chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client received her 2nd dose of the Covid19 Pfizer vaccine (Lot#FF8839) at 18:30 pm on 09/16/21.  After receiving the injection, the client and her father proceeded to the observation area to sit for 15 minutes.  At approximately 18:45, client alerted EMT she started to feel numbness in her lips and tongue around 4-5 minutes prior.  EMT immediately requested Lead RN  come over to assess the client.  At 18:46, Lead RN observed the client sitting upright in a chair, in no apparent distress.  Client communicated she was not experiencing shortness of breath, difficulty breathing, or chest pain.  Client also stated she was not having trouble swallowing.  Client indicated she felt a tickle on her tongue and her lips felt like they were getting numb, but she was not experiencing any swelling in those areas.  Lead RN requested the client open her mouth to observe the client?s tongue and throat with a pen light, and observed that the client?s tongue and throat were not swollen.  Client stated she did not experience any of these effects after receiving her 1st dose of the Covid19 Pfizer vaccine, but did experience a headache and some nausea.  Client stated she has no underlying health conditions, takes no medications, and has no known allergies.  She did state that 4 years ago she took Sumatriptan for migraine headaches and experienced minor numbness in her face, arm, and tongue, but no swelling.  Client also stated she did not take anything to treat those symptoms, but did drink a lot of water and they went away.  She also did not seek treatment, but her HCP recommend she no longer take the medication.  EMT took client?s vitals at 18:55 (BP: 122/88, HR: 75, SPO2: 98%).  Client indicated she normally has low blood pressure.  She also stated that the numbness was starting to subside and confirmed that she was still not experiencing any swelling.  The client was provided with a bottle of water per her request, which she began drinking.  Lead RN requested the client sit for another 10-15 minutes for observation and the client agreed.  At 19:06 the client stated the numbness in her lips was almost gone and she was no longer experiencing a tickle on her tongue.  At 19:08 EMT, Ali, took the client?s vitals (BP: 120/80, HR: 74, SPO2: 97%).  Client communicated ?the numbness is pretty much gone,? and she felt fine.  Lead RN educated the client and her father on both the potential side effects and adverse effects of the vaccine, when to seek medical attention, and ER precautions.  Lead RN observed the client and her father leave the observation area at 19:12.  The client was walking with a steady gait.
Had chills; legs were achy; could not get comfortable; low grade temperature of 99.2 F; slight headache; little nausea; A spontaneous report was received from a female health care provider who received Moderna's COVID-19 vaccine and experienced chills, achy legs, could not get comfortable, low grade temperature of 99.2°F, slight headache and a little nausea.   The patient's medical history, as provided by the reporter, included negative COVID-19 test 2 weeks prior to vaccine administration No relevant concomitant medications were reported.  On 29-Dec-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   The patient prophylactically took ibuprofen prior to vaccine administration on 29-Dec-2020. On 30-Dec-2020, the patient had chills, legs were achy, and she could not get comfortable. She again took ibuprofen. Later that day, she had a low grade temperature of 99.2°F, a slight headache, and a little nausea.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, chills, achy legs, could not get comfortable, low grade temperature of 99.2°F, slight headache and a little nausea, were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Muscle soreness upon waking up the next day that went away through stretches throughout the day, along with a significant headache that persisted for 24 hours. The headache has continued to impact my daily life; I have never had migraines but it feels as though what I am experiencing is prolonged migraines. There has not been a day since I received my booster that my head has not bothered me. Particularly, when I need to focus on a task, screen, or driving, the front of my head hurts and I have blurry vision.
Local reaction Rt thigh: 9x6cm area of erythema and 2x2 1/2cm induration started approximately 3 hrs post injection. (Moderate to severe local rxn).
PT CAME IN WITH APPROXIMATELY 30 SCATTERED, RED, PAPULES 7/7/07 ON ABDOMEN, THORAX, FACE; FEVER UP TO 101F; IRRITABILITY; DECREASED APPETITE
w/in several hrs p/immun pt exp an inject site involving entire arm, h/a, tingling in hands & weakness in legs; treatment included Pred; pt not seen by MD; sl induration @ inject site 1 mo later;
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with hepatitis B (manufacturer unspecified). On an unspecified date in 2012 the subject received 7th dose of hepatitis B vaccine (40 mcg, unknown). On unspecified dates in 2008, the subject received 6th dose, 5th dose, and 4th dose of hepatitis B vaccine (40 mcg, 20 mcg, unknown). On unspecified dates in 2006 the subject received 3rd dose, 2nd dose and 1st dose of hepatitis B vaccine (20 mcg, unknown). At an unspecified time after vaccination with hepatitis B vaccine, the subject experienced not responding to therapy. The subject "received three doses of hepatitis B 20 mcg vaccine in 2006 and did not respond. Subject received in 2008, two 20 mcg doses of hepatitis B vaccine and one 40 mcg dose and did not respond. In 2012, the subject received a 7th dose of 40 mcg." At the time of the report not additional information was provided.
Pain in arm, flu-like symptoms, fever, fatigue, chills, night sweats, brain fog, dizziness, I fainted and was taken by ambulance to hospital. I was sick for two weeks, with different symptoms, confined to bed .
woke up @ 1 am with severe chills fever of 99.9 @ 0700 chills @ 0830 fever @ 1200 chills @ 1400 fever @ 1700 headache from 10 - 1900 all symptoms resolved by 2100
taking Paxlovid; taking Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "taking Paxlovid". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
DIARRHEA; LETHARGIC; GENERALISED ACHING; HEADACHE; SWELLING AT INJECTION SITE; REDNESS AT INJECTION SITE; BLOOD CLOT FROM THIGH TO CALF; This spontaneous report received from a consumer concerned a 66 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included paralyzed on left side from a previous injury and not very active. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered 1 total administered on 06-APR-2021 on right arm for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported.  On 07-APR-2021, the patient had blow-out diarrhea, lethargic, body aches, headache. On APR-2021, the patient experienced leg pain (started week ago), swelling at injection site and redness at injection site.  His left foot was swollen, and called physician to check for blood clot or break. The doctor said that the test showed a blood clot from his thigh all the way down to his calf that was a medical emergency. Reporter thinks there was a possibility that they were already exposed to COVID. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot from thigh to calf, diarrhea, lethargic, generalised aching, headache, swelling at injection site and redness at injection site was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210450241- COVID-19 VACCINE Ad26.COV2. S -Blood clot. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
1-Skin discoloration 2-sleep problem 3-Joint ache 4-skin itching 5. Lower back 6. high cholslerol 7. respiratory Problem, Blister Back. I report all these condition to my VA doctor.
Mom called on 07/03 stating that she got both vaccines in the same leg on  06/30 and now has a red 1 in spot where they were given.
inadvertently administered tenivac instead of daptacel with no reported AE; administered dose of TENIVAC was expired with no reported AE; Initial information was received on 08-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional.  This case involves 4 years old female patient who stated inadvertently administered tenivac instead of daptacel with no reported ae and administered dose of tenivac was expired with no reported ae while receiving vaccine diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT [Tenivac].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included influenza vaccine INACT SPLIT 4V (Fluzone QUADRIVALENT) for Prophylactic vaccination; POLIO VACCINE INACT 3V (VERO) (Ipol POLIO VACCINE) for Prophylactic vaccination; measles vaccine, MUMPS VACCINE, rubella vaccine (MMR) for Prophylactic vaccination; and VARICELLA ZOSTER VACCINE (VARICELLA VACC.) for Prophylactic vaccination.  On 08-Nov-2022, the patient received suspect diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT Suspension for injection at a dosage of 0.5 ml once (lot C5779AA, expiry date - 02-Oct-2022) via intramuscular route in the left thigh for immunisation.  On 08-Nov-2022 the patient developed non-serious events of inadvertently administered tenivac instead of daptacel with no reported ae (wrong product administered), administered dose of tenivac was expired with no reported ae (expired product administered) (latency: same day) following the administration of diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event inadvertently administered tenivac instead of daptacel with no reported ae and was Unknown for the event administered dose of tenivac was expired with no reported ae.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Clogged ears / damped hearing in one ear, minor headache, mild covid arm.
t101-102, screamed for 7hrs p/immun w/out stopping; mom phoned MD; next day sluggish but alert; MD recommended no further Pertussis;
Patient on long term birth control to suppress periods. Developed breakthrough bleeding following the vaccine 1 day after the vaccine.
Information has been received from a registered nurse concerning a 6 year old white male with no medical history and no allergies who on 25-Aug-1999 was vaccinated (previously reported as subcutaneously with a first dose of varicella virus vaccine live (lot # not available). It was unknown if the patient was ill at the time of vaccination. Neither the patient nor his sister had an adverse event following prior vaccinations. There was no concomitant medication. On 18-May-2003 the patient developed a varicella rash. It was reported that the patient contracted chicken pox/varicella and was "into a clinic setting with objective diagnosis of varicella". No other symptoms were noted. Medical attention was sough and the patient was being treated with acyclovir (ZOVIRAX) suspension. No diagnostic studies were performed. Subsequently, on an unknown date, the patient recovered. No product quality complaint was involved.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Pt presented to pharmacy 11-12-2022 displaying localized bruise around injection site and described tenderness and pain x a "few days." Counseled patient for at-home care as well as to seek medical attention PRN.
Patient reported numbness and tingling from injection site radiating to left side of face and slight chest tightness.
Sick; Initial information received on 11-Dec-2021 regarding an unsolicited valid social media serious case received from a consumer or non-healthcare professional via social media.  This case involves Adult and unknown gender patient who experienced sick (illness) after receiving INFLUENZA VACCINE and corona virus disease 2019 (COVID-19) VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's medical treatment(s), vaccination(s) 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 received a dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur [lot number and expiry date not reported] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious sick (illness) (2 week latency) following the administration of INFLUENZA VACCINE and (unknown latency) following the administration of COVID-19 VACCINE.  It was reported "watch out I got sick for almost 2 weeks, after getting shot, beware so many other people are getting sick from flu vaccine and covid vaccine."  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
This is a spontaneous report received from contactable reporter (consumer or other non HCP). The reporter is the patient. A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Jan2021 at 15:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 15Feb2021 at 15:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 24Sep2021 at 17:00 as dose 3 (booster), single (Lot number: 301358A), in left arm and on 18Mar2022 at 15:00 as dose 4 (booster), single (Lot number: FK9895) at the age of 68 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Morphine and derivatives, reaction(s): "known allergies". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of COVID-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I was exposed to COVID-19 and  on August 17, I woke up with extreme pain and unable to stand to stand on my left leg, specifically my knee. I tested positive for COVID-19. The knee pain was so severe I could barely walk. I finally went to urgent care on September 1 and I was diagnosed with arthritis of the knee, which was most likely an after effect from COVID-19.
pt states broke out in a rash from head to toe  (rash similar to measles);
pt recv vax in 1995 & w/in 1mo of vax pt devel gen henoch-schoenlein purpura; No further details were provided;
patient received the Pfizer COVID-19 vaccine/got the COVID infection; patient received the Pfizer COVID-19 vaccine/got the COVID infection; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the Pfizer COVID-19 vaccine on an unspecified date and she and her husband both got the COVID infection on an unspecified date. The outcome of the event was unknown.   Information on lot/batch number has been requested.
I started having overwhelming fatigue and a low-grade fever, cough and runny nose. It was very mild compared to other people's issues. After about 3-4 days I got tested at a mobile test site. The COVID-19 test was positive, I reported it to my doctor, and I was told to treat it at home with home remedies. I took cough syrup and TYLENOL overall it helped.
Information has been received from an office manager in a physicians office concerning a female (age unreported) who on an unspecified date, was vaccinated with a dose of GARDASIL, no lot number reported.  It was reported that within 5 minutes of being vaccinated with GARDASIL, the patient fainted and then also experienced convulsions.  Unspecified medical attention was sought.  At the time of this report the outcome was unknown.  Upon internal review convulsions were considered an other important medical event.  Additional information has been requested.
p/vax pt had a metallic taste in mouth; goes away p/a few days; returned a wk later for a few days; this continues off & on since this week has it again
Information has been received from a physician concerning a female patient in her 20's who was vaccinated with a first and second dose of Gardasil. The physician reported that the patient had unusual soreness at the injection site after the first and second injection. He also reported that the patient had unusual stiffness and weakness with local mechanical trouble after she was given the third dose of Gardasil. The patient had not recovered as of this report day. The physician reported that this is one of the three patient who experienced similar experience. Additional information is not expected.
Severe left arm pain. After receiving injections patient's arm sore. Instead of soreness improving, soreness worsened. No onset date of symptoms. severe pain, unable to lift left arm, difficultly sleeping, migraines. Patient has been seen at medical office and ER for symptoms. Latest ER visit 2/9/22. patient believes she is having a reaction to the TD vaccine.
Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.; Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. The vial was stored in refrigerator and the date vial(s) moved from freezer to refrigerator on 3-MAR-2022. Maximum or minimum temperatures reached, as applicable was Maximum Temperature was 49 degrees Farenheit and Minimum Temperature was 37.7 degrees Farenheit. The temperature excursions occurred on 4-MAR-2022, 5-MAR-2022, 7-MAR-2022, 8-MAR-2022, 8-MAR-2022, 9-MAR2-022, and 10-MAR-2022. Vials were not visualized and  Proposed desired Use by Date is given as 16-MAR-2022 No treatment details were provided. It was reported that there were no adverse reactions or side effects to the Moderna Covid-19 vaccine.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age who on an unknown dates, were vaccinated with an unspecified number of doses of RECOMBIVAX HB (doses, routes and lot numbers not reported) that were exposed to 20C for 15 hours on 17-FEB-2014 and an additional excursion of 14C for 19.5 hours beginning on 01-MAR-2014 which was supported. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.