chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 11-OCT-2022, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
My face swelled; my tongue swelled; I couldn't feel my face or my tongue for 4 days; I couldn't feel my face or my tongue for 4 days; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 21Apr2021 (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient reported that they received the vaccine on 21Apr2021 and her husband was fine; her on the other hand, her face swelled, her tongue swelled she couldn't feel her face or her tongue for 4 days and they were swollen for four days from an unspecified date. She reported it to the pharmacy where she had the shot at, all they told her was to go to the hospital, she don't have the insurance she can't go to the hospital. They sent her a notification that she need to come and get the second one and she didn't go because she was afraid that the reaction could be worst. The patient did not recover from the events.  Information on lot/batch number has been requested.
NAUSEA, VERTIGO, VOMITING, EXTREME FATIGUE, LOW FEVER, ACHING, EXTREMELY PAINFUL ARM AT INJECTION SITE, DIMINISHING OVER TIME BUT LOST 7 DAYS OF WORK/NORMAL LIFE.
DRUG USE IN UNAPPROVED AGE GROUP; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 15 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, non alcohol user, and non smoker. The patient did not have any drug abuse/illicit drug use. The patient experienced drug allergy when treated with amoxicillin.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: not reported) dose was not reported, administered on 13-MAR-2021 to left deltoid as prophylactic vaccination. No concomitant medications were reported.  It was reported that the patient received vaccine on 13-MAR-2021 and he was too young to receive vaccine (coded as drug use in unapproved age group and off label use) and also patient denied having any adverse reactions. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the drug use in unapproved age group and off label use was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210333174-Covid-19 vaccine ad26.cov2.s-off label use and drug use in unapproved age group . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Patient got janseen & janseen  on 03/18/2021 . Did not mention it and got pfizer vaccine today.
Td applied to RD on 14AUg98;w/in 1min c/o dizziness, nausea, feeling hot face was flushed felt as if going to faint;had trouble w/vision lasting 1min;15AUG98 RD site red, lump for med site checked;
This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received Flu Seasonal TIV Dresden. On an unknown date, the patient received influenza vaccine unspecified. On an unknown date, 21 days after receiving influenza vaccine unspecified, the patient experienced vaccination failure (serious criteria GSK medically significant) and flu symptoms. On an unknown date, the outcome of the vaccination failure and flu symptoms were unknown. It was unknown if the reporter considered the vaccination failure and flu symptoms to be related to influenza vaccine unspecified. Additional details were provided as follows: The case was considered as the suspected vaccination failure as the laboratory confirmation of the event was not reported. The age at vaccination was not reported. The patient was unknown about the flu that cover four flu viruses until came on the site. The patient had all the symptoms of flu as patient got a flu shot three weeks before experiencing sickness.
8JUL91 6 months bruised, nodule on rt thigh, no fever;
pt had measles inj 10JUN97 & started getting sick that afternoon w/chest pain, itching & vomiting;went to MD 14JUN & ER on 15JUN97;in ER w/rash around inj site, itching, vomiting, chest discomfort;
At 2am I felt like I was crawling out of my skin. I had muscle spasms almost seizure like reaction. I has a fever chills and chest and back pain. These events repeated around 6am and 10 am. Tylenol helped but it was a horrific experience much like torture. Also nausea.  It was like extreme restless leg or something I can't even explaine properly.  Has taken a week to fully recover.
Hives, rash, extreme itching all over whole body. Benedryl taken. Rash and itching continue to present.
Left deltoid is swollen and warm to touch. It is also painful. Swelling and pain started at 12:00AM on 3/12/15. Mother iced left deltoid. BENADRYL 25mg and Ibuprofen 300mg given in office.
This patient developed a warm, red, hard knot at the area of injection which had lasted for 5 days.
Patient received COVID booster for ages 5-11 instead of the correct one for ages 12+.
Patient was administered 0.25 cc of the 6-11 yo Moderna vaccine, this resulted in the patient receiving half the dose that should have been received
12/10 Wed. got shot. Thursday the 11th small nickel size red area and hard, warm to touch knot. Very sore to touch. Friday morning golf ball size knot, red area and warm to touch, very tender. took BENADRYL and TYLENOL, no results, Friday night a little bigger with same s/s. Sat started getting smaller improving but not gone.
It was ear ache and ringing, hands and feet tingling and loosing feeling, thigh and calves throbbing, chest pain, back pain, weird taste, lungs hurt, body ache, sore throat and tongue and lips are numb.
Patient was given vaccine at 1515 and told to wait at facility until 1530. Patient called cf clinic at 1630 stating she had hives. Patient spoke with RN and stated that her hands were itchy on the ride home and she noticed they were swollen. She stated that she developed hives on her chest and hands. Patient denies any chest heaviness or shortness of breath at this time. Doctor consulted and advised patient take benadryl for reaction. Patient was advised if she developes shortness of breath or any further symptoms to come in and seek emergency treatement and she understood.  Patient did complete v safe today and reported on there as well.
A physician reported that a 4 month old male received Prevnar, Acel-Imune, Hib-Titer, and IPV (Aventis Pasteur SA) vaccines on 7/19/00. The next morning, he developed an injection site reaction characterized by tenderness, a mass, and petechiae at the site of Prevnar administration. The petechiae extended down the length of his right leg. The infant was seen by the physician.
Patient called our office on 11/28/2006 stating she developed pain in her injection site arm (right arm) on day of injection, 11/17/06. Pain was gone in am of 11/18/06. Pain again occurred on 11/20/06 and was still present at the time of the call. Patient did not experience unusual pain at the time of the injection.I spoke with the county health department and they suggested she see her family doctor. Patient is willing to do this. She will call her PCP today.
floaters in her vision,; she feels very weak overall; her legs feel very weak and tired; This spontaneous case was reported by a consumer and describes the occurrence of VITREOUS FLOATERS (floaters in her vision,), ASTHENIA (she feels very weak overall) and FATIGUE (her legs feel very weak and tired) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 immunisation.     Concomitant products included TRETINOIN for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VITREOUS FLOATERS (floaters in her vision,), ASTHENIA (she feels very weak overall) and FATIGUE (her legs feel very weak and tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, VITREOUS FLOATERS (floaters in her vision,), ASTHENIA (she feels very weak overall) and FATIGUE (her legs feel very weak and tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sore arm, chills, fever, fatigue, brain fog, muscle aches and headache.
Redness, swelling, little pain (not debilitating but aware of it) on 9/13/15 in the morning.
This spontaneous report was received from a pharmacy technician concerning an unspecified number of patients of unknown age and gender. On an unknown date, an unspecified number of patients were vaccinated with a dose of improperly stored GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. No symptoms were reported. This is one of the two reports from the same source. Additional information has been requested.
limp,cyanotic,apnea w/LOC;hospx24hr;disch 3JUN94 w/apnea monitor;apneaX1 in hosp;f/u23JUN94-mom rpts child woke fr nap,screamed,eyes rolled around,unable to support head,apnea followed;color changed fr red>purple>grey,lips purple,limp,pale
Patient is pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant) in a 35-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 17-Jun-2021. On 13-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported. Patient was 22 weeks pregnant at the time of vaccination.
C/O pain at site, hot, red, and the size of her fist 10/9/13. Today has increased in size to the size of her palm. Self medicating with OTC meds. Her husband is an internist and they are monitoring site together.
Pt was sitting in post-vaccination area for his 15 minute observation time when he passed out after a few minutes. He had fallen onto the floor beside his chair. I immediately went out to pt. His eyes were fluttering. I shook pt and asked if he was okay. Pt opened his eyes and sat up seemed disoriented and said that he felt nauseated. I told pt to lay down on his back and elevate his feet on the chair, and told my technician to grab a bucket, an ice pack, and to call code white. We applied the ice pack to pts head. A member of management and an EMT who happened to be in the store reported over very shortly. Pt said he did think that he hit his head and his head did hurt. We asked the pt if he wanted us to call an ambulance. Pt said no, he was feeling a little better and he just wanted to wait a little bit and then finish his shopping. Pt was feeling better and was able to get back into the chair and sit. Pt appeared pale and we got him a drink of water. Pt sat and rested for sometime and after about an hour he said he was okay and was going to finish his shopping.
HEADACHE, BODY ACHES, LEFT ARM SORE AT INJECTION SITE, DIZZINESS
This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 77-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included cardiac fibrillation. On 24th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a week after receiving SHINGRIX, the patient experienced fever. On 24th May 2018, the patient experienced tiredness, muscle pain and mobility decreased. On an unknown date, the patient experienced pain in thigh, heart rate increased, influenza like illness and wrist pain. The patient was treated with TYLENOL. On an unknown date, the outcome of the tiredness, fever, pain in thigh, heart rate increased, influenza like illness, muscle pain and mobility decreased were recovered/resolved and the outcome of the wrist pain was recovering/resolving. The reporter considered the tiredness, fever, heart rate increased, influenza like illness, muscle pain and mobility decreased to be related to SHINGRIX. It was unknown if the reporter considered the pain in thigh and wrist pain to be related to SHINGRIX. Additional details were provided as follows: On Thursday, at 11:30 am or 12:00 pm, the patient received the SHINGRIX. That evening the patient began to feel tired and she went to bed. All through the night the patient felt like very muscle in her body was hurting and felt like had to keep stretching because her body felt like it was seizing up. The patient heart rate was 80 BPM which was unusual for her because it usually runs around 57 BPM. The next morning, the patient called her pharmacy to ask if what she was experiencing was normal. The pharmacist asked the patient if she had fever. She said her temperature normally runs around 97.5 degree F, however, when she checked it, her temperature was 99.1 degree F. The patient said that she almost felt like she had the flu and took TYLENOL but the rest of Friday was just a wipe out. The patient started feeling better on Saturday but yesterday both wrists were still hurting and she was experiencing a little bit of discomfort in her left thigh. On the date of reporting, the patient was still having a little bit of joint pain in her wrists but all other symptoms have resolved.
flu; Initial information was received on 01-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a Patient .  This case involves a female patient (unknown age) who experienced flu (influenza) while receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications 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 and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I was having these done every year ,always had the flu after having it done ,i stopped having them done 5 years ago ,and ive never had a cold or cough, whats that telling us ,dont trust any toxic jab no more".  It is unknown if the patient experienced any additional symptoms/events.   Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on batch number for this case.
had both doses of the Shingrex vaccine... 6 Months later he got the worst kind of Shingles/Suspected vaccination failure; Shingles was the most dangerous type/internal shingles affected his esophagus and diaphragm; lost 11 pounds in less than a week; couldn't eat; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, 6 months after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: had both doses of the Shingrex vaccine... 6 Months later he got the worst kind of Shingles/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles was the most dangerous type/internal shingles affected his esophagus and diaphragm), weight loss (Verbatim: lost 11 pounds in less than a week) and unable to eat (Verbatim: couldn't eat). The outcome of the vaccination failure was unknown and the outcome of the shingles, weight loss and unable to eat were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, weight loss and unable to eat to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles, weight loss and unable to eat to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 25-MAR-2023 The case  was received from the patient's wife via interactive digital media. The patient never had shingles prior to that. The reporter stated that just so you all know that the vaccine did not mean you would not get shingles. The patient got the Shingles vaccine and 6 months later he got shingles. The reporter stated that his type of shingles was the most dangerous because they were internal and they affected his esophagus and diaphragm.  The patient lost 11 pounds in less than a week because he could not eat.  The reporter stated that could had been worse because the shingles could have gone to his liver, kidneys, heart, and brain and in that event he most likely would had died, so did not ever say you could not get singles after taking the vaccine. The reporter stated that vaccine was absolutely not fool proof, so do the research before thinking the vaccine was an absolute solution.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Headache,; Nausea; This is a spontaneous report from a non contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of 0.3 ML of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the arm left on 01Jun2021 at 17:45 (at the age of 29-year-old) as a single dose for COVID-19 immunization. Medical history included and concomitant medications were reported as no. The patient did not receive any medication within two weeks of vaccination. 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 four weeks prior to the vaccination. On 01Jun2021 at 17:45 after 1 hour of vaccination, the patient had headache and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of event and included treatment with tylenol. The clinical outcome of the event headache and nausea was resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Information has been received from a medical assistant concerning a male who was revaccinated with pneumococcal vaccine 23 polyvalent six years after previous dose of pneumococcal vaccine 23 polyvalent. Subsequently the patient developed a local site reaction. The medical assistant reported that the patient told her that he "felt like his skin was coming off". The patient was treated with diphenhydramine HCL (Benadryl). The outcome of the patient's events was unknown. Additional information has been requested.
The soreness and heaviness of the arm continue to remain after 3 weeks. As of this writing, it has been 3 weeks since I received the first jab of the Pfizer vaccine. I went to get my 2nd jab today, and I voiced my concern with the person administering the shot who also said the pain  is known to last for a few days at most. So for the pain to remain for so long, it was quite concerning. While the soreness is not as strong as the first 2-3 days since getting the shot, it's definitely noticeable. Occasionally, random "flashes" of a hot pain would surface in that area. However, no reddening or swelling.
fever 100.6 F (lasted ~36 hrs no anti-pyretics), myalgia, chills, headache (peaked at 24 hrs), injection site moderate soreness (decreased to mild by 72 hrs), loss of appetite, diarrhea (24-48 hrs)
Redness, swelling, and tender/hard lump on L deltoid/upper arm.  Area around injection site warm to touch.  Red/swollen area reached approximately 4.5" x 3" in diameter.  Patient also experienced significant fatigue/malaise.