chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CHILD RECEIVED VACCINE AND THEN PASSED OUT AFTER VACCINATION.  MOTHER LOWERED HER TO THE GROUND AT ENTRANCE OF CLINIC WHERE THE FLU CLINIC WAS BEING HELD AND CALLED FOR ASSISTANCE.  MOTHER REPORTED PER FORM THAT CHILD WAS ANXIOUS ABOUT GETTING VACCINATED TODAY.  CHILD AWAKENED AS SOON AS STAFF MADE IT OVER TO MOTHER TO ASSIST HER.  CHILD SAID SHE WAS FINE.  GIVEN APPLE JUICE AND A CRACKER.  BP 92/60.  SAT UP AND THEN STOOD UP WITHOUT ANY DIFFICULTY.  OFFERED TO CALL EMS, MOTHER DECLINED. TOLD MOTHER SHE COULD TAKE HER TO THE DOCTOR TO GET CHECKED OUT IF SHE WANTED BUT TO KEEP AN EYE ON CHILD AND FOLLOW UP WITH PCP IF NEEDED.  VOICED UNDERSTANDING.  ALSO TOLD MOTHER TO LET PROVIDERS KNOW OF FAINTING INCIDENT AT FUTURE APPTS.  ATTEMPTED TO CALL MOTHER NEXT DAY ON 10/3/23 AND LEFT VOICEMAIL TO CHECK IN ON CLIENT.
Patient hospitalized for pleural effusion on 5/28/2021. Patient presented to the ED and was subsequently hospitalized on 6/29/2021 for acute alcoholic intoxication with delirium, acute respiratory failure with hypoxia. These visits are within 6 weeks of receiving COVID vaccination.
began to fuss & cry which lasted about 2hr;mom unable to console him;not reported until today;
Red swollen arm hot to the touch at site of injection it is day 9 and still there, maybe worse.
Pt received Pneumovax 0.5mL IM R deltoid on August 26.  She presented to clinic on August 27 with R upper arm red, warm, swollen, and tender to touch.
The hospital was giving free flu shots. I received one and it hurt when administered. My arm continues to hurt very badly. It hurts all the time but really badly at night. It wakes me several times each night. It has been almost 4 months since I received the shot.
Body aches, fever, weakness, diarrhea, nausea,lost of appetite. Two days later cough. Albuterol Guaifenesin Prednison
Approximately 1 month after receiving hepatitis A child developed vitiligo followed by autoimmune Thyroiditis with complete thyroid failure.
Rotator cuff syndrome; Weeks later still has arm pain; This case was reported by a physician via sales rep and described the occurrence of rotator cuff syndrome in a 19-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, several weeks after receiving Bexsero, the patient experienced rotator cuff syndrome and pain in arm. On an unknown date, the outcome of the rotator cuff syndrome and pain in arm were unknown.   It was unknown if the reporter considered the rotator cuff syndrome and pain in arm to be related to Bexsero.  Additional details were provided as follows: The patient received Bexsero and weeks later still has arm pain. The patient was getting physical therapy for rotator cuff now.
Patient was administered 2nd vaccination of Moderna on 10/20/22 around 11:00 am. Patient found to have seizure like activity on 10/23/21 around 6:00 am. Patient sent to ER, blood pressure noted to be elevated at that time. In ER, CBC, CMP, CT scan of head done.  Patient returned to nursing home same day with follow up to neurology for new onset seizures. On 10/26/21 patient noted with weakness, abnormal breath sounds, high blood pressure. Clonidine given for blood pressure. CBC, CMP, CXR done. CXR negative for acute abnormalities. slightly elevated at 11.8. UA ordered at that time. Patient started on Doxycycline. Urine culture positive for >/= 100,000 colonies/mL Escherichia Coli with sensitivity to Tetracycline.
This spontaneous report as received from a nurse refers to a 5 year old patient (gender not reported). No information regarding the patient's medical history was provided. On 20-JUN-2013 the patient was vaccinated with GARDASIL, valid lot # H021608, 0.5 ml, intramuscularly. No concomitant medication was reported. The patient was 5 years old when receiving the vaccine. No adverse effect was reported. No outcome was reported. Additional information has been requested.
EARLIER MENSTRUEL CYCLE; HEAVIER BLEEDING; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced earlier menstrual cycle. On APR-2021, the subject experienced heavier bleeding. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the earlier menstrual cycle and heavier bleeding was not reported. This report was non-serious.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020). Co-suspect products included Influenza vaccine Quadrivalent. On 29th January 2018, the patient received SHINGRIX .5 ml and Influenza vaccine Quadrivalent. On an unknown date, less than a month after receiving SHINGRIX and Influenza vaccine Quadrivalent, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX and Influenza vaccine Quadrivalent. Additional details were provided as follows: The age at vaccination was not reported. The health care professional (pharmacist) stated that a patient reported that receiving a SHINGRIX and flu vaccine on the same office visit on 29th January 2018. The patient reported to health care professional contracting shingles soon after. The health care professional declined to share any patient information regarding this potential adverse event. Only shared the vaccine information. The health care professional stated that he/she would speak with safety department with more information once they speak to the patient first.
It started with a severe flu after the third shot, in 1998 from there on I had numerous problems dismissing them for flu and over working condition but more followed 2 to 3 times year since. I have experienced  pain in chest when taking deep breaths, chronic respiratory infections along with sinus infections and sneezing fits, digestive problems ranging from indigestion, severe gas pains to pain when passing stool chronic hemorrhoids, rectal bleeding. Fatigue easily joint aches, hip and back pains from time to time constant stiff elbows both left and right, started with mild tingling in right hand index finger and thumb to now carpel tunnel and severe tendonitis this required an emergency room visit Nov 20, 2004 was given a diagnosis of severe carpel tunnel and prescribed Ibuprofen 800MG. Left hand is just now experiencing mild tingling in the index and middle fingers.  Constant feet fungus problems, recently started experiencing a pain in the right foot that feels like a electric shock abnormal skin rash on top of left foot that I have had for more than 2 years. Right knee tendonitis and experience severe leg cramps at times. As of June 2005 starting losing hair in patches and has not grown back (alopecia).  Since June of 2005 I seem to be experiencing more fatigue and severe aches in both shoulders and in joints mainly my right elbow and wrist along with hot flashes and headaches also severe pain when passing stool.  I would also like to add for reference that my first son born Jan of 2001 was hospitalized when he was 1 years old for pneumonia and my daughter who was born on July of 2003 was also hospitalized for pneumonia when she was 6 months old and my final child a boy was born on May of 2005 and has been experiencing severe gas and digestive problems.
Information has been received from a 58 year old male consumer with no known medical history or allergies who in "early" January 2007, was vaccinated with a 0.5 ml dose of Zostavax. There was no concomitant medication. Subsequently the patient experienced flu-like symptoms. Unspecified medical attention was sought. No laboratory tests were performed. At the time of the report, the patient had not recovered. There was no product complaint involved. No further information is available.
Lethargy, slight muscle soreness all over in addition to site of injection, tired mostly the day following the injection, but still a bit for the next several days. Slight occasional dizziness still on 4th day after shot.
Patient stated that she thought her arm near the elbow looked swollen shortly after the vaccine was administered. I visually inspected the arm and did not see any swelling. I asked her if she felt any symptoms of pain/inflammation or irritation in the area, and she said she did not. I asked her to wait a little bit longer to monitor, and after that she said she felt fine and left after about 25 minutes of monitoring.
This spontaneous report as received from a medical assistant refers to an unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous (lot # and expiration date not reported) which was exposed to temperatures outside of recommended condition. No adverse events were reported. The patients did not seek medical attention. This is one of several reports from the same source. Additional information has been requested.
pt had profuse lacrimation, rhinorrhea, eye inj, bilat eye swelling & cough 10min p/vax;pt had not wheeze or resp distress;given epi recovered/for mild lt eyelid swelling;placed on DPH & pred;
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 13-FEB-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K005427, exp date 15-APR-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Left leg soreness; Pins and needles almost feels like restless leg syndrome - like I need to be moving leg around.; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO217) via an unspecified route of administration in the left arm on 01Aug2021 at 10:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patients' medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously took cefaclor (CECLOR) and experienced a drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 01Aug2021, the patient experienced left leg soreness, pins and needles which almost felt like restless leg syndrome - like she needed to move her leg around. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left leg soreness, pins and needles which almost felt like restless leg syndrome- like she needed to move her leg around was not resolved at the time of this report.
This spontaneous report was received from an administrator and refers to an unspecified number of patients of an unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The reporter stated that improperly stored doses of GARDASIL 9 (strength, anatomical location, dose, frequency, route of administration, lot number, and expiration date were not provided), were administered to an unspecified number of patients on an unspecified date, for prophylaxis. The vaccine had multiple unspecified excursions due to a data logger issue. The reporter provided information relevant to the temperature at which the vaccines were maintained, however it was explicitly stated that such vaccines were not administered to any patient. There was no product quality complaint involved. This is one of three reports received from the same source. Additional information is not expected as there was no information and consent to contact the physician.
Symptoms: Patient was lightheaded 5 minutes after the vaccine administration. (patient  stated she flew  home last night) Treatment: Lying down helped resolved the symptoms. Outcome: Patient was discharged to POV/Home once symptoms resolved.
Information has been received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. Since unknown dates from 07-APR-2015, the patients were vaccinated with (Oka/Merck) VARIVAX (route, dose, Lot# and expirationd date not reported), which were exposed to temperatures outside of the recommended range. No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Entire body turned red; Skin all over body peeled; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced the entire body turned red and skin all over body peeled on an unspecified date. It was reported tat the patient was hospitalized on an unknown date (at an unknown period of time). The outcome of the event was recovering.
Left deltoid area red, swollen, no fever. Pt complained of itching only. Given Benadryl chewable every 8 hrs as needed.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.     In 2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a physician for shingles. As a direct and proximate result of use of zoster vaccine live (ZOSTAVAX), patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of herpes zoster was unknown.   Additional information has been requested.
A spontaneous report was received from consumer concerning a patient of unknown gender and age. Patient's relevant history, concurrent diseases and concomitant drugs were not provided. Patient received nasal FLUMIST QUADRIVALENT (intranasal) for alternative to other flu vaccination. The patient stated that she had been getting Flu vaccines for two to three years and the flu reoccurred numerous times. The outcome of flu recurred numerous times was unknown. The company physician considered flu recurred numerous times to be non-serious.
Approximately 1 week later started to develop a rash on inner thighs. It continued to get worse over the next week, spreading over thighs, down legs and on arms. Very itchy, blotchy hive-like. Thighs developed swelling and bruising over the next week.
patient that received PROQUAD during supported TE; This spontaneous report was received from a medical assistant concerning a 5-year-old patient of unknown gender. Their concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On unknown date in August 2023, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneous injection, lot number X009130 with expiration date 24-SEP-2024, administered as prophylaxis (dosage regimen and route of administration were not reported). The vaccine had undergone a temperature excursion (TE) at a range of 6 to 14 degrees Fahrenheit for 21 hours, 48 minutes and 0 seconds (Product storage error).  This was one of two reports from the same reporter.; Sender's Comments:  US-009507513-2308USA010852:
upon day 8 post 2nd injection, around 6pm at night i felt extremely weak, chill up spine and then that night over next several weeks started noticing numbness bilaterally on face and a fullness in both ears and ringing.  i thought it would pass, but numbness took over 8 weeks to go away but the plugged ears and hearing have not improved.
This spontaneous report as received from a physician refers to a 7 week old male infant. Patient's pertinent medical history reported as none. Patient drug allergies included lactose sensitive. On 11-FEB-2014, the patient was vaccinated with ROTATEQ oral liquid, (lot number # H013164, expiry date unspecified), dose and frequency unspecified (reported as routine). Concomitant medication were reported as none. On 11-FEB-2014, the patient spit up immediately after receiving ROTATEQ. No treatment was given for the adverse event. No lab diagnostic studies were performed. No intervention performed to prevent any serious criteria. There was no significant disability or incapacity to the patient due to the event. No hospitalization required. The event was not life threatening. No product quality complaint was involved. The outcome of the event was reported as recovered on 11-FEB-2014. The reporters causality assessment for the event with the therapy of ROTATEQ was not reported. Additional information has been requested.
Distinct pain @ injection site within 2-3 hours of injection lasting 16-18 hrs. Followed by all over body ache & extreme fatigue.
almost passed out trying to get to the bathroom; I'm exhausted; no energy whatsoever; my joints ache; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on Mar2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination. The patient stated that on 12Mar2021, "I had my first Pfizer shot yesterday and it really kicked my butt! I almost passed out trying to get to the bathroom. Very nervous about the second shot! I'm exhausted, no energy whatsoever, and my joints ache!" Treatment and outcome of the events were unknown. Events did not result in visit to the emergency room or physician's office. The patient had not been tested for COVID-19 since the vaccination.  Information on the lot/batch number has been requested.
Female patient 38 years old, 16 weeks of gestation uncontrolled DM II does not comply with medical recommendations to take her medications daily or to eat an adequate diet for her dx or her pregnancy. Patient in area of observation at 5:30 feeling dizzy, cold and hot. EMT transports patient to area of observation and paramedic takes her vitals BP 140/70, HR 81, Dext 87, SPO99. 5:35 Doctor is called and gives order for patient to drink juice or 7-UP and to keep her under observation for 30min, Patient verbalizes having taken Cyclon before the vaccination on D/C; min home. Patient was kept under observation for 30min as instructed by Doctor. Patient is instructed to talk with her OBG. Patient improves and after 30min and she is discharged to go home.
I received the vaccine at 3:15, due to my allergies I stayed for 45 minutes. I walked to car and felt dizzy driving home. I was seeing lighting bolts in visual field. I felt fatigued and foggy. I had chills, fever, a pain from the top of my legs to  my feet . I had no reaction on the arm that I received the vaccine, I had pain in the opposite arm. I had pain from my neck to my waist in the back of me, no pain in chest area. Each day following I had headaches that went into optic migraines. Continues from the shot up to  present. I have been taking Tylenol each and every day.  I don't normally take over the counter medication.  I have had less stamina since the injection. I am doing 50% of my daily routine due to fatigue
hard,red,lump on left arm; hard, red, lump on left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (hard,red,lump on left arm) and VACCINATION SITE ERYTHEMA (hard, red, lump on left arm) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE MASS (hard,red,lump on left arm) and VACCINATION SITE ERYTHEMA (hard, red, lump on left arm). At the time of the report, VACCINATION SITE MASS (hard,red,lump on left arm) and VACCINATION SITE ERYTHEMA (hard, red, lump on left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information was not reported.
Arm hurts; swollen; red; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2021BI01001415 . A 57 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as unk unk, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Arm hurts"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "swollen"; VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "red".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.