chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient administered expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered expired Moderna Covid-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter.  The vial was initially stored in the refrigerator on 17-Sep-2021.The vial did not undergo any temperature excursions. The patient did not report any other adverse events.  The reporter reported about the expired Moderna Covid-19 vaccines that was administered to 17 patients.  No treatment medication was provided by reporter.
Severe pain immediately. Pain getting worse over hours of time. After 1 hour, could not lift left arm or use it to grab or pick up anything. 8 days later, range of motion in left arm is very restricted. Pain is almost constant in left shoulder. Cannot sleep on left side. Left shoulder is tender and painful to the touch.
BODY ACHES; WATERY EYES; CHILLS; HEADACHES; FEVER; 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, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced body aches. On 06-APR-2021, the subject experienced watery eyes. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced headaches. On 06-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.7 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, fever, body aches, watery eyes, and headaches. This report was non-serious.
Pt c/o abdominal pain /p the 2nd dose in series, c/o dizzness /p 3rd dose. No treatment given. Pt seems alright
seizure; Initial information received on 16-Jan-2020 regarding an unsolicited valid serious case from the consumer (office staff).  This case involves an unknown demographics patient who had seizure (seizure), when the patient received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCIN) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ).  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: not reported) via unknown route in unknown administration site.  On an unknown date, the patient developed a serious event seizure (seizure) (unknown latency) following after the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. This event was assessed as medically significant.  Detail of laboratory data were not reported.  Final diagnosis was had seizure.   It was not reported if the patient received any corrective treatment.  The outcome was not reported for the event seizure.  Information on the batch number was requested.; Sender's Comments: This case involves an unknown demographics patient who presented with seizure after the administration of PENTACEL. The time to onset was unknown. Moreover, patient's medical history, medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information the role of the suspect vaccine cannot be assessed.
Patient receive vaccine then proceeded to stand. Upon standing, patient reported back pain that became chest pain. Pain level was rated 5 on scale of 0-10.  Pain was located at substernal and described as crushing. Patient was given oxygen at 10L and began to feel better after 10 minutes. EMS contacted and transported to Hospital.
the last syringe cut her finger when it broke.; Merck representative reporting a PQC for VAXNEUVANCE. Caller stated he received an email that he would forward to attach to the case. No AE reported by representative.  "the glass portion of the syringe has broken while attempting to separate the cap; Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? YES; Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? YES; This spontaneous report was received from a physician and an office manager, referring to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date in 2023, the health care professional broke 3 syringes, while attempting to give the PCV 15 pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) 0.5 milliliters, lot Number: X004289 and expiration date on 10-DEC-2024 (route of administration and anatomical location, were not reported) administered for prophylaxis. On three separate occasions, when the medical assistant (MA) or doctor has given pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE), the glass portion of the syringe has broken while attempting to separate the cap from the syringe. Both, the MA´s and the doctors give vaccines all day every day, and over the course of a year, give thousands of vaccines. It was reported that the breaking syringe not only represents a hazard to the patients and the staff but was also lost revenue due to the wasted vaccine. They do not have any similar type of incident with other vaccine products.   The patient (also the MA) relayed that the last syringe cut her finger when it broke. At the reporting time, the outcome of the finger cut was unknown. The casuality assessment between pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) and the finger cut was not reported.
This spontaneous report as received from a physician refers to unspecified patients of unknown age and unknown gender. On an unknown date, the unspecified patients were vaccinated with unspecified doses of ROTATEQ (Lot # K013661 and expiration date: 26-APR-2016), PEDVAXHIB (reported as K004541 and expiration date: 04-DEC-2016) and GARDASIL (K006960 and expiration date: 19-FEB-2017) on unspecified dates. No adverse effects were reported. Follow up information has been received on 06-MAY-2015. The information stated that the ROTATEQ was administered was improperly stored. This is one of several reports received from the same source. Additional information has been requested. Events and narrative were updated.
pt recv vax 9AUG95 & 30AUG95 pt exp sz;pt's MD reportedly felt that the sz were not related to therapy w/varicella vax,but thought the exp should be reported;
DECIDED NOT TO CONTINUE TAKING REMAINING DOSES; TOOK A DOSE OF VIVOTIF AFTER 24 HOUR EXCURSION; This case (PVX2019-2165) was received from a pharmacist on 26-Aug-2019. It described an adult male (20-29 years) consumer who "took a dose of Vivotif after 24 hour of excursion" (PT: Product storage error) and he "decided not to continue taking remaining doses" (PT: Incomplete course of vaccination), while being on Vivotif capsule for an unknown indication.  Case report: The consumer took a dose of Vivotif on 26-Aug-2019, after the 24 hours excursion. It was also reported that instead of taking the remaining doses, he wanted to get the injectable vaccine.  Action taken with Vivotif with respect to the events was not applicable.  The clinical outcome of the reported events was unknown.  Company's Comment: The causality of the events "took a dose of Vivotif after 24 hour of excursion" and he "decided not to continue taking remaining doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the events "took a dose of Vivotif after 24 hour of excursion" and he "decided not to continue taking remaining doses" was considered as not applicable.
Mom called on 3/14/01 and stated child broke out with chickenpox, about 15 total.
Patient was administered vaccine following improper storage (vaccine was left in freezer too long and was considered expired per manufacturer due to lack of stability study data). Patient acknowledged recommendation but will likely not revaccinate.
Swelling and very itchy around the area where I got my injection. Also, a tingly, fire sensation. Mostly itchy. It just started this morning. 11:00am CST.
Left eye visual disturbance; Feeling of film debris and or feeling of lag in eye movement; This is a spontaneous report from a contactable nurse (patient) and a contactable other health professional.  A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at left arm on 19Dec2020 at 9:15 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medication included escitalopram oxalate (LEXAPRO) at 10 mg daily. On 22Dec2020 at 13:00, the patient experienced left eye visual disturbance, feeling of film debris and/or feeling of lag in eye movement. The patient outcome of the events was recovering.  Information on the lot/batch number has been requested.
Facial/periorbital edema and inflamation, wheezing, congestion and cough.
Five days after the vaccine I began breaking out in hives, having extreme and intense histamine releases that would move very quickly throughout my body. Starting at the base of my neck/upper back/chest, and then spreading down stomach, arms, and legs. Each time I spiked a temperature of around 101.5 for about 5 minutes, before returning to normal. This is the 7th day in a row of symptoms. I have never had an allergic reaction to anything before.  I am not absolutely certain that the vaccine is the cause, but the timing is strange.  I have not changed my diet, shampoo, lotion, or detergent, The vaccine is the only isolated event I can say that is new.
Red area 4x4cm in right left (thigh area) warm to touch and painful.
rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization. The following information was reported: RASH (non-serious), outcome "unknown". Additional information:The reporter mentioned that her brother got a rash after the 1st Pfizer Covid19 booster vaccine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received the covid vaccine on 12/19/2020.  C/O new onset on sore throat and diarrhea on 12/28/2020. Sore throat is worsening. Hx of colitis by well controlled with Xeljanz. Diarrhea is unusual this time. Last diarrhea was almost 1 year ago.  Denies fever, cough, loss of smell, rhinorrhea, nasal congestion, abdominal pain Awaiting PCP at medical center for evaluation and testing. Declined Employee Health Service
72-year-old female presented to the urgent care this afternoon with complaint of onset of redness and irritation and concerned about a knot at the site of the injection of her most recent (second) Moderna COVID vaccine injection (lot # 022MN20A) on 2/20/21.  Patient stated she had her second Covid vaccine 5 days ago.  Patient reported some redness, heat, and lump to the injection site just now.
Patient presented to clinic for 2nd dose of Moderna primary series.  Reported having chest pain, dyspnea for about 5 days, symptoms subsided by day 15. Due to having no insurance did not seek emergency services. Returned to clinic today for 2nd dose and follow-up assessment completed.
Chills, fever of 102, body aches, headache, fatigue, dizziness, soreness at injection site and under the arm
Inadvertently administered an expired dose to a patient on 14-jan-22; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 8-month-old female patient who received HBV (Engerix B) (batch number P7294, expiry date 3rd January 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th January 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 14th January 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   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: The case was reported by Practice Administrator. The reporter stated that, they inadvertently administered an expired Engerix dose to the patient, whic led to expired vaccine used. The reporter consented to follow up.
Patient admitted to hospital with COVID-19 symptoms on 9/10/2021 after receiving vaccination  second dose in February.  Patient ultimately discharged from hospital on 9/16/2021, never needing to be intubated during stay.
Information has been received from a pharmacy student concerning an over 65 year old female who on 28-JAN-2009 was vaccinated with a dose of ZOSTER vaccine live (Oka/Merck) (lot number, injection site and route not reported).  On 29-JAN-2009 the patient had a blood sugar level of 400.  The patient was treated at an unspecified emergency room but not admitted.  The patient was released from the emergency room on an unknown data.  The outcome of the patient's experience was unknown.  Additional information has been requested.
Post vaccine pt experienced redness and swelling at the injection site, felt sick, and experienced vomiting, headache, pallor and weakness.
"flu shot" side effects; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS ("flu shot" side effects) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 031A21A) for COVID-19 vaccination.     Concomitant products included METOPROLOL for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS ("flu shot" side effects). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and Aspirin at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS ("flu shot" side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment Medications: Aleeve and Aspirin Dose 2 Adverse events will  be submitted in a separate case.; 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.
Hives.  three days so far.  Treatment oral and injectable steroids plus Benadryl
Fever 102 degrees for 3 days plus Nausea and vomiting for 30 hours
This spontaneous report was received from a nurse regarding a 13 year old female patient. No information was provided regarding medical history and concomitant medications of the patient. Concurrent condition included seasonal allergy. The patient had no illness at the time of the vaccination. On 07-NOV-2017, the clinic refrigerator had a temperature excursions of 39/48 degrees Fahrenheit (F), on 08-NOV-2017 was 39/48 degrees F, on 13-NOV-2017 was 40/48 degrees F and 14-NOV-2017 was 37/47 degrees F. There was no temperature excursion in December 2017. On 22-DEC-2017, the state representative was notified. On 03-JAN-2018, the patient was vaccinated with improperly stored doses of GARDASIL 9 (lot # N017697 expiration date 21-JAN-2020) (dose, units and frequency was not reported) intramuscularly for prophylaxis at a public health clinic/hospital with private funds. On 04-JAN-2018, the manufacturer was notified who stated it would be ok to continue to use. On 03-JAN-2018, temperature was within the range 40/43 degrees F. The patient received immunization at a well check appointment and had no adverse event or complications were noted. It was reported that possibly a temperature excursions occurred as a result of reading from a Digital Data Logger.
Exhaustion (still sleep several hours during the day), low grade fever, chills, involuntary body jerks, headache, irregular heart beat, joint pain, muscle pain, itchy area under the shot, swelling of upper arm, red rash under shot-4"X6", continued "brain fog"
Red, swollen, painful arm below injection site appeared 24 hours after injection lasted 7 days.
This person received the Moderna COVID-19 vaccine at 2:00pm; c/o dizziness, "sticky throat", itchy hands/palms, elevated BP;  @ 2:31pm with BP 195/80; @2:49pm, BP 227/104.  Took own BP medication Labetatol HCL 100 mg 1/4 tab (25mg)  per primary care doctor's prescription when systolic BP over 180.  At 2:56pm, transferred to Emergency Room for further follow up.
struggling to catch my breath; swinging from 120+ BPM to 50 BPM in an instant; pass out; racing heart; big rush of the room spinning; I could feel the medicine in my body, almost to my toes; This is a spontaneous report from a contactable consumer.  A 37-year-old male patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; lot number: EL9267) on 26Feb2021 and the second dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; lot number: EN6202) on 12Mar2021, via an unspecified route of administration on Left Arm at single  dose for COVID-19 immunisation. The administration of first dose of BNT162B2 resulted in Palpitations, dizziness, hyperhidrosis and Syncope the same day of administration. Relevant medical history included allergy to penicillin.  Relevant concomitant medications included testosterone cipionate (TESTOSTERONE CYPIONATE). During second dose of vaccine the patient stated that he feels the medicine in his body, almost to his toes. The patient was fine for a minute or two but then he reported a big rush of the room spinning, struggling to catch my breath, racing heart. EMS personnel was called over and they monitored my heart rate. It was swinging from 120+ BPM to 50 BPM in an instant and during the low BPM was when he passed out.   The patient was treated with Epinephrine due a potential reaction and transported to hospital.  The reported events were feeling abnormal, vertigo, dyspnoea, palpitations, heart rate irregular and loss of consciousness. All events were serious as hospitalization and Life-threatening illness (immediate risk of death from the event).
pt recvd vax; 24jul95 devel a vesicular rash on thigh, stomach & chest (13-17 bumps); MD felt pt's rxn was nl;
Nauseous; had pains across my stomach/doubled up in pain; "I was sicker than a dog, throwing up, diarrhea (medicine which helped 'backed up' on me), and had sharp pains across my stomach".; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration on 13Feb2021 as single dose for COVID-19 immunisation. Medical history included visual impairment from an unknown date and unknown if ongoing. The concomitant medications of patient were not reported. Caller reported that on Monday (15Feb2021) she was sicker than a dog, throwing up, diarrhea (medicine which helped backed up on her), and had sharp pains across her stomach. Consumer stated by Monday she started getting really sick and was doubled up in pain from everything. She reported she doesn't take a lot of medications they make her sick, she thought she was going to throw up or have diarrhea. She said that this morning (16Feb2021) she got up, she was very nauseous, more than usual, she took some pills for it, she did not have diarrhea, this was what she had going on and she was just really sick to her stomach and was right now too. She stated she had pains across her stomach that she had never had before, it was severe. The patient took some pills for nausea. The outcome of diarrhea was resolved, nausea and stomach pain were unknown.  Follow-up attempts are completed. No further information is expected.
Information has been received from an RN concerning her 70 year old mother who in 2/95, was vaccinated with pneumococcal vaccine 23 polyvalent. The pt, subsequently, developed swelling at and around the injection site, fever and general malaise. The pt had sought medical attention for her experience. All symptoms had since resolved. Additional information has been requested.
Nickle size area of redness and swelling at the MMR and varicella sites.
She had the shot and we where waiting for my nephew to be seen. 30 minutes after getting the shot she complained of not being able to hear and then not see. The office staff went to get the Dr. He instructed themto bring her to a room. She collapsed as we took her down the hallway. We carried her in and placed her on a table. She woke up quickly, the Dr. sent his staff to the ER (next door) to get a wheelchair. I then took her to the ER. He said he wanted t make sure she was ok and that she had had a severe reaction to the vaccine. Upon arrive she had lab work, EKG, and an IV started. We spent several hours in the ER and then were discharged. We were told everything was fine. On 12/26/06 we received a call from the office and they told us we needed to take her to a pediatric cardiologist and that should could not participate in any of her sporting events until cleared. We were told that the ER EkG showed a prolonged QT- interval. She had an EKG a few years ago which was normal. she also had a echocardiogram done previously which was reported nornal. We went and saw a cardiologist who asked if we had any histroy of this problem. We were all tested and no family member has prolonged QT intervals. She was placed on a beta blocker Nadolol 10mg BID. She has more recently returned to WVU and had a stress test done. We were told that she would now have to take this medicine forever. syncope. Nausea no vomiting.LabsDOS 12/30/06 ER Visit DX:Chest discomfort. Complaint of funny feeling in chest. 1 week history of prolong QT (incidental finding) after passing out after meningitis shot. Started Nadelol today and now with chest tightness. PE:WNL 03/08/07-record received from cardiologist consultant DOS 02/21/07 and 2/26/07-PE:regular pulse and blood pressure, no abnormal precordial pulsations, normal JVP, normal heart sounds, no murmurs. lung bases clear, no evidence of heart failure.  Treadmill test QT interval shortened after discontinuation of beta blocker. Highly unlikely that she has a familial long QT syndrome.