chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via interactive digital media and described the occurrence of impending doom in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced impending doom. On an unknown date, the outcome of the impending doom was unknown.   It was unknown if the reporter considered the impending doom to be related to Shingles vaccine.  Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. The reporter stated that, he/she felt like he/she was dying with their 1st shot. The follow-up would not possible as no contact details were available.
her heart was going fast; This is a spontaneous report from a contactable consumer (patient's mother). A 13-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm on 28Jul2021 (at the age of 13-year-old), as a single for COVID-19 immunization. No medical history and concomitant medications were reported. No investigation assessment. On 29Jul2021, her heart was going fast. It was reported that, mother calling on behalf of daughter, aged 13-year-old, received first dose of the Pfizer BioNTech Covid 19 vaccine on 28Jul2021. That evening in the middle of the night when she got home, her daughter was crying because she said her heart was going fast, similar to if she had just been exercising. Her daughter told her that she's not in pain but still having these symptoms of a fast heartbeat now. She tried calling the doctor but was unable to make an appointment. The patient took Pfizer COVID-19 vaccine "They want to prevent getting sick from school". No product quality complaints were reported. The outcome of the event was not resolved.  The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.
no addtional AE; inadvertently administered improperly stored vaccine; inadvertentlyadministered for 2 doses to the same patient; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent condition, drug allergies/reactions were not provided. Concomitant therapy included sterile diluent.  Two doses of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U025205, expiration date 13-AUG-2023; strength, dose and route were unknown) may have been administered to the patient inadvertently(product storage error, accidental overdose) on 07-AUG-2022 (also reported as on 07-AUG-2022 and "two months later").   Temperature excursion of this vaccine was minus 80 Fahrenheit degrees for 264 hours. There was no previous temperature excursion. No additional adverse event or product quality compliant was reported.
Extreme abdominal cramps; Moderate testicle pain; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0153) via an unspecified route of administration in the left arm on 16Apr2021 at 17:15 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history included insomnia from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included trazodone (MANUFACTURER UNKNOWN) and zolpidem tartrate (AMBIEN) both for an unknown indication on an unknown dates and unknown if ongoing. The patient previously took cefalexin (KEFLEX) for an unknown indication on unknown date and experienced drug allergy. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732) via an unspecified route of administration in the left arm on 26Mar2021 at 17:15 as a single dose for COVID-19 immunisation. On 18Apr2021 at 09:00, the patient experienced extreme abdominal cramps and moderate testicle pain. The events did not result in doctor or other healthcare professional office or clinic, emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme abdominal cramps and moderate testicle pain were resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Narrative:  The patient received two doses of Pfizer COVID 19 Vaccine in Jan/Feb 2021. The patient tested positive for COVID 19 on 2 Feb 2022. The patient presented to the ED with weakness, fever, and hypoxia. The patient was admitted to the hospital with covid pneumonia and sepsis. The patient was treated with remdesivir and dexamethasone. The patient was discharged on 7 Feb 2022. Reported per EUA.
COVID Vaccine (Comirnaty-PFR 30mcg ) 4/10/21 & 5/1/21. Hospitalized with COVID 2/2/22.
devel vomiting, loss of appetite, restlessness on 20NOV92; temp not taken by mom; taking fluids poorly; cont to be ill; taken to MD; dx tonsilitis given ATB; returned to MD 23NOV w/bronchiolitis;
Parent stated - within 48 hr. developed a reaction to vaccine. At Health Dept. on 9-10-12 for PPD reading. Alerted another nurse to site of varicella vaccine administered on 9-7-12. Red, raised area with approximately 20 blisters - no fever; complained of discomfort.
Felt pain in left arm injection site a few minutes after getting vaccine, Felt tickle in my throat that made me cough, that subsided within a few seconds. With the hour I felt itchy,prickly sensation on scalp,face,shoulders,neck,lower arms,and several spots on my legs. No rash noted anywhere. Day after vaccine felt extreme tiredness and had to lay Down. Slept  From 1 pm to 8 pm. Awake for half hour. Slept again till 1am in morning. Awake till 4am then slept to 8am. Still itchy in scalp,chin,shoulders. Only slight to mild arm soreness at injection site. Just took my usual prescription meds. Did not take any over the counter meds.
experienced nausea, diarrhea and chills about 14 hours after vaccination.  Lasted a couple of hours, and by daytime patient was feeling ok.
Pt. reports LUE arm, shoulder pain with rash at injection site. Left deltoid has localized cellulitic area 8 cm L X 5.5 cm W. temp is 99.5. No other system involvement. Pt. with difficulty lifting left arm to 90 degree active ROM. reported to medical director. Pt started on KEFLEX 500 mg by mouth one tablet every 6 hrs for 10 days. Affected skin rash (immune. site) instructed Dr to go to ER if no improvement in 24 hour (Since she has no PCP for follow-up).
Recieved two doses out of 3 /in 2012; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (first dose of Twinrix series received in 2012) and Twinrix (second dose of Twinrix series received in 2012).   On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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 details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 3rd dose of Twinrix, which led to incomplete course of vaccination and his doctor was trying to give him the third dose almost 10 years later. The reporter did not consent to follow-up.
Syncopal episode, flushed, sweating. Denies medical history, allergies or meds. 1630: BP 117/89, Pulse 82, O2 Sat 99% 1645: BP 129/93, Pulse 88, O2 Sat 99%
Patient reported pain at time of Twinrix injection to left deltoid, radiating to neck.  Pain has continued at left deltoid and at anterior shoulder.  Worsens with certain movements such as abduction and external rotation.  Describes "cold" sensation at deltoid since injection.  Phone call to patient today (4/7/2014).  Continues with pain to left deltoid.  Shoulder pain has resolved.  Still doing range of motion exercises.  To follow-up with primary care provider if pain continues.
Information has been received from a physician concerning his granddaughter (a 15 year old female) with a family history of allergies who was vaccinated with the first dose of GARDASIL in the "last couple of weeks" (approximately January 2009) and had a severe reaction.  The granddaughter was in the physician's office and collapsed.  The granddaughter had a red face and ringing of unspecified ear.  The patient recovered on an unknown date.  The patient sought medical attention.  No additional information was available.
Extreme chills.  Aching all over.  Unable to get out of bed for three days because of the pain and chills.
Received the full dose opposed to the recommended half dose because the vaccine site was only authorized to give full dose. Severe side effects that included chills, muscle aches, headache, fatigue.
Large area of erythema on the arm where DTAP administered.  Mildly painful.  Treated with Ibuprofen.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with improper stored HPV GARDASIL 9 (lot# R009614, expiration date: 30-NOV-2020, strength, dose, frequency and route were unknown) for prophylaxis (Product storage error). The vaccines had temperature excursion of 32 F to 35 F (34.9) for 1 hour 10 minutes and 47 F to 77 F (51.6F) for 1 hour 5 minutes Previous temperature excursion was 32 degree F up to 35 degree F for 3 hours 12 minutes. The call was due to the digital data logger. No adverse event was reported. No product quality complaint involved.
Multiple (about 15) vesicular lesions up to 5mm, pain and itching.
Expired Bexsero administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 20-year-old male patient who received Men B NVS (Bexsero) (batch number 59M3M, expiry date 28-FEB-2023) for prophylaxis.   On 29-MAR-2023, the patient received the 1st dose of Bexsero. On 29-MAR-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired Bexsero administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-MAR-2023 A medical assistant called in to report that a patient was accidentally administered an expired dose of Bexsero.  Information about vaccine and patient was given. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.      The patient accidentally received expired dose of Bexsero, which led to expired vaccine used
Less than 12 hours started cold/flu signs & symptoms runny nose, sore throat, cough. Less than 48 hours was in ER due to difficulty breathing. Have been ill on and off ever since (stomach flu, colds)
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.  The patient's past medical history included Stent insertion NOS (The patient was doing great after receiving the stent.) on 14-Feb-2020. Concurrent medical conditions included Blood pressure high (The patient was suffering with high blood pressure for his entire life and no changes was reported), Heart disease, unspecified (no changes was reported) and Angina pectoris (The patient reported improvement.).  On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved.  mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   The patient had no allergies (medications, food and other products). The patient had both acute and chronic illnesses at the time of vaccination.  Concomitantly, the patient was taking bunch of medicines (no specific medication was reported).  The patient did not seek medical care for the event. It was unknown if the patient experienced a similar event in the past. The patient reported that he received other vaccines during his lifetime (beside Moderna COVID-19) and never had a problem with any of them.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-491816 (Patient Link).
Pfizer monovalent was administered in error. Pfizer Bivalent Omicron Booster was the intended vaccine. This was a vaccine administration error. This client did not complain of any adverse effects or unexpected side effects upon review.
Had vaccinations on 2/4/03. Appearance of raised rashes on body and arms accompanied by light-headedness and fever was noted by mother 2/7/03. No shortness of breath. Came in to clinic 2/11/03 rashes still present but decreased as per mom.
After receiving vaccine, pt walked away. I was alerted that a customer was on the floor across the aisle (approx 40 feet away). By the time I got there, another customer had revived her.   Apparently, she had fainted (the patient who just received vaccine). I stayed with her for maybe 5 minutes, she remained seated, and we gave her water. After a few more minutes she was completely revived and left with no apparent injuries.
Patient received COVID19 vaccine 3/2021, and began having pain at the site that evening. Has progressively worsened over time. Now she has weakness RUE.
incapacitating h/a-sharp pain on rt side of head, followed by spreading pain to back of head; prescribed 2 courses of treatment of methylprednisolone, w/Demerol for pain;
Presented to the ED c/o hemoptysis onset last night with associated fever. Dx COVID-19 pna; tx w/remdesivir, abx, Vit C, zinc; did not require O2; dc'd home
Developlep red lesion on left breast about 1 week after injection then next week developed red raised bumps with white centers all over abdomen progressively spread to back  breasts and neck.
I started having severe shoulder pain 2 days after injection. I believe it?s SIRVA (shoulder I hurt related to vaccine administration ? the pain persisted for over 6 weeks and now I?m still having pain. I have seen my PCP, had x Ray, doing physical therapy and acupuncture, all provided little to no relief.
pt stated she developed a warm, red, swollen area around the injection site about a week after receiving the covid vax.  Pt states on 2/26/2021 she still has a large red swollen area that is warm to the touch. Pt has only been taking Benadryl for her symptoms.
answer from my note in the plan  48-hours- flu like, aches and pains, fatigue, then a few days later more severe, fever tunnel vision, anxiety. A lot of fatigue. Cognitive decline
This spontaneous report as received from nurse practitioner refers to a patient of unknown age and gender. No information provided regarding concurrent conditions and medical history. On an unknown date the patient was vaccinated with GARDASIL (dose, route, lot # not reported). No concomitant medications were reported. It was reported that the vaccine GARDASIL was exposed to 20.5 degree Celsius for 2.5 hours and may have been administered to patients and no adverse effects reported. PQC was not involved. This is one of the 3 report reported by the same reporter (1405USA009701, 1405USA009702). Additional information has been requested.
Patient  with LOC 5-10 minutes after receiving Pfizer 0.3ml IM, unresponsive to verbal stimuli. Patient was responsive to sternal rub, able to transfer to a cot after a few minutes with assistance. BP 110/70 manual, HR 60 radial, oxygen 99% taken on great toe (due to artificial long finger nails).  After 5 minutes on the cot, she was able to sit up and take sips of water. Offered snacks and water in observation area. Grandmother accompanying patient, reassurance provided. safely discharged home.
Patient had a vaso-vagal response but then went into a seizure.  Patient has a history of seizure disorder.
Angioedema.  Started approximately midnight 4/8/2021 and finished spreading approximately 10:00 am 4/9/2021.  Fully resolved 04/12/2021.
A few hours after the vaccine she had a raspy throat that was similar to other allergic reactions she has had in the past.  She took a benadryl, and the next day the throat felt better, but she had swelling in her left arm near the injection site, and under the left axilla.  She took another benadryl and ibuprofen.  The next day the swelling was still present so she went to the walk-in clinic at her PCP office.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Plavix, notes: Taking plavix and statin.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: still test positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral details product COVID 19 Treatment, brand  Paxlovid, treatment start date 30Jun2022, treatment end date 04Jul2022, other medication details: other medication in 2 weeks product Cipro, start date 29Jun2022, stop date 06Jul2022, other medical history: Taking plavix and statin. Symptoms never completely abated but even stronger returned after finishing Paxlovid, still test positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a physician concerning his 13-year-old son who at age 10 in approximately 2003 was vaccinated with a dose of Varivax. "Approximately 10 months ago," in approximately January 2006, the patient experienced a mild case of chicken pox. No medical attention was sought. Subsequently, the patient recovered "after the third day of having the chickenpox". No product quality complaint was involved. Additional information has been requested.
No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 6-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 09-DEC-2022, the patient was vaccinated with the third dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection, in left thigh, lot #U031544, expiration date: 23-JUN-2024, administered intramuscularly for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Data logger was involved.  No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009088: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009878: US-009507513-2301USA009918: US-009507513-2301USA009933: US-009507513-2302USA000403: US-009507513-2302USA000417: US-009507513-2301USA009943: US-009507513-2302USA000452:
Patient felt dizzy after 10 minutes of vaccine administration, patient taken to examination room and remains in supine position, checked  BP -101/62, HR-52, RR-18,  O2 saturation - 98%, skin looked pale and diaphoretic but never had any loss consciousness. Was talking the whole time, reports some nausea , but denies any sob, chest tightness or wheezing. No rashes. Watched the patient for next 30 minutes and patient left home after all the symptoms completely resolved
pt had red hard area @ site of flu inject; fatigue, diarrhea, upset stomach; electrolytes off, weakness, low body temp, shivering;
Day 1: Nausea; Day3: Soreness under arm, low temperature; Day 7: Hard to move arm-felt like pulled muscle under arm-armpit area.  Vomited one.  Swollen area at shot.  Day 8: Saw medical staff, advised sleep, tylenol and vitamin C.  100 temperature.
A non-serious spontaneous report of FLUMIST syringe portion broke and caused town cuts on finger was received from a Registered Nurse in concerning a female adult of unknown age. Medical history and concomitant medications were not reported. On 04-Nov-2008, a nurse was administering FLUMIST to a patient. After removing the divider clip and depressing the plunger to the stopping point, the flange (flare) portion at the top of the barrel broke (shattered) leaving a jagged edge. The jagged edge ripped the nurse's gloves and caused two cuts on her finger. The nurse was concerned that the FLUMIST liquid went into the cuts although there was no liquid on the cuts, and inquired whether there were any safety concerns. The entire contents of the syringe was administered to the patient. The event is considered resolved.
At day 13th after my 1st moderna shot I developed ?Covid arm?/?vaccine arm?. I had a 3 inch swollen pink circle around the injection site of my upper left arm. There was NO itching or tenderness. The pink circle went away on day 15.
Fever and cellulitis of left thigh, beginning 1 day after Pneumovax.  7/6/07 Received hospital medical records which reveal patient experienced redness & warmth over anterior surface of left thigh w/fever 104.8 & diffuse abdominal pain.  Seen in ER & released 5/31 to PCP office who then direct admitted patient 5/31-6/2/07 for IV antibiotics.  Improved slowly.  Abdominal pain attributed to mesenteric adenitis.  D/C to home when afebrile x 24 hrs, cellulitis improved & able to ambulate.  Continued on oral antibiotics & was to have outpatient w/o for possible immuno deficiency. FINAL DX: cellulitis left thigh; recurrent & chronic sinusitis & otitis media; possible immunocomprise.