chrisvoncsefalvay/vaers-outcomes huggingface dataset:
died by taking his own life; transverse myelitis; paralysis; This spontaneous report was received from an office manager via company representative referring to a male patient of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were unknown.  Several years ago, the patient was vaccinated with the third dose of either hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (dose, route, lot# and expiration date were not reported; unidentified Merck hpv vaccine administered (name and lot number not provided)). It wasn't sure which was the suspect product.   On an unknown date, the patient developed transverse myelitis, paralysis, and died by taking his own life (completed suicide) after getting the vaccination. This case had been brought to a trial and settled and published in unspecified news article and this case was being associated with legal. Legal issue involved-AE sent to legal. It was unknown if patient sought any medical attention, received treatment or any lab/diagnostic tests were performed. The cause of completed suicide was unspecified. It was unknown if autopsy was done. Outcome of the events transverse myelitis and paralysis was unknown.  The causality between the suspect products and the events was not reported.  Upon internal review, transverse myelitis, paralysis, and died by taking his own life (completed suicide) were determined to be medically significant.; Reported Cause(s) of Death: died by taking his own life
High fever, shaking, changing behavior, red spot on site, rash, difficulty breathing, heart speeding up, dizzy. Was taken to ER and kept overnight. Pt given medication to control allergic reaction and for pain. Arm started hurting, couldn't move it due to swelling of the joint. Given hydrocodone-acetaminophen. Pain increasing, comes and goes. Pt. followed up with orthopedic doctor who specified it is an inflammation of the muscle and gave her more pain medicine. Today patient still has pain at injection site and can't perform daily activities since range of motion is limited.
Nightly myoclonic jerks and seizures; every single night, since receiving vaccinations. Also, random rashes on arms and periods of extreme fatigue.
Off label use; Migraines; Sensitive to light; Felt a brain fog; fever that came on gradually and increased in temperature for 2 days; Frontal lobe area headaches; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Off label use), MIGRAINE (Migraines), PHOTOPHOBIA (Sensitive to light), FEELING ABNORMAL (Felt a brain fog) and PYREXIA (fever that came on gradually and increased in temperature for 2 days) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A, 031B21A and 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sleep apnea. Concurrent medical conditions included Obesity.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced OFF LABEL USE (Off label use), MIGRAINE (Migraines), PHOTOPHOBIA (Sensitive to light), FEELING ABNORMAL (Felt a brain fog), PYREXIA (fever that came on gradually and increased in temperature for 2 days) and HEADACHE (Frontal lobe area headaches). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 500 mg. On 28-Sep-2021, OFF LABEL USE (Off label use) had resolved. On 03-Oct-2021, MIGRAINE (Migraines), PHOTOPHOBIA (Sensitive to light), FEELING ABNORMAL (Felt a brain fog) and HEADACHE (Frontal lobe area headaches) had resolved. At the time of the report, PYREXIA (fever that came on gradually and increased in temperature for 2 days) outcome was unknown.            No concomitant medication was provided.   Patient lied in the darkness to help with the headaches. He is not usually a person who gets migraines.   This case was linked to MOD-2021-080394, MOD-2021-080382 (Patient Link).
This case was reported by a physician and described the occurrence of fat atrophy in a 13-month-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline), ACTHIB. The subject's medical history included cleft lip, cleft lip repair and renal problems. Previous and/or concurrent vaccination included influenza virus vaccine; manufacturer unspecified; unknown given on 29 September 2008; PREVNAR (non-gsk); Wyeth Labs; unknown given on 29 September 2008. Concurrent medications included ENALAPRIL. On 29 September 2008 the subject received 4th dose of INFANRIX (.5 ml, unknown, right thigh), unspecified dose of ACTHIB (unknown, right thigh). On 29 September 2008, less than one day after vaccination with INFANRIX, at an unspecified time after vaccination with ACTHIB, the subject experienced fat atrophy, skin discoloration, skin indentation and pain. This case was assessed as medically serious by GSK. A physician reported that he gave a 13-month old subject his 4th dose of INFANRIX vaccine and the subject developed a small purple spot that enlarged and became pitted over the course of one month. There may have even some pain associated with the area, but the physician was not certain. The subject also received an ACTHIB vaccine in the same thigh and separate location that day. The physician is not certain if the site was of the INFANRIX or of the ACTHIB. At the time of the report, the area had not improved or worsened but currently appeared to be a discolored, indentured area where the subcutaneous fatty tissue had atrophied leaving muscle directly covered with "thin parchment like skin". At the time of reporting the events were unresolved. The physician considered the events were possibly related to vaccination with INFANRIX and ACTHIB.
pt recv vax 28OCT96 & 15DC96 pt devel a cough, restlessness, malaise, anorexia & elevated temp of 102;APAP & symmetrel prescribed;2 days later 17DEC96 pt was afeb but cough worsened;pt on ATB following day 18DEC96 pt expired-cause unk;
chills, rigors, body aches, chest tightness, lightheadedness;epi given & APAP;
He noted his skin was sensitive/tingly in his trunk/abdomen and that he felt a little achey when he woke up yesterday morning  (5/17/2021) but nothing severe, I just assumed is was post injection soreness, he also had some left arm soreness about 18-24 hours post injection.  Around 5pm yesterday (5/17/2021) he has sudden onset of fever (103 degrees) and he had just been checked for volleyball practice at 2:30pm and was afebrile.  Fever continued through the night between 102 and 104 with Tylenel every 4 hours and one episode of Ibprofen.  Fever down to 99 degrees by 7am this moring (5/18/2021).  Did rapid COVID test from drug store and was negative.  Pediatricians office said to monitor through day, call back if high fever returned and to notify VAERS.
I had 2 adverse effects after this injection: 1) rapid heart rate increase - Atenlol no longer treated. Changed to Metropolol. Started at low dose and finally ended at 75 mg twice a day to keep it under control. Before the third vaccine, without medication, my heart rate would be about 110. After the injection my average, without medicine, was 145. Now, with 75 mg twice a day of Metropolol I'm at 95-110 at rest. With Atenolol before the third injection I was averaging 80-98 at rest.  2) Developed tinnitus 24/7 non stop and still have to this day. I have seen an ENT and audiologist. There is no cure or medication for this. I have had to use white noise and can no longer enjoy quiet. Prior to third injection I would develop a little tinnitus when I had a cold or other sinus infection, but it would go away with in a day or so. Since the third injection, however, I've had the high pitched ring in both ears non stop. It has really impacted my life over the last couple of years.
Refridgeration excursions identified; No adverse event; Poor quality product administered; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event) in a 43-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-2022 at 12:13 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 26-Sep-2022 at 12:13 PM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified).    No concomitant medications were reported.  Patient received the first, second, third and fourth dose of vaccine in Intramuscular deltoid muscle.  On 07-Sep-2022, the vials were initially moved from freezer to refrigerator.  The nurse reported that, Moderna Monovalent and Bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back in Aug-2022. It was reported that, refrigeration excursions were identified, and vaccines were housed in these units. The manufactures were notified, and the department made aware of the situation. The storage condition of vial at the time of excursion was in refrigerator. The vials were not visually inspected.  No adverse reactions had been reported for the patient as per the reporter's knowledge.  No treatment medications were reported.
ptient was given pfizer bivalet booster after he got the 1st dose only before he got the 2nd dose (2nd pfizer vaccine is not available)
Patient had this vaccine administered on 1/12/22 after its "use-by date" of 1/1/22. 1/1/22 is the 31 days of refrigeration. Expiration date is February 2022. No adverse reactions reported. Per manufacturer, administration not recommended past 31 days + an additional 14 days of temperature excursion. Per manufacturer, patient will not need re-vaccination.
Headache, chills, body aches, sore arm, hallucinations, extreme fatigue.
Fever, up to 102 degrees, muscle pain, somnolence, cognitive impairment, lasting two days,
Insect bite like spots, itch will scab over, worsen after bathing. Have occurred from shoulders down to toes. Extremely dry skin. Started to occur 3 days after receiving vaccine. Red at first, some leave brown spots on skin. Has been seen by MD. Seeing Derm in 9/2012.
peeling skin of palmar aspect of both hands, no pain, no itching, no other skin reaction
I had a 102 fever, loss taste and smell, coughing, chills, body aches, running nose, earache, sore throat, foggy in the head, and still getting fevers at night but not as high. I tested positive for COVID-19 at home. My doctor put me on the Z-pack and steroids. I am feeling better. I still have no taste or smell and coughing.
pt reports 4 days p/vax c/o tenderness, swelling, red, itchy arms, moving from site to elbow;slowly improving using ice & elevation as needed;denies fever but will cont to f/u daily as needed;
It feels like is I have Covid; Chills; Headache; Tiredness; Aches in my joint; severe pain in my arm that I received the injection in; Had a temperature also; This is a spontaneous report from a contactable consumer. A 55-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 24Feb2021 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient is not pregnant at the time. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Consumer stated, I was calling regarding the side effects from the shot from the vaccine (Pfizer Covid Vaccine). I experienced severe pain in my arm that I received the injection in. That was first day and the next day I experience chills, headache, tiredness, and aches in my joint. It feels like is I have Covid. That was from my first injection and that was on Wednesday. I had a temperature also. According to the paperwork they said to notify you guys so you can know that I have side effects and I had major side effects from it. Consumer stated, "Can I ask you a question? Since that was the first vaccine and I had those side effects. Am I going to more with second one? Anything else dealing with this regarding the next shot, I mean I must speak with someone else to stand hold like this again? Are you guys accept an application? Are you guys short of help? I don't understand. The outcome of the events was unknown.   Is there a Product Complaint: Yes  No follow-up attempts are possible. No further information is expected.
Pt complained of rash / hives to injection site of Pneumo vaccine, about 24 hours after administration. Pt advised to start Benadryl every 6 hours. Pt seen at our office today 9/17/04.
A non-serious spontaneous report of gave H1N1 LAIV to person >49 years old was received from a registered nurse/healthcare professional concerning a 68-year-old female. No relevant medical history was reported for this patient. On 23-Nov-2009 the patient inadvertently received H1N1, Intranasal. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
The patient was vaccinated at 10:55. He was observed for 15 minutes s/p vaccination with no complications of shortness of breath. The patient was active and dancing during the observation period. The patient was discharged with his mother ambulating  independently.   At approximately 11: 16 am the patient returned with his mother who states she saw fine bumps on the back of his neck. The patient was wearing a new mask received from Pharmacy prior to coming to the clinic. The fine bumps were noted along the strap line of the mask on the back of his neck. The patient denies shortness of breath; pain; itching. No swelling or redness was noted. Mom stated after returning that the patient had a rash after receiving his first dose of the Pfizer vaccination.   She also stated he has a history of ADHD and was receiving medication. In addition she stated he had seasonal allergies and received Benadryl in the past. She did not report these findings on the initial interview or with the second interview conducted with the nurse.    The patient was noted to not be in distress. Monitoring was continued. The patient was able to leave with his mother ambulating independently without complications or distress.
Had first COVID-19 Pfizer vaccine on 8-14-21 and second COVID-19 Pfizer vaccine on 8-25-21, this is 11 days too soon. Client still cannot smell, taste, ears itch, has visual changes and brain fog, all of this is from having COVID in Oct 2020.
Swelling around the eyes.   They are still swelled and my doctor put me on hydroxyzine 25mg
pt recvd vax; had local rxn p/ DTAP; w/in one min, inject site turned red, about 2" in diam; mom also noted a rash on lt scapula area;to MD 's ofc,no apparent distress;md said it was a mild rxn to DTAP;dph given for rash;
vax but got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles outbreak).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, got the shingles vaccine but also got my second shingles outbreak, it was terrible ,worst then my first outbreak. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
10 minutes after injection felt extreme dizziness to the point of feeling faint, tightness in throat, severe itchiness in throat, tongue,  ears, mouth and all over my body, and felt nauseous.  Had to be treated in Urgent Care for these symptoms, Benadryl was administered, and seemed to help the itchiness and tightness of throat
Error:  this 15 year old patient was seen in our drive-thru pediatric vaccine clinic, and received the Pfizer Pediatric (5-11 years; orange top) vaccine instead of the intended Pfizer Adult (12+ years; purple top).  The error was detected and patient received a correct dose on the same day (information on adult dose lot# not yet uploaded in state registry).  No adverse events reported.  Reporting this age-related product error.
The patient never received the 2nd Monovalent dose.; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (The patient never received the 2nd Monovalent dose.) and NO ADVERSE EVENT (No Adverse Event) in a 10-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (The patient never received the 2nd Monovalent dose.) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (The patient never received the 2nd Monovalent dose.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (The patient never received the 2nd Monovalent dose.).    No concomitant medication details was reported. No treatment medication details was reported.
I felt tired, my nose started to run, and I had a cough in Oct2021. Saw the doctor 31Oct2021, doctor did not do COVID-19 test. Diagnosed with bronchitis.
Information has been received from a physician assistant and a licensed practical nurse concerning a female who was vaccinated with the first dose of GARDASIL (lot# not reported) 0.5 ml. The patient experienced seizure like symptoms after receiving her first dose. Series was discontinued and the patient did not receive any further doses of GARDASIL. The patient sought unspecified medical attention. Upon internal review, seizure like symptoms was determined to be an other important medical event. Additional information has been requested.
Swollen from shoulder to psst elbow,; Fever; Painful; Could not use left arm; Sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of mobility decreased in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced mobility decreased (Verbatim: Could not use left arm), sickness (Verbatim: Sick), swollen joints (Verbatim: Swollen from shoulder to psst elbow,), fever (Verbatim: Fever) and pain (Verbatim: Painful). The outcome of the mobility decreased was resolved (duration 12 days) and the outcome of the sickness was resolved (duration 2 weeks) and the outcome of the swollen joints, fever and pain were not reported.   It was unknown if the reporter considered the mobility decreased, sickness, swollen joints, fever and pain to be related to Shingles vaccine.     It was unknown if the company considered the mobility decreased, sickness, swollen joints, fever and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and told everyone to be prepared for sick for two weeks. The patient was unable to use his or her left arm for 12 days, hand swollen from shoulder to past elbow, had fever and it was very painful. The patient stated that he or she will never receive booster dose. Follow-up would not possible as no contact details were available.
temp of 101.8 at 11:00pm on 1/11/2021. Woke up at 4:00am on 1/12/2021 with muscle cramps in both legs; aching all over and headache and body aches ; fatigue and extreme muscle tenderness in left arm (site of injection) Temp remained at above 100.0 even with Tylenol and headache and body aches until 9:00pm.  Woke up on 1/13/2021 with only symptoms being sore arm; slight headache and muscle tightness in neck.