chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 22 year old female who on 31-JUL-2007 was vaccinated with her second dose of GARDASIL (lot# not reported).  On 14-MAR-2008 the patient was vaccinated with her third dose of GARDASIL (lot# not reported).  On approximately 14-MAR-2008 the patient experienced a raised area at the injection site.  The area was the size of an egg.  The patient's raised area at the injection site persisted and was coming to the office on 02-APR-2008 for an examination.  Additional information has been requested.
Chills, fever, weakness, frequent urination approximately 30 minutes, headaches, sore/painful kidneys, soreness at site of injection. Felt fine by afternoon of 9/24. Took 2 aspirin (twice) for headaches. On 9/25 3am woke up with fever/drenched. Felt fine by afternoon.
Big halo in the arm; It was described as a skin reaction.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Big halo in the arm) and SKIN REACTION (It was described as a skin reaction.) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (Big halo in the arm) and SKIN REACTION (It was described as a skin reaction.). At the time of the report, VACCINATION SITE DISCOLOURATION (Big halo in the arm) and SKIN REACTION (It was described as a skin reaction.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.
Subjective swelling of l/side of throat and sinus pressure.  Later, 2 hives on l/shoulder.  Rx Benadryl
ended up losing my baby at 32weeks and 5 days gestational period; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and fetus/baby. This is a maternal report. A 22-year-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FF2593), via an unspecified route of administration, administered in Arm Left on 18Oct2021 at 18:45 (at the age of 22-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included asthma, eczema, known allergies: shellfish, peanuts and turkey. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (Batch/Lot Number: RC3183), administered in Arm Left on 27Sep2021 at 06:45 PM (at the age of 22-years-old) for COVID-19 immunisation.  The patient ended up losing her baby at 32weeks and 5 days gestational period on 22Oct2021 at 22:00. The event resulted in Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for the event for 3 days. The clinical course was as follows: the Friday after the patient received her final dose of the Pfizer vaccine, she ended up losing her baby at 32weeks and 5 days gestational period. She was told getting the covid vaccine would help but in reality, in her belief, she ended up losing her baby over the vaccine and it has been reported that she was not the only person to have this happen to. She blames the Pfizer vaccine to having lost her child and no one should ever have to go through that at any moment. The mother reported she became pregnant while taking bnt162b2. The mother was 32 Weeks pregnant at the onset of the event. The mother was due to deliver on 13Dec2021. The outcome of the event was unknown.    No follow up attempts are possible. No further information is expected.
Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a Pharmacist. This case involves a 55 years old patient who received vaccine FLUZONE HIGH DOSE. The patient's past medical history and concomitant medication were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE  SUBVIRION VACCINE lot number not reported via unknown route. It was a case of actual medication error due to Inappropriate age at vaccine administration and overdose. It was unknown whether adverse event occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
pt recv vax & exp asthma sx,dry cough & SOB following vax;tx w/albuterol & Triamcinolone acetonide & sx were relieved;
Chest was heavy; Heart was racing; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Jun2021 at 17:45 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received SEPTRA and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Jun2021 at 18:00 the patient's chest was heavy and heart was racing which she had never experienced before for which she ended up at the emergency room around 19:00. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of chest heaviness and heart racing and included treatment with unknown medications for both blood pressure and heart. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events chest heaviness and heart racing were not recovered at the time of reporting.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Patient developed a cellulitis after receiving Pneumovax. Patient was seen in ER and given antibiotic. Left arm was swollen.
11 days+ (on-going) of major fatigue - sleeping 14-16 hours a day, tired most of the time. For the first 36 hours also had some nausea and painful abdominal cramps.
Information has been received from a physician concerning a 67 year old female with a medical history of restless leg syndrome, osteoarthritis GERD, fibromyalgia and allergies to LEVAQUIN, prednisone and cortisone who on 29-JAN-2007 was vaccinated with a 0.65 ml of Zostavax (lot #652947/1212F). On 16-FEB-2007 the patient experienced a very mild case of shingles. It was described a sa zoster rash with no lesions over the sternum an T5 area. The patient had a normal temperature. Medical attention was sought. Subsequently, the patient recovered from very mild case of shingles. No product quality complaint was involved. Additional information has been requested.
Broke out into a major rash/rash with COVID-19 booster; This spontaneous case was reported by a patient and describes the occurrence of RASH (Broke out into a major rash/rash with COVID-19 booster) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products DUPILUMAB (DUPIXENT) solution for injection for Dermatitis atopic and COVID-19 VACCINE for an unknown indication.    Concurrent medical conditions included Dermatitis atopic.   In October 2020, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of COVID-19 VACCINE (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Broke out into a major rash/rash with COVID-19 booster). At the time of the report, RASH (Broke out into a major rash/rash with COVID-19 booster) outcome was unknown.            The patient's medical treatments and family history were not provided. No concomitant medication was reported.  The co-suspect Dupixent delivered via dupilumab pre-filled syringe.  It was not reported if the patient received a corrective treatment for the event.  The reporter causality for event broke out into a major rash/rash with COVID-19 booster with co-suspect Dupixent  and COVID-19 vaccine was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Pt came in with severe resolving bruise on arm of FLUZONE HD administration. Arm was sore the night after the injection. Pt sleeps on that arm. Noticed next morning. Arm warm, tender and bruised. Discussed with pt. She is on blood thinners.
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. The reporter stated that on an unknown date multiple unspecified patients were vaccinated with improperly stored VAQTA (dosing details were not reported) (therapy type: Digital Data Logger) (lot # L048222 with an expiry date of 19-DEC-2016), at a temperature of 51 F for a time frame of 5 years. There was a previous temperature excursion reported for VAQTA at a temperature of 59 F for 29 hours. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports from the same reporter. Additional information has been requested.
Information has been received from an office manager concerning about 20-30 females who were vaccinated with Gardasil and have complained about injection site pain. Medical attention was sought. Additional information has been requested.
5:17 PM-Client received second dose of Moderna vaccine. C/O Dizziness when he stood.  Paramedics noted diaphoresis, client reported dizziness and feeling lightheaded.  BP=54/32 P=41, SATS= 97% on Room air.  Paramedic started IV to left AC, Normal Saline wide open.  911 notified. Repeat vitals after ½ bag of saline= BP= 120/84 HR=61, SATS= 97% on room air. Client also C/O headache to left temple. Client reported feeling better.  547PM IV saline completed. Client reports chills and feeling cold.  Client pale in color and over all physical appearance has decreased from 10 minutes prior.  Client agreed to go to hospital for further work-up. BP= 125/84 HR= 62 SATS=100% on Room air.
Pt stated "uncomfortable at first, by 4 pm pain was worse, used heating pad around 11:30 pm on 10-27-16 to help with pain" described pain as "excruciating". By date of notification (10-29-16) pt states she can still do daily activities (i.e. play bridge, etc) and move - no discomfort but "feels abnormal". I examined (R) arm and it was definitely red around upper arm, slightly swollen, and warm to touch. Redness appeared 10-28-16 but states "getting better". Pt has not sought treatment but I encouraged follow up with MD on Monday.
Suffered a right tib/fib fracture at home, came to ED and was found to have mild respiratory distress.  XR Chest 1V [Auth (Verified)] (01/10 1243): FINAL IMPRESSION: Cardiomegaly with mild interstitial opacities may represent pulmonary vascular congestion.  T: 100.5 °F  HR: 77  RR: 18  BP: 127/114  SpO2: 94%  WT: 86 kg  BMI: 33.59.  Patient was tested and results were positive for COVID-19 on 1/10/22.  Patient hospitalized for treatment of COVID and fracture.  Patient remains hospitalized however has recovered fully from COVID-19.  She had previously received Moderna on 5/4/21 & 5/22/21.
Patient received vaccine in left deltoid at 3:40PM.  During observation she became dizzy and fainted in seated position at 3:50PM.  She came to immediately with the pharmacist talking to her and grasping her shoulders.  Her BP at 3:51PM was 120/83 with HR of 60.  Patient admitted to fasting for two days prior.  She was administered Glutose gel sublingually at 3:54PM and BP was 107/81 with HR 69.  She began to feel less faint with color returning within 2 minutes of administration of the glucose.  She was observed until 4:10PM without any further incident.  She was released with pharmacist's recommendation to go to the ER if any other symptoms are experienced.
Pain in arm persisted past one week then began to hurt in the shoulder joint. Cannot lift arm past waist without pain. Any pressure used on the right results in pain. Even resting on the right elbow will cause pain in shoulder. At times the pain at rest will travel into my upper right chest. General ache in the right shoulder when not moving or applying light pressure.  Wanted to talk to practitioner before I made a doctors visit. She provided me with the information for this website to report it.
duplicate dosing of the polio vaccine form different manufacturers with no reported adverse event; Initial information on 14-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 4 years old female patient who had duplicate dosing of the poliomyelitis vaccine (inactivated) IPV (VERO) [IPOL] form different manufacturers with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Apr-2023, the patient received a Standard dose 3 of suspect poliomyelitis vaccine (inactivated) IPV (VERO) Suspension for injection at a dose of 0.5 mL total (lot V1B901M, expiry date- 2-Jun-2024) via unknown route in unknown administration site for Immunization.  On 13-APR-2023, (latency- same day), the patient developed a non-serious event of duplicate dosing of the polio vaccine form different manufacturers with no reported adverse event (extra dose administered) following the administration of poliomyelitis vaccine (inactivated) IPV (VERO).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA120468:01576513
Information has been received from a registered radiologic technologist concerning a 5-year-old male relative with no pertinent medical history and no allergies, who was vaccinated on 17-JUN-2002 in the right thigh with a single dose of varicella virus vaccine live (Oka/Merck) (lot # 638244/0466L). There was no concomitant medication given. On 14-MAR-2007, the patient experienced unspecified pain rated 8-9 out of 10. On 17-MAR-2007, the patient experienced a blister like rash on the inside of his right leg from the groin area to the foot. The rash was made up of vesicles and papules in the L1-L4 dermatome. He had a fever of 100.8. The child was take to the emergency department of a local hospital and was instructed to apply hydrocortisone cream and to take Advil. After doing so the rash became worse. On 19-Mar-2007, the doctor saw the patient and diagnosed him as having shingles. The outcome was reported as recovered. No product quality complaint was involved. Additional information has been requested.
Excruciating shoulder pain at the joint and deltoid muscle. Much, much more than regular shot pain. Still unable to lift arm above my shoulder, cannot use my left arm much due to shoulder pain.
Systemic: Nausea-Medium, Systemic: Vomiting-Medium
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease. Concomitant products included ADALIMUMAB (HUMIRA) for Crohn's disease, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in December 2020 and the estimated date of delivery was on an unknown date. On 28-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Expected due date was reported as Sep-2021.  Treatment information was not reported.
Blurry vision, confusion, nerve issues on side of body, ... ended up in er 5x after 3rd vaccine.  Severe head/nerve pain on left side of neck, jaw, face. Left foot drop. Left arm numb.  Slurred speech. Trigeminal neuralgia diagnosis
Patient received Pfizer Covid -19 vaccine around 12:30 pm.  and as instructed to remain seated for at least 15 minutes after administration. Approximately 4 minutes after administration patient blacked out and for approximately 30 secs to a minute and appeared to have a seizure per observing patients. Patient responded when pharmacist attended to him within a minute and showed no signs of anaphylaxis but was sweating profusely and couldn't remember what happened. 911 EMS arrived within 10 to 15 minutes and continued attending to patient. Patient was evaluated by EMS and stated he was fine responding to all questions and on site evaluations. He later left premises after departure of EMS on his own along with family members and appeared to be fine. Patient stated he was very nervous and was concerned about his history of allergies to a few nuts, PCN and sulfa drugs
Information has been received from a nurse's 20 year old daughter with no drug reactions/allergies and a history of knee operation in 2003 who in December 2006, was vaccinated with a first dose of Gardasil (lot# unknown). In mid January 2007 the patient had a second dose of Gardasil. On 22-MAY-2007 the patient had a third dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). It was also reported that the patient's mother had cervical cancer 14 years ago at the age of 35. On 05-SEP-2007 the patient experienced bladder spasms on the first day of college. It was also reported that the patient was experiencing urinary incontinence. None of the medication have helped the bladder spasms. On 10-SEP-2007 the patient was seen in the emergency room. On 10-Sep-2007 the patient had a PAP smear, was tested for STD's, had various blood work done all within normal limits and a pelvic computed axial tomography scan which all came back negative. All labs and tests were coming back within normal limits. On 18-Sep-2007 a cystopy was performed in a urologist office and was negative. On 26-Sep-2007 a magnetic resonance imaging of the pelvis and spine was performed (looking for spinal tumor) which was negative. On an unspecified date an ultrasound and vaginal ultrasound of pelvis showed a cyst on spleen and a fibroid tumor in the uterus which was very small. A PAP smear was performed and there was no pain, no pelvic inflammatory disease noted. The patient is currently on acetaminophen (+) hydrocodone bitartrate (VICODIN0, morniflumate (FLOMAX), amitriptyline hydrochloride (ELAVIL) and azithromycin (Z-PAK). At the time of reporting the patient had not recovered. No additional information was available. Bladder spasms and urine incontinence were considered to be disabling. The patient must stand during college classes. Additional information has been requested.
This spontaneous report was received from a office manager and refers to a 21-months-old male patient. On 23-APR-2018, the patient was vaccinated for prophylaxis with improperly stored dose of VARIVAX lot # N029631, expiration date 23-OCT-2019 (dose and route of administration were not provided), reconstituted with properly stored sterile diluent (STERILE DILUENT). The vaccine underwent a temperature excursion of 12 degrees Fahrenheit for 30 minutes. There was no previous temperature of excursion reported. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.
About three days after the shot, my arm became very itchy and hurt. Soon after, a very mild rash appeared - I'm not totally sure the rash wasn't from scratching, but I don't believe it was. 13 days out, my arm is still itchy and sore.
Patient received vaccine was sitting for 15 minutes and got up in the middle of his 15 minutes to approach the pharmacist and the pharmacist sat him down again and he passed out onto the floor hitting his head with a cut on his eyebrow and nosebleed. Ems arrived and got patient back into chair and he again passed out and began seizing. He again regained consciousness and was taken away in a stretcher.
Heavy and long periods of vaginal bleeding; This is a spontaneous report from a contactable nurse, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the right arm on 30Jul2021 at 13:15 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. On 03Aug2021 at 08:30, the patient experienced heavy and long periods of vaginal bleeding after vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event heavy and long periods of vaginal bleeding was not resolved at the time of this report.
Fever/chills, brain fog, confusion, lack of energy, muscle weakness, blurred vision, sleepy all the time, grumpy, depression