chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 30-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB which had the lot # reported as N00236, expiration date 24-OCT-2019, lot # N000235, expiration date 26-OCT-2019, lot # N003536, expiration date 02-NOV-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32 degrees Fahrenheit and the highest was 54 degrees Fahrenheit for 49 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Follow-up information has been received from a physician on 16-OCT-2017 to an unknown number of patients of unknown gender and age. The patients' concomitant medications, pertinent medical history, drug reactions or allergies were not reported. Since 29-APR-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M046140, expiration date 27-SEP-2019, dosage information and route were not provided) for prophylaxis. Additionally, it was reported that the lowest temperature was 47 degrees Fahrenheit and the highest was 49 degrees Fahrenheit for 16 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Follow up was received from the physician on 30-OCT-2017, regarding a 6-month-old patient, who on 05-AUG-2017, received a dose of improperly stored PEDVAXHIB injection, lot # N000235 with expiration date on 26-OCT-2019. The vaccine underwent a temperature excursion of 32-49 degrees Fahrenheit for 492 hours. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1709USA012766: US-009507513-1709USA007325.
Moderna Dose 1 2/5/21 (016M20A) Moderna Dose 2 3/5/21 (013A21A) Pfizer Dose 3 12/17/21 (NA) COVID Positive 3/25/22  3/23/22: Patient is a 75 year old male who presented to ED with complaints of right hip and knee pain. Patient reports sustaining a fall 4 days ago. He was walking outside to his truck when he tripped on the sidewalk and fell onto his right side. He denies hitting his head or loc. He has been ambulating with a walker and cane due to pain in his right lower extremity. Denies chest pain or shortness of breath. He has a past medical history of COPD on 2L NC at night, CAD s/p PCI, hypertension, hyperlipidemia, type 2 diabetes mellitus, anxiety/depression, tobacco use and AAA s/p repair.   Vitals stable on arrival. Labs fairly insignificant. CT head no acute intracranial abnormality. known calcified aneurysm in the region of the left MCA trifurcation. right knee xray soft tissue swelling without acute fracture. Chest xray worsening interstitial lung disease. xray of right hip showed subcapital right femoral neck fracture. Morphine 4 mg given in ED.  3/29/22: Patient is admitted to the hospital, started on pain management and orthopedic surgery consult is requested patient is seen by Dr, and had right hip repair with insertion of cannulated screws x3 on 03/23/2022. Postoperative pain management and DVT prophylaxis per done per Orthopedic Service recommendations.  His COVID-19 test is returned positive, patient was given IV remdesivir and IV dexamethasone.  Chest x-ray does not show infiltrate, patient does have a oxygen at home 2 L.  Has been afebrile.  PT and OT evaluation is done and patient is discharged to skilled nursing facility in stable condition.
Accidental administration of Pediarix instead of Infanrix to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 6-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number X9HS4, expiry date 25-MAR-2024) for prophylaxis.   Concomitant products included POLIO VACCINE and HEPATITIS B VACCINE.   On 20-SEP-2023, the patient received Pediarix. On 20-SEP-2023, an unknown time after receiving Pediarix, the patient experienced wrong vaccine administered (Verbatim: Accidental administration of Pediarix instead of Infanrix to a patient).  The outcome of the wrong vaccine administered 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: 20-SEP-2023 The reporter reported that the patient accidental received Pediarix instead of Infanrix, which led to wrong vaccine administration. The vaccine administration facility was the same as primary reporter. The reporter stated that pediarix was the patient's 3rd dose of DTaP, Hepatitis B and IPV. The reporter consented to follow up.
Had increased head pain after clinic visit at approx 9;00 pm, (or possibly later) experienced several non-epileptic form seizures for 30 secs -> 2 minutes. Had fatigue until head pain subsides (took 600 mg Ibuprofen; no relief)
Headache. Per dad patient called him he has a headache this morning and feels clammy advised dad as per vaccine reaction protocol advised dad per MenB VIS headache is a side effect of vaccine to stay home rest and give TYLENOL for HA rest push fluids no fever no nausea if headaches becomes worse high fever to be seen dad agrees.
Feeling foggy immediately after. Headache Chills Body aches so bad High fever Shaking uncontrollably
Onset of seizures 8 1/2 hr after vaccinations. Two seizures at home two seizures in ER. Treated with acyclovir until HSV PCR came back and was negative. Treated with ceftriaxone for 98 hrs. Pt had fever upon arrival to ER of 101.8. Seizures were described as tonic clonic and lasting 20 - 30 seconds. 4/20/06 Received medical records from hospital which revealed patient had fever & tonic clonic sz's witness in ER in addition to 2 sz at home.  Patient's father had cold sore & patient had vesicular rash on chin & herpes encephalitis was suspected however, septic w/u & all c/s were neg.  Dx: complex febrile seizure/ss
Experienced abrupt, very high blood pressure with no history of high blood pressure. Onset on Tuesday 10/19/2021 via a blood pressure monitor at a grocery store after experiencing symptoms.  Went to Emergency Department where blood pressure was confirmed and symptoms worsened.  IV Benadryl and Reglan.
Pt developed 9cm area of induration 40 hours after administration of Menactra only to mid outer right arm. Menactra administered on 5/2/06 at 16:00 PM. Reaction documented 5/4/06 at 08:00 AM.
it worsened my 22 year old son's eye sight; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the parent.  A 22-year-old male patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VISUAL ACUITY REDUCED (disability), outcome "unknown", described as "it worsened my 22 year old son's eye sight". Clinical course: Reporter believed it worsened both her 22 year old son's eye sight and her eye sight.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. In particular, patient's medical history and concomitant medications are not reported. However, a possible contributory role of suspect vaccine bnt162b2 to the reported event of Visual acuity reduced cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300356674 Same reporter/ SD/ AE, different patients.;US-PFIZER INC-202300360600 Same reporter, different patient/ AE (LOE);
Patient passed-out for about 1 minute after about 5 minutes after vaccine was given. When she recovered, her blood pressure and pulse were normal. Customer dizzy and nauseous. Paramedics picked-up the patient.
Fever (up to 101F recorded); chills; wet cough; vomiting; sneezing; minor aches; sensitivity to sound/light; sensitivity to sound/light; Other vaccine same date product= Flu; Other vaccine same date product= Flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Nov2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 32 years for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 03Nov2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE (Lot Number: FF8841)), administration date: 08Dec2021, when the patient was 31-year-old, for covid-19 immunization; BNT162b2 (DOSE 2, SINGLE (Lot Number: EN6199)), administration date: 11May2021, when the patient was 30-year-old, for covid-19 immunization; BNT162b2 (DOSE 1, SINGLE (Lot Number: EN6199)), administration date: 19Apr2021, when the patient was 30-year-old, for covid-19 immunization.  The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 03Nov2022, outcome "unknown" and all described as "Other vaccine same date product= Flu"; PYREXIA (non-serious) with onset 28Dec2022, outcome "recovering", described as "Fever (up to 101F recorded)"; CHILLS (non-serious) with onset 28Dec2022, outcome "recovering"; PAIN (non-serious) with onset 28Dec2022, outcome "recovering", described as "minor aches"; HYPERACUSIS (non-serious), PHOTOPHOBIA (non-serious) all with onset 28Dec2022, outcome "recovering" and all described as "sensitivity to sound/light"; SNEEZING (non-serious) with onset 28Dec2022, outcome "recovering"; VOMITING (non-serious) with onset 28Dec2022, outcome "recovering"; PRODUCTIVE COUGH (non-serious) with onset 28Dec2022, outcome "recovering", described as "wet cough". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, chills, productive cough, vomiting, sneezing, pain, hyperacusis, photophobia.
Weakness; Dizziness; Diarrhea; This spontaneous case was reported by a non-health professional and describes the occurrence of ASTHENIA (Weakness), DIZZINESS (Dizziness) and DIARRHOEA (Diarrhea) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced ASTHENIA (Weakness), DIZZINESS (Dizziness) and DIARRHOEA (Diarrhea). At the time of the report, ASTHENIA (Weakness), DIZZINESS (Dizziness) and DIARRHOEA (Diarrhea) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Treatment information not provided. List of concomitant medication were not given.
On night of vax pt's burning up t103 despite APAP & wimpery until AM;
Had vaccine on 1/11/21, did not have any problems for at least a week or two, then it was a little twinge, and it seems that every day it gets a little bit worse.  More sore every day up to the shoulder bone, down to the elbow in the muscle.  The bone at the top of her shoulder hurts as well.  Thought it was going to go away and after 3 weeks is still having these symptoms.  Takes an aspirin once a day, and Ibuprofen on occasion for the pain, but nothing more.  The pain is not so bad that she can't stand it, but it's uncomfortable and feels like it is in the bone itself.
I believe that I was exposed in a breakfast room in a hotel in country from 07/01/2022-07/03/2022. On 07/03 we flew from country to city. Around 8pm I noticed a sore throat. The next day, I had a slight fever of 99 degrees or so. I took an at home COVID-19 test which was positive. I tried to get in touch with an Urgent Care, but as it was 07/04/2022, no one was open. I was able to get in touch with my doctor on 07/05/2022. I had basically slept for roughly 24 hours. On 07/05/2022, I got a prescription for Paxlovid and I began taking it that evening. I took that for the recommended 5 days. During the course of the antiviral, I had a sore throat, elevated temperature for around 2 days, I was getting a lot of infection out of my sinuses but nothing in my chest. The infection was gone by the end of the Paxlovid course. After the Paxlovid course was complete, the infection returned for 2 days with no noticeable temperature. On 07/14/2022, I tested negative for COVID-19.
I started feeling achy in my shoulders and neck, and my injection site is swollen, red, itchy and feeling bruised.  Today I feel slightly better, but I was running a low grade fever of about 100 when I got home in the afternoon. My symptoms have not yet cleared up today, still sore, itchy and red patch on the arm.
As per Emergency Room note on 10/11/17: States rash began and itchy welts to extensor surfaces of b/l arms and thighs then progressed to larger, raised lesions. Rash has not resolved but new areas continue to appear, more macular, to back of neck, sacrum, and posterior knees. Patient denies pain, denies fevers. Did have isolated episode of dyspnea 3 days ago with mild cough but stated this has since resolved. No headache, nausea, vomiting, diarrhea, dysuria, or arthralgias. Rash: Somewhat atypical and prolonged for allergic reaction but discussed with derm, who believe allergy plausible and possibility prolonged given older age of patient. Also on ddx would be infectious causes or even paraneoplastic syndrome, though these are far less likely. For now treating allergy: Cetirizine 5m daily until rash resolves, Triamcinolone Lotion to affected skin 0.1% BID, Sarna QID as needed, PREVNAR added to Allergies in chart, f/u PRN if no improvement or worsening. Rash and Urticaria Pruritus. Triamcinolone BID, Cetirizine 5 mg every day, Camphor/menthol PRN.
Slight headache right after. I took Tylenol.   After 12 hrs, rash on chest, stomach and legs.  I took Benadryl. 2nd Day, Next morning: headaches.  Tylenol.  Foggy and not clear headed. L arm hot and hurts, Hip, knee and ankle on L side painful.  Very tired.  Rash is gone. Mid day: anxiety and feeling down.  Called Dr. and got nurse and then called therapist.   headache still continues. I took a nap, I never take naps unless very sick. Eve: Rash came back.  Benedryl  Headache. Tylenol  3rd day: Diarrhea.  headache, still foggy and tired.
Discharge Provider:  MD Primary Care Provider:  MD Admission Date: 9/20/2022 Discharge Date: Sep 22, 2022  PRESENTING PROBLEM: Pneumonia due to COVID-19 superimposed bacterial pneumonia Chronic obstructive pulmonary disease exacerbation Dehydration Orthostatic hypotension   HOSPITAL COURSE: Patient is a 71-year-old man with CHF with preserved ejection fraction, chronic obstructive pulmonary disease, OSA and some cognitive impairment who presents to the emergency department with 3-4 days of upper respiratory symptoms along with decreased oral intake, diarrhea, fevers, sweats and chills.  He was unable to eat much will last several days so decided to go to the doctor's office.  He was trying to get in to the doctor's office and almost passed out.  He was noted to be hypotensive in his primary care doctor's office and was sent to the hospital for evaluation.  He was given a 1L of IV fluids.  When he sat up at the edge of bed his systolic blood pressure dropped to 77. He felt lightheaded.  His mid to the hospital for treatment.  He had a CT angiogram thorax which showed bilateral pneumonia.  He was started on ceftriaxone azithromycin.  It appears that he likely has bacterial pneumonia superimposed on COVID-19 pneumonia.  After fluid resuscitation he felt much better and had good oral intake.  His orthostatic hypotension resolved.  Recommendations from therapy were for him to return home with supervision by family.  The family is working on getting his son to live with him.  His discharged home with his daughter.  He was sent a prescription of cefdinir to complete his antibiotic course.  He was also given a prescription of prednisone taper.  During his stay he also complained of a cough that had been going on prior to the onset of his COVID-19 symptoms.  Many of his symptoms that he described sounded like dyspepsia.  I prescribed Pepcid
Patient fell forward off exam table immediately after receiving HPV Gardasil vaccine.   Vaccine administrator was able to catch patient but she did appear to lose consciousness briefly and briefly appeared to be shaking as if seizing.   She regained consciousness and was talking to administrator and parent within 1-2 minutes of this happening.   Blood pressure and vital signs remained stable. She did not hit her head or incur any injuries from the fall.   We had her sit and drink water for about 10 minutes then after that, and she was back to normal.  She left with father who took her home.
Diarrhea after the 1st shot; This is a spontaneous report from Pfizer Sponsored Program from a contactable consumer  (patient's friend). A 92-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number Unknown), dose 1 via an unspecified route of administration, on 17Feb2021 as a single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced diarrhea after the 1st shot on an unspecified date in 2021. It was reported that the patient wanted to cancel her scheduled 2nd dose on 10Mar2021. The clinical outcome of the event diarrhea was unknown.   The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 mRNA VACCINE, were not provided and will be requested during follow up.
A report has been received from a Health Professional concerning a 9 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent started on an unknown date. It was reported that the patient was administered expired product which started on 04-Feb-2015. The outcome of the event of administration of expired product to two patients is unknown. The report was considered to be non-serious.
pain in shoulder; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 87-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th August 2019, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced shoulder pain. The patient was treated with dermatologicals nos, dermatologicals nos, dermatologicals nos, dermatologicals nos (Ointment). On an unknown date, the outcome of the shoulder pain was unknown.   It was unknown if the reporter considered the shoulder pain to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in unknown arm. The patient had pain in shoulder and did not lie on that side. It was been almost a month. (It was been three and a half weeks). The patient talked to his/her primary, said pain would eventually go away. The patient had applied ice and muscle pain ointment. The patient worried that this might become a chronic condition and patient want to know if other people have complained about the same. The reporter consented to follow up.
Seen in office on 6/21/04 with history of itchy rash on body for 2 days. Had fever scattered erythematous papules on erythematous macules on groin, upper thighs and forearms. Diagnosed by doctor as varicella. Had varicella vaccine 9/15/00.
Induration, reddness and swelling at the injection sight approx 6 x 6 cm. Education given to caregiver about cool compresses and PO analgesic. Told to seek medical care for worsening of symptoms.
D68.9 COAGULOPATHY, UNSPECIFIED TYPE 12/30/2022 C DIFFICILE INFECTION I21.A1 ACUTE NON ST ELEVATION MI (NSTEMI), TYPE 2 MI (SUPPLY/DEMAND) 12/30/2022 C DIFFICILE INFECTION I26.99 ACUTE PULMONARY EMBOLISM 12/30/2022 C DIFFICILE INFECTION I95.9 HYPOTENSION 10/17/2022 C DIFFICILE INFECTION R57.0 CARDIOGENIC SHOCK 12/30/2022 C DIFFICILE INFECTION D68.9 COAGULOPATHY, UNSPECIFIED TYPE 12/30/2022 URINARY RETENTION I21.A1 ACUTE NON ST ELEVATION MI (NSTEMI), TYPE 2 MI (SUPPLY/DEMAND) 12/30/2022 URINARY RETENTION I26.99 ACUTE PULMONARY EMBOLISM 12/30/2022 URINARY RETENTION I95.9 HYPOTENSION 10/17/2022 URINARY RETENTION R57.0 CARDIOGENIC SHOCK 12/30/2022 URINARY RETENTION
Complex Regional Pain Syndrome, Joint Hypermobility Syndrome, Orthostatic Hypotension, Dystonia, Dysautonomia, Tension Headaches, Migraines, Myofascial Pain Syndrome, Fibromyalgia, SI Joint Dysfunction, fatigue, Vasovagal Syncope.
itching; burn; scaling; rough skin an allergic reaction; rough skin an allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 25Oct2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: covid-19 vaccine (Dose 1 Single, Manufacturer Unknown), administration date: 10Apr2021, for Covid-19 Immunization.  The following information was reported: PRURITUS (non-serious), outcome "not recovered", described as "itching"; SKIN BURNING SENSATION (non-serious), outcome "not recovered", described as "burn"; SKIN EXFOLIATION (non-serious), outcome "not recovered", described as "scaling"; DRY SKIN (non-serious), HYPERSENSITIVITY (non-serious), outcome "not recovered" and all described as "rough skin an allergic reaction".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Moderna COVID-19 Vaccine EUA Noted fluttering feeling in my chest starting around the day after my vaccine, the feeling comes and goes, it does not matter if I am working or resting
in response to item 17.  I have no idea what flu shot it was brand, manufacture, ect.  I just know   injection site was hard and had red blotching, extremely painful, difficult to move arm, lasted about 7 days.  pretty extreme pain.  Body aches, headache, nausea, dizziness, 102 fever.
Rash, non-stop coughing, chills, headache, chest pain, loss of appetite, constant tickle in the back of throat and arm pain.  Several courses of antibiotics with no relief, multiple blood tests were performed and cam back with positive ANA marker with no prior history of auto immune disorder.   Arm pain continued to get worse over time and has recently been diagnosed with Postherpetic Neuralgia. She has been prescribed Gabapentin 6 tablets per day with no relief, in severe constant pain with no ability to move left arm.
Vaccine given past expiration date. Vaccine expired on 4/01/23 and vaccine was administered on 04/06/23.
2 days post vaccination pt. developed a red area size of golf ball next to injection site location. Was warm to touch, firm, & pt reported itching. Pt placed on 500mg KEFLEX PO every 6 hours.