chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist and refers to a 67 year old female patient. The patient's concurrent conditions included allergic reactions to codeine, penicillin and "sulfa". The patient's medical history was not reported and she was not pregnant. On 09-NOV-2016, the patient was vaccinated with ZOSTAVAX (route, dose, anatomical location and lot number were not reported). Information regarding concomitant medications was not reported. On 10-NOV-2016, the patient visited the pharmacy seeking medical attention; because she developed a red rash at the injection site that was warm to touch and itchy. In addition, the patient stated that she could feel a knot at the injection site. The patient was treating the event applying cool compress to the area (also reported as "no"). However, no laboratory diagnostic studies were performed. No product quality complaint (PQC) was involved. At the reporting time, the outcome of injection site nodule, vaccination site pruritus, vaccination site warmth vaccination site rash was reported as not recovered. The reporter did not provide a causality assessment between the events and the ZOSTAVAX. Additional information has been requested.
Pt was brought into office 3 days after immunization with a large (size of a baseball) bright red spot. Surrounding injection site on the right. Blotchiness all around leg itself. Started on Zyrtec 10mg Q D and Benadryl at bedtime as needed and cool compresses.
pt w/hx of 2 prev sz exp another sz temporally not related to vax;no fever
SORE THROAT; FEVER OF 104/LOW GRADE FEVER; DIZZINESS; BLURRED VISION; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, high cholesterol, alcohol consume 3 glass per week, and non smoker, and other pre-existing medical conditions included the patient had not known allergies to drug. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. Concomitant medications included lisinopril for high blood pressure. On 21-MAY-2021, the patient experienced dizziness. On 21-MAY-2021, the patient experienced blurred vision. On 21-MAY-2021, the patient experienced fever of 104/low grade fever. Laboratory data included: Body temperature (NR: not provided) fever 104. On 23-MAY-2021, the patient experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever of 104/low grade fever, and had not recovered from dizziness, blurred vision, and sore throat. This report was non-serious
muscle aches, severe headache 10/10, slight nausea, extreme fatigue.  Starting upon waking up the following day after injection , November 5th.  November 6th I woke up and almost all symptoms resolved except the nausea and a moderate headache which lasted until November 9th.
MD reported that a 22yo female w/mild allergic rhinitis had an unstated problem when adm MMR as a child; Pt developed a local rxn to skin testing w/Rubella virus live WAES 91021328; No further details were provided;
An initial report was received in the U.S.A. from a parent, who is employed by the health care provider on 07/20/2005. An 18 year old female patient developed headache and a rash on her lower back, under arms, back of knees and groin area two days after she had received an intra-muscular injection of Menactra in the right deltoid and an intra-dorsal injection of TUBERSOL in the left forearm. The rash was described as faint, pink small bumps. She does have a history of seasonal allergies for which she takes Zyrtec. She was treated with Motrin. It is unknown if she has recovered.
Left leg, ankle, and foot doubled in size, becoming swollen and numb. Once swelling subsided, the left leg, left arm, and left half of my face have been tingling non-stop. Tingling does not subside or release.
Missed the second dose and want to schedule 2nd dose now.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the second dose and want to schedule 2nd dose now.) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the second dose and want to schedule 2nd dose now.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed the second dose and want to schedule 2nd dose now.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was provided.
Moderna 4/18/21, 6/6/21, 12/11/21. Positive on 8/17/22
Headache, body aches, fever/chills, injection site soreness, muscle aches, joint pain, heart flutters/palpitations .
Bruised area of injection site, very sore arm, overnight I had to pee every two hours, headache, achy, slight fever.
A few days after receiving first vaccine, began experiencing sporadic episodes of vertigo and dizziness.  Symptoms became progressively worse and more consistent until they lasted all day (vertigo, dizziness, exhaustion, light sensitivity).  To date, symptoms have not resolved.  Attempted stretches to target vertigo, tried antihistamines (benadryl and cetirizine hydrochloride), tried dramamine.  None of aforementioned seemed to alleviate symptoms.  Still miserable.
1011-2nd Dose of Pfizer administered; 1025 pt began feeling a quivering in his stomach about where his diaphragm is located.  the feeling went away and pt went back to his office.    1045-Symptoms began again flushed/faintness accomapanied the initial quivering.  Pt bean feeling tingling his fingers and toes and felt like a lump was in his throat, his neck felt tight.  1052-Reported back to COVID pop up vaccine clinic reporting symptoms to staff in the clinic.  1100-BP 200s/90s HR 110s SPO2 96%. pt interviewed by lead FNP and evaluated.  PT given water and granola bar as he reported he did not eat that morning, only took Excedrin.  1115-BP 165/86 HR 92 SPO2 98%RA.  pt reports symptoms starting to resolve.  1120-HR 84 SPO2 98%RA. 1122-Pt dc'd to work.  pt asked to not leave the hospital for 4-6 hours, not even to work offsite.  pt agrees to report to ED if symptoms return.
After 2nd dose, period became irregular and unpredictable, heavy, then light, then heavy, some clotting.  It would stop and then begin after only a couple days. My period has never been like this. Not even after kids. It's always been every 28 days so this was very abnormal for me. It tapered off and everything went back to normal, then I got my booster shot, 09/29/21 and the same thing happened and is still going on as I write this. The only thing that changed in my life were those two  shots.
3:30pm In front of vaccination tent w/ c/o dizziness, ringing in ears+sweaty palms after vaccination.  EMS @ scene. BP 108/50, T 98.1, O2Sat 100% 3:40pm  Proceeded to observation, stated feeling much better. 3:50pm Exited observation verbalized no c/o at this time.  Advised if symptoms returned to call 911.  Friend driving car.
Had initially had heaviness in chest but tolerable. Injection site was red with bump for 2 days, then resolved.  evening of 1/6/21 itchiness returned to injection site and now today 1/7/21 injection site has a warm, red itchy area  that is 50 mm in diamter.
Pt states their arm was hurting from high up in shoulder to elbow. Pt was having tingling/numbing sensation in hands and there was a redness around injection site. Also, there was a rash about an inch tall and 3 inches wide.
Sore muscles  Lower back ache  Sore arm  Tired  Slept for about 12 hours  Got hot (not fever hot) and felt cold despite being warm  Occasional waist burning skin sensation
Information has been received from a registered nurse concerning a pt who was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine (lot 650453/0791P). Subsequently, the pt experienced pain and swelling in the injection site arm. The pts outcome was unknown. The nurse requested a lot check be performed on this lot since she was concerned about using it again.  The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards of and was released. In addition a review of the Quality control quarantine rejection system revealed that there were no open quarantines registered against this lot/fill.
Pt. states that after receiving the 3rd Booster of Phizer 10/15/2021, started experiencing symptoms 10/16/2021 of arm pain at the injection site, lymphnoid swelling under the left armpit. Swelling is slowly subsided. No noted Primary visit/communications.
felt achy all over; chills; no energy; felt like in a "fog" for about 24 hours; constipation increase; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program (060820).  A 62-years-old female patient received second dose of bnt162b2 (BNT162B2, Batch/Lot number: unknown) administration date 27Feb2021 (age at the time of vaccination was 62-years-old) as DOSE 2, SINGLE for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, for COVID-19 immunisation. The following information was reported: PAIN (non-serious), outcome "recovering", described as "felt achy all over"; CHILLS (non-serious), outcome "recovering", described as "chills"; ASTHENIA (non-serious), outcome "recovering", described as "no energy"; FEELING ABNORMAL (non-serious), outcome "recovering", described as "felt like in a "fog" for about 24 hours"; CONSTIPATION (non-serious), outcome "recovering", described as "constipation increase". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Patient reported labs stable, had Second COVID-19 vaccine on 27Feb2021 and felt achy all over, chills, no energy, felt like in a "fog" for about 24 hours and now some constipation increase. Feeling better this week. The patient was taking medication for 21 days on, 7 off.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt reports having throbbing/sore arm on 4/30/21, then on 5/5/21 has sore arm after mowing, when touches injection site (site of soreness) there is blood. There is enough blood to cover hand.  Pt reports having no blood disorders.
Pt was vaccinated with her first Pfizer Covid shot on 7/5/2022.  She reported on 7/12/22 that her arm was swelling at first.  After 3 days, the swelling came down and her arm started to be painful.  Her pain also spread to shoulder area.  Advised patient to call her primary care doctor or go to Urgent Care.  In case of emergency, she is to call.
Patient presented to emergency department on 10/15/2021 with fever.  He was found to be COVID-19 positive and was admitted for further management. He was treated with supplemental oxygen. He was discharged to skilled nursing facility on 11/6/2021.
No adverse event, Flublok gave in error to a 12 year old and should have been Fluzone.  Very busy store with one RPh and 1 tech with 3 people waiting and we were busy helping other patients.  Mom and her 12 year old Daughter gave the RPh the insurance card for a covid shot. Screened patient, Pfizer covid, claim paid, measured the Pfizer immunization and went to immunization booth to give the shot.  Mom said that the 12 year old (weighing 150-160 lbs) had her flu shot scheduled at pediatrician Dr. office at medical center tomorrow.  I said that she should either wait to get the covid shot or get both the flu and covid shot the same day.  Mom wanted her to get both shots the same day. Went to the fridge to grab the Fluzone Quad but the boxes were mixed up withe the Flublok quad. Using the handheld, scanned the Flublok quad in error and screend the Handheld clinical questions.  Added the Flublok to the hand held and waited a long time for the handheld to process the Flublok.  While we were waiting for the internet, gave the patient the shot:  eft arm was Covid and the right arm was Flublok. After administration the hand held finally updated and said there was an error.  Went to computer F6 and found that NDC was only for 18 years and older.  Told the mom what happened and called her later.  On phone call counseled mom that Flublok adult dose was given in error.  If the child was ached, tired or had fevers she could use ibuprofen or Tylenol.  If ibuprofen or Tyelonol did not work, mom should call pediatrician or go to the urgent care or emergency room because of this adult dose situation and to have a low threshold for calling for assistance. The child is taller than her mother and roughtly 150-160 Lbs so almost adult size but that I would would call pediatrician about the Flublok adult dose administration.   Technician and I re-arranged the fridge so the BLUE and WHITE boxes of FLUBLOKs were complete SEPARATED from the BLUE and WHITE boxes of FLUZONE Quad (they were mixed up because they look so similar).  Filled out report and contacted RPh. Also completed a VAERS error report to the CDC.
Whole body arthritic flare up. Off work bed ridden for five days Dr. prescribed Prednisone regimen. lingering effects for three month. Still having effects of the vaccine reaction.
Itchiness  in the arm that received the injection; Pain in the arm that received the injection; Swelling  in the arm that received the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness  in the arm that received the injection), VACCINATION SITE PAIN (Pain in the arm that received the injection) and VACCINATION SITE SWELLING (Swelling  in the arm that received the injection) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O32L2OA) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness  in the arm that received the injection), VACCINATION SITE PAIN (Pain in the arm that received the injection) and VACCINATION SITE SWELLING (Swelling  in the arm that received the injection). At the time of the report, VACCINATION SITE PRURITUS (Itchiness  in the arm that received the injection), VACCINATION SITE PAIN (Pain in the arm that received the injection) and VACCINATION SITE SWELLING (Swelling  in the arm that received the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.  Initially the patient did not experience any side effects. On 03-Feb-2021, the patient began to experience pain, swelling and itchiness in the arm that received the injection. At this point (time of report) the side effect have not subsided.
Information has been received from a physician concerning a 9 month old white female patient who was vaccinated with a first, second and third oral dose of Rotateq on 01-JUL-2006 (Lot # 653754/0139F), 11-SEP-2006 (Lot # 654248/0577F), and 14-NOV-2006 (Lot# 654248/0577F). Medical history and drug allergies were reported as unknown. Concomitant therapy was unknown. On 21-FEB-2007 the patient was diagnosed with intussusception. Patient was admitted to hospital on 21-FEB-2007. The patient underwent 2 air enemas and the intussusception reversed. On 22-FEB-2007, the patient was discharged from the hospital. Outcome reported as recovered. there was no product quality complaint involved. Additional information has been requested.
COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2021 at 13:00 as dose 1, single (Lot number: EF7534), in right arm, on 06Apr2021 at 13:00 as dose 2, single (Lot number: EW0151), in right arm and on 24Oct2021 at 13:00 as dose 3 (booster), single (Lot number: 30145BA) at the age of 71 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Jun2022, outcome "unknown" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Information: Reporter stated that, Non Serious report, No Seriousness criteria-Results in death, Life threatening, prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. Report was about COVID treatment. No Other medication in 2 weeks. Antiviral details reported as, Product: COVID 19 treatment, brand: Pfizer. No Known allergies. No Other medical history. Historical vaccine was mentioned as Yes. Case narrative reported as, Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. patient previously receive a COVID-19 Vaccine. Device date was, 30Jun2022.  No follow-up attempts are possible. No further information is expected.
** 35 weeks pregnant, due date 4/14/2021, 1st pregnancy * I had a fever about 8 hours after the vaccine. The highest I got to was 105, I also had really bad chills.  The next day I had a low grade fever and just had a headache and fatigue.  After 24 hours my symptoms went away.
This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. The patients' concurrent conditions, medical history, allergies, and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an unknown number of improperly stored doses of M-M-R II lot number M039904 with expiration date of 26-SEP-2018 and lot number M045390 with expiration date of 14-NOV-2018, for prophylaxis (strength, dosage schedule, route and anatomical location were not reported). The administered doses experienced a temperature excursion of 60 degree Fahrenheit for 4 weeks; data logger was involved. No previous temperature excursion was reported. No adverse events were reported and no product quality complaint was involved. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1709USA009559: US-009507513-1709USA009560:
? Friday afternoon on 7/24/20, around 12:30 she got the Hep B vaccine ? Friday night around 11:00 pm she noticed that her face was getting very red and starting to break out ? By 12:00am her face was very red, swollen, and she had difficulty breathing, especially out of her nose ? Around 1:00am she took Benadryl ? The redness and swelling had mostly gone down by 4:00am ? She woke up around 1:30pm Saturday afternoon, still slightly swollen   ? The swelling had completely subsided by 5:00pm Saturday
This spontaneous report was received from a physician referring to a 5-month-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 25-JUL-2017, the patient was vaccinated with improperly stored ROTATEQ orally, lot # M041184 with expiration date on 31-MAY-2018 for prophylaxis (dose was not provided). The vaccine was exposed to a temperature of 49 Fahrenheit degrees for 16 hours on 20-MAY-2017, 17-JUN-2017 and 21-JUN-2017. The vaccine was exposed to a temperature of 48 Fahrenheit degrees for 16 hours on 27-MAY-2017, 02-JUN-2017 and 03-JUN-2017. The vaccine was exposed to a temperature of 47 Fahrenheit degrees for 16 hours on 09-JUN-2017, 13-JUN-2017, 22-JUN-2017, 23-JUN-2017, 28-JUN-2017 and 29-JUN-2017 and for 70 hours on 30-MAY-2017. The vaccine was exposed to a temperature of 35 Fahrenheit degrees for 16 hours on 27-JUN-2017 and 20-JUL-2017 and for 46 hours on 17-JUL-2017 and 26-JUN-2017. The vaccine was exposed to a temperature of 34 Fahrenheit degrees for 16 hours since 29-JUN-2017 until 01-JUL-2017, on 03-JUL-2017, 06-JUL-2017, 07-JUL-2017 and 19-JUL-2017, for 40 hours on 05-JUL-2017 and for 46 hours on 10-JUL-2017. The vaccine was exposed to a temperature of 33 Fahrenheit degrees for 16 hours on 08-JUL-2017 and since 11-JUL-2017 until 15-JUL-2017. The vaccine was also exposed to a temperature of 32 Fahrenheit degrees for 16 hours on 22-JUL-2017. Additionally, it was reported that digital data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases received from the same reporter.; Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA007325: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1711USA003163: US-009507513-1711USA003164: US-009507513-1711USA003162: US-009507513-1711USA003161: US-009507513-1709USA012767: US-009507513-1711USA003159: US-009507513-1711USA003157: US-009507513-1711USA003165: US-009507513-1711USA003158:
8/22/18 Patient in office started vomiting after every feeding few hours after vaccines. Decreased urine output, no fever. Sent to ER for lab and x-ray. ZOFRAN given for vomiting. 8/23/18 Patient brought in for follow up doing much better no stools but lots of gas. Eating well vomited once at night given ZOFRAN did well. 8/24/18 Per mother, patient started vomiting again, given ZOFRAN, no vomiting since.
Information has been received from a physician who attended a conference that mentioned two patients who were vaccinated with Gardasil. Subsequently the patients died. The cause of death not reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.