chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report has been received from a Physician concerning a patient of unknown gender, who received Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. Physician had been administering FLUMIST QUADRIVALENT without removing the plastic stopper (thus administering only 0.1 ml of the 0.2 ml dose). The outcome of the event of been administering FMQ without removing the plastic stopper and administering only 0.1 ml of the 0.2 ml dose was unknown. The report was considered to be non-serious. The reporter considered that there was no causal relationship between been administering FMQ without removing the plastic stopper and administering only 0.1 ml of the 0.2 ml dose and FLUMIST QUADRIVALENT. The company physician agreed with the reporter causality assessment of the events been administering FMQ without removing the plastic stopper and administering only 0.1 ml of the 0.2 ml dose with the FLUMIST QUADRIVALENT to be unrelated.
Redness (pink) 1/2" - 1" diameter vaccine site at left deltoid.  Ice applied, Benadryl 25mg given.
Injection site red, slightly swollen, and itchy beginning 6 days after vaccination and grew in irritation on day 7. Taking Benedryl and using a topical cream to control itch.
Vaccine was expired on 17-Dec-2021 and patient administered on 08-Apr-2022; Patient received the Moderna vaccine beyond the 30-day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna vaccine beyond the 30-day use by date) and PRODUCT STORAGE ERROR (Vaccine was expired on 17-Dec-2021 and patient administered on 08-Apr-2022) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 003C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna vaccine beyond the 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 17-Dec-2021 and patient administered on 08-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna vaccine beyond the 30-day use by date) and PRODUCT STORAGE ERROR (Vaccine was expired on 17-Dec-2021 and patient administered on 08-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that patient took vaccine on 08Apr2022, after the expiration date on 17Dec2021. The date was reported as 17Dec2021. All 45 patients were adults, who received the Moderna vaccine beyond the 30 day use by date and no additional information provided. Doses was stored in standard freezer for the lot 003C21A with 2 degrees F high and minus 1 degrees F low on 22Apr2021 was reported.  No treatment medication was reported.
Knot in injection site, red swelling the size of a silver dollar. The knot has a travel tale moving down the arm. If you touch it, it sends off an itching sensation. Injection was given on 09/18/01 about 10:00 AM.
PANIC ATTACK; DIZZINESS; HEADACHE; VERY FATIGUE; LOSS OF BALANCE; CONFUSION; This spontaneous report received from a consumer concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, non alcoholic, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 18052029 expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On FEB-2021, Laboratory data included: PCR (NR: not provided) Negative. On 12-APR-2021, the subject experienced loss of balance. On 12-APR-2021, the subject experienced confusion. On 12-APR-2021, the subject experienced dizziness. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced very fatigue. On 15-APR-2021, the subject experienced panic attack. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from panic attack on 16-APR-2021, and had not recovered from loss of balance, headache, confusion, very fatigue, and dizziness. This report was non-serious.
The first day it was ok, started feeling chills on Friday mid day, arm was starting to itch.  On saturday my arm was aching, and itching a lot. I ate normally,  We had ordered a eggplant parmissian, with salad meatballs.  On Sunday there was no problems until the night time when I noticed my tongue was slightly swollen, I made a comment to my wife, thinking I had bit my tongue.  I had a slight headache and took half a Tylenol On Monday morning I woke around 7am, and I could feel my tongue was enlarged, I checked in the mirror it was red,  I went to the refrigerator and got some ice, and put it my mouth, for  about 10 minutes, I felt like vomiting, but though that wont be good if my tongue is big.  I still felt cold,   I got up to go to the bathroom and had diarrhea, and fell asleep afterwards, I woke again the tongue was more swollen, I decided to call an advice nurse,  she asked me if I could come in to ER, its hard for me, my wife has dementia. The ER doctor called me back and said I should get some anti-histamine such as Zyrtec or something. I ordered it and it was brought it over in less than 20 minutes. I took 1 10mg tablet, with a glass of water. After 45 minutes the swelling went down. I have been taking 1 tablet per day now. The Doctor said that several of his Colleagues have also had the same result after having the booster.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-APR-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 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. Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055: US-009507513-1806USA009056.
A non-serious spontaneous report of inadvertently administered expired FLUMIST was received from a health professional concerning a seven-year-old male. Neither medical history nor concomitant medication was reported for this patient. The product expired on 02-Dec-2010. On 03-Dec-2010, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Information has been received from a consumer concerning her 4 year old son with no pertinent medical history or drug reactions or allergies who in approximately September 1995, "at 18 months", was vaccinated with a dose of MMR II. In approximately 1998, "at 4 years old" the patient was diagnosed with autism. No specific information was provided regarding his symptoms. No lab tests were done. It was reported that autism improved on therapy but the patient was not recovered at the time of this report. Unspecified medical attention was sought. The mother also reported that on an unspecified date, after the patient received diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (manufacturer unspecified), he spiked a 104 degree fever. The mother also reported that the patient had adverse experiences after receiving hepatitis B Virus vaccine (name and manufacturer unknown) (WAES # 0903USA05481). Upon internal review, autism was considered to be other important medical event. This is one of several reports received from the same source. Additional information has been requested.
I did not have an adverse reaction to the vaccine. I was diagnosed with porphyria Cutanea Tarda (PCT). I take medication as an infusion every two weeks. I had gallbladder surgery 08/2022.
Has Not received the Second shot, 6 months post First vaccine; Had Issues after First Shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had Issues after First Shot) and PRODUCT DOSE OMISSION ISSUE (Has Not received the Second shot, 6 months post First vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In December 2020, the patient experienced VACCINATION COMPLICATION (Had Issues after First Shot). On 25-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has Not received the Second shot, 6 months post First vaccine). At the time of the report, VACCINATION COMPLICATION (Had Issues after First Shot) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Has Not received the Second shot, 6 months post First vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.  No treatment medications were reported by the reporter.
Thrombocytopenia. Platelet count at the time of the first iinjection on Jan 28 , 2021 was 92. The following values were noted: 2/3 = 106 2/18 = 59 Second injection Feb 25, 2021 2/26 = 46 3/5 = 41 Patient experiened no symptoms. The oncologist bellieves this is ITP. The patient was started on Prednisone 60 mg po daily on 3/7/2021 until further notice.
The shot was to the right arm. After approximately 5-10 minutes after the shot, my son noticed on the underside of his lower left arm there was a streak of dark reddish clotting or bruising underneath the skin. He felt okay, with no adverse symptoms/reactions. I notified the pharmacist and believed it was a mild rash reaction and to wait for any adverse reaction. We went home afterward and the clotting/bruising went away after a few days. I am concerned about whether he should go ahead with a 2nd shot or be evaluated due to the immediate non-adverse reaction. My son took a picture of his left arm after we got home. So if you need to look at it, we have it.
PATIENT WAS VACCINATED WITH DOSE OF FLU INTENDED FOR CHILDREN AGES 3 AND ABOVE. FAMILY WAS NOTIFIED OF MISHAP, NO REACTION TO VACCINE.
I had my vaccine at 10:55am on Saturday.  I felt completely fine the rest of the day.  Early Sunday morning, around 4am,  I woke up sweating and with a fever.  My normal temp is around 97.5.  My temp was 100.5.  For the next 30 hours, I had a fever that ultimately peaked around 101.5 on Sunday evening.  I felt very bad, like I had the flu.  It is probably the worst I have felt in several years.  I had significant muscle pain and even laying on the couch was too uncomfortable.  I laid in bed and slept off and on.  Monday, when I first woke for work at 5:35am I was still feverish and achy, although I could tell I was better than I had been at my worst Sunday evening.  After going back to sleep, I woke up at 10am feeling significantly better.  Aside from being rather flushed and sweaty, I felt fine the rest of the day.  My injection site was mottled red, swollen, and painful for about three more days, with improvement every day.    I am not concerned about my reaction.  I am only reporting it to provide data.
This spontaneous report as received from a registered nurse refers to an unspecified number of patient of unknown gender and age. It was reported that since 24-JUL-2014, impropery stored doses of (Oka/Merck) VARIVAX (dose, dose number, route, lot/batch number, expiration date were not reported) were administered to unknown number of patients in approximately 2014. No adverse effects were noted. No product quality complaint (PQC) involved. This is one of several reports from the same source. Additional information has been requested.
Patient had Chills, Body aches, felt Hot and Cold, also had Rash and itching all over body after about 10 days of vaccination. symptomps lasted for about 3 days.
Could not get warm.  Raspy voice.  Could not sleep that night. "Funny" feeling in arm - at 6:00 a.m. the next morning, red nodule at injection sight surrounded by very large bruise.  Red lines radiating toward elbow area - swelling from top of shoulder to elbow - feeling as if one banged their elbow - funny feeling in hand - still minor on Monday, March 12.  Arm was cold to touch with splotches.
pt recv vax 1995 & approx 1998 pt devel 20 vesicles;
3.5 hours after first Pfizer vaccine I became extremely dizzy, disoriented and unstable on my feet; 3.5 hours after first Pfizer vaccine I became extremely dizzy, disoriented and unstable on my feet; 3.5 hours after first Pfizer vaccine I became extremely dizzy, disoriented and unstable on my feet; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP, Physician and Other HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 10Sep2021 12:30 (Lot number: FC3183) at the age of 50 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Tramadol, reaction(s): "Known allergies: Tramadol". The following information was reported: DIZZINESS (non-serious), DISORIENTATION (non-serious), BALANCE DISORDER (non-serious) all with onset 02Oct2021 12:00, outcome "not recovered" and all described as "3.5 hours after first Pfizer vaccine I became extremely dizzy, disoriented and unstable on my feet". The event "3.5 hours after first pfizer vaccine i became extremely dizzy, disoriented and unstable on my feet", "3.5 hours after first pfizer vaccine i became extremely dizzy, disoriented and unstable on my feet" and "3.5 hours after first pfizer vaccine i became extremely dizzy, disoriented and unstable on my feet" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dizziness, disorientation, balance disorder.  Additional information: The patient was treated with Steroid for 1 day 26Jan2022 unable to take. The seriousness criteria was provided as persistent. The patient neither have Covid prior vaccination not had tested positive post vaccination. The patient did not receive other vaccine in four weeks and other medications in two weeks.  No follow-up attempts are possible. No further information is expected
LIGHTHEADED; HEADACHE THAT GOES FROM NECK AROUND THE SKULL, AROUND FACE AND HAIR AREA; NAUSEA; FATIGUE; DOESN'T FEEL LIKE HERSELF; This spontaneous report received from a patient concerned a 60 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: 204A21A, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 14:45 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced doesn't feel like herself. On 13-MAY-2021, the subject experienced lightheaded. On 13-MAY-2021, the subject experienced headache that goes from neck around the skull, around face and hair area. On 13-MAY-2021, the subject experienced nausea. On 13-MAY-2021, the subject experienced fatigue. Treatment medications included: paracetamol. Additional treatment medications (dates unspecified) included: dimenhydrinate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nausea, and lightheaded, had not recovered from headache that goes from neck around the skull, around face and hair area, and fatigue, and the outcome of doesn't feel like herself was not reported. This report was non-serious.
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On 20-AUG-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot # L046893, expiration date 23-FEB-2017; dose and route were unknown). No adverse effect was reported. The vaccine was exposure under 27 Fahrenheit degree for 12 hours. There was no previous temperature excursion. Data logger was not involved. Additional information has been requested.
Vaccine adm. on 10/29/07-woke up 10/30/07 with arm swollen-red and itchy today 11-1-07 swelling increased but still itchy.
This spontaneous report was received from a Medical Assistant, referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 09-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L042265; expiration date: 26-OCT-2017 (administration route was not provided). No concomitant therapies were reported. No adverse effects were reported. The vaccine underwent a temperature excursion (10F) for a time frame of 3 hours and 16 minutes. No previous temperature excursions were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Raised bumps (hive-like) that started on arms and legs and caused extreme itchiness. One day later experienced blotchy redness all over chest, abdomen, back, legs, arms, neck, forehead and back of the head, as well as extreme itchiness. On third day now as I report this and still experiencing red rash (some parts blotchy and some look like red dots) all over my body, mostly on arms and abdomen now. Still experiencing extreme itchiness.    Treatment:  50 mg Benadryl, 3x daily 40 mg Prednisone 1x daily 20 mg Pepcid 2x daily
Patient reported swelling and redness in her left arm. She walked into the office to advise us of the reaction. She was seen by the provider in office.
Does not have the lot number. The next day had soreness at the injection site, crescent shaped welt at the site about 3 inches long and 1 inch wide and a hard a lump that lasted for days.  Warmness lasted for at least 3-4 days. About the 3rd day it start to itch, I thought it started to go away. I felt like the lump went away. Today I noticed the crescent shape is still there, it feels warm again and the lump is back.
arm soreness; This is a spontaneous report from a contactable consumer (Patient). A male patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot number: not provided, expiration date not provided), via unknown route of administration, administered on an unknown date, as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medication was not provided. On an unknown date, following the 1st dose, the patient experienced arm soreness. Outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Information has been received from a registered nurse concerning a female patient who on unspecified dates was vaccinated with two doses of MMR II. There was no concomitant medication. Subsequently the patient developed an unconfirmed case of mumps. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No further information is available.
Arm starting hurting and swelling before leaving doctors office, at 11:00 pm started chilling got up the next morning with headache, joint and body aches this lasted for two days.  On third day my left arm turned red  at site of injection and by the fourth day redness and swelling had grown to 10 centimeters by 20 centimeters.  Doctor gave me a steroid shot and prescribed an antibiotic and steroid pills, steroid shot took the redness and swelling down by day five, but by end of day it was back even worse.  Day six I picked up the steroid pills (did not want these) started on them now redness and swelling has gone done, but now all of this has started me with hot flashes and just feeling like I have a touch of the flu.
I felt bad six hours after shot lightheaded and dizzy with headache running a low grade fever. Shakes and chills like I had the flu. Bodyaches and it hurt to touch my skin. It lasted about 12 hours.  A little Nausea. I took Tylenol 10 hours after shot and the Zofran for Nausea. The next day I was really run down for three more days.
Patient was given shot and mother reported patient was not feeling well about 5 minutes after shot was given. When asked, patient had some dizziness, skin was a different tone of color (per mother), and stated that they were breathing rapidly. Beverage was given to patient and ED called.
Rash; Tiredness on first day; This is a spontaneous report from a non-contactable consumer, the patient. A 13-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 18May2021 at 12:15 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. Medical history included heart murmur. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19May2021, the patient experienced rash and tiredness on first day. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rash and tiredness on first day were not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (unknown route and strength) lot # L000610 with expiry date of 31-JAN-2017 or lot # L007560 with expiry date of 15-JUN-2017. No adverse effects were reported. The nurse confirmed that no vaccines were administered after the labeled expiration dates. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Woke up with chills 12 hours after receiving vaccine.  Went back to sleep and slept 12 hours. Headache, low fever, achy muscles, some dizziness.  Loss of appetite.   Took ibuprofen at 12:30  pm on 3/27/2021 and it helped reduce symptoms.
Systemic: Flushed/Sweating-Mild, Systemic: Hyperventilation-Medium.