chrisvoncsefalvay/vaers-outcomes huggingface dataset:
o Exam Time 12-03-2021 11:20  Chief Complaint: weakness Additional Medical History:  Patient arrives with weakness as a chief complaint.  Patient's weakness is global and not unilateral.  Patient is seen standing getting dressed in the gown.  Patient's only other complaint is lower abdominal pain with walking.  Patient noted to have a heart rate in the 120s.  Patient denies being sick recently other than a node anterior to left ear.  Patient denies problems with bowel movements or urinating.  Patient denies fevers.  Patient denies chest pain or shortness of breath.  Patient denies nausea vomiting.  Patient has not fallen due to his weakness. Pt has had covid vaccine.  Denies Symptoms: no back pain/ no chest pain/ no cough/ no diarrhea/ no eye redness/ no fever/ no headache/ no nausea/ no rash/ no shortness of breath/ no URI symptoms/ no vomiting This is an 89-year-old male with significant past medical history of hypertension, hyperlipidemia that presented to the hospital with chief complaint of lightheadedness and dizziness when he woke up this morning.  Patient states that this has been ongoing for a while and this morning he was tired of feeling like this way.  The patient states that over the past week he has been having viral symptoms and thought he had a cold.
On 04/3/2021 I started having cold symptoms. I had running nose, congestion, sore throat, body aches & a headache. Today 04/13/2021 is my first day I'm actually feel better. I feel like I am getting better and not worst. I am 4 weeks and 6 days pregnant. My estimated due date is 12/14/2021.
Fever, severe headache, body aches, nausea, vomiting, chills, joint pain, unable to hold down any food or liquids, chemical smell, and lethargic.
PATIENT WHO IS A MINOR RECEIVED A PFIZER BOOSTER ALTHOUGH IT WAS NOT AVAILABLE YET TO THOSE UNDER 16 YEARS OF AGE. PATIENT'S MOTHER REPORTED THIS VACCINE ERROR ONE DAY LATER. PT HAD NO COVID-19 VACCINE HISTORY IN THE DEPT OF THE HEALTH SYSTEM.
Redness, warm to touch,  and swelling at injection site. Treatment-Benadryl and cold compresses
Patient was administered Moderna Booster dose (0.25 mL) instead of second dose of pediatric Pfizer by  EMT. Patient showed no immediate signs or symptoms of adverse event and left with parent. Error was noticed a few minutes later and parent was contacted.
On day 12 patient developed a fever. On day 13 temp up to 103. Parents report shaking of extremities and rolling of eyeballs. Parents report patient unresponsive and making grunting noises for 5 to 10 minutes and lips turned blue. On the way to ER, the baby came out of it and parents returned home. Fever continued through the next day. Rash appeared today day 15.
Min 15; Rubbery/slimy feeling tongue. Metallic taste. No swelling. Minor dizziness, passed within 30 minutes. Hour 3; 6/10 head ache at the temples, chills, beginning of flu like symptoms. Hour 6; Joint stiffness. Tylenol/ibuprofen had no effect. Hour 9; Very minor trouble breathing, in bed. Ignored. High fatigue. Hour 20; noticeable dry cough and chest wheezing. Watery eyes, continuation of flu like symptoms. No fever noted. Hour 24; Symptoms moderating well.  Some stiffness. Head ache decreasing. Injection site typically sore. Little appetite and very thirsty. Have consumed more than 7 liters of fluids in the last 24hrs, little output.
No additional AE/no PQC.; Merck Employee called on behalf of healthcare worker to report that a 2 year old female patient inadvertently received an expired dose of PROQUAD. Per employee, no symptoms were reported. The dose of PROQUAD expired 6/14/2023 and was administered 7/1; This spontaneous report was received from Other Health Professional and refers to a 2-year-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 19-JUL-2023, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 1 dose, expiration date: 14-JUN-2023, administered for prophylaxis (strength, lot #, and route of administration were not provided).  On 19-JUL-2023, Merck Employee called on behalf of healthcare worker to report that a 2 year old female patient inadvertently received an expired dose of PROQUAD. Per employee, no symptoms were reported. Employee stated best phone number for the healthcare worker was XXX-XXX-XXX. Agent placed outbound call and spoke to healthcare worker who stated she had already called in and reported this event. See AE case #02430867. No additional AE/no PQC.
Systemic: Autoimmune-Medium, Additional Details: Patient reported developing 2 autoimmune disorders after 2nd dose
Large, swollen, red area on left posterior upper arm.  8 x 6.5cm.  First day after vaccine was swollen.  Next day was larger after being seen and taking Benadryl area was not swollen anymore.  Swelling resolved on 3rd day.
Diffuse urticaria after receiving DTaP and Hib vaccines.  Recieved diphenhydramine prn, and urticaria resolved after one day.
CONFIRMED CLINICAL VACCINE FAILURE; CONFIRMED COVID-19 INFECTION / RECURRENCE OF ILLNESS AFTER RECOVERY, TESTED POSITIVE FOR COVID AGAIN; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 60 year old female. The patient's height, and weight were not reported. The patient's past medical history included: neutropenia, and other pre-existing medical conditions included: The patient was not pregnant at the time of reporting. The patient had no known drug allergy. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, 01 total administered at left arm on 30-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 58 years old. No concomitant medications were reported. The patient additionally received non-company suspect vaccine included: tozinameran (Pfizer/ BioNTech) (Dose number in series 2) (form of admin, route of admin were not reported, batch number: PE3590 expiry: UNKNOWN) dose was not reported, administered at right arm on 24-OCT-2021 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 2). On an unspecified date in OCT-2022 patient had illness and patient tested positive for which patient received non company suspect Paxlovid (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered from 17-OCT-2022 till 22-OCT-2022 for treatment of Covid-19. On 26-OCT-2022 08:00, the patient experienced recurrence of illness after recovery. Tested positive for Covid again (confirmed covid-19 infection). Laboratory data included: COVID-19 virus test Positive again (Dose number in series 2) which resulted to confirmed clinical vaccine failure (Dose number in series 1).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; with tozinameran was not reported; and action taken with paxlovid was drug discontinued on 22-OCT-2022. The patient had not recovered from confirmed covid-19 infection / recurrence of illness after recovery, tested positive for covid again, and the outcome of confirmed clinical vaccine failure and revaccination with different covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint. This report was associated with product quality complaint: 90000258779.; Sender's Comments: V0: 20221118958-confirmed clinical vaccine failure. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
Recieved Flumist. Within 16 hours if recieving mist noticed very blood breast milk.  No trauma, no new meds started, nothing changed.  Had been nursing at this time 10.5 months.  Sice bloody milk lactation suppply has drastically decreased.
Sore throat, mouth blisters, extreme fatigue, extreme muscle and joint ache, shivers
Moderate fever for several days then "chicken pox" rash which eventually spread over entire body, fatigue - I (her mother) have ended up with about 10 "chicken pox", headache and itching.
This spontaneous report was received from a physician assistant concerning an 11 year old male patient with slightly overweight. "Within the last week" on approximately 22-APR-2013 the patient was vaccinated in one arm with GARDASIL (Lot # not provided), 0.5 ml, intramuscular. On the same date (approximately on 22-APR-2013), the patient was also vaccinated in the other arm with ADACEL and MENACTRA. The physician assistant reported that the patient developed "redness and swelling" on the arm in which he received ADACEL and MENACTRA (approximately on 22-APR-2013). The patient was administered BENADRYL (manufacturer unknown) and ibuprofen (manufacturer unknown) as treatment for the adverse events. The outcome of redness and swelling was reported as recovered/resolved (approximately in April 2013). The patient was seen in physician assistant's office. This is one of several reports from the same source. Additional information has been requested.
Vaccines given 8-9-16 Mom called 8-11-16 because the area vaccines were given was red and raised. Patient had Hemophilia so all vaccines are given subq.  CRNP told to give BENADRYL and call back in 3 hours. Mom called back said spots are less red but same size. Told to monitor and bring in if needed.
A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy patients, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. 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), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Female patient (soon-to-be 71y/o) who is a retired ICU nurse called for her and her husband (soon-to-be 73y/o) who were prescribed PAXLOVID. Reporter stated that she had side effects and provide feedback about PAXLOVID. Also stated that she was not going to recommend other people to take it. Completed her 5-day course but her husband stopped after 3 doses, because it was too nasty. Stated that they would not do it gain. Mentioned that they also had the Pfizer vaccines.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-202201095022 Same product and event, different patient;
Date 2-7-14. Rash - swollen. Lightheaded, weak, headache, problem lifting left arm, pain. Flu -> I called pharmacy told them the problem with Flu shot, taken BENADRYL and pain reliever, became very ill.
Exactly a week after receiving the shot, a bright red welt appeared on the injection site. It was hot to the touch, hard, tender, and was itchy if scratched. It stayed hard, tender, bright red, and hot to the touch for three days before disappearing on its own. Having taken the second shot over a week ago, the welt hasn't reappeared.   If you want to reach out to me, I have photographs.
Two days after immunization, 5 yr old child experienced a severe local reaction (pain and swelling) and "passed out" twice, possible seizure or shock-like state.
Pt broke out in a rash on 12/21/00. Started on ankle area and then spread to rest of body. Rash is red, itchy, flat, and round areas, sometimes ooze. Clears some and then returns. Went to MD and then referred to dermatologist and may see allergist. Still has rash.
About 5 to 10 minutes after vaccination the patient said he felt light headed.  I rushed and grabbed a chair for him and he stated he was dehydrated and wanted water which I had my technician provide while I stayed with him.  As I was monitoring him he slumped to the side unconscious.  I had my technician call 911 while I called for help to lower him to the floor.  With help I lowered him to the floor and he immediately regained consciousness.  I monitored the patient until EMS arrived.  EMS took patient to the hospital for further evaluation.  He was discharged from the ER about an hour later.
Patient was given an injection by a nurse on 07/11/2022. Patient called the next day and reported redness, swelling of the upper arm, and warmth. Patient did not exhibit systemic symptoms and the range of motion of the left arm was not affected. PCP notified and patient was instructed to use Benadryl, ice therapy, and Tylenol if needed.
high fever 105, holding head & crying inconsolably;devel blotchy rash of small & med sized spots;white blotches visible in mouth had dry cough;rash was on head & torso w/few spots on limbs;displayed most sx of rubeola measles;
Left arm paresis, 3-5 days, post vax. Resolving paresis with physical therapy.
arm was pinkish red spreading from shoulder down to almost hiselbow at the bend then goes to the front; bit tired; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm was pinkish red spreading from shoulder down to almost hiselbow at the bend then goes to the front) and FATIGUE (bit tired) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced FATIGUE (bit tired). On 27-Feb-2021, the patient experienced ERYTHEMA (arm was pinkish red spreading from shoulder down to almost hiselbow at the bend then goes to the front). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Redness, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (arm was pinkish red spreading from shoulder down to almost hiselbow at the bend then goes to the front) and FATIGUE (bit tired) was resolving.            Concomitant medications were not provided.
Upper body aches after 2nd dose; Chills after 2nd dose; Leg aches after 2nd dose; Arm better quicker after 2nd dose; Headache after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Upper body aches after 2nd dose), CHILLS (Chills after 2nd dose), PAIN IN EXTREMITY (Leg aches after 2nd dose), PRE-EXISTING CONDITION IMPROVED (Arm better quicker after 2nd dose) and HEADACHE (Headache after 2nd dose) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022m20a and 046a21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PAIN (Upper body aches after 2nd dose), CHILLS (Chills after 2nd dose), PAIN IN EXTREMITY (Leg aches after 2nd dose), PRE-EXISTING CONDITION IMPROVED (Arm better quicker after 2nd dose) and HEADACHE (Headache after 2nd dose). At the time of the report, PAIN (Upper body aches after 2nd dose), CHILLS (Chills after 2nd dose), PAIN IN EXTREMITY (Leg aches after 2nd dose), PRE-EXISTING CONDITION IMPROVED (Arm better quicker after 2nd dose) and HEADACHE (Headache after 2nd dose) outcome was unknown. Not Provided          No relevant concomitant medication was reported.  Treatment details included, acetaminophen.
rash & arthralgias 12 days p/vax-resolved in 2 wk
Body aches, headaches, fever, tinnitus, sensitivity to light, throat discomfort,
Patient was fully-vaccinated and admitted to the hospital with COVID. Patient had multiple comorbidities and passed away while in the hospital secondary to severe respiratory failure and ARDS.
Patient stated she had difficulty bending her elbow abd felt numbness in her hands. After about a week symptoms subsided.
having a stroke; headache; eye's vision were blurred; shaking violently; blood pressure went high for 300/150/hypertension; This is a spontaneous report from a contactable consumer reported for herself. This female patient of unspecified age received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 25Feb2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient received the 1st dose on 25Feb2021. 4 days later she was hospitalized for three days from 01Mar2021 to 04Mar2021, she said she experienced a headache, her eye's vision were blurred, she said she was shaking violently at the emergency room and her blood pressure went high for 300/150. The patient said the hospital thought she was having a stroke later on, her test results came and it was hypertension she stated the doctor's couldn't tell if it was related with the Covid-19 vaccine. She mentioned her 2nd dose appointment is on 19Mar. (Scheduled more than 21 days). Outcome of all events was unknown.   Information on batch/lot number was requested.
First night , 5+hours horrible head pressure. 2 incidents of violant vomiting then fever thru night. Next day felt fine (worn out tho) and arm was incredibly sore. Currently arm still has knot in it and sore to touch and skin around sore area is slightly red still (and warm to the touch)
Info has been received from a MT concerning a 33 year old male with no medical history and no allergies who on 6/29/05 was vaccinated with an 0.5 ml dose of MMRII (lot 648482/0615P). On 6/27/05, the pt had also received a dose of diphtheria toxoid/tetanus toxoid. The pt was on no concomitant medication. On 7/1/05, the pt developed a bump, "like a pimple", on his testicle. It spread and became swollen with pain at the area. He also had developed a fever. The pt took ibuprofen. On 7/5/05, the pt was seen in the physician's office and was dx'd with orchitis. No lab studies were performed. The pt's outcome was unknown. No product quality complaint was involved. Additional info has been requested.
Two doses of different mRNA COVID-19 vaccine products are administered. Individual received Pfizer vaccine in 1/26/21 and today 2/8/21 received a moderna dose.  There are no side effects noted, mistake noted 5 minutes after receiving the vaccine. Individual is observed for 30 minutes, no side effects noted.  She is made aware that she does not need any other vaccine, and will be advised as more information and data is available. She is given information package at discharge. Also helped  with registering to V-safe to report incase of adverse effect. Individual is without any distress or issues at the time of discharge.
Blood mixed with the vaccine ran down his arm; Felt like the lady didn't puncture it correctly; Vaccine site discharge; wrong twchnique; exposure via skin; Vaccine ran down his arm; A spontaneous report was received from a 51-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood mixed with the vaccine ran down his arm, felt like the lady didn't puncture it correctly and vaccine ran down his arm, vaccination site discharge, wrong technique was used in product usage process, exposure via skin contact and  vaccine under dose.    The patient's medical history was not provided. No concomitant product use was reported.  On 01-MAR-2021, the patient received their one of two planned doses of mRNA-1273 (Lot number: 010A21A) intramuscularly for prophylaxis of COVID-19 infection.   While vaccinating the lady did not puncture it correctly and blood mixed with vaccine ran down from his arm, there was vaccination site discharge, the wrong techniques was use in product usage process, exposure via skin contact and vaccine under dose.  Treatment for the event was not provided.  Action taken with mRNA-1273 was unknown.  The outcome of the events blood mixed with the vaccine ran down his arm was unknown, felt like the lady didn't puncture it correctly, vaccine ran down his arm was recovered/ resolved.; Reporter's Comments: This report refers to a case of Product administration error for mRNA-1273, lot # 010A21A with associated Adverse events of vaccination site bleeding and vaccination site discharge. 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.
24 hours after receiving the vaccination I noticed my body was swelling, first I noticed ankles, feet. calves, then knees arms and face. Lower extremities had pitting edema: lower legs and feet. I tried a diuretic (flouresime) but it did not help. I tried elevating legs and no change. Used a tems machine with electrodes to increase blood flow in calves but it did not help. Could not get shoes or socks on and ankles were so swollen that walking was very difficult since range of motion was inhibited and could not bend ankles. No relief until 2 weeks later it is now starting to subside. Still significantly swollen when getting 2nd vaccination today 4/2 at 12;20 pm lot EP7533.
Patient over 12 years old vaccinated with Pfizer Children's dose, which is a vaccine error. At time of vaccination, patient's father stated she was 11 years old and age was not verified with patient herself. After realizing medication error, her mother was called and explained situation and asked to come in next day for another dose of vaccine correct dosage. Troubleshooting: scribe and vaccinator did not validate age. Unreported as error, found in data mining.
Patient had redness and swelling of left thigh measuring 5 x6 cm in diameter, thought to be due to inflammation and not infection. Patient also developed hives on chest.