chrisvoncsefalvay/vaers-outcomes huggingface dataset:
First injection of Engerix B: 04/17/02. Second injection: 05/16/02. Demyelinating event:07/04. Emergency room visit. CT scan and MRI with contrast. Diagnosis: gliosis associated with demyelinating events/disease. Symptoms: extreme fatigue, difficulty walking, severe cognitive impairment, chronic fatigue, night sweats, anorexia, blurry vision, balance difficulties, muscle weakness. Acutely ill and incapacitated for 3 months. Tested for Brucellosis, Japanese Encephalitis. Slow return to health and symptoms decreased. Third injection: 4/14/06. Symptoms return within a month. Acutely ill for 6 weeks. Tested for Lupus, Fibromyalgia, and Lymes disease by pcp. Referred for work-up by either rheumatologist or neurologist. Health declines. Extreme exhaustion. First diagnosis: CADISIL. Tests: MRI, spinal tap. MRI reveals no increase of gliosis from 2004. Spinal tap reveals oligoclonal bands in csf, evidence of a demyelinating event. Diagnosis: Atypical multiple sclerosis. Continued treatment with Dr. at Multiple Sclerosis clinic. Most recent MRI: 08/03/09. Assessment: No change from 2004. Possible "brain insult" from vaccine that triggered auto-immune response.  8/20/09 ER records received DOS 7/19/04. Assessment: Altered sensation with white matter disease, question ischemic versus post-traumatic. Patient presents with concerns about exposure to Asian variation of encephalitis while recently traveling in Mongolia.  Experienced strange sensations, fatigue, disorientation, sensation of 'some realism', waves of "awfulness". Fever, sweats, rhinorrhea, restlessness. Presents with headache. Also concerned that she may have had a seizure after a recent motor vehicle collision. Discharged in stable condition.  8/24/09 Received Neuro consult of 1/506-8/3/09. FINAL DX: multiple sclerosis; demyelinating disease; pre-diabetes mellitus Records reveal patient experienced viral illness during foreign travel in 2004 w/extreme fatigue, wt loss, ringing in ears, constipation, balance disorder, crying & sneezing spells which slowly resolved until spring 2006 when developed anorexia, difficulty walking, heat intolerance after additional foreign travel.  Improved slowly then developed extreme fatigue again, leg weakness & falls. Tx w/multiple meds including IV steroids but continued to decline.  Meds were discontinued & patient improved.  Dermatology consult of 3/7/0-5/16/08reveals patient received Botox & restylane treatment & had vasovagal reaction.  9/3/09 Received PCP medical records reveal when patient seen 8/3/04 that symptoms began abruptly on 7/5/04 while on foreign travel & spouse had similar symptoms that resolved.  Patient initially improved but then s/s recurred: nightsweats, HA, possible hallucinations, lack of energy, difficulty walking, backache, constipation, trouble concentrating, loss of appetite, weight loss, flu like symptoms, fatigue, dermatitis rash from 2002 aggravated.  Neuro consult done 7/19/04 final dx: altered sensation w/white matter disease, question ischemic vs post-traumatic.   2nd Neuro consult done 8/17/04 w/final dx: possible seizure disorder; possible toxic delirium related to Ambien; hx of head trauma/concussions; subclinical gliosis.
Arm pain- unable to lift without deltoid pain in both arms, neck stiffiness, numbness and tingling in arm, at 3 weeks after it was extreme to need Medrol dose pack, gabapentin, lodine
extreme stomach cramps; vomiting; dizzy; headache; chills; This is a spontaneous report from a non-contactable other health professional (patient). A 30-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number EL3302 and expiry date unknown, via unspecified route of administration on 28Jan2021 14:30 at single dose for Covid-19 immunization in a workplace clinic. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior vaccination. Historical vaccine included first dose of BNT162B2 lot number EL1284 on 01Jan2021 for Covid-19 immunization. The patient received other vaccines within 4 weeks prior to the COVID vaccine. On 29Jan2021, the patient experienced extreme stomach cramps, vomiting, dizzy, headache, chills. The patient did not received treatment for the adverse events. The patient has not been tested for COVID-19 since vaccination. The outcome of the events was recovering. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect.  No follow-up attempts are possible. No further information is expected.
Several hours after receiving FLUZONE she experienced airway swelling, tight chest, chest pin and difficulty breathing.  She also had a low grade, fever, chills, rapid heart rate, coughing, runny nose, and slight nose bleed.  Pt. took antihistamine and famotadine.  She did not seek medical help.
Upon wakening  on 9/23/21 (the day after receiving the vaccine) my arm was considerably sore (more than after any other flu vaccine I have received). That evening the pain began radiating into my armpit and down alongside my left breast area. Today (9/24/21) the pain in my arm pit remains the same, the pain along my left breast has increased and there is some increasing discomfort radiating down my left arm.
After 2nd dose given, within 10 hours, I felt pain and heat at injection site and saw a red, swollen bump about 2.5 x 1.5 inches in size. 3 days later is not as red but is still swollen, hot, sore and area has spread out to 3.5 x 2.5 inches in size. Also have felt tingling sensation from upper arm to fingertips, but this is minor
exhaustion; chills; Fever 101; This is a spontaneous report from a non-contactable consumer. An adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/lot no unknown) through an unspecified route of administration on 15Mar2021 for COVID 19 immunization. No relevant Past medical and concomitant history provided at time of reporting event. Patient was not tested positive for covid19 since vaccination and not diagnosed for it prior to vaccination. On 15Mar2021, the patient started experiencing Fever 101, chills, exhaustion. No therapeutic measures were taken for the adverse event. The patient not recovered from the events at the time of reporting. Information about lot/batch no cannot be obtained. No further information is expected
I experienced shortness of breath that got very severe but got better around August or September. Then in November, when the booster was taken, I have had severe shortness of breath and has not gotten better.
Vaccinated at  school on 9/24/10. Came home with a 100.7 fever. Slept, woke up at 3 AM with lung tightness and then very dizzy - slept, 9/25/10 dizzy at noon, slept. Fever 99.9 6P Sat. Sunday Ok.
Nausea, dizziness, fatigue, fever, chills. Diagnosis: Generalized vaccinia vs. viral infection
Flu vaccine given in left arm was moderately sore. Pneumonia vaccine given in right arm was extremely sore and could not raise arm for 3 days. On 11/14/01 evening, had a high fever, fatigue and sore muscles. Had the same reaction last year.
This spontaneous report as received from a pharmacist refers to a female patient of about 55 to 60 years old who on an unspecified date in 1960 received a dose of (Enders-Edmonston) ATTENUVAX (dose, route, anatomical location, lot number and expiration date not reported). The pharmacist reported that the patient experienced an unspecified severe reaction to the vaccine. The patient recovered on an unspecified date. No further information was reported. Additional information has been requested.
Confusion, Headache, Myalgia, Fever, sweats, chills Narrative:
had complications with her breast lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (had complications with her breast lymph nodes) in a female patient of an unknown age 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (had complications with her breast lymph nodes). At the time of the report, LYMPHADENOPATHY (had complications with her breast lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product use was reported.  The reporter stated that their female friend who was the patient had complications with their breast lymph nodes after getting a Covid-19 Vaccine of unknown manufacturer.  No treatment information was provided.
Headache, Myalgia, NauseaVomiting, chills, pain at injection site Narrative: will report to work
collapsed and dies during conditioning practice; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves a 15 years old and unknown gender patient who collapsed and dies during conditioning practice while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect Influenza Vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a serious event "collapsed and dies during conditioning practice" (circulatory collapse) (unknown latency) following the administration of Influenza Vaccine.   Action taken : not applicable.  Corrective treatment : No corrective treatment for the event (collapsed and dies during conditioning practice).  Event outcome : At time of reporting, the outcome was fatal for the event collapsed and dies during conditioning practice. It is unknown if an autopsy was done. The cause of death was reported as Circulatory collapse.  Seriousness criteria : This event was assessed as medically significant and was leading to death. Final diagnosis was (fatal) collapsed and dies during conditioning practice.; Sender's Comments: Sanofi company comment dated 02-Feb-2022: This case involves a 15 years old and unknown gender patient who collapsed and dies during conditioning practice while receiving vaccine Influenza Vaccine. The causal role of the suspect vaccine cannot be assessed based on the temporal relevance. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event, latency to onset, concomitant medications, medical history, family history for unexplained death, autopsy details if available, interventional therapy (if received), established cause of death, pre-existing risk factors would aid in a complete case assessment. ; Reported Cause(s) of Death: collapsed and dies during conditioning practice
12 year old child in with family group with other children was given the pediatric Pfizer dose for 5-11 year olds. No S/S of adverse effect.
my lt. arm felt like lead , so heavy and very sore; my lt. arm felt like lead , so heavy and very sore/felt soreness if she lifted up her arm; This is a spontaneous report from a contactable healthcare professional (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EUA), intramuscular in the left arm on 21Dec2020 16:45 at single dose for COVID-19 immunization. Medical history included the patient being pre-diabetic. The patient's concomitant medications were not reported. The patient previously took epinephrine, norethindrone, and comtrex cold medicine and experienced drug allergy. The patient didn't have anything until around 2:00am on 22Dec2020 - her lt. arm felt like lead, so heavy and very sore. Her arm felt better after getting up - having shower around 6:30am. By 2 pm she only felt soreness if she lifted up her arm. No treatment was given for the events. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient also did not receive any other vaccines within 4 weeks prior to the COVID vaccine and have not received any other medication within 2 weeks of vaccination. The outcome of the events was recovering.  Information on the Lot/batch number has been requested.
Sore arm for 2 days, severe stomach pains with diarrhea for 2 days, chills for 2 days.  Had to leave work early on 1/21 and I could not go to work on 1/22
Chronic Urticaria - intense burning, itchy rash on skin that becomes hive-like upon scratching.  Sporadic and lasts about 30-60 minutes.  Began 10 days after receiving the booster and has not subsided without medication since.  Sought dermatological care and have been taking one 10mg Zyrtec in the morning and one in the afternoon and two Benadryl at night.
feeling weak; feeling sick; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feeling weak) and MALAISE (feeling 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 02-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (feeling weak) and MALAISE (feeling sick). At the time of the report, ASTHENIA (feeling weak) and MALAISE (feeling sick) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.  No Relevant concomitant medications was reported.  Treatment information was not provided
Swelling, redness, warm to touch approx, 24 hours after injection. Also itching. Redness spread 5 1/2" x 5 1/4". Parents treated with ice denies fever. Benadryl for itching, Tylenol for discomfort.
This is a 62y.o. male with hx of COPD on 2-3L Home O2 and HTN, who presents to Facility with a chief complaint of respiratory distress. Patient arrived via EMS with SpO2 of 57%, which did not resolved with NRB and positional changes. Initial CXR demonstrated small left basilar pneumothorax with no appreciable mediastinal shift -- ER resident then placed L Chest Tube, which the patient tolerated with no reported issues, where SpO2 returned to low 90s. Patient currently on 1L NC, SpO2 96% and in no respiratory distress.   Upon my examination s/p chest tube placement, patient denies any current SOB, palpitations, headache, or COV -- does not some tenderness at the site where the chest tube was placed.   Patient found to be COVID+, received 2nd dose of Pfizer vaccine in April 2021. States for the last ~5 days he has had increasing SOB -- denies any fever/chills, productive cough, N/V/D   Upon arrival to the ED:  o Vitals: T 97.1°F, BP 145/104, HR 114, RR 18, SpO2 57% on RA.  o Lab work obtained and remarkable for:  ? COVID+ | WBC 14.4, Neutrophils 12.8 | Hgb 8.7 | Na 129 ? D-Dimer 1041, LDH 535, CRP 12.9 o Imaging demonstrates: ? CXR: small left basilar pneumothorax with no appreciable mediastinal shift o ID and Surgery has been consulted
This case was reported by a nurse and described a subject (age and gender unknown) who did not respond to immunization to Engerix-B. On an unspecified dates, the subject received Engerix-B. On an unspecified date before that the titers were taken from one to five months after the third dose of Engerix-B. No adverse events were reported.
Left arm numbness, headache, all over muscle pain, kidney pain, chest pressure, nausea, vomiting, dizziness
Within 24 hours of receiving vaccine - developed severe lower back pain, diffuse H/A, Shoulder joint pain and upon rising from suppine position I would have a 2-3 second cascade of pain starting in the pelvic area and radiating down my thighs.  This has been consistent since 2/14/09 and over the past 24 hours has just begin to resolve - todays date is 2/25/09. Tx with rest and advil.
Extreme muscle/body aches and pains aggravating arthritis areas lasting approx 30 hours
Parents got the packet from clinic with instructions on how to get child vaccinated without a parent present. They sent in the consent forms as instructed to the school and planned on having their child vaccinated at school on the 12th. At some point before the 12th, the school nurse or some other school representation told parents that they would have to bring their child to school on Tuesdsay, Nov. 9th and that parents needed to be present. So, the parents took their child in-person to school on Tuesday, November 9th and got them vaccinated. Then the child went to school on Friday, November 12th and got vaccinated again because they were in the school nurse's stack of consents of those needing to be vaccinated through the pilot.
About one month later I started to have heavy menstrual cycles which I never had ever before. I had an ablation surgery on 05-04-2021 and since then I am doing better.
Inflamed lymph node left armpit area; 2 days after vaccine developed bruise the size of a quarter (only noticed it the morning; I have mild psoriasis on my forehead. I noticed that a day after the vaccination, the redness of my  psoriasis flare was barely noticeable; I have mild psoriasis on my forehead. I noticed that a day after the vaccination, the redness of my  psoriasis flare was barely noticeable; Sore arm; fatigue; This is a spontaneous report from a non-contactable consumer (patient). A patient of 38-year-old female patient received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247), via an unspecified route of administration 02Mar2021 01:15 PM in the left arm at single dose for COVID-19 immunisation. The patient age at vaccination was 38 Years. The patient's medical history included psoriasis and underactive thyroid. No allergies to medications, food, or other products. Facility where COVID-19 vaccine was administered was other. The patient was not received any other medications within 2 weeks of vaccination and any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior and after the vaccination. Concomitant medications included vitamin D3 and cyanocobalamin (B12 [CYANOCOBALAMIN]). On 02Mar2021, the patient experienced sore arm, fatigue, 2 days after vaccine developed bruise the size of a quarter (only noticed it the morning), On 03Mar2021, Inflamed lymph node left armpit area. Also, I have mild psoriasis on my forehead. I noticed that a day after the vaccination, the redness of my psoriasis flare was barely noticeable. This also happened after the first dose (although it became red a couple of days after). This could be unrelated but thought I'd share anyway since this happened again. I currently do not use any treatment for my psoriasis. No treatment received for the adverse event. Outcome of the events was recovering.  Follow up attempts are needed. Further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021238667 Pfizer
Per husband "fever, vomiting and her skin is yellow" --student back in class 3/25/04 with no ill effects by report.
On the same day (11/18/20) that patient received the vaccinations, at 9 PM patient had shivers, achiness and nausea. Patient took 1 dose of aspirin at 10 PM and went to bed at  10:30 PM. Patient better the next morning and all symptoms listed above were gone.
Sickness; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sickness). At the time of the report, ILLNESS (Sickness) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   This case contains information about patient 03 out of 04 patients. No concomitant medication was provided by reporter. Four adult  patient was impact due to Moderna COVID-19 Vaccine for Illness. Reporter assumed patient  get sick because of the vaccine . Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-737834 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737834:Patinet 3
Pts temperature was 102 - 103; hard knot at injection site; swollen and warm to the touch. Treated with Motrin; Tylenol; cool compresses to injection site.
This spontaneous report as received from a consumer refers to his wife, a 63 years old female patient with pain. The patient's medical history included MRSA, neuropathy and previous shingles history before receiving the vaccine. She received an unspecified pneumonia vaccine 8 months prior to ZOSTAVAX. No previous drug reactions or allergies were reported. The patient was vaccinated with ZOSTAVAX on 18-APR-2012 (also reported as 18-APR-2011). Dose and route of vaccination were unknown. No other co-suspects were reported. Concomitant medications included gabapentin, metformin, hormones (unspecified) and hydrocodone. On an unknown date in April 2012 (7-10 days after receiving the vaccine) the patient developed rash and blisters after receiving ZOSTAVAX. The blisters appeared on both arms between the shoulders and the wrists, with little sores that eventually scabbed over. A week after that outbreak had healed she had another breakout with the same sores that eventually scabbed over in the same location, and 3 weeks after that breakout healed there was another breakout that occurred in the same manner. The physician biopsied the blisters and send them to the company (results unknown). About 1 month after the patient had her third outbreak of blisters the reaction developed again, this time appearing on the patient's face accompanied by a severe headache all of which required admittance to the hospital for a 1 week hospital stay. The physician who treated the patient diagnosed her condition as Erysipelas. The patient was with clindamycin, which helped to stop the reaction from becoming a full breakout. The patient was then switched to penicillin, which has worked better to control the breakout symptoms. The patient has not had any further breakouts since switching to the penicillin. Unspecified blood work was taken. The outcome of erysipelas was reported as recovering/resolving. The relatedness for erysipelas was not reported for ZOSTAVAX. Additional information has been requested.
RECEIVED VACCINE AT 359PM AND AT 415PM BECAME DIAPHORETIC, PALE, EPISODE OF URINE INCONTIENCE,MOMENT OF "RIGIDNESS AND EYES ROLLED BACK" AND "HAD A BRIEF EPISODE OF NON REPONISIVENESS AND CAME THRU" (PER EMS). PROVIDER ASKED TO EVALUATE PATIENT AFTER EPISODE, IN TENT. PER PROVIDER SEND PATIENT TO HOSPITAL OF CHOICE FOR HIGHER LEVEL OF CARE. NO PO MEDS PROVIDED TRANSFERRED AT 1641PM IN STABLE CONDITION( TO HOSPITAL) , IN STABLE CONDITION.
This spontaneous report as received from a certified medical assistant (CMA) refers to a male patient of unknown age. Concurrent conditions and medical history were not reported. On an unknown date, the patient was inadvertently administered a dose of VAQTA (lot# H012642; expiration date: 16-APR-2015, 0.5 ml, intramuscular). Concomitant therapies were not reported. The CMA stated that this VAQTA had been improperly stored. No adverse effects were reported and product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.