chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was administered improper stored dose of VARIVAX; No additional AE reported; This spontaneous report has been received from a registered nurse concerning 14-years-old female patient. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions and allergies were not provided.  On 25-OCT-2020, there was a temperature excursion. On an unknown date (conflicting information reported as 15-SEP-2022), the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX), subcutaneously, in the left arm, (lot number T003706 had been verified to be a valid number; expiration date 30-JAN-2022, and upon internal validation established as the same date) administered as prophylaxis (dosage and frequency were not provided). However, this administered dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) was stored at an unspecified temperature, during an unspecified time frame (product storage error). No additional adverse events were reported in the patient.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA002212:
At approximately 9 PM on 11/29 I experienced full body aches, followed by a severe headache that lasted two days, joint pain, chills, high fever of 104 that lasted 2 days and tapered into a fever of 101,  abdominal pain that lasted approximately 12hrs, nausea and dizziness that lasted 12hrs, vomiting that started around 1am on 11/29 and continued through until 11/30 at 3:00pm. I am still experiencing muscle fatigue, predominately in the legs and on and off headaches and upset stomach.
8/31/2021 approx 15 mins after vaccination, pt c/o vertigo, nausea, vomiting, heart flutters. sts has multiple new allergies after pregnancy.  2:45pm BP 144/90 P 84 3:00pm BP 144/90 p 82 3:30pm BP 128/80 P 80 symptoms continued even after and hour of rest and was helped to car by husband to transport to ED.  Pt ended up going directly home and not going to ED. rested and drank fluids at home.  Pt symptoms persisted until approx noon today 9/1/2021 with rest.  Pt continues to feel better at 7:00pm  advised to call PCP if symptoms persist or worsen.
fever, chills, body aches, nausea, diarrhea, neck pain, headache, injection site reaction  treatment: alternating ibuprofen/acetaminophen, zyrtec, cortisone cream
Went to bathroom to urinate and felt dizzy until I lost balance and stumbled/fell on bathroom floor. Approximately 2 to 5 minutes later I again felt dizzy and heard loud noises/echoes inundating my ears and subsequently fainted for an unknown amount of time. I awoke sweaty and cold on the floor.
This spontaneous report has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 11AN-2016 the patient was administered a dose of improperly stored ROTATEQ (strength, dose not reported, lot # L016202 and Exp. date 27-JAN-2017) orally. The vaccine was exposed to 34 F for 8 hours, and there was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
4 days after getting vaccine, he developed a rash at b/l thighs and legs. this rash has persisted. on examination today, rash appears to be eczema.
administered second flu block. Patient, however  received on  12/9/22. Patient was notified of med error as of today 1/25/23 no side effects.
Early period, heavier and longer lasting period, irregular spotting, and period every 2 weeks instead of every 4
Patient was administered with vaccine that was beyond use date after the thaw process; This spontaneous case was reported by an HCP and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the age of patient was 31 years 7 months. No concomitant medications were reported On 10-Jun-2022, medical was notified about an audit that was done and they were then made aware of vaccines that were administered beyond use date after the thaw process Reporter stated that there was no patient that had any adverse reactions and there were no reports of any reactions after the administration of vaccines. Patient had reported no adverse reactions after the administration of vaccine. Treatment details were not reported by the reporter. Vaccine Ndc Code was reported as 80777-0273-99.
Chills; Fever; Symptoms of tiredness; Muscle aches; watery/weapy eye; This is a spontaneous report from a contactable pharmacist, the patient. A 48-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot number: EN6205), via an unspecified route of administration in the left arm on 07Mar2021 at 09:15 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot number: EL9266), via an unspecified route of administration in the left arm on an unknown date in Feb2021 at 09:00, as a single dose for COVID-19 immunisation. 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 4 weeks prior to the COVID vaccine. The patient did not have allergies to medications, food, or other products. On 08Mar2021 at 03:00, the patient experienced chills, fever identified in morning and fever ranged from 102 to 103.8 F for several days. Symptoms of tiredness, muscle aches, chills, water/weepy eye were also reported. Therapeutic measures were taken as a result of fever and included treatment with acetaminophen 500mg (single dose) on 10Mar2021. The fever abated on 11Mar2021. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events chills, tiredness, muscle ache, watering eyes and fever was resolved on 12Mar2021.   No follow-up attempts are needed. No further information is expected.
A non-serious spontaneous report of breathing difficulty, chest discomfort, dizziness, sore throat and headache has been received from a nurse concerning an adult female, subsequent to administering FLUMIST. Neither the patient's past medical history nor the concomitant medications were reported. The patient did not receive FLUMIST. A registered nurse who worked in an area remote to city, reported that on specific days when she was involved in administering FLUMIST to 30 or more students at school vaccination clinics, she developed sore throat, dizziness, headache and chest discomfort that resulted in breathing difficulty. The events resolved about an hour after she left the school. The events, breathing difficulty, chest discomfort, dizziness, sore throat and headache, were resolved. The reporter indicated that these schools have been flooded in the past and has considered the possibility that the events were related to mold exposure that may have developed in these schools.
BODY ACHE; DIZZINESS; GETTING COLDER; SWEATING; CAN'T MOVE LEGS AND INJECTED ARM; HEADACHE; NAUSEA; HIGH FEVER; INJECTION SITE ARM SORENESS; This spontaneous report received from a vaccine facility concerned a 30 year old female. 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: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 29-MAR-2021, the subject experienced body ache. On 29-MAR-2021, the subject experienced dizziness. On 29-MAR-2021, the subject experienced getting colder. On 29-MAR-2021, the subject experienced sweating. On 29-MAR-2021, the subject experienced can't move legs and injected arm. On 29-MAR-2021, the subject experienced headache. On 29-MAR-2021, the subject experienced nausea. On 29-MAR-2021, the subject experienced high fever. On 29-MAR-2021, the subject experienced injection site arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, body ache, dizziness, nausea, high fever, getting colder, sweating, injection site arm soreness, and can't move legs and injected arm. This report was non-serious.
Sneezing, runny nose, achy, headache, extreme soreness and stiffness of arm. Took 50 mg Benadryl.
Fever up to 101.3; Body aches; Headache; Fatigue; Treated with ibuprofen. Resolved after approximately 24 hours
PATIENT STARTED TO PASS OUT AND LOOSE CONSCIOUSNESS 2 MINUTES AFTER GETTING HIS JANSSEN & JANSSEN VACCINE. HE WAS KEPT OUT SITTING ON THE CHAIR. HE HAD HIS JAW TO LOCK BUT I WAS TRYING TO KEEP HIS MOUTH OPEN IN ORDER FOR HIM TO NOT BITE HIS TONGUE. HIS EYES WERE ROLOONG OUT. IN ABOUT 20 SECONDES HE RECIVERED BUT HE WAS COMPLAINING ABOUT BLURRED VISION. WE CALLED 911. I TOOK HIS BP. FIRFIGHTERS & PARAMEDICS CAME INSTANTLY AND TOOK OVER HIM. THEY OFFERED HIM TO BE TAKEN TO THE HOSPITAL , BUT HE SAID HE WAS OK AND LEFT WITH HIS GIRLFRIEND. I DID  A FOLLOW UP CALL AFTER 2 HOURS  WITH HIM. HE SAID HE WAS FEELING MUCH BETTER.
Influenza vaccine administered 11/16/12. Parents report a day later child had a fever 102.8 degrees which would respond to TYLENOL. Fever lasted 24 hours. No other symptoms. Parents did not seek medical care.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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 "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: after 4 negative,antigen tests 4 different days; Negative, notes: after 4 negative, antigen tests 4 different days; Negative, notes: after 4 negative, antigen tests 4 different days; Negative, notes: after 4 negative, antigen tests 4 different days; positive, notes: new positive test with moderate symptoms Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: No, other medication in 2 weeks. Rebound in six days, after 4 negative antigen tests 4 different days, new positive test with moderate symptoms covid. No known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the events  drug ineffective, covid-19 and the suspect drug BNT162B2 cannot be excluded.
IM injection, skin surrounding injection swelled, patient complained it was itchy, gave patient BENADRYL & ice pack N.P. saw patient. Patient ok'd to leave. Called patient at 5:30 pm said was in pain advised to give ibuprofen.
Diarrhea started around 9:30 and then I got a fever around 11:00 on the 11 and it lasted through the following Tuesday, May 13. I also was very achy throughout my joints. The fever left during the night on that Tuesday. But the achiness lasted for about another week.
pt recv vax 12JAN95 & MAY96 lab eval revealed a titer of 12 (greater than 15 positive);
My shoulder hurt; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (My shoulder hurt) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0016210 and 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced ARTHRALGIA (My shoulder hurt). At the time of the report, ARTHRALGIA (My shoulder hurt) outcome was unknown.            No Concomitant medications were provided No treatment medications were provided.  Patient reported after second dose of Moderna Vaccine he didn't have any side effects
SLIGHT PAIN AT INJECTION SITE FOR 30M; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced slight pain at injection site for 30m. The action taken with covid-19 vaccine was not applicable. The patient recovered from slight pain at injection site for 30m. This report was non-serious. This case, involving the same patient is linked to 20210551420.
got the first dose of the vaccine but missed the second dose; This non-serious case was reported by a nurse via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: got the first dose of the vaccine but missed the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 14-JUL-2023 The reporter enquired that if you got the first dose of the vaccine but missed the second dose (window of 2 to 6 months), do you had to repeat the series? MI did not spoke with the Health Care Provider, so please follow up with the Sales Representative for more information.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
No additional AE reported; 1 dose of GARDASIL was administered following the improper storage; This spontaneous report was received from a nurse referring to a 13 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 02-DEC-2020, the patient was vaccinated with an improperly stored dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) pre-filled syringe, lot # 1637648 expiring on 19-JUN-2022, for prophylaxis (dose, route and site of administration were not reported).    The administered dose of the vaccine experienced a temperature excursion of 33F for 120 hours, as recorded by a data logger. The vaccine had not had any previous temperature excursion.  There was no adverse effect reported and no product quality complaint involved. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637648; expirationdate: 19-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
I went to urgent care on June 27, 2022 to have a COVID-19 PCR test completed due to my husband being positive. They called me around 6:00PM told me I was positive. I called my primary care physician and he sent in a prescription in for PAXLOVID. I experienced a loss of appetite and a headache. Which I started taking the following afternoon. I have fully recovered from this episode. I had taken 2 negative test prior to my PCR test.
Information has been received from a licensed practical nurse (LPN) concerning a healthy 13-month-old male, who approximately 11-Jun-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. Approximately two weeks post vaccination, on about 25-Jun-2007, the patient came down with a "mild case, a mild outbreak of varicella" that was considered to be not life threatening. No medications were given to the patient during the time of the outbreak. It is unspecified if medical attention was sought. On an unspecified date, the patient recovered. This is one of several reports from the same reporter. Additional information has been requested.
Severe burning/itching rash on legs. Started as mild on one leg next day, by Thursday (day 5) rash covering both shins, burning and severe itch. Currently 13 days out,  rash continues to spread.
48 hours after vaccine child developed 15-20 watery stools per day. On third day diarrhea he had bloody diarrhea, which continues today.
CLIENT RECEIVED THIS IMMUNIZATION AT A WORK FLU CLINIC. ONE HOUR AFTER THE IMMUNIZATION, THE CLIENT FELT SHARP PAIN AT THE INJECTION SITE WHEN SHE WOULD MOVE HER LEFT ARM OR UPON INJECTION SITE PALPATION. ACCORDING TO THE CLIENT, THIS LASTED ABOUT 3 WEEKS. AT THE END OF 3 WEEKS, CLIENT SAID THE PAIN WOULD OCCUR WITH SUDDEN MOVEMENTS OF THE LEFT ARM OR DOING ACTIVITIES SUCH AS DRESSING HERSELF AND WHEN SHE LIFTED HER ARM UP SUDDENLY. THIS LASTED ABOUT 3 WEEKS. NOW CLIENT SAYS THAT PAIN IS MUCH LESS AND IS A DULL PAIN THAT OCCURS ABOUT TWO TIMES A DAY, AGAIN, WHEN SHE LIFTS HER ARM. CLIENT DENIED ANY SWELLING OR REDNESS AFTER THE INJECTION. Client instructed to see her doctor for pain.
Inmate reported myalgias overnight after J & J vaccination. Altered mental team in AM. Upon arrival to inmate's cell, he was breathing heavily, shaking, and unable to walk. He was unable to state his name fully or recall his registration number.
Pt received FLUMIST on 27Sep13. Pt found out she was pregnant on 01Oct13. Pt stated she had been pregnant for a couple weeks. Pt has no signs/symptoms of any adverse reaction but was concerned since it is live.
Woke up at 3 am with the worst chills I have ever experienced.  I can usually do deep breathing or relaxing to calm my chills, but these would not let up.  It felt like my body was being squeezed.  I was finally able to get up and used a walker to get to the kitchen and took 1000 mg acetaminophen.  Without the walker, which I don't usually use, I was afraid I would not be able to stand up or would stumble due to my shaking.  By 4 am, the shaking had stopped enough for me to lay back down and I was able to get to sleep.  I had a fever of 99.8 when I woke up.  Later that morning it was 100.8.  By that night it had gone down to 98.7 and the next morning it was my normal 97.6 and I feel great.
5 hrs after vaccine, tingling noted in (L) hand for about 5 hrs - until patient went to sleep (vaccine in (L) deltoid).
no adverse effects reported; improperly stored dose of vaccine was administered to the patient; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 16-APR-2019, the patient was vaccinated with improperly stored dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA, lot # R026720, expiration date: 17-MAY-2020 for prophylaxis (dose and route of administration were not reported) reconstituted in sterile diluent (STERILE DILUENT) (lot # and expiration date were not reported). It was unspecified of sterile diluent underwent any temperature excursions. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 16.6 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.  Lot No. R026720 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), expiration date reported as 17-MAY-2020, but upon internal validation established as 17-MAR-2020.; Sender's Comments:  US-009507513-1905USA004595: US-009507513-1905USA011854: US-009507513-1905USA011855: US-009507513-1905USA011860: US-009507513-1905USA011857: US-009507513-1905USA011858: US-009507513-1905USA011859: US-009507513-1905USA011861:
Covid monitoring documentation. PT admitted 12/28/21 documented to have positive covid. PT received Moderna 1/27/21 Lot 028L20A for dose 1. Dose 2 was Moderna given on 2/22/21 Lot 030M20A.
No reactions other than a little soreness from one of the shots; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 09-Dec-2020.  This case involves a patient of unknown demographics who experienced no reactions other than a little soreness from one of the shots (Vaccination site pain), while the patient received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient got flu shots A and B, shingles shot, pneumonia shot and DPT (diphtheria, pertussis, and tetanus) shot, all on the same day. The patient reported no reactions other than a little soreness from one of the shots.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Patient experienced lightheadedness, nausea, vomiting and dizziness (possibly a vasovagal reaction) few minutes after vaccination. Patient was asked to sit inside the pharmacy for monitoring at least 30 minutes. No vitals were taken, patient was asked to rest and was provided with water for hydration. She went home approximately 45 minutes after the immunization.   On patient phone call follow-up done 1/23, patient reported that she is sore on the injection site and slept for 5 hours during the day.  She said she felt better on 1/23 than on the vaccination day and will not get the 2nd dose of the vaccine.
1)  Muscle Pain at Injection site with large red area of swelling at injection site 2) Severe headache for several days 3) Chills & Fever 4) Fatigue