chrisvoncsefalvay/vaers-outcomes huggingface dataset:
left eye had burst blood vessels; bruise on the injection site; temperature was higher by one or two degrees; tired; cough; voice went out; throat was rough; voice keeps going in and out; headache; A spontaneous report received from a consumer, who was also a female patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cough, voice went out (aphonia), throat was rough (oropharyngeal discomfort), voice keeps going in and out (dysphonia), headache, tired (fatigue), left eye had burst blood vessels (eye haemorrhage), body temperature was higher by one or two degrees (body temperature increased),and bruise on the injection site (injection site bruise).  The patient's medical history was not provided. Concomitant medications included an unspecified thyroid medication.  On 01 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 010A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 01 Mar 2021, the patient experienced cough. her voice went out like her throat was rough.  Her voice kept going in and out.  That night, she had a headache.   On 02 Mar 2021, the patient felt tired, still had headaches, and her temperature was higher by one or two degrees.    On 03 Mar 2021, the patient woke up and her left eye had burst blood vessels. She also had a bruise on the injection site on left, non-dominant arm.  Treatment for the events included paracetamol.  Action taken with mRNA-1273 in response to the events was unknown.   The events of cough and voice went out like her throat was rough were considered resolved on 01 Mar 2021.  The outcome of the events of voice keeps going in and out, tired, left eye had burst blood vessels, headache, bruise on the injection site was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
ACUTE RESPIRATORY FAILURE 5/1/2022 CHRONIC ULCER OF SKIN, UNSPECIFIED SITE AND DEPTH  ACUTE ON CHRONIC RESPIRATORY FAILURE 5/1/2022 CHRONIC ULCER OF SKIN, UNSPECIFIED SITE AND DEPTH  SHOCK, UNSPECIFIED 5/1/2022 CHRONIC ULCER OF SKIN, UNSPECIFIED SITE AND DEPTH  ACUTE RESPIRATORY FAILURE 5/1/2022 SHORTNESS OF BREATH  ACUTE ON CHRONIC RESPIRATORY FAILURE 5/1/2022 SHORTNESS OF BREATH  SHOCK, UNSPECIFIED 5/1/2022 SHORTNESS OF BREATH
This case was reported by a pharmacist via call center representative and described the occurrence of localized itching in a 70-year-old male patient who received SHINGRIX (batch number A2JL7, expiry date 22nd March 2021) for prophylaxis. On 18th October 2018, the patient received the 2nd dose of SHINGRIX .5 ml. In October 2018, less than a week after receiving SHINGRIX, the patient experienced localized itching, fever, headache, shivering, insomnia and nausea. On an unknown date, the outcome of the localized itching, fever, headache, shivering, insomnia and nausea were recovering/resolving. It was unknown if the reporter considered the localized itching, fever, headache, shivering, insomnia and nausea to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right deltoid. The patient experienced itching on upper torso and arm and extreme shivering. No further details were provided by the pharmacist.
Expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered). On 02-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Expired doses administered) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 800 to 900 (Inconclusive) All the patient's antibody numbers were in the 800-900 range..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information  were reported.  It was reported that they got 10 vials Moderna vaccine 037C21A delivered on 24-May-2021 and immediately placed the vaccine into refrigerated storage. Then stated that the doctors did not know a 30-day expiration date applied to vaccines kept in the refrigerator and they administered that vaccine to patients after that 30-day mark. That vaccine vials were never punched until use. Reporter reported that the vaccine was given unknown amount to patient past 30-day beyond use date BUD. Patient did not report any adverse events or symptoms.   This case was linked to MOD-2021-415889.
This adult female nurse received 2nd dose of vax. Approximately one year following vax, the pt sought medical attention and a serum VZV antibody test. No positive titers following exposure to herpes zoster."
Breakthrough case admission after 3 vaccines Pfizer 3/8/21 Lot# EN6299 ; Pfizer 3/29/21 Lot# Er8732;  Pfizer 11/10/21 Lot# 320308D
missed his second Bexsero shot of the primary series; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a 17-year-old male patient who received Men B NVS (Bexsero) 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 an unknown date, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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 reported as follows: The reporter was patient's parent. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Bexsero which led to incomplete course of vaccination. The reporter stated that the patient missed his 2nd Bexsero shot of the primary series and asked what they should do. The follow-up would not possible as no contact details were available
mixing error occurred, patient may have been given just diluent. Patient was revaccinated 5/5
Measles given 3/24/06, 7 days later, pt was noted by parents and family friends that pt was staring off and eyes went back in head often X 1 wk, then resolved.
8 days after vaccine, site of injection has become red, swollen, painful, and itchy.  Still experiencing these symptoms.
shot twice and at 89 years old l got the shingles/ got the shot four years ago and now I got the shingles/Suspected Vaccination Failure; shingles; pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 89-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional case details were reported as follows: The case was reported by the patient for himself/herself. The age at vaccination was not reported. The patient got the shot twice four years ago from reporting date and now before reporting the patient got the shingles and the pain was so bad and was in lot of pain, and on third week the pain pills also did not work. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting.
diagnosis of inflammation of the gangloids; high white cell count; swollen neck; This case was reported by a consumer via call center representative and described the occurrence of lymphadenitis in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced lymphadenitis, white blood cell count increased and neck swelling. On an unknown date, the outcome of the lymphadenitis, white blood cell count increased and neck swelling were unknown.   It was unknown if the reporter considered the lymphadenitis, white blood cell count increased and neck swelling to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's brother. The age at vaccination was not reported. The patient received the 2nd dose of Shingrix and experienced a swollen neck and a diagnosis of inflammation of the gangloids and a high white cell count. The reporter did not consented to follow up This case was linked with US2021089130 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021089130:same reporter
Taken by ambulance to ED on 11/18/2021, couldn't walk or eat properly. Released on 11/19/2021 Taken by ambulance to ED on 11/25/2021, couldn't walk, seizure. Admitted for 3 weeks. Diagnosed with 4 strokes (ischemic).
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided. Date of refrigeration of vaccine: 05-JUL-2021   This case was linked to MOD-2021-363245, MOD-2021-363032, MOD-2021-363226 (Patient Link).
Information has been received from a physician referring to multiple unspecified patients of unknown age and gender. Concurrent and historical condition was not provided. On multiple unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # L018351 with expiration date 11-AUG-2017; dose and route unknown). Concomitant therapy was not provided. The physician reported there were no adverse effects. There was no previous excursion. The vaccine was exposed to 33.3F for 3 hours and 59.1F for 5 hours. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician assistant via a company representative referring to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose, route, lot # and expiration date were unknown) along with other unspecified vaccinations. On an unknown date the patient experienced Guillain-Barre syndrome. The patient was taken to the emergency room where she received unspecified treatment (date unknown). The outcome of Guillain-Barre syndrome was unknown. Upon internal review, Guillain-Barre syndrome was considered to be medically significant. Additional information has been requested.
felt dizzy; heart beats very strong; This is a spontaneous report from a contactable consumer (caregiver) via Medical Information team. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 02Jun2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 12May2021 (Batch/Lot number was not reported) for COVID-19 immunisation. On 02Jun2021 (also reported as yesterday), she got the second dose; after that she felt dizzy, like her heart beat very strong. The reporter asked if this was normal. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: ER8729), in right arm, on 30Apr2021 as dose 2, single (Lot number: EW0167), in right arm and on 21Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 44 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Aug2022 as dose 4 (boster), single (Lot number: 053B22A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL, stop date: 03Sep2022; AMBIEN, start date: 03Sep2022, stop date: 08Sep2022.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.
There is a possibility patient may have received 0.25 ml of vaccine rather than the recommended 0.2 ml. of the Moderna Bivalent presentation for 6 months to 5 years.  A staff member was not aware of the correct dosing of the bivalent vaccine. The system in place for drawing up vaccine and administering vaccine may have allowed for staff member to have drawn up 0.25 ml and another staff member to give the vaccine. It cannot be determined if the correct or incorrect amount was drawn up or given. There has been no reported adverse reaction from the parents to date.
"Feeling weak, my head feels stuffed or bloated and I got a runny nose". Sent to nurse office to call Mom/Dad.
Heart rate 104, dizziness, weakness, Fever 101.8, chills,  headache, tiredness, muscle pain, feeling unwell.
Vaccine was received on 12/17/2020. Patient states that he did not start experiencing symptoms until 12/25/2020. Patient states that he doesn?t think his symptoms are related to the vaccine and that he may need to be tested for Covid. Patient states that his symptoms are sore and itchy throat, congestion and runny nose, no coughing, no fever, no chills, no body aches. Patient states that his kids go to daycare and came home with a runny nose, no travel history, no exposure to Covid that he is aware of, never tested positive for Covid.
cant sleep on the left side; area is bruised; very sore/it was really hurting and it still hurts/She cant sleep on the left side/sore arm; little bit swollen in the area; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (cant sleep on the left side), VACCINATION SITE BRUISING (area is bruised), VACCINATION SITE PAIN (very sore/it was really hurting and it still hurts/She cant sleep on the left side/sore arm) and VACCINATION SITE SWELLING (little bit swollen in the area) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A, 037A21B and 048O21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: FLU VACCINE VII in September 2021. Past adverse reactions to the above products included No adverse effect with FLU VACCINE VII. Concurrent medical conditions included Blood pressure high, COPD (uses an inhaler.), Arthritis and Deaf (is deaf and uses sign language to communicate.). Concomitant products included LOSARTAN for Blood pressure high.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (cant sleep on the left side), VACCINATION SITE BRUISING (area is bruised), VACCINATION SITE PAIN (very sore/it was really hurting and it still hurts/She cant sleep on the left side/sore arm) and VACCINATION SITE SWELLING (little bit swollen in the area). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination site pain, at an unspecified dose and frequency. At the time of the report, DISCOMFORT (cant sleep on the left side), VACCINATION SITE BRUISING (area is bruised) and VACCINATION SITE SWELLING (little bit swollen in the area) outcome was unknown and VACCINATION SITE PAIN (very sore/it was really hurting and it still hurts/She cant sleep on the left side/sore arm) had not resolved.            Other concomitant medication included inhaler for COPD nad allergy medications.
hair loss diagnosed as telogen effluvium by 2 separate dermatologists after completing a full panel of bloodwork from my primary doctor which came back normal. hair loss started immediately after becoming fully vaccinated on late June 2021.
This case was reported by a healthcare professional and described the occurrence of erythema i a 4-year-old female subject who was vaccinated with (KINRIX, GlaxoSmithKline). The subject's medical history included hearing loss and otitis media. Previous and/or concurrent vaccination included tuberculin PPD (Sanofi Pasteur MSD, unknown) given on 10 April 2009 and VARIVAX (non-gsk, Merck, unknown) given on 10 April 2009. There were no concurrent medications. On 10 April 2009 at 10:38 the subject received unspecified dose of KINRIX (.5 ml, unknown, right thigh). This vaccine was reported as the 5th dose of the vaccination series. On 12 April 2009, 2 days post vaccination with KINRIX, the subject experienced erythema and itching. Medical attention was required at the doctor's office. At the time of reporting the events were unresolved.
Dizziness; Don't feel well; Mild lightheadedness; BP still elevated/ BP 152/82/ BP repeated 148/85; Feeling warm surge to body; This is a spontaneous report from a non-contactable pharmacist.  A 69-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 intramuscular, administered in the right arm on 03Mar2021 (Batch/Lot Number: EN6199) as 2ND DOSE, SINGLE (at the age of 69 years old) for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. Historical vaccine included fist dose of BNT162B2 on 10Feb2021 intramuscular (at the age of 69 years old) in the right arm (lot number: EL9262) for covid-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced blood pressure (bp) still elevated/ bp 152/82/ bp repeated 148/85 on 03Mar2021 at 11:05 with outcome of unknown, feeling warm surge to body on 03Mar2021 at 11:05 with outcome of unknown, mild lightheadedness on 03Mar2021 at 11:22 with outcome of unknown, dizziness on 03Mar2021 at 11:39 with outcome of unknown, and don't feel well on 03Mar2021 at 11:39 with outcome of unknown. Details were reported as follows: 11:05: Patient complained of feeling warm surge to body; vital signs: BP 152/82, heart rate (HR) 67, respiratory rate (RR) 16, 100% RA 11:19: BP repeated 148/85, HR 54-64, RR 16 1120: drank 3 bottles of water, feeling better 11:22: Patient ambulate in hallway w/ mild light headedness 11:39: BP repeated sitting 140/90, RR 16, HR 61, standing BP 158/102, HR 59, associated lightheadedness/ dizziness. Patient reported "I don't feel well". It was recommended patient be seen in emergency department. 11:57: Now complained of lightheadedness, BP still elevated. Patient transferred to emergency department for further evaluation and work up. No medications given in emergency department. Treatment was not received for any of the events.    No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based from limited information at the time of reporting, the causal association of reported event BP increased in relation to suspected drug BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be totally excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 57 years old male patient who received vaccine FLUZONE HIGH DOSE. The patients past medical history and family history were not provided. The patient did not receive any concomitant medication. On 12-Oct-2018, the patient received a 0.5ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ039AB, expiry date May-2019 via unknown route in the left arm. It was an actual medication error due overdose and inappropriate age at vaccine administration. It was reported that a male 57-year-old patient received the FLUZONE HD. The pharmacist states that it most likely occurred due to the similar sounding name of FLUZONE HD vs FLUZONE QUADRIVALENT. 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.
Information has been received from a physician concerning a 4 year old male who on 06-JUN-2002 was vaccinated with a 0.5ml SC dose of Varivax. On 16-MAR-2006 the patient experienced breakthrough varicella. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Shortness of breath, fatigue, pounding heart beat, chest pain, heaviness in chest - onset ~4 days after vaccine. Swelling in calves - onset ~10 days after vaccine. Given prednisone 20mg for 5 days, swelling in calves resolved and other symptoms improved, but still present as of 2/26/22.