chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At approximately 12 noon on 09/04/2014 (approx 5 hrs after flu vaccine) I began to have extreme nasal congestion and general feelings of fatigue. That night symptoms progressed to fever of 100-101 degrees with extreme chills and rigors. The next morning on 09/05/2014 I was extremely dizzy, continued with rigors, chills, and fever, "foggy" mental status, and could hardly walk due to weakness in my legs. Nasal congestion continued to be present. Thinking I had a virus of some kind, I went to an urgent care clinic. They immediately sent me to an ER where I received 2 Liters of Normal Saline IV. I tested negative for influenza & WBC was 11,000. UA was negative, the rest of my CBC was normal, CMP was normal. The fluids improved my symptoms, but did not make them completely go away & I was sent home. I was in the ER for approximately 5-6hrs. I continued the rest of that day and night of 09/05/14 with weakness, severe chills and rigors, and fever. Vital signs showed tachycardia & temp of 100.1 on ER visit. BP, SPO2 normal. On 09/06/2014 my symptoms were completely resolved.
Congenital Hip Dysplasia; umbilical hernia; The mother of infant of an unknown gender   The mother of infant of an unknown gender received mRNA-1273 for COVID-19 prophylaxis.   The report describes a case of DEVELOPMENTAL HIP DYSPLASIA (Congenital Hip Dysplasia). The occurrence of additional non-serious events is detailed below.     The subject's past medical history included Maternal exposure during pregnancy.    On an unknown date, the mother received dose of mRNA-1273 (unknown route) 1 dosage form at an unspecified frequency.    On 06-Apr-2022, the infant was diagnosed with DEVELOPMENTAL HIP DYSPLASIA (Congenital Hip Dysplasia) (seriousness criteria medically significant and congenital anomaly) and UMBILICAL HERNIA (umbilical hernia). The delivery occurred on an unknown date, which was reported as Abnormal Pregnancy Outcome. For neonate 1, The outcome was reported as Term Birth w Cong Anomaly. At the time of the report, DEVELOPMENTAL HIP DYSPLASIA (Congenital Hip Dysplasia) and UMBILICAL HERNIA (umbilical hernia) had resolved with sequelae. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: Bilateral infant hip ultrasound was performed and Congenital Hip Dysplasia was ruled out.    The action taken with mRNA-1273 (Transplacental) was unknown.   Company comment: This non-interventional study case concerns am infant subject which mother was exposed on mRNA-1273 during pregnancy, who experienced the unexpected, serious (medically significant/ congenital anomaly) event of developmental hip dysplasia and non-serious event of umbilical hernia. The events occurred unknown days after mother`s exposure to a dose of mRNA-1273 vaccine. Patient had ultrasound scan which rule out congenital hip dysplasia. Patient will be followed up by orthopedics at 2 years old. No treatment drug information was provided. The causality of the events umbilical hernia and developmental hip dysplasia was assessed as related, however limited information regarding risk factors, etiology and exact date of vaccination and events is provided in this case. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reporter's Comments: This non-interventional study case concerns am infant subject which mother was exposed on mRNA-1273 during pregnancy, who experienced the unexpected, serious (medically significant/ congenital anomaly) event of developmental hip dysplasia and non-serious event of umbilical hernia. The events occurred unknown days after mother`s exposure to a dose of mRNA-1273 vaccine. Patient had ultrasound scan which rule out congenital hip dysplasia. Patient will be followed up by orthopedics at 2 years old. No treatment drug information was provided. The causality of the events umbilical hernia and developmental hip dysplasia was assessed as related, however limited information regarding risk factors, etiology and exact date of vaccination and events is provided in this case. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
area around the injection site has rash; injection site started itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection site started itching) and VACCINATION SITE RASH (area around the injection site has rash) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (injection site started itching). On 14-Mar-2021, the patient experienced VACCINATION SITE RASH (area around the injection site has rash). The patient was treated with CORTISONE for Vaccination site pruritus and Vaccination site rash, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (injection site started itching) and VACCINATION SITE RASH (area around the injection site has rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
No additional adverse event; Improperly storage vaccine was administered; This spontaneous report was received from a healthcare business professional referring to a patient of unknown age and gender.   The patient's concurrent conditions, medical history and concomitant therapies were not provided.   On 08-OCT-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status of recombinant human albumin [rHA]) (PROQUAD) (strength, dose, route, frequency, were not provided) for prophylaxis; lot No. U010745 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live; expiration date reported as 03-OCT-2022 and upon internal validation established as the same.   The reporter stated that the administered dose of the vaccine was improperly stored (incorrect product storage). The administered dose of the vaccine experienced a temperature excursion of -14.6 degrees Celsius (°C), for 6 hours (temperature Excursion had occurred on 08-OCT-2021). It was reported that previous temperature excursion occurred on 04-OCT-2021, from -10°C to 8°C (0.91 °C) for 6 hours; and on 05-OCT-2021, from -10°C to 8°C (1.45 °C) for 6 hours. Additional excursion had occurred after patient was administered the improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) on 13-OCT-2021, from -10°C to 8°C (0.54°C) for 13 hours. There was no additional adverse event (AE). No product quality complaint (PQC) involved.
This spontaneous report was received from a nurse concerning  a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 15-JUL-2016, the patient was vaccinated with a dose of M-M-R II lot # L049316 with expiration date of 03-DEC-2017, subcutaneously (dose was not reported) and with a dose of PROQUAD lot # M012986 with expiration date of 12-SEP-2017 (dose and route of administration were not reported) for prophylaxis.
patient presented to pharmacy for first dose of Moderna Covid 19 vaccine, with no symptoms. Pt made me aware of allergies to items listed, we discussed types of reactions. patient had had PEG previously with no reaction. we discussed remaining for 30 minutes. patients vaccine was administered in the left arm at 9:40. at 9:50 patients daughter let us know she was feeling lightheaded. i immediately checked her, breathing was fine, no hives or urticaria. we elevated her legs, and began talking with her. she continued to feel extremely lightheaded.. at 9:50 911 was called. pt was lightley responsive, and no other symptoms. paramedics arrived just after 10am. blood pressure and oxygen were checked both were within normal range. Ambulance arrived shortly after and patient was transported.
This is a spontaneous report obtained from a contactable physician through a sales representative. The physician's son of an unspecified age, and ethnicity received, on an unspecified date, TRUMENBA at single dose, via an unspecified route of administration. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced redness and pain. BENADFRYL was given as a therapeutic measure and event lasted for 3-4 days. The patient recovered from the events on an unspecified date.
At 1606 Patient reporting lightheadedness, bilateral hand tingling and numbness. Also reporting generalized headache 6/10. States that she has not eaten any food today except coffee. BP 88/49. HR 45 Patient was laid flat and legs elevated. Repeat BP 1613 101/59. Patient reported bilateral arms feeling "cold".    O: Patient alert and oriented, following commands, no focal weakness. BUE cool to touch.     EMS called at 1609. ED arrival 1620. Repeat VS 1620 105/65 HR 55   Upon EMS arrival patient declined to receive further treatment and signed AMA paperwork.    Discussed with patient to return to ED for any further worsening of symptoms.
No other adverse event for this patient; The caller said a patient received PROQUAD after a temperature excursion.; This spontaneous report has been received from a healthcare worker referring a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 19-AUG-2022, the patient was vaccinated with an improperly storage dose of measles, mumps, rubella and varicella recombinant human albumin (rHA) (OKA-MERCK) virus vaccine live (PROQUAD) (lot number u022729 had been verified to be a valid number; expiration date was reported as 16-JAN-2023, and upon internal validation established as the same date), 1 dose, for prophylaxis (strength, exact dose, anatomical location and route of administration were not provided) (product storage error). Administered dose of vaccine experienced temperature excursion of 11.5 Fahrenheit (F) for 52 minutes. There was no previous temperature excursion. No additional information of adverse event was reported.; Sender's Comments:  US-009507513-2208USA008545:MSD US-009507513-2208USA008698:MSD US-009507513-2208USA009042:MSD
Localized injection site to left arm of redness & swelling diameter of 8cm round & c/o itching to head, face, behind ears & chest.
Mom states that on Tues., July 26 around 5pm the parents noticed pt's leg swollen, red, and hot where child received (2) shots on Monday in the (Lf) leg. States will bring child to doctor. Had appointment w/doctor 7/27/11. Doctor feels that it may be a mild allergic reaction to the shot, not an infection. 7/28/11 mom states that today lf. thigh is still hard and turning dark like a bruise.
Fever 102F; 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 PYREXIA (Fever 102F) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever 102F). At the time of the report, PYREXIA (Fever 102F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was received by the patient No Treatment was received by the patient.
Information has been received from a consumer (the patient's husband) for the pregnancy registry for GARDASIL concerning "his wife (a 24 year old female), with no drug allergies who on approximately 19-JAN-2010 (about 5 weeks ago) was vaccinated with her first 0.5 mL dose of GARDASIL (lot number unspecified). There was no concomitant medication. Later she found out that she was approximately 2 weeks pregnant at the time of vaccination. A urine pregnancy test was performed. Her LMP was estimated to be approximately 04-JAN-2010. On 22-FEB-2010, at 7 weeks gestation, his wife had a miscarriage. His wife was admitted to the hospital (name and address unspecified) over night and she was released in the morning on 23-FEB-2010. The outcome was unknown. No further information is available.
More than 42 days from first dose; high fever; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 42 days from first dose) and PYREXIA (high fever) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], COLECALCIFEROL (VITAMIN D3 5000), LISINOPRIL and TOPIRAMATE for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 42 days from first dose) and PYREXIA (high fever). On 29-Apr-2021, PYREXIA (high fever) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 42 days from first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided.
Pt recvd 2nd dose of Hep B vax & subsequently devel diarrhea;
administered a 2 year 2 ml of the 6 months to 5 years of age Moderna COVID-19 vaccine instead of 0.25 ml; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (administered a 2 year 2 ml of the 6 months to 5 years of age Moderna COVID-19 vaccine instead of 0.25 ml) in a child male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 milliliter. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (administered a 2 year 2 ml of the 6 months to 5 years of age Moderna COVID-19 vaccine instead of 0.25 ml). At the time of the report, ACCIDENTAL OVERDOSE (administered a 2 year 2 ml of the 6 months to 5 years of age Moderna COVID-19 vaccine instead of 0.25 ml) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Body aches, severe headache, vomiting, insomnia, fatigue, black stool
Body started twitching on 4/17/2021 in the morning has continued on and off since. The eye twitches have been continuous everyday. I?m afraid to get the second dose which is scheduled tomorrow 5/6/2021 at 2:09pm at. I received the first dose of Pfizer on 4-15-2021
This case was reported by a nurse and described the occurrence of wrong vaccine administered in a male patient who received ENGERIX B adult (batch number FB3A3, expiry date 28th January 2016). Previously administered products included TWINRIX (Dose 1). On 8th September 2041, the patient received ENGERIX B adult. On an unknown date, an unknown time after receiving ENGERIX B adult, the patient experienced wrong vaccine administered. On an unkonwn date, the outcome of the wrong vaccine administered was unknown. Additional information received: A patient was started on TWINRIX on 0. 1 and 6 months schedule. He received TWINRIX at 1st dose on 05 August 2014 and then a 2nd dose on 08 September 2014 ENGERIX B was given.
It made me sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were as follows: The age at vaccination was not reported. The patient refused the vaccine and would not be getting a flu shot anymore as it was made her sick. The patient stated that she would take chances without certain vaccines.
Near Syncope. Began late in the evening, laying in bed, nothing unusual, started feeling extremely lightheaded and the room starting to black out. Blood pressure at home was extremely low. Went to local ER, fluids given, treated and released to follow up with both primary care physician and cardiologist.
pt recv vax 2PM 26SEP96 approx 4hr later mom called stated pt has redness swelling @ inj site;projectile vomiting;crying;
Arm was a little bit sore; Pressure headache, throbbing in the temple on the left side/ same type of headache on the right side; Hearing to be muffled on the left side; Slept really hard last night; Felt really tired; This is a spontaneous report from a contactable consumer (patient herself) via a medical information team. A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 21Apr2021 (at the age of 63-year-old) as a single dose for COVID-19 immunization. The patient's medical history included deaf in right ear (she was deaf in right ear). Concomitant medications were not reported. It was reported that, she has questions about her symptoms from receiving the first dose of the Pfizer COVID-19 vaccine on 21Apr2021. She states that her symptoms started the next day (22Apr2021), "arm was a little bit sore but most concerned about the pressure headache, throbbing in the temple on the left side on an unspecified date in 2021 which caused her hearing to be muffled on the left side (she was deaf in right ear) on an unspecified date in 2021. Patient took arthritic Tylenol 2 in the morning, 2 afternoon and 2 at night which helped. After the headache stopped yesterday morning, she thought her side effects were done. Then late yesterday afternoon she had the same type of headache on the right side. Patient slept really hard last night (on an unspecified date in 2021) and felt really tired on an unspecified date in 2021. Patient have no headache as of right now." The caller states that she never gets headaches. She also states that usually if something "strange" was going to happen to someone it happens to her and she wants to know if this was "out of the ordinary" with the Pfizer COVID-19 vaccine. Referred caller to her healthcare professional if symptoms persisted or become worrisome. Caller wants to know if there was a possibility that she would experience the same side effects with her second dose of the Pfizer COVID-19 vaccine. The outcome of the event pressure headache, throbbing in the temple, same type of headache on the right side was recovered on an unspecified date in 2021 and unknown for the other events.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
hoarseness- feeling of fullness in throat tingling of tongue nausea diarrhea headache blurry vision lo-grade fever
Pt recv vax on 9/30/98; on 10/1/98 pt exp erythema & raised area at vax site, lightheaded, cold extremities, dizzy
Contact with and (suspected) exposure to covid-19; COVID-19 PCR; COVID-19 (SARS CoV-2,RNA Molecular Amplification); Sore throat; Elevated blood pressure reading
has been 7 months since 1st dose of shingles/Due to the 2 doses if Covid; This case was reported by a consumer via call center representative and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknown date approximately 7 months before day of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not applicable for this report. The reporter mentioned that he or she missed the dosing schedules of Shingrix. The reporter enquired what happened if approximately 7 months had been past since first dose due to COVID shots being administered. The reporter asked could he or she get the 2nd dose. The follow up was not required.
I had a nosebleed about 1 hour after the shot. I just had an unexpected another nosebleed on 3/19 at 12:00.
Complaints of left sided tongue swelling, scratchy/sore throat, dizziness with onset appx 30mins post vaccine administration.
I had a strong immune reaction to the first; Doctor recommended that I wait the full 6 months before getting the second. Then I lost track and didn't get it; This case was reported by a consumer via call center representative and described the occurrence of immunization reaction in a 71-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 19th June 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced immunization reaction and incomplete course of vaccination. On an unknown date, the outcome of the immunization reaction and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the immunization reaction to be related to Shingrix.  Additional details were provided as follows: The patient had a strong immune reaction to the first injection therefore the doctor recommended that he/she should wait the full 6 months before getting the second dose. Then the patient lost the track and did not received 2nd dose, which led to incomplete course of vaccination. The patient was being told to stay at home because of Covid 19. The patient asked to wait for it or received the dose.
-Sore injection arm (left) starting at 4pm on day of injection (12/16/20) and resolved on 12/20/20. -Chills starting at 5pm on second day (12/17/20) and resolved on 12/18/20.
no adverse event; a patient was inadvertently administered VAQTA instead of a COVID-19 vaccine; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 22-SEP-2022, the patient was inadvertently vaccinated with hepatitis A vaccine, inactivated (VAQTA) 0.3 milliliter, lot #U024094, expiration date: 10-MAY-2023 (strength, anatomical location, and route of administration were not provided) as prophylaxis, instead of a COVID-19 vaccine (manufacturer unknown) (wrong vaccine administered). The reporter stated that the patient received a partial dose of hepatitis A vaccine, inactivated (VAQTA). No adverse event was reported.
Patient had abnormal vaginal bleeding the same day of administration of the 2nd Pfizer vaccine. patient's mother stated the bleeding was heavier than patient's normal menstrual bleeding.
Chest pain several hours after vaccine - seen at local ED - ECG, CXR normal. Some chest wall tenderness to palpation. Discharged home. Seen in office 1 week later with normal exam.