chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered expired vaccine to patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date the vial initially stored in the refrigerator was reported as unknown. Vaccine manufacture date of expiry was reported as 09-Nov-2021 with total of 168 doses. The vial did not undergo any temperature excursions.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow up received contains non significant information.
Axillary Lymph node swelling on arm of vaccine. Tingling and numbness to arms
Approximately 1 hour and 20 minutes after receiving the vaccine, I started feeling very dizzy and disoriented. I had trouble speaking and forming sentences. I felt very shaky and had tremors throughout my entire body. My heart was racing and pounding out of my chest.
I broke out in hives around 7:45pm last night, which was about 4 days, 3 hours after my second shot. The hives started mainly on the back and sides of my body, but overnight they spread to areas on the front as well. The highest concentration of hives are at joints (knees, ankles, elbows), then spread out from there. There are also dense patches on my ?butt cheeks,? particularly at the sitz bones, and my ears. The palms of my hands also began itching overnight.
Diziness; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chronic fatigue.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was unknown.   It was unknown if the reporter considered the dizziness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had a history of chronic fatigue. The patient also mentioned dizziness.
Full body hives the third morning after the vaccine-advice nurse said go to the ER within the hour, they gave me a steroid shot and said was an allergic reaction. I don?t have any known allergies and never had hives before. I also had diarrhea, chills, fever, right lymph node swollen and painful, and exhaustion the second day after the vaccine.
On 11-02-2007 during routine office visit for arthritis and HTN, Flu vaccine given. Pt left the office with no c/o any. She went to shop and few hours later she was brought back in lethargic condition. O2 - 4 Epipen - applied, 911 - called, and she was transported by ambulance to Emergency Room.  12/11/07 Reviewed hospital ER records & death summary which reveal patient experienced severe substernal chest pain & collapsed while shopping 11/2/2007.  EMS took to ER where she developed complete heart block & bradycardia.  Tx w/meds, pacemaker & intubation.  Resuscitated & taken for cardiac cath.  In cath lab, arrested & CPR started.  Developed ventricular fibrillation non responsive to defibrillation & meds & pronounced. 1/11/08 Received death certificate which states COD as ventricular fibrillation, acute MI & ateriosclerotic heart disease.
03/31/18 6:30 pm: Patient has developed some swelling of her her periorbital skin and her lips. Has had some mild runny nose in the past few days, but no fever or hives rash. No labored breathing or vomiting. No new foods ingested and no exposure to new clothing or products. Just had her well visit yesterday and had a normal exam. Mom just also noticed that patient's entire left leg is swollen. She does not appear to be in any distress. No discoloration of the skin. Recommended that mom take pt to the ER or urgent care now for evaluation, given concern for worsening swelling of multiple parts of the body - allergic reaction. Mom agreed - will take her to be evaluated in ER now.
mom states pt jerked all extremities, lips were blue, out of it x approx 2 mins last noc-went to ER thought to have febrile seizure-7 days p/vax t102;
R arm under the vaccine area - below on lower arm yesterday redness and itching and swelling started  also flu shot in the other arm which is fine
HiB vaccine was given to patient is error. He was suppose to be given Hep. B vaccine. Medical assistant selected the incorrect vaccine and it was given to the patient.
Information has been received from a nurse on 11-FEB-2015 referring to a patient of unknown age and gender. On 15-JAN-2015 the patient was vaccinate with a dose of PROQUAD (Merck) injection, 0.5 ml, subcutaneously (lot# was not reported) which underwent a temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Oral Rota given without incident. First injected was Pentacel to left thigh, patient did not cry. Second injected was Prevnar. Patient was noted to have very hard cry and then held her breath. MD notified and upon entry to the room, child was noted to have pallor with rolling eyes and head. Face appeared red and blochey. Patient then began crying and was difficult to console for approximately 2-3 minutes. MD then was able to calm patient down. Respirations remained non-labored, HR WNL, good tone, no erythema/edema to injection site. Right side of face and right lower extremity with some blochiness which improved as the patient relaxed. Patient ultimately fell asleep and was observed for around 10 minutes post vaccination.
red hot area at injection site measuring approximately 4 x 4 inches. Tempurature of 99.8 orally.
Slurred Speech; This case was reported by a pharmacist via call center representative and described the occurrence of slurred speech in a 79-year-old male patient who received Herpes zoster (Shingrix) (batch number AH992, expiry date 8th March 2022) for prophylaxis.   On 3rd September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than 2 weeks after receiving Shingrix, the patient experienced slurred speech. On an unknown date, the outcome of the slurred speech was unknown.   It was unknown if the reporter considered the slurred speech to be related to Shingrix.  Additional details were provided as follows: The patient developed slurred speech for days after receiving Shingrix vaccine The reporter did not consent to follow up.
Patient developed itching of face and mouth on the evening of 9/23, also complains of development of rash and mouth ulcers which she noticed on 9/24/15. She has received the flu vaccine in prior years with no allergic reaction reported. She denies any egg allergy.  She is not experiencing any skin reaction near the injection site.  She also reported eating out at a restaurant immediately following vaccination at the pharmacy. It is  possible that the symptoms she is experiencing were a result of some food type allergy, although she is not aware of any food allergies at this time.    Patient is currently managing symptoms with over the counter Benadryl. I instructed patient to contact her PCP is her symptoms worsen or do not resolve for further treatment.
By the following day after getting shot 1 in the covid series Pfizer, she started breaking out in a rash all over her body that itches and hurts. We went to the Dr and she was given hydrocortisone that doesn't help. Its been 4 days and the rash is still slowly spreading
FEVER LAST NIGHT: 99 AX. THIS AM VOMITING/DIARRHEA. SLEEPING; MOM WENT TO WAKE HIM,REPORTS HIS EYES ROLLED BACK IN HEAD AND ALL EXTREMITIES SHOOK. BECAME HIMSELF IN A FEW MINUTES. TEMP. TODAY AT E.R. VISIT 97.3 AX. HX. OF E.R. VISIT 10/21/07 POSSIBLE PERF. LEFT T.M. PUT ON  ZITHROMAX.
Lymph node on right side behind ear swelled up then entire right side of face and ear swelled up to the point I had water blisters on ear eye swollen shut and ear was so swollen couldn?t even put a Q tip in my ear nose swelled all up
This spontaneous report as received from a patient's wife refers to a 63 year old male patient. The patient's concurrent conditions included high blood pressure and leg spasms. He did no have any drug reactions or allergies. On an unknown date, the patient was vaccinated with ZOSTAVAX (strength, dose, route and site of administration, lot # and expiry date were not reported). Concomitant therapies included ZESTRIL. On an unknown date, the patient had unspecified blood work done due to leg spasm and the results came back positive for antinuclear antibody (ANA) titer. There was no treatment given for the event. The outcome of the event was unknown. The patient received medical attention via office visit. The relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
Systemic: Other- lost vision, elevated blood pressure and pulse, returned to normal quickly thereafter administration
This case was reported by a healthcare professional via a sales representative and described the occurrence of an unspecified adverse event in a subject of unspecified age and gender who was vaccinated with FLUARIX. On an unspecified date the subject received a dose of FLUARIX (unknown). At an unspecified time after vaccination with FLUARIX, the subject experienced unspecified adverse event. At the time of reporting the outcome of the event was unspecified. The sales representative received a call from another sales representative regarding a physician's assistant that was trying to report an unspecified adverse event following administration of FLUARIX.
Received Prevnar #1 on 7/25/01. Parents say fever developed the same day and has persisted. A rash started, 2 days later, a papular rash especially on chest and abdomen. On exam, no other source of fever found. Parents gave Tylenol and Benadryl. Rx'd on 7/30/01 with Atarax syrup.
After both vaccines, I passed out, however, I pass out after every vaccine I receive so that was normal. Since I have received the vaccine, I have gotten sick easier. My stomach has been more sensitive to food and drinks that I regularly ate and drank before. I feel more exhausted day to day since the vaccine as well.
A 52 year old female pt has received a SC injection of TET TOX ADS USP, Lot number U1351AA in the right deltoid, on 3/24/06. Two days later, she experienced a 12cm area of redness and itching. She also complains of generalized body itching that resolved the next day. at the time of this report, the pt had not recovered from these events. Follow up information received on 4/7/06. per reporter immunization was required due to a cut to the pts left hand from a piece of wood that had a rusty nail protruding from it. TET TOX ADS was received on 3/24/06 and symptoms began two days later at 8:00am. Pt was started on Keflex 500mg Q6H on 3/24/06. Indication for Keflex was not reported. Per reporter, the pt has recovered, No further information expected.
I noticed my left side of my face begin to feel weird then as the day progressed food on my left side tasted different and my left eye became droopy as well my doctor recommended medication and acupuncture. Doctor prescribed me prednisone.
Visual disturbances began. "Sunspot" like symptoms began and an increase in headaches/eye soreness began. I have been seen by multiple medical professionals (my primary care physician, a neurologist, an opthamologist, and a retina specialist). I have had multiple blood test work ups and the only "solution" anyone was able to provide to me is that I was slightly vitamin B12 deficent. I have been taking supplements for the past month and have not seen a significant increase in my symptoms. It has been three months and I still have the visual disturbances, and no answers. Prior to the vaccine, I was a healthy young women without health issues.
While attempting to vaccinate the pediatric client with the Moderna vaccine, the parent was instructed how to hold the client and confirmed that he understood, once the needle entered the client's arm, the client began to move around  the parent released the child's arm causing the needle to come completely out of the arm, the medication from the  vaccine was released outside of the arm onto the client's skin.
This spontaneous report was received from a Nurse Prescriber referring to a 49 year old female patient. The patient's concurrent conditions and medical history were not reported. On an unspecified date, (reported as when the patient was child), the patient might have had vaccination with the series of M-M-R II (doses, route, anatomical location, lot number and expiration date were not reported) for prophylaxis. Recently (unspecified date) the patient had titers drawn which showed she was "not immune to mumps" (Mumps antibody test negative). The nurse indicated that as a treatment (also reported as treatment no) the patient was administered a dose of M-M-R II on 04-FEB-2019, while the patient was also on therapy with XELJANZ. The nurse also reported that there was no adverse effects to report. At the reporting time the outcome of the event Mumps antibody test negative was unknown.
103 - screaming 1 hr, sore @ inject site; fever off & on - did not visit MD but called; Screaming episode lasted 1 hr;
Warm sensation in chest 10 minutes after receiving vaccine,  tight feeling in face 30 minutes after vaccine, tingling numbness in face 1 hour after vaccine,  warm and tingly feeling down back between shoulder blades 1 hour 30 minutes after vaccine, ears felt warm and ringing 3 hours after vaccine, cool tingly feeling on entire back 8 hrs after vaccine.
Left arm swelling, pain, redness and induration within 24 hours of vaccine administration. Treated with ice, elevation, Benadryl.
Decreased ability to use repetative motion (knitting) in arm muscles after first Covid 19 shot.  Patient stopped knitting for one week, then was able to resume. Second shot was given one month later. Three months after second shot, patient who was generally strong, tore a tendon in the left arm (after a minor exertion). This was the first time the patient ever tore a tendon. Note that this patient is sensitive to (and cannot tolerate) Statins. Statins cause the patient to have weakened muscles.
Patient was given 0.2ml of 5-11 year pfizer covid vaccine that was not diluted. Patient experienced no adverse effects at this time.
PATIENT RECEIVED MODERNA BIVALENT COVID VACCINE.  FACILITY NURSE REPORTED THE PATIENT DEVELOPED SYMPTOMS OF FEVER, BODY TENSION, CLINCHING, AND JERKING MOVEMENTS.  PRESCRIBER WAS CONTACTED AND PATIENT WAS SENT TO THE EMERGENCY ROOM FOR EVALUATION. PATIENT HAS BEEN ADMITTED AND IS CURRENTLY IN THE HOSPTIAL.
Pain and bruising first three days after injection, then starting just before the seven day mark a hard, red, itchy lump appeared just below the injection site (while still having major bruising above). Soreness is also coming back into the arm, and it is only getting worse as time goes on, now almost at the nine day mark.
11 weeks pregnant received fluarix vaccine; This prospective pregnancy case was reported by a consumer via call center representative and described the occurrence of vaccine exposure during pregnancy in a 33-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th September 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Fluarix Quadrivalent 2021-2022 season at week 11 of the pregnancy. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: This case was reported by the patient herself. A 11 weeks pregnant patient reported that she had received her fluarix vaccine through her employer, which led to vaccine exposure during pregnancy. She was not experiencing any symptoms and was advised by her employer to report pregnant, when getting the vaccine.  Obstetrician gynecologist (OB/GYN), the patient's health care professional information obtained for any necessary follow-up. The reporter consented to follow up.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a physician concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number not reported and expiry: Unknown) dose not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 18-May-2021, the doctor called in for efficacy of the vaccine given to one of his patient (confirmed immunological vaccine failure) experienced on an unspecified date, and measured the spike protein about a month apart. On 19-APR-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) undetected antibody. On 17-MAY-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) undetected antibody.  The action taken with covid-19 vaccine ad26.cov2. s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210546864-covid-19 vaccine ad26.cov2.s-confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
3rd dose was administered/extra dos on April 12th 2020; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 79-year-old male patient who received Herpes zoster (Shingrix) (batch number t79d7, expiry date 1st October 2022) for prophylaxis.   Previously administered products included Shingrix (patient had got 2 doses of Shingrix in 2019).   On 12th April 2020, the patient received the 3rd dose of Shingrix. On 12th April 2020, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.       Additional Information: GSK receipt date: 13-JAN-2023 Reporter's comment: The pharmacist had reported on 13 January 2023 that they realized after verifying records that patient got two doses of Shingrix on 2019 and 1 extra dose on 12 April 2020. The patient had never reported adverse event (AE) after the administration of a third dose. The pharmacist wanted to verify about safety data in case of possible questions after letting the patient know. The vaccine administration facility was the same as primary reporter. The reporter had consented to follow-up. Additional supportive information: At the time of reporting, the patient had received the third dose of Shingrix vaccine, which had led to extra dose administered.
Body aches; Had blood in diarrhea; Throwing up bile; Patient got super dizzy; Congestion; Swelling; Feeling tired; Headache; A spontaneous report was received from a Consumer concerning a 56-years-old female patient who experienced blood in diarrhea, throwing up bile (bilious vomiting), body aches (myalgia), felt congestion (nasal congestion), headache, felt tired (fatigue), swelling, and super dizzy (dizziness).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot : 007M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 30 Jan 2021, the patient experienced swelling, headache, and tiredness shortly after receiving the vaccine.   On 02 Feb 201 the patient felt congestion.   On 03 Feb 2021, the patient experienced diarrhea which was bloody, throwing up bile, and having body aches but no fever. The patient also was super dizzy.    Treatment details included bismuth subsalicylate, Ibuprofen  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, blood in diarrhea, throwing up bile (bilious vomiting), body aches (myalgia), felt congestion (nasal congestion), headache, felt tired (fatigue), swelling, and super dizzy (dizziness) were unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
This patient received the annual influenzas vaccine and 2 days later started with shoulder pain and swelling and limited ROM.
1. My menstrual cycle is usually 28 days, but after the first dose of pfizer, it delayed for seven days. 2. arm pain after several hours of first dose,  then in around 24 hours, I had a low grade fever and felt fatigue for about 3 hours.
Case number PHEH2016US021870, is an initial spontaneous report received from a physician on 25 Aug 216. This report refers to a 36-year-old male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1517501, expiration date: Jun 2016) at 0.5 ml intramuscularly on 25 Aug 2016. It was reported that FLUVIRN was expired on Jun 2016. No adverse event was reported following this administration error (expired vaccine administered).
This is a spontaneous report from a contactable consumer via Pfizer sales representative. A 19-year-old male patient of an unspecified race/ethnicity received the first dose of TRUMENBA, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient developed pain at the injection site and the area was red and warm for 3 to 5 days. Final outcome was unknown.
Patient had known exposure to COVID-19 approximately 2 weeks prior to vaccination and again within days of vaccination. Approximately 1-2 days prior to admission, patient became symptomatic with cough, shortness of breath, fatigue, myalgias, and nausea/vomiting. Patient had tachycardia and tachypnea. Patient received IV fluids during ED stay and remained tachycardia and tachypneic. Patient is febrile at 100.5 F. O2 saturation 95%, pulse 109, Resp 25, BP 119/68. Patient will be admitted for close monitoring of vitals.
New 0.25ml Moderna for age 6mo-4yr single dose vial had 0.50ml and patient was given full 0.50ml instead of 0.25ml.