chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received an expired dose of Pentacel with no adverse event reported; Initial information received on 03-Jun-2021 regarding an unsolicited valid non-serious case received from a other health professional via Medical Information (Reference number- 00627057).  This case involves a 6 month-old male patient who was vaccinated with 0.5 mL (once, standard) expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (batch number UJ227AA-for HIB component and expiry date 23-Apr-21) via an intramuscular route at the left thigh on 28-May-21 for prophylactic vaccination (expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  Result of assessment was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Developed a red raised macular papular rash on (L) arm and shoulder that was itchy and spread to trunk. Random distribution.
electrical shooting pains in fingers and toes, joint pain and bilateral tinnitus since 2nd vaccine
After monitoring time was complete, client stood from sitting position and fell forward and sustained ecchymosis to forehead and nose.  He became less alert with delayed response to verbal commands. VS measured; BP 78/50, Pulse 65, O2 Sat 96% Room Air, R 16.  He became clammy with repeat of BP 161/60, Pulse 63, O2 Sat 91% Room Air.  EMT summoned and client transferred to ER for further assessment and treatment.   Call to local hospital confirmed ER visit and release same day.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 08-JUL-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Zoster vaccine administered right arm on 2/13/2017. Pt. called 2/14/2017 reporting itching, redness, and "golf ball" sized swelling. Advised to continue ice, BENADRYL, and start NSAIDS. On 2/15/2017 pt. called reporting worsening of cellulitis. Rx with KEFLEX by M.D.  pt. works with. On 2/17/2017 pt. called " full blown cellulitis". Rx with ROCEPHIN 2/16 and 2/17. Symptoms resolved approximately 3/15/17.
Very sore and tender breast started with swollen lymph nodes under one arm then the other and then both breast got sore. Hurts to not have support or roll over. Has lasted for 10 days.
- Experienced Autoimmune Hepatitis and have been receiving prednisone 40 mg daily starting 05-13-22.  - Experiencing Tinnutis w/ no treatment in progress
The patient was sitting on a cot and after administering Twinrx and Typhoid vaccines he  asked some questions, then had a syncopal episode. He was laid down and oxygen was applied via nasal cannula.  He recovered shortly thereafter and was sent upstairs for observation. No further action was required.
Red arms and stuffy nose appeared approximately 3 hours after administration of flu shot.Was seen at MD office. DX:   ? Adverse Reaction Flu Shot. RX: Claritin 10 mg 1 po q day x 4. After administration of Claritin symptoms resolved.  Patient has had influenza  vaccine before without any adverse reaction.
Subsequent to receiving vax pt developed swelling, pain, warmth and erythema at injection site.
fast heart beat; Fever; body aches; significant arm pain; headache; tiredness; feeling unwell; This is a spontaneous report received from a non-contactable consumer (patient). A 37-year-old female patient (non-pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: unknown), in left arm via an unspecified route of administration on 18Apr2021 at 12:15 PM (at the age of 37-year-old) as single dose for Covid-19 immunisation. The patient was not pregnant at the time of vaccination. She took her first dose of vaccination at the age of 37-year-old on 21Mar2021 at 12:15 PM in left arm via unspecified route of administration as single dose for Covid-19 immunisation. Past drug included bactrim and erythromycin for allergies. Medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. No any other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After vaccination, on 18Apr2021 at 16:00, the patient experienced fever, body aches, significant arm pain, headache, fast heartbeat, tiredness, feeling unwell. Since the vaccination, the patient had not been tested for COVID-19. Device date was reported as 29Apr2021. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information expected.
The pt complained of continued soreness post vax. Pt denies redness, swelling, fever or hot to the touch areas of the arm. Pt does report she had not had a TD booster in more than 30 years. Pt reports she had used Tylenol or ibuprofen without much improvement and quit using them.
Employee received MMR & Hepatitis B vaccines. One week after vaccines were given, she experienced "swelling" in both knees.  Two weeks after vaccines were given, she experienced "swelling" in both hands. She has episodes of "hands falling asleep when sleeping".
Patient reported swelling, redness, pain at injection site starting day after injection. At time of visit, 6 days had past since immunization.   The induration on the left deltoid was 40cmx40cm with erythema. Nontender to palpation.
dizziness, fogginess, and brain fog.; dizziness, fogginess, and brain fog.; This spontaneous case was reported by a health care professional and describes the occurrence of DIZZINESS (dizziness, fogginess, and brain fog.) and FEELING ABNORMAL (dizziness, fogginess, and brain fog.) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced DIZZINESS (dizziness, fogginess, and brain fog.) and FEELING ABNORMAL (dizziness, fogginess, and brain fog.). At the time of the report, DIZZINESS (dizziness, fogginess, and brain fog.) and FEELING ABNORMAL (dizziness, fogginess, and brain fog.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Things were normal for about 6 hours, I started feeling very fatigued. It started with a low fever around 100.5 and I was a little achy. The next day I was about 25% worse. Overall, I felt badly for about 2 1/2 hours. After about a week I felt fine, but the symptoms came back. I was tested again for COVID and the flu. Both were negative and I was instructed to just rest for 10 days and work from home. Experienced the same with 2nd dose, but twice as bad. Did not see a doctor in person.
5 hours after initial hepatitis B vaccine onset of migrating paresthesias. Has lasted 3 weeks - also sore eye symptoms. No motor symptoms.
Probable SIDS.  3/9/06 Received autopsy report which revealed patient experienced cold s/s with COD Sudden Infant Death Syndrome/ss
Case number PHEH2014US024971, is an initial spontaneous report from a nurse received on 09 DEC 2014. This report refers to a 20 year old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN 2014/2015 (batch number: 145701) intramuscularly at a dose of 0.5 ml on 11 NOV 2014. The  nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 OCT 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration (incorrect storage of drug).
On 08/15/2022, in the morning, I woke up with swollen hands and pain in joints of all fingers. I had to go to a jeweler to have engagement ring cut off. That pain and swelling still continues and I still cannot put on rings. I went to my doctor. No treatment.
Had vaccines on 5-18-10. Returned to mobile clinic on 5-20-10 c/o large red swollen area on back of right arm at varicella injection site. Swollen area was hot to touch and measured 6 3/4" x 4 1/2". Patient stated she had a fever. Area was painful and itchy. Sent to urgent care. She was told it was an allergic reaction - given BENADRYL and an antibiotic. Recovered after treatment. Patient states she had chicken pox at age 23 but did not report that at time of vaccine.
Stiffness/achiness,  fever and chills, brain fog, tired, breakthrough menstrual bleeding, muscle ache at injection site. Itchiness right after injection, but resolved before leaving pharmacy
I went to the clinic and had my 4th COVID-19 shot I waited the 15 minutes and went back to work. The next day I noticed in the afternoon I had bad back ache and headache. It last for about 2 days and then I was better.
THE PT IS A 2 YEAR OLD FEMALE AND THERE WERE 3 SIBLINGS IN THE ROOM ADMINISTERED 0.5ML OF NOVARTIS 4 YEAR AND OLDER H1N1 VACCINE.
pt recv vax & 5 days p/vax pt exp erythema, swelling, induration (3-4cm), sore arm  @ the inj site & a h/a;arm is still red as of 27SEP95;
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 14-OCT-2012 19:58, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Extreme pain and swelling at injection site, could not sleep on arm (R) swelling and pain descending from shoulder to upper arm, day 2, day 3 swelling down to elbow w/ pain and now lower arm pain and swelling cannot sleep on (R) side due to pain, within hours of vaccination could not use (R) arm due to extreme pain.
Patient experienced a period of unconsciousness while waiting during the post-vaccine period of 15 minutes
Information has been received from a pharmacist via a company representative referring to some patients of unknown gender. On unknown dates these patients were vaccinated with doses of ZOSTAVAX (dose and frequency were not reported) before they were 50 years of age (Inappropriate schedule of vaccine administered). This is one of several cases received from the same source. Additional information has been requested.
Arm pain as usual at injection site 1-3 days and hard to touch. Headache in the AM's, and would awake with intense headache. Tension headache caused vomit ( salvia) in AM x3., blood pressure would rise and fall intermittently for various day. Left entire arm became very hard to touch, full pressure, inflammation and raised blood vessels and raised blood vessels in right arm also. 01/01/21 Cardiac pain and pt went to ER Hosp; Discharged with referral to Cardiologist, ER stated occurred events could have been of muscular cause at discharge. Appt with Cardiologist 1/20/21
accidentally administered expired Daptacel to an 18 month old/no AE; Initial information received on 09-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 18 months old male patient who received an expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACT-HIB) for Immunisation; INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On 08-Oct-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5281AA (expiry date: 05-OCT-2019) via intramuscular route in right leg.  It was of action medication error due to expired vaccine used.  It was unknown whether adverse event was experienced or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Itchy sensation, hives. Went to ER, BENADRYL, Steroids.
Hypersensitivity; This case was reported by a nurse and described the occurrence of an allergic reaction in a 32-year-old male who received hepatitis B vaccine recombinant (Engerix-B). Medical history included allergies to Augmentin and amoxicillin. On 15 September 2004 the patient received the third dose of Engerix-B (lot number ENG5595A6). During the administration of the third dose of Engerix-B, the nurse stated that the "patient had commented that the injection hurt on administration as opposed to the previous two Engerix-B injections." Approximately one day later, on 16 September 2004, the patient experienced a mild fever and swelling, pain, and redness at the injection site. On 17 September 2004, the injection site redness and swelling extended "from shoulder to elbow." The patient was seen at a physician's office and was diagnosed with an allergic reaction. The patient was treated with Benadryl. The events resolved on 22 September 2004. The reporting nurse considered the events to be related to vaccination with Engerix-B.
About 3min following 1st Covid vaccine administration pt began coughing and having shortness of breath during 15min of observation by facility staff.  Pharmacist immediately notified and pt requested we administer her personal EpiPen.  EpiPen administered in right leg.  Coughing slowed, pt relaxed.  After immediate reaction slowing patient said she did not feel like it warranted an ER visit.  Pharmacist contacted primary healthcare dr and nurse informed pharmacist that pt should go to ER if we believed it was necessary.  Pharmacy depot leader contacted and advised protocol directs pt to be sent to ER.  Patient agreed to be sent to ER.  Facility staff contacted 911, ambulance arrived within 5-10 min, pharmacist relayed all information to emergency personnel  and took patient to ER for followup.
Hip flexor pain; This is a spontaneous report from a contactable physician. This Physician reported similar events for three patients. This report is for 2nd of three patient. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a Dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Facility of the most recent COVID-19 vaccine was administered was reported Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The reporter was EM physician and mentioned that, approximately 5 days after vaccination reporter got hip flexor pain. The reporter stated that, the reporter knew 2 others with similar experience and reporter advised them to contact Pfizer also. The reporter stated that keep up the good work! Thanked Pfizer for all that you did. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
I was vaccinated on the afternoon of 3/5, then woke the next day with fever, chills, myalgias and headache. These persisted all day and into the next, 3/7. I was also very fatigued and slept most of these 2 days.
had vaccine and still got shingles / suspected vaccination failure; still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had vaccine and still got shingles / suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got shingles). The outcome of the vaccination failure and shingles were not reported.   It was not reported if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was not reported if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 01-MAR-2023 This case was reported by a patient via interactive digital media. The patient stated that the shingles was not as severe as if the patient had not gotten the Shingles vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
devel significant fussiness, screaming, tender abd, felt clinically to have intussusception (guiac positive stool);work up negative;observed in hosp x 2 days & dxed w/ pyelonephritis.
Rash, hypersensitivity on skin, diarrhea. All of those are still present, but getting better through the last four weeks.
Shortness of breath, swelling of nasal tissues, dizziness, slight nausea, itchiness all over body, significant soreness in shoulder muscle where vaccination was administered, swollen & sore gland in armpit of shoulder in which vaccination was administered, weakness & tremors, soreness in joints, lowered body temperature (96.4°), chills / cold sweats, normal pulse but slightly elevated blood pressure.  Symptoms have persisted for 60 hours as of the completion of this report, but seem to be getting a little bit less severe.
Received the following information from pt's mother during a phone conversation. The pt received Hep-A and Hep-B on 7/19/01 and he also received meningitis vaccine from his PMD that same afternoon. On 7/22/01, the pt developed nausea, headache, fever to 101.5F (usually at night), achy and "hot" joints, and cough. Saw PMD on 7/26/01 and dx'd with "flu".
Second dose:  A few minutes after getting vaccine. I was sitting in the observation area and I started feeling a pinch in my arm, then I started feeling  warm and light headedness. Then they checked my bp and it was 149/93 . Then I had to stay for 30 mins, then I left to go home. I had body ache and a mild temperature. It was 98.2 .My arm is sore, and my joints and body hurts. I have a headache too , and I just took an ibprophen.  I am still not feeling well.  I did not go to the ER, hospital or doctors office about this ae.
Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included SERTRALINE, ATORVASTATIN, OLANZAPINE, CLONIDINE HYDROCHLORIDE (CLONIDINE [CLONIDINE HYDROCHLORIDE]) and CARVEDILOL for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced RASH (Rash). The patient was treated with ECONAZOLE NITRATE (ECONAZOLE [ECONAZOLE NITRATE]) (topical) for Rash, at an unspecified dose and frequency and FLUOCINONIDE (topical) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (Rash) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication also included supplements.  The patient received second dose of the vaccine in mid February.   This case was linked to MOD-2021-294486 (Patient Link).
Patient states that they felt very tired/ run down the day after getting vaccinated. Patient was told to contact physician about how they were feeling.