chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported. No treatment medications were provided. This case concerns a 72-year-old patient, unknown gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after third dose of mRNA 1273 vaccine. The rechallenge is not applicable due to the nature of the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 72-year-old patient, unknown gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after third dose of mRNA 1273 vaccine. The rechallenge is not applicable due to the nature of the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Swelling at site of injection from axilla to elbow.  Fever to 101 degrees.  Occured at site of varicella vaccine.
FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms on MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210429317.
Patient received undiluted dose of pediatric Pfizer COVID 19 vaccine. Patient required additional observation time to monitor for any adverse effects. None noted and patient asymptomatic.
Received boostrix on 9-9-13; developed an itchy swollen area under the right jaw line that evening spread to neck and chest over the next 24 hours. Took benadryl regularly for 24 hours and symptoms improved - has couple hives remaining 9-9-13.
Soreness at injection site; Mild fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), 6 hrs after the suspect product(s) administration, outcome "unknown", described as "Soreness at injection site"; FATIGUE (non-serious), 6 hrs after the suspect product(s) administration, outcome "unknown", described as "Mild fatigue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient stated experiencing radiating pain down the left arm beginning several days after the vaccine administrated. Patient went to ER for treatment.
This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 30-OCT-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot# L013428, expiry date 03-FEB-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to temperature excursion (date unspecified): lasting for 72 hours, with the lowest recorded temperature of 31 degrees Fahrenheit (-1.11 degrees Celsius). No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Itchy painful rash on neck and chest. Rash is bumpy and red. Symptoms began on 4/9 and have not resolved as of 4/12. Currently applying topical, cold compress, and OTC antihistamines.
Hives that appeared 2 hours after receiving vaccines according to child's father. States the rash was itchy. Given BENADRYL and Triamcinolone cream.
Information was received from a nurse concerning a first grade student who on 22 MAR 1999 was vaccinated with a dose of Varicella.  In mid DEC 2004 the student developed chickenpox.  According to the school nurse there were 58 other elementary school students and 34 of them had previously been vaccinated with a dose of Varicella.  Unspecified medical attention was sought.  There was no information regarding the present status of the first grade student.  No product quality complaint was involved.  Additional information was requested.
Client called  Health Dept on 1/15/04 around 1:15pm to report that on 1/14/04 around 2pm that her right arm in deltoid region became red, sore and swollen and then began getting hives on right arm. Client called her Drs office around 5pm on 1/14/04 to report symptoms. Was Rx Atarax to take TID for itching. States hives continue on 1/15/04 on right arm down to elbow. Instructed client to call her physician if symptoms worsen if hives increase and/or any difficulty breathing.
I'm a lifelong tinnitus sufferer. I have managed living with the sounds 24/7 in both ears. The volume has definitely increased after the 2nd dose. I noticed no volume change after the 1st dose. Second dose received 9/18 with noticeable volume and pitch increase since 9/27 and remains consistently louder than my usual volume. It is noticeable and life-altering, especially in moments of silence. I had heard this was a possibility to happen with the vaccine but I felt forced to get it. Kind of regretting it now.
Left Eye swelling; Severe Itching all over; Severe Headache; Stiff neck; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient she received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6198) via an unspecified route of administration in the left arm on 26Feb2021 at 16:30 (at the age of 40-years-old) as a single dose for COVID-19 immunization. Medical history included variable immune deficiency, asthma, and eosinophilic esophagitis (EOE). Allergies to medications included amoxicillin, erythromycin, clindamycin, ciprofloxacin (CIPRO), sulfamethoxazole/ trimethoprim (BACTRIM), and oxycodone/ paracetamol (PERCOCET). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 26Feb2021 at 17:15, the patient experienced left eye swelling, severe itching all over, severe headache, and stiff neck. The patient was not treated for left eye swelling, severe itching all over, severe headache, and stiff neck. The clinical outcome of left eye swelling, severe itching all over, severe headache, and stiff neck was not recovered.
Per recovery RN documentation:05/17/2021 0813 MRN 1572066 Patient Sex: female DOB: 07/02/1967 Vaccine time: 0754 Reaction time: 0813 Symptoms: Patient was discharged from the clinic and she came back into the building c/o itchy throat and heavy shoulders. Intervention: RN had patient sit down in waiting room and monitored vital signs. BP 152/91 Right arm, sitting. O2 sat 98%. HR 62. RR 18. Patient was monitored for another 15 minutes. Response: Patient reported feeling better and verbalized was okay to drive home,  patient discharged.  Patient aware that she will need to call 911 or go the nearest emergency room if her symptoms worsen.
After the second dose, same symptoms (night sweats, chills, vomiting); After the second dose, same symptoms (night sweats, chills, vomiting); After the second dose, same symptoms (night sweats, chills, vomiting), still vomiting at 4 days post-vaccine; Night Sweats, Chills, Vomiting. After first dose; Night Sweats, Chills, Vomiting. After first dose; Night Sweats, Chills, Vomiting. After first dose; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 18Apr2021 (at the age of 16-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EUU0173) via an unspecified route of administration in the left arm on 08May2021 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram oxalate (LEXAPRO) taken for an unspecified indication from an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021 at 19:00, after the first dose, the patient experienced night sweats, chills, vomiting and the symptoms had lasted for 4 days. On an unknown date in May2021, after the second dose, the patient experienced the same symptoms (night sweats, chills and vomiting); vomiting continued at 4 days post-vaccine. The patient was able to hydrate, but could not keep food down yet. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. Following the first dose, the clinical outcome of the events night sweats, chills and vomiting were recovered on 22Apr2021. Following the second dose, the clinical outcome of the events night sweats and chills were unknown and vomiting was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Severe vomiting, diarrhea and dizziness for 24 hours. Ongoing tiredness and mild to moderate dizziness continues as of 1/31/2020.  1/27/2020 lesions erupted on left buttock ( same site as previous shingles outbreak) .  Diagnosed by APN 1/29/2020 as shingles. Started Meclizine 25 mg up to tid  1/25/2020, started Valacyclovir HCL 1 gr. Tid.
The patient has a history of COPD. He was brought to the ED by EMS on 4/8/23 for evaluation of weakness. Patient lives independently, and reported that he was too weak to get out of his chair and was not able to eat or drink anything for the past three days. Per EMS, O2 sats were in the high 80's. Notably, a rapid COVID PCR test resulted positive in the ED. Ultimately, the patient was admitted 4/8/23 - 4/13/23. Discharge diagnoses included severe COVID-19, COVID pneumonia, and acute hypoxemic respiratory failure due to COVID. During admission, the patient required up to 5L supplemental O2, however was able to be weaned down back to his baseline oxygen needs. He was treated with dexamethasone during admission.  Of note, the patient has received the primary COVID vaccine series and one booster.
Pt had 5/10 pain in arm upon palpation for x6 days, diarrhea on 2nd day after shot,  fatigue x5 days.   treatment was rest and good diet with probiotics.
This spontaneous report was received from a supervisor, referring to a currently 21 months old female patient. The patient's historical drugs, medical history, drugs allergies and concurrent conditions were not reported. The patient's concomitant therapies included sterile diluent. On 12-FEB-2019, the patient was vaccinated with an improperly stored dose of VARIVAX subcutaneously, lot# R018142 and expiration date 25-JUN-2020, for prophylaxis (strength, dose and frequency were not reported). The temperature excursion was of 6 Fahrenheit degrees (degrees F) to 14 degrees F, during 2 hours 20 minutes. However, a previous temperature excursion of 15 degrees F to 46 degrees F for 11 hours was also reported. A digital data logger was involved. No adverse effects were reported. Sender's Comments: US-009507513-1903USA000678; US-009507513-1902USA012055; US-009507513-1903USA000677; US-009507513-1903USA000681; US-009507513-1903USA000682; US-009507513-1903USA000683; US-009507513-1903USA000684; US-009507513-1903USA000685.
Uneasy feeling in your stomach - felt funny. Next day, I felt fine. Tuesday night (12th, evening) I went to bed at 07:00 pm - exhausted - and really exhausted all the next day (13th) - extreme exhaustion - crashed really early. Thursday, I felt fine. Early Friday morning, I woke up 02:00 am with a headache. Then it became a full on migraine and it  hurt to hear - puked for 6 hours - throw up and break; throw up and break - threw up hard each time. (That was full 7 days later.) I took migraine medication wouldn't fix it on Friday. Saturday and Sunday, migraine med finally helped that day and I  felt groggy but migraine was better. Was Better the next week. Also, the arm with injection site was really sore the night of the injection and for three or four days. Emailed Dr through out but did not have a doctor appointment.
The day after receiving the flu shot, patient states she developed sudden onset of diarrhea, shorly after joint pain in shoulders, knees, ankles and arches of feet.  No pain in hips or elbows.  Also had trouble swallowing for few hours, resolved now.  C/O significant swelling in hands, unable to make fist.  Joint pain and swelling still persist today.
they administered expired TYPHIM VI to a patient with no reported adverse event; Initial information was received on 27-Oct-2021 regarding an unsolicited valid non-serious case received from other healthcare professional via MI (Medical Information - 00831260).  This case involves a 16-years old female patient who was vaccinated with expired dose of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (Expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) for Immunization; and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Immunization.  On 27-Oct-2021, the patient received a 0.5ml {total; once} dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (Solution for injection, lot number R24741M and expiry date 05-Oct-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was reported "Nurse manager asks what they should do after administering expired product; is it safe to administer expired TYPHIM VI; and what are the most common adverse events of TYPHIM VI?"  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.  Event outcome was unknown.  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.
Myalgia; Chills; Headache; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Myalgia), CHILLS (Chills) and HEADACHE (Headache) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 042B21-2A) for COVID-19 prophylaxis.     Previously administered products included for Pain: Ibuprofen (Route-oral and 200 mg). Past adverse reactions to the above products included No adverse event with Ibuprofen. Concurrent medical conditions included Sulfonamide allergy (Sulfa drug allergy), Drug allergy and Acid reflux (oesophageal). Concomitant products included ALGELDRATE, SODIUM ALGINATE (GAVISCON [ALGELDRATE;SODIUM ALGINATE]) for Acid reflux (oesophageal).   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Myalgia), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, MYALGIA (Myalgia), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.            Treatment medications were not reported.   This case was linked to MOD-2022-668484, MOD-2022-670156 (Patient Link).
SUSPECTED IMMUNOLOGICAL  VACCINE FAILURE; FELT LITTLE SLEEPY; FATIGUE; This spontaneous report received from a consumer concerned a 50 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: 23-JUN-2021) dose was not reported, 1 total, administered on 03-MAY-2021 vaccination at left arm for prophylactic vaccination. No concomitant medications were reported.  On 04-MAY-2021, the patient felt little sleepy the day after the vaccine and experienced fatigue. On 17-MAY-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) Negative (Coded suspected immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, and the outcome of suspected immunological vaccine failure and felt little sleepy was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000180552. The suspected product quality complaint has been confirmed to be voided, this did not meet the defined definition for lack of effect on a vaccine product. based on the PQC evaluation/investigation performed.; Sender's Comments: V0:20210545203-COVID-19 VACCINE AD26.COV2.S-Suspected Immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
On Jan 18th, patient experienced re-swelling at injection site with redness and cellulitis; enlarged lymph nodes in armpit; stomach pain.  she had a follow-up appointment with her primary physician who prescribed an antibiotic.  She reports that that the issue has not resolved at the time of this report
Initial healthcare professional report was received on 04 Mar 2010: This patient was vaccinated with FLUVIRIN, batch no: unknown, 0.5 ml, intramuscular, on an unknown date. In Nov 2009 (day unknown), the patient experienced injection site pain in their arms near the sites of injection. The outcome of the events were not reported.
pt reported being really warm, and then passed out; all vitals were good; ems was called; (pharmacy is in a clinic so provider responded and helped with vitals and managed situation).  Patient and husband called to tell me she was ok, then while on phone she passed out again in parking lot.  I ran outside and pt was laying in parking lot, did sternum rub again, and patient began seizing.  Pt had approximately 8 seizures occuring about every 30-45 seconds and lasting anywhere from 15-30 seconds each.  EMS arrived, pt came to and was put on stretcher.  Spoke to patient last night about 10pm, and she was home, feeling tired.  Hospital told her that it was a normal reaction to vaccine and she would be ok.  I think it was a combination of her being overwhelmed and scared of the shot and her anxiety and ptsd took over.
"This is a 13 month old female complaining of skin rash for 2 days.  Patient had her 1 year vaccines on 6/17/2022.  Patient complains of rash to the right thigh, where she got her vaccines on."
Information has been received from a consumer and follow up information from a physician concerning a 16 month old female patient. The consumer reported the patient had no allergies and had a history of ventricular septal defect at birth and ventricular septal defect repair two months later. Follow up information from the physician reported that the patient had no illness at the time of vaccination, no medical history and no adverse events following prior vaccinations. On 8/22/02 the patient was vaccinated SC in the right anterior thigh with a first dose of MMR vaccine live (second generation)(lot #642695/0490M). The physician reported that on 10/8/02 the patient presented with new onset insulin dependent diabetes mellitus and was transferred to a hospital for pediatric endocrine evaluation. The child was hospitalized for 3 days. Lab evaluation revealed serum glucose of 525 and moderate ketones and 2+ glucose in the urine. The physician reported on 4/29/03 that the patient had not recovered from the event of insulin dependent diabetes mellitus and the event had resulted in a persistent or significant disability/incapacity. The physician reported link unknown. No further information is expected.
Received vaccine on 1/4@1530. Around 8pm soreness in left arm started worsening throughout night. When I woke up on 1/5/21@0445am for work I had a low grade fever of 100.5, headache, muscle aches all over body, chills, fatigue, joint pains all over. Around 0700am I developed weakness, dizziness and nausea with the other symptoms throughout the rest of the day. Took Tylenol and rested but woke up feeling the same at 4pm. Took my temperature at 5pm which was 100.00. Attempted to call vaccine information line but they closed at 5pm and left voicemail message with VAERS.
3 nurses recvd dose #1 of Engerix-B & devel muscle ache w/in 8 to 12 hrs of inject; also fatigue, nausea & h/a; sx subsided over time;
I experienced fever of 102.8, chills, tremors, leg pain, body aches, dizziness, diarrhea, "foggy" brain
Flu vaccine administered to (R) deltoid 9/18/15 and (R) submandibular ln swelling-pain noted 9/19/15.
Patient awoke the day after the vaccine and noticed her left ear swollen and trouble moving parts of her face, the symptoms progressed over the course of the next few days until she was unable to move the entirety of the left side of her face and head. At this moment in the fear of a stroke she went to a local Emergency Department where she was given the diagnosis of Bell's Palsy secondary to the vaccine