chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Menveo went in eye; Menveo went in eye; vial stopper leakage; defect was classified as Vial stopper integrity issue.; This case was reported by a other health professional via call center representative and described the occurrence of occupational exposure while preparing product for administration in a female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced occupational exposure while preparing product for administration, exposure via eye contact, vial stopper damage and pharmaceutical product complaint. On an unknown date, the outcome of the occupational exposure while preparing product for administration, exposure via eye contact, vial stopper damage and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date: 10-OCT-2022 and 17-OCT-2022 Reporter's comment: Health Care Professional reported that after reconstituting the Menveo it exploded and some went in her eye.  The reporter wanted to know if we had guidance.  The reporter said she will call back tomorrow with lot and expiration. The vaccine administration facility was the same as primary reporter. As per the QA department the reported defect was classified as vial stopper integrity issue. The reporter consented to follow-up. Additional Supportive Information: After reconstituting the Menveo it exploded and some went in her eye, which led to Occupational exposure while preparing product for administration, Exposure via eye contact, Vial stopper damage and Pharmaceutical product complaint.
achy/sore; clammy; This is a spontaneous report from non-contactable physician (patient) via Pfizer Sales Representative. This male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Jan2021 at single dose for covid-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation. The patient felt achy, clammy and sore in Jan2021.  Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
On 9/11/14 patient was given a MENACTRA vaccine. After she received the dose, it was noted to have expired on 9/4/14.
This is a spontaneous report from a contactable MA calling on behalf of a physician who reported for a 12-year-old male patient. A 12-year-old male patient of an unspecified ethnicity received TRUMENBA  (Lot # M77282, Expiry Date Jun2017, NDC # 0005-100-10) intramuscular at 0.5ml, single in left deltoid on 31Mar2017 for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced red, swelling, hot to touch and ring at injection site on an unspecified date in 2017 with outcome of unknown.
This is a spontaneous report from a Pfizer sponsored program Pfizer RXPathways. A contactable physician reported that a patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that  in the allergy section of the application the following was noted: pneumococcal vaccine. The outcome of the allergy was unknown.
Swelling below knees and in feet after 1st dose; Swelling below knees and in feet after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Swelling below knees and in feet after 1st dose) and PERIPHERAL SWELLING (Swelling below knees and in feet after 1st dose) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced JOINT SWELLING (Swelling below knees and in feet after 1st dose) and PERIPHERAL SWELLING (Swelling below knees and in feet after 1st dose). At the time of the report, JOINT SWELLING (Swelling below knees and in feet after 1st dose) and PERIPHERAL SWELLING (Swelling below knees and in feet after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.   This case was linked to MOD-2021-060904 (Patient Link).
pt received undiluted vaccine - at time of contact with pt she reported arm soreness and slight rash
A non-serious spontaneous report of given expired FLUMIST was received from a health professional concerning a four-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 10-Dec-2011, the patient inadvertently received expired FLUMIST. The product expired on 05-Dec-2011. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information as received on 30-Mar-2012 and incorporated into the narrative: No late occurring adverse event.
Right hand through wrist swollen; severe muscle pain, shoulder pain, getting around is hard; Severe joint pain, shoulder pain,getting around is hard; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Right hand through wrist swollen), MYALGIA (severe muscle pain, shoulder pain, getting around is hard) and ARTHRALGIA (Severe joint pain, shoulder pain,getting around is hard) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and METOPROLOL for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced PERIPHERAL SWELLING (Right hand through wrist swollen) and MYALGIA (severe muscle pain, shoulder pain, getting around is hard). 19-Feb-2021, the patient experienced ARTHRALGIA (Severe joint pain, shoulder pain,getting around is hard). At the time of the report, PERIPHERAL SWELLING (Right hand through wrist swollen), MYALGIA (severe muscle pain, shoulder pain, getting around is hard) and ARTHRALGIA (Severe joint pain, shoulder pain,getting around is hard) outcome was unknown.
8/15/21: Patient arrived at the ER due to nausea, vomiting and generalized weakness for the past 5 days. Patient tested positive for COVID on 8/15/21.  Diagnosed with: COVID-19 pneumonia, acute hypoxic resp failure, SIRS Note: patient previously vaccinated with Pfizer COVID-19 vaccine in March 2021. Please note: Patient received first dose Pfizer vaccine on 3/11/2021 Lot # EN6199 and the second dose on 3/31/2021 Lot # ER8737 8/18/21: Patient discharged to hospice care 8/19/21: Patient expired. Time of Death 1710
Within 24 hrs of getting the shot, the patient reported intractable vomiting, fever, myalgia, headache, and general body spasms. She was unable to leave her home for 3 days.
red rash  diarrhea ,vomiting,fever.chills head heach pain. chills vain in forehead poped out ;
No adverse effects; 18-year-old patient received an adult dose of VAQTA; This spontaneous report was received from a licensed practical nurse and refers to an 18-year-old patient. There was no information about the patient's concurrent conditions, concomitant therapies, previous drug reactions, allergies or medical history.  On 24-APR-2019, the patient was vaccinated with an adult dose of hepatitis a vaccine, inactivated (VAQTA), intramuscular route (formulation, strength, dose, frequency, anatomical location, indication, lot #, and expiration date were not reported). No adverse effects.
Side effects after getting the second shot: Fever 103.1, muscle pain, headache, chills, dizziness, swollen arm
Patient received covid vaccine and also flu vaccine and after a minute fainted and regained consciousness. Ambulance was called and patient was given glucose gel and then lost consciousness after a minute and was foaming at the mouth and then regained consciousness after a minute again. Ambulance came and took vitals, which were stable and then she went with the ambulance
patient fainted after receiving COVID 19 vaccine Pfizer-biontech 1st dose vaccination. Ambulance arrived and patient was evaluated. Patient didn't need to be transported to the hospital. patient stayed 30-40 minutes at the vaccination area after vaccine was adminsitered
Information has been received from a nurse practitioner concerning a 16 year old female who on 04-JUN-2007 was vaccinated IM with a 0.5 ml first dose of Gardasil. Five minutes later the patient experienced dizziness and fainted while sitting in a chair. Unspecified medical attention was sought. Subsequently, the patient recovered from dizziness and fainting. This is one of several reports received from the same source. Additional information has been requested.
Muscle knots on left side of back that will not go away with acupuncture and massage therapy (referral from Clinic). Constant back pain, more-so on my left side. general feeling of muscle fatigue and tiredness. a feeling of having "waxed canvas under my skin at the injection site" that is persistent to today (25AUG2021). Joint pain primarily on left side of body that I never had before (specifically in my shoulders and shoulder blade).
1/22/22 pt presents to hosp with c/o lethargy, SOB, weakness, mild productive cough, states tested positive for COVID 8 days prior (1/14/22); has had increasing weakness and SOB, poor oral intake, difficulty urinating; increased O2 to 6L via NC; severe sepsis with acute organ dysfunction; given ABX, IV fluids, dexamethasone; placed on BiPAP; pt's condition worsened; palliative care called in to see pt; pt expired in the hospital; med records and death certificate emailed per VAERS request.
Fever, myalgias, arthralgia, nausea, diarrhea, fatigue, frontal headache, dizziness, insomina. Symptoms lasted for 6 weeks. Treated symptomatically. Unable to return to work.
This case was reported by a pharmacist and described the occurrence of raised bump at injections site in a 30-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 17 January 2013 at 9:00 the subject received 1st dose of BOOSTRIX (unknown route, right arm). On 17 January 2013, "within" 2 hours after vaccination with BOOSTRIX, the subject experienced raised bump at injection site and hotness at injections site. The subject "noticed a raised bump on her arm. The bump was giving off some heat/fever like sensation (hotness at injections)." At the time of reporting the events were unresolved. The pharmacist considered the events were possibly related to vaccination with BOOSTRIX. Case correction on 8 February 2013. The lot number from the reporter was incorrectly reported as AC52B099AA. Upon lot number review, this lot number has been corrected as AC52B099AA.
itching; Rash; fatigue; joint pain; low blood sugar; This is a spontaneous report from a contactable consumer (patient). A 78-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EM9809/Expiry date: unknown), via an unspecified route of administration on 04Feb2021 at 11:00 AM in the left arm (at the age of 78-years-old) as single dose for COVID-19 immunization. The patient medical history included ongoing diabetes from 2000 and hysterectomy in the year 2000. The patient had received some other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No pre-disposing factors was reported. Follow up received on 21Apr2021, it was confirmed that on 27Feb2021 at 10:00, the patient experienced rash, fatigue, joint pain and low blood sugar (previously reported as, 05Feb2021, 12:00 AM, the patient experienced rash, fatigue, joint pain, and low blood sugar. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient was given advice and reassurance for the treatment of the adverse event). The patient had received treatment for rash. No treatment medication for received for events fatigue, joint pain, and low blood sugar. The patient was not hospitalized as a resulted of these events. Patient reported that the Doctor suggested taking benadryl for itching due to rash. The patient reported that she required a virtual visit to Physician office. It was unknown if the patient had any primary infection site. No culture was performed. The patient reported that she was fine now at the time of reporting. The clinical outcome for the event itching was unknown and the outcome of other events had recovered.  Information on the lot/batch number has been requested.  Follow up(21Apr2021): This is a follow up-spontaneous report from a contactable consumer received in response to Non-HCP letter via follow-up letter which included: Added patient's age at vaccination, medical history, suspect drug details (Lot number, Time of vaccination), updated event details (onset date and outcome), clinical course and narrative updated accordingly. Follow-up attempts completed. No further information expected.
Information has been received from a female consumer, referring to a currently 21 year old daughter. Information of concurrent condition, medical history and concomitant therapy was not provided. In 2013 (the patient's age of 16), the patient was vaccinated with GARDASIL for prophylaxis (dose, strength, lot# and expiration date unknown). The patient was unsure whether she got subsequent shots.
4 year old was given expired daptacel/no AE; Initial information was received on 16-Jul-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old female patient who was vaccinated with once 0.5 ml fifth dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (vial) which was already expired (batch number C5367AA, expiry date 30-Jan-2020) via intramuscular route in the left thigh on 17-Jul-2020 for prophylactic vaccination (expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used.  At the time of report no adverse event was 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.
Fever Chills ,fatigue   Narrative:  Received 2 covid vaccine on 2/26/21 at 300pm on Sat started expericing fever, chills, moderate fatigue, advised to take per package directions OTC acetaminiophin or ibuprofen and if not feeling better to follow up with PCP  Other Relevant History:
2 days p/vax pain inc & could no longer hold a book a glass or even sleep;felt like an injured nerve;applied moist heat & took extra strength APAP;
On 10/28/09 the facility recieved delivery of Fluvirin. Expected delivery of H1N1. Review of packaging listed H1N1 as one of the strains in vaccine. Insert in packaging gave no clarification on contents of vaccine, however listed multiple references to H1N1 vaccination. Nurse involved consulted with pharmacist re: content of syringes when it was validated that the vaccines recieved were H1N1. We at this facility proceeded to vaccinate 479 in a 14 day period. On 11/12/09 after review by the medical director and director of nursing, it was discovered that we had vaccinated with seasonal flu and not H1N1. Corrective action was initiated with mailing to community patients, residents and staff regarding the error. DPH and State lab were also notified and a full Root Cause analysis has been filed with DPH.  There are no adverse effects from this administration however concerns on clarification from manufacturer may help in future cases.
Administered an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB39AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 3rd August 2022, unknown after receiving Bexsero and Bexsero 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: 3-Aug-2022 Reporter's comment: The reporter reported that on the day of reporting they administered an expired dose of Bexsero to a patient. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Hives on the trunk of my body, legs, arms, and all over my face along with swelling of my right eyelid. I went to urgent care where it was determined to be due to the vaccine and was given prednisone, which has cleared up the hives.
Pt received 2 Varicella Vaccines years ago: 5-14-99 and 5-25-07. Today 8-6-2012 he came to my office and has shingles. No history of chicken pox disease.
Lips started swelling; Tingling in mouth; Sneezing; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING, PARAESTHESIA ORAL and SNEEZING in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced LIP SWELLING, PARAESTHESIA ORAL and SNEEZING. The patient was treated with BENADRYL at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, LIP SWELLING, PARAESTHESIA ORAL, and SNEEZING outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Patient received the second dose.
This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2589) via intramuscular route of administration in the right arm on 23Nov2021 at 12:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medication was not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via intramuscular route of administration in the right arm on 22Feb2021 at 13:00 (at the age of 51-year-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via intramuscular route of administration in the right arm on 15Mar2021 at 13:45 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. On 24Nov2021 at 09:00, the patient experienced swelling under right armpit, dizzy and change of voice which she hadn't realized the first times when she received the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swelling under right armpit, dizzy and change of voice was not resolved at the time of this report.
Initial report received from a healthcare professional on 05 June 2013. A 58-year-old female patient had received second dose of FLUZONE (lot number-UH716AA, route of administration was not reported) in left deltoid on 23 October 2012. The patient's pre-existing physician diagnosed allergies, birth defects and medical conditions were unknown. The patient had no illness at time of vaccination and had not received any concomitant medications. On 17 May 2013, the patient developed dimple, not scar, no pain and no tenderness. It was reported that the patient would go to her own physician. Laboratory investigations/details and corrective treatments were not reported. At the time of this report, the patient had not recovered from the event. List of documents held by sender: none.
myalgias, fatigue, chest heaviness after receiving the Johnson and Johnson vaccine at about 9:00 a.m. Patient states that she went to bed at about 9:00 p.m. And began to feel flu-like symptoms.  Patient is not having any shortness of breath or difficulty breathing.   Ed medications- Motrin
I was fine the day of the vaccination.  I started feeling bad overnight - got a headache and arm got sore.  When I woke up in the morning to get ready for work I felt very weak.  I walked into my bathroom and lost conciousness.  I woke up on the floor and had hit my forehead on the tile floor.  I was confused when I got up, and proceeded to get into the shower.  I then passed out again in the shower and hit the back of my head against the shower wall.  My husband found me as I woke up on the shower floor.  He called my doctor and took me to the emergency department on doctors advice.
Nose bleeds started a week after first shot. They have continued intermittently since. I've had about 12 nosebleeds total. I've never experienced a nosebleed before this. They last about 5 minutes. My nose just starts bleeding spontaneously.