chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician concerning to a 14 years old male patient. It was reported that the patient was "a previously perfectly healthy 14 year old boy". Information regarding the patient's medical history and concomitant medication was not reported. On unknown date the patient was vaccinated with the second dose of GARDASIL for prophylaxis, (strength, dosage, route of administration, anatomical location, lot # and expiration date were not reported). On unknown date (reported as 5 days after vaccination), the patient was diagnosed with acute disseminated encephalomyelitis (confirmed by biopsy), additionally, the patient was hospitalized due to the event on an unknown date. The reporter described the acute disseminated encephalomyelitis as severe, with a left hemiparesis and progressive very impressive changes on magnetic resonance images (T2 MRI). His cerebrospinal fluid (CSF), contained two oligoclonal bands, but a massive serologic studies for autoimmune neurologic disease have otherwise been negative. The patient received some intensive steroids and plasmapheresis medication due to the acute disseminated encephalomyelitis. The following test was performed: Biopsy (unknown date): acute disseminated encephalomyelitis. Nasopharyngeal polymerase chain reaction (PCR) (unknown date): positive to rhinoenterovirus. The patient was reported to VAERS, and the reporter stated that some studies such as antibody index on his CFS and serum, which required determinate specific levels of human papillomavirus (HPV) quantitative immunoglobulin G (IgG) and serum, could help to determine the cause of acute disseminated encephalomyelitis. The reporter stated he was very aware that the association with GARDASIL, may just was an example of the "post hoc ergo propter hoc fallacy" (after this, therefore because of this). At the time of this report the outcome of acute disseminated encephalomyelitis was unknown. Upon internal review the acute disseminated encephalomyelitis was considered as serious event. The reported did not provided the causality assessment between GARDASIL, and acute disseminated encephalomyelitis. This is an amended report, the correct codification of the suspect therapy is GARDASIL 9.
Hives/Rash. Various places on my arms, legs, neck, vaginal area. Itchy. Took Benadryl even 6 hours. Lasted 3 days  Tingling in arm in the exact area shot was given started on  3 day after injection.  Nausea and diarrhea started on 3rd day after injection
A family of three came to get the COVID vaccination on 07/18/2021 at 3.30pm. Pt , the 13 year old boy, had the vaccine at about 3.55pm. After the vaccine he was advised to sit for 15 minutes after the IMZ for observation. While I was administering a vaccine to another patient, his dad came running and said his son had a reaction and is having a hard time breathing. Right away I went out to check his condition and found that he was pale and was struggling to breathe lying on the floor. I told my technicians to call 911 and notify the store management . I knew it was time to administer the Epipen and I told his father I will administer it. I administered one Epipen at 4.08 pm, recorded the time and waited for the emergency personnel to show up . After the Epipen was administered Pt's situation became better . The emergency personnel took him out to monitor his vitals.
could not get out of couch; could not go to work; she felt tired; chills; muscle ache; fever; teeth are clatterig; bite side of her tongue; This spontaneous case was reported by a consumer and describes the occurrence of BRUXISM (teeth are clatterig), TONGUE BITING (bite side of her tongue), MOVEMENT DISORDER (could not get out of couch), IMPAIRED WORK ABILITY (could not go to work) and CHILLS (chills) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OXYCODONE for an unknown indication.   On 12-Mar-2021 at 11:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced BRUXISM (teeth are clatterig). 12-Mar-2021, the patient experienced TONGUE BITING (bite side of her tongue). On 12-Mar-2021 at 9:00 PM, the patient experienced CHILLS (chills), MYALGIA (muscle ache) and PYREXIA (fever). On 13-Mar-2021, the patient experienced MOVEMENT DISORDER (could not get out of couch), IMPAIRED WORK ABILITY (could not go to work) and FATIGUE (she felt tired). On 13-Mar-2021, BRUXISM (teeth are clatterig), TONGUE BITING (bite side of her tongue), CHILLS (chills) and PYREXIA (fever) had resolved. On 15-Mar-2021, MOVEMENT DISORDER (could not get out of couch), IMPAIRED WORK ABILITY (could not go to work), MYALGIA (muscle ache) and FATIGUE (she felt tired) had resolved.            No treatment medications were reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
feel prickly; both arms broke out in raised hives and rash; both arms broke out in raised hives and rash; This is a spontaneous report from a contactable consumer (patient). A 49-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration on the left arm on 14Jan2021 at 13:00 at a single dose for COVID-19 Immunization. Medical history included severe asthma, depression, anxiety, sinus problems, and known allergies with Penicillin and intravenous (IV) iodine. Concomitant medications included duloxetine hydrochloride (CYMBALTA) and aripiprazole (ABILIFY).  The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. About 15 minutes after the shot, on 14Jan2021 at 1330 hours, the patient started to feel prickly and both arms broke out in raised hives and rash. Treatment for the events included intramuscular (IM) 50mg Benadryl. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included nasal swab: negative on 14Nov2020. The events resolved in Jan2021.   Information on the lot/batch number has been requested.
On Saturday I felt chills, joint pain, fatigue, light headed. On Saturday checked my temperature, 99F. On Sunday I lost my sense of smell and taste. On Monday, Tuesday and Wednesday I felt so sick, my headache was horrible and I returned to the hospital to get tested. Negative. 7 days later I am still sick and then I decided to go back to get tested again and it was positive.  The symptoms lasted about 2 weeks, lost sense of smell and headache. Really bad headache.
I normally get begin my menstrual cycle every 29 days. After vaccination my next full cycle was only 22 days.
I started getting a sore throat. I tested myself on Thursday evening and i was negative. The next day I received a call from my friend who stated that she had tested positive for COVID-19 so I retested the next day and was positive for COVID-19. I went the next day to the Infusion Center and was given the monnoclonal infusion.
delayed reaction shot site red rash; delayed reaction shot site itchy; delayed reaction shot site swollen; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (delayed reaction shot site red rash), PRURITUS (delayed reaction shot site itchy) and VACCINATION SITE SWELLING (delayed reaction shot site swollen) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced RASH ERYTHEMATOUS (delayed reaction shot site red rash), PRURITUS (delayed reaction shot site itchy) and VACCINATION SITE SWELLING (delayed reaction shot site swollen). At the time of the report, RASH ERYTHEMATOUS (delayed reaction shot site red rash), PRURITUS (delayed reaction shot site itchy) and VACCINATION SITE SWELLING (delayed reaction shot site swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information was provided. Concomitant medication was not provided.
Approximately 11 days after my Moderna Booster shot I broke out in  Large patches of red hives that started at my neck line and quickly spread to my entire body. They were uncontrollably itching and felt hot to the touch, there were raised red hives all over my body.
Booster shot on 1/11/22 Blood pressure went sky high right after injection then dropped very low. Dizziness nausea and threw up, passed out in a sitting down position.   Initual shot on 7/22/21  Reaction after first shot was skin rash 24 hours after the vaccine
Patient reports spread of Petechiae starting on firearms and extending onto his trunk and lower legs and chest/face. Abnormal bruising localized to forearms. Few lesions in his mouth, mainly on tongue. Some bleeding from his mouth, could not identify source. Obtained ultrasound which confirmed no enlarged mass or DVT in (L) upper thigh. Told Patient that Petechia should resolve on its own but if it gets worse he needs to contact his Doctors office.
Arm very very sore; Shoulder is hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm very very sore) and ARTHRALGIA (Shoulder is hurting) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm very very sore) and ARTHRALGIA (Shoulder is hurting). At the time of the report, PAIN IN EXTREMITY (Arm very very sore) and ARTHRALGIA (Shoulder is hurting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was provided.
just had second shot and im Really sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (just had second shot and im Really sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (just had second shot and im Really sick). At the time of the report, ILLNESS (just had second shot and im Really sick) outcome was unknown.            Concomitant product usage were not provided. Treatment details were not provided.
Blood clot in left leg; first noticed on March 17; swelling and pain bad by March 19, called advice nurse who told me it sounded like a blood clot and told me to go to emergency room.
Patient developed a sustained headache after vaccine, that has persisted to this day, though has gotten a bit better
Initial Health Authority report received on 05 Jan 2010: This patient received H1N1 influenza vaccine (manufacturer unknown), on 12 Dec 2009. The patient experienced conjunctival haemorrhage and rash on 12 Dec 2009. Outcome of events were not reported. Follow-up report received from local Health authority on 30 Mar 2010: The patient did not receive FOCETRIA. Therefore, this case became invalid and would be deactivated.
Patient reported feeling light headed 10-15 minutes after receiving the vaccine.  As he stood up from the observation chair he fell to the floor and was caught by the pharmacist before hitting his head.  The patient did not lose consciousness.  The patient was moved to the counseling room under his own power and laid down on the floor with his knees elevated and a pulse oximeter and blood pressure cuff was placed on the patient.  Pulse and blood pressure was normal.  911 was called and responded.  The patient refused the offer to go to the hospital and went home under his own power.
H1N1 vaccine administered to client. Approx. 15 minutes after receiving vaccine, "knot formed" at injection site. No redness @ site.
Pt. started having aches and pain about 5 hours after shots. Temp 103. Loss of appetite. Pain in joints. Could not lift herself out of chair. Swelling and redness in L arm 5 inches x 3 inches in size.
Incomplete course of vaccination; fatigue; headache; shortness of breath; wheezing; This case was reported by a nurse via call center representative and described the occurrence of fatigue in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 1st May 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 1st May 2019, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fatigue, headache, shortness of breath and wheezing. On an unknown date, the patient experienced incomplete course of vaccination. On 4th May 2019, the outcome of the fatigue, headache, shortness of breath and wheezing were recovered/resolved. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the fatigue, headache, shortness of breath and wheezing to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and experienced fatigue, headache, shortness of breath and wheezing. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. Limited information was provided by the nurse practitioner (NP) because the first injection was given by another facility.
Patient lost pregnancy after her first dose of vaccine Patient has had increase in disruption of taste and smell (first starting after her prior COVID infection) since vaccine series.
Red, swollen, sore from injection site to elbow, ROM was bad, couldn't lay on that side, shoulder pain.
FATIGUE, CHILLS, PAIN/SWELLING INJ SITE  Narrative:
Approximately 5 minutes after receiving the vaccine, patient tried to stand up, mother noticed that he looked unsteady, he started to fall, mother caught him, he had a few seconds of twitching, and seemed to pass out. Was conscious after a few seconds.  Seemed dazed, but was responsive and oriented.   vital sign were normal. Patient had some juice, crackers, and water. Was monitored in clinic x 20 more minutes, then felt fine.
Patient had experienced menopausal amenorrhea for 20 months prior to Moderna vaccine. Nine days after the 1st dose of Moderna, pt had a menstrual cycle, and has continued to menstruate monthly since. The 2nd dose of Moderna was administered on 1/15/21. Patient is scheduled for an endometrial ablation.
Information has been received from a female consumer, concerning her 13 year old daughter with no medical history or allergies who on 12-FEB-2007 was vaccinated with the first dose of GARDASIL, the second dose on 30-APR-2007 and the third dose on 07-AUG-2007.  There was no concomitant medication.  The consumer reported that, in August 2007, "not too long after receiving the third dose of GARDASIL", the patient started to have severe stomach pain on her upper left side.  The reporter stated that her daughter's pain level on a scale of 1 to 10 was a 7.  The consumer reported that the patient had blood work, ultra sounds and CAT scans done and they all came back normal.  The reporter stated that the next time the patient saw the physician they may have to "put a scope in her to check out her stomach area".  The patient was not recovered at the time of this report.  The patient sought medical attention with a physician.  No further information is available. This is in follow-up to report (s) previously submitted on 11/14/2008.  Information has been received from a female consumer, concerning her 13 year old daughter with no medical history or allergies who on 12-FEB-2007 was vaccinated with the first dose of GARDASIL, the second dose on 30-APR-2007 and the third dose on 07-AUG-2007.  There was no concomitant medication.  The consumer reported that, in August 2007, "not too long after receiving the third dose of GARDASIL", the patient started to have severe stomach pain on her upper left side.  The reporter stated that her daughter's pain level on a scale of 1 to 10 was a 7.  The consumer reported that the patient had blood work, ultra sounds and CAT scans done and they all came back normal.  The reporter stated that the next time the patient saw the physician they may have to "put a scope in her to check out her stomach area".  The patient was not recovered at the time of this report.  The patient sought medical attention with a physician.  This is an amended report.  The vaccination date of the third dose of GARDASIL now reads 07-AUG-2007 instead of 07-AUG-2008.  No further information is available.
The pt experienced severe headaches from 5/00 to the present, with fatigue and joint pain.
The COVID-19 vaccine administered throughvaccine administrator, between June 25 and July 30 came from the lot number 039K20A.  It was discovered that this particular lot was beyond its frozen expiration date by five (5) up to forty (40) days.  A case was opened with Moderna (Case #: MOD21-126790).  Please refer to this case number if you would like to contact Moderna directly.  Moderna confirmed that the vaccine doses administered maintained the activity necessary to protect against the COVID-19 virus.  Moderna also confirmed there is no danger to anyone's health from receiving a vaccine past its frozen expiration date.  No adverse reactions were identified.
Chills; Fever; Fatigue; Headache; This is a spontaneous report from a contactable consumer. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the arm right on 29Mar2021 at 09:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient received unspecified medications within two weeks of vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the arm right on 08Mar2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021 at 01:00, the patient experienced chills, fever, fatigue and headache. No therapeutic measures were taken as a result of events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events chills, fever, fatigue and headache were recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
102 fever, nausea,  headache, left swollen armpit (swollen armpit remains into second day)
Pt had fever 102 up to 105; Pt taken to MD who did U/A & started pt on ATB then had roseola rash; 2nd day fever down & rash started to fade; By 9AUG91 rash gone; ATB restarted by mom; MD felt UTI vs MMR rxn; moderate bacteria in U/A;
Tinnitus/Three months later ear still feels stuffy and ringing; Three months later ear still feels stuffy and ringing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Dec2021 (Batch/Lot number: unknown) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Penicillin" (unspecified if ongoing); "Interchange of vaccine" (unspecified if ongoing). Concomitant medication(s) included: CENTRUM FOR WOMEN. Past drug history included: Erythromiacin, reaction(s): "Allergy". Vaccination history included: Moderna (Dose Number: 2, Lot No: Unknown. Arm Left), administration date: May2021, when the patient was 48 years old, for Covid-19 Immunization; Moderna (Dose Number: 1, Lot No: Unknown. Arm Left), administration date: Apr2021, when the patient was 48 years old, for Covid-19 Immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had not received any other vaccine within 4 weeks prior to the COVID-19 vaccine. The following information was reported: TINNITUS (disability) with onset Dec2021, outcome "not recovered", described as "Tinnitus/Three months later ear still feels stuffy and ringing"; EAR DISCOMFORT (disability) with onset Dec2021, outcome "not recovered", described as "Three months later ear still feels stuffy and ringing". Therapeutic measures were not taken as a result of tinnitus, ear discomfort. The lot number for bnt162b2 was not provided and will be requested during follow up.
Notified by pt's family member that pt stated at the dinner table he was not feeling well and went to lay down. Pt then later called out for his family member stating he was bleeding from his dialysis access in his leg. Pt's family member called EMS, pt was transported to the hospital. Pt member stated the pt passed away that evening "because of all the blood he lost from his access." Pt's nephrologist and NP were notified. Pt's death per nephrologist was felt to be due to blood loss from his graft and not related to the vaccine.
No additional AEs; 4 year old child received an extra dose of MMR-II; This spontaneous report was received from the nurse, and refers to a 4-year-old child of unknown gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not provided.  On 17-AUG-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, administered for prophylaxis (anatomical location, strength, lot #, expiry date, and route of administration were not provided); and varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered for prophylaxis (anatomical location, strength, lot #, expiry date, and route of administration were not provided). On 27-SEP-2022, the second doses of suspect therapies were administered. On 14-MAR-2023, the child received third, additional doses (extra dose administered). No additional adverse event information was provided.
Adverse effect:  Chronic Spontaneous Urticaria and Angioedema. (CSU/A).  First informed  it should last 3 months, then 6 months, then it may go into remission by Dr.  As of current day still experiencing CSU/A.   With medication of antihistamines, episode as recent as June 2, 2023, Angioedema episode.