chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This report describes the occurrence of pervasive developmental disorder NOS in a 17 month old male who was vaccinated with hep B vaccine recombinant (Engerix B) for prophylaxis. This report was received as part of litigation proceedings and has not been verified by a physician or other healthcare professional. The subject was allegedly "born a perfectly normal, healthy baby boy. He achieved all expected neurolgoical and social developmental milestones anticipated for a seventeen month old child." Concurrent conditions and medications  were not reported. He received injections of Engerix B on 2/7/94, 4/8/94 and 8/10/94. He also received injections of Tri-Immunol 3/11/94, 5/6/94 and 7/8/94; Tripedia 7/3/95 and Hib-Titer 3/11/94, 5/6/94, 7/8/94 and 5/24/95. The subject's attorney alleged that the subject "At approximately seventeen months of age, the subject was neurologically devastated and overwhelmed" by mercury from thimerosal-containing vaccines '" and he suddenly regressed developmentally, losing milestons of neurological development previously achieved. Starting at seventeen months of age, he became withdrawn, stopped interacting with others, demonstrated poor eye contact, and his speech stopped progressing." The attorney further alleged that the subject "has been diagnosed with an autism spectrum disorder: pervasive developmental disorder, not otherwise specified." Treatment and outcome of the reported events were not provided. The pervasive developmental disorder NOS and mercury poisoning in this report are considered medically serious (OMIC).
Approximately 12 hours after receiving the shot I developed chills and a fever of 102F, extreme pain at shot location and severe headache. At 9am  I took 800mg of Ibuprofen. Two hours later I took 3 Extra Strength Tylenols. I developed pain in my chest on the left side. The fever subsided to about 99F. I had a slight headache for the next 3 days and was cold.  I received the shot on February 11. The symptoms started Early morning February 12. On the morning of February 15 all the symptoms were gone and I felt ok again
The patient became unresponsive on the day after the vaccine, was unable to communicate or eat and died 6 days later.
Massive swelling, pain, redness, difficulty using arm, slight itching. Has not abated as of 12/11/16.
Patient received flu shot 10/6/11. Reports on 11/7/11 that a reaction continues at injection site. Consists of a red circle about the size of a dime.
Nurse at middle school called and reported that the child was complaining of his face itching and his face was red after receiving the shot. Nurse stated she planned to give him Benadryl. Mom states child recovered after being Benadryl.
Our arms we can't hardly move them/we hardly move our left arm; Nothing but pain; I mean it hurts so bad you can hardly move your arms; Our arms we can't hardly move them/we hardly move our left arm; Nothing but pain; I mean it hurts so bad you can hardly move your arms; Shoulders are locking up; hers was four Moderna (suspect captured as COVID-19 Moderna Vaccine) and one Pfizer. And the last one the fifth one was Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 60-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 moderna vaccine (DOSE 1, SINGLE, Lot number and expiration date not provided.), for COVID-19 immunization; Covid-19 moderna vaccine (DOSE 2, SINGLE, Lot number and expiration date not provided.), for COVID-19 immunization; Covid-19 moderna vaccine (DOSE 3, SINGLE, Lot number and expiration date not provided.), for COVID-19 immunization; Covid-19 moderna vaccine (DOSE 4, SINGLE, Lot number and expiration date not provided.), administration date: Aug2022, when the patient was 59 years old, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 11Nov2022, outcome "unknown", described as "hers was four Moderna (suspect captured as COVID-19 Moderna Vaccine) and one Pfizer. And the last one the fifth one was Pfizer"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (non-serious) all with onset Jan2023, outcome "not recovered" and all described as "Our arms we can't hardly move them/we hardly move our left arm; Nothing but pain; I mean it hurts so bad you can hardly move your arms"; JOINT LOCK (non-serious) with onset Jan2023, outcome "not recovered", described as "Shoulders are locking up". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain, vaccination site joint movement impairment, joint lock.  Additional Information: Patient was given Advil 200mg a piece. The patient had tried everything and nothing was helping. Actually she had an MRI. It was still the same every morning and it was like ache and the patient could hardly move her left arm. Lot number of Moderna was 014M2OA (further not clarified). Fifth dose was taken on 11Nov2022 and lot number reported was GT25Z4 or 24 (not clear).   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300250768 same reporter/drug, different patient/event;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient was treated with Anti-viral Paxlovid via oral from 08Aug2022 to 13Aug2022 for the treatment of COVID-19. The patient did not received any other medication in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug Ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
This spontaneous report was received from the patient's mother referring to her 11 year old daughter with no history of drug reaction or allergies. Another concurrent conditions and medical history were not provided. On an unknown dates reported as "in 2006 or 2007", the patient had her 3 doses of GARDASIL injection, 0.5 ml (route, anatomical site of vaccination, lot number and expiration date were not provided). The patient did not had concomitant therapies. On an unknown dates reported as "in 2006 or 2007" and each time the patient received a dose of GARDASIL the patient experienced injection site pain. The reporter stated that on an unknown dates in 2006 or 2007 and after each injection of GARDASIL the patient recovered from the injection site pain and that the patient did not receive any treatment for the adverse event. On 29-DEC-2015, the patient was vaccinated inadvertently with a 4th dose of GARDASIL and in the same date experienced injection site pain. At the time of the report, the outcome of injection site pain was reported as unknown. Additional information has been requested.
black and blue mark on his arm; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (black and blue mark on his arm) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040321A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Apr-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced SKIN DISCOLOURATION (black and blue mark on his arm). At the time of the report, SKIN DISCOLOURATION (black and blue mark on his arm) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No other relevant concomitant medication were reported.  No treatment information was reported.  As per the received TCR follow up document reporter stated that patient had taken 2nd dose and no additional adverse events were observed.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Significant follow up received, Event outcome was updated.
Sever pain all over the body, stiff joints, difficulties moving, skin color changes, dry and itchy skin, loss of appetite, loss of taste, pain in lower back, swollen fingers.
redness, warmth, and swelling below her L should injection site of Shingrix given 3 days ago. Symptoms started 2 days ago. Was already on Motrin-600mg TID for another issue. Redness, swelling, and warmth has already started to improve. No difficulty swallowing or breathing. No fevers.
dark; It got itchy/ very very itchy; small bump pupping in her injection site, it got flat and speared out; rash some small and large as a penny; Nasty scars; This spontaneous case was reported by a consumer and describes the occurrence of SCAR, VACCINATION SITE DISCOLOURATION (dark), VACCINATION SITE PRURITUS, INJECTION SITE URTICARIA (small bump pupping in her injection site, it got flat and speared out) and INJECTION SITE RASH (rash some small and large as a penny) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported. No concomitant medication was reported.     On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced SCAR, VACCINATION SITE PRURITUS (It got itchy/ very very itchy), INJECTION SITE URTICARIA (small bump pupping in her injection site, it got flat and speared out) and INJECTION SITE RASH (rash some small and large as a penny). On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (dark). At the time of the report, SCAR, VACCINATION SITE DISCOLOURATION (dark), VACCINATION SITE PRURITUS, INJECTION SITE URTICARIA (small bump pupping in her injection site, it got flat and speared out) and INJECTION SITE RASH (rash some small and large as a penny) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment details included ice for itching.  No concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: patient shared pictures describing the event.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Mild, Additional Details: Patient recieved first dose of covid-19 pfizer vaccine, appeared fine, was sitting in the chair, about 2-5 minutes later patient fell over and appeared unresponsive for about 30-60 seconds, emergency was called immediately, mother and pharmacist checked to see if she was okay, she gained consciousness and was given water and soda while we waited for medics and police - patient was then taken by medics out of store - appearing okay - blood pressure and blood sugar were in normal range
Itchy; Redness; Sore arm; Headache; Shingles between his ear and temple, down to the back of his neck; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles between his ear and temple, down to the back of his neck), PRURITUS (Itchy), ERYTHEMA (Redness), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PREDNISONE for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 HERPES ZOSTER (Shingles between his ear and temple, down to the back of his neck), PRURITUS (Itchy), ERYTHEMA (Redness), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache). At the time of the report, HERPES ZOSTER (Shingles between his ear and temple, down to the back of his neck) had resolved and PRURITUS (Itchy), ERYTHEMA (Redness), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, COVID-19: negative (Negative) Negative.         No treatment information was provided  Prior to the vaccine around last holiday season, patient  has been getting lots of headache and blurred vision. Several tests were done and doctors then found out that he had a condition that could cause blindness if not treated. That is why he was prescribed with Prednisone.   This case was linked to MOD-2021-318230 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Sep-2021: Follow-up information received on 12-SEP-2021 and contains non-significant information
Pt developed fever 12 hrs after vaccine 103F accompanied by nausea and vomiting diarrhea fever increased to 104F within 24 hrs requiring IV fluid at hospital. No abnormal findings on exam except dehydration and vital signs. HR 144.
Reaction to shot DTAP. (R) arm red, painful per pt. Tx: KEFLEX & triamcinolone 0.1% oint given.
Approximately 5 minutes after receiving vaccine, patient reported dizziness, sweating and nausea. Since then, patient reported hot flashes and nightly dizziness; sometimes multiple times per night.
Fatigue,  body aches, low grade fever and right side of body felt heavy and weak0, almost numb
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 09-SEP-2011, the patient was administered with a dose of VARIVAX (Lot # 0750Z expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of 121 reports received from the same source. Additional information has been requested.
Per patient report: noticed soreness, warmth in the injection site area the day following the injection, then a round rash, about 3 inches diameter appeared on 9/6/18, about 3-4" below the injection site.
pt recv vax DEC96 & JUL97 blood work in MAR showed no sign of disease;cancer of colon w/advanced metastases to liver detected in AUG because of rapid onset, want this on record;
achiness & rash/hives 24yr p/vax;no history of allergy;
The patient arrived at work on 03/09/15. He received vaccinations on 3/13/15 at which time he was in his normal state of good health. The patient denied having any local or systemic side effects after vaccination. On 3/26/15 the patient reported to medical with complaints of a cough for 6 days and bilateral eye pain and green discharge. He was diagnosed with bacterial conjunctivitis and bronchitis. On 4/14/15, the patient complained of right sided upper and lower extremity weakness. The patient was seen in the ER where he was noted to have a cough with moderate rhonchi noted in the right posterior middle and lower lobes with scattered wheezing and a normal neuro exam. The patient was released. On 4/15/15 the patient collapsed stating that "his feet gave out from beneath" him. His VS were stable (156/68, 89, 16, 98.6); PE noted extremity weakness. The patient was seen in the ER where no focal neuro or sensory deficits were noted, motor strength was recorded as 3/5 in both hands/feet and arms, gait was normal and DTRs were recorded as 2+; moderate rhonchi were heard diffusely. The patient was treated with a nebulizer treatment and IV SOLU-MEDROL, ROCEPHIN and ZITHROMAX. He was then released back to work. On 4/16/15 the patient was seen in medical with complaints numbness of his feet, cramping right calf and difficulty trying to stand up from the lying position. He was transported to the ER where on PE the following was noted: 3/5 strength bilaterally upper and lower extremities, significant proximal motor weakness, waddling gait, trace patellar reflexes, absent Achilles reflexes bilaterally. A neurology consult revealed the following physical findings: normal shoulder shrug, no fasciculations, muscle strength 3/5 in the arms -slightly stronger in the triceps bilaterally, legs show 3 to 4/5 strength with the proximal legs stronger than distal and left leg slightly stronger than the right waddling gait, no ataxia. DTRs 2+ except absent bilaterally at the Achilles. The patient was diagnosed with Guillain-Barre syndrome and pneumonia; he was admitted to Hospital ICU and started on IVIG 1g/kg 3 day course. The patient's cough resolved on 4/18/15. He was transferred out of ICU on 4/19/15. It was noted that "strength in UE/LE was 3/5 with improvement in proximal muscle strength". The pt. was transferred to the rehab unit on 4/20/15 where he received PT/OT until his release on 5/6/15. His discharge summary indicates that "he transfers and ambulates with modified independence and that he would benefit from continued aggressive PT." On 5/11/15 the patient was evaluated by PT at clinic. Weakness of the ankles, hand grips and arms was noted (the pt. was unable to do pull-ups or pushups)-a treatment plan for 2 weeks of PT was established. The pt. continued PT and determination of level of recovery. The pt. continues to improve.
Rt upper arm SQ - redness, swelling, soreness, warm to touch, 2 days with headache, 1 day with temp 99.5: cool compresses and BENADRYL and monitor and notified PCP.
Headache; Hot red swollen arm; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old female patient received second dose of BNT162B2{COVID-19 MRNA VACCINE BIONTECH, batch/lot number: EM9809], via an unspecified route of administration in the left arm on 13Mar2021 01:30 PM {age at vaccination 66 years} as a single dose for COVID-19 immunisation. Medical history includes diabetes and Chronic Obstructive Pulmonary Disease (COPD). The patient received the first dose of BNT162B2 [COVID-19 MRNA VACCINE BIONTECH, batch/lot number: EN6208], via unspecified route of administration in the left arm on 20Feb2021 01:45 PM as a single dose for COVID-19 immunisation The patient had not been diagnosed with COVID-19 before and after vaccination. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient didn't have any allergies related to medication, food, or other products. Concomitant medications were reported however, it was not specified. The patient experienced Headache, Hot red swollen arm and fatigue on 16Mar2021 at 04:45 AM. Adverse event resulted in emergency room / department or urgent care. It was reported that patient not received any treatment for the reported events. The clinical outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
Menstrual cycle changes.   I received my first dose 4/6/21 and second 4/27/21. My prior period was 4/18-4/23/21. My cycles are ways 30 days.   I started my period 5/10/21. 8 days early. Exactly 14 days from my second shot. This means I ovulated on the day of my second dose. My cycles was 22 days. There is no explanation for this other than the shot made me ovulate early.  This is terrifying. I could have become unintentionally pregnant.  I am on day 3 of this period and it is by far the heaviest bleeding I have ever experienced in my life.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose12/23/21 2nd dose01/12/21 Diagnosed covid positive:08/3021 Symptom onset:08/26/21 Exposure: Symptoms:cough, SOB,loss of smell,sore throat,diarrhea,headache,nasal congestion
Severe back pain; severe pain in the side; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Severe back pain) and PAIN (severe pain in the side) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Severe back pain) and PAIN (severe pain in the side). At the time of the report, BACK PAIN (Severe back pain) and PAIN (severe pain in the side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were  not provided by the reporter.  Treatment information was not provided.
Unusual and uncomfortable joint popping and crunching. In most joints: shoulders, clavicle, wrists, hips, knees and ankles etc. more so in injection arm. But uncomfortable all around.
Cellulitis (L) upper arm and axilla s/p Pneumovax. Given Keflex.
PATIENT EXPERIENCED A FEVER THE DAY AFTER RECEIVING THE SHOTS, THEN DEVELOPED A 4 INCH RASH THAT WAS WARM TO THE TOUCH.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting injection site arm soreness Narrative:
Patient described severe pain at time of immunization.  Patient returned to pharmacy 9/24/2014 to report continued pain.
24 hrs after...funny taste in mouth...48 hrs in, numbness left cheek, tongue swelling / distortion.
Recurrent herpes zoster sores on mouth. Or has started treatment daily with valacyclovir. If med is not taken sores return within 24 hours
Sharp chest pains. For second time. Also happened last year with first bivalent shot. No issues with prior Covid shots
My 13 year old (almost 14) was given pediatriac Covid Vaccine instead of the teen/adult  vaccine even though she was scheduled for the correct vaccine.
Tinnitus began spontaneously in the left ear 18 hours post-vaccination, followed by tinnitus in the right ear 12 hours later.   Tinnitus is high pitched and constant.   Symptoms have persisted without change.    No associated ear pain, dizziness, headache or systemic symptoms.   No prior history of tinnitus, no environmental risk (eg, loud noises) and no predisposing medical conditions.
Induration and wheal on left arm; slight cellulitis; temperature 99.8F Keflex ordered for 7 days
Patient received Janssen vaccine when scheduled for Pfizer being under 18 years old. Pediatrician contacted for further monitoring.
He had rigors starting 6 pm the day after the vaccination. He was treated with one 500 mg tylenol. He had increased wheezing but did not complain of SOB. At 0400 the next morning, he died.