chrisvoncsefalvay/vaers-outcomes huggingface dataset:
39-year-old ADA WM who was in his usual state of excellent health until he was diagnosed with Type I diabetes mellitus in September 2006. Service member received his Hepatitis B (2) vaccination in Jan 2005. He denies any unusual vaccine site reactions or unusual or prolonged systemic symptoms within first week of vaccine receipt. He received his first 4 AVA immunizations between Mar and Oct 2004. He noted some soreness and a small nodule lasting about 2 days following each vaccine, but denies any unusual or persistent vaccine site reactions or systemic symptoms. In April 2004, service member received his SPV (2) in his upper left arm (15 jabs). He recalls that his smallpox vaccine site progressed as expected and was assessed as a 'take'. He denies axillary lymphadenopathy. He does not recall any unusual or persistent vaccine site reactions or systemic symptoms. Looking back, the first symptoms that the service member can recall are blurry vision and fatigue. The blurry vision was noted around August 2006. Service member attributed visual changes to exposure to cigarette smoke affecting eyes (had just re-started smoking) and did not seek medical evaluation. He began noting an increase in fatigue around July 2006. In late June, his unit was ordered to stop PT in order to concentrate more on Deployment. They were required to work long hours. When he noted feeling more fatigued, he attributed it to working long hours and the lack of exercise. Around August, he was waking up 'fully changed', but by 1400 or 1500, he was 'pooped' and ready for a nap. He rates his energy level as 60-75% using a scale of 0 (=baseline energy level) to 100 (=no energy/bedridden). He later developed polydipsia and polyuria which began around the middle of August 2006. He did not experience weight loss or paresthesias. (Between June and Sept, he had actually gained about 15-20 pounds after regular exercise was discontinued.) In mid-September 2006, service member had lab work done as part of predeployment process and SRP. His glucose levels in his urine and blood were elevated. He was diagnosed with diabetes a few days later (after the weekend). He was initially started on oral medications and taught self blood glucose monitoring as an outpatient.  His blood glucose levels were running in the low to high 300-400s. His pills were increased and his BGs levels decreased to the 200-300 range. About 1 week after diagnosis, he was evaluated by an endocrinologist who had him complete additional labwork. Because he was GAD antibody positive, which is consistent with Type 1 diabetes, his oral medication were discontinued and insulin was initiated. Service member has a family history of Type 1 diabetes (brother-diagnosed around age 10). He denies symptoms of viral or bacterial infections prior to symptom onset.
My daughter had the series of GARDASIL vaccination on 10/3/2007, 12/14/2007 and 4/25/2008. Starting in October, 2008 she started having pain in her feet and by the end of the college year May/June 2009 the pain had spread to her ankle and knee joints. Later in June the pain had spread to all the joints in her body, to the point she had difficulty getting out of bed in the morning. She has since been diagnosed with rheumatoid arthritis. I heard that one of the possible side effects of the GARDASIL vaccinations is auto-immune diseases, so I thought this should be reported.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. On 13-JUL-2018, the patient was vaccinated with properly stored but expired PROQUAD (rHA) 1 dosage form (DF) lot # N001490 expiration date 12-JUL-2018  (dose, route of administration and anatomical location were not provided) for prophylaxis. Concomitant therapies included sterile diluent (lot# and expiration date were not reported). No adverse effects were reported.
Pt. received 5 vaccines with 3 in the left deltoid and 2 vaccines in the right deltoid. After giving the last two vaccines Polio and HPV at 1156am in the right deltoid. The patient began to feel dizzy, nauseated, sweaty, weak. Vitals were taken at 11:57. BP 79/ 57 p- 63 O2 sats 99% temp.  97.8 Vitals were retaken again by provider and she retook them at 12:04 pm 96/63 p- 71, O2 sats 99%. Vitals retaken again at 12:07 pm, BP 99/66, p- 69, O2 sats 99,  temp 97.9. Provider stated patient is at baseline. Her baseline vitals are 99/58. Patient ambulated out of the clinic with mother with the steady gait.
pneumonia; uti; still got flu; Initial information received on 14-Dec-2022 regarding an unsolicited valid social media serious case received from a consumer/non-healthcare professional (hcp).  This case involves an unknown age and unknown gender patient who experienced pneumonia, uti and still got flu after 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 suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, dose: unknown) (lot number and expiry date: not reported) via unknown route in unknown administration site for Flu (Influenza).  On an unknown date, the patient developed serious events of pneumonia (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  On an unknown date, the patient developed non-serious events of uti (urinary tract infection) and still got flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported, take of yourself & don't be embarrassed to wear a mask in crowded situations.. It is unknown if the patient experienced any additional symptoms/events. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (pneumonia, uti, still got flu).  At time of reporting, the outcome was Unknown for all events.; Sender's Comments: Sanofi company comment dated 20-Dec-2022: This case involves an unknown age and unknown gender patient who experienced pneumonia, uti and still got flu after receiving vaccine INFLUENZA VACCINE. Additional information regarding condition at the time of vaccination, concomitant disease or risk factor, medical history, vaccination and lab investigations excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
This spontaneous report as received from a health care professional refers to multiple unspecified patients of unknown ages and genders. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # N000238, expiry date: 25-OCT-2019, lot # N001348, expiry date: 31-OCT-2019) (incorrect product storage). The vaccines were stored at a temperature of 9°C (degree celsius) to 25°C (10.4°C) for 1 Hour 22 Minutes. Previous temperature excursion was 9°C to 25°C (13.1°C) for 1 Hour 39 Minutes. Data logger was involved. No adverse effects reported.; Sender's Comments: US-009507513-1708USA011296:
I am currently experiencing ?Moderna arm.? I have two blotchy red areas on my upper right arm, am experiencing non-injection site pain and soreness. This started on or about 4/24/2021, less than 72 hours after the second dose of my vaccine.
pt recvd vax 1JUN93 & had fever over 104 since shot; had some spasms-sl jerking;
101F fever,  chills, extreme headache, extreme shivering, entire body muscle fatigue, muscle spasms
Next day was red around injection site, then became more raised and continued to spread slowly, on 10/11/17 area became pruritic and painful. Patient advised to apply cold compress, topical steroid cream or calamine, and to give oral BENADRYL.
This spontaneous report as received from a Licensed Practical Nurse (L.P.N.) refers to a patient of unknown gender and age. The patient was respectively vaccinated with the first, second and third dose of GARDASIL, injection (dose and lot numbers not reported) intramuscular on the following dates: 03-MAY-2012, 22-SEP-2012nad 24-NOV-2012. No adverse effects reported. Additional information has been requested.
Gave liquid vial without reconstituting with powder vial; Gave liquid vial without reconstituting with powder vial; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 30th August 2021, the patient received Menveo. On 30th August 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The age at vaccination was not reported. The nurse gave a patient the liquid Menveo vial without reconstituting with the powder vial. Shortly after that, the nurse gave the same patient a fully reconstituted dose of Menveo, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
really strong reaction to that; for three days, she was in bed; awake 6 hours in 3 days/laying in bed; terrible shakes; muscle jerking/breasts are jumping up and down; couldn't eat; nauseous; wasn't just chills; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (really strong reaction to that), HYPOKINESIA (for three days, she was in bed), SOMNOLENCE (awake 6 hours in 3 days/laying in bed), TREMOR (terrible shakes) and MUSCLE TWITCHING (muscle jerking/breasts are jumping up and down) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (really strong reaction to that), HYPOKINESIA (for three days, she was in bed), SOMNOLENCE (awake 6 hours in 3 days/laying in bed), TREMOR (terrible shakes), MUSCLE TWITCHING (muscle jerking/breasts are jumping up and down), FEEDING DISORDER (couldn't eat), NAUSEA (nauseous) and CHILLS (wasn't just chills). At the time of the report, VACCINATION COMPLICATION (really strong reaction to that), HYPOKINESIA (for three days, she was in bed), SOMNOLENCE (awake 6 hours in 3 days/laying in bed), TREMOR (terrible shakes), MUSCLE TWITCHING (muscle jerking/breasts are jumping up and down), FEEDING DISORDER (couldn't eat), NAUSEA (nauseous) and CHILLS (wasn't just chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was reported. Patient  had an antibody test three weeks ago on 01Nov2021, but it said "20 plus".
2nd booster COVID Moderna at pharmacy.  Light headedness Brief episodes of vertigo Results of this is nausea and unsteadiness Emergecy Room
Red rash, warm, swollen, slightly tender to touch - Cellulitis. Knot at injection site. Hospitalized for pneumonia (separate?).  10/18/2007 MR received for hospital DOS 9/27/2007-10/01/2007 for D/C DX:  Cellulitis, L Arm following Shingles injection.  Possible Pneumonitis.  Possible UTI.   Pt awoke during the night with shaking chills and presented with fever and SOB.  Swelling noted at injection site and pt feels a lump there. Tenderness noted on PE. Pt was txd with abx and released
Pain & swelling with redness started to Rt deltoid 2 hours after injection. 12/11/19 with mod-severe swelling, redness & tenderness to Rt deltoid. Pt has temp 99.86). Tylenol given, Benadryl 50mg one time oral given. Peptobismol for nausea given. Ibuprofen 400mg BID x 10 day, & Benadryl 25 mg BID x 7 days ordered. Daily vitals check.
This spontaneous report has been received from a licensed practical nurse referring to a 12 year old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported. In April 2018, the patient was vaccinated with improperly stored vaccines of GARDASIL 9 lot # N025428 with expiration date of 19-JUN-2020 (strength, dose, route, and anatomical location were not provided), RECOMBIVAX HB, VARIVAX and M-M-R II (strength, dose, route, anatomical location and lot/batch# were not provided) for prophylaxis. The vaccines were exposed to a temperature excursion below 32 degree Fahrenheit (31.1 degree F) for 8 hours and 27 minutes, also between 32 degree F to 35 degree F (32.5 degree F) for 4 hours and 33 minutes, which were called by a data logger. No adverse events were reported. Product quality control issue was not involved. This is one of the 46 reports from the reporter.
Employee vaccinated with FLUBLOK. Ten minutes post-vaccination she developed hives, facial/upper body flushing and slight edema as well as increasingly persistent cough, raspy voice and vomiting.
Within 30 min of shot, starting feeling itchy tongue and throat.  Drank water and within a few minutes got a full body heat flush and starting shaking all over.  Heart beating fast and having some pain in chest.  Drove to her work place and was assessed by MD and RN on staff.  BP was 220/120, pulse over 100.   She took a Claritin and was monitored in the work place.  She became lethargic and chest pain continued so she went to the closest Emergency Room.
Pt. believed to get varicella from sibling that received MMRV on 9-11-20 Pt fully immunized.
This spontaneous report as received from a nurse practitioner refers to a 40 year old female patient. Medical history and concurrent conditions were not reported. On 25-JUL-2014, the patient was vaccinated with (Oka/Merck) VARIVAX, subcutaneous, 1 single shot. Dose, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. On 01-AUG-2014, the patient developed herpes zoster along the trunk of one side after receiving (Oka/Merck) VARIVAX. The outcome of herpes zoster was unknown. No lab diagnostics studies were performed. The event was treated with VALTREX. The patient did seek medical attention. Additional information has been requested.
Diarrhea Numbness to Right hand and feet and sore throat Narrative: Employee had above symptoms for three weeks. Symptoms resolved without any medical intervention.
We had a pediatric member present as a walk-in to the Adult Covid Vaccine Clinic on 11/30/21, the father requested a Pfizer vaccine and in an attempt to help our registration staff accommodated, unfortunately the member is 11 years old and was given the adult Pfizer dose.    Member completed her 15min wait period without complication.    The error was discovered after the clinic closed, discussed case with infectious disease, no change in plan of care other than increased monitoring for side effects, phoned Parent and updated regarding wrong dose being provided and signs/symptoms to monitor for.  The members mother was understanding, pediatric 2nd dose booked per protocol.
Patient called today stating with in one hour her upper arm/shoulder and axillary region became very swollen.  It is currently still swollen even with taking advil several times daily.  She had an appointment with her PCP Monday 12/6/2021.
muscle pain of lt deltoid muscle;vesicular herpetic rash over distribution of the palmar/radial aspect of lt thumb lasting 3wk duration partially resolved on 7NOV96;
Numbness of the face.  Numbness started to subside by 2:30 pm.
MENSTRUAL CYCLE LASTED 10 DAYS; FEVER; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no illness at the time of vaccination, no known allergies. with the existing information. in the past 14 days, patient had not been in close contact with anyone who tested positive for covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A, and expiry: JUN-2021) .5 ml, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, Laboratory data included: Body temperature (NR: not provided) 97.5 F. On 13-MAY-2021, the subject experienced fever. On JUN-2021, the subject experienced menstrual cycle lasted 10 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and the outcome of menstrual cycle lasted 10 days was not reported. This report was non-serious.
Patient refers to itching and rash. Refused treatment. The event occurred approximately 35 minutes after administration of vaccine.
Patient had 3 seizures at home hours at receiving the second vaccine shot. First one occurred while sitting on the couch. She fell on the floor and started convulsing/shaking. That lasted about 15 seconds. This occurred at approx. 5:30 p.m. 30 minutes later, patient had another seizure while heading to the kitchen. She stated she couldn't see and fell. She then started shaking and her eyes rolled back. The last one occurred while she was in bed trying to relax after the previous 2 seizures had occurred. Same effect occurred.
Patient felt nervous about getting vaccinated. upon administration of Janssen booster vaccine, he felt lightheaded, dizzy, sweating  when he started getting up and almost fell forward. He was immediately caught by family member present and sat down. He was given water and pedialyte and after 10 minutes started feeling better. No medical intervention needed. Upon follow-up , patient felt normal that evening.
received the flu shot, still came down with the flu. ugh; Initial information was received on 03-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a patient.  This case involves a patient with unknown demographics who received the Influenza vaccine flu shot, still came down with the flu.  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) (with unknown strength, dose, route, administration site, lot number and expiration date) for prophylactic vaccination and still came down with the flu (influenza) (unknown latency).  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.
headache; Received the meningococcal B, Bexsero in the same right deltoid as the Covid vaccine and then received Menactra in the left deltoid today; received 0.5 ml instead of 0.3 ml of the Pfizer covid vaccine; This is a spontaneous report from a contactable other health care professional (Nurse).  A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0150; Expiration Date: Jul2021), via an unspecified route of administration, administered in Deltoid Right on 29Jun2021 15:04 as dose number unknown, 0.5ml single for covid-19 immunisation and meningococcal group b rlp2086 (MENINGOCOCCAL GROUP B RLP2086, Batch/Lot Number: ABXB29BA; Expiration Date: Jun2022), via an unspecified route of administration, administered in Deltoid Right on 29Jun2021 as 0.5 mL, single for an unspecified indication and meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA, Batch/Lot Number: U6690AB; Expiration Date: 23Aug2021), via an unspecified route of administration from 29Jun2021  to an unspecified date, at 0.5 mL for an unspecified indication. The patient medical history and concomitant medications were not reported. No prior Vaccinations (within 4 weeks) other vaccinations within four weeks prior to the first administration date of the suspect vaccine. It was reported that On 29Jun2021 the patient received 0.5 ml instead of 0.3 ml of the Pfizer covid vaccine and experiencing headache within an hour of administering. Caller just administered the Pfizer Covid vaccine to a (withheld) and gave her 0.5mL instead of 0.3mL, a vaccine error. They want to see if there is any concerns and what to tell mom about the vaccine error. States patient also received other vaccines today along with the Covid vaccine. Received the meningococcal B, Bexsero in the same right deltoid as the Covid vaccine and then received Menactra in the left deltoid today. No problems with vaccines in past and none given in the past 4 weeks. When providing product details for the Covid vaccine, caller takes off her glasses and provides details. Causality not provided. States patient has not been to emergency room or seen physician and is still there and doing just fine at the moment, hopefully. No further details provided. Yes patient took additional Vaccines Administered on Same Date of the Pfizer Suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect. Reporter seriousness for gave her 0.5mL instead of 0.3mL; vaccine error, received other vaccines today Medically significant. The outcome of the event was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Site: Itching at Injection Site-Mild, Additional Details: Pressure radiating up the neck to occipital ridge to forehead
Per NP pt had urticaria, facial swelling and eye swelling. Pt was treated at hospital. Was given epinephrine, BENADRYL, and prednisone. Pt returned to clinic for ER follow up.
Patient had a positive COVID-19 PCR on 10/14/2021 after receiving three doses of Pfizer vaccine
p/vax pt exp chest tightness & dyspnea especially w/exertion & myalgia of lower extremities;pt given 24hour rest; pt has persistence of these symptoms & unable to participate in daily physical fitness activities due to SOB;sx persist
Leg pain and odd tingling and pain in right hand and arm.  Dizziness before tingling happens.