chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Death; had vomited and was found unresponsive and covered in stool, intubated and then went in to PEA in the field and passed despite lengthy resuscitation.
Client complained that it hurt to breathe to mother that night.  Denies injury.  Chest hurts to breathe and was in tears.  Mother gave ibuprofen.  Monday 5-14-12 it hurt to move but was better at rest. Instructed to call their doctor to follow up with.
Burning arms/legs; Weakness; Vomiting; Muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 11Mar2021 at 12:15 (at the age of 73-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified medications within two weeks of vaccination. On 11Mar2021, the patient experienced burning arms/legs, weakness, vomiting and muscle pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events burning arms/legs, weakness, vomiting and muscle pain was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
expired moderna vaccine administered to patient; The vial was initially stored in the refrigerator on 05-Apr-2022, expired on 01-Apr-2022, administered on 06-Apr-2022 to 09-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine administered to patient) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 05-Apr-2022, expired on 01-Apr-2022, administered on 06-Apr-2022 to 09-Apr-2022) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine administered to patient) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 05-Apr-2022, expired on 01-Apr-2022, administered on 06-Apr-2022 to 09-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine administered to patient) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 05-Apr-2022, expired on 01-Apr-2022, administered on 06-Apr-2022 to 09-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided. It was reported that the administration of vaccine occurred from 06-Apr-2022 to 09-Apr-2022. Patients did not report any adverse reaction after the vaccination. The manufacturing date of the vial was 01-Dec-2021 Vial was initially placed in refrigerator on 05-Apr-2022. The product didn't undergo any temperature excursion issue. Reporter wants to know if the patients need to be re-vaccinated. No treatment drug information was reported.   This case was linked to MOD-2022-538688, MOD-2022-538614, MOD-2022-538698, MOD-2022-538689 (Patient Link).
flushing of face and upper chest, tongue tingling,  and mild upper body itching.
2JUN93 states 12-18 hrs post inject felt as if had the flu, prespiring heavy & dizziness w/ears ringing & difficulty breathing; c/o tingling in arms, legs, & chest constriction; ER dx hyperventilation; liver enzymes elevated, tachycardia;
45-year-old female received her second dose of the Covid-19 vaccine mRNA Moderna on September 03, 2021. On September 03, 2021, the patient stated she felt dizzy after vaccine. Patient also complained of feeling very sore on her right arm after receiving vaccine and was in pain. Patient was given acetaminophen 325mg and recommended to rest. On September 07, I spoke with health care provider who state that patient is doing okay, and pain related to COVID-19 vaccine has resolved.
Patient is a 80M h/o suspected autoimmune ILD/Rheumatoid arthritis on MMF/prednisone taper, recurrent/frequent pneumonia, emphysema, esophageal dysmotility/Schatzki ring, mild-to-moderate AS, GERD, suspected polymyalgia rheumatica, provoked DVT, mild pHTN, COVID vaccinated + booster, p/w COVID-19 infection. .      He presented with symptoms since the holiday with progressively worsening cough, sob, found to have new diagnosed of covid-19 pneumonia. Unfortunately he had just gotten his booster shot the day after mild symptoms started. Required up to 3L of oxygen, but able to wean down, continued to improve. CXR without infiltrates. Treated with dexamethasone, remdesivir. Wean off oxygen and will stop dexamethasone on the day of discharge return to this usual prednisone day the day after discharge per pulmonary recs. His MMF was held while here and will continue to be held for another 2 weeks. He knows to return if his symptoms worse but was eager to leave as his wife was sick at home as well.   He was mildly bradycardic, ecg showed no pauses or blocks.
Received Moderna vaccine and since has had irregular periods.  Late menses after first vaccine by 2 weeks; 2nd vaccine no menses x 3 weeks; on OCP's.
Again, I got anxiety and depression after the vaccine sometime which is new. Also an inability to sleep, which started around mid July 2021. I contacted my DR about it September 1st 2021, The DR referred me to a social worker for assessment. I do not have any other information to share.
administered Twinrix after the expiration date; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 64-year-old female patient who received HAB (Twinrix) (batch number GG3S5, expiry date 28th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th April 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 4th April 2022, unknown after receiving Twinrix and Twinrix 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 Information: GSK Receipt Date: 04-Apr-2022 Reporter's Comments: The reporter stated that the patient was administered Twinrix after the expiration date. The reporter consented to follow up via post.
I woke up with terrible lower back pain and shooting pains in legs. I had difficulty and extreme pain standing and walking. Doctor's examination revealed inflammation of lower back around spine. X-rays revealed arthritis in lower back and minor disc slippage/bulging, as expected for age. Since no back injury or strain, Doctor diagnosed it as probable immune system going into over-drive due to vaccine and attacking lower back arthritis resulting in inflammation and pinched nerves. Treatment was muscle relaxers for a few days and Physical Therapy for lower back. Cleared sufficiently in 2 weeks to get second dose of vaccine on time, with no problem.
struggled to use it afterward due to soreness; This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (struggled to use it afterward due to soreness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cerebral palsy.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (struggled to use it afterward due to soreness). At the time of the report, MYALGIA (struggled to use it afterward due to soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant medication was not provided.  Patient requested to be vaccinated in his good arm and struggled to use it afterward due to soreness.  He was wondering if his second dose can be given IM in his gluteal muscle.  treatment information was not provided.
Rheumatoid Disease; This case was reported by a physician via call center representative and described the occurrence of rheumatoid arthritis in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rheumatoid arthritis (serious criteria GSK medically significant). On an unknown date, the outcome of the rheumatoid arthritis was unknown.   It was unknown if the reporter considered the rheumatoid arthritis to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had a rheumatoid disease and was going to start an immunosuppressive therapy before receiving the second dose of Shingrix. The physician mentioned that he had done the same with other patients, administering Shingrix while they were in an immunosuppressive therapy. The reporter consented to follow up.
patient received expired dose of Ipol/ no adverse event; Initial information regarding an unsolicited valid non-serious case was received on 31-Mar-2021 from a nurse via Agency (Reference number- 00543194) and transmitted to Sanofi on 31-Mar-2021.  This case involves a 5 year-old male patient who was vaccinated with expired dose of IPV (VERO) [IPOL] (batch number P1F541M and expiry date 07-Mar-2021) via an intramuscular route at the left deltoid on 08-Mar-2021 for prophylactic vaccination (expired product administered).   The patient's medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  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.
Pt got chickenpox and had already had vaccine 11 1/2 months ago. Per call to co-worker of reporter, the health dept doesn't have a record of vaccine given on 3/22/00 for this pt. They also have no record of his ever receiving Varivax; however, the pt's sister did receive vaccination on 3/22/00, including Varivax. The reporter's co-worker states that the pt's mother still maintains her son had Varivax on 3/22/00. No further follow-up is possible at this point.
Pt. states that after receiving the 2nd dose of Moderna 08/15/2021, started experiencing symptoms 08/16/2021 of body aches, joint pain, and a rash throughout the left arm forming overnight 08/16/2021 into 17th. Still continuing to experience the rash, but body aches and joint are subsiding. No noted Primary visit.
Ache and pain at site. For the past 2 months pain radiated down to elbow and up to shoulder into scapula. Pain limits range of motion. Loss of sleep due to excruciating pain.
10/13/09 Received vaccines, that night pain and couldn't move (L) arm, chills, HA and aching all over, took pain pill felt better 'per patient'. 10/14/09 Redness from shoulder to elbow and hot to touch (L) arm) per patient. 10/16/09 Pt reported symptoms so appt made - redness (hard above elbow); none noted on upper arm (deltoid), gd ROM, still "hot to touch", achiness and HA gone pt reports. Examination 10/16/09 by Doctor - LCTA, HEENT stable, heart regular, audible and stable, full ROM of elbows and shoulder; she did have some slight tracheal wheezing that she feels may or may not have had previously. No fever. BP stable. Pt thought it was the pneumonia vaccine, but according to charting it was influenza.
worsening pre-existing conditions due to stressful events; worsening pre-existing conditions due to stressful events; decreased mobility (surgery); increase anxiety; flares-ups of fibromyalgia/osteoarthritis.; flares-ups of fibromyalgia/osteoarthritis.; blood pressure elevated; foot pain; Low vitamin D (before therapy) improved for the first time; This is a spontaneous report from contactable other health professional and consumer (patient) via a Pfizer-sponsored program. A 51-year-old female patient started to receive tofacitinib citrate (XELJANZ XR; strength 11mg), oral from Mar2021 (Batch/Lot number was not reported) to 21Jun2021, at 11 mg once daily and via oral from Sep2021 (Batch/Lot number was not reported) and ongoing, at 11 mg once daily for rheumatoid arthritis; BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation; and influenza vaccine (Manufacturer unknown) via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date at dose number unknown, single for immunisation. Medical history included low vitamin D. The patient has unspecified concomitant medication. The patient initially started therapy with XELJANZ XR from Mar2021 to 21Jun2021 and restarted at the end of Sep2021. Most recent shipment was on 07Oct2021 due to right ankle reconstruction/tibial bone graft from 06Jul2021 to 07Jul2021 (2 days hospitalization), COVID-19 vaccine (Pfizer), and flu shot.  In 2021, the patient experienced worsening pre-existing conditions due to stressful events, out of work, disability, decreased mobility (surgery)/increase anxiety after being off therapy resulting in flares-ups of fibromyalgia/osteoarthritis. The patient is coping and taking unspecified medication for the events. MD was aware. The patient also experienced blood pressure elevated (onset eight months ago) could be due to foot pain. Low vitamin D (before therapy) improved for the first time. The action taken of tofacitinib citrate in response to the events was dose not changed. Outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: The reported events are likely intercurrent conditions and are not related to the suspect drugs.
This spontaneous report as received from a pharmacist refers to a pediatric female patient of unknown age with no pertinent medical history and no drug reactions/allergies. On 10-MAR-2014 (reported as one week ago) the patient was vaccinated with a dose of M-M-R II (route, dose and indication not reported). No concomitant medication reported. The pharmacist reported that the pediatric patient who received a dose of M-M-R II last week came to pharmacy and filled prescription for BACTRIM. No lab diagnostics studies were performed. At the time of the report, outcome of the event was not reported. Additional information is not expected.
Received vaccine to prevent me from having shingles in my own doctors lab on March 24. On April 4th I had shingles.
This case was reported by a healthcare professional and described the occurrence of fever in a child of unspecified gender who was vaccinated with Pediarix for prophylaxis.  On an unspecified date on or before 18 December 2006, the subject received unspecified dose of Pediarix.  At an unspecified time after vaccination with Pediarix, on an unspecified date on or before 18 December 2006, the subject experienced fever, pain and crying.  The subject was seen at a physician's office.  The healthcare professional considered the events were clinically significant (or requiring intervention).  The outcome of the events was not reported.  The healthcare professional considered the events were probably related to vaccination with Pediarix.  Follow-up information was received on 13 April 2007 via a registered nurse, who reported that the subject was 4 months old (gender unspecified).  The subject received Prevnar and PedvaxHIB intramuscularly on 14 December 2006.  On 15 December 2006, the subject experienced fever, pain and crying.  As of 18 December 2006, the events were resolved.  The subject experienced no adverse events following previous vaccinations.  At the time of reporting, Pediarix had been reintroduced to the subject and the symptoms did not recur.  The reporting nurse initially indicated the events to be clinically significant (or requiring intervention); upon follow-up, the nurse also considered the events to be not serious.  The reporting nurse considered the events were possibly related to vaccination with Pediarix.
Information has been received from a pharmacist on 11-FEB-2015 referring to a 34 year old male patient. On 10-FEB-2015 the patient received a dose of M-M-R II (route, lot number and dose were unknown). The patient called the pharmacy on 11-FEB-2015 and stated that he should have requested an unspecified meningitis vaccine not the M-M-R II vaccine. He stated that he requested the incorrect vaccine yesterday, 10-FEB-2015. No adverse effect reported. Additional information is not expected because the reporter did not want to be contacted.
PATIENT CALLED PHARMACY STATING THAT SHE HAD CONTINUED SORENESS AT INJECTION SITE, VACCINE WAS GIVEN OVER 3 WEEKS AGO. ADVISED PATIENT TO MONITOR SORENESS, AND TO APPLY COLD PACK TO SORE AREA TO SEE IF IMPROVEMENT OCCURS, AND TO KEEP PHARMACY UP TO DATE ON OUTCOME - NO OTHER SYMPTOMS WERE MENTIONED.
This case was reported by a physician and described the occurrence of shoulder pain in a 63-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). In September 2008, the subject received a dose of FLUARIX (.5 ml, unknown, left arm) and within 24 hours she experienced shoulder pain and shoulder tendonitis. The reporting physician stated that the subject experienced left shoulder tendonitis and left shoulder pain within 24 hours after receiving the FLUARIX. The report indicated this was a local reaction, however it was specified as the left shoulder. At the time of reporting the outcome of the events were unspecified. The physician considered the events were possibly related to vaccination with FLUARIX. Follow-up information was received on 14 November 2008, via physician who repeated the vaccine was administered on 23 September 2008. The events occurred on 24 September 2008. On 14 October 2008, the subject was treated with a tapering dose of prednisone for 10 days. The subject returned for follow-up on 16 October 2008 and had improved. The subject was instructed to follow-up as needed and has not returned. The physician considered the events possibly related to vaccination with FLUARIX.
"Covid Arm" Red itchy blotch at vaccination site.  Approximate size 3"x3 1/2".
Inflamation @ site of injection 30 min /p inject.  Headache /p 1 hr of inject. Dry mouth, flushed, warm 1 hr /p inject.  14Dec90 still has headache
11/19/2004: 4pm woke form nap. Left arm swollen form injection site to wrist painful. Approx reaction pod 5-10 minutes. More painful took two Aleve. Slept with arms on pillow 11/20/04. Awoke in morning. Temp 101 degrees oral. Elbow swollen to wrist top of hand and fingers fluffy. 11/23/04: first day able to raise hand to his mouth. 11/29/04: spoke with patient. Arm fine now. Doesn't hurt and all the swelling has gone down.
10/23/08 injection shot hurt when given, muscle soreness, point of injection stayed red x3 wks, (and area) scab over point of injection-would bleed when scratched. Muscle stayed sore, painful to use hand x 2 mo. Seen by dR 12/17/08, antibiotic (KEFLEX) given and MOTRIN (800 mg) prn for discomfort. Much improved except not healed completely-remains sore in one spot.
Fluarix vaccine was received in clinic on 9/15/21. Reportedly, it was discovered to be out of refrigeration around 9/20/2021 and was placed in the fridge at that time and the person didn't tell anyone what they did.  I received the vaccine on 10/6/2021.  Someone in the clinic told us in Dec 2021 that the vaccine had been left out of the refrigerator without knowing that 7 of us in the pharmacy had received that vaccine.
experiencing acute memory loss; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male 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: AMNESIA (non-serious), outcome "not recovered", described as "experiencing acute memory loss".  Additional information :Patient's second dose was scheduled for Today but he had an issue with work. He tried to reschedule the vaccination at his facility but it was too packed that they told him they cannot schedule him for an appointment until 30 days later. As reported by the patient that he and his male partner received their 1st dose of the vaccine and have been experiencing acute memory loss that has not gone away. He mentions that it was very concerning and has made him vary wary because he can't remember anything anymore such as day to day things like where he placed his key. it was reported by the patient that he and his partner was very healthy, did not take medication, with his partner not been having a vaccine ever since childhood, and are vegetarian. This was the first time that has happen to them, given his old age. he was aware that the side effects of the 2nd dose might be worse than the 1st dose as said by his community members. He also mentioned that he saw in the news today that Dr. mentioned that about 5800 people who got fully vaccinated had full blown covid and even 73 of them died.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021427876 same reporter/drug/AE, different patient
Fever for 4-5 hours, chills,  achy ness, pain in joints and all over.