chrisvoncsefalvay/vaers-outcomes huggingface dataset:
immed p/vax pt fell backward on chair & became rigid & had mild convuls for approx 30second, p/which resumed nl behavior, stated felt fine
Received HPV #2, Flu shot, MCV, fainted 2mins after administration, became stiff, eyed rolled back, didn't respond to verbal questions. She was assisted to the floor, became responsive after two mins, stated she felt she was out for an hour.
Patient received vaccine at 1344.. Upon the end of observation time at 1400  patient's caretakers began to wheel the patient out. Patient's caretakers did not check in with the medical team. When they discovered she was unresponsive in wheelchair in hallway of facility they alerted the medical team. Several staff members (RN's, ER MD)  at patient's side  obtaining VS, changing out pts home O2 NC to a NRB mask. Patient appeared to have vomited on self before medical team arrival. Vitals taken at 14:05 BP 127/106, HR 64, SP02 89%. Emergency department team arrived. Patient transferred to gurney and taken to emergency department for treatment.
staff gave the Moderna COVID 19 vaccine to a patient after 30-day use by date. The vaccine was administered to the patient on day 31; The vaccine was administered to the patient on day 31; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (staff gave the Moderna COVID 19 vaccine to a patient after 30-day use by date. The vaccine was administered to the patient on day 31) and PRODUCT STORAGE ERROR (The vaccine was administered to the patient on day 31) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (staff gave the Moderna COVID 19 vaccine to a patient after 30-day use by date. The vaccine was administered to the patient on day 31) and PRODUCT STORAGE ERROR (The vaccine was administered to the patient on day 31). At the time of the report, EXPIRED PRODUCT ADMINISTERED (staff gave the Moderna COVID 19 vaccine to a patient after 30-day use by date. The vaccine was administered to the patient on day 31) and PRODUCT STORAGE ERROR (The vaccine was administered to the patient on day 31) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.
facial redness; injection site warmth; tenderness; swelling; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (facial redness), INJECTION SITE WARMTH (injection site warmth), INJECTION SITE PAIN (tenderness) and INJECTION SITE SWELLING (swelling) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included HYALURONIC ACID, LIDOCAINE (RESTYLANE L) from 11-Jan-2021 to an unknown date for Skin cosmetic procedure.    On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced ERYTHEMA (facial redness). 27-Jan-2021, the patient experienced INJECTION SITE WARMTH (injection site warmth), INJECTION SITE PAIN (tenderness) and INJECTION SITE SWELLING (swelling). The patient was treated with METHYLPREDNISOLONE (MEDROL DOSEPAK) at an unspecified dose and frequency. On 01-Feb-2021, ERYTHEMA (facial redness), INJECTION SITE WARMTH (injection site warmth), INJECTION SITE PAIN (tenderness) and INJECTION SITE SWELLING (swelling) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.
This spontaneous report was received from a physician concerning a 67 year old male patient with penicillin allergy and Formoterol allergy. The physician declined to provide information regarding the pertinent medical history of the patient. On 21-FEB-2013, the patient was vaccinated with a dose of PNEUMOVAX23 (lot number and expiry date reported as H013399 and 07-MAR-2014 respectively, dose unspecified), intramuscularly. The physician declined to provide information regarding the concomitant medications. Approximately on an unknown date in February 2013 (over a four-day period), the patient experienced painful, palm-sized, red rash at injection site. The patient sought medical attention (called the physician). No treatment was given. The physician declined to provide information regarding lab tests performed. Approximately on 28-FEB-2013 (within one weeks after administration of the PNEUMOVAX23, the patient recovered fully. The relatedness for painful, palm-sized, red rash at injection site was unknown for PNEUMOVAX23. Additional information has been requested.
Dizziness; Nausea; A spontaneous report was received from a consumer concerning a 63-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events dizziness, nausea.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: UNKNOWN) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events, dizziness, nausea.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, dizziness, nausea was unknown.
This case was reported by a consumer via call center representative and described the occurrence of foggy feeling in head in a 78-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included non-Hodgkin's lymphoma (9 years ago from the date of reporting). Concurrent medical conditions included neuropathy (Permanent, due to chemotherapy treatment). In February 2019, the patient received the 2nd dose of SHINGRIX .5 ml. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced foggy feeling in head and erythromacular rash. On an unknown date, the outcome of the foggy feeling in head was recovered/resolved and the outcome of the erythromacular rash was not recovered/not resolved. It was unknown if the reporter considered the foggy feeling in head and erythromacular rash to be related to SHINGRIX. Additional details were provided as follows: The patient was currently cancer-free. The patient received the dose of SHINGRIX on left arm. Roughly a week later after receiving SHINGRIX, the patient developed red spots on both of his lower legs that have not resolved. The red spots were about 6 inches below his kneecaps on the same area on both legs. The patient stated that it was not a rash, not oozing, not itching, and not painful. When the area was wet, such as in the shower, the red spots appear darker, but when they are dry they lighten up again. The patient also mentioned that he felt foggy for a few days initially after the vaccination. The reporter consented to follow up. In core outcome of the event fogginess was recovered/resolved and the outcome of the red spots was not recovered/not resolved, however in source document the outcome of the fogginess was recovered/resolved with sequel and the outcome of the red spots was recovering/resolving.
Blacked out; Vertigo; Diarrhea; Extreme Fatigue; sicker; This is a spontaneous report from a contactable nurse which is also the patient. A 48-year-old female patient received the first dose in the series of bnt162b2, lot number: EK5730, intramuscular in the left deltoid on 17Dec2020 at a single dose for COVID prevention. There were no medical history and concomitant medications. The patient received her COVID vaccine last Thursday evening, and she has been getting progressively sicker for the past couple of days on an unspecified date in Dec2020. On 20Dec2020, the patient experienced blacked out, vertigo, diarrhea, and extreme fatigue. The patient mentioned that she had extreme fatigue yesterday, with vertigo that started afternoon, and this morning her vertigo was so bad, that she blacked out in the shower, and the room is still spinning for her at this time. Outcome of the events blacked out and sicker was unknown, for the other events was not recovered. The seriousness of events blacked out, vertigo and diarrhea was reported as serious enough that she could not go to work, or get behind the wheel of a car so medically significant. Extreme fatigue was assessed as non-serious. The reported assessed the events extreme fatigue, vertigo, blacked out, and diarrhea as related to bnt162b2. The patient added that vertigo was worsened.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, there is a reasonable possibility that the events are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Tuesday evening on the 26th, the injection site felt warm and started to swell and hardened to the size of a tennis ball it was flesh tone and didn't get red, it was hot to touch. I took Advil, it helped with pain, the swelling didn't go down for 3 days. The pain was not localized, the pain was shooting down my rib cage and abdomen .
About 5-10minutes after vaccine I felt flushed/warm.  Reported to nurse who took my vitals. Elevated blood pressure and heart rate.  Also felt slightly dizzy.  Symptoms lasted about 45 minutes. At no time did I experience itching/swelling or rash. Also did not experience wheezing or difficulty breathing.   Only treatment needed was vital sign monitoring.  Vitals improved and no intervention was needed. I have had no further complications.
Flu Vaccines received were in transit too long due to delayed delivery with no adverse event; Initial information received on 08-Sep-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 9 months old female patient and the flu vaccines received were in transit too long due to delayed delivery with no adverse event for influenza quadrival A-B vaccine [Fluzone Quadrivalent].  The patient had no medical history, concomitant disease or risk factor.The patient's medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received 0.5 ml of suspect influenza quadrival A-B vaccine, single dose pre-filled syringe lot UT8040KA via intramuscular route in unknown administration site for flu prevention(strength, expiry date: unknown), flu vaccines received were in transit too long due to delayed delivery with no adverse event (poor quality product administered) (latency same day). There were no lab data/results available.  Reportedly, the Flu Vaccines received were in transit too long due to delayed delivery therefore they were considered ineffective. Vaccine had been administered prior to getting this information. There have been no signs or symptoms of any type of reaction to the adverse event  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event poor quality product administered   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 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.
No problems with 1st 2 shots in series other than fever/fatigue side effects. Candidate for 3rd dose due to immusuppression with Symzia. No problems during injection, 24 hours later reported itching around throat, trouble breathing, and hoarsness in throat. Due to her history of allergic reactions she took a benadryl 25 mg which resolved side effects after 3 doses. Stated she was traveling and not able to go see a Dr or ER when symptoms occurred. Reported this side effect to pharmacy on 9/8/21 and back in normal state with just a slight hoarse throat.
Vaccine was stored in the refrigerator on 13-Jan-2022, patient received Monovalent shots on 23-Feb-2022; No adverse event; Received Expired Monovalent vaccine after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent vaccine after 30-day Use By Date), PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 13-Jan-2022, patient received Monovalent shots on 23-Feb-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 025L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 23-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent vaccine after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 13-Jan-2022, patient received Monovalent shots on 23-Feb-2022) and NO ADVERSE EVENT (No adverse event). On 13-May-2022, NO ADVERSE EVENT (No adverse event) outcome was unknown. At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent vaccine after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 13-Jan-2022, patient received Monovalent shots on 23-Feb-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent vaccine after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 13-Jan-2022, patient received Monovalent shots on 23-Feb-2022).    This case is for adult patient 4 from 7 adult patients who received monovalent dose on 23-Feb-2022, as described by the reporter. No concomitant medications were reported. The vial could be either from individual vials or unbroken cartons and was of the size of 2.5 ml. 7 adult patients received monovalent dose on 23-feb-2022 which was shipped on 13-jan-2022 thawed in a cooler while being transported. The vial did not undergo any temperature excursions.Treatment in formation was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-682174, US-MODERNATX, INC.-MOD-2022-682176, US-MODERNATX, INC.-MOD-2022-682100 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2022: Follow-up contains: Reporter added , Narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-682174:Monovalent (Same reporter) US-MODERNATX, INC.-MOD-2022-682176:Monovalent (Same reporter) US-MODERNATX, INC.-MOD-2022-682100:Monovalent (Same reporter; Adult patient 4 from 7 Adult patients Monovalent shots on 23FEB2022)
1/14/2022 Employee called the Vaccine Support line to report symptoms post COVID-19 Moderna booster. Vaccine Name - Moderna Vaccine Date - 1.12.2022 / Location: Left Deltoid Booster Dose - Yes Date of Symptom Onset - 1.12.2022 Symptoms - 1.12 Pain to Left arm, chills, runny nose, diarrhea; 1.13 Fever (Tmax: 101F) Treatment per COVID-19 Vaccine Adverse Reaction Triage and Return to Work Procedure algorithm, is to Manage per TCH Illness in the Workplace Policy.  If develops worsening symptoms, return call Vaccine Support or for respiratory symptoms, go to nearest Emergency Center or call 911.
This spontaneous case, initially received on 09-Aug-2016, was reported by a health professional and concerns a female non-pregnant patient. The patient's medical history is unknown. Administration of company suspect drug(s): The patient received AFLURIA from 04-AUG-2016 to 04-AUG-2016. Dose regimen: 0.5 ml once, Route of administration: Intramuscular. Batch number: Unknown. The product had been stored correctly. No additional suspect drugs. Adverse reactions/events and outcomes: In Aug-2016 following vaccination, the patient experienced severe body aches (outcome: not recovered / not resolved). No additional information is available. AFLURIA dechallenge: N/A for the event(s) body aches. AFLURIA rechallenge: N/A for the event(s) body aches. The pharmacist considered the event non-serious.
Vertigo, nausea, ringing in ears, rashes, gastrointestinal issues, extremely dry eyes, runny nose, clearing throat, arm and hand pain where vaccine was given
pt recv vax; 28feb94, exp a burning sensation & rubbed inject site very hard; also devel a rash that was 2" in diam;RN felt that there was no problem w/ the particular lot of vax;
Pt describes fever, chills, nausea, frozen shoulder, and overall feeling of sickness.
Information has been rec'd from the mother of a 7 yo male consumer who on 6/20/95 was vaccinated with varicella virus vaccine live. There no concomitant medication. On 12/7/00 the pt developed a mild rash primarily on his trunk, a fever and headache. The itching lasted approximately 2 days. The mother also reported that her other son had a rash after vaccination with varicella virus vaccine live (MSD) (WAES01030915) Additional information has been requested.
racing heart.. dizziness.. felt like she was going to pass out said tongue was swelling and hard to breath
pt recv vax 1hr later devel inconsolable crying (not shrill but unhappy cry) & a low grade fever of 101 treated w/APAP;that the crying lasted almost 5hr per mom hx;
Red, hot, swollen area at injection site. Onset within 6 hours of vaccine. Progressively spreading to cover the entire thigh within 45 hrs.
right deltoid pain, fatigue, headache, neck pain, low back pain, right axillary lymph node swollen/discomfort
01/19/21 @ 2:00 pm: Headache, mild chills, lethargy, and body aches for 48 hours. Symptoms are resolved. Feeling well.
Swelling 24 hours post vaccination. Pain and itching in arm. Unable to raise arm 24 hours post vaccination but mom reported that it was improving at the visit 48 hours post vaccination. Mom treated with Benadryl and Motrin (3 doses) which seemed to improve symptoms. Doctor prescribed Bactrim and Prednisone for the symptoms.
1 of 8 pts who recvd vax exp pain @ inject site w/in 24 hrs of vax; pain lasted 1-5 days;
polyneuropathy w/ objective weakness lower extremities, onset approx 2 wks post vax.
Adverse event includes: Starting 06/16/2021 - extreme shortness of breath, irregular & pounding heartbeat that can be felt throughout the body, loss of voice, headaches, nausea, stomach pain and abdominal pressure and pain with excessive bloating.  Treatment:  06/18/2021  PCP  Suggests this is anxiety. Take meds, buspirion, which I took for 4 weeks with no relief from symptoms, although not able to sleep and felt strange and distanced during the day  06/22/2021  Urgent care. Diagnosis: inflamed trachea and laryngotracheitis. Prescribed Prednisone and Zithromax.  CONTINUED BELOW
diffuse itching began less tan 12 hours after first hepatitis B vaccine; no hives/blisters; mother treated today for poison ivy exposure
He states that he had no reaction after his previous shots except for "a little bit of sore arm".; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-MODERNATX-MOC20230519000021 (Moderna).  A 71-year-old male patient received BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: but controlled with meds. The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "He states that he had no reaction after his previous shots except for "a little bit of sore arm"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "He states that he had no reaction after his previous shots except for "a little bit of sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "He states that he had no reaction after his previous shots except for "a little bit of sore arm".".  Additional information: Patient did not receive any other vaccines 4 weeks prior to COVID-19 vaccine. Patient later received Moderna Covid-19 Vaccine, Bivalent (Original and omicron BA.4/BA.5), Davesomeran, Elasomeran on 09May2023 (Batch/lot number: 016H22A) via intramuscular route for COVID-19 prophylaxis and experienced achy and arm hurt/a little bit of sore arm (vaccination site pain), chills, fever/Low grade fever on 09May2023, which were not recovered at the time of this report. Patient stated that he had his 6th shot last 09May2023, lot number 016H22A. He had the 1st 4 (Pfizer) and the last 2 were Moderna. He stated that he had no reaction after his previous shots except for "a little bit of sore arm". But the last dose of Moderna which he had 8 days ago, in about 7 hours he had a reaction. He stated it was nothing significant - "little chills, fever, achy and my arm hurt, and he expected that and it was okay because he knew that his body was working". After a day or two almost all of them went away except for a low-grade fever. It had been 8 days and he still had fever which is a little less high than it used to be. He had already consulted with his doctor, but he could not give him an explanation. Had there been reports of fever lasting for about a week after getting the vaccine. The patient was in a rush, so he only provided the details of the last bivalent dose, but he agreed with Safety follow up.  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.
Patient received full 0.5 ml dose instead of booster dose 0.25 ml for Moderna on 10/25. On Wednesday 10/27 wife stated that he did not feel well and rested that day.