chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient had an interruption in schedule regarding the administration of Gardasil 9; no adverse event; This spontaneous report was received from a physician assistant referring to a current 20 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On an unknown date in 2013 (also reported at the age of 12), the patient was vaccinated with the first hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, frequency, route, lot # and expiration ndate were not reported). The patient had an interruption in schedule regarding the administration of the suspect therapy. No additional adverse events reported. No product quality complaint reported, and no further details were provided.
Pt complained of itching localized to his left arm. There were diffuse patches of redness on the anterior and lateral aspects of his arm. There was one patch of redness that also produced raised urticaria. The pt had no other signs of allergic reaction. His lung sounds were clear and his airway was unaffected. His vitals were monitored as shown on paper report. The pt was observed for an additional 15 min after the development of his symptoms. His hives resolved and the redness reduced significantly. The pt's family was warned of the risks of continuing and worsening reactions. They were advised to treat with Benadryl at home if redness or urticaria returned/continued and to call 911 if difficulty breathing developed.
Rash to trunk groin. Tiny vesicles surrounded by erythema. 2 weeks post Varicella injection. Culture taken. Result negative for Varicella.
experiencing again only soreness at injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on 13th January 2020, refer case US2020056770).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The reporting nurse was the concerned patient. The patient again experienced only soreness at injection site after 2nd dose of Shingrix.  The reporter consented to follow up. This case has been linked to US2020056774 and US2020AMR057294, reported by the same reporter.
Began with slurred speech, tingling to leg and weakness on 10/16/04.  Not progressing at present time. Medical records state dizzy, viral syndrome. msv
observed injection site that afternoon when removing bandage:  my upper arm was full of tiny pinpoint dots, injection site was swollen/hard.  I was busy that day finishing payroll and preparing for trip .  I did not notice so much in the morning, I drove to visit family for a few days.   Upon return home, I read the paperwork provided by the clinic after I had received the shot...and began examining my body for tiny blood spots.  Now, with each shower  etc I would notice random spots and try to remember if they  had been there before...  My doctor was retiring and called last weekend to followup on a lab test he had previously  ordered to take in May.   During that conversation I asked him about the random spots, and he made an appt for me to see the  PA  the next day and do my urine sample for the lab order.   PA ordered bloodwork for low platelet counts, which I had had previously,  and urine test for abnormal immunofixation.
Approximately four days after I received the vaccine, I got an all over body-rash which occurred for approximately 6 hours and subsided after taking an antihistamine.
Has itching all over; Reddish skin all over; Allergic reaction; Very uncomfortable; This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (Has itching all over), ERYTHEMA (Reddish skin all over), HYPERSENSITIVITY (Allergic reaction) and DISCOMFORT (Very uncomfortable) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PRURITUS (Has itching all over), ERYTHEMA (Reddish skin all over), HYPERSENSITIVITY (Allergic reaction) and DISCOMFORT (Very uncomfortable). At the time of the report, PRURITUS (Has itching all over), ERYTHEMA (Reddish skin all over), HYPERSENSITIVITY (Allergic reaction) and DISCOMFORT (Very uncomfortable) 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.   Treatment information was not provided. Concomitant medication was not provided. Med Info Agent:  Caller is a  LPN, Multi Skill Tech (MST),HHA, CNA retuning call she received from Moderna and was retuning it. Provided update contact information and gave consent to reach back out.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Non-significant Follow-up appended to AER. : contact information updated and gave consent for further follow-up.
Myalgia, Arthralgia, NauseaVomiting, CHILLS, INSOMNIA Narrative:
Fever, chills, body aches. Hydration and Tylenol every 6 hours as needed
Heart attack like symptoms.  Severe chest pain, shortness of breath, Heart rate elevated around 10 bpm from normal, tired, thumping heart beat, occasional murmur.  Symptoms start about a week after first vaccine shot.
Patient is a 65 year old male who received the PCV13 vaccine on 3/29/17. At allergy clinic visit on 5/12/17 patient reported that after the vaccine he had burning and irritation on his hands which progressed to arm and both feet. He was advised by the call center to take antihistamine and patient took loratadine which helped but dried out his nasal mucosa. There are environmental factors at patients home that may contribute to patients condition. Consults were placed to social work and immunology in attempt to improve patients living situation and attempt to avoid other mitigation factors so that patient can stop loratadine.
Headache, chills, aches starting overnight and into the following day (at time of submission). Soreness of injection site started within a couple of hours and persisted to time of this submission as well. None of the symptoms are severe.
arm was swollen from his neck to his elbow and around the circumcision of his arm. it was red, hot to the touch; arm was itchy; arm was swollen from his neck to his elbow and around the circumcision of his arm. it was red, hot to the touch and itchy; Initial information received on 26-Jul-2019 regarding an unsolicited valid non-serious case received from a other health care professional.  This case involves a 4 years, 5 month old male patient who experienced arm was swollen from his neck to his elbow and around the circumcision of his arm. it was red, hot to the touch and itchy, while he received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patients past medical history, concomitant medication and family history were not provided.   On 24-Jul-2019, the patient received a first dose 0.5ml of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5532AA, expiry date 09-Oct-2020 via intramuscular route in the right arm.  On 26-Jul-2019, the patient developed a non-serious arm was swollen from his neck to his elbow and around the circumcision of his arm. it was red, hot to the touch (inflammation) (pruritus) (vaccination site reaction) 2 days following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  On 26-Jul-2019, the patient visited doctor. HCP instructs mother to continue benadryl and monitor for worsening symptoms.  Lab data was not provided.  Final diagnosis was arm was swollen from his neck to his elbow and around the circumcision of his arm. it was red, hot to the touch and itchy.   The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]).  The patient outcome is reported as Recovering / Resolving for all the events. Mother states that benadryl was helpful with itching.  List of documents held by sender: none.
pretty sore arm; slight fever; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2022, the patient received the 1st dose of Shingrix. In March 2022, several hours after receiving Shingrix, the patient experienced pain in arm and fever. On an unknown date, the outcome of the pain in arm and fever were recovered/resolved.   It was unknown if the reporter considered the pain in arm and fever to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-Apr-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient got the first Shingrix shot about a month ago and had zero pain getting shot but pretty sore arm developed hours later and lasted for days. Also had slight fever for about 24 hours. The patient would get 2nd shot in about 2 months. Additional Supportive Information: The follow-up would not be possible as no contact details were available.
SORE ARM; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported, per procedure no follow up will be requested for this case. No concomitant medications were reported.  On 2021, the subject experienced sore arm. On 2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102.4 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 2021, and the outcome of fever was not reported. This report was non-serious.
Myalgia developed about 6 hours after the dose.  Resolved within 24 hours.  Patient took 1300 mg acetaminophen for the pain.
Patient received vaccine dose, pharmacist applied Band-Aid to arm but Band-Aid not sticking well, so pharmacist went to get another Band-Aid and by the time the pharmacist returned, patient had fallen down on the floor and lost consciousness. Patient woke up in just 1 to 2 minutes, we called 911 emergency, made patient comfortable until paramedics arrived within 5-minutes of our 911 call. Patient skin red in color, skin clammy, felt nausea. The paramedics examined her, asked her some questions and patient was complaining of nausea, head pain, and was taken to the hospital by the paramedics.
Engerix B pediatric dose administered to 2 adult patients; Engerix B  pediatric dose administered to 2 adult patients; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 59-year-old female patient who received HBV (Engerix B pediatric) (batch number 77X47, expiry date 22-DEC-2023) for prophylaxis.   On 25-SEP-2023, the patient received Engerix B pediatric. On 25-SEP-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Engerix B pediatric dose administered to 2 adult patients) and adult use of a child product (Verbatim: Engerix B  pediatric dose administered to 2 adult patients). The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-OCT-2023 Engerix B pediatric dose administered to adult patient, which led to underdose and adult use of a child product. Same lot number and expiration date for both vaccines. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter. This case has been linked to the case US2023145301 reported by the same reporter. ; Sender's Comments:  US-GSK-US2023145301:another adult patient./ same product and same event
SORENESS AT INJECTION SITE; TIRED; This spontaneous report received from a consumer concerned a 19 year old male. The patient's weight was 117 kilograms, and height was 187 centimeters. The patient's concurrent conditions included: seasonal allergy, and non smoker, and other pre-existing medical conditions included: The patient had no pre-existing illness (no prior history of autoimmune disease, arrhythmias, myocarditis, pericarditis, seizure disorder, brain disorder, Guillain-Barre syndrome, other nervous system problem, chronic condition or long term health problem), no family history of cardiovascular and metabolic diseases, no illness at the time of vaccination, and no adverse event after any previous vaccinations. The patient had never received the pneumonia vaccine or shingles vaccine. The patient' brother was allergic to kiwi. The patient was not on home infusions, weekly injections, steroid therapy, anti-cancer drugs, radiation therapy, aspirin or aspirin containing therapy. The patient had not received a transfusion of blood or blood products or immune globulin in the past year. The patient experienced hives when treated with cefprozil. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808482 expiry: UNKNOWN) dose was not reported, administered on 13-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced soreness at injection site, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness at injection site and tired was not reported. This report was non-serious. This case, involving the same patient is linked to 20220253441.
chest pain during physical activity. cardiac workup.  Currently wearing Holter Monitor until 9/16.
Left thigh with 4 inch x 4 inch red area at site of injection of DTaP (DTaP given on 3-30-04); area with swelling/ hardness/ & hotness on 3-31-04.
Pt was given a Pediarix instead of a prevnar. This was a vaccination administration error. No adverse reactions. The patient's mother was notified. Staff has been retrained accordingly and will triple check vaccinations in the future.
Pt broke out in a rash on back and face which moved to extremities. Rash consisted of bright red, pin sized bumps. Mother thinks the rash was itchy.
Marked swelling/redness/fever to 103.6. 48 hours after DTaP + IPV injection in left deltoid muscle.
This spontaneous report was received from a physician who referred to a 61 year old male patient with diabetes and immunodeficiency. The patient did not have any known drug reactions or allergies. On 02-NOV-2017, the patient was vaccinated with PNEUMOVAX 23 (lot# and expiration date were not reported) for immunodeficiency. Other suspect therapies also included ZOSTAVAX, hepatitis A vaccine (manufacturer unknown) and hepatitis B vaccine (manufacturer unknown) all administered on 03-NOV-2017 (lot numbers and expiration dates were not reported). On the same day (also reported as 24 hours after receiving PNEUMOVAX 23), the patient experienced a skin reaction, described as a "17 cm, erythema, circular area with induration, appeared like a Arthus reaction. The physician was not able to clarify further. The patient sought medical attention and unspecified treatment was given for the adverse event. There were no lab diagnostic studies performed. The patient was recovering from the event, at the time of the report. The relatedness between the event and all suspect therapies was not reported. Upon internal review, the event of Arthus reaction was considered to be medically significant.
Patient became unresponsive and limp while sitting in a chair two minutes after receiving a Novartis pre-filled syringe flu shot (lot: 1343 2P; Exp: 04/2014).  The patient first lost consciousness while a second immunization was being administered (Zostavax (lot:j001002)).  The patient was in and out of consciousness; conversating when awake. 911 was called and an AED was brought to the scene immediately.  The patient became pale and profusely diaphoretic while waiting for the EMT.
FEVER, LIGHT HEADED, INJECTION SITE SORE, TIRED AND FATIGUED.
Initial information received on 18-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown gender 15 months old patient who was vaccinated with a 0.5 ml dose of DAPTACEL (Batch number: C5065AA, expiration date: 08-Oct-2018, route: intramuscular and site of administration: left thigh) on 10-Oct-2018. The patients medical history and concomitant medications were not reported. Nurse reporting the incident did not know if the any other vaccines were given. It was an actual medication error due to expired vaccine used (It was reported that inadvertently administered DAPTACEL that expired on 08-Oct-2018, no AE). No adverse event reported at time of call. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. 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. List of documents held by sender: none.
Information has been received from a pharmacist concerning a 60 year old male with penicillin allergy and allergic reaction to antibiotics who on 13-OCT-2008 was vaccinated with PNEUMOVAX 23 vaccine. Concomitant therapy included influenza virus vaccine (unspecified) in the opposite arm. On 13-OCT-2008 the patient experiences swelling, pain and redness at the injection site. The patient reported to the pharmacist that the area affected looked like 2 welts, one on each side of the injection site. This is the second patient of 2 patients who developed swelling, pain and redness at the injection site after receiving PNEUMOVAX 23 vaccine. The patient had made phone call for medical attention. The pharmacist was requesting a lot check on lot # 0619X. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Raised, red, warm rash.  Right thigh/leg involved.  Cellulitis 2 hours to MMR.  Prescribed: Benadryl/Augmentin.
possible expired dose administered; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (possible expired dose administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (possible expired dose administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (possible expired dose administered) outcome was unknown.            No concomitant medication details was reported.  Patient received the second booster dose. Patient also reported that the lot number does not exist when he puts in the Moderna lot lookup tool and the pharmacy called him and said they put the wrong sticker on his card and asked him to get a new sticker.  No treatment medication details was reported.
On Monday I had chills which were expected and no big deal, but on Tuesday, I experienced severe nausea,  loss of appitite, and lightheadedness to a point where I had to call an ambulance. The side effects of nausea, loss of appitite, and lightheadedness havent gone away, but they are not as bad as Tuesday. The symptoms are at their worst during the mid day.
Drug ineffective; COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 4 (booster), single (Lot number: GH9693), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Dec2021 as dose 3 (booster), single (Lot number: 030H21B), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Cefixime, reaction(s): "Known allergies: Cefixime". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 28Sep2022, outcome "recovering"; COVID-19 (medically significant) with onset 12Apr2023, outcome "recovering"; DRUG INEFFECTIVE (medically significant) with onset 12Apr2023, outcome "recovering". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Apr2023) Negative; (11Apr2023) Negative; (12Apr2023) Positive; (13Apr2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300156338 same reporter/patient with different drug/event;
This spontaneous report was received from a nurse concerning to a 5 months old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 16-JUN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # K023534, expiration date: 22-MAY-2016) (strength and dose were unspecified), the route was defaulted to oral. No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
7:12PM  PT LEAVING FACILITY. MENTIONS 'EYES BEGAN ITCHING AND COULD FEEL RASH ON BACK A FEW MINUTES AFTER GETTING HIS SHOT. HE DID NOT WANT TO TELL ANYONE. IT HAS STAYED THE SAME AND NOT GOTTEN ANY WORSE'. A/O, PINK, W/D, RESP REG WITH EASE. DENIES SOB, DYSPNEA, DIFFICULTY SWALLOWING.  STATES HE IS GOING HOME WITH HIS WIFE.  NO ACUTE/OBVIOUS DISTRESS. 3-5-21 3:30PM TC - PT STATES S/S HAVE RESOLVED - STATES THEY WERE 'VERY MILD'.