chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Caller stated she is 28 weeks pregnant.; she is not experiencing any side effects at this time.; She was seen in her provider's office today and was expecting to receive TDap, but was accidently administered GARDASIL 9 instead.; Caller stated she received her first dose of GARDASIL 9 when she was in high school (approximately her freshman orsophomore year of high school) and was not going to receive the second dose, but was accidentlyadministered GARDASIL 9 today.; This spontaneous prospective report was received from a pregnant 22-year-old female patient reporting about herself. The patient's medical history and concurrent conditions were not reported. The concomitant therapy included minerals NOS (+) vitamins NOS (PRENATAL VITAMINS).  On an unknown date (reported as "when she was in high school"), she received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered as prophylaxis (dosage regimen, lot #, expiry date, anatomical location and route of administration were not provided).  On 15-DEC-2021, the patient had her last menstrual period (LMP) and on 29-DEC-2021, she became pregnant (estimated date of conception) (estimated delivery date was 21-SEP-2022).  On 29-JUN-2022, the patient accidentally received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered intramuscularly (dosage regimen, lot #, expiry date, and anatomical location were not provided) (Inappropriate schedule of product administration) instead of diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) (Wrong product administered). At the time of vaccination, she was 28 weeks pregnant (Exposure during pregnancy). The patient stated that she was not experiencing any side effects at the time of reporting (No adverse event). No additional adverse events and product quality issues were reported. At the time of reporting, the outcome of wrong product administered was unknown, the outcome of the pregnancy was pending, and the fetal outcome was unknown.
Winter of 2000, balance problems. Spring 2001, treated for inter ear, no help! Vallance, weakness legs and arms-2003, treated with Docephin not enough.  02/04: Starting on Cefuroxine and Zithromax
I had some head pressure - dull headache each day for a couple of weeks starting about five days after vaccine; I didn't notice until the evenings when I was relaxing. From day 5 or so - for about two weeks I noticed this head pressure. My blood pressure did rise  at that time-it was elevated - within about two weeks after the shot, I couldn't control my blood pressure. I went to the doctor  - they had to raise my blood pressure medication to the max because I couldn't get my blood pressure down and I even donated blood.  Today I am at 135 over 90 which is good for me but at that time  when I noticed the rise after the vaccine - I was running 165 over 115 . I'm still taking the maximum blood pressure medication that I can take currently but it is at a good level currently. I was taking 20 mg pills and after the vaccine we tried to raise it to  25 mg and then raised it up to 30 mg and then they finally said up to 40 mg a day. It's the most I can take.   I have chest pains on the right side of my chest -it will start (on a scale from 1 to 10 -  it's about a four) - it's shooting pain - in my chest for about 10 minutes and then it will move to my left side - not my pecs -  it feels like it's my  heart. It's not enough that I feel like I'm having a heart attack - it happens about four days a week. It doesn't last real long - but it's intense. A "4" pain for me is intense. It goes on for about 5 minutes - switch sides and then another five minutes - I try to relax/watch tv during that.  I did have leg pains in the middle of all of this time - hand, inner thigh, then on my right leg - single spots of pain that moved - like ant bites - that happened in the beginning - at day five and after - the same time I was getting the head pressure. I would rub over the spot with my hands and then it would go away and go to a different spot.
Information has been received on 10-MAY-2017 regarding a case in litigation from a lawyer and a consumer concerning a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 15-JAN-2010, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 10-JUL-2010, the patient was treated by a physician for a painful vesicular rash that was diagnosed as shingles. The patient has been prescribed Acyclovir to manage his symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sudden onset of recurring and severe symptoms of Reynaud's disease.  No prior Hx of these symptoms.
sore throat before she got the shot, but it made it worse; sore throat before she got the shot, but it made it worse; Body aches; She couldn't swallow; This is a spontaneous report from a non-contactable consumer (patient's coworker). A female patient of an unspecified age received bnt162b2 (BNT162B2, lot no. and expiry date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history included sore throat. The patient's concomitant medications were not reported. The patient got the shot on Tuesday and on Thursday (unspecified date) she got sore throat and body aches. She gargled with salt water and drank tea and felt better the next day. It was clarified that the patient had the sore throat before she got the shot, but it made it worse. She said she couldn't swallow. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Report a side effecT; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Report a side effecT) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Report a side effecT). At the time of the report, VACCINATION COMPLICATION (Report a side effecT) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
LOCALIZED REACTION WITH REDNESS, WARMTH, EDEMA INDURATION WITH TENDERNESS,AND URTICARIA  TREATMENT CONSISTED OF COLD COMPRESSION, ADVIL,AND BENEDRYL
Initial and follow-up information has been received from a physician and a female consumer who in 2005 was vaccinated with Pneumovax 23 (manufacturer unknown).  Subsequently, the patient's arm tripled in size from swelling.  She also experienced soreness and pain.  There was no PQC.  In follow-up it was reported that the patient had swelling, erythema, left (L) arm and tenderness that resolved.  The patient recovered.  No additional information is expected.
The patient received the IMZ and was waiting in the post vaccination area and noticed that her hands had turned blue. The patient said she had no symptoms and no complaints of any fever, tingling, or chills. As a precaution, the patient received a dose of diphenhydramine to counter the potential reaction. After advising the patient to seek medical attention, the patient mentions she spray lavender on her hands and that could have been it. Janssen was contacted and notified. They stated that that symptom was not a symptom found in their drug trials but that they would note it and to advise the patient to seek medical care, which was my recommendation as well.
I noticed a couple of days ago my upper arm area was very sore.  The injection site is red and has warmth . It aches when moving my arm which is very uncomfortable.  It has now lasted 3 days so far and started a week after injection.
pfizer injection 1  given 2/11/21 and 2 given 3/9/21 were given.  Hospital f/u last month for an acute episode of expressive aphasia and dysarthria. He has chronic AFib and is anticoagulated. Symptoms resolved after 15-25 minutes. Work up non-acute to include CTA h/n and brain MRI. Routine vascular labs normal. Compliant on Eliquis. No further events since discharge. During the hospitalization we did speak about his exertional dyspnea, of which I suspected was due to his AFib. Saw his cardiologist and is referred to EP for ablation consideration
SYNCOPE Narrative: Patient hx: ALLERGIES:pcn,sulfur,peanuts(states now she is highly allergic just to the smell of peanuts),bees,wasps,yellow jackets,ppi's(gets tachycardia on proton pump inhibitors such as omeprazole,nexiun,lansoprazole etc.)shingles vaccine 1/2016-post hepetic neuropathy, influenza vaccine 11/2018
About 1 minute after the patient received the COVID-19 vaccine, the patient reported feeling dizzy, light-headed, and nauseous. Nurses laid the patient down onto the ground and elevated his feet. He reported having a headache, felt feverish, and started shaking/shivering. 911 was called. A cold compress was placed on his forehead, and he took a few small sips of water.  Before EMS arrived, the nurses checked his pulse (within normal range) and his blood pressure was low (90/66 mmHg). After EMS arrived, his O2 sat was taken (normal range) after the patient expressed difficulty breathing, and his BP was retaken and was elevated. The patient continued to lay on the floor for about 20-30 minutes before he felt better.
Patient reported feeling lightheaded and having a bad headache 45 minutes after receiving the vaccine. The patient was still in the pharmacy.
Pt was ambulating to car with mom who states he fell into wall hitting right shoulder, did not fall to ground, she accompanied him back to observation area and Pt was assisted to gurney area with legs elevated slightly.  Pt had received  First Pfizer vaccine approx 20 min before.  Pt states he feels dizzy, reports he ate a croissant this am and a few sips of water this morning.  Denies and mom confirms no prior reactions with vaccines, allergies or medical problems. 10:12 am  VS 90/50, p 93, 02 sat 99%, mild diaphoresis noted.  Drank apple juice slowly and ate a few animal crackers when feeling well enough to.  VS 10:17 90/50 p 91 and 02 sat 100%. 10:20 90/50 p 92 O2 sat 99%. Consumed additional juice, skin color improved, no diaphoresis noted and denies dizziness.  Able to move shoulder without difficulty. Pt stated he was feeling well enough to walk to car where his father is waiting and will sit in back seat with Pt. Given additional juice and snack to consume as needed.  Given protocols for contacting provider/EMS if does not continue to improve.  Ambulated to car with mom with steady gait.  Advised father by phone to relay history of this vaccination and request Pt be vaccinated lying down.   Father states Pt is currently eating breakfast and is feeling back to normal.
Vaccine was administered to the patient in his left deltoid.  When the needle was removed, blood started running down his arm and a large "knot" started to form at the injection site.  Bandage was applied.  Pharmacist told patient that we most likely hit a vein and that caused the bleeding.  Told him that he would most likely end up with a nasty bruise and arm tenderness. and that he could take Tylenol or ibuprofen if needed.  Also advised that a cold compress would likely help.  Pharmacist called patient on 5/22  (the next morning).  Patient said that he was "doing fine" and his arm "didn't bother him a bit."
Menstrual period started early, very heavy; Menstrual period started early, very heavy; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2589) via an unspecified route of administration on 02Oct2021 (at the age of 41-years-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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Oct2021, the patient had her menstrual period started early, very heavy. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events menstrual period started early, very heavy was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Pt. states that after receiving the 1st dose of Phizer 06/18/2021, started experiencing symptoms 08/21/2021 of HBP, Liver inflammation, severe headaches, and heart palpations. Still continuing, Primary visits (estimated) every 2 weeks.
Bleeding injection site; Big bruise injection site; Hard as a rock injection site; Swollen Right Arm; Red shoulder (as a clown nose); This spontaneous report was received from a consumer concerning a 64-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swollen arm/ vaccination site swelling, red shoulder (as a clown nose)/ vaccination site erythema, bleeding/ vaccination site haemorrhage, big bruise/ vaccination site bruising and hard as a rock/ vaccination site induration.    The patient's medical history included post cancer (younger age) and stroke. No relevant concomitant medications were reported.~     On 22 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch Number: 031L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 22 Feb 2021, the patient experienced started with swollen arm, red shoulder (as a clown nose), bleeding, big bruise and hard as a rock. Treatment details included ibuprofen, ice and aloe vera.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  The outcome of the events, swollen arm, red shoulder (as a clown nose), big bruise and hard as a rock was not reported. The outcome of the event bleeding was resolved on 22 Feb 2021.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
PT RCV'S VACCINES ON 5-22-23, RXN OCCURRED 5-23-23 WHILE AT SCHOOL CONTINUED TO SWELL TO 5-24-23 WHICH IS WHEN HE HAD A PCP VISIT.  PT HAD CELLULITIS IN BILATERAL ARMS--WORSE ON RIGHT ARM. PCP RX'D KEFLEX, HYDROXYZINE, AND HYDROCORTISONE 1% CREAM. PT AND GMA TOLD TO COME BACK TO PCP IF WORSENING RASH, FEVER OR NEW S/S. PT WAS ALSO REFERRED TO DERMATOLOGY FOR A RASH ON FACE THAT APPEARED AFTER VACCINATIONS.
Patient got welts on both legs. The welt on left leg where the MMR was given was larger then the one on the right. Patient was given 1 tsp of Benadryl.
This is a spontaneous report from a non-contactable consumer. This consumer responded to a post on one of the parenting listserve. This consumer (age and gender unknown), with a medical history of sickle cell disease reported that he had had pneumonia about 4 times due to sickle cell disease. Due to recurrent pneumonia the patient was immunized with TRADE NAME UNKNOWN). After immunization, the patient had pain in the injected arm and could not even lift it. At the time of reporting, the outcome of the events was unknown. No follow-up attempts possible. No further information expected. Pfizer is the Marketing Authorization Holder for PREVNAR 13 has submitted the same report to the regulatory authorities.
This spontaneous case, initially received on 19-Dec-2016, was reported by a health professional and concerns a(n) 23-year-old female patient. Weight: not provided; Height: not provided. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): The patient received AFLURIA from 27-NOV-2016 to 27-NOV-2016. Dose regimen: 0.5 ml, Route of administration: Intramuscular, Batch number: WT57008. No additional suspect drugs. Between 20-Nov-2016 and 21-Nov-2016, the AFLURIA vaccine underwent first excursion. The vaccine was stored at 35.78 degree F for about 2 hours. The pharmacist stated that the thermometer was fluctuating in the previous location in the refrigerator and was moved to the top shelf. On 21-Nov-2016, the patient received the vaccine that underwent temperature excursion. Special circumstances: Incorrect product storage without adverse event. Drug administration error without adverse event.
Following this 2nd dose of Moderna, this gentleman went to various other sites to obtain J&J and Pfizer.  In total, he has had 5 vaccines.  He has not received the 2nd dose of Pfizer.  This director called him and he states, "I'm doing an experiment and I'm not depriving anyone of vaccine".  He was informed that he was deceptive in denying he had had a vaccine during the assessment prior to other vaccine doses.  He was further informed, he will not receive any further vaccine from the county health department.   He denies having any side effects from the vaccines.
Face is flushed; Feels like she has a fever/head feels warm; Just felt terrible; Achy all over; Soreness at injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Just felt terrible), FLUSHING (Face is flushed), MYALGIA (Achy all over), VACCINATION SITE PAIN (Soreness at injection site) and HEADACHE (Headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021 at 2:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION COMPLICATION (Just felt terrible), MYALGIA (Achy all over), VACCINATION SITE PAIN (Soreness at injection site) and HEADACHE (Headache). On 12-Mar-2021, the patient experienced FLUSHING (Face is flushed) and PYREXIA (Feels like she has a fever/head feels warm). On 11-Mar-2021, VACCINATION COMPLICATION (Just felt terrible), MYALGIA (Achy all over), VACCINATION SITE PAIN (Soreness at injection site) and HEADACHE (Headache) had resolved. At the time of the report, FLUSHING (Face is flushed) and PYREXIA (Feels like she has a fever/head feels warm) had not resolved.            No concomitant medication provided.   Treatment information included acetaminophen, lots of water and Gatorade.
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 military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had and 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.
I got the vaccine at : around 16:15 then I went home and until like 22:30 everything was fine. Then after 10:30 I started to get fever and headache. Then I went to sleep I think around 2AM. I was having headaches, chills, fever, and I was feeling week. I could not really sleep well. I was constantly moving from one side to another and moving my body.  The next day I woke up around 9:30 and I had huge headed, my eyeballs ware hurting as well, fever and chills. Also my eardrums ware hurting me as well as the stomach a little. Honestly I was moving my body all the time I could not stay still for more then 3 minutes. My muscles ware tired. I was not really be able to sleep, probably i have not feel this bad in years.   Now after like 18:30 I started to feel better and my headache is starting to fade. No issues with the eyeballs or stomach. I could not really eat anything beside drinking tea and also I was so weakened I did not move much beside staying in bed.   At around 20:30 I still feel I have fever but not as bad and no headaches anymore
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 08-MAR-2016, the patient received a dose of VAQTA 0.5ml, intramuscularly, lot # L023232, expiration date 02-JUN-2017, for prophylaxis. On 08-03-2016, slightly less than 6 months, the patient received another dose of VAQTA 0.5ml, intramuscularly, lot # L023232 (expiration date was not reported). No adverse effects reported.
No additional AE reported; Patient was administered Expired PNEUMOVAX 23 on 04/11/2023; indicate at which point in the process the medication error occurred: dispensing; This spontaneous report was received from a pharmacist and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 11-APR-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, expiration date: 25-MAR-2023, administered for prophylaxis (strength, dose lot #, and route of administration were not provided) (expired product administered). No additional adverse event (AE) was reported.  This case was considered as non-valid due to lack of patient's identifiers.  Follow-up information has been received from a clinic manager referring to the 81-year-old male patient on 18-MAY-2023.  On 11-APR-2023, the patient was vaccinated with the first dose (number of previous doses reported as no) pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (lot# U027357, expiration date 25-MAR-2023, strength and dose were not reported) intramuscularly at right deltoid for prophylaxis.  The operator of vaccine was a healthcare professional, and the operator was trained. The vaccine was used according to the instruction leaflet. The suspect vaccine had not been involved in any temperature excursions through the date of administration. The suspect vaccine was available for return/evaluation. The suspect vaccine had been returned to distributor.   It was reported that the medication error occurred at the dispensing (product dispensing error). There was no product quality complaint. This adverse event had been reported to doctor previously.   The case became valid because patient's identifier was added.