chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mom states he felt warm when I laid him down for a nap. Then I saw his body start shaking so I picked him up and his eyes rolled back in his head. I called 911; they took his temp but didn't tell me what it was. We took him to the ER. The doctor there said he had a ear infection and along with the shots, it probably caused the seizure. Seizure lasted 2-3 minutes and occurred only once. Parents are Spanish speaking only.
Pt presented at ED by ambulance 01/01/2022, from outside assisted living facility. Pt was having behavioral changes and combativeness. No other sxs.  Tested + for COVID. Admitted. Pt died 01/11/2022.
06/19/2022, sore throat in the evening, 6/20 tested positive and still had a sore throat, slight nasal congestion and a very slight headache. 6/21 Sore throat went away, congestion got worse and fatigue became noticeable and headache was unchanged. Started PAXLOVID on 6/21. Symptoms remained the same through 6/24 when I began to noticeably feel better. On 6/30 my voice was scratchy and horse; and sore throat returned. 7/1, no sore throat, but vocal symptoms persist.
PATIENT STARTED GETTING A LARGE RED BUMP SHORTLY AFTER ADMINISTRATION. ON 1/12/17 SHE WOKE UP WITH SWOLLEN LIPS, BLISTERS IN HER MOUTH, A RASH ON HER CHEST, AND SHE COUGHED UP BLOOD. THE KNOT AT THE ADMINISTRATION SITE WAS STILL PRESENT. RASH WAS SPREADING OVER ENTIRE BODY BY THE TIME SHE REACHED THE ER. ACCORDING TO HER HUSBAND THEY GAVE HER A SHOT OF STEROIDS AND CALLED IN AN RX FOR PREDNISONE TABLETS. HE STATED THAT THE ER DOCTOR FELT IT WAS A REACTION TO THE VACCINE.
Rash on face, arms and stomach. Severe bone and muscle ache and tiredness. I didn?t get very much sleep Saturday night at all. Also, A a 102 fever,  Sweating and chills.
Patient came with mother to get his 2nd HPV9, waited 15 minutes and fell to the floor on his right side (right arm hit the floor) according to his older brother.  Pt was taken to the treatment room, assessed vital sign and given a box of juice.  Dr. spoke with both patient and mother.
Patient became fussy and had a temp of 101. I administered Tylenol and help him while he slept because he would not sleep alone as he normally does. Highest temp was 102.4. He dropped the fever on 12/03/14. After the fever went away his posterior and anterior torso and neck broke into a concentrated small red bumps and his skin turned a bit jaundice. The rash spread from the bottom of his butt to his hairline (posterior) and his pubic bone to his chin. He had diarrhea from 12/02-12/06. Still sick. Wanted to file this report before it ended.
A report has been received from a physician concerning a 7 year old female patient. Relevant medical history and concomitant disease were unknown. On 23-Oct-2013, patient received nasal FLUMIST QUADRIVALENT. On 18-Nov-2013, the patient developed the flu. She was treated with TAMIFLU. Patient was a healthy child-no medical issues. The outcome of the event of flu diagnosis after vaccination with FLUMIST was unknown. The reporter assessed the event of flu diagnosis after vaccination with FLUMIST to be non-serious.
My menstrual cycle started the day after dose 1 and again after dose 2. My cycles have been very regular. I have also started having cystic acne since I have been vaccinated. I have started having multiple periods in a 28 day cycle. I have never in my almost 40 years of life had cystic acne and multiple menstrual cycles in a months time.
Dizziness headache fever chills exhaustion  Extreme swelling itchy hives at injection site Numb fingertips
Client called complaining of abdominal/back pain and spotting starting two days after the vaccinations. The abdominal/back pain lasted approximately 4 days, but the vaginal spotting has continued intermittently. Has had history of long-term menses in past; doctor has been consulted previously for it.
Right side facial numbness starting 10 days after vaccination.  Moved to feeling of right arm going to sleep a few days later.  Wednesday 8/4/21 moved to sleep feeling in right leg which now drags unless patient makes conscious effort when walking.
a lot of headache; fever; nausea; vomit; dilation of the genitals; tingling on her arms and legs; pain in the abdominal area; pain in the legs; a lot of muscle pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (a lot of headache), PYREXIA (fever), CHILLS (chills), ABDOMINAL PAIN (pain in the abdominal area) and PAIN IN EXTREMITY (pain in the legs) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism, Type 2 diabetes mellitus, Hypertension and High cholesterol. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), METFORMIN, GEMFIBROZIL, ROSUVASTATIN, HYDROCHLOROTHIAZIDE, LOSARTAN and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced CHILLS (chills) and MYALGIA (a lot of muscle pain). On 17-Jan-2021, the patient experienced ABDOMINAL PAIN (pain in the abdominal area), PAIN IN EXTREMITY (pain in the legs), GENITALS ENLARGED (dilation of the genitals) and PARAESTHESIA (tingling on her arms and legs). On 18-Jan-2021, the patient experienced HEADACHE (a lot of headache), PYREXIA (fever), NAUSEA (nausea) and VOMITING (vomit). The patient was treated with IBUPROFEN at an unspecified dose and frequency and ACETAMINOPHEN at an unspecified dose and frequency. On 18-Jan-2021, CHILLS (chills), ABDOMINAL PAIN (pain in the abdominal area), PAIN IN EXTREMITY (pain in the legs), MYALGIA (a lot of muscle pain), GENITALS ENLARGED (dilation of the genitals) and PARAESTHESIA (tingling on her arms and legs) had resolved. At the time of the report, HEADACHE (a lot of headache), NAUSEA (nausea) and VOMITING (vomit) outcome was unknown and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment provided was Ibuprofen and Acetaminophen.; 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.
aprx 2 1/2 hrs later, slight cough turned into, weezing and breathing difficulty. It lasted about 6hrs. I thought I was getting sick, so went to bed early. When I woke following am, I felt better and realized it was an allergy attack.  That kind of attack only happens to me when I visit a friend who has a cat.
stiff neck; blood in my stool; had difficulty getting comfortable; increasing neck pain; fever; chills; major fatigue; increasing back  pain; unable to sleep due to the pain; This is a spontaneous report from a contactable consumer (occupation: other health professional), the patient. A 34-year-old male patient received second dose of BNT162B2 (COVID-19 vaccine, Solution for injection, Lot number: EM9810) via an unspecified route of administration in the left arm on 12Feb2021 at 09:00 AM as a single dose for COVID-19 immunization. Medical history included 1 kidney stone. The patient had allergies of whey (milk and cheese). Patient had no vaccination prior to COVID. Concomitant medication included Calcium supplement gummies (from two weeks). Patient did not receive any other vaccine in four weeks. The patient previously received the first dose of BNT162B2 (COVID 19 vaccine, Solution for injection, Lot number: EC9261 or EL9261) via an unspecified route of administration in the left arm on 22Jan2021 at 02:45 PM. Since the vaccination, the patient had not been tested for COVID-19. On 12 Feb2021, the patient had no side effects for almost 12 hours (Fri 9am-9pm). After that at 21:00PM, patient had major fatigue, chills, fever as well as increasing back and neck pain. The Patient was unable to sleep friday night due to the pain and on saturday had difficulty getting comfortable. By sunday the back pain subsided but the neck pain and stiff neck remained, patient had difficulty turning the head. The patient continued to have chills and fever. Ibuprofen helped some with the symptoms. By sunday night patient had no major symptoms but had blood in stool on Sunday and Monday. Event blood in my stool was considered as medically significant. Patient had fully recovered in 2021.; Sender's Comments: Considering a plausible temporal association between the event 'Hematochezia' and the suspect drug BNT162B2, a causal relationship cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Received flu shot 10/28/2003.  Changed cloths 10/29/2003 and noted red hot area where flu shot had been given.
After getting the 2nd dose, she started to have difficulty in breathing.; This is a spontaneous report from  sponsored program  support from contactable consumer (patient, self-reported) via medical information team. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number and expiry date were not reported), via an unspecified route of administration, on 30Apr2021, as a dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a dose 1, single for COVID-19 immunization. On an unspecified date in Apr2021, after receiving the second dose the patient started to have difficulty in breathing. It was reported that she realized it could be a severe allergic reaction as mentioned on the fact sheet, she read about the vaccine. The patient also reported that is over and done with and she went to the hospital, and she does not have any questions at this time. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Extreme dizziness before going to bed, and especially when getting up from bed at night or getting up the next morning. Dizziness was such that I could barely walk and crashed into walls.  Also, extremely intense headache behind the eyes;  Headache was slightly better after taking 1 or 2 full-sized aspirin.  Fever and muscle soreness was probably typical.  Symptoms came on the night of the vaccination and seemed to subside the next day. Dizziness was notable upon getting up in the morning but went away slowly, as I attempted to "walk it out".
Patient contacted the office on 10/08/2020 and stated that she received the pneumonia vaccine in her right arm yesterday and the injection site is red, swollen and aches.  She stated that she had hives and the chills.  She tried taking Benadryl and Tylenol-did not really help.  Appt was given to be seen in the office @ 11:30AM on10/08/2020.  There were no hives when she came to the office.  She was not having any issues breathing, joints were aching.  She was instructed to take Benadryl 25mg ever 4 hours as needed and she may take an extra Ativan or 2 if necessary.  She returned on 10/12/2020 and the erythema and swelling at injection site was gone and was not bothering her anymore.
1 hr after receiving vaccine, pt had numbness in lips, dry throat, itchy. Pt went to ED & received epinephrine, prednisone.
Mom reports that 4 hours after 2mo imm were administered pt developed persistent vomiting & was taken to emergency.
Fever; runny nose; feeling poorly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A child patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1), for Covid-19 Immunization.  The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; RHINORRHOEA (non-serious), outcome "unknown", described as "runny nose"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "feeling poorly".  Additional Information: Batch number was Not available or provided to reporter at the time of report completion. Event reported Fever, runny nose, feeling poorly after second dose. Awareness Date reported as 24Dec2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Tightness in the chest, Heart rate racing or too low, Lightheaded and dizziness, Pass out a few times after the Second dose on 9/21/2021.  I lost complete sense of my smell. I know have heart palpation after both and its still ongoing. After the second dose I have nausea. I can not eat like I used to nothing looks or sounds good.
Explain immunizations ordered by physician. Administer vaccine to (L) leg and then (R) leg. Next retrieve immunization record from printer return to room where mom reports patient fainted "fell back" in my arms. RN observes patient pallor with eye rolling assist to exam table give water and monitor. Patient resume behavior same as at the start of the visit.
Within 12 hours: Significant swelling at injection site and redness, 101 - 102 Fever, Chills, Muscle pain. After 30 hours: Wet Cough (diagmosed as bronchitis), tight chest. After 2 days: Headache, eye pain. After 4 days: Dizziness and itching of tongue, hands mouth prompts ER visit. Went to ER and released. Thought to have adverse reaction to medication, but unsure of which. Told to drink water to expel from system. Followed by severe Vomiting, Diarrhea, Muscle twitching especially in feet, muscle contractions in legs, blood pressure swings. Out of body feeling and brief syncope.  After 6 days: No more fever, but stomach pain and muscle pain continue. Dizzy and hazy. Unable to drive. Went back to doctor. Sent for bloodwork. After 8 days: No fever or cough. Dizziness and muscle aches continue. Difficulty focusing eyes. Noticeable stiffness in hips, at base of neck, and shoulders.
shingles; Information was received from a lawyer regarding a case in litigation concerning a male patient (pt) of unknown age. The pt's medical history, concurrent conditions, or concomitant medication were not provided. In or around 17-AUG-2017, he pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after zoster vaccine live (ZOSTAVAX) vaccination, the pt suffered a burning rash on the left side of the back and left buttocks and was diagnosed with shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms have resulted in physical limitations not present prior to using the company's product. The pt also experience mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster was reported as not resolved. The causal relationship of herpes zoster was reported as related to zoster vaccine live (ZOSTAVAX).   The reporter considered herpes zoster to be a disabling event.
Patient received Trihib vaccine in our office on Wednesday 7/7/04 and later that evening, he experienced symptoms of diarrhea. Diarrhea continued for 24 hours. Mother of patient feels diarrhea was caused by vaccination.
Patient reports severe burning in mid section after 2nd Shingrix vaccination.  Patient stated it started at least 2 weeks ago (~9-1-19).  Patients primary care physician treated patient (unknown treatment) and sent him to us (pharmacy) to report to VAERS.
I?m suffering from right arm pain that began a week after my first injection. I?m currently in a lot of pain, unable to use my arm.  I?m taking Aleve and Tylenol intermittently.
Patient reported just before  he was about to receive the 2nd shot that he felt numbness and tingling in his right arm and hand immediately after receiving the first shot yet he did not mention this to anyone. The numbness and tingling advanced to include his left arm and hand and he found it difficult to make a fist with either hand. Problem continues. Patient did not get the 2nd shot and was advised to contact his MD as soon as possible.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021 at 1:08 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 12:24 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 59.76 for dose administered on 27-Feb-2021 and 59.84 for dose administered on 27-Mar-2021. No concomitant medications were reported.  Batch number 019B21A administered on 27-Mar-2021 underwent temperature excursion with temperature range of 35 degrees Fahrenheit from 09:00 to 10:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021.  Batch number 014M20A underwent temperature excursion on 27-Feb-2021 with temperature 35 degrees Fahrenheit from 01:00 PM to 02:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
Within 5 minutes of receiving Gardasil 9, first dose, and Menactra, second dose, patient reported throat feeling dry like it was closing and developed a repetitive dry cough. No visible facial, tongue or lip swelling, no hives. Chest clear to auscultation. No tachycardia. Symptoms began to resolve within 15 minutes. Follow up call on 5/6/16, patient doing fine.
Grandmother called and spoke to doctor and states pt awoke with rash from head to toe, positive itching and feels chilled. Grandmother denies SOB and throat swelling. Also, states coughing but feels pt had cough previous. Pt saw Dr. on 03/04/2011. Dr. noted macular papular erythema on face, trunk and extremities. Dr. gave pt Benadryl.
COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19 infection. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 infection was not reported. This report was non-serious. This report was associated with product quality complaint : 90000205851.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
This spontaneous report was received from a pharmacy student regarding her friend's daughter, a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unspecified date, the patient was vaccinated with (Oka/Merck) VARIVAX injection (dose, route, lot # and expiry date unknown). On an unspecified date, the patient had negative titers (antibody test negative) after receiving (Oka/Merck) VARIVAX. No adverse event was reported. The outcome of antibody test negative was unknown. Causality was not provided by the reporter. Additional information is not expected as the reporter did not provide contacts details to follow-up.
REDNESS, INFLAMMATION  Patient is to use prescribed ointment , return to office if not better, avoid irritant agents. Use Keflex if redness spreads in the area of the shot.
Patient got rotavirus vaccine 6/8/17 and developed intussusception three days later.