chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Day 1- (April 1st - bearable arm pain & low fever that night (nothing bad) Day 2- @5:00PM - arm pain was unbearable hurt from the root of the arm to my elbow, including lymph nodes and all the part of the arm that touches the ribs, a headache that fluctuates from bad to my head is going to burst, from there it became a very weakening fatigue where I could hardly get around, lots of joint pain, nausea and I do not know if the vaccine provoked the diarrhea or if it triggered the Crohn's. To this day I am still dealing with the headache, the pain not just in the arm but allover, gastro intestinal problems. It has impacted my sleep tremendously because the level of pain is very high. The one thing that went away that very first night was the low fever.  But this vaccine is like a Wish (cheap store) Vaccine. They SHOULD NOT give this to immunocompromised people and the "few days" rhetoric does not apply to us and that should be specified! Initially I thought this was to be expected when I heard a Doctor on the news say: "if you fell like you got ran over by a truck, that is normal." So,  that is how I felt, so I thought it was normal.
Noticed swelling and hardness of right shoulder.  Associated fever and right axilary pain.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX with an associated reaction of herpes zoster (received 13 years before the date of reporting, broke out with shingles on right side of neck, 1 to 2 years later).  In May 2018, the patient received SHINGRIX. In May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. In May 2018, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in mid May 2018 on the left arm. Her arm became sore within a couple of hours which lasted 24 hours. The reporter gave consent to follow up.
Information was received on 10-APR-2017 from a medical assistant who was reporting on a 15 year old female patient. No medical history or concomitant medications were reported. The medical assistant reported that on 06-APR-2017, the patient received a dose of PROQUAD (lot: M033209, expiration: 20-MAR-2018)(dose and site not reported). No adverse effects were reported. No further information was provided. Additional information has been requested.
First dose 12:30pm metallic taste, slight nausea, brief light headed. Approx 1:20pm moderate arm soreness lasting 2 days.  Second dose administered about 3:00pm about 1hour later injection site soreness. Next day about 4:30pm extreme arm pain, 100.4 fever and chills. Took 2 Tylenol. Approx 11:30pm no fever or arm soreness.
Extremely swollen lymph nodes in the arm pit of the injected arm.  Red, hot and swollen.  Sore and painful. Last almost 5 days.
arm was not functional for 7-8 days; This is a spontaneous report received from a non-contactable reporter (Consumer) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "lymphedema" (unspecified if ongoing), notes: left arm; "shoulder replacement" (unspecified if ongoing), notes: with a carbon fiber shoulder in her right arm. The patient's concomitant medications were not reported. The following information was reported: MUSCULOSKELETAL DISORDER (non-serious), outcome "recovered", described as "arm was not functional for 7-8 days". Additional Information: Patient could not get the first dose in her left arm due to lymphedema. She had a shoulder replacement with a carbon fiber shoulder in her right arm and when she was given the vaccine there, her arm was not functional for 7-8 days. Patient asked if they give it in her thigh, will it still be effective?  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I, MA, administered Dtap into the Left deltoid at 1426 on 5/04/2017.The correct immunization should have Tdap.
The patient was given the immunization on 10/24 in right arm. He states today that he is still having pain in arm at injection site area,. He states that when he was given the vaccination in his right arm that it was red and swollen for a few day and then turned into a bruise at injection site. Today upon presentation to pharmacy his arm appeared red at injection site but not bruised or swollen. He states that he is still experiencing pain at injection site when he lays on that arm or certain movements.
The site stung upon needle injection going in and burning coming out. Immediate swelling of arm, stiffness followed by low grade fever within 4 hours. Swollen to size of orange and hard even after massage. Took TYLENOL - pain subsided 3rd day, still some swelling.
no additional AEs,; HCP calling to report medication error: GARDASIL 9 was inadvertently administered to 76 year old patient instead of PREVNAR on 02MAR2023. No further information provided, no additional AEs, no PQCs.; HCP calling to report medication error: GARDASIL 9 was inadvertently administered to 76 year old patient instead of PREVNAR on 02MAR2023. No further information provided, no additional AEs, no PQCs.; This spontaneous report was received from a pharmacist referring to a 76-year-old female patient. Patient's concurrent conditions, medical history, concomitant medications and drug reaction/allergies were not reported.  On 02-MAR-2023, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (0.5 milligram, once, lot #W011266, expiration date: 05-SEP-2024 for prophylaxis) (strength, anatomical site of administration and route of administration were not provided) was vaccinated inadvertently to the patient instead of pneumococcal vaccine conj 7v (crm197) (PREVNAR) (product administered to patient of inappropriate age, wrong product administered). No additional adverse events (AEs) (no AE).
This is a spontaneous report obtained from a contactable nurse who is calling on behalf of her mother (nurse's mother). A 87-year-old female patient received intramuscular PREVNAR 13; Lot J80525; Expiration Date Apr2016) in the left arm at 0.5 ml single dose on 13Feb2015 around 11:00 or 12:00, for immunization. Previously in 2013 she received pneumonia vaccine as immunization. Patient took hydrocortisone cream in Jan 2010. Medical history included ongoing arthritis, high blood pressure for twenty five years and ongoing, acid Reflux for 10 years and ongoing. She had allergy to DEMEROL and allergy tot adhesive tape. Concomitant medication included atenolol for blood pressure, NEXIUM for acid reflux, hydrochlorothiazide at 25mg 1x/day since more than 20 years for high blood pressure, pindolol orally at 5 mg 1x/day since more than 20 years for high blood pressure, KLOR-CON orally at 10mg 1x/day since more than 20 years, omeprazole 20mg 1x/day for reflux, diazepam orally at 5 mg as needed, Multivitamin orally 1x/day and Ibuprofen 200 mg as needed. On 13Feb2015 the patient experienced ached all over, joint pain, she had fever and chills during the night, she received the injection in the left arm and it was sore as the devil, her arm hurt red about the size of baseball with heat in it and she was unable to sleep; she was not exactly well, not feeling her best, she had extreme fatigue, muscle pain and appetite decreased. Patient did not received any treatment for the event unable to sleep, which recovered on an unknown date. She took ibuprofen for pain in arm and aches all over (with frequency of 2x/day) and also for fever chills and joint pain and these events recovered. Due to the event fatigue, patient followed a naps healthy diet; event arm with redness was treated with hydrocortisone cream. It was reported that 9 days post injection, the patient did not fully recover from fatigue, red/hot arm; she felt badly, she had still redness but fading. Patient had to continuously take Ibuprofen. The clinical outcome of the other events was unknown. Follow-up (17Feb2015): New information obtained from a contactable nurse includes: medical history updated (high blood pressure), additional concomitant drug, events updated (not feeling her best, Fatigue, Muscle pain, Joint pain, Appetite decreased, Arm hurts red about the size of base ball with heat in it, unable to sleep, ached all over, Fever chills). Follow-up (09Mar2015): New information received from the same contactable nurse includes: lot and expiration date, event details (outcome, treatment), concomitants, vaccination and medical history.
Large amount of swelling very red and itchy cellulitis. Area covers the entire top of her thigh, starts out the size of a quarter and has expanded in diameter to the size of a softball.  Fatigue. Ibuprofen every 6 hours, Triamcinolone acetonide cream use 2 to 4 times a day, Loratadine syurp once daily and 2 hot baths a day with a 1/4 cup of bleach added to the water, was told if doesn't look better by Monday 01/09/2012 to bring her back to Dr. office first thing in the morning.
On-set of symptoms began 10-12 hours after administration of vaccine: "flu like" full body aches for exactly 24 hours. On a scale of 1-10 (where 10 is worse), body aches were consistently a "level 6" for the full 24 hour period. In a cycle of every 4 hours, pain would increase to level 8 (i.e. for a few hours I would have all over "level 6" body aches, then for a few hours I would have almost unbearable "level 8" body aches, then for a few hours it body aches would decrease to "level 6". This cycle continued for the full 24 hours. At one point I was in tears and called my doctor for pain or sleep meds - since I was unable to sleep at all the night before due to pain and was in fear this would happen again).  Body chills would "come and go" during the 24 hours period. Fever (>100.3 and <101.3) began in the last 8-10 hours of the 24 hour period. All symptoms ended 24 hours after symptom onset (9-10pm on 3/2 to 9-10pm on 3/3).
CHILLS; HANGOVER; This spontaneous report received from a consumer concerned a 23 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced hangover. On 09-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and hangover was not reported. This report was non-serious.
A non-serious spontaneous report of administration of expired vaccine was received from a health professional concerning an eight-year-old female. Neither past medical history nor concomitant medications were reported for this patient. The FLUMIST expired on 22-Dec-2010. On 27-Dec-2010, the patient received expired FLUMIST. 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. Additional information received on 21-Apr-2011 and incorporated into case: no late occurring adverse events.
Cough; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COUGH (Cough) and PYREXIA (Fever) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced COUGH (Cough) and PYREXIA (Fever). At the time of the report, COUGH (Cough) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was on unspecified medications for high blood pressure.   The patient's healthcare provider told him to rest, hydrate, and to take Tylenol or ibuprofen.
within a couple hours of the shot I felt a nervous feeling inside. this continued to grow in me a couple of days along with an increasing headache. I started breaking out in a rash mostly on my head, around my right eye,  chest and back, on about the third or forth day. I also developed diarrhea.  I went to Urgent care on 03/17/21. the doctor there gave me a shot of prednisone and things quickly cleared up.
Severe cardiomyopathy with EF 10% and some calculations showing 7% Subsegmental pulmonary embolus
Full body rash & itching;  facial swelling; itching of mouth, itching of eyes.  All symptoms lasted three (3) days.  Treated at home with Allegra as patient is allergic to benedryl and prednisone.  Resolved without lingering adverse effect.
Admission to critical care hospital with COVID-19 diagnosis on admission. No record of Moderna lot numbers in patient record.
The vaccine expired past the 30-day recommendation. At this time there have not been any s/s of an adverse event
Shortly after receiving the COVID-19 vaccination, I began having a strange sensation of my tongue. It intensified after the 2nd shot. It felt like it was burnt on a hot beverage. To this day it has not gotten better.
Broke out in severe hives 2 hours after the vaccine. Had shortness of breath and my blood pressure dropped to 70/40. Went to urgent care for treatment.
Information has been received from a Doctor of Pharmacy concerning a patient (age and gender not reported) who "within the last 3 months" was vaccinated with a dose of PEDVAXHIB (OMPC).  The patient was given a subcutaneous vaccination instead of intramuscular.  The patient subsequently developed redness and swelling at the injection site.  The outcome was unknown.  No additional information is expected.
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 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 07-Sep-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. No treatment was provided by the reporter. It was stated that the date of refrigeration was 06 Aug 2021.   This case was linked to MOD-2021-365136 (Patient Link).
On 3/25/21, patient presented to the ED with several days history of nausea, vomiting, and upper abdominal pain, and 1 day history of shortness of breath and wheeze.  Patient recently received her first dose of Moderna COVID vaccination on March 10.  Patient's daughter first developed COVID symptoms approximately 1-2 weeks prior, and was tested positive.  Patient developed nausea, vomiting, and upper abdominal pain 6 days prior on March 19.  She was tested positive for COVID several days prior to admission (either the 22 or 23rd, patient not sure).  On the morning admission, patient had significant worsening of shortness of breath and wheeze.  Patient also became significantly more weak and fatigued, and was eventually brought to ED.  Patient reported chills, but denied headaches, chest pain, or diarrhea. Patient admitted to the hospital on 3/25/21 with main diagnosis COVD-19 pneumonia and patient expired on 4/13/21.
Major depression lasted about 3 days after first dose.  Then lasted for about 24 hours after second dose.
The child immediately became pale and went into a seizure at the completion of the vaccines administrations-while applying band aids lasted < 1 min
Injection site was warm; Injection site was blotchy; Injection site was red; Soreness at the injection site; Body ache; Fever; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site was warm), VACCINATION SITE DISCOLOURATION (Injection site was blotchy), PYREXIA (Fever), CHILLS (chills) and HEADACHE (headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PYREXIA (Fever), CHILLS (chills), HEADACHE (headache), VACCINATION SITE PAIN (Soreness at the injection site) and MYALGIA (Body ache). On 13-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Injection site was warm), VACCINATION SITE DISCOLOURATION (Injection site was blotchy) and VACCINATION SITE ERYTHEMA (Injection site was red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Injection site was warm), VACCINATION SITE DISCOLOURATION (Injection site was blotchy), PYREXIA (Fever), CHILLS (chills), HEADACHE (headache), VACCINATION SITE ERYTHEMA (Injection site was red), VACCINATION SITE PAIN (Soreness at the injection site) and MYALGIA (Body ache) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment for the events included cold compresses.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.
pt recv varicella vax 4/3/98 approx 5 days later pt started not to feel well, thought had fever along w/tiredness & malaise, sx resolved & pt devel 1 lesion & also swelling & a vesicle below the inject site
Injection site began to itch 10 days after COVID shot given.  Red circle, about 3" in diameter, on arm at injection site.
Had vaccines on 3/2/10. Fever, redness and warmth at L arm site.
She was having female health issues/yeast infection; This is a spontaneous report from a contactable consumer or other non-HCP. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6201), via an unspecified route of administration on 25Feb2021 as single dose (at the age of 65-year-old) for covid-19 immunization.  Medical history included thyroid disorder included Thyroid medication. Concomitant medication(s) included budesonide, formoterol fumarate (SYMBICORT). On an unspecified date the patient experienced she was having female health issues/yeast infection. Therapeutic measures were taken as a result of she was having female health issues/yeast infection. The outcome of event was unknown.    No follow-up attempts are possible. No further information is expected.
have this very bad cough since one year and suddenly it is just gone; Threw up little bit because of ciprofloxacin; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (have this very bad cough since one year and suddenly it is just gone) and VOMITING (Threw up little bit because of ciprofloxacin) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     Concurrent medical conditions included Bladder infection. Concomitant products included CIPROFLOXACIN for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced COUGH (have this very bad cough since one year and suddenly it is just gone) and VOMITING (Threw up little bit because of ciprofloxacin). At the time of the report, COUGH (have this very bad cough since one year and suddenly it is just gone) and VOMITING (Threw up little bit because of ciprofloxacin) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided
Booster dose of Pfizer was given too early.  1st dose - 5/4/21  - 2nd dose 5/25/21  - Booster dose 11/16/21
Patient reports sweating, nausea, some vomiting/diarrhea, lack of appetite starting 2 days after vaccination and continuing to 6 days post vaccination and beyond
Patient came back to clinic 2 days later with arm red where PNEUMOVAX vaccine given. Dr saw patient and states patient had erythema (skin) and painful rash. Dr advised Ibuprofen 400 mg TID, warm compresses, elevation. Follow-up if persistent or worsening.
Pt. was given .5ML dose and NOT the .25ML booster dose. Pt. Did not qualify for the .5ML booster dose.   Pt reported severe sickness. Symptoms were severe body and muscle aches, sensitive skin to touch, injection site was very tender and hot. Pt reported his hair hurt when bathing, his teeth hurt when he brushed them, he had hot and cold flashes, he reported sensitivity to light and suffered from constant headaches. Pt. stated he was severely fatigued, and exhausted.
Developed sore throat and cough on 10/28/14 at night including nasal and chest congestion. Felt fatigued.
Patient was due for booster shot of Hepatitis A vaccine and signed the consent form. Patient was offered influenza vaccine but declined and signed a declination form.  Vaccine was administered and they called afterwards to explain that had given the flu vaccine and not the hepatitis vaccine.
Clinical Resource Nurse states Fluarix and Boostrix were exposed to minus 2.04 C and administered to a patient.; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 13-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2023-2024 season) (batch number 5KT7B, expiry date 30-JUN-2024) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number 54CP2, expiry date 11-JAN-2026) for prophylaxis.   On 31-OCT-2023, the patient received Fluarix Quadrivalent 2023-2024 season and Boostrix. On an unknown date, an unknown time after receiving Fluarix Quadrivalent 2023-2024 season and Boostrix, the patient experienced incorrect storage of drug (Verbatim: Clinical Resource Nurse states Fluarix and Boostrix were exposed to minus 2.04 C and administered to a patient.). The outcome of the incorrect storage of drug 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: 15-NOV-2023 Clinical Resource Nurse stated Fluarix and Boostrix were exposed to minus 2.04 degree C and administered to a patient, which led to incorrect storage of drug. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via postal.
Pt was given Pfizer vaccine that had a BUD of 10/16/2021.
pt recv vax in NOV95 & 12JUN96 pt devel chickenpox @ the time of the report, the number of lesions was unk;
Broke out with a severe rash on buttocks and arms, itchy and burning. I went to emergency at hospital, diagnosed as hives and given Hydroxyzine pills to take on Sat. Went to see my doctor on Monday, given an injection and a saline to use. Fluocinonide ointment 0.05%.