chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from Registered Nurse regarding to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-JUN-2016, the patient was vaccinated with improperly stored VARIVAX (lot # L004649, expiry date 11-FEB-2017) (therapy type digital data logger) dosage regimen unknown. It was reported that the vaccine was exposed to a temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes and the temperature was back in range. It was reported that the vaccine was not subjected to precious temperature excursion. Product quality complaint (PQC) was not filed. This is one of the several reports received form the same reporter. Additional information had been requested.
tremors; cold sweat; cough; high fever; chills; This is a spontaneous report from a contactable pharmacist. A 64-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number: not reported) via an unspecified route of administration on 02Oct2021 as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 11Oct2021 (9 days after vaccination), the patient experienced high fever, chills, tremors, cough and cold sweat. The patient's body temperature was high when tested on 11Oct2021. Patient wanted to know if these side effects were reported 9 days after they got the vaccine. Outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Since receiving vaccine, directly after Patient has had moderate Pain from injection site to upper neck, and down to elbow, and in left shoulder blade. Patient took ibuprofen today, throughout day with no relief, Patient has to keep arm still due to movement of shoulder hurts.
Fever of 102 for three  day with migraine (light sensitive, sound sensitive) for three days.   GI upset including diarrhrea.   Took tylenol for fever, zofran for nausea.
Pt given vaccines and approximately 4 minutes later skin turned lace like pink and blotchy resembling hives. Dr. notified eval pt and given 10 mg Benadryl PO. The rash went away in about 5-10 minutes, Pt released.
pt recvd vax & a few yr later, pt was hospitalized for hepatitis; lab eval was pos for anti-HBs & hep B core antibody; further eval revealed hepatitis was clearly a chemical hepatitis;
Some soreness the following day but primary report was of a fever for following 9 days. Normal temperature reported around 97.5, was consistently reading around 98.9F. Achy legs and back for the 9 days as well. Reporting that she is feeling fine now.
After using the RICE method for the swelling around the injection site on Sunday, pt. woke up on Monday with a swollen lower arm that had blotchy red spots. There was also pain described when touching the area. The redness continues this day.
Red, swollen, inflamed and splotchey area around the injection site was noticed about 36-48 hours after the vaccinations. The thigh that had the reaction had the HepA and PCV13 vaccines. The Varicella did not cause any reaction because it was given by itself in the opposite thigh. After 72 hours, the red, swollen, inflamed area had grown to double the size and was larger than the size of my fist. The pediatrician was notified 3/10/17 and I was informed to give benadryl, motrin and warm baths to work the leg out. The reaction started to subside about 4 to 5 days after the vaccines were given.
ON THE MORNING OF 10/26 I EXPERIENCED SEVERE HEADACHE, NAUSEA, VOMITING, DIARRHEA, VERY DISORIENTED INCLUDING LOSING THE ABILITY TO SPEAK COHERENTLY AFTER ABOUT 5 HOURS.  I WENT TO THE EMERGENCY ROOM AT 5:00 PM AT THE ADVICE OF MY PRIMARY PHYSICAN.  MY HUSBAND ACCOMPANIED ME AND WAS ABLE TO SPEAK TO THE DOCTORS AND NURSES ABOUT MY SYMPTOMS, ETC.  I WAS AT THE HOSPITAL FROM 5:00 PM UNTIL 10:30 PM OR SO.  I WAS FEELING SOMEWHAT BETTER - ABLE TO SPEAK CLEARLY BUT WAS STILL VERY UNCOMFORTABLE - PARTICULARLY HEADACHE AND NAUSEA.  THEY ADMINISTERED A BAG OF SALINE AND INFUSION OF ANTI-NAUSEA AND HEADACHE MEDICATION BEFORE DISCHARGE.  I STILL FELT VERY FATIGUED WITH A HEADACHE FOR THE NEXT 2 DAYS (WEDNESDAY & THURSDAY) BUT FEEL MUCH BETTER TODAY (10/29)
My symptoms began on August 02. I had a sore throat, congestion, and was a little achy and tired. I took a COVID-19 Home test and neither time did I get a strong positive. My provider prescribed Paxlovid since my entire had been impacted by COVID-19. My symptoms improved within 2 days. I still had a really light cough which is worse due to other health issues. I do feel like I have completely recovered from this breakthrough event.
Patient was doing yard work and noticed a strange sensation in her fingers of her right hand.  She looked down at her fingers and the looked "pure white, tinged with yellow".  They felt like they were covered in "scotch tape".  The patient said this only lasted for a few hours and they were complete back to normal by 4:00pm the same day.
Vertigo, taste metal, smell ammonia at random, body aches, nausea, lungs feel sticky even though my O2 level is good, feel like I need to sneeze but can?t for days (which is not normal for me) I feel fevered but my thermometer says I?m normal.  Extreme fatigue for days. I?m sleeping 12 hours a day.
Pt recv vax on 12/22/98; 10 min post vax pt exp skin flare rx; tx=Benadryl
This is an instance of breakthrough COVID-19 after which death occurred.   The individual was vaccinated with the Pfizer product on 01/11/2021 and 02/01/2021. They tested positive for COVID-19 on 10/05/2021, twice, upon admission to hospital. The individual was hospitalized 10/05/2021-10/22/2021. They were seen in a clinic on 10/29/2021 and 11/03/2021. They were then hospitalized again 11/04/2021-11/06/2021. They were found to have pneumonia and acute kidney failure. They were discharged to a hospice facility, and remained at this facility until their death on 11/11/2021.
10-22-19 Beginning at 5-45PM (Approx) Scratchy, sore, thick throat. Followed by itchy running eyes. 200am - Lips, eyes & face swollen, generalized itching on Limbs. Took 50mg Benedryl. Symptoms SL. Relieved 10-26 all symptoms gone. If I had not had Benedryl Avail. To me I would have driven myself to the E.R.
blood clot; Incredibly excruciating pain in left thigh; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 77-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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: THROMBOSIS (medically significant), outcome "unknown", described as "blood clot"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Incredibly excruciating pain in left thigh". Clinical course: Reporter stated, her husband who is 77 got his fourth booster (clarified as COVID booster) yesterday and last night on here which both had that is not a problem but now he has an incredibly excruciating pain in left thigh. She was just wondering he is in good physical shape he is an athlete but just wondering if that is a complication or is normal like blood clot or something. Reporter was informed about the role of Safety and informed that Medical Information is the concerned department to answer the question. Reporter was provided with the number of Medical Information department as [withheld] followed by Option # with the timing 8am to7pm on Monday to Friday. Further probing could not be done as reporter hung up the call abruptly. Thus, product details (NDC#, UPC# and expiry date) and purchase details were unknown. Hence, limited information was available over the call.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
second dose was administered this past March/ A few weeks age we both contracted the virus; second dose was administered this past March/ A few weeks age we both contracted the virus; This is a spontaneous report from a contactable consumer. This consumer reported similar events for himself and his wife. A male patient of an unspecified age received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration in Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that, on an unknown date, a few weeks before this report, he contracted the virus (COVID-19). He was not aware he had the virus and infected one of his friends. He could have infected other people. Luckily, he got out the alarm and they were all self-isolated. He doesn't remember ever hearing the virus could be disseminated by a vaccinated person. The event outcome was unknown at the time of the report.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101419694 Same reporter/vaccine/event, different patient
I became very dizzy  about 1.5 hours after receiving the shot. I cannot shake the feeling of my equilibrium being off. I feel like i just got off of a spinning ride at an amusement park and I cannot get my bearings. I never have had dizziness like this before so i feel that it must be related to the shot.
SIDE EFFECTS; This spontaneous report received from a consumer via a representative concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose,(Dose number series: 1) start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced side effects. The action taken with covid-19 vaccine was not applicable. The outcome of side effects was not reported. This report was non-serious.
Knock him out for a day; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Knock him out for a day) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in August 2020.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced FATIGUE (Knock him out for a day). On 19-Feb-2021, FATIGUE (Knock him out for a day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Treatment information was not provided.
PATIENT HAD LARGE RAISED RED SPOT ABOUT 8 INCHES IN DIAMETER ON UPPER LEFT ARM WHERE SHOT WAS GIVEN.
ABOUT 45 MINUTES AFTER SHOT, PATIENT EXPERIENCED BACKACHE, BECAME VERY HOT AND SWEATY, LASTING FOR ABOUT 10 MINUTES BEFORE SUBSIDING.
PPSV-23 vaccine given 2/13/18 - pt. reports arm started to feel itchy in the late evening after vaccine administered. Pt. reports later in evening arm started to swell and she developed pain at site of injection. Took BENADRYL: - some improvement. Pt. reports headache, no nausea, vomiting, or chills. Recent reaction to clindamycin. Follow up with PCP 2/15/18 started on ZYRTEC 10 mg, ZANTAC 150 mg, and given referral to allergy and immunology.
reported to exp vomiting, limpness 1 day p/vax 18JAN95; seen in ER @ hosp where oral electrolyte fluid given (Pedialyte) & pt observed;
Information has been received from a physician concerning a 10 year old female who on 28-OCT-1988 and 19-MAR-1992 was vaccinated with a first and second dose of MMR II. "Recently", in approximately January 2007, the patient had a negative antibody test for measles. Antibody levels for mumps and rubella were satisfactory. The reason for testing was not provided. The vaccine was not administered at the present office and no further records are available. Unspecified medical attention was sought. There is no other information to report.
Patient had injection site reaction starting as a dime size raised red welt and growing to a size around 1.5 inches in diameter. This reaction peaked approximately 1 week after the injection. Patient also experienced muscle soreness radiating into her neck and down her arm, this muscle soreness and residual visual evidence of redness remain 1 month after administration. Currently the patient is still experiencing muscle tenderness and itching at the injection site. She also describes, but is not visually evident to me, a slight indent in the deltoid muscle near the injection site.
Patient's mom falsified child's age stating they were 5 yo. Patient was actually <5 yo and not eligible for COVID vaccination.
received shingrix vaccine while still having shingles,  vaccine in a patient with active case of shingles; This case was reported by a pharmacist via call center representative and described the occurrence of off label use in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles.   On 17th May 2022, the patient received Shingrix. On 17th May 2022, unknown after receiving Shingrix, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown.   Additional Information: GSK receipt date: 17-May-2022 and 18-May-2022 Reporter's comment: The pharmacist submitted afterhours webform, which was retrieved by Medical Information at start of business on 18th May 2022. The reporter reported that what did he/she need to do to knew if a patient received Shingrix vaccine while still having shingles.  No further details were provided on form. The reporter submitted potential adverse event with all available details. Consented to follow-up. Additional Supportive Information: The patient received Shingrix with active  case of shingles, which led to off label use. The case US2022080583 was identified as duplicate of US2022080584. The case US2022080583 was deleted and all future correspondence would be added in the present case which stands as case of record for this patient.
itching at injection site measuring 70 milimeter X 50 milimeter; edema and erythema at injection site measuring 70 milimeter X 50 milimeter; Injection site reaction to the left arm having an area of edema, erythema, and itching measuring 70 mm X 50 mm.; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Medical Information (Reference number- 00829592) and transmitted to Sanofi on 26-Oct-2021.  This case involves a 43 year old female patient who experienced itching, edema and erythema at injection site measuring 70 milimeter x 50 milimeter (pruritus, inflammation and vaccination site reaction) after receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past vaccination(s) included influenza for prophylactic vaccination every year.  The patient's past medical treatment(s) and family history were not provided.  At the time of the event, the patient had ongoing medical history of allergy.  Concomitant medication included unspecified medication for allergy   On 24-Oct-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via intramuscular route in the left arm for prophylactic vaccination.  On 24-Oct-2021 the patient developed a non-serious itching, edema and erythema at injection site measuring 70 milimeter x 50 milimeter (pruritus, inflammation and vaccination site reaction) on same day following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported "Caller stated she had a reaction to FLUBLOK at the injection site and wanted to know the ingredients so she won't have the reaction anymore. The consumer reported that the reaction is still continuing; that she has been taking allergy medication and using Benadryl cream for the reaction; that she gets a flu vaccine every year; that it is unknown to the caller if she had the FLUBLOK in the past; that she has known allergy issues; and that her entire family received the FLUBLOK on the same day and no other member had a reaction"  No laboratory data was provided  At time of reporting, the events were not recovered.
Right bicep and shoulder had severe swelling accompanied by severe pain and discoloration of right hand. His bicep swelled almost as large as my thigh. Went to emergency room around 4:30 PM, advised to apply ice every 20 minutes and was given Naproxen by emergency room doctor.
Sunday 11/13 felt slightly dizzy and headache.  On 11/14 approx 1:45pm began to have trouble breathing, felt faint, broke out in hives and very dizzy.
walking pneumonia; did not have immunity to Rubella; injection site hives; unable to move; broke out in massive hives on right side of body; This spontaneous report was received from a 36 year old male patient, reporting on himself.  the patients concurrent conditions and pertinent medical history were not provided. On an unspecified date the patient was vaccinated with M-M-R II vaccine but she did not complete the dose series due to religious reasons, the patient was also vaccinated with an unspecified 'nasal spray flu vaccine' and she had formaldehyde allergy.   On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not provided) for prophylaxis.  It was confirmed that the patient did not have immunity to Rubella (rubella antibody negative).  Since an unspecified date, the patient experienced walking pneumonia (atypical pneumonia). It was mentioned, that after the corresponding, unknown, flu vaccine injection, the patient was in bed for 5 Days, she was unable to move, and could not go to bathroom (movement disorder), and also had 'broke out in massive hives on right side of body (injection site urticaria).   The outcome of atypical pneumonia, urticaria, movement disorder, injection site urticaria and rubella antibody negative was unknown. The causal relationship between the events and the suspect vaccine was not reported.  Upon internal review, atypical pneumonia was considered a medically significant event.
Got 2nd shot on 17Feb2021 only had 4 hives; This is a spontaneous report from a contactable consumer or other non HCP (patient). A 87-year-old patient of an unspecified gender received bnt162b2 (Pfizer/BioNTech COVID-19 vaccine ,Formulation: Solution for injection), via intramuscularly on 17Feb2021 (Batch/Lot Number: EL9269) as Dose 2, Single (at the age of 87-year-old) for covid-19 immunisation. Medical history included ongoing CHF (cardiac failure congestive), ongoing COPD (chronic obstructive pulmonary disease), ongoing heart (Heart disorder) and Cancer (Chemo and Radiation Onset Date: Apr2013, Stop date: Jul2013) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 on 25Jan2021 (Anatomical site location: Upper left arm, Route of administration: Intramuscular, Lot number: Pfizer EN5318) for covid-19 immunisation and experienced itch and Hives. The patient experienced got 2nd shot on 17feb2021 only had 4 hives. The outcome of event reported as recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Initially after second vaccination had fever, chills and fatigue....sweating and waking up in cold sweats(03/03/21-03/04/2021),  a week later noticed muscle twitches in body hands neck and arms,  it has continued.  mid march woke up in cold sweat, no fever  April 16 woke up in cold sweat...no fever muscle twitches continue
Patient complained of 3 wheals/hives that formed on arm and back (1 on arm and 2 on back).
severe shortness of breath; postural tachycardia; dizziness; chronic fatigue; pins and needles in my feet; left leg calf pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 28-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 (Lot number: EN6205) at the age of 28 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Allergies: almonds" (unspecified if ongoing); "Allergies: cashews" (unspecified if ongoing). Concomitant medication(s) included: LAMICTAL; WELLBUTRIN; LUVOX [FLUVOXAMINE MALEATE]; TRAZODONE; SINGULAIR. Past drug history included: Amoxicillin, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6207, Location of injection: Arm Left), administration date: 01Mar2021, when the patient was 28 years old, for covid- 19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Four months after vaccination (12Jul2021), the patient developed severe shortness of breath, postural tachycardia, dizziness, chronic fatigue, pins and needles in feet, and left leg calf pain. Full cardiac and neurological workup could not find definitive cause. Symptoms continued and the patient was currently on disability. The following information was reported: DYSPNOEA (disability) with onset 12Jul2021, outcome "not recovered", described as "severe shortness of breath"; TACHYCARDIA (disability) with onset 12Jul2021, outcome "not recovered", described as "postural tachycardia"; DIZZINESS (disability) with onset 12Jul2021, outcome "not recovered", described as "dizziness"; FATIGUE (disability) with onset 12Jul2021, outcome "not recovered", described as "chronic fatigue"; PARAESTHESIA (disability) with onset 12Jul2021, outcome "not recovered", described as "pins and needles in my feet"; PAIN IN EXTREMITY (disability) with onset 12Jul2021, outcome "not recovered", described as "left leg calf pain". The adverse events resulted in emergency room/department or urgent care. The patient underwent the following laboratory tests and procedures: investigation: (unspecified date) could not find definitive cause; sars-cov-2 test: (Jul2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of dyspnoea, tachycardia, dizziness, fatigue, paraesthesia, pain in extremity. Since the vaccination, the patient has been tested for COVID-19. No follow-up attempts are possible. No further information is expected.