chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacy technician and a healthcare worker refers to 4 patients of unknown age. The pharmacy technician mentioned that a medical assistant for a physician reported that on an unknown date the patients were vaccinated with PNEUMOVAX 23 lot # H014561 Exp 21-MAR-2014 (dose and route unknown). On an unknown date the 4 patients experienced "gross swelling" around the injection site. The patient sought unspecified medical attention. The outcome of the event was unknown. The healthcare worker requested a lot check for PNEUMOVAX 23 (lot # H014561 Exp 21-MAR-2014) due to patients having adverse experiences. Additional information has been requested.
My doctor wanted me to contact you because I contracted covid after being vaccinated.  I had sneezing, diarrhea, coughing, runny nose, sore throat, headache, body aches, fatigue, facial pain.  I started with sneezing and diarrhea on the 11th of July and everything else came on July 20th.
This spontaneous report was received from a nurse referring to multiple patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 21-JUN-2016, multiple unspecified patients received improperly stored ROTATEQ lot # L013204, expiration date: 28-JAN-2017, via oral (concentration, dose and frequency were not reported) with a temperature of 10.2 degrees Celsius for 6 hours, 35 minutes due to digital data logger. Additionally previous excursions were reported on 09-AUG-2016 with a temperature of 1.4 degrees Celsius for 53 minutes and also on 15-AUG-2016 with a temperature of 1.5 degrees Celsius for 29 minutes. No adverse effects were reported. Information regarding concomitant medication was not reported. Additional information has been requested.
developed red lesions on his left thigh.  Slightly raised.  No itch.  No pain.  no fever
Approximately 6-7 hours after receiving my 3rd Pfizer Covid-19 booster vaccine, I experienced EXTREME chills, sweating, shivering, body aches, muscle and joint soreness and debilitating fatigue.  The extreme symptoms last about 24 hours, but I had moderate full body soreness, weakness and fatigue for an additional 24 hours.  I did not experience any GI symptoms except a decreased appetite during this time.  I also experienced very bad soreness at the injection site, which I did not with the first 2 in the series.
Patient received 2023-2024 Moderna COVID-19 vaccine on 10/05/2023 which is sooner than recommended 60 days since last dose of bivalent vaccine on 08/17/2023.
Per patient, she has been experiencing pain near the injection site area ever since she got her flu shot. Her upper arm is in pain - unable to move it around as much, difficult to sleep on it, continuous pain. Patient occasionally took ibuprofen 200 mg, 2 tablets by mouth once daily to help with the pain. This does alleviate the pain, but patient does not wish to take this on a daily basis for her pain.
This case was reported by a consumer via call center representative and described the occurrence of hives in a infant female patient who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received the 1st dose of FLULAVAL QUADRIVALENT .5 ml. On an unknown date, less than an hour after receiving FLULAVAL QUADRIVALENT, the patient experienced hives and rash. On an unknown date, the outcome of the hives and rash were unknown. It was unknown if the reporter considered the hives and rash to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The patient was reporter's granddaughter. The reporter did not want to provide demographics. The reporter did not know the name of patient's physician.
boosted a month ago which helped her but had mild symptoms last Sunday; boosted a month ago which helped her but had mild symptoms last Sunday; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "pneumonia" (unspecified if ongoing); "respiratory issues." (unspecified if ongoing), notes: respiratory issues. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Nov2022, outcome "unknown" and all described as "boosted a month ago which helped her but had mild symptoms last Sunday". The reporter wanted to know if she can start taking Paxlovid tonight, no intake yet. She mentioned that she had been boosted a month ago which helped her but had mild symptoms last Sunday, had slight chills and cough and head was congesting.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
8/20 PT REC'D VACCINE, FELT FINE. 8/22 PT WOKE UP NOT FEELING WELL; FATIGUE, MALAISE, ACHE, FEVER, CHILLS, SLEEPY. 8/23 INJECTION SITE STARTED TO HURT, FELT HOT, ITCHY, RED, TENDER TO TOUCH. TOOK TYLENOL FOR PAIN. 8/26 PT CAME TO PHARMACY STATED TO REPORT; ADVISED PT TO CALL MD IN THE MORNING.
Been having frequent cough, started as dry cough with chest congestion lasting for a week or 2, been taking over counter MUCINEX or NYQUIL for sleep. Cough is on and off.
Arm became very sore and swollen. She said it was not the shot itself but felt it was the vaccine.
This case was reported by a pharmacist and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with (FLULAVAL, GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced injection site pain. At the time of reporting the outcome of the event was unspecified.
Post vax, had a few, scattered fine bumps to face and trunk, no scratching x 2 days. Treatment advised to use Hydrocortisone, bathe with gentle soap (DOVE) monitor symptoms, if worsens or no improvement, return to clinic or nearest ER. On 5/12/00, rash gone and no fever.
Booster (#2 in series) received 04/23/2022.  Approx. 0430 hours 4/25/2022, awakened in severe pain over entire body and in joints.  Severe pain has persisted and not lessened to any degree in the interim (to date; 5/04/2022).  Pain rating is averaging 5-6 on the 0-10 scale and fatigue has set in.  Developed mild (100.0 degrees F.) temperature on 5/2/2022, which has since subsided.  Have been taking Naproxen Sodium twice daily, assistance with this is minimal.  Have sought treatment at Urgent Care for pain/fatigue, however Urgent Care doctor's recommendation(s) included to continue with Naproxen Sodium and report back to Urgent Care if pain/fatigue worsens or fails to subside.
Pt walked in to vaccination clinic on 2/2/21, reporting to have left upper arm redness, had COVID-19 vaccine at outside vaccination site 1/31/2021. Reviewed by provider on site and mild redness of left upper arm.  Patient was advised to go to urgent care for further evaluation.  Pt was agreeable and left clinic to go to urgent care. Appointment at urgent care was made for 2/2/21 but patient no showed to visit.
I noticed I starting to feel not well, but 2 days later after the vaccine, I noticed it when I exercised. I went to a doctor and said I had high Blood Pressure, which I never had before, and this time it lasted for 3 months. I had headaches. I lost my strength (physical capacity), it resolved itself.
Fever 105 r approximately 9-10 hours after vaccination. Fever 103-104 persisted almost 3 days- High irritability, vomiting on & off for 7 days.
HIVES; This spontaneous report received from a patient via a company representative 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, 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 an unspecified date, the subject experienced hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hives was not reported. This report was non-serious.
Patient developed a "water blister" like rash on the palms/fingers of both hands after getting the flu vaccine. She said that this has happened the past 2 years as well but it was never reported before. I saw her hands as they were "healing" and they were covered in small white patches of what looked like dry skin (a couple millimeters in diameter each). She described the reaction as raw skin or open blisters that were painful only on contact with objects. They did not itch or burn. She did not report any treatment.
I experienced extreme fatique and as of today,  July 7, 2021, I am just starting to feeling somewhat normal energy level.  As far as the vertigo, I am a hiker and whan I went to hike an area that I had hiked in the past, vertigo kicked in and I was unable to complete the hike.  It was terrifying.  I have never had vertigo in the past.
Dose 1: 20210401Dose 2: 20210419; Fever chills with a temperature of 102.4 deg Fahrenheit; This is a spontaneous report from a contactable consumer. A 46-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 19Apr2021 at 14:30(at the age of 46-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in left arm on 01Apr2021 at 12:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 20Apr2021 at 09:00, the patient experienced fever chills with a temperature of 102.4 degree Fahrenheit. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever chills was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
following initial vaccine 12/30, pt had skin irritation directly around the injection site, itiching and states redness has now grown 2" wide x 4" long, spoke with PCP who advised to apply benedryl cream to site, pt has done so.
Around 10:30pm the day of the vaccination, she experienced back pain, arm pain and achiness. The next morning around 9am she experienced "burning up" & "radiating heat". She checked her temp at 1pm and it was 101.7F. She had chills, lower back pain, hip pain, body aches, arm extremely sore. Fever broke that night by 7pm. Severe fatigue lasted about 1 week.
Patient had emesis and fever evening of 11/4/04. On morning of 11/5/04, mom found patient unresponsive. Diagnosed with cardiomyopathy; transferred to care center. Questionable myocarditis. Follow up 01/20/05: Patient has not fully recovered. He has cardiomyopathy, on Digoxin and Enalapril, requires close cardiology follow up. Also, had a stroke while on ECMO with residual neurological deficits, which are unknown in detail to us at this time. As Per annual Follow up: cardiology note dated 8/12/05 states he had biopsy done 7/22/05 with signs of myocarditis evident, despite considerable immunosupression. He is on Imuran, Predinsone, Cyclosporine, Enalpril, as well as Amiodarone. he has had evidence of myocarditis for m months. Long term sequelae of this is yet to be known. Medical records state respiratory failure, septicemia, systemic inflamation, congestive heart failure, hyper potassimia, hypertension, respiratory virus, occluded cariotid artery, swallowing problems, dyspnea, left sided weakness. msv
Dizziness one hour after second vaccine on the next day sore arm at side of vaccine and drowsiness tiredness. On Monday afternoon noticed lymph node in front of right ear opposite side of vaccine was swollen on Tuesday notice that there was fluid swelling directly under my right knee went to the doctor they said to monitor symptoms Thursday woke up to swelling in face on the left side between nose and cheek. Today feeling tinglingness in both legs hands and swelling continues in face right lymph node in front of ear is not as large.
- Soreness at injection site (subsided within 24 hours)  - Low grade fever (99.5-100.1, current at time of report)  - Cough (sporadic, resolved within two hours)  - Nasal congestion (sporadic, resolved within two hours)
Approx. 1.5 hours after administration, child a red tongue and hives on tongue.  Parent consulted with private physician who advised anbesol topically.  The next morning, approx. 18 hours after intra-nasal administration, signs and symptoms were gone.  Parent notified our department today, 10/23/2009.
Shingles; This case was reported by a consumer and described the occurrence of shingles in a 59-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of herpes zoster (received 1st dose on 25th September 2019, refer case US2020AMR112938).   On 18th March 2020, the patient received the 2nd dose of Shingrix. On 16th April 2020, 29 days after receiving Shingrix, the patient experienced shingles. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The NDC number was provided as 58160-0823-11. The patient received Shingrix and had Shingles on 16th April 2020 and 22nd May 2020. The patient was put on medicine for 6 months and had 10 *5 they talked into shots. The patient still got 6*5 for shot plus. The reporter thinks he/she deserve money back after both doses.
Initial and follow up information has been received from a physician and an 81 year old male consumer with no known allergies and with a history of atrial fibrillation and severe balance issues (for 2 years and most recent episode approximately 21-FEB-2008) who on 27-FEB-2008 (also reported as 28-FEB-2008) was vaccinated with 0.65mL of zoster vaccine live (Oka/Merck). Concomitant therapy included COUMADIN and simvastatin (manufacturer unknown). Subsequently, on 13-MAR-2008 the patient developed a blister rash on his anterior left thigh. On 14-MAR-2008 he presented to the physician's office. Upon exam the patient had shingles on left leg. He was treated with VALTREX 1 gram every 8 hours X 7 days. Patient reported that on 12-MAR-2008 he "was walking and it was hard to straighten out, he drifted backward." EMS was called, vital signs were ok and there were no speech problems. "Carotids-no bruits, ROMBERG-negative, movement within normal limits and tandem walking was ok." Impression was imbalance. An MRI and MRA of the head were planned. As of 18-APR-2008 the patient was recovered from the shingles. There was no product quality complaint involved. Additional information is not expected.
The swollen part red; Swollen part little painful; Swollen lymph node having almost size of peas below the right chin; Fever 101 f; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Er2613) via an unspecified route of administration in the left arm on 31Mar2021 at 17:30 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 COVID vaccine. On 10Apr2021 at 06:00, the patient experienced swollen lymph node having almost the size of peas below the right chin. The swollen part was red and it was a little painful when it was touched. On the same day, during the evening, the patient got a fever of 101 Fahrenheit (f). The patient did not get any other side effects of fever even after 10 days of taking the vaccine. 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 event swollen lymph node having almost size of peas below the right chin, fever 101 f, the swollen part red, and swollen part little painful were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
24 hours after shot, a rash developed around two mosquito bites near my injection site and has gotten progressively worse (currently 4/9, vaccinated 4/5) & spread to all mosquito bites & minor scrapes on both arms. Each bump/cut got redder & raised & slightly scaly - resembles poison ivy (which I?m not allergic to.)
Pharmacist knocked on clinic room door to interrupt NP during a patient visit.  She reported a customer was just administered Moderna COVID-19 vaccine dose #1 (lot # 088D21A) at 4:30pm and immediately started to have an allergic reaction.  NP grabbed vitals basket and emergency kit and immediately assessed the visitor.  Her complaints were nausea, abdominal discomfort, facial and mouth itching.  Noting that these were signs of an allergic reaction, epinephrine 0.3mg/0.3mL was administered to right anterior thigh at 04:36pm.  Diphenhydramine 50mg PO was administered at 4:38pm.  Blood pressure, heart rate, oxygen level, and RR were obtained following medication administration (120/80, 115, 100%, 20).  VS were repeated at 4:45 and 4:50pm and remained stable.  (130/80, 105, 100%, 24; 116/82, 110, 100%, 22). After 10 minutes since 1st epi injection, patient did not achieve resolution of symptoms.  She denied worsening and denied improvement.  Second dose of epinephrine 0.3mg/0.3mL administered to Left anterior thigh at 4:46pm.  EMT/firemen arrived.  They explained that paramedics were en route.  Paramedics arrived at approximately 5:05pm.  Report of events was given to paramedics and they they assumed care of the patient.  They took with them the used epinephrine pens.    Patient remained stable, conscious, alert throughout entire event.  Her grandmother and aunt were with her and followed to the hospital in their car.  Patient and her family expressed gratitude for the care received at our pharmacy today.  Patient was also instructed not to receive a 2nd dose of Moderna, nor Pfizer.  She had reported multiple drug allergic reactions in the past which required emergency treatment.
Patient received a fourth dose of the Covid Vaccine, 3rd "booster" dose administered on 10/26/2021
Patient received the FlLULAVAL 2009-2010 flu shot on 9/22/2009. He developed shingles about 4 days later and was seen at the Clinic. He still had the rash on his arm, but it is getting better.
Dizziness, Headache, Diarrhea & NauseaVomiting Narrative: taking Tylenol for pain
Initially an itching bump on the left leg the afternoon after the injection. I used steroid cream and it seemed to go away after about 3 days.  On the fourth day a large, itching rash came up on my left upper leg (thigh area).
Hives, he had on face then on his neck; Arm is just sore; 2nd dose yesterday and it is Pfizer vaccine; This is a spontaneous report from a contactable consumer or other non hcp. A 21-years-old male patient received second dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Lot Number: EN0167, Expiration date: Unknown) via an unspecified route of administration on 18May2021 as dose 2 (initial Pfizer dose), single and first dose of covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE, Batch/Lot number was not reported, Expiration date: Unknown) via an unspecified route of administration on 21Apr2021 as dose 1, single for COVID-19 immunization. Medical history included urticaria from an unknown date and unknown if ongoing, hypersensitivity from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Transferring agent stated on call ,"She was calling on behalf of her son, they were calling because they received from first dose of the vaccine not from Pfizer it was from Moderna on 21Apr2021 and 2nd dose yesterday (18may2021) and it was Pfizer vaccine and according to the mother, she mentioned that her son noticed that (statement incomplete), experiencing a hives in the skin and his son had previous hives, history of hives before, actually they know the reason before like that, so got hives but now at this time they don't if that was from Pfizer Covid 19 vaccine. When paraphrased the concern, Reporter stated, "He had them (hives), they kind of went away, he had on face then on his neck but he took a shower they seems like they going away but I don't know, should just took him to emergency or because I know even with each one of shot you could have some sort of reaction even that if it properly administered so we are just wondering. When clarified if event occurred after Pfizer Covid 19 vaccine, Reporter stated, "He just got hives today, he is experiencing anything now is his arm is just sore. He had little bit of hives on his face and on his neck (further not clarified). Reporter added, "I want to know, I mean your personal opinion do you think it worth taking him to emergency because there was just so much unknown about people receiving two doses, everyone kind of giving big answer about if anything should be done or not. Patient did not receive any treatment. The outcome for the events was unknown.  Follow-up attempts completed. No further information expected.
I thought the Abrysvo was being administered but I pulled the Arexvy instead which was the one administered to the patient is pregnant so the Abysvo is the only one indicated in pregnancy. I spoke with patient but unaware of any adverse events at this time.
Red, swollen, rash with extreme itching extending from upper arm to wrist of left arm.
11 year old female brought by both parents with mild redness and swelling at the site of Varicella vaccination in the right upper arm 2 days ago. No fever or breathing difficulty. No pus at the punctum.Skin: 7 x 6 cm area of redness with a 2.5 x 2 cm area of induration at the site of injection in the posterolateral aspect of the right upper arm, no pus in the punctum; no streaking