chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Period began as it should on the evening of July 28; however, it has been extremely light. I have only spotted.
expired twinrix was administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) (batch number unknown, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd March 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 3rd March 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that, Twinrix was expired on 8th February 2022 and was administered to the patient. The reporter did not have permission to give out any details of patient. Consented to follow was provided.
pt recv vax & reported fever (not measured) & sz;mom described eyes rolling back & arms shaking (pt demonstrated tonic-clonic activity);called 911;rule out sepsis work up was done (blood cult, urine cult, CSF cult);
had a headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (had a headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (had a headache). At the time of the report, HEADACHE (had a headache) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  Patient had a headache since his  2nd vaccination 15 days ago at the time of report.  Concomitant and treatment medication were not provided.
pt recvd vax; muscle aches generalized p/ 4 dose 20jan94;still persists;tx w/ flexeril;was taking zocor at time;CPK levels elevated:20jan94 391, 31jan94 1000, 2feb94 487, 9feb94 598;
Passed out in Dr office. Then extremely dizzy. Had to have wife come bring me home. I couldn?t stand up or walk for 2 weeks after and felt like I was going to faint every time I got up. Couldn?t drive for 3 months. Now I have ongoing anxiety from reaction and still get dizzy.
Information has been received from a medical assistant, who reported that her approximately one year daughter received her first dose of Rotateq at 2 months and the second dose at 4 months in January 2007. In February, the patient was taken to the emergency room for projectile vomiting and diarrhea and was treated for dehydration. The patient was not admitted to the hospital. Onset date was also reported as "one month after the second dose (January 2007)". The medical assistant reported that the patient was exposed to two other children who had similar symptoms. These children had not been vaccinated with Rotateq. There was no product quality complaint. In follow-up information it was clarified that the patient was experiencing rotavirus and not intussusception. Additional information is not expected.
Headaches, chills, runny nose sore throat body aches, 5 hours after the Vaccine
This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The physician wanted to know request timing recommendations if a patient missed the 3 week dosing interval between the first and second dose of the Pfizer BioNtech Covid-19 Vaccine. The physician stated that there is an individual who missed the 2nd dose of the Pfizer BioNtech Covid-19 vaccine due to a delayed hives reaction after the first dose. The physician wanted to know if we have additional guidance in the administration of the 2nd dose of the Pfizer BioNTech Covid-19 Vaccine if a patient experienced a delayed adverse reaction (hives). The outcome of the event was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up
High blood pressure (190/100) immediately following injection. Fell to 148/99 after 10 minutes. Mild nausea persisting until evening.
Student reported not feeling well. At that time she became non- responsive.  She remained safe in the chair and a nurse at her side.  Student then became responsive and opened her eyes, as well as began speaking.  Student received apple juice and remained with the nurse for 30 minutes.  Student showed no further signs of difficulties.  Mother informed of the above, stated this is common for her.  She needs to eat prior to vaccines.  Stated she will see that she eats before the next vaccine.
Bell Palsy; pain in arm; pain in neck; headache worsen from center of head to neck; dizzy; nausea; chills; tongue swollen; no taste; This is a spontaneous report from a contactable consumer (patient). A 51-year-old (also reported as 52-year-old) female patient received bnt162b2 (BNT162B2), via an unspecified route of administration at the age of 51-years-old, administered in Arm Left on 10Mar2021 10:45 (Lot Number: EN6202) as single dose for COVID-19 immunization. Medical history included asthma and high blood pressure. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient experienced "Bell palsy", pain in arm, pain in neck, headache worsen from center of head to neck, dizzy, nausea, chills, tongue swollen, no taste; all on 19Mar2021 22:30. Description was as follows: "pain in arm, neck, headache, dizzy, nausea, chills and then days later other symptoms, headache worsen from center of head to neck, neck hurting, tongue swollen, no taste, and then woke up with Bell Palsy and was taken to the emergency room". Therapeutic measures were taken as a result of Bell palsy. The outcome of the events was recovering. The events were considered as serious (Disability or permanent damage/ Disabling/Incapacitating). The adverse events resulted in any Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. 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. Since the vaccination, the patient has not been tested for COVID-19.  More information has been requested.
expired vials were used to provide 38 doses of of the Moderna Covid-19 Vaccine.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses of of the Moderna Covid-19 Vaccine.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses of of the Moderna Covid-19 Vaccine.). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses of of the Moderna Covid-19 Vaccine.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.  The storage of refrigerator thawed and given on the same date but never stored in refrigerator.   No vial had undergone any temperature excursions.   There were no adverse reactions to the vaccine as reported by the patient.   This case was linked to MOD-2021-391439 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow up received contains Non significant information,added secondary reporter information.
Mother called 4/11/11 at 10:30 am & states "has red area on (Lt) leg the size of a baseball". She describes it as "hot to touch" at injection site of KINRIX given on 4/7/11. Recommend BENADRYL 3/4 tsp bid & warm compress also to follow-up if symptoms did not improve - verbal understanding given.
The patient was set to receive the second dose of the series on 1/27/21 and instead received it on 1/19/21. The patient reported redness around the injection site, headache, body aches, and chills in the 24 hours following administration of the vaccine.
screaming x 72 hrs; rx 1/2 tsp Advil q 6 rs;
Information has been received from a medical assistant referring to multiple patients of unknown age and gender. On unknown dates the patients were inadvertently vaccinated with doses of improperly stored GARDASIL 9 (lot #, expiration date and route were not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from an immunization official referring to multiple unspecified patients of unknown ages and genders. The patients' medical histories and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses VARIVAX (lot# M004326, expiration date 25-JAN-2018; lot# M005973, expiration date 02-FEB-2018; lot# M002064, expiration date 12-JAN-2018; lot# M004330, expiration date 26-JAN-2018; lot# M008171, expiration date: 16-FEB-2018; lot# M000995, expiration date 07-JAN-2018, route not reported). Concomitant therapies were not reported. The vaccines were improperly stored in 3.1 degrees Celsius for 1 hour. Previous temperature excursions included -13.1 degrees Celsius for 7 hours and -4 degrees Celsius for 14 hours. Cumulative time out of range (including present excursion) was 7 hours in unlimited range and 15 hours in refrigerated range. The vaccines were back in range. Data logger was involved. No adverse effects were reported. Additional information has been requested.
Seizures for approximately 5 hours. Treated with Tylenol and Ativan to stop seizures and tested for all possible causes, perfectly healthy and proved that seizures were caused by vaccines.
Pt. reported having severe headache, back pain, chills and felt like her body was on fire 8/21 5 PM. Took 2 TYLENOL at 2:30 A 8/22/12. 8/22 Talked with pt. Symptom much improved at 4 PM.
Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. The reporter was reporting 2 doses of M-M-R II) (rHA) (lot # L026551, expiration date 16-JUL-2017) (dosage, strength and route unknown), that had been improperly stored (temperature and time frame: 34 degree F for 3 hours 24 minutes and 47 degree F for 6 minutes), were inadvertently administered to the unspecified patients on unspecified dates. No adverse effect was reported. Follow up information has been received from medical assistant via phone call on 26-APR-2016. The patient was vaccinated with improperly stored M-M-R II on 08-MAR-2016. This is one of several reports received from the same reporter. Additional information has been requested. Patient tab, product tab, event tab and narrative updated.
4/25/2021 - He was apparently well until 2 days prior to admission when he developed spontaneous left calf pain and swelling.  He denies any associated trauma, recent travel and immobility.  He is not taking any new prescription, including steroids. One day prior to admission, he started experiencing left-sided pleuritic chest pain up to 9/10 in intensity and exertional shortness of breath.  He denies any fevers, hemoptysis, sputum production, diaphoresis, nausea, vomiting, abdominal pain, dizziness or lightheadedness.  The pain was persistent throughout the day.  Today, his chest pain persisted and his shortness of breath had progressed.  He also noted left arm swelling with mild discomfort.  He felt that his left leg swelling and pain had improved today.  Nevertheless, given persistent symptoms, he decided to come to the emergency room for further evaluation management.   In the emergency room, his initial blood pressure was 218/104 with mild tachycardia of 99, normal oxygen saturation and no fevers.  CBC showed a white count of 12.35, hematocrit of 50.4 and normal platelet count 198.  INR was normal at 1.06.  BMP showed mild hyperglycemia at 148.  Troponin was 5 and BNP was 8.  Imaging studies show extensive left upper extremity DVTs that involved the left subclavian vein, left lower extremity DVTs and bilateral lower lobe pulmonary emboli.   4/30/2021 Presumed unprovoked extensive DVT of the left upper extremity and left lower extremity.  However, he did recently receive Johnson & Johnson Covid vaccine.  Now status post catheter directed thrombolysis to the left upper extremity.
I developed optic neuritis about 3 weeks after receiving my vaccine. It started with pain when moving my eye and then caused diminishing color vision and spots in vision.
Approximately 9 hours after vaccination, mild to moderate generalized symptom of not feeling well for 1/2 hour followed by sudden and rapid onset of perfuse sweating, feeling weak and off balance, and generalized symptom of feeling very poor. Husband and 6 friends were present and said that my facial color quickly disappeared. I felt nauseous and was helped to the bathroom as I felt too weak to walk and I vomited the dinner I had just eaten. At the same time I lost temporary control of my bladder and anal sphincter. I went home and immediately went to bed. I did not have any other episodes of vomiting or diarrhea. I felt weak in the morning but felt back to almost normal (90%) after breakfast and hot tea. I had normal bowel movements the next day and urine was clear.
PATIENT RECEIVED VACCINE AT 1410. PATIENT STATED THAT SHE FELT DIZZY. PATIENT BEGAN SLURRING HER WORDS AND HER EYES BEGAN FLUTTERING. WHILE NURSE WAS EVALUATING HER SYMPTOMS. EMS WAS CALLED AT 1420 AND PATIENT WAS TRANSFERRED TO HOSPITAL VIA AMBULANCE. RECEIVED A CALL FROM A FAMILY MEMBER TO REPORT THAT SHE WAS EVALUATED IN THE ER. THEY PERFROMED LABS AND A CT. ACCORDING TO THE FAMILY MEMBER, EVERYTHING CAME BACK NORMAL AND THAT SHE HAD A SEIZURE DUE TO HER EPILEPSY. PATIENT WAS RELEASED FROM THE ER TO HER HOME.
Syringe separated from needle after vaccinator inserted into arm.  No vaccine was injected, so vaccinator withdrew needle and successfully vaccinated patient with a new needle and syringe.  No AE.
Significant dizziness for several mornings after vaccination. General malaise for several days. Possibly triggered Shingles virus to emerge as she got shingles the next day after the first dose of the COVID-19 vaccination. After the second dose of the COVID-19 vaccination, the dizziness and malaise returned the very next morning (today 02/10/2021).
21 cm itchy red area on upper arm treated with clobetasol cream followed in 3 days by cephalexin oral.
Upper arm hurts when moved; Itchiness at the injection site; redness at the injection site measuring 1.5 by 1 inches with ragged edges; Soreness at injection site; Injection site warm to the touch; Left arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm hurt), VACCINATION SITE WARMTH (Injection site warm to the touch), PAIN (Upper arm hurts when moved), VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site measuring 1.5 by 1 inches with ragged edges) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), SIMVASTATIN and LOSARTAN POTASSIUM (LOSARTIN) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (Left arm hurt). On 04-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warm to the touch), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site measuring 1.5 by 1 inches with ragged edges) and VACCINATION SITE PAIN (Soreness at injection site). On 05-Feb-2021, the patient experienced PAIN (Upper arm hurts when moved). At the time of the report, PAIN IN EXTREMITY (Left arm hurt), VACCINATION SITE WARMTH (Injection site warm to the touch), PAIN (Upper arm hurts when moved), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site measuring 1.5 by 1 inches with ragged edges) and VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment included Advil
MISSING MENSTRUAL PERIOD; HEAVY MENSTRUATION PERIOD; PASSING OUT MENSTRUAL BLOOD CLOTS A LOT; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sulfa allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On JUN-2021, the patient experienced heavy menstruation period. On JUN-2021, the patient experienced passing out menstrual blood clots a lot. On AUG-2021, the patient experienced missing menstrual period. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passing out menstrual blood clots a lot on JUL-2021, had not recovered from heavy menstruation period, and the outcome of missing menstrual period was not reported. This report was non-serious.
Pt received Tetanus and Diphtheria on 9-12-08 (L) Deltoid. PT came to clinic on 9-15-08 states pain and swelling at injection site X 3 days.  States she had previous symptoms from T.D vaccine previous, Pt forgot to notify M.D,. of previous symptoms.
A report has been received from a Health Professional concerning an 11 year old, Female subject who had been receiving Nasal FLUMIST (INTRANASAL) FLUMIST (INTRANASAL) started on 17-Feb-2015. It was reported that inadvertently administered an expired dose of FLUMIST to a patient. The outcome of the event of EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
Patient receiced Fluzone Quad 2022 Lot number: UT7695NA on 10/12/2022 . She forgot she had already received  influenza vaccine for the season and had another Fluzone Quad 2022 vaccine administered on 11/21/2022 Lot number UT7701MA. No adverse reaction noted at this time
Immediately after the shot was given on Saturday 3/6/21, I felt very nauseas. The nausea continued for the next two days. Body aches, headache, and chills set in same day, in the afternoon. I took Tylenol every 6-8 hours until Monday 3/8/21. Exhaustion, dizziness, and some shortness of breath occurred on Monday 3/8/21. Nausea, headache, and exhaustion is still ongoing but not as intense.
Hurting in chest; Head is killing; itching; Sneezing my head off ever since/tired of sneezing; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Hurting in chest), HEAD DISCOMFORT (Head is killing), PRURITUS (itching) and SNEEZING (Sneezing my head off ever since/tired of sneezing) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Hurting in chest), HEAD DISCOMFORT (Head is killing), PRURITUS (itching) and SNEEZING (Sneezing my head off ever since/tired of sneezing). At the time of the report, CHEST PAIN (Hurting in chest), HEAD DISCOMFORT (Head is killing), PRURITUS (itching) and SNEEZING (Sneezing my head off ever since/tired of sneezing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was provided by the reporter.
Patient developed hives all over the body as per mother, a day after vaccination. She was taken to her doctor and was prescribed Benadryl.
slight stiffness & tenderness in jab site; slight stiffness & tenderness in jab site; This is a spontaneous report from a contactable consumer.  A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 01Feb2021 as single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced slight stiffness & tenderness in jab site on an unspecified date, which were non-serious. Prior to vaccination, no diagnoses of COVID-19 was noted and since the vaccination, it was unknown if the patient was tested for COVID-19.  The outcome of slight stiffness & tenderness in jab site was unknown; it was unknown if treatment was given for the events.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2022 at 15:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Sulfonamide, reaction(s): "Known allergies- Sulpha ". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (05Sep2022) Negative; (07Sep2022) Positive; (09Sep2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: There was no other medication in 2 weeks. The patient received Paxlovid from 29Aug2022 to 03Sep2022 for Treatment of COVID-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.