chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired dose administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 72-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB58AA, expiry date 30th September 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 27th October 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 27th October 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: 28-Oct-2022 Reporter's comment: The adverse event contains all reported information. The reporter consented to safety team follow-up. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Severe pain episodes; Arm soreness; fatigue; intermittent body pain; intermittent headaches with highest level of pain at 7; This is a spontaneous report from a contactable consumer. A 16-years-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 13Feb2021 at SINGLE DOSE for covid-19 immunisation. Medical history included neurological issues for over 2yrs. The patient's concomitant medications were not reported. It was reported that, after first dose of vaccine, since Feb2021, the patient experienced arm soreness, fatigue, intermittent body pain, intermittent headaches with highest level of pain at 7, using scale of 0-10, with 0 being no pain. Intermittent pains still continue. The patient had a history of neurological issues for over 2yrs. Severe pain episodes requiring hospitalization in Feb2021. Triggers for episodes have not been determined. The patient was on 25mg amitriptyline QHS (before bed). It's possible that the first dose of the BNT162B2 has triggered the beginning of an episode. Lab data on Feb2021 included pain highest level of pain at 7, using scale of 0-10, with 0 being no pain. The event outcome was reported as unknown.  Information about Batch/Lot number has been requested.
muscle pain; Vertigo; vomiting; fatigue; dizziness; This is a spontaneous report from a contactable consumer (patient). A elderly female patient (65+ years) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: El3247, Expiration date: May2021), via an unspecified route of administration in left arm on 20Jan2021 at 15:00 as single dose for COVID-19 immunization. The patient's medical history included high blood pressure. The patient had no known allergies. Concomitant medications included lisinopril, atenolol and tamoxifen. The patient did not receive other vaccine in four weeks. The patient did not receive COVID vaccination prior and was not tested for COVID post vaccination. On 21Jan2021, the patient experienced vertigo, vomiting, fatigue, dizziness and muscle pain. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of vertigo and dizziness included antivert and anti-nausea for vomiting. The outcome of the events was recovering.
4 1/2 month healthy infant died 4/12 days after vaccinations. Autopsy said "SIDS" which mean nothing. I have copy or report if you want copy.
pain under skin above muscle on left side of lower back reach towards the front of the torso; PHN type pain in thigh radiating to the leg; Tender to touch,; itchy; tingly; This case was reported by a pharmacist via sales rep and described the occurrence of back pain in a 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, 4 weeks after receiving Shingrix, the patient experienced back pain, post herpetic neuralgia, tenderness, pruritus and tingling. On an unknown date, the outcome of the back pain, tenderness, pruritus and tingling were unknown and the outcome of the post herpetic neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the back pain, post herpetic neuralgia, tenderness, pruritus and tingling to be related to Shingrix.     Additional Information: GSK Receipt Date- 25-FEB-2023  Reporter's Comments- The reporter reported that 4 weeks post 2nd dose had pain under skin above muscle on left side of lower back reach towards the front of the torso. The patient had tender to touch, itchy, tingly. The reporter stated that lasted one month then transitioned to post herpetic neuralgia type pain in left thigh radiating down the leg, could still feel it 1 year later. The reporter consented to follow-up.
Pt reported feeling hot. Denies any other symptoms. Resolved with drinking water. No sever reaction noted. No CP, SOB, swelling or hives noted. Patient in stable condition. Patient educated on signs and symptoms of severe reactions. Sent home in stable condition.
could not sleep; chills; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (could not sleep) and CHILLS (chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Covid-19 Vaccination.     No Medical History was provided by the reporter.  Concomitant products included LEVOTHYROXINE for an unknown indication.  On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 17-Mar-2021, the patient experienced INSOMNIA (could not sleep) and CHILLS (chills). On 18-Mar-2021, INSOMNIA (could not sleep) and CHILLS (chills) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-078972 (Patient Link).
Fever (102), body aches, headache, diarrhea; fatigue; ?red? upper arm (inflamed, hot, painful, itchy) around injection site
Area where vaccination was given is Red, inflamed and itchy the next day. Pt taking Benadryl, applying cool compress and taking Acetaminophen at night.
pt recv vax 14MAR96 & became pregnant & elected to terminate the pregnancy;no further info was available, & the pt did not want to be contacted to obtain addtl details;
Onset on 3/12/00 of itching around both wrists. By 3/13/00, she experienced itching and hives "everywhere". Treated with 50mg Benadryl X 2, over 6-8 hours and symptoms abated. No SOB or other related symptoms described. No further Hep-B doses to be given.
Wheezing around 9am on 5/18 (took 25mg Benadryl then later wheezing stop). Pt stated that she also has fever, severe pain on the upper arm, neck, shoulder.
Patient started experiencing chest pain, fever and chills 3 hours after receiving his third dose of Moderna. Chest pain, fever and chills continued into Tuesday. Early Wednesday morning, the chest pain had not lessened, so the patient went to the emergency room. Emergency room visit showed no sign of a heart attack or other critical medical condition and patient was sent home. Doctor believed all symptoms to be related to his third shot. He received his first shot 2/5/21 and second shot 3/5/21. Symptoms of fever, chills and chest pain lasted for 8 days after his third shot. He had no reports of side effects after his first and second shot.
A mother reported that her 10 month old son with an ear infection received his 2nd dose of Prevnar on 2/1/01. That day, he developed a fever of 100F to 102F, diarrhea, nausea and vomiting. He was treated with azithromycin and cephalexin. As of 2/14/01, the fever resolved but the nausea, diarrhea and vomiting persisted.
Left deltoid 1.75 inch induration. Left localized hypersensitivity reaction to Td booster 10/27/03. Motrin 400 mg Q 6hours prn pain, swelling. Ice/heat/massage (10'/10'/10')
back problem got worse after got the 1st booster dose; herniated disc; sciatica; pinched nerve; This spontaneous case was reported by a patient and describes the occurrence of BACK PAIN (back problem got worse after got the 1st booster dose), INTERVERTEBRAL DISC PROTRUSION (herniated disc), SCIATICA (sciatica) and NERVE COMPRESSION (pinched nerve) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 031L20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Back disorder (little bit of a back trouble prior to getting the 1st booster dose of the vaccine).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced BACK PAIN (back problem got worse after got the 1st booster dose), INTERVERTEBRAL DISC PROTRUSION (herniated disc), SCIATICA (sciatica) and NERVE COMPRESSION (pinched nerve). The patient was treated with NAPROXEN SODIUM (ALEVE) for Back disorder, at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) for Back disorder, at an unspecified dose and frequency. At the time of the report, BACK PAIN (back problem got worse after got the 1st booster dose), INTERVERTEBRAL DISC PROTRUSION (herniated disc), SCIATICA (sciatica) and NERVE COMPRESSION (pinched nerve) outcome was unknown.            Patient asked if it was okay for them to get the second booster dose tonight on 27-Jul-2022 as they were taking Motrin and Aleve for little bit of a back trouble prior to first booster dose of the vaccine but it  was got worse in Dec2021 after they got the first booster dose. No concomitant information were reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-615244 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-615244:Dose 2
Patient developed varicella (varicella zoster PCR from one of the 4 vesicles at vaccine site was positive) 10 days after VARIVAX given.
About 10 days after pain under my left arm.  Lump/swelling appeared and became persistently worse (painful).  Started feeling nerve/muscular pain in abdomen, back and skin of arms.
Patient received Tetanus and Pneumococcal vaccines IM on 8/14/06. On 8/16/06 patient comes to office with swollen and red right humeral area. Edema was moderate.
Achiness, fatigue, pain for several days after flu shot. Pectoral lymph node enlargement (R) anterior ribs. Rash on (R) foot.
Initial unsolicited report received from a consumer via social media on 09-JUL-2016. This case involves a female patient (unknown age, reported as "age 1 1/z") who was vaccinated with a dose of MENINGOCOCCAL VACCINE (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had 12 days of coma. On an unspecified date the patient was hospitalized for 21 days. It was reported that "the patient had to learn how to walk again but hasn't missed a lick since." Lab data and corrective treatment were not reported. On an unspecified date, the patient recovered from the event. List of documents held by sender: none. Sender's Comments: This is a poorly documented non-medically confirmed case. Further details on the course of events the patient developed which led to coma, vaccination details, time to onset, detailed medical history especially congenital disorder, any recent infection, etc., immunization history, concomitant medications, etc. are needed to further assess the case. Based on the information available, the role of vaccine cannot be assessed.
Headache I never get headaches and my head began to ache the next day- it subsided and is gone now but I had a fairly good headache; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 09:15 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications taken within two weeks of vaccination included olmesartan (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 08:00 the patient experienced headache. The patient never gets headaches and his head began to ache the next day- it subsided and was gone at the time of report but the patient had a fairly good headache. The patient did not receive any treatment for the event. The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event headache was recovered on an unknown day in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Red arm syndrome, headache + fever treated with  Keflex 500mg - PO TID X 10 days.
Dizziness, lightheaded, headache, tachycardia HR 173, HTN  BP 143/102. Palpitations
Internal Medicine note date 19 Nov 2009, reports evaluation at medical center 7 days ago - Admitted to MICU on Insulin drip (11 Nov), then transferred to ward on LANTUS/NOVOLOG. Discharged just over 24 hours after presentation (13 Nov), on METFORMIN 500 mg BID. Two to three weeks prior to admission (end of Oct 2009), SM noted increased thirst, increased urination, and fatigue, as well as 20-pound weight loss. After initial evaluation and discharge, SM sought evaluation again on 19 Nov 2009 and reported not feeling well since discharge, with lowest BG level of 270 per self blood glucose monitoring. At time of this re-evaluation, SM was admitted to medical center with diagnosis of Diabetic Ketoacidosis (DKA) and diagnosed with T1DM. After 3 days, he was discharged on bedtime GLARGINE and premeal NOVOLOG with regular outpatient follow-up. On 19 Nov 2009, his serum glucose level was 692, his HgbA1c was 13.6. SM received diabetes self management training. SM's diabetes has been followed by local health care providers, including nurse practitioner in Endocrinology and another Endocrinologist. He is currently on an insulin pump. *SM received Flu vaccine (Aventis, U3254DA) on 17 Nov 2009 which was after symptom onset but prior to diagnosis of T1DM.
shingles; Information has been received regarding a case in litigation concerning patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. In 2016, patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, unit, route of administration, lot # and expiration date were not reported), as prescribed and/or administered by a healthcare provider at Urgent Care for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, patient was treated by a healthcare provider at Urgent Care located for shingles. As a direct and proximate result of patient's use of zoster vaccine live (ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
I was lying on my bed reading and suddenly I felt my nose bleeding.  I don't get nosebleeds so it was unusual.  I was able to stop it fairly quickly, but it was a very unusual event for me.
patient vaccinated with janseen vaccine on 6/8/21. tested positive for covid on 10/26/2021. admitted to Hospital on 10/26/2021. Expired on 10/31/2021 while still hospitalized.
Patient given flu shot after checking for any allergies or previous problems with flu vaccine. Pt tolerated well. Watched while RN gave her son his Flu shot. After getting up and walking to window to pay client c/o feeling lightheaded. Was seated in chair. Clt clammy, heart rate 108-160 and irregular SPO2 98-99% BP 160/100 ambulance called and arrived. Started IV. Pushed BENADRYL & Epi via ambulance personnel and then pt transported to ER. 330pm TC to daughter. Mother is being discharged from ER. Tired but feeling better.
Tingling of the scalp, arms, buttocks, back, hands, legs, and feet. Heavy feeling in legs. Patches of goosebumps on body. Panic attacks, depression. Elevated heart rate and blood pressure. Feeling of weakness. Soreness in ribcage, upper back. Sharp pains in chest. Headaches, dizziness, personality changes. New allergies to foods I was not allergic to before.
This spontaneous report as received from a registered nurse refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 02-FEB-2015, the patient was vaccinated with improperly stored PROQUAD (dose, frequency and route unspecified) (lot number: K011314 with expiry date of 14-FEB-2016). Concomitant medications were not reported. The reporter stated that, between 07-JAN-2015 through 19-FEB-2015, PROQUAD was exposed to 34.4 Fahrenheit temperature which was outside the recommended condition. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PROQUAD was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
bleeding; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (bleeding) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    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 HAEMORRHAGE (bleeding) (seriousness criterion medically significant). At the time of the report, HAEMORRHAGE (bleeding) had resolved.        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.   No concomitant medications were reported.  The patient had bleeding and the patient had to go to the hospital. It happened over a year ago.  Treatment information was not provided.  Company comment: This is a spontaneous case regarding a patient of an unknown age and gender, with no reported medical history, who received a dose of mRNA-1273 vaccine and experienced unexpected, medically significant event of Haemorrhage. Vaccination date and onset date of the event were not provided, latency cannot be assessed. According to the report, approximately a year ago, patient experienced bleeding and had to go to the hospital. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case regarding a patient of an unknown age and gender, with no reported medical history, who received a dose of mRNA-1273 vaccine and experienced unexpected, medically significant event of Haemorrhage. Vaccination date and onset date of the event were not provided, latency cannot be assessed. According to the report, approximately a year ago, patient experienced bleeding and had to go to the hospital. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
temperature of 102.4; Fatigue; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FATIGUE (Fatigue) and PYREXIA (temperature of 102.4) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 22-Jan-2021, the patient experienced FATIGUE (Fatigue). On 24-Jan-2021, the patient experienced PYREXIA (temperature of 102.4). At the time of the report, PAIN IN EXTREMITY (sore arm), FATIGUE (Fatigue) and PYREXIA (temperature of 102.4) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature:.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
4 months old received kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number E2L54, expiry date 3rd March 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 01-MAR-2023 Reporter's Comment: A reporter reported that a 4 months old patient received a Kinrix dose. The reporter consented to follow up. Additional Supportive Information: A reporter reported that a 4 months old patient received a Kinrix dose, which led to inappropriate age at vaccine administration.
Arm is sore; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is sore) and PYREXIA (Fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 025A21A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, the patient experienced PAIN IN EXTREMITY (Arm is sore) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Arm is sore) and PYREXIA (Fever) outcome was unknown.            No relevant concomitant medications were reported. No treatment was received.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow-up information included no new information