chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (route, dose, and lot # not provided). The vaccine "did" function as intended [considered meant the vaccine did not function as intended] and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated at a hospital for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Information has been received from a medical assistant concerning a patient who was vaccinated with a dose of PNEUMOVAX (lot number 662785/1124X, route and site not reported). It was not known if this was the first dose of PNEUMOVAX for the patient. After vaccination the patient developed erythema, swelling and warmth at the site of injection and going down the arm and fever. The patient also developed abdominal cramps, nausea, pain and cold feet, and change in bowel movements (cycles of 2 large bowel movements, cramps, and constipation). The outcome was unknown. Additional information was received from the medical assistant. The patient was taking the following concomitant medications: SYNTHROID, aspirin and ASTELIN. The patient went to the emergency room but not admitted to the hospital. Follow-up information has been received from the medical assistant concerning an 80 year old female with CIPRO allergy (nausea, vomiting), chronic obstructive pulmonary disease, hypothyroidism and hypertension who on 02-APR-2009 was vaccinated with PNEUMOVAX (lot number 662785/1124X, route and site not reported) IM on 02-APR-2009 the patient experienced redness and swelling at the site of injection. The patient had fever, erratic heart rate, nausea, cold feet, burning back and burning stomach. The patient was sent to a emergency room. It was unknown if there was illness at th etime of vaccination. The patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
myelitis transverse; idiopathic polyneuropathy; Information has been received from a lawyer, regarding a case in litigation, concerning a female patient (pt) of unknown age. There was no information provided regarding the pt's concurrent conditions, medical history or concomitant medications. In or around May 2017, the pt was inoculated with the zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, anatomical location, and route of administration were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, reported as shortly after receiving the zoster vaccine live (ZOSTAVAX), the pt suffered transverse myelitis and idiopathic polyneuropathy. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX), the pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of the zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of company wrongful conduct, the pt suffered serious, progressive, permanent and incurable injures, as well as significant conscious pain suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The outcome of the events was not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX). The reporter considered the events to be disabling. Upon internal review the events were considered to be medically significant.
Nonspecific reaction, This case was reported by a healthcare professional via a sales representative and described the occurrence of nonspecific reaction in a child subject of unspecified gender who was vaccinated with combined DTaP and KINRIX, GlaxoSmithKline, and MMR vaccine (non-gsk) for prophylaxis. On 12 March 2009 the subject received unspecified dose of KINRIX (unknown, right arm) and unspecified dose of MMR vaccine (Non-GSK). KINRIX was given at night. On 12 March 2009, less than one day after vaccination with KINRIX and MMR vaccine (Non-GSK) at an unspecified time during the night, the subject experienced nonspecific reaction. The sales representative received an email from a nurse reporting that a child had received both MMR vaccine and KINRIX, both given in the same arm. The child developed a significant site reaction which was unspecified in the email. The nurse was unsure as to which vaccine may have caused the reaction. At the time of reporting the outcome of the event was unspecified.
N/A, Vaccine was given on 03.17.14 and expiration date was 03.15.14. PENTACEL from UFC stock.
2 days after patient reported arm soreness (pain with arm abduction over 90 degrees) and swelling at injection site; denies redness, fever, tender to touch; currently plans on starting ice treatment and contact clinic if not improved in next 5 days.
The child developed severe reaction with elevated temp, febrile seizure. He was admitted to the hospital and treated with epinephrine. Child also developed eye and lip swelling, respiratory difficulty, and injuration in the left thigh injection site.
Initial report received on 20 June 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of Pertussis disease in a 13-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; received on 16 June 2011, 16 August 2011 and 18 October 2011 (lot numbers, routes and sites of administration not reported). The subject developed a paroxysmal cough with posttussive vomiting on 28 May 2012, approximately six months after the last dose. No laboratory testing was done. Corrective treatments consisted of azithromycin starting on 04 June 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 18 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
On 10/27/04, pt noted burning sensation when given anthrax vaccine booster SC over left deltoid. Within 1-2 hrs pt experienced the onset of a frontal, dull aching headache, generalized body aches and chills. By 1400 he felt so bad he left work. When he awoke on 10/18/04 he continued to experience a dull aching headache, as well as chills, sweats, generalized body aches and stiffness and knee pain (r-l). Pt was able to carry out daily duties but noted symptoms on and off throughout the day. Also on AM of 10/28/04, pt noted local reaction. There was localized swelling, redness, pruritus and tenderness approx 80mm x 40mm surrounding the vaccine site. He presented on AM of 10/29/04 with above complaints. Treated with TID Motrin 800 mg and topical corticosteroid cream.
Myalgia, Fever, Chills, Sweats, Swollen Lymph notes to Left axillary  Narrative:
This spontaneous report was received from a licensed practical nurse (LPN) and refers to a 12 years old male patient. Information regarding the pertinent medical history, drug reactions or allergies was not provided. The patient's concomitant medication included MENVEO and diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid. On 04-AUG-2017 in the afternoon, the patient the patient received his second dose of VARIVAX that was improperly stored, Lot # N007930 with expiry date 08-MAR-2019 (dose, route and anatomical location not reported) that was reconstituted with sterile diluent (DILUENT MRK INJ) for prophylaxis. No adverse effects were reported. The administered dose of the vaccine underwent a temperature excursion between -9 ° Celsius (C) and 8 °C for 57 hours and 40 minutes. Previous temperature excursions were between -14 °C and -10 °C for 23 hours and 57 minutes; and between -9 ° C and 8 °C for a time frame of 4 hours and 43 minutes. The call was not placed because of a data logger. This report is one of multiple reports received from the same reporter.; Sender's Comments: US-009507513-1708USA009081: US-009507513-1708USA010551: US-009507513-1709USA012931: US-009507513-1709USA012932: US-009507513-1708USA010551: US-009507513-1710USA006528:
Patient received second dose of Pfizer vaccine, moved to recovery area and passed out while sitting in chair; patient fell from chair to ground. Per witness, patient slightly broke his own fall, however he did hit head on ground. Pt found lying on the ground, conscious and easily holding conversation. VS taken - 151/93, 80bpm, 95% on RA. Patient denied other symptoms, stated this has never happened before. EMS called to assess neuro status after hitting head. Pt refused transfer to hospital.
8MAY94 sl pruritic rash in face, torso, extremities DPH ordered; 11MAY94 numbness & heaviness in lt arm & leg;
Covid arm. Large, red area around injection site (size of my whole hand). Hot to the touch and tender as well. Itchy at times.  Hard and raised like a large lump which seems to be subsiding.  Still tender, hot and red but not as raised and  am 3 1/2 days post injection.
Throat tightness; difficulty swallowing; Slight feeling of general malaise; Slight arm soreness; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 14Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer- Unknown, Dose number unknown), for COVID-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 14Dec2021, outcome "unknown", described as "Booster"; MALAISE (non-serious) with onset 15Dec2021 09:00, outcome "unknown", described as "Slight feeling of general malaise"; VACCINATION SITE PAIN (non-serious) with onset 15Dec2021 09:00, outcome "unknown", described as "Slight arm soreness"; THROAT TIGHTNESS (non-serious) with onset 15Dec2021 11:30, outcome "unknown", described as "Throat tightness"; DYSPHAGIA (non-serious) with onset 15Dec2021 11:30, outcome "unknown", described as "difficulty swallowing". Follow-up on (15Dec2021 ) information included.  Updated Information : New Events Throat tightness, difficulty swallowing added. Additional information :Yesterday, after sending the report below, I also experienced throat tightness and difficulty swallowing (around 11:30am on 15Dec2021).
Sore arm (both doses) tired (mid-day naps required after dose 2/booster) fatigue, aching legs, drinking less coffee than usual (after dose 2/booster) All symptoms lasted 3 days after booster.
winded fast; panic attacks; fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (winded fast), PANIC ATTACK (panic attacks), PYREXIA (fever) and FATIGUE (fatigue) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included Bronchitis (started on antibiotics) and COVID-19 (11 days quarantined.) on 15-Jan-2021. Concurrent medical conditions included Fibromyalgia, Anxiety, Obsessive-compulsive disorder, Stomach discomfort and Hypertension.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced DYSPNOEA (winded fast), PANIC ATTACK (panic attacks), PYREXIA (fever) and FATIGUE (fatigue). The patient was treated with COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (winded fast), PANIC ATTACK (panic attacks), PYREXIA (fever) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, SARS-CoV-2 antibody test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included medications for blood pressure, OCD and Anxiety, Stomach issues.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: No new information.
At 1259 client aged 19yo, was vaccinated in her left arm with the Janssen vaccine lot#205A21A.  At 1306 client  requested a bottle of water as she reported feeling dizzy.  Vaccine monitor brought a bottle of water to vaccination room and immediately observed client's eyes begin to lose focus, so client was supported as she fainted, and placed safely on the floor with her legs elevated her legs on a chair and within seconds she regained consciousness. RN conducted a neuro-check on client and confirmed client was AxO x4.  The zero gravity chair was retrieved and EMT summoned, and at 1310 client was assisted to her feet by Co-Lead RN and RN and transferred to this chair.  At 1311 water was offered to client and she took a few sips and admitted she felt a lot better.  At 1312 EMT took client's first set of vitals which were: BP 110/70, HR 60, RR18, and O2 98%.  Co-lead confirmed with Vaccinator that client had been appropriately screened, that client had denied past syncopal episodes and had ate food today at 1000.   At 1314, Co-Lead RN asked client again if she had ever experienced syncope, and she admitted that she had once when visiting her uncle in the hospital. Co-Lead then educated client that it is not uncommon to faint due to anxiety related to medical procedures and encouraged her to report this to her physician and to any medical personnel in the future during medical procedures so proper safety precautions can be engaged.  Co-Lead then applied a cold pack to the back of client's neck, and EMT took a second set of vitals: BP 120/70, HR 63, O2 100%.  Client remained in the vaccination room 1328 when she felt well enough to walk to the observation room escorted by EMT to complete a 30 minute observation period.  At 1339 when EMT approached client to take her vitals again, client stated she was dizzy again, so EMT requested she remain for another 15 minutes and have a snack.  At 1400, client stated she felt better, her vitals were taken for the last time by the EMT: BP 110/60, HR 56, O2 98%, and EMT then escorted client downstairs where her mother was waiting with the car.  EMT and Co-Lead RN educated client to take it easy for the rest of the day and seek additional care with her PCP or Urgent Care if symptoms worsened.  EMT observed client ambulating independently with a steady, even gait.
No additional AE; doses were administered following the excursion; This spontaneous report was received from a physician referring to a 4-year-old patient. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.     On 14-DEC-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rha) (PROQUAD) lot # T021642, expiration date 21-DEC-2021, at a dose of 0.5 milliliter for prophylaxis (vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported).   The vaccine was stored in a temperature of 16.2 degree Fahrenheit (°F) for 1 hour 14 minutes as recorded by a data logger. There was no previous temperature excursion reported.
Information has been received from a pharmacist referring to 11 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 28-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
16 year old son given vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old son given vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old son given vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old son given vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.   Reporter did not allow further contact
A lot of brain fog and chest tightness the day after the vaccine. Brain fog has subsided partially and turned into chronic migraine headaches.   Chest tightness gets very bad randomly.
Patient itching badly, raised bumps, like big mosquito bites, primarily on arms, shoulders, and back. Left arm was hurting during the night. Mother has not called doctor yet but applied hydrocortisone and gave child Benadryl and has decreased scratching.
SkinRash Narrative:  patient had non itching non painful raised red hives 8 days after the first dose
Patient stated that when she came in for her second dose on 05/22/2021, that her right arm where she received her first dose on 04/24/2021, was still sore. She also stated that she had difficulty rotating her arm. The soreness went away and then returned between that month period.
Patient administered with the Moderna vaccine, which were beyond the 30day beyond use date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered with the Moderna vaccine, which were beyond the 30day beyond use date) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053c21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered with the Moderna vaccine, which were beyond the 30day beyond use date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered with the Moderna vaccine, which were beyond the 30day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient administered with the Moderna vaccine, which were beyond the 30day beyond use date).    Concomitant product use was not provided by the reporter. Patients administered Moderna vaccine monovalent beyond the 30 day beyond use date. Batch number 053C21A (BUD- 01Jul2021). No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Non significant Live Follow up; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Patients presented 4 days after injection with left arm swollen, red, warm and very firm at the injection site. Suspect cellulitis
Fever starting 2 hours after vaccination   Increased jaundice and hemolytic anemia in setting of patient with hereditary spherocytosis starting ~24 hours after vaccination
Sharp shooting pain down arm at time of injection.  Subsided quickly and then 20 minutes later arm got sore, painful to lift or move around. Icy feeling and aching when arm is quiet.  Painful to rotate shoulder. Some dizziness and lightheadedness.
08Jan2010 @ 7:50AM Received H1N1 flu shot (Sanofi lot# UP106AA)  08Jan2010 7:00PM Fever, body ache, sinus congestion, chills, cough  10Jan2010 Increased fever, body ache, sinus congestion, chills, cough  10Jan2010 @ 7:00PM Took Nyquil, 1 tspn  11Jan2010 Fever, body ache, chills  11Jan2010 @ 9:37AM Took Alka-Seltzer Plus Cold Formula, 2 effervescent tablets, Lot A9B10A)
Approximately around 2 -3 weeks after my 4th dose, I contracted COVID and had the following symptoms: Sore throat, Fever, Body aches, Stuffy head. I called my doctor and was prescribed with Paxlovid for 5 days and I took my last dose this morning (05/17/2022) and have been feeling better ever since. However, when I tested myself today using a rapid test - the result was still positive.
The pt developed hyperpyrexia of over 105 within 12 hours of vaccine and lethargy.
Patient was at home cleaning and experience a sudden onset of shortness of breath.  She felt her lungs close and she could not take a breath for about a minute. Then when she was able to breathe, she heart a whistling sound.  Her daughter called 911. By the time they got to the ER, she felt perfectly fine and the ER was full so she asked to leave.  Her bp was high in the ambulance 156/89, O2 sat 99% on room air. BMP, CBC, troponin and CXR in ER all normal.  She remained symptomatic so a CT scan of chest was done and  negative for PE on 04/05/21