chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received phone call from pt's mom 06/20/02 c/o swelling of left thigh from knee to top of thigh since shortly after vaccine was administered the previous day at left anterior left thigh. No fever, no redness. Advised mom to bring pt in for eval but she did not do so. A follow-up call to pt's home the next day revealed that the swelling was subsiding.
per patient, new onset sneezing, running nose, headach, pain around eyes and check bones, chest and shoulder tightness. No visible symptoms at present, he seemed to indicate the symptoms were ongoing today. However he described the symptoms as lasting about a week when interviewed earlier by employee health nurse.  Speaking english as a second language, not sure which duration of illness is correct.
On 03/25/04, tetanus and typhoid given.  Friday night, 03/26/04, felt as if coming down with sinus infection.  Fever 101 orally.  Saturday morning, nasal drainage, sneezing, and cough.  Malaise.  Monday, 03/29/04, went to allergist who did not diagnose sinus infection.  Told patient he was allergic to shots received.  Out of work on Monday, Tuesday, and Wednesday (03/29-03/31)
Reported sensation of tongue swelling during post-vaccination observation at 10 minutes. Epinephrine was refused and she was taken to ED for observation where she was given oral dose of Benadryl and Pepcid. Discharged with instructions to return PRN and follow up with PCP. Elevated BP noted.
Immediately had a cold hand in injection arm. Fever and chills began at 10pm same night. Following day fever lessened until 4pm. Then major chills and fever all night. Did not take temp till next morning.  At 10:30 am on 12/31/21 temp was 98.8 which is high for me.
Chills at 12 hours after shot.  Abdominal aches around the rib cage and gut starting 48 hours after shot.  Aches were severe for 14 days, moderate for 12 additional days, mild for 10 additional days.  Treated abdominal pain with Advil.  Shortness of breath after mild exertion - like walking the dogs around the block.  Shortness of breath still persists today after 5 weeks.  I am concerned the shortness of breath may be due to a PE blood clot.
Presented in office with vesicular rash on trunk ext. Dx varicella >50pox.
Breathing problems at times; Does not feel secured; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Breathing problems at times) and EMOTIONAL DISORDER (Does not feel secured) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 046B21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Depression, Anxiety and Gastrointestinal disorder NOS.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Breathing problems at times) and EMOTIONAL DISORDER (Does not feel secured). At the time of the report, DYSPNOEA (Breathing problems at times) and EMOTIONAL DISORDER (Does not feel secured) outcome was unknown.            No concomitant and treatment were not  reported by reporter . patient did not remembered  reporting negative adverse events .   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Follow up information included no new information.
significant asthma; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; manufacturer unknown), for COVID-19 immunization, reaction(s): "inflammation"; Covid-19 vaccine (booster dose # unknown, manufacturer unknown), for COVID-19 immunization, reaction(s): "inflammation". The following information was reported: ASTHMA (non-serious) with onset Nov2023, outcome "not recovered", described as "significant asthma". Therapeutic measures were taken as a result of asthma.
Ears ringing; Light headedness; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ears ringing) and DIZZINESS (Light headedness) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2022, the patient experienced TINNITUS (Ears ringing) and DIZZINESS (Light headedness). At the time of the report, TINNITUS (Ears ringing) and DIZZINESS (Light headedness) outcome was unknown.            Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.
Information has been received from a nurse concerning a 19 year old female who received all 3 doses of GARDASIL (on 27-DEC-2006 was vaccinated with the first dose, on 05-MAR-2007 with the second dose and on 12-JUL-2007 with the third dose) and at an annual check up at obstetrician's office, she tested positive for an HPV infection.  It was unknown if the patient sought medical attention.  Additional information has been requested.
Patient received her first dose of Pfizer today (7/30/21).  Five minutes after administration, patient reported feeling very hot and throat closing up.  She said it felt like something was slithering from her brain to her neck.
The pt arrived at the medical center in full arrest. Grandmother had found him struggling for breath in bed. Death certificate received states cause of death: respiratory arrest due to cardiac arrest due to respiratory distress. Other significant conditions noted was a brain tumor.
pt was hyper @ 3:30 by 4:00 had high pitched screaming & fever 103;mom gave APAp 20min later temp 104.6;pt lost consciousness & devel jerking motions;cont x 1-2hr by 730PM was doing fine;
Information has been received from a physician concerning a 7-year-old male with no pertinent medical history or drug allergies who "had received the two doses of varicella virus vaccine live (Oka/Merck)". The last subcutaneous dose of 0.5 ml was "over a year ago". There was no concomitant medication. On an unspecified date, he developed episodes of clusters of blisters. Medical attention was sought via an office visit. The patient' pediatrician states that "these are chicken pox", however it was reported that an infectious disease doctor was not sure if the blisters were chicken pox. On 20-Feb-2008 the patient had IgG and IgM testing performed and had negative results. The patient has been out of school for 6 weeks due to his recent outbreak. The outcome was reported as recovering. No product quality complaint was involved. The physician also reported that the patient's sister developed adverse events following vaccine administration (WAES numbers: 0803USA02974). Additional information has been requested.
Received a first dose of the the Pfizer Covid Vaccine on 8/14/2021.  Came in on 9/4/2021 to receive my second dose and the pharmacist gave me the J&J shot instead of the second Pfizer dose.
Initial report received from a healthcare professional on 03 May 2010: This patient was vaccinated with S-OIV FLUVIRIN, batch no: 101330, intramuscularly, on 03 May 2010. The patient inadvertently received a 0.5 mL intramuscular dose of expired H1N1 vaccine. No adverse effects were noted. The outcome of the event was not reported.
This vaccine should have been administered intramuscular and not subcutaneous.   Patient experienced no adverse reaction.
PATIENT IS 6 YEARS OLD BUT RECEIVED THE DOSAGE FOR 6 MONTHS TO 4 YEARS.
Mom states patient started running a fever a couple of hours after vaccines were given and had a fever for 48 hours. She took child to walk in clinic and they told her to give him BENADRYL, TYLENOL, and ibuprofen. After the fever subsided, he started vomiting and the next day had fever again. On 8/16/17 she took the child to ER and said they told her to follow up with PCP. The child has an appointment on 8/18/17 with PCP. Mom stated that he also has a knot in his left thigh. Mom was told to be sure to keep appointment with PCP and take the child back to the ER if there is any difficulty breathing or if his fever gets any higher.
Intense shivering. Room temperature was mid 60s with plenty of covers on bed. Shivering was strong enough to prevent sleep. Continued off and on for 3 hours then subsided. Shivering was strong enough to disturb sleeping partner.
This spontaneous report was received from a female patient of unknown age, regarding herself. The patient's medical history, concurrent conditions and concomitant medications were not unknown. On 10-JUN-2015, the patient was vaccinated with an expired dose of ZOSTAVAX, one vial, injection (lot number unspecified, expiry date 26-DEC-2014). The patient did not experience any adverse reactions. The patient did not seek medical attention. No product quality complaint (PQC) was involved. No further adverse event (AE) information was provided. Additional information has been requested.
2 year old received flublok quadrivalent today with no reported adverse event; Initial information received on 13-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 years old female patient who received influenza quadrivalent recombinant vaccine [Flublok QIV] today with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Sep-2023, the patient received 0.5 ml  dose (once) of suspect influenza quadrivalent recombinant vaccine, (lot U8058BA: expiray date: 31-May-2024) (formulation, strength not reported) via intramuscular route in the left thigh for Immunization with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  Action taken: not applicable.  Outcome : Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report was received from a physician via a company representative and refers to a 11 year old male patient. On 02-JUL-2015, the patient was vaccinated with the first dose of GARDASIL 9 (left arm, route of administration, dose, lot number and expiry date were not reported) and with a dose of MENACTRA (right arm, route of administration, dose, lot number and expiry date were not reported). On 03-JUL-2015, the patient developed swelling in the left arm (unspecified location of the arm), and then on 04-JUL-2015, the patient developed swelling and redness "along the left jaw side". On an unknown date, the patient was seen in an unspecified emergency room for the symptoms that he developed and two days later, the patient was seen by a physician for a check-up. It was reported that the patient was diagnosed with irritation from vaccine, possible cellulitis from the emergency room and treated with KEFLEX. On an unknown date, reported as two days later, the patient was seen in the physician's office and the site was notably improved. The relatedness between the suspect therapies and the adverse events was not reported. Additional information has been requested.
Rash on outside of both knees that started the day after.  She can not think of anything that may have caused it.  She ruled out coming into contact with something.
Had the vaccine 11:30am. Beginning around 5pm, I began to feel nauseous and have extreme chills. I took Tylenol and felt better until about 8pm. I then began to feel nauseous again and get extreme chills. I vomited multiple times, and was curled up in a fetal position crying from the nausea, headache, and a feeling of pressure in my chest. I ended up going to bed to sleep it off, waking up in a pool of sweat. I felt better the next day.
This case was reported by a consumer and described the occurrence of multiple sclerosis in an adult female patient who received hepatitis B vaccine recombinant (Engerix-B). The consumer reported that "two women" developed multiple sclerosis following the administration of Engerix-B, however, patient identifiers were not provided. A physician or other health care professional has not verified this report. On an unspecified date, the patient received a dose of Engerix-B (dose number not provided). At an unspecified time following the administration of Engerix-B, on an unspecified date, the patient experienced multiple sclerosis. The outcome of the event was not reported. Report received via manufacturer. Multiple sclerosis was assessed as medically serious by manufacturer (OMIC).
At 9:30 PM after the injection her back started itching all over, and looked in the mirror and her back looked like she had the measles.  Left arm down to her wrist she could not move, immobile.  She had to use her right hand to move her left arm, but the pain was intense.   The area where the shot was was swollen.  She took Benadryl and Ibuprofen and went to bed.  The next morning about 9:00 AM the itching had stopped and she was able to move, could not pick it up, but gradually during the day it was back to normal.   The area on her back went up to her neck, but the red marks are still on her back, just under the skin.  They do not itch.  She does have a lot of reactions to medicines, see list.  Her entre back from her neck to almost her waist was covered with the rash.
She was sweating like crazy; Fever; Chills; Rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERHIDROSIS (She was sweating like crazy), RASH (Rash), PYREXIA (Fever) and CHILLS (Chills) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 011L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced RASH (Rash). On 29-Jan-2021, the patient experienced HYPERHIDROSIS (She was sweating like crazy), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (She was sweating like crazy), RASH (Rash), PYREXIA (Fever) and CHILLS (Chills) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. This case was linked to MOD-2021-015178 (Patient Link).
Information has been received from an office manager concerning a 42 year old white female with no allergies or medical history who on 16 Aug 2006 was vaccinated SC in the left arm with a 0.5 mL first dose of MMR II. There was no concomitant medication. There was no illness at the time of vaccination. On 26 Aug 2006, the patient developed a fever and a rash along the entire torso. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. At the time of the report, the patient was recovering. The patient has no adverse events following prior vaccination. A product quality complaint was not involved. Additions information has been received from a medical assistant who reported that on 25 Aug 2006, the patient developed a rash on the limbs and trunk patient recovered on 30 Aug 2006. No further information is expected.
Swelling of lymph nodes for two days under right arm (injection site); fever the night of injection
Moderna COVID-19 Vaccine EUA  The day of the shot I started having difficulty breathing and fatigued. As time went on, it got worse and I had to go to hospital on 03/25.
5 days p/vax pt broke out w/severe hives covering entire body x 6 days;tx- over the counter antihistamine;
Systemic weakness following PREVNAR. Dx: Guillain-Barre Syndrome.
Numbness in left foot, pins and needles in shins, legs & feet, constant charlie horses in calves and feet, anterior shin splints (like growing pains from puberty), severe back ache, weak ankles, balance issues,  gait in step; feet would kick out after 3 minutes on the treadmill and then lock up and was unable to walk (resolved with physical therapy) - all symptoms appeared 7 days after second dose (July), and were tolerable by December 10th, after the booster, all symptoms are back minus gait in step. Feels impossible to stretch legs enough - super tight feeling like my nerves have receded. Taking iburophen and tylenol and nothing stops chronic pain. No health issues, EGK and bloodwork are clean.  33 years old and I feel like an 80 year old man.
Headache, Arthralgia, Fever, fatigue, chills,  Narrative:
INFANT SAW DR ON 10-22-03.  ULTRASOUND OF HEAD ORDERED FOR 10-23-03, JUST TO BE SURE NOTHING WAS IRREGULAR AS BABY'S HEAD WAS SLIGHTLY LARGER THAN SCALE. NO IMMUNIZATION CONTRAINDICATIONS.  IMMUNIZATIONS GIVEN 10-22-03 AT HEALTH DEPARTMENT.  2 1/2 HOURS LATER BABY FOUND UNRESPONSIVE IN PLAYPEN.  RECIEVED REPORT OF PENDING PROBABLE SIDS. Follow up: Autopsy to be mailed upon receipt of payment.
This spontaneous report as received from a pharmacist refers to a 59 year old female patient with allergy to sulfur. The patient had no pertinent medical history.; On 14-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (dose, route not reported, lot # K000326, expiration date 27-FEB-2015). No concomitant medications were provided. The pharmacist reported that the patient experienced "injection site reaction" and a rash across her back which itches on 21-OCT-2014 after receiving ZOSTAVAX. The pharmacist declined the varicella zoster virus (VZV) packet. No treatment was given for the events. No lab diagnostics studies were performed. The patient did not seek medical attention. The outcome of the events was reported as recovering. Additional information has been requested.
Pt. received Covid #1 vaccine. 5 minutes later, experienced, lightheadedness and was diaphoretic. BP 98/67, heart rate 57. Patient was given juice. Pt. states she has vasovagal reactions in the past. After 5 minutes, patient was moved to a quieter area for monitoring. BP 100/74, heart rate 69, other VS stable.  MERT was called for a precaution.  Pt. stable after 20 minutes. 02 sat 100%. A and O x 3. Was released back to her unit.
I woke up in the am to a headache, The headache got worse, I started seeing double, I had a slight fever. as the day wore on I lost my appetite. The next day a could not walk without holding on to the wall, I totally lost my appetite. My vision was double and I could not watch TV without my head feel like I was getting hit in the left side of my head. It took 3 days of none eating and only drinking Gatorade before while laying in bed my fever must of broke, I became soaking wet and had to get out of bed and take a shower. The next morning I started feeing better, but my double vision did not go away, and I still had a nasty headache. On Sunday my headache stopped unless I try to read and I cannot, my double vision has not gone away when I try to read.
Nothing other than some minor arm pain but on the 3rd day, I developed a very runny nose and watery eyes.  Reminded me of spring allergies and lasted 3 days.  I used an antihistamine for the symptoms that helped.  Back to normal after 3 days.
11 yo healthy male, received Tdap & MENACTRA on 1/25/13; had significant swelling. Redness to (L) upper arm starting the next day.
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who was administered dose of GARDASIL (dose and route unknown) on 29-JUL-2013, lot # H021608 expiration date: 13-AUG-2015). No adverse event was reported. This is one of the report from the same source. Additional information is not expected.
Trigger finger in middle finger after second vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 2021 (Lot number: EW0182) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; SINGULAIR. Vaccination history included: Bnt162b2 (Covid vaccine details: product: COVID 19, brand: Pfizer, lot number: EW0161, lot unknown: False, administration date: 28Apr2021, administration time: 11:00 AM, dose number: 1, vaccine location: Left arm), administration date: 2021, for Covid-19 immunization, reaction(s): "Tingling in finger tips after first vaccine.". The following information was reported: TRIGGER FINGER (non-serious) with onset 2021, outcome "unknown", described as "Trigger finger in middle finger after second vaccine". Additional Information: Reporter stated that, Other vaccine (Dose 2) date reported as, 28Apr2021. Facility type vaccine mentioned as, Pharmacy or Drug Store. No other vaccine in four weeks. Other medications taken in two weeks: Vitamins, Syntroid, Singular. Adverse event for dose 1 reported as, Tingling in finger tips after first vaccine on 29Apr2021 which was Recovered with lasting effects. No treatment ae. No covid prior vaccination. No covid tested post vaccination.  Follow-up attempts are completed. No further information is expected.
between 6PM-7PM n/v;temp up to 102.7 then on 1OCT96 t101.7, vomited 5-6x all noc;given clear liquids & pepto bismol;temp 1OCT96 9AM 98;last vomited 1OCT96 @ 6AM;
Patient, was administered initial dose of Pfizer vaccine per proper protocol on 11/29/21 at 2:19 pm at facility, during the weekday COVID Vaccination clinic.  At approximately 2:30 pm, it was reported to me, RN and clinical lead, that the patient began experiencing symptoms of dizziness. The three nurses present in the Pfizer vaccination area, Provided the patient a bottle of water and continued to monitor her closely. I was drawing vaccines at that time but immediately responded to the patient to obtain vital signs while the nurses contacted EMS. An elevated BP and HR were noted. Vitals were reported to EMS The patient was able to speak calmly and describe her symptoms of lightheadedness, warmth, and mild tightness of her throat. The nurses in the Pfizer area had an Epi Pen ready if needed, assisted by pharmacist. The nurses and I continued to keep the flow of the clinic in progress. I checked on the patient a short time again. She remained closely monitored by the three nurses in the area. She reported that she was beginning to feel less lightheaded and that her throat was feeling better. We were concerned that EMS had not yet arrived at 2:45 pm. Contacted EMS a second time, as did another two employees. I returned to assess the situation and the patient?s symptoms had increased. Epi administered x1 at 2:55 pm. I obtained a second set of vital signs. EMS arrived at that time. Patient was able to speak with EMS members. Patient transported from facility via stretcher without incident at approximately 2:10 pm.
FEVER FOR 10 DAYS. HIGHEST 103.6 ON DAY 7.
Headache INJECTION SITE PAIN, BODY ACHES, FATIGUE, CHILLS Narrative: SYMPTOMS LASTED APPROX 3 DAYS