chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered an expired vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 72-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number XK524, expiry date 8th October 2022) for prophylaxis.   On 14th October 2022, the patient received Boostrix. On 14th October 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 14-OCT-2022 Reporter's Comment: The case was reported by pharmacist. The reporter administered an expired vaccine expired by 6 days, an expired Boostrix 8th October 2022 on 14th October 2022 in their facility. The reporter was seeking to get information for follow up. Alternate pharmacist inquired should patient repeat the dose. Reporter did not consent to follow. Additional supportive information: As patient administered expired dose which led to expired vaccine used.
pt recv vax 31MAR97 & 16MAR97 pt was exposed to cousin who devel varicella on 31MAR97;2APR97 pt devel about 50 lesions on chest & face;pt also devel many lesions on trunk & head as well as a few on extremities;
after all of my covid vaccines I felt tired for a few days after starting day after but this has persisted to today, I am tired all the time, poor attention/concentration. this is similar to my episodic energy loss i have had since as well as i can remember since 10yo-no episode has ever lasted this long
Patient states that after injection experienced extreme burning in her arm and shoulder which did not go away.  It became worse and she states she has gone to her doctor and is still in extreme pain, tendonitis and is continued pain.
Pt developed vertigo and headaches. Went to ER 4/6. Was given meclizine and ondansetron. Pt reports improvement of symptoms 4/7
Pt received Menactra and Adacel 11/18/09 as part of routine physical exam. Later that day, pt became fatigued. By 11/19/09 pt felt too weak and tired to get out of bed - also experienced shooting pain and muscle spasms in her arms and legs. Legs felt heavy - to get out of bed no fever also c/o decreased appetite.
ANXIETY; INJECTION SITE PAIN; DIARRHEA; SHORTNESS OF BREATH; NAUSEA; VOMITING; HEADACHE; CHILLS; MUSCLE ACHES; LOW/CENTRE BACK PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included hydrocephalus. The patient experienced rhabdomyolysis when treated with ciprofloxacin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 05-MAR-2021 11:30 for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced shortness of breath. On 05-MAR-2021, the subject experienced nausea. On 05-MAR-2021, the subject experienced vomiting. On 05-MAR-2021, the subject experienced headache. On 05-MAR-2021, the subject experienced chills. On 05-MAR-2021, the subject experienced muscle aches. On 05-MAR-2021, the subject experienced low/centre back pain. On 06-MAR-2021, the subject experienced diarrhea. On 10-MAR-2021, the subject experienced injection site pain. On an unspecified date, the subject experienced anxiety. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, chills, and muscle aches on 06-MAR-2021, and low/centre back pain on 05-MAR-2021, and had not recovered from diarrhea, shortness of breath, nausea, injection site pain, vomiting, and anxiety. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
sore arm, stuffy nose, achy 4/2 - sore arm, stuffy nose, bloody nose, achy 4/3 - sore arm, stuffy nose, headache, achy 4/4 - stuffy nose, headache, achy 4/5- work up congestion, stuffy nose, slightly achy but better than previous days, slight headache
Pt was given FLUZONE/Hep A. Then broke out head to toe in a rash.
severe COVID-19 disease complicated by pulmonary embolism despite receiving three doses of the BNT162b2 mRNA vaccine; severe COVID-19 disease complicated by pulmonary embolism despite receiving three doses of the BNT162b2 mRNA vaccine; severe COVID-19 disease complicated by pulmonary embolism despite receiving three doses of the BNT162b2 mRNA vaccine; This is a literature report.  A 67 year old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "overlap connective tissue disease" (ongoing), notes: on mycophenolate mofetil. Concomitant medication(s) included: MYCOPHENOLATE MOFETIL taken for connective tissue disorder. The following information was reported: DRUG INEFFECTIVE (caused and prolonged hospitalization, medically significant), PULMONARY EMBOLISM (caused and prolonged hospitalization, medically significant), COVID-19 (caused and prolonged hospitalization, medically significant), outcome "unknown" and all described as "severe COVID-19 disease complicated by pulmonary embolism despite receiving three doses of the BNT162b2 mRNA vaccine". The event "severe covid-19 disease complicated by pulmonary embolism despite receiving three doses of the bnt162b2 mrna vaccine" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test positive: Positive. Therapeutic measures were taken as a result of vaccination failure, pulmonary embolism, covid-19.  Follow-up (30Jun2022): This is a literature report. This is a follow-up report based on the receipt of the publication; the case has been updated to include additional information identified in the publication.  Updated information included: Reporter and literature information, lab test, product details and event details updated.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.Based on the current available information, a possible contributory role of the suspect product BNT162B2 to the development of events Pulmonary embolism, 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.
Fever, pain at site and mainly Severe headache- to the point  laying down in a dark room , even after taking Tylenol- which she NEVER requests because she hates to take pills! Additionally she had fatigue- which is not even listed as a possible side effect.   'What you need to know' sheet was given to us after the vaccine, with NO information verbally stated. I think that the sheet needs to be given out BEFORE any vaccine and people strongly encouraged to read the sheets with the strongly probable  ( and 10% or more is strongly probable) You have a trust issue and giving sheets out after the fact and basically sending people away to bear the brunt of any side effects breaks trust.    What if my daughter had to go to work that evening? She needs to have enough information to plan.
Severe Muscle ache 18 hours following vaccination and the muscle aches subsided leaving me with weakness and  loss of muscle coordination. Multiple falls due to loss of muscle control since the vaccination.
I26.92 SADDLE PULMONARY EMBOLISM 7/31/2022 ACUTE PULMONARY EMBOLISM I26.99 ACUTE PULMONARY EMBOLISM 7/9/2022 ACUTE PULMONARY EMBOLISM
Arm very swollen from shoulder to fingertips. Skin split open and oozing began. Letter and pictures enclosed. Swelling has gone down on its own but hasn't yet returned to normal after 2 months.
-Had rash/swelling/pain and warm to touch -> treated w/BENADRYL (lasted 10 days) -Still has itching all over body and treating w/BENADRYL.
The patient presented herself to the pharmacy for her annual flu shot on October 24th, 2017. After receiving her flu shot she asked how long will this hard bump on her arm stay from when she got the shingles shot (ZOSTAVAX). I felt the bump and visually inspected it. It was about a 2 cm diameter nodule under the skin and it was relatively hard. There was not any redness and the area was not warm to touch. She said that the nodule had been there every on the backside of her right arm ever since she got the shingles shot back in June 2017. I told her to have her doctor examine the nodule on her next visit to make sure that it wasn't a hematoma which can develop after vaccination with ZOSTAVAX.
Received 1st (Dec 2020) and 2nd dose  (Jan 2021) of Pfizer COVID vaccination at facility. A week or so after 2nd dose, started noticing bilateral edema in my feet and ankles that progressed to 1-2 pitting edema to knees. Mentioned this to several doctors virtually. Seen in office recently (so they can see it for themselves) and now being sent for further testing.
Numbness started on Day 2 of the vaccine and has never stopped.  Started with left ring and pinky fingers.  Received Vaccine #2 on 5/11/2021 and now there is a line down my left arm from the point of the shot to my middle finger and it is entirely numb, leaving me with 3 fingers that are numb - left pinky, ring and middle finger.
The patient received the vaccine then about 10 minutes later she passed out then began having seizures.  The paramedics were called and she went to the hospital in an ambulance.
no adverse event; product storage error; This spontaneous report has been received from a medical assistant concerning to a 4-years-old male patient.  The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 21-DEC-2022, the patient was vaccinated with an improperly dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) intramuscularly in the right thigh (lot#: W019628 and expiration date: 19-DEC-2023) (dose number, dose were not provided) as prophylaxis (product storage error). No additional adverse event was reported. No further information was provided.
Left ear tinnitus (hissing sound, constant). Still persists. Had hearing checked; normal.
Redness, hives, itching to right thigh @ first, lessened with Benadryl.  Then on 12/11/2009 she was found to have itching, hives, and severe redness to left and right legs at several different sites.  Also, has a large red whelp to left calf area with itching, which lessened with Benadryl.  Developed a spastic like cough this evening also and a low grade fever.
I developed body aches 12 hours after vaccination that lasted about 36 hours. Low grade fever of 99.9  developed 24 hours after vaccination, and then increased to 100.1  about 28 hours after vaccination. Fatigue.
Admit for COVID pneumonia; tested positive 7 days PTA. Completed vaccine in Feb 2021. Treated w/ zpack PTA. He had his Pfizer vaccine. Despite tested positive and got sick. However his COVID19 IgG antibodies were negative. Was treated with convalescent plasma. Was given Remdesivir for 5 days. Was started on high dose steroids, empiric abx. Over the course of hospitalization his inflammatory markers improved. O2 requirements came down from 4 to 2 liters. Was eventually sent home on Oxygen with steroid taper.
started as itching on neck, then progressed to coughing and chest tightness approx 1 hour after receiving the vaccine, then progressed to shortness of breath. Benadryl given initially. epidural pen used with progression of symptoms, as well as Pepcid and prednisone.
Patient received first expired dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received first expired dose of the Moderna vaccine) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received first expired dose of the Moderna vaccine). On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received first expired dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-338604 (Patient Link).
Jan 21st 2021: Within 24 hours I had fever, red stingy eyes Within 2 weeks I had my first tinnitus attack February 13th approx noon: that caused me to loose the rest of my hearing in a sudden onset of tinnitus with some ear pressure. One week after taking presidone I regained some of my hearing however the  severe tinnitus had not stopped and continues to increase anytime I try to use my hearing aid.
Information has been received from a pharmacist concerning a 19 month old female with a history of chronic ear infections and ear tube insertion who was vaccinated with a first and second dose of varicella virus vaccine live in May 2002 and December 2002, respectively. In December 2002, the pt was inadvertently vaccinated with a second dose of the vaccines. Shortly thereafter, the pt had two exacerbations of ear infections and also bronchitis and was hospitalized. It was reported that the physician does not believe the infections to be vaccine related, but the parents are "not sure." Unspecified medical attention was sought. Additional info has been requested.   Reported on 03/26/2003: "Two days after the second dose of the vaccine, the patient developed severe otitis media and bronchitis and was hospitalized.  It was reported that the physician does not believe the infections to be vaccine related, but the parent's are "not sure".  Unspecified medical attention was sought.  At the time of this report, the outcomes were unknown.  Follow-up information indicated that the patient developed "no other problems."  Additional information has been requested.
Flu-like symptoms for 5 days?particularly bad for 3 days. swelling at injection site for 8 days, mild spleen pain & fatigue the came and went for 2 weeks.
Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a 33-year-old male consumer who experienced headache, feeling tired and achy. At 33 years of age, the patient received a dose on 09-Dec-2003. Medical History: Relevant medical history was not provided. Product Details: Indication for Flumist (2003-2004 Formula) was immunisation. Product was administered on 09-Dec-2003. Dose regimen was 1 dose (intranasal). Concomitant Therapy: Concomitant medications were not reported. Event Details: On 10-Dec-2003, 1 day post-immunization, the patient experienced headache and was feeling tired. On 15-Dec-2003, he was tired and achy. No additional information was available at the time of this report.
The vaccine that was given to patient was expired on  08/08/2020 Patient was monitored for 15 minutes, NO adverse reaction, provider in office informed, and we are currently contacting parents to let them know.
A physician reported that a 2 month old male received his 1st dose of Prevnar on 10/26/01. That same day, the infant developed a fever, decreased appetite and became listless. He was hospitalized. F/U states: The reporter stated that the symptoms resolved "about 24 hours later". F/U information received from the physician on 11/28/01, indicated that the infant also displayed a lack of eye contact and was "less interactive". The infant was treated with ampicillin and Rocephin (ceftriaxone).
Became allergic to iodine  approximately 1 week after getting first dose resulting in severe hives like reaction at iodine application site. Skin scaleing, red and swelling.
Patient felt very sleepy; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Patient felt very sleepy) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Patient felt very sleepy). At the time of the report, SOMNOLENCE (Patient felt very sleepy) outcome was unknown.     It was unknown if any treatment was given or if patient was under any concomitant or regular medication.
Pt developed about 2 x 4mm vesicles at edge of bandaid (about 4mm) from injection site for IPV and right arm=IPV and DTaP swollen with circumscribed macular rash. Left arm with area of induration-2 x 3cm at edge of bandaid from injection site for measles. Rash resolved by next day, only blister on right arm remained by 7/31/03.
Eosinophilia, low grade leukocytosis, monocytosis, without neutrophilic predominance  patient received vaccine on 6/17. These were normal when checked 6/3 monocytes and wbc normal when check 6/16 (eso not checked 6/16)  Next time these labs were check was on 6/25 - WBC and eso - elevated  eosinophils & monocytes remained elevated until 7/13 WBC still elevated more substantial now - maybe be increased for other reasons now  Inpatient from 6/27- to present  Patient admitted for other reasons -
Excruciating pain in both eyes, starting 24 hours after receiving the vaccine. Pain subsided after 5 hours.
no adverse effect reported; one dose of expired M-M-R II with no prior temperature excursion was reconstituted with properly stored and not expired STERILE DILUENT; This spontaneous report was received from a registered nurse and refers to a 12 month old patient of unknow gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 06-AUG-2019, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), lot number N020925 with expiration date 01-AUG-2019 with no prior temperature excursion  and reconstituted with properly stored sterile diluent. No adverse effect was reported.
pt recvd vax & devel hundreds of eruptions on body & was hospitalized;pt was treated w/Acyclovir;pt did not devel pneumonitis, nor worsening hepatitis;MD noted that the pt was probably lymphopenic @ the time of vax;no further details;
I found a cyst in my left breast; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03May2021 (Lot number: EW0175) at the age of 27 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. There were no concomitant medications. Vaccination history included: Bnt162b2 (product= COVID 19, brand= Pfizer, lot number= EW0158, administration date= 12Apr2021, administration time= 03:00 PM, dose number= 1, vaccine location= Left arm), administration date: 12Apr2021, when the patient was 27 years old, for COVID-19 Immunization. The following information was reported: BREAST CYST (non-serious) with onset 19Jun2021, outcome "not recovered", described as "I found a cyst in my left breast". The event "i found a cyst in my left breast" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reported Event: About 3 weeks later she found a cyst in her left breast which was not there prior to her shots. It was not a swollen lymph node-she went to her(withheld) and they did an ultrasound-it was a cluster of cysts. She found it interesting that it happened right after her shots and she want to know 3 other women who developed breast cysts after a Pfizer vaccine. Wanted to at least share this information in case other women also have been experiencing this. Thank you. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination The patient was not diagnosed with COVID-19, Prior to vaccination. The patient had been tested for COVID-19, Since the vaccination.  No follow-up attempts are possible. No further information is expected.
Patient came in for Pfizer second dose. This dose expired 8/4/2022. Patient had no adverse reaction to expired vaccine.
Information has been received from a certified medical assistant concerning a 69 year old female patient with allergic reaction to CECLOR and AUGMENTIN who on 04-MAY-2009 was vaccinated with a dose of ZOSTAVAX (lot # 663883/0132Y; 6018Y diluent), 0.65ml subcutaneously in her left arm. Concomitant therapy included multiple unspecified medications. The medical assistant reported that on 05-MAY-2009 after receiving the ZOSTAVAX, the patient developed itching, redness and swelling of her left arm at the injection site, and was diagnosed with cellulitis. The patient was treated with KEFLEX and BENADRYL and on 12-MAY-2009, was noted to be 90% improved. There were no laboratory diagnostics studies performed. The patient sought medical attention at the physician's office. Additional information has been requested.
This spontaneous case reported by a pharmacist, describes the occurrence of vaccination site pruritus (red swelling itchy at site), vaccination site erythema (red swelling itchy at site) and vaccination site swelling (red swelling itchy at site) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination site pruritus (red swelling itchy at site), vaccination site erythema (red swelling itchy at site) and vaccination site swelling (red swelling itchy at site). At the time of the report, vaccination site pruritus (red swelling itchy at site), vaccination site erythema (red swelling itchy at site) and vaccination site swelling (red swelling itchy at site) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reporter did not allow further contact.
fever of 100.5, injection site arm swollen to about the size of a softball, hard when pressed, warm to touch, no coloration
the patient came in the pharmacy with a severe inflamed arm. it looked red, inflamed and it had pus coming out of it. I advise the patient to immediately go to a minute clinic or urgent care to have this checked by doctor. Patient said he was going to the doctor and would let me know the outcome.