chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient passed out; hit her head; concussion; This spontaneous report has been received from a physician via a company representative referring to a 12 year old female patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.      On 16-SEP-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # S022598, by intramuscular route (strength, dose, frequency, and anatomical location were not provided) for prophylaxis. Other suspect therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus, meningococcal vaccine (unspecified), and influenza virus vaccine. On the same date, the patient passed out and hit her head (loss of consciousness, concussion and head injury). The outcome of loss of consciousness, concussion and head injury was unknown. The causality assessment was not provided.  Upon internal review, loss of consciousness was determined to be medically significant. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022598; expirationdate: 25-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
woke up with trouble breathin like couldn't get enough air into lungs,  happened when sleeping  for several nights
swollen lump in left side of neck near where neck meets shoulder, may be lymphadenopathy.; swollen lump in left side of neck near where neck meets shoulder, may be lymphadenopathy.; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 21Jan2021 09:30 (Batch/Lot Number: EL3247) as single dose for covid-19 immunization at a workplace clinic. The patient has no medical history. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and has not received any other medications within 2 weeks of vaccination. The patient experienced swollen lump in left side of neck near where neck meets shoulder, may be lymphadenopathy on 26Jan2021 20:00 and resulted in doctor or other healthcare professional office/clinic visit. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was not recovered.
Pt has a red irregular rash at the injection site that is hot to the touch. The rash seems to be growing. Pt has been keeping an eye on it and has an outline on the rash to see if it gets bigger.
This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 01-MAR-2018, the patient was vaccinated with RECOMBIVAX HB for prophylaxis, lot number N022563 with expiration date of 10-MAY-2020 (dose and route of administration were not reported). The patient was inadvertently administered the dialysis dose and the patient was not on dialysis and was not considered to be pre-dialysis. No adverse effects were reported.
she hasn't been eating like she should; lost eye sight for 5 minutes, everything was grey; could hear her niece, but that her niece sounded far away; very nauseated/wanted to throw up but couldn't; This is a spontaneous report from a contactable consumer, reporting for herself. A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9265), via an unspecified route of administration at the left arm on 29Jan2021 14:00 at a single dose to prevent getting COVID-19. Medical history included cholesterol, high blood pressure, arthritis, medications for her heart, and medication for her stomach. Concomitant medication included amlodipine for high blood pressure and atorvastatin for cholesterol. The patient has been on amlodipine in a good while, 7-8 years and atorvastatin for 5 years. The patient had the COVID shot on Friday, 29Jan2021 at 14:00, and about 4 hours afterward, she had a bad experience. She became very nauseated and lost her sight for 5 minutes. Everything was grey. She was wondering if there is anything she can take afterward. She was scheduled for her next one on 19Feb2021. She was wondering if she will experience the same thing. She has lost about 11 pounds because she has been on a diet. She gave up sugar. After getting the vaccine, she was on her way back. She began to feel very nauseated in the car. Then, all the sudden she wanted to throw up, but couldn't. She couldn't hear her niece or say anything to her. She clarified she could hear her niece, but that her niece sounded far away. She couldn't respond. She rolled the window down to get air in her face. She hadn't eaten. In about 25-30 minutes got better. Since then, she hasn't been eating like she should, so she was still a little nauseated. It has improved though. She got the vaccine in her left arm.  Her right arm is mostly metal. She decided to get it because she is over 70 and wanted to prevent getting COVID-19. It was also reported that she was also on an arthritis medication, medications for her heart and a medication for her stomach. She has had no problems with those medications though. The patient underwent lab tests and procedures which included weight: lost on an unspecified date. She has lost about 11 pounds because she has been on a diet. She gave up sugar. The outcome of the events "lost eye sight for 5 minutes, everything was grey", "could hear her niece, but that her niece sounded far away" and "very nauseated/wanted to throw up but couldn't" was recovered on 29Jan2021 while the outcome of all other events was unknown.
Myopericarditis, diagnosis by clinical exam, ECG, Serum Cardiac Marker Elevations, and Echocardogram.
Pt recvd DTP/HIBTITER following day had fever of 105.6 but no other sx; seen in office; tx included & sponge baths; recovered w/o residual sequelae;
This spontaneous case, initially received from other non-health professional on 26-Oct-2018, concerns a female patient of an unspecified age. It was reported that whenever flu vaccine was drawn up, it leaked out from the rubber stopper (explicitly coded as product leakage). One of the nurses noticed when they popped the secured lock off the vial the rubber stopper was dented in and off a little. The nurses advised when they removed the hard cap and stuck the needle in the middle, there was a corner on the top where the rubber stopper was dented in causing a hole (explicitly coded as product closure issue) where the medication would leak. About 5 doses were drawn out of 10 doses in the vial. The vials leaked and only 4 vials were leaking so far. On 03-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location:deltoid, batch number: 252234 and expiry date: 30-Jun-2019] from the leaking vial (explicitly coded as drug administration error). No adverse events were reported after administration of the vaccine. This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding PTC reference number was 1034101. Bases on the QA investigation report, it was concluded that FLUCELVAX Batch 252234 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process. A known trend was identified for the FLUCELVAX batches from the 2018/2019 FLUCELVAX commercial season for vials leaking at the stopper during dosing. The review revealed that the complainant was adding air to the vial prior to extracting doses and was inverting the vial when withdrawing the needle from the stopper. It is known that the addition of air to the vial can over pressurize the vial and cause leaking. In addition, inverting the vial while trying to extract a dosage can increase the potential for the vial to leak. The root cause for this investigation was found to be user-improper handling (explicitly coded as wrong technique in product usage process). The reporter assessed this case as non-serious. This case is linked to 201804823 due to the same reporter. Follow up report received from QA department on 19-Nov-2018: The QA investigation report stated that, the root cause for the leaking FLUCELVAX MDV of Batch 252234 was due to user or improper handling. Added new event (wrong technique in product usage process) in event tab. The narrative was amended accordingly.
Information has been received from a woman in a doctor's office concerning a 43 year old white female with an allergy to PCN and no pertinent medical hx who on 13OCT2003 at 2:00pm was vaccinated IM in the upper right arm with a first 0.5 ml dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant medication. There was no illness at the time of vaccination. The reporter indicated that the pt developed a localized injection site reaction to the vaccination. The pt experienced redness and inflammation at the injection site. Unspecified medical attention was sought and a prescription drug was not required. A product quality complaint was not involved. Follow up information was received form the woman in the doctor's office which indicated that on 13OCT2003 at 4:00pm, the pt's RA developed terrible pain, swelling and redness. A doctor visit was required and the pt subsequently recovered from the right arm pain, swelling and redness.  The records of testing prior to release of this lot have been checked by QA and found be to satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  No further information is expected. The reporter also indicated that one pt experienced a swollen tongue after therapy with pneumococcal 23v polysaccharide vaccine and that two pts experienced redness and inflammation at the injection site after therapy with pneumococcal 23v polysaccharide vaccine.
Case number PHEH2015US024824 is a spontaneous report initially received from a health care professional on 23 Nov 2015. This report refers to a 44 year old male patient. Medical history was not reported. The patient was vaccinated with unknown vaccine and it was tolerated. Concomitant medications was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) multi dose vial (MDV) intramuscularly into left deltoid at a dose of 0.5 ml on 23 Nov 2015 at 11:55 am. It was reported that the vaccine administered was out of temperature range at 46.8 degree Fahrenheit for 24 hours. The case was reported as non-serious. No adverse reaction was reported following this maladministration. Follow up report received from other health care professional on 21 Jan 2016: Added batch number, vaccination site and vaccination time.
Headache, chills, nausea, dizziness, extreme weakness, orbital pain.
I asked the patient if he had had any vaccines in the last 2 weeks, he answered, "no." I went to input his information in to MIIX and he had gotten pfizer on 04/01/2021 at a different location.
THE NEEDLE WAS APPARENTLY LOOSE WHEN I I INJECTED THE VACCINE INTO HIS LEFT DELTOID, SOME OF IT RAN OUT BETWEEN THE  SYRINGE & NEEDLE AND DOWN HIS ARM. Agree with Assessment & plan
Left arm became red, hot, itchy & hard to touch 2 days after vaccinations. Allergic reaction was diagnosed, patient treated with oral BENADRYL which lead to resolution of symptoms.
Patient explains that she has pain in her left shoulder, and decreased range of motion. She explains that she saw her PCP who did an x-ray of her left shoulder which showed a bursitis. Patient explains that she did a course of oral steroids. Her range of motion to that shoulder has returned to normal, she continues to have some pain, which she says she takes Motrin for.
Consistent headaches, at various degrees of severity, started about a week following the second injection. The headaches were around the monthly period but those usually last for no more than a day, this time they've been going on for a week.
p/vax pt had local red swelling 5x8 cm around area of inj
Information has been received from a health professional concerning a female who was vaccinated with the first dose of GARDASIL (lot number not reported), 0.5ml via intramuscular. There were no concomitant medications reported. No pertinent medical history reported. A nurse reported that the patient received the first dose of GARDASIL and experienced muscle pain in her lower back and her legs. No further information provided. On unspecified date, the patient sought unspecified medical attention. Additional information is not expected.
Information has been received from a medical assistant concerning an elderly female (age not reported) who on 18-DEC-2006 was vaccinated with Pneumovax 23 (lot # 651404/0352F) 0.5 ml.  On approximately 18-DEC-2006, the patient experienced redness and swelling of the injection site, fever of 102-103 F, insomnia, and sweating.  The patient sought medical attention.  The patient was treated with BENADRYL.  The outcome of the events was not reported.  Additional information has been requested.
Patient given vaccine on 8/12/09. Hospitalized for respiratory illness/pneumonia 8/27-9/1, given steroids during hospitalization. Rash developed on 9/1/09, day of discharge. Saw patient on 9/2/09, started on oral acyclovir. DOH and hospital notified.  11/13/09 Death Certificate received DOD 11/2/09 Cause of Death: Multisystem Organ Failure, Acute Respiratory Distress Syndrome, Varicella Pneumonitis.   12/9/09 DC summary received for dates 8/27/09. DX: respiratory difficulty, bronchospasms, hypotonia. Chief c/o respiratory distress, URI x1day, fever, tachypnea, retractions. Caretaker reports pt having difficulty breathing, fever, irritable. Assessment, (+)fever, grunting, retractions, hypotonia, O2 sat 91% on 3LNC. Speech and swallow eval: oropharyngeal dysphagia. Pt improved over 3 days, stable at dc.  ER/hospital 9/5/09 to 10/29/09. DX: muscular weakness disorder, viral pneumonitis, varicella. Resp distress, fever. Parent states varicella vax 8/12/09. Varicella skin rash formed 8/31/09.EMS presented pt. to ER. Assessment: stridor, rash, fever, mild distress. Pt admitted and following day resp distress increased, grunting, increase in fever 103F, pt found to be irritable, O2 sats 92% w/ O2 therapy. Tylenol given, within 30 min temp 104.5F. One hr later pt HR 220-240bpm. Pt later stabilized but prognosis guarded.
Information has been received from a mother-in-law concerning a 32 year old female who in approx. 1977 was vaccinated with varicella virus vaccine live at approx. 8 years of age. Subsequently, in approx. 1977, the pt developed acne that has lasted 24 years. The mother-in-law wondered if "this is why her daughter-in-law has kept a bad case of acne in the face. The pt did not seek medical attention. Additional information has been requested.
Five months after vaccine had a UTI, Sinus Infection and Vertigo. Was prescribed Levofloxacin for UTI and got better soon. Doctor gave me a shot for Vertigo. Everything cleared up except having the Sinus Infection for about a month.
Extreme soreness and discomfort at base of skull, sinus cavity?s below eyes felt inflamed and dried, unable to sleep or get comfortable, alternated between feeling chills and feeling overheated, vomiting
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Concurrent condition and medical history were not reported. On an unspecified date, the patients were vaccinated with improperly stored doses of VARIVAX (Lot #s K021487, expiration date 03-NOV-2016; L008271, expiration date 11-MAR-2017) (Strength, dose and route were not reported). Concomitant medications were not reported. No adverse reactions were reported. This is one of several reports from the same source. Additional information has been requested.
sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site arm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.    Concurrent medical conditions included Immunocompromised.  On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore injection site arm). At the time of the report, VACCINATION SITE PAIN (sore injection site arm) outcome was unknown.  Concomitant medication of the patient was not reported.  The patient did not remember on which arm he received his Moderna COVID-19 vaccine.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-467633, MOD-2021-435280 (Patient Link).
Patient received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
Syncopal Episode, approximately 1 minute after receiving the vaccine.  Patient awoke immediately on his own after falling off the exam table.  No injuries were sustained.  Patient was stable soon after and left with mother without any further incident.
Patient admitted for fatigue and AKI thought to be due to COVID infection and poor oral intake. She was started on IVF hydration with resolution of AKI. Patient remains on room air without resp symptoms of COVID. She is stable for discharge home an encouraged to increase oral intake and ensure hydration.    Clinical Summary   Assessment and Plan Patient is a 66 y.o. female patient of DO with history of mitral regurgitation status post mitral valve replacement, valvular atrial fibrillation, hyperlipidemia, anxiety, hypothyroidism, hypertension, GERD, and CKD stage III.  She is admitted as a transfer from freestanding for AKI and fatigue in the setting of recent COVID diagnosis.   AKI-resolved Metabolic acidosis-resolved Suspect most likely prerenal in the setting of COVID-19 and decreased intake.  Continue IV fluids-change to bicarb infusion Avoid nephrotoxins Held home hydrochlorothiazide and lisinopril S/P IVF   Covid-19 Virus Infection Date of onset of symptoms: 2/5/2023 Symptoms present on admission: Malaise Date of covid positive test: 2/6/2023 Vaccination status: Only received Johnson & Johnson vaccine Imaging: Chest x-ray 2/9/2023 unremarkable Oxygen requirements on admission: None Current oxygen requirements: None Medical therapy: Not indicated Anticipated special isolation end date: 2/14/2023  Hypertension Held home lisinopril and hydrochlorothiazide in the setting of AKI  Held home diltiazem in the setting of soft BPs on admission and poor intake Continue home metoprolol Restart BP meds when able DC back on home meds  Mitral valve insufficiency status post replacement Valvular atrial fibrillation Continue home Coumadin (takes 3 mg daily) INR goal 2.5-3.5, pharmacy to dose Continue home metoprolol and holding home diltiazem as above  GERD Continue PPI  Hypothyroidism Continue home Synthroid
No Adverse Event; Received first dose on 29JAN2021 and second dose on 10MAR2021/40 days after received the Second dose; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose on 29JAN2021 and second dose on 10MAR2021/40 days after received the Second dose) and NO ADVERSE EVENT (No Adverse Event) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 041L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose on 29JAN2021 and second dose on 10MAR2021/40 days after received the Second dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose on 29JAN2021 and second dose on 10MAR2021/40 days after received the Second dose) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.            No concomitant information provided.  Patient has received Moderna covid-19 vaccines by injection to the left arm on 29JAN2021 (expiration date 31JUN2021).  Patient has not had any reactions with previous doses.  No treatment information provided   This case was linked to MOD-2022-662394 (Patient Link).
Arm hurt and alot of swelling and redness where shot was given. Got red and hard like a baseball got very large. It really hurt and stayed that way for about two weeks, than the hardness and the big red spot went away. I still have alot of pain in tha area of the shot. Pain inside my arm, when I more it lift it out and away from my body. I cannot lay at night on my arm it becomes very painful. When I even put a coat on I cannot lift my arm high enough without alot of pain. This is my left arm. I can still see where the needle was put in. I am in alot of pain and it has been about two months. I cannot use my arm it is too painful.
Started having some itching in the left eye and then 2 days later developed a rash left forehead consistent with shingles.
PATIENT WAS 5 YEARS OLD AND RECEIVED COMIRNITY 0.3MCG/0.2ML DOSE. NO ADVERSE OUTCOMES HAVE BEEN DOCUMENTED.