chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had an immediate reaction after receiving the  vaccination. Immediately a bump (1/2 inch) was seen and patient  became diaphoretic, voices distorted  and feeling bad. EMS was called with her approval. Patient was denied request for water to prevent aspiration. EMS came but did not transport patient as she reported feeling better. A technician/employee was with the patient the entire time. The pharmacist was in and out of the room frequently to monitor her status while speaking to EMS
Pruritis at the injection site at 5:15 p.m. - put Eucerin Calming once - no relief - intense redness and swelling at injection site. About 3 cm - talked with doctor and told to use Zyrtec and hydrocortisone and have Albuterol inhaler on hand - at 6:00 pm, felt dizzy and didn't feel so good barely made it to  e chair and passed out for about 20 seconds - pulse 6, B/P 135/95 - recovered. Speech was slow - went home after 30 minutes with my husband - took Zyrtec - used HC on injection site - on 10-11-08, the injection site was about 5 cm and very sore and hot to the touch. By 10-12-08, the swelling had decreased and redness had decreased.
14 days p/vax pt exp 25-30 lesions that were scattered over the body. addl info req
Information has been received from a Registered Nurse concerning a female patient who was vaccinated with a dose of GARDASIL (Lot # not reported) 0.5ml.  Patient had a "severe allergic reaction" after received the vaccine and was hospitalized.  The reporter did not know what the "severe allergic reaction" consisted of.  Additional information has been requested.
This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (expired dose administered beyond-use-date) and product storage error (vial refrigerated Feb 7, 2022; administered Apr 18, 2022) in an 86-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 083J21A) for COVID-19  immunization. No medical history reported. On Apr 18, 2022, patient received the fourth dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 18, 2022, patient administered expired product (expired dose administered beyond-use-date). On an unknown date, patient experienced product storage error (vial refrigerated Feb 7, 2022; administered Apr 18, 2022). At the time of the report, administered expired product (expired dose administered beyond-use-date) and product storage error (vial refrigerated Feb 7, 2022; administered Apr 18, 2022) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. The patient received a total of 4 doses (second booster). The vial initially stored in the refrigerator Feb 7, 2022, did not undergo temperature excursions.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 17-month-old patient of unknown gender. On 10-APR-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot number N027002 (expiration date 28-SEP-2019). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
5 x 4 cm red/warm/ sl. swollen area on (L) thigh beginning day of immunizations, and worsening. Treatment: amoxicillin, BENADRYL prn, ice.
Patient was vaccinated with only the liquid portion of Pentacel vaccine/No AE; Initial information was received on 15-Jun-2020 regarding an unsolicited valid non-serious case received from a consumer/ non-healthcare professional (office staff).  This case involves a seven months old female patient who received only the liquid (Dtap/IPV) portion 0.5 ml dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ196ABA and expiry date 02-Mar-2021) via intramuscular route in the right thigh prophylactic vaccination on 15-Jun-2020.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation.  Doctor wrote the order for the vaccination and patient was kept for observation afterwards.  It was an actual medication error case due to inappropriate reconstitution technique.  At a time of reporting no adverse event was reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. The patient was treated with cetirizine hydrochloride (Zyrtec), benadryl (nos) (Benadryl) and cortisone (non-proprietary) (Cortisone Cream). On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional case details were provided as follows: The patient's age at vaccination was not applicable for this report. The age group was not reporetd but was captured as adult as per the vaccine indication. The two to four patients received the dose of Shingrix and experienced rash. The pharmacist instructed them to take Zyrtec in the morning and Benadryl at night and use Cortisone cream 4 times a day and it worked for them. Afterwards, the patients were feeling better. No information was available regarding the patients or product. This was the case linked to US2019065871, reported by the same reporter.
allergic reaction to it; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (dipht crm197 protein), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced allergic reaction to it on an unspecified date. The outcome of the event was unknown.   Pfizer is a marketing authorization holder of [Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein] has submitted the same report to the regulatory authorities.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a physician concerning an 8 week old male, with a family history of allergies, who on 8/24/06 was vaccinated with a 2ml oral dose of Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine). On 9/5/06 the pt experienced orange stool and questionable blood and mucus in stool. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. The pts blood in stool was considered to be an other important medical event (OMIC). Additional information has been requested.
Pain and redness on bicep after injection in deltoid. I'd be happy to send a photo if desired.
Red area approximately 3 inches by 2 inches in size; somewhat warm; itching; slightly swollen; slight pain at injection site; symptoms lasted approximately four days then began to subside slowly.
Rash occurred 1.5 days after vaccine. The rash was all over my face, chest, under breasts, arm pit area. I was given steroids to help with getting rid of the rash.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022SA199767. A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunization, immunization; dupilumab (DUPIXENT), (Batch/Lot number: unknown) at single (dose number unknown, single). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), CONTUSION (non-serious), outcome "unknown" and all described as "sore arm which bruised". The action taken for dupilumab was unknown. Additional information: The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient started taking Dupixent injection (with an unknown strength dose, frequency, route, lot/batch number and expiration date) and Tozinameran (with an unknown strength dose, frequency, route, lot/batch number and expiration date) for Prophylactic vaccination. Information on lot number was requested. On an unknown date (Unknown latency), the patient had a non-serious "sore arm which bruised" (Pain in extremity) and (contusion) respectively with intake of Dupixent and Tozinameran. It was reported "Pfizer booster: sore arm which bruised Description: My way nurse transferred consumer who asks for timing of second Pfizer booster and DUPIXENT injection. It is unknown if the patient experienced any additional symptoms/events. Unknown It is unknown if the patient had any concomitant disease or risk factor. It is unknown if there were lab data/results available". Action taken with Dupixent was unknown and not applicable with Tozinameran. It was not reported if the patient received a corrective for the events. At time of reporting, the outcome was unknown for the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Approximately 24 hours after vaccination patient developed 4" x 6" area of redness, swelling, and tenderness. This area began about 3' below injection site. No open areas or blistering. Pain 2-3 on 0-10 scale. Treatment advised elevation, cold compress, TYLENOL and BENADRYL.
Information has been received from a registered nurse concerning an unknown number of pts who were vaccinated with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine) The pts mother reported that, 5-7 days post vaccination, her son developed severe cramping for a couple of days. The patient's pediatrician thought he had colic and it was not the vaccine. Subsequently, the patient recovered.  No further information is available.
vomiting x 3 hrs p/3rd vax some tingling in finger tips;
Within 4 hours had loose bowel movements for approx. 12 hours. Next day felt different, a little weak, nose started running, no appetite.  Cold like symptoms on Saturday started. Noticed my weight down approx. 5 lbs.  Appetite returned by Sunday. No fever. Checked daily during entire time. Little to no headache during entire time or nausea. Sore throat for about a week, mild and not severe compared to past times I?ve had a cold.  Major sinus drainage and cough most of the time. Slight upper chest burning. Sometimes wake up at night with terrible coughing. Went to see doctor on 12/07/2021 @ 3:00 PM. Doctor perscribed Zithromax and DELTASONE. Five days treatment. Within two days was feeling much better and pain in chest was leaving. About a week after taking meds the cough was much better.  As of 01/05/2022 I am feeling great and now able to exercise as before. Was very weak during the coughing and chest burning.
mom states that pt began to have sz & was taken to hosp & adm for febrile sz w/a t104;states test were run w/hosp & that pt had some kind of infect but does not know what type of infect;pt ok now;
Initial unsolicited report received from nurse on 14 October 2016. This case involves female patient (age no reported) who was vaccinated with dose of FLUZONE INTRADERMAL (Batch number, expiration date, dose site and route of administration was not reported) on an unspecified date. Medical history and concomitant medication were not reported. On an unspecified date, following vaccination patient experienced Itching, burning and bigger rash than expected (softball size). Lab data and corrective treatment was not reported. Outcome of events was not reported. List of documents held by sender: none.
Pt recv vax on 9/3/98; 15 mins later pt became pale, weak & fainted then vomited.
Infant developed hives over entire body approx. 5 1/2 hours after receiving her vaccines. BENADRYL was given 2 x that evening for hives. This morning hives resolved and no further reaction. Infant evaluated in office at 9:30 am (2/18/15) and diagnosed with vaccine reaction.
Local reaction with erythema about 6 cm. the patient did not have any fever and no other symptoms
This spontaneous report was received from a Registered Nurse referring to a multiple, unknown patients of unknown age and gender.  The patients' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.   In April 2017, reported as between 18-APR-2017 and 26-APR-2017,  the patients received multiple doses of improperly stored ROTATEQ Lot #M040269 with an expiration date on 28-APR-2018 (strength, dose, and route of administration were not reported) for prophylaxis. The vaccines were stored at a Temperature of 47°F to 77°F during 84 hours. There was no previous temperature excursions and the call was not because of a data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA007430: US-009507513-1705USA015670:
Received first pfizer shot on 10/03/2021 without issue. Proceded to receive routine yearly flu shot 8 days later on 10/11/2021 and began feeling very fatigued within 2 hours before leaving work for the day. Bedbound for the entire evening and next day. Experiencing fever up to 102 the first night with night sweats, body shaking chills, headaches, concentrated urine, no appetite, and nausea. The symptoms have improved some but as of Friday October 15 still experiencing night sweats, nausea with sensitivity to smells, extreme fatigue, and headaches. Last date of high fever was on Thursday October 14.
Pt received routine IZ's on 7-15-08.  Got DTaP, IPV, MMR, VARIVAX, Hep A, and PPD.  Mom states next day L arm swollen, red & painful.
Arm and neck completely sore, large bump at injection site, and very lethargic. Patient is fine now.
Patient noticed itching at the site of her vaccination on 9/26/12 in the afternoon.  She checked her arm on 9/27/12 in the morning and noticed that a red rash had developed.  She is not certain of the date of onset.
About 3 hours after patient was given the vaccine he had intense pain in his left arm and it started to swell into his shoulder,his blood pressure went up due to the intense pain, he went to the emergency room and had a sonogram, his shoulder swelled up and it looked to be about the size of a grapefruit,not hot to touch and no streaking,they discovered that he had a bursa and after the injection the doctor thinks that it caused the hematoma,he was given steroids and pain medicine.
pt recv vax 1/5/98 & contracted chickenpox 1st noticed 6/6/99;
Pt. given Typoid OI and Hepatitis A left arm, Yellow fever right arm- next day pt complained of severe pain in the site are of the left arm where injections were given radiating some what to the back area on inwards side of chest wall. Severe pain for 3 days and 2 weeks later pain when lifting.
administered an 8 day expired Daptacel; Initial information received on 29-May-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 months old male patient who received fourth dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C50202AA, expiry date: 16-MAY-2019 via unknown route in the left vastus lateralis On 28-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to Expired vaccine used. Caller stated that the office administered an 8 day expired Daptacel.   It was unknown if any adverse event was occurred.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.  Documents held by sender: none.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: after 5 minutes of receiving dose he saw black dots, he blacked out and fell from chair in observance area
I think I injected some people today with some moderna vaccines that were from a vial that was punctured more than 12 hours ago; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I think I injected some people today with some moderna vaccines that were from a vial that was punctured more than 12 hours ago) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (I think I injected some people today with some moderna vaccines that were from a vial that was punctured more than 12 hours ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (I think I injected some people today with some moderna vaccines that were from a vial that was punctured more than 12 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment information was provided
Case number PHEH2013US022170 is an initial spontaneous report received from a pharmacist on 18 OCT 2013 with a follow-up received on 16 DEC 2013. This report refers to an adult male patient. His medical history was not reported. He was vaccinated with FLUVIRIN 2013/2014 (batch number: 13375P) intramuscularly into left deltoid on 18 OCT 2013 at 10:00 am. The pharmacist stated that during administration of FLUVIRIN, the needle was not attached properly and subsequently vaccine spilled out of syringe and on to the patient's arm. Pharmacist mentioned that the patient did not receive full dose of the vaccine. Upon follow-up the pharmacist stated that there was no adverse events occurred just had malfunction with needle dispending medication. No additional information was available.  Follow-up received from a pharmacist on 16 DEC 2013: Site and time of vaccination administered and reporter's comment was updated.
Headache--24 hours in length Fatigue--48 hours in length Pressure in ears--8 hours in length Soreness at injection site--24 hours
states on 24MAY94 had pain in arm, shoulder et chest area difficulty swallowing on 1MAY94 seen by MD; knot in neck c/o inc BP, aching all over;
2 days after vaccine, right arm more sore than normal, progressively getting worse each day. Now has decreased ROM and increased pain. Basically unable to use right arm.
Tingle in hands and feet; Headache; Chills; Fatigue; Swelling in arm; Pain in arm where shot was administered; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 29Apr2021 at 18:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to latex and avocado. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 19:00, the patient experienced tingle in hands and feet, headache, chills, fatigue, swelling in arm and pain in arm where shot was administered. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in Apr2021, the patient underwent Nasal Swab and the result was negative. The clinical outcome of the events tingle in hands and feet, headache, chills, fatigue, swelling in arm and pain in arm where shot was administered was recovering at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.