chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered past the published expiry date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions.
Breakthrough case admission after 2 vaccines Pfizer 4/1/21 Lot# ER8733;  Pfizer 4/22/21 Lot# EW0164
I had an eczema flare up and it was only on my thighs and it was worse on my right thigh. I was just using OTC cortisone cream at first. I had it for 5-7 days before I went to the Dr. The Dr. prescribed me some ointment and I used it or about 5 days and it was gone. I haven't had any trouble since.
This spontaneous case, initially received from a pharmacist on 12-Nov-2018, concerns a female patient of an unspecified age. The patient was allergic to egg. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported). On an unspecified date, after vaccination, the patient developed a hard knot under her arm. At the time of this report, the outcome of the event was not reported. The reporter assessed this case as non-serious.
expired Tenivac was administered to a patient/no AE; Initial information received on 31-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 36 months old female patient who received an expired dose of vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] for prophylactic vaccination.  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapy was received.   On 31 Jan 2020, the patient received a 0.5 ml single dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot number U5854AA (expiry date: 25-Jan-2020) via intramuscular route in right deltoid.  It was of actual medication error due to expired vaccine used (expired product administered).  It was unknown whether adverse event was noted or not.  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.
Flu shot this morning; dry throat 1.5 hours afterward and has been feeling worse; severe sore throat, fever, body aches.
Received First Dose of Heplisav-B, and Second Dose Engerix; Initial Report Received on 07-Sep-2023  A pharmacist reported that a 45-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as the first dose and ENGERIX B as the second dose.  The patient has no allergies and has had no previous reactions to other vaccines.  No concomitant medications were reported.    On 21-Feb-2023, the patient received HEPLISAV-B (Lot #941054, expiration date 23-Nov-2024, NDC # 43528-003-05) in the right deltoid as the first dose for hepatitis B immunization. On 16-Aug-2023, the patient received ENGERIX B (no Lot # or expiration date were reported) in the left deltoid as the second dose for hepatitis B immunization.  No adverse events were reported.  No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Vasovagal syncope after vaccination, assessed by EMS, BP 97/54, Pulse 64.  EMS placed patient on stretcher, given water.  Patient reported feeling better after 10-15, and declined transport to ER for further assessment.
Patient inadvertently received 0.5 mL flu vaccine instead of 0.25 mL flu vaccine. No other symptoms noted or reported to us by parent. Mother was informed of error immediately after it occurred.
Patient was breathing very deeply.  Patient was very sweaty.  Did not respond to my voice or shaking.  Continued to shake the patient and he came too.  Said he felt like he was dreaming.  He was very pale.  Called 911.
Immediately after the vaccine was completed pt began to develop a periorbital headache.  That headache persisted and worsened over the following 1-2 months.  She then developed a 6th cranial nerve palsy.  A brain/orbital MRI with contrast showed diffuse inflammation and enhacement of the orbit consistent with an auto-immune Tolosa Hunt Syndrome.  She is currently getting an extensive work up for other possible causes of this but the temporal correlation to the vaccine was a concern that warranted reporting.
This spontaneous report was received from a medical assistant concerning a 15 year old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 16-MAR-2018, the patient was vaccinated with a dose of VARIVAX (lot # N014631, expiry date: 11-MAY-2019), and a dose of M-M-R II (lot # M015930, expiry date:29-MAR-2018) for prophylaxis. Then, on 17-APR-2018, the patient was vaccinated with a dose of PROQUAD (lot # N025718, expiry date: N025718), as well for prophylaxis (dose # and route of administration were unknown for all vaccines). Details regarding sterile diluent used for reconstitution were not provided. No adverse effects were reported.
Severe whole body pain and weakness; muscle pain; difficulty breathing; severe headache; vertigo; vomiting; diarrhea; elevated blood pressure; heart palpitations. Symptoms lasted for 3 days and started about 10 hours after the injection.
Patient with Pfizer vaccines x2, last dose 05/18/21, who admitted to hospital with COVID complications.  Provider discharge summary below:  "The patient presented to ED on 1/27 unresponsive following O2 saturation drops to the 50-60s. Per family report, multiple family members had tested positive for COVID 19 and the patient had subsequently developed fevers, SOB, and decreased oral intake with O2 saturatinos in the mid 70s on home O2 monitor. She was found to be COVID positive in the ED and started on BIPAP. She subsequently failed BIPAP support and required intubation on 1/28. Pt's respiratory status continued to decline despite maximal vent support and therapy. On 2/3, her O2 saturations continued to drop into low 70s despite max vent support and son made decision to make her a DNR. She developed PEA arrest at 1433 on 2/3 with pt's son at bedside. There were no doppler pulses or heart sounds noted on auscultation.  Decision was made to discontinue ventilatory support at 1440 and pt went into asystole at 1444. Time of death 1444."
Patient presents to pharmacy and reports loss of consciousness immediately after arriving home following vaccination administration. Patient also reports head injury as a result of LOC and inability to leave bed until today 2/3/2023.
pt is foster parent to child who recv varivax;24JUL96 pt devel severe abd pain was adm to hosp 26JUL96;pox began 26JUL96;dx made by dermatologist on 31JUL96;pt remains hosp w/chicken pox;
FEVER; MUSCLE ACHES; FATIGUE; This spontaneous report received from a patient concerned a female 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, intramuscular, batch number: Unknown) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On 11-MAR-2021, the subject experienced fever. On 11-MAR-2021, the subject experienced muscle aches. On 11-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, muscle aches and fatigue was not reported. This report was non-serious.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a dose of ZOSTAVAX (lot number, injection site and route not reported).  Two weeks after the vaccination the patient experienced acute arthritis pain.  The patient's knees were swollen and she was having trouble walking.  The patient was sent to see the specialist.  The patient's acute arthritis pain, swollen knees and trouble walking persisted.  According to the physician, the patient's acute arthritis pain and swollen knees and having trouble walking were considered to be disabling.  Additional information has been requested.
Registry reveals Patient received J&J  on 04/08/2021 for primary series, received Moderna Booster on 11/11/2021 and received Pfizer Booster today.
Tingling and numbness in arm with the vaccination.  Fever over 100F later that day with body ache, chills, and headache.
There is a large local reaction to the vaccine. The vaccine was administered too low and appears to have been given subcutaneous instead of intramuscular in deltoid. The injection site is red, bruised, warm to the touch, is hardened/raised, and painful. Healthcare provider recommended antihistamine treatment, cold compress for 20 min. If symptoms do not get better within a few days, return for follow up.
Starting about 14 hours after the injection my heart rate increased.  I slept poorly but didn't realize until I got up in the morning that my heart rate was off. I wear a fit watchand it told me my heart rate was above resting 97% of the night (its usually below resting 97% of the night). My heart rate increased to 140  when I got up in the morning. I called my doctor who told me what to do to try and reduce the bpm and when to go to the ER if needed.  I stayed in bed all day and laying down I was able to keep my bpm in the 90's (about 20 bpm higher than usual) I experienced the other expected flu like side effects and headache as well.  24 hours after the side effects started, they began to decrease and for the next 24 hours I felt only slightly ill and my bpm resting was about 10 bpm over my usual. The next day  (2/14/21) I felt 100% myself and my heart rate was back to normal.
Throwing up after taking first dose of the COVID vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious), outcome "unknown", described as "Throwing up after taking first dose of the COVID vaccine".  Additional information: Reporter wants to check if throwing up is normal after taking first dose of the COVID vaccine because her sister is experiencing that side effect or adverse reaction. The patient was vomiting and she can't keep any fluid down; she can't retain any liquid like she can't hold any water down:  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient "feels fine" / patient is not currently experiencing side effects; accidental overdose; Product packaging confusion; Wrong product administered; This spontaneous report was received from a physician concerning a 69-year-old male patient with dementia. The patient's medical history, drug reactions/allergies, historical drug and concomitant therapies were not provided.  On 28-SEP-2020, the patient received by mistake pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) lot number S017429 and expiration date 28-MAR-2021 (route of administration was not provided). The patient was supposed to received a different medication, and additionally he was given 4 times the recommended dosage (Accidental overdose). The patient is not currently experiencing side effects, but caller is requesting a  consult.  The physician stated the vials were confused with epoetin alfa-epbx (RETACRIT) by the office staff due to having a similar vial size and top color (Product packaging confusion). The patient was sent home and lives with a family member so he is being monitored.
4hrs post vax became ill; temp 103.6R, lethargic; Had to be woken up to feed (breast fed); Irritable; Temp normal approx 48hrs p/onset;
skin rashes, red color, itchy. applied anti-itch lotion and moisturizer, it helped. took Claritin tablet (antihistamine 10mg) for 2 days, 1 /day. Rashes are gone.
Got shot and got shingles/suspected vaccination failure; Shingles/ got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 16-Oct-2022 Reporter's comment: The case was received from the patient's friend via interactive digital media. The reporter reported that the patient (his/her friend) got the shot and got shingles. The reporter stated sorry but it did not work. The reporter prayed for soon relief. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Digetive symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administration date 12Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "Digetive symptoms".  Additional information: Reporter got the shot with her son and daughter who both also had digestive symptoms.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Chills, Fever and totally tired for 24 hours, then warn out, feelings of headaches and chest uncomfortable and then after that resolved had three cold sores at once.
The night after the vaccine, I had a headache. The headache has never went away since the vaccine. I take Tylenol that does help relieve the headache but it comes right back again. I have a headache all day and night.
Immediate reaction was typical for any vaccine I receive - muscle aches and pain, fatigue and general discomfort.    The "event" that you have contacted me about began on Oct. 12, 2021 - and it was severe abdominal pain and gas, blood work was done that indicated an infection.  Diverticulitis was suspected due to the fact I already had diverticulosis found on a previous colonoscopy.  I was put on Flagyl and Keflex, went on a clear liquid diet for 3 days, and am currently on a bland diet.  Symptoms have improved since.
Pt recvd DTP/HIB/OPV @ clinic on 8OCT91 then pt presented  to clinic 9OCT91 w/hx of onset of fever (t104) 2 hrs p/inject; 9OCT91 t102.6 R & lt thigh minimal induration;
Information has been received from a physician who was getting ready to give his patient a shot of GARDASIL when the patient informed him a girl friend experienced seizures after getting GARDASIL (lot # not reported). At the time on the report the outcome of seizures was unknown. It was unknown if the patient sought medical attention. Upon internal review seizures was determined to be an other important medical event. Attempts to verify the existence of an identifiable patient have been unsuccessful. Additional information is not expected.
Sunburn like feeling starting on stomach, forearms and but cheeks. Head pain on left side Sunburn like feeling now in armpits and neck pain running down thru back
pt recv vax 11NOV98 & devel an inj site rxn characterized by a 25 cent size area of erythema & itching;pt recovered w/in 1hr;
3:28 patient feels  dizziness, blurred vision, states she is having trouble focusing her vision. C/O feeling flushed and feeling disoriented. It oriented to person, place, and time upon further assessment.  Denies itching or feeling hot. Is experiencing shakiness, does have hand trembling. EMT from vaccine site in attendance. BP 118/66; HR 76; O2 sat 98% on r/a. EMT recommended ambulance transport, patient refused.  3:36 HR 68. 3:45 BP 122/68; HR 67; O2 sat 97% on r/a.  3:50 Patient requested to go to restroom. Attended by nurse P. H. Patient states she feels like her skin is crawling. With assistance examined abdomen region. No redness, swelling or hives noted.  3:54 Patient left with assistance of facility w/c to awaiting personal car driven by husband.
Had covid; Coughing; sick; sore on her chest and body; has diarrhea; Nausea; throwed up; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Had covid), COUGH (Coughing), ILLNESS (sick), CHEST PAIN (sore on her chest and body) and DIARRHOEA (has diarrhea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O38A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Had covid), COUGH (Coughing), ILLNESS (sick), CHEST PAIN (sore on her chest and body), DIARRHOEA (has diarrhea), NAUSEA (Nausea) and VOMITING (throwed up). The patient was treated with GUAIFENESIN (MUCINEX) at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, COVID-19 (Had covid), COUGH (Coughing), ILLNESS (sick), CHEST PAIN (sore on her chest and body), DIARRHOEA (has diarrhea), NAUSEA (Nausea) and VOMITING (throwed up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information included nausea medication.
her arm was so sore for a full day; headache; lymphocytic colitis; This spontaneous case was reported by a patient and describes the occurrence of COLITIS MICROSCOPIC (lymphocytic colitis) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In January 2023, the patient experienced COLITIS MICROSCOPIC (lymphocytic colitis) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (her arm was so sore for a full day) and HEADACHE (headache). At the time of the report, COLITIS MICROSCOPIC (lymphocytic colitis), PAIN IN EXTREMITY (her arm was so sore for a full day) and HEADACHE (headache) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. It was reported that over 55 years old patient was diagnosed with lymphocytic colitis in January. She stated that her arm was so sore for full day and a headache. She was not clear to which dosage it was but she received all 4 doses. No treatment drug details was reported.  Company comment: This spontaneous case concerns an elderly female patient of an unspecified age, with no medical history reported, who experienced the unexpected serious (medically significant) event of Colitis microscopic (Lymphocytic colitis) that occurred in the context of mRNA-1273 Bivalent BA.4/BA.5 vaccine in COVID-19 vaccination series. Latency could not be assessed as the date of vaccination was not available. No further information regarding risk factors, clinical course, medical history, concurrent conditions, concomitant medication, additional vaccination details, investigations and treatment received were provided. The outcome of the event was recovered. The benefit-risk relationship of mRNA-1273 Bivalent BA.4/BA.5 Vaccine in not affected by this report.