen and tried to go back to sleep. I awoke at around 11:30 am, and I have had a mild headache since then; I have not taken any more medication. I have been drinking water and eating soup. Chills have been random and sporadic throughout the day. I tried to log into the v-safe app, but it would not let me submit today's report. I will try again, and if I have any other symptoms and can't submit them through the app, then I will report them here. Thank you everyone for your hard work!
golf ball size round mas; This is a spontaneous report from a non-contactable consumer or other non hcp.    A patient of unspecified age and gender received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 1 via an unspecified route of administration on Jan2021 as 1st dose, single dose for covid-19 immunisation.  Medical history included joint swelling from Aug2020 to an unknown date swelling on my Left knee Aug2020. The patient's concomitant medications were not reported. It was Reported that, My experience is good regarding Pfizer vaccine felt on my knees and had a huge swelling on my Left knee Aug2020. For several months could felt pain on that part of my knee but there was no swelling. In Jan2021 had my first Pfizer vaccine. Within 48 hours there was a golf ball size round mass on the area. Non tender but was scared. It persisted until my second dose. However, within 48 hours the mass disappeared, and my knee was back to normal. I have no more pain no stiffness on the area.  The event golf ball size round mass on an unspecified date with outcome of unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
Over the three days since the shot was administered I have suffered from disorientation, nausea,  and diarrhea.  On October 5, 2008 it became necessary to call the paramedics because I had a brief coma type event.  I continue to have headaches, general body aches, and difficulty in mobility.  The paramedics indicated that they felt the problem came from the shot.  I am stille xperiencing a variety of pains, difficulty in maintaining the food that I eat and in my ability to walk safely.  No other vaccines were given on this date nor had there been any other vaccines given within the past year.  The only medicines that I take are for high blood pressure and for a thyroid deficiency.  Prior to the vaccine all of my vital signs were excellent based on testing that had been done in early September. PLEASE NOTE THAT IN ERROR I ENTERED  AN ITEM IN BOX 14.  NONE SHOULD HAVE BEEN ENTERED BUT THE FORM WILL NOT PERMIT ME TO REMOVE IT.
Immediate reaction: fatigue only Approximately 1 week after vaccine, developed rash on back of hands. I have had this twice before but this time it did NOT respond to any topical treatment. Urgent care gave me medrol pack and it cleared 90%. days later moved to my face--everywhere I touched  (e.g., around eyes) or had pressure (e.g., forehead where I rest when sleeping). Again no response to topicals--another medrol pack and it cleared 90%. I've had lingering symptoms for the past 4 weeks, but it is getting worse again.
pt recv vax & 2-3 hr later had rash w/whelps & itching;denies breathing diff or other sx;
Injection site pain; lethargy; This is a spontaneous report from a contactable Other Health Professional. A 28-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, FORMULATION: Solution for injection, Lot Number: Unknown), dose 1 intramuscular, administered in arm left on 28Jan2021 13:15 PM as 1st dose, single for covid-19 immunization. Medical history and concomitant medications were not reported. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. And also reported that any other medications the patient did not received within 2 weeks of vaccination. The patient experienced injection site pain and lethargy on 28Jan2021 at 21:00. No treatment was given for events. No COVID prior vaccination. Patient has not tested COVID post vaccination. The clinical outcome of events were recovering.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Patient had adverse reaction to Botox and covid vaccine and will have delay in botox treatment per doctor request due to adverse reaction.
Nose bleed, 10:15 pm on 13 May 2021.  Pinched nostrils and held head down, chin to chest for about 10 minutes before it stopped bleeding.  No additional bleeding after initial episode.   Called pediatrics advice line that night but didn't recieve a call back.  Called again the next morning and spoke with nurse, she advised keeping watch but did not recommend further evaluation unless there was another episode or any additional potential side effects.  She agreed that I should report as potential side effect as he has not had any nose bleeds for about 11 years prior to this.
Severe neck and shoulder pain above the injection site, swolen glands.  Injection site itself is OK and there is full range of motion.  Pain started to resolve after 72 hours
she was having severe bleeding; blood clots; This is a spontaneous report from a contactable pharmacist. A 25-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced she was having severe bleeding and blood clots and was hospitalized 2 or 3 times all of which happened just right after the vaccine on an unspecified date. Of note, her MD didn't advise her to receive the second dose and the caller does not feel comfortable administering it, given her response after the first dose. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The information available in this report is limited and the reported events haemorrhage and thrombosis cannot be totally excluded/assessed. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product 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.
he next day I woke up With facial Paralysis; rigth after 5 month I still can talk right and have weakness in my right arm am; it course verry Sever anxaity and depression; it course verry Sever anxaity and depression; This is a Spontaneous report from a contactable consumer. This 46-year-old female consumer reported for herself that:   A 46-years-old non-pregnant female patient received bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, Formulation; Solution for Injection, Batch/Lot number and expiry date was not reported) via an unspecified route of administration, Administered in Arm Right on 11Jun2021  (at 16:45) (at the age of 46-year-old) as Dose 1, Single for Covid-19 Immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccine in four weeks and in two weeks. The patient did not have Covid prior vaccination. The patient was not tested Covid post vaccination. The patient experienced He next day i woke up with facial paralysis, Right after 5 month i still can talk right and have weakness in my right arm, It course very sever anxiety and depression, It cause very severe anxiety and depression on 12Jun2021 (at 09:00). The patient was hospitalized for the events. Therapeutic measures were taken as Steroids a result of the events. The events were assessed as hospitalization, life threatening illness (immediate risk of death from the event),disability or permanent damage.The outcome for all the events was not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
More than 28 days in between doses of the Moderna Covid-19 vaccine,did not come back for their second dose until today; very sick; lethargic; tired/Very tired and run down; sore left arm; This spontaneous case was reported by a pharmacist and describes the occurrence of ILLNESS (very sick), LETHARGY (lethargic), FATIGUE (tired/Very tired and run down), PAIN IN EXTREMITY (sore left arm) and PRODUCT ADMINISTRATION INTERRUPTED (More than 28 days in between doses of the Moderna Covid-19 vaccine,did not come back for their second dose until today) in a 29-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 058A22A) for COVID-19 vaccination.     Concurrent medical conditions included Hemoglobin low.    On 14-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Jun-2022, the patient experienced ILLNESS (very sick), LETHARGY (lethargic), FATIGUE (tired/Very tired and run down) and PAIN IN EXTREMITY (sore left arm). On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (More than 28 days in between doses of the Moderna Covid-19 vaccine,did not come back for their second dose until today). At the time of the report, ILLNESS (very sick), LETHARGY (lethargic), FATIGUE (tired/Very tired and run down), PAIN IN EXTREMITY (sore left arm) and PRODUCT ADMINISTRATION INTERRUPTED (More than 28 days in between doses of the Moderna Covid-19 vaccine,did not come back for their second dose until today) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2022, Blood test: low hemoglobin.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Patient height and weight were unknown. No concomitant medications was reported. Patient went for a blood test and her iron test and had a low hemoglobin. No treatment medications was reported.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 29-MAR-2013 at 11:00 am, the patient was vaccinated with GARDASIL (lot # H010915, expiration date 13-FEB-2015) (dose, therapy route and anatomical location unspecified). The physician that on unknown dates, GARDASIL was exposed to multiple low temperature excursions. Excursion time at -1: 221.50 hours (also reported as 17 hours -1, 420 2, -5.4 hours, 228 hours, 2 admin). The patient was not experiencing any known symptoms. This is one of several reports from the same source. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients was vaccinated with VARIVAX (Merck) (dose, route and lot# was unspecified) which was improperly stored. No adverse effects were reported. No product quality complaint was involved. No additional information to report. This case is linked to MARRS # 1411USA004971 with the same reporter link. Additional information has been requested.
TESTED POSITIVE FOR COVID-19; This spontaneous report received from a consumer via a company representative concerned a 25 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers.   No concomitant medications were reported. On 23-MAR-2021, the subject tested positive for covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid-19 was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.
Delayed hypersensitivity skin reaction - began 3 days after vaccination, resolved 6 days after vaccination. Associated with hot, red rash at vaccination site that spread around the deltoid region. Treated with Benadryl and doxycycline as a precaution against cellulitis, as the rash resembled cellulitis. Fever - began ~10 hours after vaccination, continued until the AM 3 days after vaccination. Greatest temperature ~39C. Treated with Tylenol. Resolved on the third day without Tylenol use. Associated with chills, muscle aches, and anorexia.