chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Refridgeration excursions identified/vaccines have undergone several temperature excursions; No adverse event; Patient was administered vaccine which had undergone several temperature excursions; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 27-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Sep-2022 at 2:13 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 17-Sep-2022 at 2:13 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/vaccines have undergone several temperature excursions).    Concomitant product use was not provided by the reporter.  Dose 4 anatomical site was also reported as deltoid.  It was unknown if the patient had ever tested positive or been diagnosed with COVID-19.  It was reported that the vaccines had undergone several temperature excursions in August 2022.  Refrigeration excursions were identified, state vaccine was housed in the units. There were excursions noted. Manufactures were notified and the local department was made aware of the situation.  No adverse reactions were reported for patient at the time of the report.  Treatment information was not provided.
Pt called in to cancel appt today due to the fact that she had aches all over nausea, skin itches, and pain in chest at one point.
By error the nurse administered Jynneos vaccine beyond use date to 6 patients; Case reference number US-BN-2022-004309 is a spontaneous case report initially received on 24-Oct-22 from health care professional (reference: USBAV22-1762) and concerns a patient of unknown age and gender.  The patient's medical history and concomitant medications details were not provided.  On 21-Oct-2022, six patients were vaccinated with an unknown dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FPD00013, Expiration date: Sept,2024) at an unknown dose, through unknown route of administration, at unknown anatomical location, for monkeypox prophylaxis.  On the same day, as reported by error, the nurse took the box that had a beyond use date of October 18, 2022, and administrated six doses to patients, (explicitly coded as 'Expired product administered'). Vials were not punctured prior to administration.  As reported, patients have not reported any adverse events.  The Reporter did not assess the event per seriousness criteria and assessed causality between the event and Jynneos as possible related.  This case is linked with the case US-BN-2022-004306, US-BN-2022-004307, US-BN-2022-004308, US-BN-2022-004310 and US-BN-2022-004311 (same reporter).  Additional information received from Bavarian Nordic on 31-Oct-2022 included local case ID.; Reporter's Comments: Six patients of unknown demographics were vaccinated with vials of Jynneos which were 3 days past the beyond-use date, which is considered expired product administered. No adverse events were reported. Expired product administered is considered listed per company convention. No medical history or concomitant medications information was reported. The event is considered not related to Jynneos, but to human error. The case is non-serious.; Sender's Comments: Six patients of unknown demographics were vaccinated with vials of Jynneos which were 3 days past the beyond-use date, which is considered expired product administered. No adverse events were reported. Expired product administered is considered listed per company convention. No medical history or concomitant medications information was reported. The event is considered not related to Jynneos, but to human error. The case is non-serious.
This spontaneous case, initially received from other non-health professional on 26-Oct-2018, concerns a 74-year-old, elderly male patient. On 16-Oct-2018, the vaccine underwent temperature excursion. On an unspecified date in Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252664 and expiry date: 30-Jun-2019). The patient did not experience any adverse events after vaccination. The reporter assessed this case as non-serious. This case (201805004) was cross-linked to the case: 201805002 reported by the same reporter. Follow-up received from other non-health professional on 13-Nov-2018: The onset date of the event incorrect product storage was updated as 16-Oct-2018 and expiry date of the suspect vaccine was updated as 30-Jun-2019. The reporter confirmed that, the patient did not experience any adverse events after vaccination. The reporter refused to provide the patient's initials and date of vaccine administration. The narrative and case comment were amended accordingly.
This was my second shot.   The first one I had without any adverse side effects in December.   As directed I had the follow up shot on February 3.   This time I had shivers, pain in my stomach, general malaise, sinus congestion, headache and fever.   They lasted throughout the night.   I took an Advil in the morning and the sinus congestion and headache dissipated.   By the afternoon (approximately 30 hours after the injection I was feeling much better).
This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received INFANRIX (batch number AT57M, expiry date 19th June 2016). On 10th September 2014, the patient received the 1st dose of INFANRIX. On an unknown date, the dose was an unknown dose. On 10th September 2014, an unknown time after receiving INFANRIX, the patient experienced inappropriate age at vaccine administration. INFANRIX was continued with no change. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information: On 10 September 2014, HCP gave a dose of INFANRIX to a 7 year old patient as the 1st dose in the DTaP series.
More than 0.25 ml given as single dose vials were overfilled by manufacturing.
Administered Moderna vaccine after the 9/1/22 switch to the Pfizer Bivalent vaccine for the Boosters.  Unaware of any signs or symptoms of negative reaction occurred to patient.
Patient received 2nd Pfizer vaccine on 01/20/2021. Symptoms of a fever, body aches, nasal congestion, and fatigue started on 09/02/2021. Patient was tested  for Covid-19 on 09/08/2021. Positive results received on 09/10/2021.
injection site soreness; fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (injection site soreness) and FATIGUE (fatigue) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included Abscess drainage on 05-Jan-2021.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced VACCINATION SITE PAIN (injection site soreness) and FATIGUE (fatigue). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Vaccination site pain, at an unspecified dose and frequency. On 30-Dec-2020, VACCINATION SITE PAIN (injection site soreness) and FATIGUE (fatigue) had resolved.        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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Received RSV injection in right arm from Pharmacy, 9/25/2023 Begin having symptoms related to vaccine around midnight 09/26/2023: Aching, fatigue, feverish, confusion, dry mouth, nervous system issues (slight hand coordination), extremely weak feeling
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 10-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was given.  First vaccine was administered after 8 days from first puncture.  No treatment medication was given.   This case was linked to MOD-2021-333899 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up information received contains no new information.
09/18/18 received vaccines MMR, VZV, KINRIX. 09/19/18 patient returned with complains of bil. swelling ears and rash over body, BENADRYL started. 09/21/18 patient presented to emergency room with persistent hives and swelling of lips and tongue. EPI given which failed to resolve. Patient admitted to hospital. 09/23/18 discharged home on prednisone and BENADRYL. 09/28/18 seen for hospital follow up and referred to allergy immunology.
3 days p/inject pt c/o lt leg aching, reddened sl swollen warm to touch; t99.4; c/o unable to sleet it hurts;
Dad states patient felt "hot" within 1/4 hr. of receiving his shots (MMR, VARIVAX and Hep A) on 8-12-10. He had fever Thurs, Fri and Sat and it "broke" Sunday. Today, Tues, he broke out in a red pinpoint rash on his torso.
Patient came in to get bivalent moderna. Both moderna boxes moderna and moderna bivalent on the same shelf. Pharmacist chose the wrong box
Spotting, bleeding g, abnormal bleeding continues, heavy bleeding, awful cramps, horrible pain in sides near ovaries
Information has been received from a certified medical assistant concerning a 7 year old female patient who on 25-JAN-2003 was vaccinated with the first dose of VARIVAX (Merck) and had no adverse effects after her first dose. However, today on 29-JUN-2009 post vaccination with the second dose of VARIVAX (Merck) subcutaneous back of left thigh (there were no concomitant medications) (lot # 664020/0503Y) the patient was standing at the front desk at the doctor's office and fell to the floor, hit her head, and had "a mild seizure" which including trembling of her legs and arms. Caller says her legs, arms, and head could not be straightened. The patient was dizzy and felt sick to her stomach. Ice pack was placed on the patient's head, and she was monitored for at least 30 to 40 minutes. Blood pressure and blood oxygen level were "good", but the patient was still very weak when she left the office. Fall to the floor, hit head, mild seizure, dizzy, felt sick to stomach and still very weak were considered to be other important medical events by the certified medical assistant. This is one of several reports received from the same source. Additional information has been requested.
Immediately following shot pain in arm. Couple of hours later swelling and redness. Following day, Red swollen upper arm, went to ER, placed on antibiotics.
Information has been received from a physician concerning a patient (age and gender not reported) who was vaccinated with a dose of VARIVAX (Oka/Merck).  Subsequently the patient experienced an injection site reaction.  The patient's sought unspecified medical attention.  The patient's status was reported as "improved after a couple of days".  There was no product quality complaint involved.  Attempts are being made to obtain additional identifying information to distinguish the individual patient mentioned in this report.  Additional information will be provided if available.  This is one of several reports received from the same source.  Additional information has been requested.
Patient states that since she received the second dose she is having episodes of hives every week or so.  States that her granddaughter and daughter in law also have been having same symptoms.  She will take benadryl and then it goes away.  States she spoke with PCP and he doesn't feel it is related.
Patient received IM injection Nov. 3rd for H1N1 and still c/o sore spot where injection was given.
w/in 5min p/vax pt became cold, clammy, & nauseous;pt recovered w/in 10 to 15min;this is 1 of  3 pt from this site to devel these sx p/vax;
Shingles; Information has been received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) as prescriber/administered by a pharmacist (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date (reported as subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation), the patient was treated by a physician for shingles (herpes zoster); therefore, on an unknown date, she was hospitalized due to the event. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of herpes zoster was not recovered.  The reporter assessed that the event was related to zoster vaccine live (ZOSTAVAX).
Within 2 minutes after getting the second dose I felt like passing out. Within the hour I had a severe gush of blood as if I was miscarrying but I wasn't even supposed to be on my period nor was I pregnant. The hemmorhaging continued for 4 days when I went to the er and they noted that there was no cause and couldn't say it was the vaccine. I bled out for 9 days total, extremely heavy to the point where I became severely anemic. No reason for it other than the vaccine.
Pt lost consciousness, went into a seizure, stopped breathing, had no pulse. Called 911. Approx 30 seconds went by and pt began breathing on her own. She was checked by EMTs and mom insisted that she go home.
Client received TDAP on 03/21/2018 @ 30 weeks gestation. She had received a previous TDAP on 08/14/2017. Client called in the am of 03/22/2018 with C/O pain in her shoulder and back with some nausea. She stated she might have had a fever but did not check herself. I encouraged her to contact her OB/GYN for instructions. Client did contact and was advised to rest and drink plenty of fluids. I F/U with her today at 09:15 am and she said she was much better in the afternoon of 03/22/2018.
Had a stress test after the first shot which made them do cardiac catheterization; This spontaneous case was reported by a consumer and describes the occurrence of CATHETERISATION CARDIAC (Had a stress test after the first shot which made them do cardiac catheterization) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CATHETERISATION CARDIAC (Had a stress test after the first shot which made them do cardiac catheterization). At the time of the report, CATHETERISATION CARDIAC (Had a stress test after the first shot which made them do cardiac catheterization) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Lab data include stress test.
welts; welts that are very itchy; burning sensation; This is a spontaneous report from a contactable consumer (patient). A patient of unknown age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) as a single dose for Covid-19 immunization. It was reported that the patient had a reaction to second dose of covid vaccine. Patients entire body has raised welts as a result of shot. This is not a rash but welts that are very itchy and have a burning sensation. Patient have taken photos and would like the opportunity to send them to Pfizer. Patient don't have medical insurance so I am unable to have a doctor certify my condition. This side effect must be entered in CDC data to warn potential patient side effects. The outcome of events was unknown.  No follow-up attempts are possible;information about lot/batch number cannot be requested.
fever with temperature of 100.5; feel like I have the flu; freezing cold chills; nausea; not feeling well; swollen lymph nodes; poking under my arms. little bit to be irritated; more pain and discomfort under my arm/soreness on the arm; discomfort under my arm; This is a spontaneous report from a contactable consumer. A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was previously vaccination with first dose of BNT162B2 on unspecified date and experienced "soreness at reaction site, it was red and swollen. The patient got all but 1-2 regular small effects, fever with temperature of 100.5. The patient stated, "I feel like I have the flu, hit by a bus, freezing cold chills, nausea, not feeling well, swollen lymph nodes, poking under my arms, little bit to be irritated and on a scale of 1-10, it's a 4". The patient have more pain and discomfort under arm, soreness on the arm itself. On Saturday morning, the patient had all the other side effects. The patient has been taking 600-800mg of Tylenol for the events. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Initial report was received from a health care professional through another manufacturer on 09 July 2012 (Service Request Number 1-5286072512). A patient (age and gender not reported) had received a tetanus vaccine (manufacturer, lot number, date, site and route of administration not reported) and after the vaccination had an anaphylactic reaction where the patient's throat closed up. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: None.
Went to hospital with elevated blood pressure, chest pain, pulse in left finger tips and numbness in left arm.   Heart / troponin levels were normal but kept for additional testing.   Echocardiogram was performed and diagnosed with severe hypertrophic cardiomyopathy.