chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe pain at the injection site; This spontaneous report was received from a nurse referring to 4 patients of unknown age and gender. There was no information about the patients' concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.  On an unknown dates, some of the patients received a first dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(lot# S027047, expiration date was 20-MAY-2021), and some of the patients received 2 other unspecified lot numbers pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(strength, dose, frequency and route were not reported)for prophylaxis.   On an unknown date (reported as a few hours after vaccination), the patients experienced severe pain in their entire arm. They sought medical attention and called to the clinic. The outcome of the event was reported as recovered (reported as the pain resolved after a week or so). The causality between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.  This is a non-valid case due to lack of patient identifier.  Follow up information has been received from a medical assistant via company representative on 11-DEC-2019 refers to an elderly patient. No product quality complaint (PQC) was involved with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1912USA006268: US-009507513-1912USA006286:
itchiness; with warmth; they had injection site redness, with warmth to touch and one of them said that the redness; injection site redness; the word hives spread down their arm; Initial information received on 18-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer..  This case is linked to cases 2019SA327309 and 2019SA327308.  This case involves female patient (age not reported) who experienced itchiness (pruritus), they had injection site redness, with warmth to touch and one of them said that the redness (vaccination site inflammation) and  the hives spread down their arm (vaccination site urticaria), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  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 QUADRIVAL A-B VACCINE lot UT6719KA via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious itchiness (pruritus), they had injection site redness, with warmth to touch and one of them said that the redness (vaccination site inflammation), the hives spread down their arm (vaccination site urticaria), with warmth  (vaccination site warmth) and injection site redness (vaccination site erythema) unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Other relevant tests were not reported.  Final diagnosis was pruritus, vaccination site inflammation and vaccination site urticarial.  It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown.
Got sick and end up in bed for several days; Initial information was received on 28-Oct-2021 regarding an unsolicited valid serious case from a consumer (patient) via Social media.  This case involves an adult patient of unknown gender who got sick and end up in bed for several days (illness), after receiving INFLUENZA VACCINE.  The patient's past vaccination(s) included INFLUENZA VACCINE for prophylactic vaccination and got sick (illness). The patient's medical history, concomitant therapy, medical treatment(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 and expirydate not reported) via an unknown route at an unknown administration site for prophylactic vaccination  On an unknown date, the patient got sick and end up in bed for several days (illness; serious) (unknown latency) following the administration of INFLUENZA VACCINE. This event was lead to disability.  Patient took flu shot every year and end up in bed for several days and when he/she did not get the flu shot was not sick at all.  It was unknown if the patient experienced any additional symptoms/events.   Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, outcome of the event was unknown.  Information on the batch number was requested.; Sender's Comments: This case concerns a patient of unknown gender who experienced illness after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. Additional information regarding concurrent condition at the time of vaccination and lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Information has been received from a pharmacist concerning a male with no allergies and a history of recurrent shingles who in April 2007, was vaccinated subcutaneously with a dose of Zostavax (Oka/Merck).  Since being vaccinated, in 2007, the patient developed two outbreaks of shingles on the same hip.  At the time of this report, 11-DEC-2007, the patient is currently recovering from his second outbreak since his vaccination.  The area is about 2 inches in diameter.  It was unspecified if medical attention was sought and no laboratory or diagnostic tests were performed.  No product quality complaint was involved.  Additional information has been requested.
senior citizen has prescription for BEXSERO; This case was reported by a consumer via call center representative and described the occurrence of off label use in a elderly female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   The patient's past medical history included splenectomy.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The reporter was the patient. The age at vaccination was not applicable. The patient had a prescription for Bexsero from her infectious disease doctor and had not yet received the vaccination. She stated that she had a splenectomy and described herself as a senior citizen, which led to off label use.  The patient did not consent to follow-up.
Narrative:  68yo male Pt - H&R per Md note on admission on 12/22/2021 "CC:acute on chronic hypoxic hypercarbic respiratory failure 68y.o.  MALE with h/o HGpEF (EF 45% in 2017), COPD on 2L O2, morbid obesity, HTN, HLD, IDDM2, OSA and anxiety presents as a transfer from  Hospital for acute on chronic hypoxic/hypercarbic respiratory failure.  Patient is intubated and sedated so history obtained via outside records and patient's wife. Patient's wife states that for the past month he has  had difficulty waking in the morning taking 1-1.5 hours to wake up then over the  last few days started complaining of progressive shortness of air. She checked his  O2 sats at home and was found to be 75% so called EMS and was taken to  Hospital. She denies any recent fever, chills or cough. Does endorse orthopnea and sleeps in a hospital bed at home as well as progressive LE edema for the last 1-2 months. He was admitted for COPD and CHF exacerbation 1 month prior. On arrival to hospital on 12/20 he was somnolent with ABG showing 7.25/85/82/36 on 7L. He was started on IV steroids, duonebs as well as diuretics with concern for COPD exacerbation vs decompensated HF. He was started on BIPAP with minimal improvement so elected for intubation. First intubation  attempt was unsuccessful and patient became bradycardic and went into asystole arrest. He received 3 of epi, 1 of atropine and was eventually intubated and ROSC obtained and he was transferred to Specialist Hospital as multiple other hospitals refused  him due to limited ICU beds. Medical Hx: HFpEF (EF 50% in 2017), COPD on  2L O2, CAD, morbid obesity, HTN, HLD, IDDM2, OSA and anxiety Surgical Hx: Gastric bypass, cardiac catheterization w/ 90% occlusion of L circumflex w/ angioplasty 2015" Pt was admitted to ICU at hospital on  12/22/2021. Pt then died on 12/25/2021 during this admission. "Death was caused by: Severe Anoxic brain injury 2/2 AHRF" per Md death note. Per MD note on 12/25/2021 "Assess:Anoxic encephalopathy 2o to cardiac arrest during attempted intubation at Hospital". Pt had received covid vaccines on 2/26/2021 & 3/26/21. This death is not related to covid vaccines.
feet were warm; rapid test came back positive; felt very tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (feet were warm), SARS-COV-2 TEST POSITIVE (rapid test came back positive) and FATIGUE (felt very tired) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041220A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced FEELING HOT (feet were warm), SARS-COV-2 TEST POSITIVE (rapid test came back positive) and FATIGUE (felt very tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 29-Jan-2021, FEELING HOT (feet were warm) and FATIGUE (felt very tired) had resolved. At the time of the report, SARS-COV-2 TEST POSITIVE (rapid test came back positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Severe nausea, vomiting, severe headache, sick in stomach, sensation of diarrhea but no actual diarrhea happen, chills, shoulder muscle ache.  Had an acupuncture treatment.
35 y/o ADAF with multiple symptoms within 30 minutes of receiving H1N1 on 7 July 2010. Service member (SM) received vaccine in her left arm and within 10 minutes, clinic staff noted "puffy eyes" and SM was asked if she was okay. She initially reported she was feeling fine, but within minutes began to c/o chest pain, arm pain, itchiness and was taken to the ER. In the ER, physical exam and ECG were normal. SM was treated with oral ZANTAC, BENADRYL, and KCl (Potassium level 3.3), IV TORADOL and Albuterol neb with symptoms resolved upon discharge. On 8 July, at follow up visit, symptoms reported following vaccine included chest pain, stomach and left arm pain, puffy/watery eyes, itchiness to fingers, left side of tongue, arm, chest, leg and ear. SM noted to be "doing much better...having some residual fatigue". However, during follow-up phone call on 30 July, SM reported continuing sharp chest pains and "just doesn't feeling right".
vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
3-4 days after receiving Zostavax developed herpes zoster in V. nerve distribution.
student presented to center with red, swollen , painful right deltoid at site of injection about 2cm or more in diameter
Rash on feet, legs, thighs, and forearms and painful calves cramps while standing and walking. Started Prednisone on Tuesday March 16th until April 2dn. 4x/4days, 3x/4days, 2x/4days, & 1x/4days.
Suspected case of GUILLAIN-BARRE SYNDROME: Received the jab 5 days ago on 8/9/21 - two hours after receiving the injection to the right arm my face numbed up with tingling especially pronounced in the jaw and thick tongue felt similar to the numbing effect after a dentist appointment. Awkward trying to move my jaw around. Face tingling was worst the first day and symptoms were more mild the next day regarding tingling in the face but have been consistent and ever present.  8/11 numbness in legs after a long walk. Today 8/14 tingling/numbness continues in the face and the lymph nodes behind my jaw are swollen and today observed numbness and pain in both legs pain is a rated a 3 out of 10 with 10 being most severe
Patient developed red raised rash bumps on top half of body, including arms, neck, chest, back which itched significantly.  We gave her oral diphenhydramine 50mg within 15 minutes of reaction, which relieved the itching and no further outbreak occurred under our observation which for approximately one hour after.
I had body aches, fatigue, sore throat, congestive, and fluid in both ears.  I also had nausea, diarrhea, and a headache.  These symptoms are still ongoing after 7 days.  I went to my doctor on the Dec. 29th.  They did a Covid-19 test, positive results.  They did a flu test, negative on that.
patchy vesicular rash radiating from inj site outwards towards groin & to knee;started as rash around site & becoming progressive more extensive;mom though looked like poision ivy;31JAN96 f/u w/MD probably was poision ivy;
headache, fatigue. nausea, diarhea, congestion in head, congestion in chest, runny nose
PAIN IN THE RIGHT KNEE; INFECTION IN THE TOP RIGHT TOOTH/SHOOTING PAIN IN THE TOP RIGHT FRONT TOOTH; PAIN IN RIGHT ARM/FEELING OF A SPLINTER MOVING UP DOWN IN THE RIGHT SHOULDER/PAIN MORE IN THE CUFF AREA; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no history of other life style changes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 07-AUG-2021) dose was not reported, administered on 08-JUN-2021 for prophylactic vaccination. Concomitant medications included lisinopril. On 18-JUN-2021, the subject experienced pain in right arm/feeling of a splinter moving up down in the right shoulder/pain more in the cuff area. On 06-JUL-2021, the subject experienced infection in the top right tooth/shooting pain in the top right front tooth. On 12-JUL-2021, Laboratory data included: X-ray (NR: not provided) Tooth infection. On 19-JUL-2021, the subject experienced pain in the right knee. Treatment medications (dates unspecified) included: amoxicillin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in the right knee on 19-JUL-2021, and pain in right arm/feeling of a splinter moving up down in the right shoulder/pain more in the cuff area on 21-JUN-2021, and had not recovered from infection in the top right tooth/shooting pain in the top right front tooth. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non serious.
Information has been received from a registered nurse concerning a "couple of female patients" who were vaccinated with a 0.5 ml dose of Gardasil. Subsequently, the patients' experienced syncope. The nurse stated that the events were not reported because there were no adverse outcomes and most of the patients' had a history of fainting. Unspecified medical attention was sought. At the time of this report, the patients' recovered. No product quality complaint was involved. Additional information is not expected.
Mild Reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Mild Reaction) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Mild Reaction). At the time of the report, VACCINATION COMPLICATION (Mild Reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported. No treatment details were reported.
10MAY93 pt inadvertently recvd vax ID instead of PPD mantoux; pt exp 10 cm of erythema @ site of administration; No other reactions reported; pt recovered w/no sequelae;
The History & Physical dated Jan 25, 2021 indicates, "Patient is a 37 Y at 34w2d presenting with leakage of fluid. She had a large gush of fluid at roughly 0600 this morning. Since that time has been leaking clear fluid intermittently. She denies contractions, no vaginal bleeding. Good FM. She denies any dysuria, hematuria, foul-smelling discharge, fevers or chills."
This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age an gender. No information regarding the patients' concurrent conditions, medical history and concomitant therapies was reported. On unknown dates, the patients received incorrectly stored doses of RECOMBIVAX HB (dose and route of administration were not reported) lot # M044032, expiration date: 03-JUL-2019. No adverse effects were reported. The vaccines were stored in 48 degrees Fahrenheit for 36 minutes. The temperature excursion was detected by a 'Digital Data Logger'. There were no previous temperature excursions. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA009664: US-009507513-1705USA004464:
Swelling under right arm pit for 3 to 4 days. Self apply pain relieving patches that contains Methyl salicylate 10.0%, Menthol 6.0%, Camphor 3.1% for 4 days before the swelling slowly disappear.
Swollen left axillary lymph nodes - 11/19 CT Scan Pain in left axillary  Upper and lower back and shoulder pain - still experiencing now for about 3 weeks Chest pain Extreme fatigue- currently  Stomach aches Metallic / bitter taste in mouth Weakness that rotates on both side starting with leg  going out and tensing up leading to affecting both sides
Tdap was given 1yr after child recieved Td. Immunization record presented at time of vaccination was incomplete. The child showed no adverse symptoms after administration.
26 year old male who presented with progressive right eye vision loss; painless. Had ? hemorrhage. Also had blood in anterior chamber. Was sent for further care. Told had optic neuritis.
I got it an inch from my old small pox vaccine scar and the spot where the covid vaccine is is fine but  my small pox scar is slightly inflamed and raised and red; I got it an inch from my old small pox vaccine scar and the spot where the covid vaccine is is fine but  my small pox scar is slightly inflamed and raised and red; I got it an inch from my old small pox vaccine scar and the spot where the covid vaccine is is fine but  my small pox scar is slightly inflamed and raised and red; I got it an inch from my old small pox vaccine scar and the spot where the covid vaccine is is fine but  my small pox scar is slightly inflamed and raised and red; This is a spontaneous report from a contactable consumer. A 25-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection via an unspecified route of administration, administered in Left Arm on 26Aug2021 16:45 (Batch/Lot number was not reported, expiry date: unknown) as dose 1, single for COVID-19 immunisation from Pharmacy or Drug Store. Medical history included bipolar, epilepsy and covid-19. Concomitant medications included levetiracetam (KEPPRA), lamotrigine, and quetiapine fumarate (SEROQUEL). All were taken for an unspecified indication, start and stop date were not reported. No known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient had received other medications within 2 weeks prior to the vaccination includes Keppra, Lamotrigine, and Seroquel. Prior to the vaccination, the patient was diagnosed with COVID-19, and post the vaccination, the patient had not been tested for COVID-19. On 28Aug2021 at 12:00, the patient experienced i got it an inch from my old small pox vaccine scar and the spot where the covid vaccine is is fine but my small pox scar is slightly inflamed and raised and red. The patient had not received treatment for all the events. The outcome of the events was not recovered.  Follow-up (07Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Bad headaches, tingling and numbness in hands and feet, getting weaker, unable to move around. Getting very weak. Knew it was GBS. Went to hospital for plasmas exchange. Has had GBS before. Worried about taking Covid vax. Needs walker to get around. Taking physical therapy at home.
This literature marketed report has been received from the authors of a published literature article, and refers to a 30-month-old patient of unknown gender. The patient's concurrent condition included Ataxia Telangiectasia, reported as inherited immunodeficiency and cutaneous granuloma. The patient's medical history and concomitant medicines were not reported. On an unknown date at age of 24 months, the patient was vaccinated with a dose of M-M-R II (exact dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date, the patient developed immunodeficiency-related vaccine-derived rubella virus (iVDRV). The patient had skin involvement that was described as initially psoriasiform or resembling pyoderma gangrenosum. The patient had chronic inflammation in skin where the rubella was detected by immunofluorescence or polymerase chain reaction (PCR). The rubella capsid protein was detected and the iVDRV strain with multiple non-overlapping mutations was identified in the skin biopsy by sequencing viral genome. The patient's CD3 count was 240 cells/uL, CD4 count 153 cells/uL, CD19 count 77 cells/uL and natural killer (NK) cell count 184 cells/uL. The authors assessed CD3 and CD4 count as low, and NK count as normal. The patient underwent antimicrobial treatment (cryotherapy, erythromycin, imiquimod) and immune modulatory treatment (tacrolimus cream, hydroxychloroquine, topical steroids). Both treatments were unsuccessful, but prednisone given orally led to some improvement. The patient was additionally treated with intravenous immunoglobulin (IVIG) still without improvement. Nitazoxanide was used for one year, largely as salvage therapy in this extremely ill patient but it had no obvious benefit. Granulomas progressed with persistent rubella on repeated biopsy. At the time of the report, the patient did not recover from the rubella. The authors considered the iVDRV to be related to M-M-R II. Upon internal review, the iVDRV was determined to be medically significant as the patient was treated with intravenous immunoglobulin therapy. This is one of seven reports derived from the same literature article (linked 902USA003143, 1902USA004784, 1902USA004785, 1902USA004786, 1902USA004787, 1902USA004788). Sender's Comments: US-009507513-1902USA003143.