chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 14 year old male patient who on 14-NOV-1996 was vaccinated with a first dose of VARIVAX (Merck) (Lot # not provided). On 16-APR-2010 the patient received a second dose of VARIVAX (Merck) (Lot # 665969/1447Y), 0.5 mL, SC in the right upper arm. On the same day the patient received a dose of tuberculin purified protein derivative vaccine. It was reported that the patient broke out in chicken pox rash at the injection site. At the time of report, the patient was recovering with no treatment. The patient sought unspecified medical attention. Follow-up information has been received from a registered nurse concerning a 14 year old student male with allergy to ibuprofen and no history of chickenpox who reported that on 16-APR-2010, the patient was vaccinated with a second dose of VARIVAX (Merck) (Lot # 665969/1447Y), 0.5 mL, SC, in the right upper arm, at 4:00 pm. On 18-APR-2010, the patient developed varicella-like rash at immunization site which was burny and itchy for 2 weeks, and red mark/red area persisted for 1 month. On an unspecified date, the patient recovered from varicella-like rash at immunization site. The registered nurse stated that the patient did not have a recent exposure to chickenpox or herpes zoster and direct fluorescent antibody test and Polymerase Chain Reaction test were not performed. This is one of several reports received from the same source. Additional information is not expected.
She was diagnosed with PMR (polymyalgia rheumatica); Four hours later she started to have symptoms of: body and joint pain; Four hours later she started to have symptoms of: body and joint pain; patient had fever; weak; patient had confused; patient had no appetite; patient started to have light headedness; patient had symptom of fatigue; patient had malaise; patient had trigeminal neuralgia; Initial information received on 09-May-2022 regarding an unsolicited valid  serious case received from a patient via call center.   This case involves a 59 years old female patient who experienced she was diagnosed with pmr (polymyalgia rheumatica) and patient had trigeminal neuralgia while receiving vaccine influenza quadrivalent recombinant vaccine [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 05-Oct-2021, the patient received a  dose of suspect influenza quadrivalent recombinant vaccine (lot UJ725AA) (dose, formulation, strength, and expiry date: unknown) via intramuscular route in unknown administration site for Flu vaccination.   On 05-OCT-2021 the patient developed a serious she was diagnosed with pmr (polymyalgia rheumatica) with symptom [body and joint pain (pain and arthralgia), pyrexia, asthenia, confused (confusional state), no appetite (decreased appetite), light headedness (dizziness), fatigue asthenia and malaise] (latency 4 hours) following the administration of influenza quadrivalent recombinant vaccine.  On 05-OCT-2021 the patient developed a non-serious patient had trigeminal neuralgia (trigeminal neuralgia) (latency 4 hours) following the administration of influenza quadrivalent recombinant vaccine.   Seriousness- medically significant for polymyalgia rheumatic   trigeminal neuralgia (non- serious)  Action taken: not applicable.  The patient was treated with prednisone for Polymyalgia rheumatica and Trigeminal neuralgia.  Outcome- Recovered / Resolved for Polymyalgia rheumatica and Trigeminal neuralgia; Sender's Comments: Sanofi Company Comment dated 16-May-2022: This case involves a 59 years old female patient who experienced she was diagnosed with pmr (polymyalgia rheumatica) while receiving vaccine influenza quadrivalent recombinant vaccine [FLUBLOK QIV]. The causal role of the company suspect drug cannot be excluded based on the temporal relevance instead of the time to onset is compatible with the role of the vaccine. However, information regarding condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of  vaccine cannot be assessed.
Shortness of breath during the day, Dizziness, Heart Fluttering, Unable to sleep at night because I could not breath. My sleep apnea was intensified to a point that I could not sleep. Woke up every few minutes gasping for air. Very scary.
I got very sick from my second dose; I was sick, terrified; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for covid-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I got very sick from my second dose"; FEAR (non-serious), outcome "unknown", described as "I was sick, terrified". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
11/27 patient was found sleeping on toilet at her ALF  Paramedics were called and evaluated her.  She stayed at facility. 11/28 patient was brought to ER due to swelling on left leg.  She was evaluated and treated for UTI 12/1 patient was brought to ER due to swelling on left lower extermidty and left upper extremity edema. Exam revealed thrombus   left upper extremity veins, deep and superficial. 12/8/21 patient
My body is totally magnetic and my forehead my arm and my chest the silverware can stick forks scissor spoons anything metal.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), solution for injection, administered in arm left, administration date 12May2021 16:00 (Lot number: EW0186) at the age of 59 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Penicillin, reaction(s): "Known allergies: Penicillin", notes: Known allergies: Penicillin. The following information was reported: FEELING ABNORMAL (non-serious) with onset 06Jun2021 01:00, outcome "not recovered", described as "My body is totally magnetic and my forehead my arm and my chest the silverware can stick forks scissor spoons anything metal.". The event "my body is totally magnetic and my forehead my arm and my chest the silverware can stick forks scissor spoons anything metal." was evaluated at the emergency room visit. Therapeutic measures were not taken as a result of feeling abnormal.  Follow-up attempts are completed. No further information is expected.
-diffuse hives and erythema (arm, neck, head) - no airway/breathing problems - relieved by Benadryl
Got shingles after second vaccination/ Suspected vaccination failure; Got 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient got shingles after 2nd dose of Shingles vaccine. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were not provided.
Chest pain started 1-2 days after vaccine dose, rated a 9/10 in intensity. Clinical diagnosis - Acute myopericarditis Treated with ibuprofen 800mg q8h with resolution of symptoms shortly after 1-2 doses.
Headache, Myalgia, Arthralgia, Neck pain, chills Narrative:
Moderate erythema at injection site (L) arm with swelling lasting two weeks (3mm induration on 5/26/10); papular erythematous rash developed 2 days after immunization over entire body.
COVID-19 infection/Hospitalization due to COVID-19; DRUG INEFFECTIVE; Cancer; left arm turned red; left arm was sore; fever of 102.5  degrees Farenheight.; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (Cancer) and COVID-19 (COVID-19 infection/Hospitalization due to COVID-19) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (left arm turned red), VACCINATION SITE PAIN (left arm was sore) and PYREXIA (fever of 102.5  degrees Farenheight.). On an unknown date, the patient experienced NEOPLASM MALIGNANT (Cancer) (seriousness criterion medically significant), COVID-19 (COVID-19 infection/Hospitalization due to COVID-19) (seriousness criterion hospitalization) and DRUG INEFFECTIVE (DRUG INEFFECTIVE). At the time of the report, NEOPLASM MALIGNANT (Cancer), COVID-19 (COVID-19 infection/Hospitalization due to COVID-19), DRUG INEFFECTIVE (DRUG INEFFECTIVE), VACCINATION SITE ERYTHEMA (left arm turned red), VACCINATION SITE PAIN (left arm was sore) and PYREXIA (fever of 102.5  degrees Farenheight.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Company Comment: This case concerns a  89 year-old, female subject  with no clinical history who experienced the unexpected events of COVID-19, and NEOPLASM MALIGNANT, DRUG INEFFECTIVE and other non-serious events. The events occurred on unknown days after two doses of [Spikevax]  The rechallenge is unknown as per no information is available at the time of the report. The benefit-risk relationship of the vaccine is not affected by this report   This case was linked to MOD-2021-347627 (Patient Link).; Sender's Comments: This case concerns a  89 year-old, female subject  with no clinical history who experienced the unexpected events of COVID-19, and NEOPLASM MALIGNANT, DRUG INEFFECTIVE and other non-serious events. The events occurred on unknown days after two doses of [Spikevax]  The rechallenge is unknown as per no information is available at the time of the report. The benefit-risk relationship of the vaccine is not affected by this report
Systemic: Dizziness / Lightheadness-Mild, Systemic: fainted but responsive-Mild
No additional adverse events; Product storage error; This spontaneous report was received from a physician refers unspecified number of patients on unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.   On an unspecified date, the patients were vaccinated with improperly stored doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot number 1621926, expiration date 28-NOV-2021, lot number R025729, expiration date 18-JUN-2021; Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot number S006052, expiration date 07-DEC-2020, lot number S004400 expiration date 14-NOV-2020, lot number 1660951, expiration date 11-NOV-2020, lot number R025733 expiration date 30-MAR-2020; varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number R024023, expiration date 22-AUG-2020, lot number S012037 expiration date 17-APR-2020, and lot number S021927 expiration date 15-JUL-2021 (dose and route of administration were not reported). The sterile diluent that was used to reconstitute the varicella virus vaccine live (Oka/Merck) (VARIVAX) was properly stored. There was no adverse effects reported. Administered doses of vaccines HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) experienced the temperature excursion of above 9 degrees Celsius (°C) for 99hours and 45 minutes. Also, for varicella virus vaccine live (Oka/Merck) (VARIVAX) experienced the temperature excursion of -14°C to-10°C (-14 °C) for 122 hours and 45 minutes, and -9°C to 8°C (1.2 °C) for 129 hours and 45 minutes. No data logger was involved. There were no previous excursions reported.   This case is considered to be non-valid due the lack of patient identifiers.  Follow up information was received from the reporting physician on 13-FEB-2020. The patient was male. On 28-JAN-2020, the patient was vaccinated with  HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9).  The physician reported that the patient received only  HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9).  This case was previously classified as Non valid due to lack of patient identifiers, however up on follow up information the case was confirmed to be a valid case as patient identifier was reported.  This is one of the several reports from the same reporter.; Sender's Comments:  US-009507513-2002USA001552:
Pt with dementia presented to ED w/ failure to thrive x3 days. Per husband, wouldn't eat, weak, etc. Pt had tonic-clonic seizure in ED. Admitted. Neurology consulted and ordered MRI. MRI showed lacunar infarct. Date of occurrence not identifiable. Seizure was then correlated to be post stroke. Pfizer covid vaccine booster received 2/28/23 (COVID-19 Vaccine Pfizer (12yr+) Bivalent Booster, Lot #GH9694, Exp. 3/29/23, 0.3mL administered to left deltoid). Date of entry to ED was <7 weeks from time of Pfizer booster dose. Given recent correlations to stroke risk in patients 65+ within 6 weeks of Pfizer booster, feel this is pertinent to report. Unclear time/date stroke occurred, but given patient was symptomatic, thought to be failure to thrive, multiple days prior to ED presentation, likely stroke occurred during 6 week post vaccination window.
Vaccines given appropriate for age and catch up schedule. Patient suffered febrile seizure early morning ambulance transfer to Emergency Department.
Extreme pain at site of injections with rash 2"x4" at injection site - progressively getting worse.
Starting on 1/11/2021 patient states she noticed the injection site becoming red, swollen, itchy and warm to the touch.  Pt states it is approximately 3" wide.
Abnormal lesion in conus.  Competitive gymnast, no significant medical history. Developed constant bilateral low back pain. X-ray, MRI in August 2021, and PT, no significant improvement. January 2022 one night developed severe back pain and a sense of numbness and tingling, leg weakness, and could not walk.  Urinary incontinence. Prednisone 20 mg. daily for 6 days.  LS spine 2022 MRI lumbar spine demonstrates new abnormal signal within conus medullaris slightly greater within left hemicord. No definite mass thickening . Contrast MRI 1/31/22 Inflammatory demyelinating involving the conus medullaris and associated reactive inflammation of the ventral cauda equina nerve.  MRI February 2022 Brain no evidence of acute infarcation, C-spine no abnormal cord signal. Secon opiion Dr. at hospital, No evidence of MS. Back pain continues and competitive gymnastic career handicap persists with lower back pain and inability to fulfill skills. Scratching our heads!
Approximately 2.5 hours after vaccination, I experienced difficulty breathing, overheating, and a sensation of my head, neck, and chest swelling up. Emergency inhaler was used. Ice packs were applied to head and chest areas for 45 min. Breathing eased up slightly after about an hour. Tightness in chest and neck for next 4 hrs.  Continued bouts tightness in chest and neck with labored breathing, lightheadedness, and vertigo over next 8 days. Took Zyrtec 2 times daily, inhaler 3 times daily, and Flexeril 2 times daily.  Went to Urgent Care on day 8 after calls to allergy dr and gp dr were not returned. Prescribed Prednisone to help with inflammation.
received shot at 1130 am on 2/19.  client developed chills/ fever that evening on 2/19. on 2/20, woke up feeling well, was getting dressed to go out to lunch at 12 when he had a seizure, as per his wife, it lasted for about 5 sec. then he recovered and states had lunch and took a nap. no other issues after that.
NUMBNESS IN RIGHT HAND / RIGHT FOOT /  LEFT ARM; INJECTION SITE PAIN; FEVER; This spontaneous report received from a patient concerned a 22 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced fever. On 15-APR-2021, the subject experienced numbness in right hand / right foot / left arm. On 15-APR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 13-APR-2021, was recovering from numbness in right hand / right foot / left arm, and had not recovered from injection site pain. This report was non-serious.
This spontaneous report as received from a pharmacist via Merck Vaccine Customer Care (MVCC) refers to two unspecified patients with unknown demographics. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with ZOSTAVAX (lot number and expiry date were unspecified). On an unknown date, it was reported that the patients experienced shingles after they were vaccinated at pharmacy. Product quality complaint (PQC) was not involved. The present status of the patients was unknown. Causality assessment was not provided by the reporter. Additional information is not expected as there is no consent to contact the reporter.
10:30 - profuse sweating 11:30 - body aches 12:30 - stomach ache 2:30 - vomiting
12-2-21 - Patient was hypoxic and so came to the ER for eval and altered mental status Patient was started on the nasal cannula The patient is currently maintained on baricitinib 2 mg. The patient is also on Rocephin and Decadron  12-3-21 - PT dx acute hypoxic resp failure 12-4-21 - Development of Pneumonia and pulmonary congestion and cardiomegaly 12-5-21 - Rapid response due to low pulse ox 12-9-21 - Palliative care consult (DNR) 12-10-21 - PATIENT EXPIRED
Patient is a reasonably healthy 71-year-old male and with obesity, hypertension, hyperlipidemia, and controlled diabetes presenting with approximately 8 days of upper respiratory symptoms and increasing shortness of breath particularly with exertion.  Diagnosed with COVID-19 10/25/2021.  Is vaccinated x2 with Moderna.  Presented to urgent care with increasing dyspnea on exertion.  Was found to be hypoxic in the 80s required 3 L of oxygen.  Chest x-ray consistent with COVID-19.  Labs centrally unremarkable and without sign of secondary bacterial pneumonia or VTE.  CRP elevated at 15.8.  Patient was given 6 mg of dexamethasone transferred for further cares.
Patient said "a little later after receiving the vaccine", she started to experience lip swelling, eye swelling, inside of mouth "felt like it was on fire", and she had a headache. She said she never had any difficulty breathing. She said the symptoms went away in less that 24 hours and she "felt fine". She reported this information to the pharmacist on Dec 2, 2020.
This spontaneous report received from a patient concerned a 65-year-old white female of unspecified ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose, 1 total administered on 02-SEP-2021 to left arm as prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 03-SEP-2021 (day 2 after vaccination), the patient experienced low blood pressure. Laboratory data included: Blood pressure (NR: not provided) low. On an unspecified date, the patient was passed out and landed on floor, and reporter stated that it could be due to dehydration. The action taken with covid-19 vaccine was not applicable. The patient recovered from passed out and landed on floor, and low blood pressure, and the outcome of dehydration was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220115924- Covid-19 vaccine Passed out and landed on the floor. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Vaccine administered at approx. 9 am. At 1000am , began feeling very tired, dizzy. S/sx increased over the next 2 hours. - began vomiting, felt very "slow motion". At approx. 1 pm, went back to vaccine area; felt like there was more effort to breath (heaviness); given epi-pen in ED, S/sx improved, Hydration started.
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. This spontaneous report was received from a physician, via a company representative, concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 17-DEC-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # L007720 Expiration date: 08-JUL-2018, 0.5 ml (route and anatomical location of administration were not reported). The sum of hours in excursion was 32 hours and the lowest recorded temperature reported was 34 Fahrenheit (F) (1.111111111 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.