chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. The reported stated that, he/she had the shingles after was vaccinated with Shingles vaccine. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule, time to onset for event and laboratory confirmation for shingles were not provided.
I began to feel scratchy throat, mild coughing, some sneezing, and congestion.  I took a COVID-19 home test on October 20, 2022.  It was negative.  The next day I was feeling worse and had a low-grade fever.  I took an oxygen stat test at home, and it read 92/93.  I went to the doctor and got a PCR test.  I began to feel worse, and I had the worst sore throat I had ever had.  I used Tylenol, antihistamines, decongestants, and Ibuprofen.  By Saturday I was worse and exhausted.  Monday I was feeling better.  Tuesday I was better.  Wednesday, I tested negative on my home test.  The following Sunday I started sneezing all day long.  I tested positive again.  I have tested positive for COVID-19 now for five days for the rebound.
First day, high fever, chills, achiness, nauseated.  After first day, only symptom is major nausea.  Still today, 1/29, some nausea
Shocking sensation to right popliteal (behind right knee) while watching tv, sitting down. It caused me to jerk and bolt upward momentarily. I got up and walked around and it also happened while doing that. TV was fairly loud while this was going on. This probably happened around 7-10 times before I went to bed. Thunderstorm moved in after I went to bed. While lying there, almost asleep, a thunderclap either caused it to happen again 4 different times, or it was a coincidence it happened each time a loud thunderclap happened. My sound system has aggressive sub-woofer but I did not tie the two together or notice before bed if I thought it was triggered by sound.
This case was received from a consumer on 05 November 2007. A 74-year-old male patient, with a history of heart valve replacement and elevated cholesterol, received an intramuscular left deltoid injection of Fluzone (lot number not reported) on 19 October 2007. The injection was administered in the morning, and by evening the patient was experiencing a red raised rash at the injection site, as well as muscular and joint pain in the left arm. On 24 October 2007 he was seen by his physician, who diagnosed shingles and prescribed a 7-day course of famiclovir. He was also seen by an acupuncturist, and the consumer reported that the pain was subsequently relieved. In the days following vaccination he also experienced intermittent swelling in the left hand and bilateral ankles, which was relieved by elevation. Per the reporter, the patient had also been experiencing fatigue and stress. The events had not yet recovered. Follow-up information received on 07 January 2008 from a health care professional. FLUZONE, lot number U2478BA, was administered on 15 October 2007 (previously reported as 19 October 2007). The adverse event onset date was 15 October 2007 (previously reported as 19 October 2007). Per the reporter, the patient recovered from the event.
soreness; Injection site was swollen in oblong shape like a welt; injection site was also red; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness), INJECTION SITE SWELLING (Injection site was swollen in oblong shape like a welt) and VACCINATION SITE ERYTHEMA (injection site was also red) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced INJECTION SITE SWELLING (Injection site was swollen in oblong shape like a welt) and VACCINATION SITE ERYTHEMA (injection site was also red). On an unknown date, the patient experienced PAIN (soreness). At the time of the report, PAIN (soreness), INJECTION SITE SWELLING (Injection site was swollen in oblong shape like a welt) and VACCINATION SITE ERYTHEMA (injection site was also red) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.       Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Events about the 2nd are added.
pt recv vax 12DEC94 & exp rubella like rash & fever of 102; fever lasted for 3 days;
1st mensural cycle after shot was very heavy and lasted 3 weeks, had one week off now on 2nd mensural cycle started 10/22/2021 and has not stopped as of 11/16/2021.  Doctor is doing bloodwork and ultrasound  later this week but nothing changed except for the covid vaccine
Extreme Somnolence, fatigue, arm pain, joint pain, chills X 3d days
Approximately 5 weeks post-vaccine, developed severe spike in tinnitus and plugged feeling in ears, primarily on right side.
Extremely fussy, screaming, inconsolable for 2 days. Mom could not put baby down.
Sore at injection site, increased to 8/10 by evening. Unable to sleep, unable to lie down w/out 8/10 pain. Used heat, ice, acetaminophen q 6 hrs, massage. Called ER Family practice resident on call, who could recommend nothing else. Could not work next day, pain too severe. By Friday, 2/14/2014, I regained functional use of arm by taking acetaminophen q 6 hrs. During the week I had a 1 degree fever, nausea, and muscle aches.
Immediate severe pain and swelling at injection site. Lasted approximately 72 hours.  Fever, loss of appetite, chills, flushed skin, lethargy within 1 hour of receiving vaccine. Lasted approximately 72 hours. Visible enlargement of veins in wrist and along chest within 1 hours of receiving vaccine and lasted approximately 48 hours Overall sense of itching 24 hours after vaccine. Lasted 72 hours
Patient did not experience any reaction. Vaccinator states that the connection between the needle and syringe was loose and a quantity of vaccine leaked out of the fitting during the injection process.  Vaccinator states that most of the vaccine was injected, but some  wept out of the syringe/needle.  It is not possible to quantify exactly how much vaccine escaped in milliliters of fluid or mcg of vaccine.
TIRED, DECREASED APPETITE, PAIN, NAUSEA, VOMITING, ITCHING.
PATIENT RECEIVED PFIZER BIVALENT VACCINE AFTER BEING STORED AT ROOM TEMPERATURE OF 75 DEGREES FAHRENHEIT FOR 31 HOURS.
Positive Covid: started with sore throat and fever, progressed to body aches and chills by evening of first day, then tested positive on at-home test, cough developed on second day and fever and body aches continued through third day, by day 7 was back to normal
Red pruritic rash at the injection site Two days following vaccination, she had an episode of syncope with fall, head trauma, rhabdomyolysis that resulted in hospitalization
Roughly 7 days after 2nd vaccine dose patient reports he noticed an itchy red rash on the right upper arm near the injection site.
After receiving the vaccine on 3/30/21 the next day 3/31/21 I started my menstrual cycle which was odd due to my last day of my previous menstrual cycle was 3/29/31.  Ever since starting my menstrual cycles a day after the vaccine I've experience severe back pain, abnormal acne on my face, engorged breast, and a heavy menstrual cycle with large blood clots.
Headache, NauseaVomiting, extrreme exhaustion, site soreness both doses .  headache,nausea for 2 weeks after 2nd dose Narrative:  used 2 days sick leave
Erectile Dysfunction; Panicking; This spontaneous case was reported by a consumer and describes the occurrence of ERECTILE DYSFUNCTION (Erectile Dysfunction) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jun-2021, the patient experienced ERECTILE DYSFUNCTION (Erectile Dysfunction) (seriousness criterion medically significant) and PANIC ATTACK (Panicking). At the time of the report, ERECTILE DYSFUNCTION (Erectile Dysfunction) and PANIC ATTACK (Panicking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was mentioned No treatment medication information was mentioned  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Rash (bright red) over most of body, bil. wheezing, no edema. Pulse ok 130-145, O2 Sat. 97%. 10:20 am 1 tsp (12.5mg) Childrens Benadryl-no swelling to lips, tongue or throat.  Taken to ER by school
1st vaccine: 11/28/08; Rash on hands appeared soon after, seen by Dr. on 12/7/09 for rash; 2nd vaccine: 2/7/09; 3rd vaccine: 5/1/09 followed by extreme tederness at site and muscle fatigue and pain all over body; numerous doctor visits, tests, and muscle bioposies led to diagnosis on 8/6/09 of dermatomyositis by Dr. During this period (11/28/08 - 5/1/09) rashes also appeared on elbows, knees, hips, and face. In looking back over the time period, there appears to be a connection between the vaccinations their impact on her immune system. Medical literature suggests a possible link between Gardasil and juvenile dermatomyositis, a disease that only affects 5 in 1 million people.  9/1/09 PCP medical records received DOS 2/3/09 to 8/19/09. Assessment: Nonspecific liver enzyme elevation. Nonspecific myalgias, joint complaints, possible rheumatological disorder. On 5/1/09 patient presented with complaints of a red, puritic rash. On the dorsum of and fingers of both hands, concentracted around MCP joints. Later complains of achiness and fatigue on arms and legs, sleeping more. Rash on elbows and knee.   1/7/2010 ED records received. Service date 6/29/09. Assessment: Lympahdenopathy, difficulty swallowing. Patient c/o that it is hard to swallow. Cervical lymphadenopathy. Body aches. Myalgia, sore throat, rash.
after receiving vaccine started to get anxious due to environmental factors was feeling faint and wanted to lay down  assisted to stretcher   placed in trendelenburg  snacks and  water and juice provided  bp elevated  sat up bp cont to be elevated  pt states having anxious thoughts about covid vaccine  expressed to nurse  bp elevated  pt agrees to lay down and rest for a few minutes and close eyes  deep breathing exercises enc to pt.  per pt stress relieved after a few minutes and feeling better and requesting to leave,  escorted to exit ambulated without difficutly, spouse awaiting in car and driving pt home.   pt left at 1053   vs as noted VS 1015 bp 144/89 hr 72 rr 18 o2 95,  1020 bp 157/91 hr 80 rr 18 o2 98  1025 bp 177/107 hr 81 rr 18 o2 100 1035 bp 162/83, 1041 bp 137/87 1045 bp 155/84  1051 148/89
9 doses were administered post excursion; 9 doses were administered post excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses were administered post excursion), POOR QUALITY PRODUCT ADMINISTERED (9 doses were administered post excursion) and NO ADVERSE EVENT (No adverse event) in a 4-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses were administered post excursion), POOR QUALITY PRODUCT ADMINISTERED (9 doses were administered post excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses were administered post excursion), POOR QUALITY PRODUCT ADMINISTERED (9 doses were administered post excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses were administered post excursion) and POOR QUALITY PRODUCT ADMINISTERED (9 doses were administered post excursion).    Concomitant medication was not reported.  Storage condition at the time of the excursion was frozen. Temperature noted in that condition was -2 to -18 C. Excursion duration was for 2hrs. The vial belongs to one of the following batch numbers AR9236B, Exp date: 22-Aug-2023 / AS1903B, Exp date: 14-Jun-2023 / AS7170B, Exp date: 09-Jun-2023. Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2023: Events added.
Administer MODERNA covid-19 vaccine to patient and significant amount of vaccine (more than 70% of vaccine) leaked due to syringe and needle malfunction. Did research on CDC guideline about COVID-19 vaccine, CDC recommend to administer the authorized dose immediately in the opposite arm. Explained and printed out CDC guideline to patient about incident and patient agreed to get full amount (5 mL) vaccine on opposite arm.
infection; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient's wife). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 30Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The caller wanted to reschedule their second dose appointment because his wife got hospitalized due to infection. They missed the second dose last 24Apr2021. They received the first dose last 30Mar2021(More than 3 weeks). The outcome of the event was unknown.
PT REC'D VAX @ 1600, AT 1930 WAS LIFELESS, CLOSED EYES, MOM WOKE HER UP. T=101 ax, GAVE APAP, WOKE AT 0100 SCREAMING, WOULD NOT OPEN EYES, CRYING AS IF IN PAIN, GIVEN APAP; TO SLEEP. MOM WOKE 0530, T 103.8ax, TEPID BATH, APAP, T 102ax.TO ER
Received two steroid shots and curious if steroid shots weaken the COVID-19 Vaccine; Bronchitis; weak; Had a bad temperature on Thursday; did not feel good; tickling in her throat with a dry little cough; tickling in her throat with a dry little cough; This is a spontaneous report from a contactable consumer reporting for herself. An 82-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9262, expiration date: May2021), via an unspecified route of administration on left arm on 01Feb2021 at SINGLE DOSE for COVID-19 immunization. The patient medical history included Minimal COPD and Had bronchitis all winter of last year. The patient did not receive any other products. The patient received two steroid shots in physician's office for bronchitis on left hip on 08Feb2021. The patient received flu shot in the Fall; not within 4 weeks prior to the COVID vaccine. Historical vaccines included first dose of BNT162B2; Solution for injection; Lot number: EL3246, expiration date: Apr2021), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization and had no problem with first COVID-19 Vaccine. The patient had no problem with first COVID-19 Vaccine. On an unspecified date after the second vaccine, the patient felt fine after she got the second COVID-19 Vaccine. Tuesday night, she started having tickling in her throat with a dry little cough. Wednesday, Thursday and Friday, she did not feel good. Had a bad temperature on Thursday (for one day). The patient thought that she was told not to get shots for 14 days after first vaccine. The patient felt curious if steroid shots weaken the COVID-19 Vaccine. The Treatment included the patient took Tylenol for the body temperature. The outcome of the events body temperature was recovered, and bronchitis was not recovered while other events was unknown.
Flu vax given at 5 pm on 9-25. Wheezing and chest fullness occurred around 6:15 pm. Severe respiratory distress to acute respiratory failure at 3 am on 9-26-13.
LMP 9/15/2021 positive pregnancy test patient states heavy vaginal bleeding on 11/20/2021
No additional AE information; she had received an 9-valent HPV vaccine while pregnant; This spontaneous prospective pregnancy report was received from a female consumer of unknown age reporting on herself. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.     The patient became pregnant on an unknown date. The LMP and EDD were not known.  On 09-MAY-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date not reported) (exposure during pregnancy). No adverse event was reported.  The pregnancy outcome was unknown.
potentially given a vaccine which expired 3 days before; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (potentially given a vaccine which expired 3 days before) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 007J21) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (potentially given a vaccine which expired 3 days before). At the time of the report, EXPIRED PRODUCT ADMINISTERED (potentially given a vaccine which expired 3 days before) outcome was unknown.            It was reported that Lot number 007J21 - written on the vaccination card. Agent tried to enter lot numbers as 007J21A and 007J21B) but it said the lot number does not exist. Patient enquired what would happen if he was given an expired vaccine and which was expired 3 days before. Patient read some information in the form that he was given by the vaccine provider that said 0.25 ml/0.5 ml VIS 01221 and OXP Apr 19. No concomitant medications information was reported. No treatment medications information was reported.   Reporter did not allow further contact
throwing up; legs went limp; This is a spontaneous report from a contactable consumer (patient) via Pfizer Oncology Together. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unknown date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient was in the hospital for 4 days from Covid vaccine and was in rehab. Was throwing up, legs went limp, and had a bad reaction. Stretching her last bottle of Inlyta to hold her over until approval and another bottle arrives. The outcome of events was unknown.   Information about lot/batch number had been requested.
This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 56-year-old male patient who received HAV (Havrix) (batch number F4EL2, expiry date 11th September 2021) for prophylaxis. On 6th December 2021, the patient received the 2nd dose of Havrix. On 6th December 2021, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional details were provided as follows: The age at vaccination was not reported. The practice manager called to report that a male patient was administered an expired dose of his Havrix vaccine, which led to expired vaccine used. The reporter consented to follow up.
No adverse effects.; Patient received an improperly stored ROTATEQ; This spontaneous report was received from a nurse practitioner, referring to patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications and previous drugs reactions or allergies were not provided.  On 05-NOV-2019, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, as prophylaxis (concentration, number of administered dose and vaccination scheme frequency were not reported; lot number R035374,  has been verified to be a valid lot number, expiration date reported was 15-SEP-2020). No adverse effects were reported for the patient.  According to the reporter, the temperature excursion was 47.1 degrees Fahrenheit for a time frame of 30 minutes on an unspecified date (product storage error), with a previous temperature excursion of 32.9 degress Fahrenheit for 24 hours; which was detected by a digital data logger.
Patient stated that within a few hours had gotten the chills and cold sweats. She said it only lasted a few minutes. She said she developed stiffness in her hands that lasted a few weeks. She came to report it on 10/31/2018. We instructed her to check with her doctor. She said she wanted to wait a bit more. We had contacted the manufacturer the next day. They said that arthralgia and myalgia were side effects. We again followed up with her that next day and a few days later. We had submitted a report previously on this, but the computer was freezing up. So we submitted another report just in case. We had also submitted a VAERS Report when we contacted the drug company.
Persistent pain deep in my right arm near injection site.  Difficulty lifting right arm and pain when using my arm.This pain started right after the injection and has not gone away.  Reported pain to my primary care doctor on March 29, 2021.