chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mom noticed cold sweats immed p/vax;vomited p/nap 3 hr later, lethargic, wobbly on feet;mom notified FMD told to observe pt, to ER only if necessary;pt alert, playing @ home during conversation;
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patients were inadvertently administered VARIVAX, subcutaneous for prophylaxis (doses, lot numbers and expiration dates were not reported) that had been reconstituted with sterile water, rather than Merck sterile water diluent. No adverse effects were reported. Additional information is not expected, as the reporter did not wish to be contacted. This is an amended report, as corrected: the suspect therapy sterile water has been deleted from the case.
itchy and cold lower legs to feet; itchy and cold lower legs to feet. Felt like no blood flow wasnt getting to my feet. Veins looked like venous veins in lower legs.; Veins looked like venous veins in lower legs.; Felt like no blood flow wasnt getting to my feet.; This is a spontaneous report from a contactable healthcare professional, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Apr2021 at 15:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Information on whether the patient received any medication within two weeks of vaccination was reported as not available. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Apr2021 at 20:00, the patient experienced itchy and cold lower legs to feet. The patient felt like no blood flow wasnt getting to her feet. Veins looked like venous veins in lower legs. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events itchy and cold lower legs to feet; felt like no blood flow wasnt getting to feet; veins looked like venous veins in lower legs. was resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I was having a sore and scratchy throat for about two days. I took a COVID-19 test and it was negative. I took a test on the 24th and that was positive. I was very congested and had a head cold. I ended up going to the ER because I was traveling. They gave me Paxlovid and that helped with the symptoms I was experiencing. I have recovered other than having a horse sounding voice/throat.
The patient began to experience itching rash around 5 days after vaccine rash started around neck/collar and has migrated to the "sweat zones" - armpits, medial thighs/grain and around waist line.
Tiredness (high), Headache (high), Muscle pain (low), Chills (low), Fever (low). Impacted daily activities. Minor stomach upset. All of this happened after the 2nd dose. No side effects after the 1st dose.
C/O pulling feeling or tingling sensation in chest. difficulty swallowing in neck area of esophagus. VS monitored x3 over one hour. Breath sounds clear. Vital signs stable during observation. Discharged  home to self.  No Distress noted at time of discharge.  Pt states took Benadryl 50 mg at 4pm before vaccine given.
Vaccine received 1000 on 1/26/2022. I felt a little foggy as the evening progressed. I awoke with a headache at 0345 on 1/27/2022 and my face was numb. I did not note any drooping or facial paralysis and this episode lasted 30-45 minutes. At 1415 on 1/27/2022 I had a feeling of pins and needles in my left chest and under my left armpit radiating down to my hip area that lasted approximately 30 minutes. This episode repeated at 2045 on 1/27/2022 lasting approximately the same amount of time. Aside from nausea and malaise lasting 36-48 hours, I have  still been getting frequent headaches that seem worse when I lie down. Treatment has been either Motrin, Tylenol, or Alleve.
No adverse event.  Patient was administered Covid-19 vaccine on 6/15/2022 and the vaccine expired on 6/3/2022.  Scheduled for revaccination.
Father reports seizure at home at 4:00 AM, and was taken to Medical Center in Scottsville.
1/29/21 0700 received vaccine                 2100 started not feeling well fever of 99 1/30/21 0300 fever was between 102 and 103.5                 1000 fever stayed around 101 to 102 1/31/21 1000 fever was down to 99 and disappeared around 1500 2/4/21 I started having a sore throat and some mild ear pain. 2/5/21 ear pain was getting worse. 2/6/21 ear pain was very bad 2/7/21 went to the clinic they gave me amoxicillin for and ear infection 2/10/21 ear pain was still the same and things were not getting any better.  I called my doctor and he switched me to amoxicillin-clav. I was not able to pick it up until 1/11/21. 1/11/21 my left eye started bothering me and if felt like pink eye. 2/12/21 I started getting a metal taste in my mouth and it started feeling numb.  I called my doctor back around 1300 and he told me to switch back to the regular amoxicillin.  By 1640 my vision in my left eye started to get blurry and my entire left side of my face was numb and paralyzed =.  My doctor told me to go to the ER.  Being the stubborn person I am I didn?t go right away. 2/13/21 I went to the hospital.  I was diagnosed with Bell?s Paulsy.  The doctor did not seem to think I had an ear infection.  My entire left side of my face is paralyzed.  I still have pain behind my right ear and around the ear canal.  My vision in my left eye is terrible.   My speech is getting slurry.  2/16/21 I followed up with my primary doctor.  He is hoping with the treatment I'm on this will go away in 1 to 2 weeks.  He encouraged me to fill this adverse reaction form out. I have a follow on 2/17/21 with and ophthalmologist for my blurred vision.
Crohn's disease flared up; A spontaneous report was received from a consumer, concerning a 20 year old male patient, who received Moderna's COVID-19 vaccine and experienced Crohn's disease flared up.  The patient's medical history included Crohn's disease. Concomitant medications included ustekinumab.  On an unspecified day in Mar-2021, prior to the onset of events, the patient received his first of two planned doses of mRNA-1273 (lot number 014M20A) via intramuscular route on his left arm for prophylaxis of COVID-19 infection.   After the first dose of vaccine patient experienced Crohn's disease flared up. Treatment medication included steroids.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the events Crohn's disease flared up was not recovered at the time of this report.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
pt recvd vax & was screaming for 1 hr then limp for approx 1/2-3/4 hr; fever of 102;
Fridge was high at 46.13 no alarm, someone open frudge that caused alarm to go off; This spontaneous report was received from a Nurse referring to a 22 year old female patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.   On 01-SEP-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)(strength, dose, dose number, frequency, and anatomical location were unknown) with lot # R030456 and expiration date reported as July 2021, but upon internal validation established a 23-JUL-2021, via intramuscular route for prophylaxis.   There was a digital data logger involved, it was reported that the fridge was high at 46.13 °F degrees Fahrenheit  with no alarm, it seemed that someone opened the fridge and caused the alarm to go off. Additionally, it took 3 days to the Nurse to report the excursion, it was reported that the minimum temperature was 37.23 °F degrees Fahrenheit  and the maximum temperature was 47.65 °F degrees Fahrenheit with an undefined duration in the alarm report, and the minimum temperature was 36.46 °F degrees Fahrenheit and the maximum temperature was 43.30 °F degrees Fahrenheit  with an undefined duration in the no alarm report . 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: R030456; expirationdate: 23-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2009USA009568: US-009507513-2009USA009587: US-009507513-2009USA002514:
very sore arm; general malaise, dizziness, chills ~8 hours post vaccine.  Next morning, extreme nausea, dizziness, fatigue, muscle aches until noon.  General malaise and fatigue lasting remainder of day until bedtime.
Patient called stating that she was experiencing eye pain after getting the vaccine. She said this has happened before when she got the moderna vaccine but previously she ignored it and did not seek medical advice. When she started feeling eye pain again she thought it might be from the vaccine and called her eye doctor, she has an appt to see the eye doctor on 8/8/22. Patient called before her appointment with eye doctor. On the form the patient filled out with us before she got her vaccine she checked off  that she had never experienced any adverse side effects from any vaccine before.
Fatigue; Headache; Muscle pain; Some nausea; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain) and NAUSEA (Some nausea) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) 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) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain) and NAUSEA (Some nausea). On 17-Mar-2021, FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain) and NAUSEA (Some nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.    Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow up received on 09 Jul 2021 with route of administration and patient's address was provided.
Patient felt her heart raising her apple watch said 139, brought to EMS room and monitored untill 845 am then discharged in no distress, denied any chest pain nausea, or shortness of breath.
This spontaneous report as received from an officer manager referring to a currently 4 year old female patient. No information was provided regarding the patient's medical history and concurrent conditions. The patient's concomitant medications included sterile diluent (MERCK STERILE DILUENT). On 24-APR-2018, the patient was vaccinated with an improperly stored dose of VARIVAX (dose and anatomical location and route of administration were not reported)  lot # M046004, expiration date: 18-NOV-2018 indicated for prophylaxis. The vaccine had not had any previous temperature excursions as recorded by a data logger. On an unknown date, VARIVAX had temperature excursions of   -14C to -10C  for a time frame of 7 minutes which was called by a data logger. There were no adverse effects reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1805USA000841: US-009507513-1805USA000922: US-009507513-1805USA000923: US-009507513-1805USA000928: US-009507513-1805USA000925: US-009507513-1805USA000926: US-009507513-1805USA000921: US-009507513-1805USA000924:
LOT OF PAIN IN ARM; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight was 145 pounds, and height was not reported. The patient's pre-existing medical conditions included: The patient had no medical conditions or relevant medical history. The patient received covid-19 vaccine ad26.cov2.s (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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced lot of pain in arm. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lot of pain in arm was not reported. This report was non-serious.
Patient started getting sore 2 hrs after, that night developed fever, insomnia, chills, nausea. Fever did not respond to ibuprofen or APAP. Patient's arm is red, swollen, not to touch and sensitive to touch.
Patient came in to pharmacy on 12/3/17 complaining of redness on inside of left arm. Area was sore, hot to touch, and swollen. There was no redness where injection site was on outside of arm. Patient did not use any ice, advil, etc to alleviate symptoms but said she thought it was getting better today. I advised patient to ice the area since she did not want to take any pills to help the swelling. I told her to go to her doctor if it does not get any better or it gets worse and to contact us.
Low grade fever, croup cough, stuffy nose. I'm currently giving him breathing treatments every 4 hours for the tightness he seems to have.
low energy; red on his skin, raised up; soreness; joint soreness; rash; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (low energy), ERYTHEMA (red on his skin, raised up), PAIN (soreness), ARTHRALGIA (joint soreness) and RASH (rash) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A, 014M20A and 027B21A) for COVID-19 vaccination.   The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced ASTHENIA (low energy), ERYTHEMA (red on his skin, raised up), PAIN (soreness), ARTHRALGIA (joint soreness), RASH (rash) and FATIGUE (fatigue). At the time of the report, ASTHENIA (low energy), ERYTHEMA (red on his skin, raised up), PAIN (soreness), ARTHRALGIA (joint soreness), RASH (rash) and FATIGUE (fatigue) had resolved.      Patient stated that started something that is not necessarily a rash, it looks like poison ivy but it is not poison ivy, most of it is more like a straight line, like a saw machine. It is red on his skin, raised up, and it itches, like poison ivy.  He had a real big one on his right inner upper thigh, with a smaller one next to that, and then had a couple very small spots on his lower abdomen. He also stated that on his upper inner right thigh he had a large rash by the lines that are there. he stated that the information about urticaria was pretty close to what he was experiencing, he is not certain if it is a side effect, it could be the hives, not really spreading much but not really going away.  Concomitant medications was not reported.  Treatment medications was not reported.
This spontaneous report was received from 25 year old female consumer, reporting on herself. The patient's concurrent conditions included irritable bowel syndrome and colitis. The patient did not have any allergies. There was no reported information on the patient's pertinent medical history or concomitant medications. On 22-MAY-2018, the patient was vaccinated with a dose of GARDASIL 9 for prophylaxis, (product circular # uspi-v503-i-1802r007) (dose, route of administration, lot number and expiration date were not reported), and on an unspecified date in May 2018, reported as "a few days after the injection", the patient noticed soreness and redness around the injection site (Injection site pain, Injection site erythema); the patient also noted "a small bump" at the injection site that "looked almost like a pimple" (Injection site mass). She saw her health care provider and was advised to "monitor and have ice applied to the area". There was no additional information provided. It was reported that, there were no laboratory diagnostics or studies performed, and there was no need for hospitalization for the event. At the time of the report, the patient had not yet recovered from the events. The reporter did not provide a causal assessment between the therapy with GARDASIL 9 and the events.
Tinnitus (ringing in ears), at about 10 KHz frequency, mild but constant. Gradually has lessened and/or is occasionally not noticable. This began about 1 week after receiving second Pfizer shot.
A report was received from ah health care professional on 11/22/2002 concerning a group of vaccinees less than 4 years old of unknown demography who inadvertently received Fluvirin from approximately 11/07/2002 onwards. From 11/07/02002 Fluvirin was administered to vaccinees less than 4 years old. There were no reported adverse events. There was insufficient information to determine the reporters causality assessment. Update1. 12/10/2002: A follow up report was received from a health care professional on 12/10/2002 indicating that a 9 month old male vaccinees who was inadvertently administered Fluvirin intramuscularly on 11/15/2002. The vaccinees experienced no adverse reactions. Cross Reference with: PJP200200848, PJP200200849, PJP200200850, PJP200200851, PJP200200852, PJP200200853, PJP200200854, PJP200200855, PJP200200856, PJP200200857, PJP200200858, PJP200200859, PJP200200860, PJP200200805, PJP200200862, PJP200200863, PJP200200864, PJP200200865, PJP200200866, PJP20020867, PJP200200868, PJP200200869, PJP200200870, PJP200200871, PJP200200872, PJP20200873, PJP2000200874, PJP200200875, PJP200200876, PJP200200877.
I got my flu shot and it caused my head to explode in 18 parts; Initial information was received on 02-Dec-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves a patient with unknown demographics who got flu shot and it caused head to explode in 18 parts (head discomfort), while being treated with INFLUENZA VACCINE.  The patient's medical history, past medical treatments, past vaccinations, family history and concomitant medications were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after getting the suspect vaccine therapy, it caused patient's head to explode in 18 parts (head discomfort).  No laboratory data reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
Rash on face - couple of spots on 2/16, definite rash on 2/17.
Patient is a 4mo healthy boy who presented to ED after a seizure that occurred in the evening. He had his 4mo WCC in the morning and received vaccines. Was in normal state of health at that appt. In the evening, he had an episode of 3 minutes where his eyes were rolling and he was shaking (dad took video). Mom called 911. He had some mild congestion in the afternoon and seemed more tired than usual. His oldest sister was sick with URI symptoms, but otherwise no sick contacts. He has never had a seizure before. He is now back at baseline, except for being a little fussy. Mom and dad denied the following: emesis, cough, cyanosis, swelling, diarrhea, constipation, decreased urine. A referral to neuro was ordered prior to discharge so pt could be evaluated with an outpt EEG given family history of seizures. It was recommended that the patient follow-up with PMD within 1-2 days.
sleepiness; fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of SOMNOLENCE (sleepiness) and FATIGUE (fatigue) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVETIRACETAM (KEPPRA), ATORVASTATIN, METOPROLOL, DOFETILIDE (TIKOSYN), RIVAROXABAN (XARELTO) and OMEPRAZOLE for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced SOMNOLENCE (sleepiness) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 22-Jan-2021, SOMNOLENCE (sleepiness) and FATIGUE (fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked  (E2B Linked Report).; Sender's Comments:  Same patient, 2nd dose
No additional AE reported.; patient was accidently administered an expired dose of MMR II; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 13-MAY-2022 the patient was vaccinated with a expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) rHA (Dose frequency: once, lot # T016195, expiration date: 11-MAY-2022, dose, strength and route were not provided) for prophylaxis (expired product administered). Product had no prior temperature excursions. No further information provided. No additional adverse event reported.
One week post-vaccine, I woke up with a sore throat (that never turned into anything and was gone within 24 hours) and I noticed a hard, tender and swollen lymph node over L bicep.  Swelling has gone down, but remains hard to date of this report (1/25/2021).
Patient states that on 6/10/13 (6 days after vaccination) she had a massage for the tense arm. After she got home she had blood on her shirt and now it swollen and hard at the injection site.