chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from the nurse refers to unspecified number of patients. No medical history and concurrent conditions were reported. On an unknown date, the unspecified number of patients were inadvertently vaccinated with improperly stored PNEUMOVAX23 (lot number, dose, frequency and route of administration were not reported) and did not experience any adverse event. The outcome of the reported events were unknown. The reporter considered incorrect product storage to be not related to PNEUMOVAX23. No product quality complaint (PQC) was filed. No further information was provided. This is one of the 4 reports of the same reporter. Additional information has been requested.
broke out in rash w/in 5min of inj;alert, eye contact, response to verbal stimulation;
This case was reported by a nurse and described the occurrence of antigenemia in a 55 year old male subject who was vaccinated with Engerix-B for prophylaxis. Subject is currently a dialysis patient. Medical history included diabetes, cirrhosis,hypertension, alcoholism and athersclerosis. Concurrent medications included Lortab, Nephro-Vite, Plavix, Vytorin, and Amaryl. On or before July 25, 2006, the subject tested negative for hepatitis B. On 25 July 2006 at 16:30am, the subject received the initial dose of Engerix-B (40 mcg, left deltoid). On 27 July 2006, two days after vaccination with Engerix-B, the subject experienced antigenemia. At the time of reporting, the outcome of the event was unspecified.
Client c/o headache and dizziness.  Client seen and assessed by EMD and vital signs are:  BP 164/92, HR 76, O2 100%.  Client stated that symptom has decreased and cleared to go home.
A report was received from a health care professional on 22OCT2003 concerning a 45 year old male vaccinee who experienced low grade temperature and general body aches 12 hours after receiving Fluvirin on 17OCT2003. On an unspecified date , 12 hours after receiving Fluvirin, the vaccinee experienced low grade temperature and general body aches. The vaccinee recovered 12 hours later. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Cross reference with PJP200300876.
highest temperature of IPOL reached 53.6 F and the total excursion lasted 3 hours and 40 minutes and was administered post excursion with no reported adverse event; highest temperature of IPOL reached 53.6 F and the total excursion lasted 3 hours and 40 minutes and was administered post excursion with no reported adverse event; Initial information received on 27-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2022SA401711 (cluster).  This case involves a 4 years old male patient who was administered IPV (vero) [ipol] post excursion which was exposed to highest temperature 53.6 F and the total excursion lasted 3 hours and 40 minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (dtap); measles vaccine, mumps vaccine, rubella vaccine (MMR); varicella zoster vaccine (varicella vaccine); and influenza vaccine (influenza) for prophylactic vaccination (Immunisation).  On 26-Sep-2022, the patient received a 0.5 ml dose once of suspect IPV (Vero) (Suspension for injection) (lot: V1A121M; expiry date: 15-Feb-2024; strength: standard) via intramuscular route in the left thigh for prophylactic vaccination (Immunisation) after Ipol was exposed to highest temperature 53.6 F and the total excursion lasted 3 hours and 40 minutes with no reported adverse event (product storage error) (poor quality product administered) (latency: same day).   It was unknown if there were lab data/results available.  Action taken: Not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
TYLENOL given before bed at 8:30pm. Awoke & emesised, 2:30A. Ibuprofen given 3AM, awoke & emesis 6AM. Bath to clean emesis. Shaking. TYLENOL given 6:45A. 11A became unresponsive eyes rolled back, shaking all limbs. Seizure lasted 5-10 mins EMS called. Transported to hospital. Temp 101 degrees diagnosed with "febrile seizure".
Low grade fever, chills, fatigue, joint achiness, headache Fever and chills treated with acetominophen fever and chills resolved by next day fatigue and joint pain resolved by next day headache resolved in two days
little jolts of itching / had 2or 3 itchy pattern spots /nerve itching; also had pattern spots in areas that went away; feels like jolts of tingling; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced itchy rash, spot-like rash and tingling. On an unknown date, the outcome of the itchy rash and spot-like rash were unknown and the outcome of the tingling was recovered/resolved.   It was unknown if the reporter considered the itchy rash, spot-like rash and tingling to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced jolts of itching, had 2or 3 itchy pattern spots and felt like jolts of tingling after vaccination. The patient had not receive the 2nd dose if Shingrix. The patient asked whether there was a need to see the physician.
she has no strength and wants to sleep; feels lifeless; sweating; freezing; weakness; very tired; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in May2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed; but unknown manufacturer), for Covid-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset May2023, outcome "recovering", described as "feels lifeless"; PYREXIA (non-serious) with onset May2023, outcome "recovering", described as "fever"; FEELING COLD (non-serious) with onset May2023, outcome "unknown", described as "freezing"; HYPERHIDROSIS (non-serious) with onset May2023, outcome "unknown", described as "sweating"; FATIGUE (non-serious) with onset May2023, outcome "recovering", described as "very tired"; ASTHENIA (non-serious) with onset May2023, outcome "unknown", described as "weakness"; SOMNOLENCE (non-serious) with onset 31May2023, outcome "unknown", described as "she has no strength and wants to sleep". The events "very tired", "fever", "she has no strength and wants to sleep" and "feels lifeless" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had a dose of the Pfizer BioNTech COVID-19 bivalent vaccine and experienced sweating, freezing and weakness. She was very tired. She broke with a 101 degree F fever. She has no strength and wants to sleep. She feels lifeless. She went to the doctor and was feeling better but today (31May2023) she only wants to sleep. She was a healthy woman before. Today (31May2023) was the eighth day since she got the vaccine.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Difficulty breathing, wheezing, tightness in chest, erratic heartbeat, dizziness, slight swelling of tongue and throat, chills, achy joints, redness of eyes, thirst, fatigue. Patient took Benadryl, albuterol inhaler, inhaled steam, and relaxed. Worst symptoms resolved within 2-3 hours with some residual cough, chills, and soreness.  Patient fatigued through the next 24 hours.
sudden cardiac arrest that required intubation and defibrillation during this admission one day post vaccination.
Hives covering legs bilaterally within 5 minutes of receiving (Comvax , DPT, IPV and Prevnar). Benadryl was given 10 mins post vaccine. Hives faced over next 45 mins.   Follow up: No notation of what caused general hives.
Patient had slurred speech, headache, pain in the thigh muscles, bloody nose, lost strength in the arms, hands and legs, could not chew or swallow. She was diagnosed with Guillian Barre Syndrome and hospitalized from 04/04/2021-04/18/2021.
During screening process for second dose, was reviewing any reactions to first dose and pt stated had sore arm and experienced lip swelling.  Did not state how long experienced for nor did she state that she took any OTC medications for treatment.  Pt did not experience swealling of mouth or throat or difficulty breathing.
Parents noticed swelling and redness at site of vaccine the morning after the  vaccine. When patient came to office, site was warm to touch, red and swollen. Dr. dx with cellulitis. Dr. prescribed; clindamycin oral, probiotics and Benadryl.
Contracted COVID-19 infection; Contracted COVID-19 infection; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 64-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number was not reported) via an unspecified route of administration on 23Aug2021 (at the age of 64 years old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The patient was contracted COVID-19 infection and received Regeneron. She was told that could not get any vaccination for 90 days. Caller has not received her second dose of the Pfizer COVID-19 vaccine yet. Caller would like to know if she receives the second dose of the Pfizer COVID-19 vaccine 90 days or more after the first dose, does she have to start over the vaccination series.Therapeutic measures were taken as a result of contracted covid-19 infection (suspected covid-19). The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
pt recv vax 23SEP96 & pt had a negative titer prior to vax & a weakly positive titer (1.21) in NOV96;17DEC97 pt devel papulovesicular rash that looked like varicella, albeit atypical lesions;MD did not feel rash was chickenpox;exp tiredness
Burning tingling sensations chest pain heart pains I believe heart feels like it?s working harder
Rash and itching to face, arms, back. Child was given 25mg of BENADRYL.
should have had 3 full doses for the primary series and 2 halfdose boosters according to the recommendation; immunocompromised patient should have received a full dose, but received half dose; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (should have had 3 full doses for the primary series and 2 halfdose boosters according to the recommendation), UNDERDOSE (immunocompromised patient should have received a full dose, but received half dose) and NO ADVERSE EVENT (No adverse event) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised. Concomitant products included NATALIZUMAB (TYSABRI) for Immunomodulatory therapy.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (should have had 3 full doses for the primary series and 2 halfdose boosters according to the recommendation), UNDERDOSE (immunocompromised patient should have received a full dose, but received half dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (should have had 3 full doses for the primary series and 2 halfdose boosters according to the recommendation), UNDERDOSE (immunocompromised patient should have received a full dose, but received half dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (should have had 3 full doses for the primary series and 2 halfdose boosters according to the recommendation) and UNDERDOSE (immunocompromised patient should have received a full dose, but received half dose).    The patient received 4 doses of Moderna COVID-19 vaccine, 2 full doses and 2 boosters. Patient received 4th dose as a second booster.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-635832 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2022: Additional information received and included reporter details were updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-635832:
Information has been received from a licensed practical nurse concerning a female who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (route and administering site not reported). Subsequently the patient experienced atrial fibrillation. The patient believed this happened because of this immunization. The patient sought unspecified medical attention. It was noted that this was a new patient to the office and she had not been to the doctor in approximately 10 years. Additional information has been requested.
Patient stated that he felt lightheaded. He was told to sit down on a chair. A moment later, patient was found slumped over on his chair. Tapped on pt's arm to wake him up and pt woke up a few seconds later. pt drank some water and felt better. pt declined to call 911
Psoriatic arthritis related to a reaction to Moderna vaccine; Injection Site Bled; Can Feel Under Skin Where Injected; Gave injection and much of medication; This spontaneous case was reported by a physician and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis related to a reaction to Moderna vaccine) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    Previously administered products included for Diabetes: Insulin. Concurrent medical conditions included Diabetic.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg every two weeks. On an unknown date, the patient experienced PSORIATIC ARTHROPATHY (Psoriatic arthritis related to a reaction to Moderna vaccine) (seriousness criterion medically significant), INJECTION SITE HAEMORRHAGE (Injection Site Bled), PRODUCT ADMINISTRATION ERROR (Can Feel Under Skin Where Injected) and INCORRECT DOSE ADMINISTERED (Gave injection and much of medication). At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis related to a reaction to Moderna vaccine), INJECTION SITE HAEMORRHAGE (Injection Site Bled), PRODUCT ADMINISTRATION ERROR (Can Feel Under Skin Where Injected) and INCORRECT DOSE ADMINISTERED (Gave injection and much of medication) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Concomitant administered medication could be potentially confounders/co-suspects for the events.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Concomitant administered medication could be potentially confounders/co-suspects for the events.
pt recv vax 11DEC96 & 27JAN98 pt devel a rash typical of varicella (huebnus clestial phenomenon) full bloom chickenpox, greater than 50 lesions;MD noted that the number of lesions too numerous to count;rash was not limited to any one area;
Patient was transferred from ancillary facility with complaints of fatigue, generalized weakness, and mild shortness of breath. Was found to be COVID-19 positive. Patient was admitted for further management of infection.  He is still admitted at time of writing.
Patient developed red rash (not hives) sporadically located and below injection site. He states that the onset of rash occurred hours after the 2 vaccines. He felt like he had a fever but it did not appear to be cellulitis. I still referred him to be seen by a doctor just to be sure. Doctor believed that diabetes complicated the vaccine administration and caused him to react the way he did. Doctor prescribed cephalexin the following night after immunization. Patients arm cleared up.
Patient began to experience dizziness, nausea, vomiting, and tremors 3 minutes after vaccine was administered. A code blue was immediately called and patient was examined by provider. Vitals were take and paramedics were called immediately. Patient was transported to Hospital for further evaluation.
has been feeling really bad, ¨i have never felt this bad before; my body hurts really bad; bone pain; chills; have been tired all day, can´t wake up from bed; Legs hurt a lot; is not able to walk due to the pain; think she has fever; terrible headache; arm is really sore and hurts; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (has been feeling really bad, ¨i have never felt this bad before), MYALGIA (my body hurts really bad), BONE PAIN (bone pain), CHILLS (chills) and FATIGUE (have been tired all day, can´t wake up from bed) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 01-Apr-2021, the patient experienced FEELING ABNORMAL (has been feeling really bad, ¨i have never felt this bad before), MYALGIA (my body hurts really bad), BONE PAIN (bone pain), CHILLS (chills), FATIGUE (have been tired all day, can´t wake up from bed), PAIN IN EXTREMITY (Legs hurt a lot), GAIT INABILITY (is not able to walk due to the pain), PYREXIA (think she has fever), HEADACHE (terrible headache) and MYALGIA (arm is really sore and hurts). At the time of the report, FEELING ABNORMAL (has been feeling really bad, ¨i have never felt this bad before), MYALGIA (my body hurts really bad), BONE PAIN (bone pain), CHILLS (chills), FATIGUE (have been tired all day, can´t wake up from bed), PAIN IN EXTREMITY (Legs hurt a lot), GAIT INABILITY (is not able to walk due to the pain), PYREXIA (think she has fever), HEADACHE (terrible headache) and MYALGIA (arm is really sore and hurts) outcome was unknown.
Narrative: No documentation located in the chart describing ADR apart from 11/19/21 PCP note report that "(Patient) reports that he had reaction to pfizer COVID vaccines...needing exemption to avoid getting booster. Per Agency rash is a documented hypersensitivity reaction to the Pfizer COVID-19 vaccine.
Headache, Myalgia, Arthralgia, PAIN AT INJECTION SITE, CHILLS, FATIGUE Narrative:
5-11 COVID vaccine not diluted. 0.2mL of undiluted vaccine administered to left arm. After drawing up 5th dose of vial LVN noticed there was not sufficient amount for all 10 doses. LVN realized the vial was not diluted. LVN notified MD.
Patient inadvertently given a hepatitis A at 4 months of age and developed fussiness.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2013, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unspecified date in 2014, the patient was treated  for a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the 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 (emotional distress), and other damages.  The outcome of the events was unknown. Causality assessment was related.
4 days following shot, Oct. 30, severe dizziness. Ringing in ear. ER->Doctor->ENT. Started 60 mg prednisone. Symptoms persist 2 wks later.
When I got the vaccine, immediately within like 5 minutes I started having a lot of pressure in my chest, it felt like a band going around my chest. They had me sit there for 45 minutes. Everything looked fine. The chest pressure went away in about 30 minutes. I had flu like symptoms for a couple of days. But then I started experiencing a lot of fatigue. About a week and a half later I went to the ER because I had chest discomfort, fatigue, and I was not feeling well. They said my blood work and EKG were fine. They think my autoimmune disease was acting up. On Sunday I started feeling bad. I got tested for Covid and it was negative. They thought it might have been too soon to get tested. They did not see me at my doctor's office because I had Covid like symptoms even though I tested negative. I have been having coughing, sneezing, fatigue, headaches. I do not have a fever. I had to go to urgent care instead.