chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After getting the first dose of the COVID Vaccine @10:30am on 4/7/21, I only experienced a sore arm for the rest of the day. Next morning around 10am, I woke up with hives on my left and right forearm/elbow area, and on my left and right knee area. No other symptoms besides the sore left arm. I took one anti-histamine pill (diphenhydramine hcl 25mg) every 6 hours, and applied cortizone (hydrocortizone) on the areas mentioned every 6 hours as well. It helps, but it comes back every 6 hours. I am worried if it will affect my status on getting the second dose of the COVID Vaccine. I also had almonds, but I never had a history on allergies related to nuts, dairy, and bread.
Information has been received from a physician referring to multiple patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were each vaccinated with a dose of RECOMBIVAX HB (lot # L035881, expiration date 26-JUN-2017, temperature: 49 Fahrenheit, no previous temperature excursion; route not reported) that was improperly stored. No adverse effects were reported. Additional information has been requested.
vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 33-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040AZIA) for COVID-19 vaccination.     Concomitant products included PROGESTERONE (ENDOMETRIN) and ENOXAPARIN SODIUM (LOVENOX [ENOXAPARIN SODIUM]) for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 28-Sep-2021. On 12-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). On 12-Mar-2021, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Information received post vaccine pt experienced arthritis like pain in the arm in which she recd the vaccine that went down her leg. The pt's arthritis like pain in the arm persisted.
"Headache-very top of head-felt like a lot of pressure" 8 on pain scale of 0-10. Began at 7 PM, ended 11 PM on 11/9/09.
Patient received vaccine and was under observation from the nurse when he got up (5 mins after vaccine) to throw away a water bottle when he got dizzy and loss consciousness. He said he remebered going down and woke up after 5 seconds per the nurse in the room. patient was put in prone position and given an ice pack. Patient said he gets nervous and anxiety type symptoms around needles. He said he  has a history of this reaction to other vaccines. Patient was observed for an additional 30 minutes and recovered. Patient did not report any injuries from fall.
devel hives @ MMR site w/in 10 minutes of administering to pt; hives cont & spread to forehead;
Eyelids are swollen since four hours after the injection; Palpebral portion of my eyelids are swollen; This is a spontaneous report from a contactable consumer (herself). A 50-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: RW0180), via an unspecified route of administration, administered on left deltoid on 26Jun2021 12:30 as DOSE 1, SINGLE for covid-19 immunisation (at the age of 50 years). Medical history included hypertension and thyroid ablation (thyroid disorder) from an unknown date and unknown if ongoing. Concomitant medications included METOPROLOL, levothyroxine sodium (SYNTHROID) and HYDROCHLOROTHIAZIDE taken for an unspecified indication, start and stop date were not reported; METFORMIN taken for hypertension, start and stop date were not reported. The patient did not have any family history of swollen eyes. No known allergies were reported. It was reported that the patient did not received any prior vaccination within 4 weeks. And also reported no Platelets Antibody factor IV Test done. The patient received the vaccine on Saturday, the 26th and the symptoms began within an hour of receiving the vaccination and had a reaction to her first Covid19 Vaccine, On 26Jun2021 her eyelids are swollen since four hours after the injection; palpebral portion of my eyelids are swollen. And persisting the same way for two days. The shot that was administered was her first shot and she had not yet had the second shot was due to receive second shot on Saturday, July17. Therapeutic measures were taken as a result of adverse events and included treatment with Zyrtec, the antihistamine, patient thought it is 10 mg but not sure, by mouth. The clinical outcome of the event was not recovered.   Follow up attempts are possible. Further information is expected.  Follow-Up (23Jul2021): Follow-up attempts are completed. No further information is expected.
No adverse event, but patient was given high dose flu vaccine (fluad) and is only 63 years old.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 3:06 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 3:06 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 31.68 years.  Concomitant products were not provided.  On 06-Apr-2021, the vaccine with batch number 044B21A was moved to fridge. On 15-Apr-2021, 18 vials were moved to the clinic. On 15-Apr-2021 at 9 AM, vials underwent temperature excursion with temperature of 34 degrees Fahrenheit. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 09-May-2021.   It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree Fahrenheit.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Both knees became swollen and painful and she could not walk for 2 days.  Also had some groin pain which she has had in the past but this was a lot more intense pain.
Ischemic stroke.  Loss of ability to speak, loss of creativity center, fine motor skills, loss of equilibrium, extreme depression, unable to self care, extreme executive dysfunction, inability to carry a thought, loss of large chunks of memory.  Previous marketable and artistic skills gone.  Lack of cognitive function.  Inability to complete even simple task, unable to complete ADLs.  Medications ceased to work properly.
pt complained of dizziness, lightheadedness, and headache 10 minutes after vaccination. B/P 150/91 HR 66 RR 16 O2 Sat 99% on room air. Prolonged monitoring and hydration with electrolytes. Pt with hx of HTN and did not self medicate before A.M. Transferred to medicine clinic for evaluation due to persistent headache/lightheadedness; Dizziness resolved.
Vaccine was given to patient after expiry; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was given to patient after expiry) and NO ADVERSE EVENT (no adverse event) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was given to patient after expiry) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was given to patient after expiry) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was given to patient after expiry).    Concomitant drugs were not reported.  It was reported that the 6 doses monovalent vial of 5. size was initially stored in refrigerator on 16-Feb-2023 and was administered to patients on 24-Feb-2023, 28-Feb-2023, 01-Mar-2023 and 06-Mar-2023. The vial was not exposed to temperature excursion.  Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-715780, US-MODERNATX, INC.-MOD-2023-715730, US-MODERNATX, INC.-MOD-2023-715785, US-MODERNATX, INC.-MOD-2023-715792, US-MODERNATX, INC.-MOD-2023-715806 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715730:same reporter US-MODERNATX, INC.-MOD-2023-715780:same reporter US-MODERNATX, INC.-MOD-2023-715785:same reporter US-MODERNATX, INC.-MOD-2023-715792:same reporter US-MODERNATX, INC.-MOD-2023-715806:same reporter
Influenza and Shingles vaccines.   Severa epigastric pain, bloating, belching, nausea continuing for 3 days (ongoing) 24 hours significant malaise, headache and severe muscle and joint pain
On 1/11/01, in the afternoon, pt looked flushed and had a temperature of 103.9F and was irritable. Temperature came down to 102.9F with Tylenol in 1 hour but then took a bath after which he starting shaking his head side to side and shook his arms in rhythmic and tremulous fashion. His eyes were not focused. The episode lasted 1 minute. No tonic/clonic movement.
Information has been received from two consumers, the mother and father of a 4 month old male infant, who on 02-MAR-2007 was vaccinated with a single dose Gardasil by mistake. Concomitant therapy included Dtap (unspecified), IPV (unspecified), OPV (unspecified) and Prevnar. The mother and father of the child reported that their son should have received the "HIB" vaccine (not specified) "but instead (was) given (Gardasil)." On 20-MAR-2007, the mother of the infant reported that the child had been experiencing "diarrhea for over a week," and reported that Pedialyte had been ordered. She added that on 16-MAR-2007, the HIB vaccine was administered. The mother stated that her child did "not appear dehydrated," and continued to have "wet diapers." The patient's twin brother also experienced the events as described above after vaccination with Gardasil (WAES # 0703USA01783). Additional information has been requested.
Patient reported during a lab draw appointment on 10/5/11 that on the evening of his flu vaccination he had a fever of 41.7 (ear thermometer), body aches, and hallucinations (per wife).  He did not seek medical care and by the next afternoon he was recovered.
This spontaneous report as received from a physician refers to a female patient of unknown age. The patient was vaccinated with a dose of GARDASIL (lot #, dose and route not reported) on an unspecified date. No other co-suspects and no concomitant medications were reported. Since an unknown date the patient had been experiencing periodic syncopal episodes. The patient was seen by a pediatric cardiologist for the syncopal events. The parent of the patient was told by the cardiologist that he has seen an increase in adolescent patients coming to him with syncope events post vaccination with GARDASIL. No treatment information was reported. The outcome of periodic syncopal episodes was unknown. The relatedness for the reported event was unknown for GARDASIL. Additional information is not expected.
high pressure; This is a spontaneous report from a contactable consumer. A 72-years-old female (who was not pregnant at time of vaccination) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration date: unknown), via an unspecified route administration on an unspecified date as single for COVID-19 immunization at a medical center. The patient medical history and the concomitant medications were not reported. The patient did not had allergies to medications, food, or other products. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive Other medications in two weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. The patient had experienced high pressure on an unspecified date. The patient did not receive any treatment for the adverse event. The patient underwent lab tests and procedures which included blood pressure measurement: high on an unspecified date. The outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
all 32-36 weeks gestation, receiving Arexvy off-label; This non-serious prospective pregnancy case was reported by a pharmacist via sales rep and described the occurrence of vaccine exposure during pregnancy in an unspecified number of female patients who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patients received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: all 32-36 weeks gestation, receiving Arexvy off-label). The outcome of the vaccine exposure during pregnancy was unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt date: 02-NOV-2023 A pharmacist reported multiple incidents of maternal patients, all 32-36 weeks gestation, receiving Arexvy off-label.  No specific adverse events had been reported and vaccine was approved for non-pregnant, older adults (60 years and older). The patients who were pregnant were received Arexvy vaccine, which led to vaccine exposure during pregnancy. The reporter was GSK/ViiV field staff employee. The reporter agree to follow up from GSK.
Localized allergic reaction (left arm) (doubt cellulitis) due to varicella.
Pt. states that after receiving the 3rd Booster of Moderna 10/20/2021, started experiencing symptoms 10/21/2021 of vomiting, nausea, extreme fatigue, and dehydration. Primary communications 10/25/2021 recommendation for Emergency Room visit 10/25/2021 treated for Dehydration and IV Zofran (sent home with Zofran tablet). Still experiencing light headedness, fatigue and constipation (self-treating with stool softener/water).
The following day after the injection, I started developing stomach pain which progressively got worse causing me to go to the emergency room. The pain continued in my stomach and started going into my back.
Information has been received from a physician concerning a 16 year old female with penicillin allergy who on 14-AUG-2007 was vaccinated intramuscularly (IM) with the first dose of Gardasil (Lot #654702/0011U). Subsequently, the patient experienced peeling of the skin on the palms of both hands and the soles of both feet. The physician felt that this incident had caused a significant disability because it was very painful for the patient to walk with the skin on the soles of her feet peeling off. As of 28-AUG-2007, the patient had not recovered from the peeling of the skin on the palms of both hands and the soles of both feet. Additional information has been requested.
3 pound weight gain overnight, significant  edema left arm and hand with pain in arm and numbness a no tingling in left arm
The vaccine was refrigerated on 25-Feb-2022, but it got expired on 25-Mar-2022 and later was administered on 01-Apr-2022; Patient received the vaccine on 01-Apr-2022, which has got expired on 25-Mar-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 01-Apr-2022, which has got expired on 25-Mar-2022) and PRODUCT STORAGE ERROR (The vaccine was refrigerated on 25-Feb-2022, but it got expired on 25-Mar-2022 and later was administered on 01-Apr-2022) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Patient had no known drug allergies, none daily medications were reported. Patient did not have positive or negative COVID-19 within last month of vaccination. None acute or chronic illness was reported.     On 01-Apr-2022 at 9:21 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2022 at 9:21 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 01-Apr-2022, which has got expired on 25-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was refrigerated on 25-Feb-2022, but it got expired on 25-Mar-2022 and later was administered on 01-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 01-Apr-2022, which has got expired on 25-Mar-2022) and PRODUCT STORAGE ERROR (The vaccine was refrigerated on 25-Feb-2022, but it got expired on 25-Mar-2022 and later was administered on 01-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details were not given.  Patient received a vaccine past the 30 day storage on the refrigerator. The Moderna vaccine in question had been put aside and was not currently being used until further notice.  The vaccine was refrigerated on 25-Feb-2022, but it got expired on 25-Mar-2022 and later was administered on 01-Apr-2022 (administered after 30-day Use By Date). Vial did not undergo any temperature excursions.  The patient was not experiencing any side effects yet.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.     On or about 18-FEB-2015, the patient was inoculated by a pharmacist with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient treated by a physician for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
anaphylactic reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of ANAPHYLACTIC REACTION (anaphylactic reaction) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (anaphylactic reaction) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (anaphylactic reaction) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported.  On 05-AUG-2022, it was reported that a patient started treatment on an unspecified date with Moderna COVID-19 vaccine at unspecified 1 dose/frequency for unknown indication. It was reported that the patient had an anaphylactic reaction to the Moderna Covid-19 vaccine.  No treatment medication information was reported.  Company Comment: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who experienced the expected serious (medically significant) event of Anaphylactic reaction which occurred unknown number of minutes/days after receiving a dose of COVID-19 vaccine mRNA-1273, dose number unknown. There is no available information regarding clinical course, diagnostic tests/procedures, and treatment medication. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who experienced the expected serious (medically significant) event of Anaphylactic reaction which occurred unknown number of minutes/days after receiving a dose of COVID-19 vaccine mRNA-1273, dose number unknown. There is no available information regarding clinical course, diagnostic tests/procedures, and treatment medication. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.