chrisvoncsefalvay/vaers-outcomes huggingface dataset:
IMMUNIZATIONS GIVEN AT APPROXIMATELY 9:30 AM. INFANT SLEPT FOR APPROXIMATELY 1 HR AFTER VACCINATIONS, THEN BECAME INCONSOLABLE CRYING FOR APPROXIMATELY 3.5 HRS AFTER IMMUNIZATIONS. INFANT GIVEN DOSE OF TYLENOL AT 1PM, INFANT EXHAUSTED, FELL ASLEEP BUT CONTINUED TO MOAN/WHIMPER WHILE SLEEPING. 1HR AFTER TYLENOL INFANT SLEEPING COMFORTABLY BUT FUSSES WHEN LEGS MOVED
the senior flu shot in Oct. Got the flu first week in Dec; Initial information received on 15-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced the senior flu shot in oct. got the flu first week in Dec while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, frequency, dose, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious the senior flu shot in oct. got the flu first week in Dec (influenza) (unknown latency).  Lab data was not reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (the senior flu shot in Oct. Got the flu first week in Dec).  At time of reporting, the outcome was Unknown for the event the senior flu shot in oct. got the flu first week in Dec.
On 10/11/2022 From approximately 09:30AM to 10:00AM I had severe ocular disturbances in both eyes. I could barely see anything. There were flashes of light and floaters. Everything was really fuzzy as well; it was like an extreme version of a migraine aura. There was numbness around my eyes, leading into my temples and back around my ears, but no pain. I could not contact my primary care physician, so I called a local urgent care who suggested I go to the emergency room. I then spoke with my neurologist who also urged me to go to the emergency room. I went to a local emergency room where they inquired about dizziness which I did not experience but there was severe disorientation. It took around 30 minutes for the experience to end. The last 10 minutes, the sensations were dissipating. At the emergency room, they did blood work and other tests to rule out issues. They were unable to conclude a cause of this issue but did suggest it might be due to the vaccine.
Patient inadvertently received vaccine after published expiration date. Moderna Company analyzed vaccine and advised lot 007B21A maintained activity needed to protect against covid 19 on date vaccine was administered. Also patient did not call in to complain of adverse event.  This is administration error with no adverse event.
patient stated that she had a migraine with nausea and vomiting for 5 days
2/23/2017 - received a phone call from my mother while I was at work. The baby had turned blue and quit breathing during her nap. My mother turned her stomach down over her arm and ran to my grandmother in the next room (retired RN). Before my grandfather could call for an ambulance, my grandmother/mother got patient breathing again by dipping her bottom in water. I went home and took the baby to the hospital where the ERMD called the event a BRUE (brief resolved unexplained event) and stated that she was low risk for SIDS and sent us home.
I AGREE THAT I RECEIVED THIS SHOT IN MY LEFT ARM.  ON 12/31/19 I WOKE UP IN THE MORNING AND FOUND MY LEFT ARM WAS SWOLLEN, PAINFUL, FEVERISH, HAD A RED STREAK FROM SHOT ENTRY 6 INCHES LONG & 2 INCHES WIDE DOWN TO MY BICEP, AND AN EGG SIZE KNOT IN MY BICEP. I TOOK PAIN MEDS AND APPLIED LINIMENT TO MY BICEP. I LOOKED UP SIDE AFFECTS FOR THE SHINGLES SHOT ONLINE AND FOUND MY SYMPTOMS WERE VERY SIMILAR. THE INFORMATION TOLD ME TO CONTACT VAERS. AS OF TODAY MY SYMPTOMS HAVE DIMINISHED, BUT ARE NOT COMPLETELY GONE.
I received first HPV vaccine 2/2/16 & second HPV vaccine 7/6/6/2016. A couple months following I noticed these symptoms: severe persistent headaches, extreme fatigue, abdominal pain, food intolerance, sore throat in the mornings, multiple canker sores@ one time, hair loss/bald spot, yeast infections, change in menstrual cycle, heart murmur, teeth enamel missing.
Pt given a Zostavax instead of Varivax at age 1. Error found at approx 5:00pm on 2-23-07. HD #10 aware. No treatment advised. Pt mother notified on 2-26-07. Information has been received from a registered nurse concerning a 12 month old white female with no allergies or medical history who in the AM of 23-FEB-2007 was inadvertently vaccinated SC in the right leg with a first dose of Zostavax (lot # 656606/0033U) instead of dose of Varivax. Other concomitant vaccination at the same time included a first SC dose in the left leg of measles MMR II (lot # 645654/0235F), a first IM dose in the right leg of hepatitis A vaccine (inactive) (lot # 656320/1281F), a third IM dose in the left leg of pneumococcal 4 (PREVNAR) ( lot # 808674F). There was no illness at the time of vaccination. Unspecified medical attention was sought . At the time of the reort no symptoms had been reported. It was reported that the product confusion was ruled out and that this event occurred due to human error. There was no product quality complaint involved. Additional information has been received from the registered nurse who reported that the mother stated the child developed a 101 degree temperature two days after the vaccination, on 25-FEB-2007, which lasted one to two hours. On the third day after vaccination, two to three small red spots at the injection were noted. In one to two days, the spots were gone. As of 20-MAR-2007, no other reactions were observed. No diagnostic laboratory tests were performaed. There was no adverse events following prior vaccination. No further information is expected.
Child received PENTACEL, PREVENAR, GENHEVAC B, and ROTATEQ on 5/4/09. On 5/5/09 child dev'd factile fever and red maculopapular rash on chest/back/face/abdomen which subsequently resolved.
Patient came in very anxious.  She stated that she did not want the vaccine, but her job was mandating it.  After receiving her vaccine, she complained of feeling weak and faint.  We checked her manual BP and it was 168/92, HR 93.  EMS was called because she appeared to be slumping over, but remained alert and responsive during entire episode. Vitals done by EMS were as follows: 153/85, HR 95, O2 sat 100% on RA.  Fingerstick reading 114.
Patient received 0.25 mL of Bivalent dose instead of 0.5 mL/wrong dose for Bivalent Vaccine booster dose (underdose)/Patient was administered an invalid dose of Moderna COVID-19 bivalent booster; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received 0.25 mL of Bivalent dose instead of 0.5 mL/wrong dose for Bivalent Vaccine booster dose (underdose)/Patient was administered an invalid dose of Moderna COVID-19 bivalent booster) and NO ADVERSE EVENT (No adverse event) in an elderly 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) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient received 0.25 mL of Bivalent dose instead of 0.5 mL/wrong dose for Bivalent Vaccine booster dose (underdose)/Patient was administered an invalid dose of Moderna COVID-19 bivalent booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received 0.25 mL of Bivalent dose instead of 0.5 mL/wrong dose for Bivalent Vaccine booster dose (underdose)/Patient was administered an invalid dose of Moderna COVID-19 bivalent booster) 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 assessment was provided for ACCIDENTAL UNDERDOSE (Patient received 0.25 mL of Bivalent dose instead of 0.5 mL/wrong dose for Bivalent Vaccine booster dose (underdose)/Patient was administered an invalid dose of Moderna COVID-19 bivalent booster).    No concomitant product reported by reporter.  It was reported that nurses had no standing order other than what they had for second booster, when first administering bivalent boosters. So they assumed the same dose as the second booster and administered 0.25 ml instead of 0.5 ml to uncompromised adults. It was reported that CDC had recommended to re-vaccinate the patient with a full dose of 0.5mL.  No adverse events were reported.  No treatment medication reported by reporter.
82 year old female with a PMH of CAD, HTN, HLD. Received Decadron,Remdesivir and Barcitinib. Ended up going to the ICU for shock and VT arrest.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored ZOSTAVAX 19400 PFU, lot # M001746 with expiry: 17-APR-2017, (dose, route and anatomical location not reported), which had a temperature excursion of 31 degree Fahrenheit for 1 hour 30 minutes. No adverse effects reported. No further information provided. Additional information is not expected as the reporter did not give consent for follow up.
Patient is a 62 y.o. male with past medical history significant for DM type 2, OSA, and bipolar who presented to ED with right leg swelling. Patient reports he noticed right leg swelling since 6/4. The entire right leg is swollen. He endorses pain to the leg due to the swelling. He did have a fall from bed onto his knee on 6/4 but denies injury.  Diagnosed with Lower leg DVT (deep venous thromboembolism), acute, right.
Information has been received from a registered nurse and the consumer (patient's father) concerning a 10 week old male with no pertinent medical history or known drug allergies who on 02-APR-2008 was PO with a 2.0 ml dose of ROTATEQ (lot# 659915/0015X). There was no concomitant medication. On that same day in the evening, the patient experienced vomiting. There were no other symptoms or treatment information noted. The father notified the physician's office by phone for medical attention. No labs or diagnostic studies were performed. The patient's vomiting persisted. There was no product quality complaint. Additional information has been requested.
-slight fever -headache -body aches -chills -fatigue -nausea -diarrhea
FEVER; MORE THAN 1 SHOT; This spontaneous report received from a parent concerned a 20 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included autism .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021 15:00, the subject experienced more than 1 shot. On 09-APR-2021 19:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 10-APR-2021, and the outcome of more than 1 shot was not reported. This report was non-serious.
Elevated her blood sugar; Enhanced her sensitivity to her allergies; Asthma attack; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing, hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. She reported that vaccine elevated her blood sugars, enhanced her sensitivity to her allergies and she had an asthma attack, on unknown date. She was diabetic when she came home from being administered that first dose, she wanted to know what she was supposed to be eating so she always checks her blood sugar that day her blood sugar was 210 which was raised quite a bit from her normal blood sugar level of 150. The day after she was administered the first dose of vaccine, she also had high blood sugars the whole day. Usually when she got up in the morning, she was on special product that keeps her blood sugar low-special product name, lot, NDC, expiry was not provided. The blood sugar test that she took was 150 and then it was later on it was 181 so she could not get her blood sugars down until later that day and not until she called the doctor's office and they advised her to drink a lot of water, which she did and brought the blood sugars down that way. The patient underwent lab tests and procedures which included blood glucose abnormal: 150 Her normal blood sugar level, blood glucose abnormal: 210 which was raised quite a bit from her normal blood sugar, blood glucose abnormal: 150 Blood sugar test that she took was 150 and then it was later on it was 181, blood glucose abnormal: 181. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Left-side numbness, swollen tongue, difficulty swallowing, rapid heart beat, increased blood pressure and dizziness.
This non-serious spontaneous case, initially received from a pharmacist on 14-Mar-2018, concerning a 56-year-old adult, female patient. The patient's medical history and concomitant medications were not reported. On 06-Feb-2018, the patient was administered with AFLURIA (TIV) with foreign particles floating in syringe (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: XT33908 and expiry date: 30-Jun-2018). This case was associated with PTC (product technical complaint) reference number: PR485504. It was reported that, the patient did not experience any adverse event. Follow-up received with IRD 16-Apr-2018: Updated age at vaccination (in patient tab). Added start date of vaccination (in product tab). Added start date for 'drug administration error' in the event tab. Upon external review, it was realised that the event coding for the event was incorrect in the event tab. Hence, the LLT for the event (Particles in the AFLURIA pre-filled syringe/[Four patients were administered vaccine with] foreign particles floating in syringe) was corrected from 'product contamination particulate matter' to 'particle present in liquid product' in the event tab. The narrative was amended accordingly.
No sx in 1st 24 hrs p/immun; pt found dead in crib on morning of 19SEP91 approx 48hrs p/vax; SIDS dx p/exam in ER @ Hosp & autopsy;
Weakness; Arm is still very sore; Extremely tired/Fatigue; Headache; Muscle pain; Chills; Joint pain; Fever never got over 99.9; unwell; Nausea; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 25Feb2021 (Lot Number: EN6198) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On unspecified dates in 2021, the patient experienced weakness, arm is still very sore, extremely tired/fatigue, headache, muscle pain, chills, joint pain, fever never got over 99.9, unwell, and nausea. The patient still had weakness, arm was still very sore, extremely tired and fatigued, feels very unwell and weak. The patient's headache, muscle pain, chills, joint pain, fever, and nausea went away. The outcome of headache, nausea, muscle pain, chills, joint pain, and fever never got over 99.9 were recovered on unspecified dates in 2021 while the remaining events were not recovered.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On 26-MAY-2015, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 (lot number, dose and route were not reported). No adverse experienced were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt received vaccine 09/10/09 from employee health. On 09/14/09 pt developed diffuse arthralgias, rash, fever and SOB. She presented to her PCP where medrol dose pak was prescribed with some relief. On 09/21/09 she was unable to get out of bed on her own power due to severe arthralgias. She reported to her PCP who diagnosed her with serum sickness.
Extreme fatigue; self-injurious behavior; aggressive; extremely irritable for 7 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 10 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Nov2021 15:00 (Lot number: UNKNOWN) at the age of 10 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "DMDD" (unspecified if ongoing); "GAD" (unspecified if ongoing); "ASD" (unspecified if ongoing); "allergies: Artificial dye" (unspecified if ongoing), notes: known allergies: Artificial dye. Concomitant medication(s) included: ZOLOFT; LITHIUM OROTATE; RITALIN; INTUNIV; MAGNESIUM. The following information was reported: FATIGUE (non-serious) with onset 10Nov2021 15:00, outcome "recovering", described as "Extreme fatigue"; SELF-INJURIOUS IDEATION (non-serious) with onset 10Nov2021 15:00, outcome "recovering", described as "self-injurious behavior"; AGGRESSION (non-serious) with onset 10Nov2021 15:00, outcome "recovering", described as "aggressive"; IRRITABILITY (non-serious) with onset 10Nov2021 15:00, outcome "recovered" (Nov2021), described as "extremely irritable for 7 days". Therapeutic measures were taken as a result of fatigue, self-injurious ideation, aggression, irritability with Magnesium, Epsom Salt bath, Pure Body detox.  Additional information: Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine and was not diagnosed with COVID-19. Since the vaccination, patient not been tested for COVID-19. Patient reported very difficult days at school and home. The pediatric vax contains tromethamine/tromethamine hydrochloride. Patient read that it could interact with stimulant medications, lithium and should not be given to people with dye allergies.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Fatigue; Slight sore arm; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in the left arm on 27Mar2021 at 09:45 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 28Mar2021 at 07:00, the patient experienced fatigue and slight sore arm. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the adverse events. The clinical outcome of the events fatigue and slight sore arm were resolving at the time of this report.    No follow-up attempts are needed; information about lot number cannot be obtained.
Pt recv vax 07Aug97 & Sept97 pt exp joint pain of fingers,knees,elbows,shoulders & neck.Pt to rheumatologist who felt  he had "inflammatory arthritis of unclear etiology". Lab eval sedimentation rate of 20; neg ANA & RP.
Skin: left outer deltoid: approx. 2 inch diameter raised erythematous area. Feels warm to touch, firm flat nodule. No fluctuance, no blisters.
Patient was given immunization in right upper thigh. Parent stated it was red at the site for about one week and then blistered and drained over last few days. Given BACTROBAN for 7 days.
Starting 10/26/2021, I woke up feeling generally unwell. I slept poorly and felt the oncoming of an illness. It was very mild and my daughter and I went to get tested for COVID-19. We tested positive for COVID-19 and were isolated for 10-12 days. We both felt lethargic and had some sinus issues, but no fever. It was getting better as time went by. It wasn't until January that I started feeling extreme exhaustion to the point where I would need 1-2 (3) hour naps just to function. Recently I finally saw my doctor (3-4 weeks ago) and was diagnosed with Epstein Barr Re-activation. Also, they thought I could be experiencing long COVID-19 symptoms. I'm also experiencing memory issues and I feel like I have lost time.
A few days after the administration of the booster, I developed pain at the inection site in my upper right arm. Since that time the pain as increased. It radiates up to my shoulder and down to my wrist. It has affected my range of motion. I now have difficulty dressing. I often wake up at night with the pain. I am awaiting insurance since I started a new job. I have not been seen yet by a doctor. I know they will order xrays. I cannot afford that out of pocket expense at this time. I have to wait another month. I have been taking Naporxan 660 mg daily and applying Valteran gel on the affected areas of my arm. I plan on seeing a doctor as soon as I get my insurance.
This spontaneous report as received from a consumer refers to a her daughter, a female patient of unknown age. The patient was vaccinated (route not reported) with dose 1 GARDASIL in December 2011 and she received her second dose in February 2012, but she has not received her third dose yet. No other co-suspects were reported. No concomitant medications were reported. No adverse event involved. Additional information has been requested.