chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A nurse reported that a male patient received an injection of Prevnar vaccine and developed overwhelming sepsis. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose. The reporter stated that the patient received at least one dose of Prevnar, maybe two. Concomitant medications were not reported. At the end of January 2004, a male patient developed overwhelming sepsis and was hospitalized. On an unspecified date, blood cultures were performed; results were positive. As of 3/8/04, the patient recovered. No additional information was available at the time of this report.
Muscle ached later the day of shot. Limited ability to raise arms. Taken ibuprofen does not help. Family doctor gave pain medicine for back pain, and it is helping.
This report describes the occurrence of hives in a 1 day old male who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  This report was received from the pt's mother and has not been verified by a physician or other healthcare professional.  The subject had no relevant medical history.  Concurrent medical conditions and concurrent medications were not specified.  On 11/06/2002, the subject received his first injection of hepatitis B vaccine recombinant (Engerix-B). Twelve hours later, the subject developed hives.  The hives resolved two days later.  The reporter stated the subject had developed hives after each subsequent injection of Engerix-B and diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) (see report number A0388124A).  The subject was seen by a dermatologist who allegedly reported the hives may be a reaction to the vaccines.  Comment: This report has been linked to report A0388124A due to the same pt and same reporter.
fevers; congestion/stuffiness; This is a spontaneous report from contactable consumer (patient). This consumer reported similar events for two patients. This report is for the first of two patients.   A 77-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 09Jan2021 at a single dose for COVID-19 immunization. Medical history included hypertension. Concomitant medication included metoprolol for high blood pressure. The patient experienced fevers and congestion/stuffiness on 15Jan2021. Patient stated that she and her husband got the first shot of the COVID 19 vaccine on 09Jan2021. She began to run a fever today and has stuffiness. Patient wanted to know are these side effects of the vaccine and would these side effects start so many days after the vaccine. She was told that she can not get tested for COVID because she has had the vaccine. Patient is supposed to go back on the 30th for second shot. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021046472 same reporter, drug, event, different patient
Information has been received from a 66 year old male patient who in January 2012 was vaccinated with a dose of ZOSTAVAX (Merck). His concomitant medications were CELEBREX and LIPITOR. He stated that the nurse practitioner did not give the vaccine as a subcutaneously injection, but rather as intramuscular injection. His major concern was about efficacy. The patient experienced little site pain tenderness which subsided after a few days. Quarterly blood work was performed (result not provided). No further information is available.
THE VACCINE WAS ADMINISTERED TO PT,PRIOR TO VACCINATION SHE CONFIRMED THAT SHE HAD NEVER FAINTED AFTER VACCINES AND THAT SHE HAD NO ALLERGIES AND PT WAS ADVISED TO WAIT IN THE PHARMACY AND WALKED TO THE WAITING AREA AND ENSURED THAT SHE REMAINED SEATED FOR 15 MINUTES.A FEW MINUTES LATER, ANOTHER CUSTOMER CALLED OUT FOR HELP AND STATED THAT SHE WAS HAVING  SEIZURES, PHARMACY STAFF IMMEDIATELY NOTIFIED THE EMERGENCY DEPARTMENT, WHICH ARRIVED WITHIN MINUTES, ACCORDING TO PATIENT SHE PASSED OUT BRIEFLY AND FELL OFF THE CHAIR, SHE DESCRIBED HER SYMPTOM AS "LIGHT-HEADED AND DIZZY,"SHE WAS ABLE TO SPEAK AND STATED THAT SHE HAS IRON DEFICIENCY ANEMIA. SHE ASKED FOR WATER AND WAS PROVIDED WITH SOME.APPROX. 15 MIN LATER SHE WAS EXAMINED BY ER CREW AND LEFT THE PHARMACY SAFELY.
This spontaneous report as received from a healthcare worker refers to multiple patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unknown dates, the patients were vaccinated with improperly stored VARIVAX (Merck) (lot#, expiration date, dose and route were not provided). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a health department nurse concerning a 5 year old female who on 3/1/00 was vaccinated with a dose of varicella virus vaccine live (lot # 631775/1032J). The nurse reported a case of break through varicella between May and July 2004. The case appeared mild. It was unknown if medical attention was sought or if treatment was required. A product quality complaint was not involved. Follow up information was received from the nurse who reported that in late spring of 2004, in approximately June 2004, the patient developed varicella after being exposed at her day care to an infectious, unvaccinated 5 year old male child who had a fever and greater than 100 lesions and vesicles on his face, chest, back, arms, and legs. The patient's mother stated that the varicella was mild with about 15 lesions and no fever. The varicella lasted a few days and the patient recovered. The nurse reported that there were no adverse experiences related to vaccine, but rather evidence that the vaccine prevented the child from developing a severe case of varicella. No further information is expected.
Lot of pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain 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, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Lot of pain). The outcome of the pain was resolved (duration 1 week).   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 1-AUG-2023 This case was reported by a consumer via interactive digital media. The patient have had the 2 vaccinations and got it twice, but it was mild, very painful for a week.; Sender's Comments:  US-GSK-US2023AMR105058:Second dose
Swelling, erythema, warmth left upper arm. 16cm in length not below elbow.
have Covid and have majority of the symptoms; have Covid and have majority of the symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "have Covid and have majority of the symptoms". The patient provided feedback after getting Pfizer Covid vaccine and booster. She has had both vaccines and the booster, and was told if she does get Covid it would not be that bad dimly a headache and sore throat but she definitely wouldn't. It get all the symptoms like someone who is unvaccinated. Well she got Covid and had majority of the symptoms, fever, chills, body aches, headache, sore throat, cough, congestion, extreme tiredness and difficulty breathing with any movement.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient came in and stated needed booster for moderna, had only been 6 months and booster not yet approved for patient type.  Age 77 and a retired Physician but not Immunospressed or other as reported on news .
Per patient she experienced rash on chest and back of legs, c/o of itching. Self medicated with Benadryl with relief.
Symptoms started with general fatigue which lasted all day.  By next morning patient had severe joint pain in elbows, knees, and back and a headache.  Patient was treated with 800 mg Motrin 3 X daily.
Pt was given rotavirus vaccine and within a minute, cheeks became blotchy and a few areas to the trunk became red. Withheld all other vaccines due and reported to provider who examined patient and recommended holding other vaccines at this time and monitoring patient.
fever up to 101.2, chills, achy all over, tired - all day the following day on 7th, nauseas for about 3-4 hours that morning.  achy and tired continued for several days
Bell's Palsy; Left sided droop of her mouth; Slight change in sensation all over her mouth; Unable to tightly close left eye, or able to raise left eyebrow; Slight numbness left side of face; This is a spontaneous report from a contactable consumer (patient).   A 68-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EM9810) in the left arm, at single dose, on 04Feb2021 at 14:15, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included high cholesterol and lichen planopilaris of the scalp, both from an unspecified date. No known allergies were reported. The patient had not experienced Covid-19 prior vaccination. Concomitant medications included ergocalciferol (VIT D); ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS); doxycycline; rosuvastatin and minoxidil. On 04Feb2021, at 17:00, the patient experienced a slight change in sensation all over her mouth with left sided droop of her mouth, unable to tightly close left eye, or able to raise left eyebrow. Also slight numbness left side of face. Emergency room/department or urgent care required. The patient went to Urgency Care diagnosed with Bel's Palsy. Treatment was received: prednisone and valacyclovir. The patient did not recover from the events a time of this report. Post the vaccination, the patient has not been tested for COVID-19.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Flagyl, reaction(s): "known allergies:Flagyl". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative; (01Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: The patient was taking Prozac within 2 weeks of starting COVID-19 treatment also patient had previously received COVID-19 Vaccine. Rebound Covid. Positive test on July 1st after testing negative after treatment on 18Jun, adverse event start date 01Jul2022 and stop date 07Jul2022 with outcome Recovered. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current limited available information, a possible contributory role of the suspect product BNT162b2 to the development of events drug ineffective and COVID-19 cannot be excluded.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 09-DEC-2015 at 17:55, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 6.2 and 4.7 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
On 02/06/2023, I tested positive for COVID-19.  I had had cold symptoms and was very tired the night before. I was exposed at work two weeks prior. I had a sore throat.  I did a telehealth visit on 02/07/2023.  I was prescribed antivirals. I tested negative on 02/11/2023. I tested negative on 02/13/2023.
COVID+ 12/29/2022.  Vaccination status - pfizer x4 + Pfizer BIVALENT x1 Initial hospitalizion 12/29/22-1/6/23: BRIEF OVERVIEW: Discharge Provider: DO  Primary Care Provider at Discharge: MD  Admission Date: 12/29/2022 Discharge Date: 01/07/2023 Discharge disposition: Home Condition on discharge: Stable.   DETAILS OF HOSPITAL STAY:   Generalized weakness [R53.1] COVID-19 [U07.1]   ADMISSION AND DISCHARGE DIAGNOSES:  HOSPITAL COURSE:   Generalized weakness Mechanical fall with right shoulder pain CT head and cervical spine negative for any significant findings Right shoulder x-ray negative for any fracture or dislocation PT and OT initially recommended inpatient rehab but patient improved and went home    COVID-19 infection Currently on room air Supportive care   Chronic diastolic heart failure Paroxysmal Afib Hypertension Dyslipidemia Continue home meds of Norvasc, metoprolol On anticoagulation with Eliquis   Cerebellar ataxia Continue home dose of Sinemet Follows outpatient with Neurology   Mild neurocognitive disorder Anxiety and depression Morbid obesity and deconditioning Continue Celexa  Re-admission 1/7/23-1/12/23- Hospital: BRIEF OVERVIEW: Discharge Provider: MD Primary Care Provider: MD Admission Date: 1/7/2023 Discharge Date: Jan 12, 2023   Active Hospital Problems   Diagnosis Date Noted POA ? Weakness 12/29/2022 Yes ? Physical deconditioning 12/30/2022 Yes ? COVID-19 virus infection 01/07/2023 Yes ? Cerebellar ataxia (HCC) 10/22/2019 Yes ? Essential hypertension   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Weakness generalized [R53.1] COVID-19 virus infection [U07.1]   HOSPITAL COURSE: 80 y.o. male who presents today with weakness. Of note, patient was admitted 12/30-1/6 for similar complaints and just discharged yesterday. Wife states that once discharged yesterday and getting out of car had a fall. Were able to get him up with assistance of son and get him into the house. Later when trying to get into bed, slipped onto floor and needed help to get back into bed. May have fallen again overnight out of bed. Wife states that patient had a total of 4 falls since discharge. Wife states that before COVID infection, was walking pretty well was not having falls. Thinks falls are just because he is having significant amount of lower and upper extremity weakness. Does not think he is losing consciousness during falls, but did not witness a couple of the falls and just found him later laying on floor.    Patient otherwise hemodynamically stable. CMP and CBC grossly unremarkable. Patient saturating well on RA without respiratory complaints. Patient admitted to hospitalist service for repeat PT/OT evaluation. PT/OT recommended SAR. Patient was discharged on 1/12/2023.    Discharged to rehab 1/12/23-present
Patient reported to me over the phone tonight that she is experiencing swelling and extreme soreness in her left arm. She stated that her bicep area is swollen down to her elbow and that her arm is sore so that she cannot raise it above her head. She did not report any hives/rashes, trouble breathing, swelling of lips, tongue, throat, etc. I advised her to continue to watch for these signs/symptoms. I advised her to take TYLENOL for the pain.
PT WAS ADMINISTERED A 2ND MODERNA BI-VALENT BOOSTER.
headaches / can headaches last this long after the shot?; fever; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th September 2020, the patient received the 1st dose of Shingrix. In September 2020, immediately after receiving Shingrix, the patient experienced headache and fever. On an unknown date, the outcome of the headache was not recovered/not resolved and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the headache and fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication.  The patient received the first dose and every day since then the patient experienced headache, some fever.  The patient had no fever the past 3 days but still headaches on the day of reporting. The reporter asked could headaches last this long after the shot.
This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL PAIN (Tremendous/severe pain in right gluteal/ Can not bend down/over/Difficulty getting off sofa), SOMNOLENCE (All she wanted to do was sleep), PERIPHERAL SWELLING (Arm was swelling), ERYTHEMA (Arm was red) and PAIN IN EXTREMITY (Arm was painful) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A and 088Z21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Ankle sprain in 2016.   On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Oct-2021 at 7:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Oct-2021, the patient experienced MUSCULOSKELETAL PAIN (Tremendous/severe pain in right gluteal/ Can not bend down/over/Difficulty getting off sofa), SOMNOLENCE (All she wanted to do was sleep), PERIPHERAL SWELLING (Arm was swelling), ERYTHEMA (Arm was red), PAIN IN EXTREMITY (Arm was painful), FEELING ABNORMAL (Feeling bad/ Whole life has turned upside down), PAIN (Entire body ached), FEELING COLD (Feeling of being cold), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Just can't function), THINKING ABNORMAL (Not speaking or thinking clearly), SPEECH DISORDER (Not speaking or thinking clearly), CHILLS (Chills) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose > 36 days after first dose). On 07-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose > 36 days after first dose) had resolved. On 08-Oct-2021, PAIN (Entire body ached) had resolved. At the time of the report, MUSCULOSKELETAL PAIN (Tremendous/severe pain in right gluteal/ Can not bend down/over/Difficulty getting off sofa), SOMNOLENCE (All she wanted to do was sleep), PERIPHERAL SWELLING (Arm was swelling), ERYTHEMA (Arm was red), PAIN IN EXTREMITY (Arm was painful), FEELING ABNORMAL (Feeling bad/ Whole life has turned upside down), FEELING COLD (Feeling of being cold), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Just can't function), THINKING ABNORMAL (Not speaking or thinking clearly), SPEECH DISORDER (Not speaking or thinking clearly) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Sep-2021, X-ray: abnormal (abnormal) diagnosed  with tendonitis.         On 23-SEP-2021, patient had irritated her foot so she visited orthopedic doctor and she confirmed that the pain is 100 times worse what she is experiencing after she had gluteal pain.She is healthy and  works out 6 times a week and her ankle only hurts if she work out too hard. No treatment medications were provided by the reporter.
On 4/5/2021 at 9:30pm chills started followed by body aches, joint aches all over, swollen fingers and sore finger joints with difficulty to make a fist/to open a water bottle, fever 100.8, headache with flashes of sharp pain.  I took Advil at 5:30am. Got out of bed  around 8am.  On 4/6/2021 at 2:00pm chills, body aches and fever 101.7 came back. I took Tylenol at 5:30pm with no relief and then took Advil at 6:30pm and got  relief. My body  was sore I think from laying down so much and I was tired and fatigued for several days. However, on 4/5 I slept from 11pm-1am and then on 4/6 from 2pm-4pm and went to bed at 11pm that night.  Sore arm. Some site redness.  Sore arm with first dose too.
Woke up Sat am (IZ give Thurs. 4pm) with fever (did not take temp), chills, achiness all over, extreme fatigue-slept most of Sat.
5/9 - Received vaccine. Pt experienced chills day of administration. 5/10 - Redness appeared below injection site; painful to touch; warm to touch; no itching; not around inj site. Dr prescribed Abx for possible infection.
Patient complained of pain at time of injection. Later, she reported a small nodule at the site that showed erythema, itchiness, and pain when at rest. There was no blood loss so I ruled out a hematoma (plus, it likely would not have been itchy). Additionally, SIRVA is unlikely since it was far enough from her acromion process/capsule and she retained full ROM. My unofficial diagnosis is an unintentional subcutaneous injection (patient is very overweight and her anatomy was hard to visualize) leading to localized chemotaxis. Incidence is around 2 or 3 per 10,000 and is mostly seen with SQ injections. In the future, we will use 1.5 inch needles and will use better techniques to visualize her anatomy. Despite the fact that this is not life-threatening and most cases resolve spontaneously without intervention I instructed her to reach out to her provider for f/u.
8 Days from MMR injection Patient developed fever of 102.8 and had multiple joints hurting ( back and neck the worst).  11th day couldn't move neck.  BP elevated due to pain and erythrocyte sedimentation rate elevated at 45.  Pt seen in family medicine clinic on 12th day from vaccine and diagnosed with severe neck spasm with unkown etiology.  Pt seen by neurosurgeon afterwards who had an MRI done of the patients c-spine and neck.  Neurosurgeon felt her symptoms of neck and back pain were due to MMR vaccine adverse reaction.  Patient's symptoms resolved without long term problems and at the date of this report is feeling well. Patient unfortunately missed two weeks of work due to the above pain syndrome.
Erythematis rash after last inject which resolved.  1 wk later, developed a diffuse gastroenteritis consisting of emesis, nausea, vomiting to the point where can no longer hold fluids.  Adm to hosp for IV alimentation. Rec'd steroid too
Pt reports redness, swelling, pain at site. Also reports nausea and vomiting since she received medication (vaccine). Pt has been using Tylenol for pain.