chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Report 20010047761 describes injection site pain in a 34 year old female who received hep B vaccine for prophylaxis of hep B. This report was received from a person of unspecified professional identity and has not been verified by a physician or other healthcare professional. Allergies, medical history, and concomitant medications were not specified. On 02/06/2001, the vaccinee received her first IM dose of Engerix-B. Post vaccination, on 02/06/2001, she experienced "severe" pain at the injection site. The vaccinee complained of soreness for two days after the immunization. No treatment was given. Engerix B was not discontinued. As of 02/12/2001, " the pt is ok."
103 fever, congestion, nausea, headache, chills, muscle pain, insomnia
Patient admitted for metastatic lung cancer and discharged 6 days later to a long-term care facility.
Stroke paralyzed right side, able to walk slowly, talk, still no use of right arm. Physical therapy since 2 days after stroke, still in therapy.
Presented to pharmacy 3/14 with redness / rash at injection site. Patient was told to monitor but redness at injection site was normal. n 3/15 presented to pharmacy with a large upper body rash and rash on neck. Rash is itchy.
Generally healthy 3 yo male developed vesicular rash on L knee which spread rapidly up thigh, hip, buttocks. No fever but pain, itching and limp. Large 3-4cm clusters of vesicles with confluent erythema in the L2-L3 dermatome. Suspected varicella exposure at day care. This is the worst case of shingles I've seen in 13 yrs of pediatric practice.
This report was received from Pfizer and was assigned manufacturer report number 2010122964 concerning a 61 year old elderly patient with IgG and IgA deficiency who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot# unknown). The physician reported that the patient was given PNEUMOVAX 23 and had no immune response. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. This was originally reported by a physician. Additional information has been requested.
a 9 month old patient who received Havrix.; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-month-old patient who received HAV (Havrix) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a 9 month old patient who received Havrix.). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 11-JUL-2023 The healthcare professional asked if it was a valid dose or if the patient still needed 2 doses. The reporter did not provide any information about the patient nor the Havrix dose administered, since she mentioned that this event happened at a different office. The reporter called to ask for information regarding a 9-month-old patient who received Havrix, which led to inappropriate age at vaccine admisnitration.
Dizziness lasting 10 days, starting two days after shot administered.  Mild nausea
Foggy headed (confusion), felt cold, leg pain, low pulse rate, maladministration (above recommended age), tired, weak - report 2001015290-1 described foggy headedness in a pt who rec'd Lyme disease vaccine recombinant OspA (Lymerix) for the prevention of Lyme disease. This report was rec'd from the pt and has not been verified by a physician or other HCP. Reportedly, the pt is allergic to all narcotics and to Robaxol. Reportedly she has had arrhythmia's (NOS) for approximately 5 years which were treated with metoprolol (Toprol XL). On 5/31/01, the pt rec'd her 1st dose of Lymerix, she was above the maximum recommended age for immunization. Subsequently, on 5/31/01 she reportedly felt weak and tired. On 6/1/01, reported, she experienced extreme fatigue and felt cold to the bone. The fatigue and coldness persisted on 6/2/01, and she then experienced leg pains and a low pulse rate (50-52 beats per min) all day. She contacted her physician who reportedly feels all adverse events (were) related to vaccine. On 6/3/01, all symptoms continued and she reported that she began feeling very foggy headed. On 6/4/01, she reportedly started to feel better. However, her symptoms did not completely resolve for approximately 2 wks after the vaccine was administered. As of 6/20/01, the adverse events had resolved. The adverse event of foggy headedness does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the 6/28/00 letter. The follow up states that the vaccinee was allergic to "all" narcotics, to Robaxil, and to sulfa. Her medical history included hysterectomy, upper back mass NOS, osteoporosis and plantar fasciitis. She received montelukast sodium. On 05/23/2001, the vaccinee received her first .5cc right deltoid dose of LYMErix; she was above the maximum recommended age for immunization. When seen by the physician on 05/23/2001, she complained of a sore right heel and a tick bite. She had a macular rash on the thigh and right abdomen. Impression: rule out Lyme secondary to tick. Amoxicillin three times daily for three weeks was prescribed. Subsequently, on 05/31/2001, she reportedly felt weak and tired. On 06/01/2001, she experienced extreme fatigue and felt "cold to the bone." The fatigue and coldness persisted on 06/02/2001, and she then experienced leg pains and a low pulse rate all day. She contacted her physician, who reportedly "feels all adverse events were related to vaccine." On 06/03/2001, all her symptoms continued and she reported that she began "feeling very foggy headed." On 06/04/2001, she reportedly started to feel better. However, her symptoms did not completely resolve for approximately two weeks afterthe vaccine was administered. As of 06/20/2001, the adverse events had resolved.
info has been received from a CMA concerning an 8 year old female with no medical history or allergies who on 7/7/98 was vaccinated, SC, with a 0.5 mL dose of varicella virus vaccine live (lot 25043/1567E). There was no concomitant therapy. The CMA reported that on 1/25/06, the pt broke out in a diffuse "pox-like" rash. No fever or other symptoms were noted. Unspecified medical attention was sought, but no treatment or lab/diagnostic testing was required. At the time of this report, the pt was recovering from her "pox-like" rash. Additional info has been requested.
Beginning in October 2021, I began experiencing episodes  where I would get a sensation in my right nostril followed by numbing on the right side of my face, sweating, severe dizziness, labored breathing, slurred speech and blackouts. I went to Hospital on 10/16/21 where they did blood work EKG and Cat Scan. I then went to my Cardiologist and he had me schedule appointments for ENT and Neurologist. After visiting the ENT he instructed me to ask my cardiologist for a Heart Monitor. On December 1st I received the monitor and on December 3rd after having an episode at 630am i was later contacted and told my heart had paused for 7 seconds. I was called later that day and told to report to the heart doctor on Sunday December 5th where i was told i would be admitted to the hospital for further testing. On Monday December 6th around 8am i experienced another episode where my heart paused for 5 seconds. around an hour to hour and half later i experienced another episode where my heart stopped for 9 seconds. They performed an ECHO cardiogram and later told me i would need emergency surgery for Pacemaker placement to alleviate my heart from stopping. Surgery was around 2:20 pm that afternoon. Now that I have the pacemaker, my heart is no longer stopping but I still experience the episodes. I still get the right nostril sensation, numbing in my face and the sweating. I was told by the Dr.s that the ECHO cardiogram shows my heart is excellent condition and they believe a nerve is causing this problem.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: dry rash
Information has been received from a health professional concerning a 72 year old white female with no known drug allergies who on 29-JAN-2007 was vaccinated in the left deltoid with a first dose of Zostavax (lot # 656413/1477F). Concomitant vaccination the same day included a dose of Pneumovax. Other concomitant medication included CELEBREX, DIOVAN, EFFEXOR XR and alendronate sodium. No illness was noted at the time of vaccination. On 29-JAN-2007 the patient started vomiting and had a rash for two days. The vomiting lasted 24 ours. Medical attention was not sought. It was reported that the patient had no adverse events following prior vaccinations. Additional information has been requested.
Child developed chicken pox. 2 weeks later 9 month sibling developed chicken pox. Sibling too young for vaccine. Nurse follow up on 05/20/04 states: None.
The patient lied about having received this covid vaccine previously, in order to get a booster shot, so he actually received his 3rd dose from us instead of his first dose.  His 1st and 2nd dose were given at the Health Dept in Feb 2021.
Moderna COVID-19 VAccine EUA Red, hot, sometimes itchy arm at site of injection. Minor pain 4-5 inches long and 3 inches wide.  Trying ice and Zyrtec.
First night (7/26) rigors Second night (7/27) Low grade temperatures with night sweats Third, Fourth and Fifth Nights (7/28,7/29.7/30) light red rash neck and arms; itchy
A non-serious spontaneous report of "administration of expired product" and "vaccine given to a patient" was received from a non healthcare professional concerning a 84-year-old male out of 18 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 15-Jan-2010. On 20-Jan-2010, the patient received expired H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered resolved.
mom states p/vax pt turned purple, eyes rolled back in head & sz like activity;seen in ER & told had an allerg rxn to immun;was given APAP & sent home;shaking, lips purple & trouble breathing;+ runny nose;glassy eyed;shallow resp;
TIREDNESS; ANAPHYLAXIS (SEVERE ALLERGIC REACTION, ITCHING IN HAND AND NAPE OF NECK, VOIDED AND VOMITED FOR THREE HOURS, SWELLING IN HANDS, SWELLING ON FACE, RED HANDS AND LEG AND DRIPPING WET WITH SWEAT); SLEPT FOR MOST OF THE NEXT DAY; GENERAL MALAISE; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis, penicillin allergy, and allergy to wasps. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 025A21A, expiry: UNKNOWN) dose was not reported, administered on 29-APR-2021 at right arm for prophylactic vaccination. Concomitant medications included naproxen sodium for arthritis, chlorphenamine maleate for itchy skin, cyanocobalamin, and fluticasone propionate. Patient experienced tiredness, some general malaise and slept for most of the next day of vaccination, but did not experienced other significant symptoms after the vaccination. However, on 29-JUN-2021, patient had severe allergic reaction included anaphylaxis and her hand started itching then swelling spread to the hands and face. She had put her hands under cold water and by then they were completely red, Legs then became red, then the nape of the neck began to itch, She was dripping wet with sweat at that point. She then had to immediately get to the bathroom as she voided and vomited for the next three hours. EMS was called at 10 o'clock and was taken to the hospital. At the hospital no medications were given. Vitals were fine, Blood pressure was 128/76 mmHg, pulse was 83 bpm, and oxygen saturation was 97%. Treatment medications (dates unspecified) included: epinephrine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slept for most of the next day on 30-APR-2021, and the outcome of general malaise, anaphylaxis (severe allergic reaction, itching in hand and nape of neck, voided and vomited for three hours, swelling in hands, swelling on face, red hands and leg and dripping wet with sweat) and tiredness was not reported. This report was serious (Other Medically Important Condition).  Version created to amend previously reported information on 02-JUL-2021. Upon review the following information was amended: Onset date for event general malaise was updated in event section and vaccination site was updated into the narrative.; Sender's Comments: V1: This version is updates, Onset date for event general malaise and vaccination site. This does not change the causality of the previously reported events. 20210710040-COVID-19 VACCINE AD26.COV2.S-anaphylaxis. This event(s) is labeled per Safety Information and is therefore considered potentially related.
Report received from a paramedic/fire fighter on 05-Nov-2008. Reporter stated that four patients experienced flu-like symptoms (nasal congestion, chest tightness, general muscle aches, and malaise). One out of the four experienced chest congestion (see case 200914610). All four patients received the AFLURIA dose on approximately 29-Oct-2008 and experienced the adverse effects three days later (01-Nov-2008). As of 05-Nov-2008, all symptoms are milder for all patients. No patients went to the emergency room. (See cases 200914591, 200914609, and 200914610). Several attempts have been made to the reporter to confirm and verify the number of patients involved. To date, reporter has not provided a response. Patient outcome is unknown. No further information is expected. The manufacturer considered causality as possible in relation to the administration of AFLURIA. Information derived from this ADR report does not change the current safety profile of the product.
This spontaneous report as received from a Licensed Practical Nurse refers to a 14 year old male patient. Medical history and concurrent conditions were not provided. On 15-FEB-2011, the patient was vaccinated with a dose of GARDASIL, received other dose on 09-FEB-2015 (inappropriate schedule of drug administration) and another dose on 11-APR-2015 (dose, route, lot number and expiry date were not reported). No adverse experience had been observed or reported. There was no concomitant medication provided. Additional information has been requested.
Vaccine Reaction; Warmth, swelling, raised red welts on arm around injection sites; Nausea,  dry heaving;  Hasn't eaten anything; Difficulty sleeping; Never had reaction to any immunizations before;  Malaise;  Took tylenol, hasn't taken anything else.
Information has been received from a registered nurse concerning a 16 month old male with Down's syndrome and cardiac issues, and a history of atrial septal defect and ventricular septal defect (repaired in January 2008) who was orally (via feeding tube) vaccinated with three doses ROTATEQ (1st lot #659682/1733U, 2nd lot #656184/0558U, and 3rd lot #659855/1692U) on 26-FEB-2008, 21-APR-2008 and 01-JUL-2008, respectively. The patient had no known drug allergies. Concomitant therapy included famotidine (MSD) and REGLAN. On 08-MAY-2009 the patient developed rotavirus. He experienced diarrhea and was very lethargic. On 09-MAY-2009, the patient was admitted at a hospital and was still hospitalized at time of reporting. The patient was diagnosed with rotavirus. The patient was recovering at time of reporting. The patient went to hospital for medical attention. Additional information has been requested.
Information has been received from a medical assistant concerning a 46 month old male with no known drug allergies and no past medical history who on 01/14/1999 was vaccinated with a first dos SC in the right thigh of varicella vaccine. Concomitant medications included a fourth dose IM in the left thigh of Acel-Imune, a fourth dose IM in the left thigh of Hib-TITER and a first dose SC in the right thigh of MMR vaccine. There was no illness at the time of vaccination. On 05/20/2001 the pt developed a rash on his head and arms. On 05/21/2001, the pt was seen by a doctor for a 102 deg F fever and lesions covering his entire body. The diagnosis was varicella. The pt was treated with Tylenol and Aveeno baths. Follow-up info has been received from a physician who reports the event began on 05/22/2001 with a high fever of 105.2 and chicken pox lesions. It was noted that Tylenol and Ibuprofen were given and no lab tests were performed. The pt recovered.
Vaccine was administered on 29 Feb 2012. Patient states felt tightness in chest started 9 Mar 12.  Shortness of breath occasionally through 23 Mar 12. Patient came in to Clinic on 23 Mar 2012 and was seen by Dr. Patient is a pilot so he was restricted from flying duties and from running/speed walking for 30 days.
Syncope that lasted greater than 30 mins after getting listed immunizations. Sent to ER via EMS for observation/treatment. F.U. with ER: Nurse reported client was treated for anxiety and discharged.
Date of Admission: 10/12/2022   Date of Discharge: 10/13/2022   Admission Diagnosis: COVID-19 virus infection      Hospital Principal Problem (Discharge Diagnoses): COVID-19 virus infection
Very swollen lymph nodes both arm pits, left worse. Lymph nodes in breasts, throat and pelvic area swollen.  Slight headache.
Day of immunization 5/22/13 (L) arm red, itchy and painful. Muscle aches and neck pain. WO fever. 5/30/13 lump (L) arm 20mm and redness 40mm.
May 10 th  no sense of smell and taste .  Everything has funny smell and taste. everything tastes same no matter what it is . can eat pineapples , some salads . The smell of food cooking makes the nauseas.
Bell's palsy developed on R face PM 10/22.  No additional neurologic findings on exam.  No additional abnormal physical findings.   Patient placed on Valtrex and prednisone for 7 days.
aches and pain; muscle pain; dizziness; This is a spontaneous report from a contactable consumer (patient). This case is generated for the 2nd dose of reporter self.  A 87-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on 19Mar2021 (Lot number: unknown) as dose 2, single for COVID-19 immunisation. Medical history included urinary tract infection and exposure to COVID-19 (my daughter-in-law, my son, and one of his sons all got COVID). Concomitant medication(s) included ciprofloxacin (CIPRO [CIPROFLOXACIN]) taken for urinary tract infection, start and stop date were not reported. The patient previously received the first dose of bnt162b2 in Feb2021 for COVID-19 immunization and experienced sore arm. On an unspecified date, the patient experienced aches and pain, muscle pain and dizziness. The patient reported that on Saturday night, she went out with her son, who just had 1 shot of his vaccine (he did not tell which one he got) and his wife and their 2 children. The patient's daughter-in-law came down this COVID-19 the previous day. The patient don't have to do anything. She live alone. She don't see anyone. Her daughter-in-law, her son, and one of his sons all got COVID. She further reported that she was taking Cipro for a urinary tract infection so she did not know if they were symptoms of the antibiotic or of COVID illness. After the first shot, she had a sore arm. After the 2nd shot maybe for 3 days, she had aches and pain. A day an half of muscle pain and very bad dizziness. She wanted some guidance or what to do since she was exposed to someone with COVID over the weekend. The outcome of the events was unknown.  The lot number for the vaccine, (bnt162b2), was not provided and will be requested during follow up.
Patient presented to clinic with mother for immunizations.  Mother is non-English speaking. LPN, was present interpreting. Patient visibly upset and uncooperative due to requiring multiple vaccines; therefore, RN, assisted by holding the patient in her lap with her arms encircling the patient. While holding patient's arm with my left hand, I injected the vaccine into the right deltoid with my right hand. While injecting the vaccine, the patient screamed and jerked her arm away.  I removed the needle to engage the safety, and as patient was flailing her arm about, scraped my left thumb and RNs right forearm. Attempted phone call to patient's mother, unsuccessful.
reconstituted with sterile water instead of supplied adjuvant; reconstituted with sterile water instead of supplied adjuvant; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) (batch number DC439, expiry date 3rd February 2023) and (batch number ASO1B, expiry date unknown) for prophylaxis.   On 29th October 2021, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On 29th October 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse supervisor reported that a nurse administered a Shingrix vaccine to a patient, however the vaccine was reconstituted with sterile water instead of the supplied ASO1B adjuvant which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not have patient details at the time of reporting. The reporter consented to follow up.
About 4 days after the vaccination, I developed a rash, first a large patch on my lower back, followed by other areas, including another large one on my upper left arm (the injection site) and many other smaller ones on my fingers, abdomen, leg, and arms. The rash was initially made up of small clusters of intensely itchy bumps, which would eventually redden and join together. The worst areas also swelled a bit and the skin started to feel dry and began peeling in places.  The rash drove me crazy all day and woke me at night. I treated myself at home with o/c antihistamines, anti-itch creams (hydrocortisone, etc.), and ice packs for a week and a half; but the rash did not subside and was continuing to pop up in new places. I had my appt with the doctor on 04/7/21. Due to my allergy to medrol, I was not prescribed oral steroids. I was prescribed doxepin for pm (sleep and itching), o/c Allegra for am, and a steroid cream. The treatment has been effective and the affected skin is healing.
Received Covid 19 vaccine on  1/6/2021 Left arm. Immediately had left arm pain and next day had numbness and tingling,along with rash upper chest and neck.
Information has been received from a consumer concerning her approximately 12 month old son who in 2006 was vaccinated with the first dose of MMR II 0.5ml SC (therapy site unknown). In 2006 the patient got a very bad reaction to the first dose. After getting the shot, he had a high fever for 10 days and his temperature went up to 105 degrees. The patient was taken to the hospital 3 times in one week. X-ray and blood work were done (results unknown). At the hospital (name and location unspecified), they treated him and brought the fever down, but when the patient got home, the fever would start all over again. Subsequently, "10 days after", the patient recovered. Also, the patient developed epilepsy in approximately 2007, "about a year later". Upon internal review, epilepsy was determined to be an other important medical event. Additional information has been requested.
Member noticed reaction approximately 1/2" diameter 3 days post injection. Site redness then grew to 3" diameter by 6 days post injection. While deployed reported to Dr who noted "oval shape, erythematuous, tender to palpation, warm".