chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received a dose from a vial that was expired; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that was expired) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that was expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that was expired) outcome was unknown.        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.
pt had whelps all over her body, under her arm pits, back, thighs, abdomen and arm. pt received whelps after 1 and 2nd booster
About 3 weeks after my vaccine I was in the shower and I thought (2-3pm) I don't know where my husband was but he was at work and I knew that he was at work but I just couldn't comprehend where he was. I felt like I had to call him but I did not know how to call him. I dressed and as I dressed I realized he would be at work and heading home soon. I tried to reach him and told him of my confusion. He took me to the ER and I sat there for an hour before I saw a doctor. The first thing they did was take my BP and it hurt my arm soooo badly. 220/180 was my BP. I was admitted and they ran tests. The did an MRI, XRAYS and Heart tests and blood work. I was diagnosed with a TIA stroke at that time. I have had problems with my memory since then.  I also have tinnitus. I don't know when it started but it has gradually gotten worse.
Woke up 7 days after receiving the vaccine and am extremely dizzy; Was very dizzy the day of the vaccine but that went away; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via an unspecified route of administration in the right arm on 19Mar2021 at 12:00 (at the age of 55-years-old), as single dose for COVID-19 immunisation. The patient had no medical history and no known allergies to medications, food, or other products. Concomitant medications included vitamin d (MANUFACTURER UNKNOWN), potassium sulfate (MANUFACTURER UNKNOWN) and multivitamins (MANUFACTURER UNKNOWN); all from unknown dates for unspecified indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 19Mar2021, on the day of vaccination, the patient was very dizzy but that went away. On 27Mar2021 at 06:00, 7 days after receiving the vaccine, the patient woke up and was extremely dizzy. It had been going on for 3-4 hours and had not subsided at all. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the dizzy with onset of 19Mar2021 was recovered, while clinical outcome dizzy with onset of 27Mar2021 was not recovered at the time of this report.   No follow up attempts are needed. No further information is expected.
I had an allergic reaction; My tongue starts very heavy; Roof of my mouth and I guess back of my mouth close to my throat  were itchy; progressed to feeling  like I have sand under my tongue; My throat was extremely dry; I had difficulty in swallowing the water; My voice was very raspy; This is a spontaneous report from a contactable consumer or other non healthcare professional (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 02Apr2021 (Batch/Lot Number: ER 3734, Expiry Date and NDC number were unknown),  as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  On 02Apr2021, the patient reported that had couple of different side effect within 8 minutes of taking the shot had an allergic reaction, tongue starts very heavy, roof of mouth and guess back of mouth close to throat were itchy, progressed to feeling like having sand under tongue, throat was extremely dry, had difficulty in swallowing the water and voice was very raspy. The patient stated that they gave Benadryl, 2 doses.  LOT#: consumer stated, ER is that 3734, its 3 or 8, can't read it, let me see if can get something like a power glass if can make it little, larger, if can be more sure, it looks like it could be Pfizer ER looks like it might be could be a 3 could be a 8 can't really tell 734. The patient reported that, has a couple of quick question about Pfizer Vaccine, had the first vaccination, and had an allergic reaction. So, the CDC is saying that they don't recommend a second dose if you had reaction to first dose and want to know whether there is any allergist that could test me to see what it was that was allergic to shot. do you have list of those?  So, patient was referred, called the number and they referred patient to you regarding a negative response that had to the first Pfizer Vaccine, and have seen on the CDC website that if you have negative or allergic reaction to the first vaccine then the second vaccine should not be taken. The patient actually has two questions. Does Pfizer have a list of providers or allergic that could test to see what people are allergic to in their shot? So, you have any information so that patient could contact or get an appointment to the allergist in my state? The next question is if patient not able to take the second dose, would be able to check the MODERNA dose because it is also an MRNA shot. The outcome of the events was unknown.  Product details (LOT, Expiration Date, NDC and UPC) and Pharmacy details could not be probed as consumer hung up the call abruptly. Hence further probing could not be done. Consent to follow up with the patient which stated, so that why they need my email address so that can follow up with me, that makes sense. ok that's fine, well they can follow up with me by phone.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
nausea/vomiting, paleness, headache, flu-like symptoms including chills within hours of vaccine administration.
Body aches; soreness in arm; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), VACCINATION SITE PAIN (soreness in arm), HEADACHE (headache) and CHILLS (chills) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 23-Jan-2021, the patient experienced PAIN (Body aches), VACCINATION SITE PAIN (soreness in arm), HEADACHE (headache) and CHILLS (chills). At the time of the report, PAIN (Body aches), VACCINATION SITE PAIN (soreness in arm), HEADACHE (headache) and CHILLS (chills) had resolved.            No relevant concomitant medications were reported Treatment medications used were ibuprofen and acetaminophen
Pt presented with redness at the site and was warm to the touch. Pt stated they had headache following vaccination that did not respond to Tylenol. Pt was seen and was prescibed antibiotic because of possible cellulitis at the site.  Told to return Monday if they saw no improvement over the weekend.
Pt presented to ER with rash (bilateral) on arms and legs, chest, back, and neck. BP 131/73, Temp 98, Pulse 85, Resp 18.  Pt given Solu-Medrol 125mg IV, Pepcid 20mg IV, and Benadryl 25mg IV.  Discharged at 7:10 PM.
Vaccine was given 7 days past beyond use date. Per Pfizer Manager of Quality Operations,  Employee, their data stated, "Stability assessment indicates there is no product quality impact and the vaccine was suitable for use."
Red raised rash appeared on my arm at the injection site. Rash was very hot and burned as well as itched. Rash lasted about 10 days.
local area of erythema & sl tenderness lt deltoid area 3" x 1 "2" starting 24-48hrs p/vax;
Adacel was given to an 18 month old by mistake/ no symptoms; Initial information received on 13-Jun-2019 regarding an unsolicited valid non-serious case received from Other health care professional (office staff).  This case involves an 18 months old male patient who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE (HIB) for Immunisation.  On 11-Jun-2019, the patient received a 0.5ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot C5560AA, expiry date 21-Jan-2021 via intramuscular route in left leg.  It was an actual medication error due to Inappropriate age at vaccine administration.  It was reported that Adacel was given to an 18 month old by mistake.  The patient did not experience any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  List of documents held by sender: none.
Pt saw red mark rear area where shot was given. Unsure if shot causesd the irritation.
Information has been received concerning a 4 year old male with asthma who on 07/28/97 was vaccinated with one dose of varicella virus vaccine live. On 11/22/00, the patient experienced breakthrough varicella. On 11/25/00, the patient recovered from breakthrough varicella. Other patients were reported with similar symptoms following varicella virus vaccine live (WAES 01072609-01072615, 01072617, 01030289, 01072717 01072719). No further information is available.
Hurting all over body; Started feeling sick; Running a high Fever; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 05Apr2021 at 14:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included COVID-19 (in Dec2020) and was requested to go into the hospital which the patient chose to go home to be with her family. The patient's concomitant medication included levothyroxine (MANUFACTURER UNKNOWN) for an unknown indication since an unspecified date. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021, after the vaccination the patient felt fine. On 06Apr2021 at 15:00, almost 24 hours after the vaccination, the patient started feeling sick. By the night the patient was hurting all over her body and was running a high fever. The patient was worried about getting the 2nd shot on 26Apr2021. Therapeutic measures were not taken as a result of these events. The clinical outcome of the event started feeling sick, hurting all over body and running a high fever was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
4 seizures within 24 hours of the shots.  11/05/2007 MR received for DOS 10/19-21/2007 for DX: Seizure- like event.  Child awoke the morning following vax with irritability and fever, then became stiff and his eyes rolled back in his head.  EMS summoned and child had several more similar episodes in the ER. Pt desaturated into the 80's during one event. PE WNL except pt is sleepy but arousable. Admitted for w/u, IVF and antibiotics. D/C in stable condition.
I had a really painful headache. I normally don't have headaches. I took TYLENOL. The next day I had an appointment and on my way home I noticed my eyes sensitive to light. The next morning I started feeling stuffiness. I did a COVID-19 at home test and it was negative. I stayed home. The next day I started getting a slight fever of about 99.5 degrees. No sore throat though. I had a dry non-productive cough. Everyday I tested negative until December the 5th, 2022, I test positive. I was still feeling feverish, coughing and stuffy. I lost my sense of taste and smell for about a week and a half but slowly came back and now seems to have returned completely.
Vaccine given at 2/21/06.  Fever and chills 12 am. 02/22/06 increase headache. Arthralgia, chills, T=103, nausea
Disturbed menstruation I took my pfizer vaccine second dose and i missed my periods for a whole montj after that. Then it came. And the. It cam again after 20 days.. I duno what is goin on but i am afraid... I had alot of pain never had it happen ever. I am 30 year old mom
Patient developed cough, poor appetite, decreased po intake, altered mental status, failure to thrive, increased work of breathing, approximately three weeks after vaccine administration. He presented to the hospital where he was found to be covid-19 positive on admission. Patient is currently hospitalized (hospital day 1)
First dose given 07/02/2023 and second dose given 07/21/2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 55-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 21-JUL-2023, the patient received Shingrix. On 21-JUL-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: First dose given 07/02/2023 and second dose given 07/21/2023).  The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 09-OCT-2023 The pharmacist reported 1st and 2nd doses of Shingrix given 2 weeks apart. The first dose was given on 02-JUL-2023 and second dose given on 21-JUL-2023. Healthcare professional did not have information for lot number/expiration date for 2nd dose. Healthcare professional did not have further patient information. No additional AE information available. HCP gave consent for Safety team to follow up, via phone or email. The patient received 2nd dose of Shingrix, earlier than the recommended interval, which led to shortening of vaccination schedule.
From telephone contact received at manufacturer on 12/06/2002, it was reported that a 53-year-old male pt was administered Imovax Rabies, lot number U0448-2, intra-muscularly in the left deltoid on 11/22/2002. By the next day, 11/23/2002, the pt called to complain of painful joints in his fingers, wrist, elbow and knees. Reportedly, the symptoms went away on the 4th day without treatment. The case is closed.
Patient received Pfizer Bivalent 2 weeks apart. she has been feeling very tired since
Narrative: COVID infection following COVID vaccine series 02/17, Pfizer, dose #1 03/10, Pfizer, dose #2 09/22 COVID swab, result: detected 09/22 pt cc: cough, fatigue, loss of taste or smell, myalgias, rhinorrhea, dyspnea exposure; unknown 09/26 pt admit ED cc: cough, fatigue, dx: covid infection, hepatic fibrosis, lymph node enlargement LOS: 1 day 09/26 CTA PE impression: 1. Negative for pulmonary embolism. 2. Hepatic steatosis, and findings suggesting an underlying element of hepatic fibrosis. Suspected perigastric varices. 3. 8 mm pulmonary nodule within the right lower lobe. Follow-up examination in 6-12 months time is recommended to ensure stability. 09/26 CR impression: No pulmonary consolidation or overt edema identified. No pneumothorax or significant pleural effusion. Nonenlarged cardiac silhouette. 10/2 clinically resolved
Had vaccine on Tuesday, 3/9 and on Thrusday night and Friday evening , my right elbow area was very sore.  The pain is very localized and responded to a couple of days of ibuprophen. Started again this week and  the arm is swollen/inflammed.   Uncomfortable for daily activities like typing or eating.   Does respond to ibuprophen.   Trying to rest it and have it in sling to rest it.
Headaches; pain/extreme body aches (worse than my fibromyalgia); a little difficulty to breath; extreme tiredness; swelling; woke up with my face swollen it went down after hot shower; Nauseous throughout the day; eyes burning; cold sores on my mouth; This is a spontaneous report from a contactable health care professional nurse, the patient.  A 50-year-old non-pregnant female patient (health care professional) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3248), in the right arm on 19Jan2021 13:15 as a single dose, for COVID-19 vaccination. The vaccine was administered at a Public Health Clinic facility. Medical history included asthma, Fibromyalgia and known drug allergy to penicillin.  Concomitant medication included diclofenac (DICLOFENAC), clonazepam (KLONOPIN).  No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 19Jan2021 20:00, the patient experienced pain started at exactly 8:00pm; extreme body aches (worse than my fibromyalgia), a little difficulty to breath, extreme tiredness, swelling, woke up with my face swollen (it went down after hot shower). Nauseous throughout the day, eyes burning and cold sores on my mouth and Headaches. No treatment was received given for the event. The clinical outcome of pain, extreme body aches, difficulty to breath, extreme tiredness, swelling, face swollen, nauseous, eyes burning, cold sores on mouth and Headaches were recovering.
Received the chicken pox vaccine at 1 and now 4 1/2 has the chicken pox.
First event was hair loss, then progressed to headaches, vertigo, weakness in extremities, visual disturbances, anxiety, depression, chest pain, irregular heartbeat, nausea, difficulty swallowing.
About 10 minutes after injection, left arm suddenly became markedly weakened...from my shoulder, travelling to my hand. Could still use my arm...just very weak. Second day...morning, felt okay, except for left arm. About 10am, began to ache, especially my neck, my lower back and began noticing a headache. By the end of the day, I was achey all over. (Was at work). Lost my appetite and felt very, very tired. Took 2 Tylenol. Went to bed at 10pm. Left arm began to hurt with swelling and reddness. Third day, woke up feeling much better, but, still tired, a little achey. Neck still uncomfortable. Ate breakfast without incident. Arm still very sore. This is the third day, so have no further events to detail.
Fever as high as 102.4, generalized body aches, mild headache all lasting about 24 hours
patient after 1 hour of shot had a big bump around injection site and a little itchy. this morning at 930 am patient came back to the pharmacy and showed a big rash around the injection site and still a little itchy per patient . pharmacist  suggested her to go to urgent care
Oct. 1 - Fatigue, leg weakness, athlete says his legs now "feel like jello." Oct 17 - Missed school. Falling down. Dr. run labs. Moved to different medical provider. Oct 19 - Hospital. Testing r/o tumor. R/O Guillain Barre because not ascend. Dx poss virus. Oct 24 - To Rehab for 10d (now wheel chair). Oct 30 - Home. Now walking - still endurance issues.
ACUTE STROKE DUE TO OCCLUSION OF RIGHT CEREBELLAR ARTERY ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY
slept 2 hrs following inject; woke w/high pitched cry x 2 1/2-3 hrs; Tempra given; TC to MD encourage cold compress/Tempra; avoid future pertusis vax; paternal aunt had sz age 16 yrs resulting in cardiac arrest & Mental retard;
This spontaneous report has been received from a healthcare worker referring to a male patient of unknown age. On 16-NOV-2015 the patient was inadvertently vaccinated with (Merck) VARIVAX (dose, route and lot# not reported) instead of ZOSTAVAX (wrong vaccine administered). No adverse effects reported. Additional information has been requested.
Information has been received from a RN concerning a 22 yr old female who on 01Aug05 and 06Oct05 was vaccinated with the first and second doses, respectively, of varicella virus vaccine live. The RN reported that on 06Oct05, the pt's varicella titer was negative. Unspecified medical attention was sought. At the time of this report, the outcome was unk. Additional information has been requested.
mild fatigue ST; cough; HOME AG:Positive; HOME AG:Positive; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 37 year-old male patient received bnt162b2 (BNT162B2), administration date 23Nov2021 (Lot number: FF2589) at the age of 37 years as dose 3 (booster), single, administration date 16Feb2021 (Lot number: EL3247) as dose 2, single and administration date 26Jan2021 (Lot number: EL3247) 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Feb2022, outcome "unknown" and all described as "HOME AG:Positive"; FATIGUE (non-serious) with onset 19Feb2022, outcome "unknown", described as "mild fatigue ST"; COUGH (non-serious) with onset 19Feb2022, outcome "unknown", described as "cough". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Feb2022) positive, notes: Home AG. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, fatigue, cough. Clinical course included "Household member with positive  COVID, 2 children then he had symptoms on 18Feb2022 and positive COVID 19Feb2022 mild fatigue ST and cough"  No follow-up attempts are possible. No further information is expected.
I had no reaction with the first dose of Moderna, a sore arm for a couple of days with the second dose of Moderna and with the third dose, I had muscle soreness and weakness - was afraid I?d drop the gallon of milk as I was taking it out of the refrigerator.  The muscle soreness, which I would rate at a 3-4 on a scale of 1-10,  persists almost three months post last injection.  The ?discomfort? seems to migrate from  central deltoid at the injection site to  the right side of the deltoid, to the left side of the deltoid and even up into shoulder muscles and is present all day, every day.   Arm movement is uncomfortable. Taking Ibuprofen does nothing to eliminate or relive the discomfort.
This spontaneous report as received from a nurse refers to a female patient of an unknown age. The patient's current conditions and medical history were not reported. On 04-JUN-2015, the patient was vaccinated with first dose of ZOSTAVAX in the right arm and was inadvertently vaccinated with a second dose of ZOSTAVAX on 10-JUN-2015. Concomitant medications were not reported. No adverse effects were reported. The outcome of the event was unknown. There was no product quality complaint involved. Additional information is not expected as the reporter did not wish further contact.
large lump under armpit39x19x23mm enlarged lymph node with edema and inflammation. diagnostic breast mammography performed to get size of lump and diagnosis. ultrasound was done as well follow up is recommended.