chrisvoncsefalvay/vaers-outcomes huggingface dataset:
blood clots, Clots were going down the back of her throat; currently feels very weak; nose bleed; This is a spontaneous report from a non-contactable consumer. This report was received via a sales representative. A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), single dose via an unspecified route of administration in Apr2021 for covid-19 immunization. The patient's medical history was not reported. The patient has been on icosapent ethyl (VESCEPA) and ibuprofen for years and currently feels very weak on 25Apr2021. Concomitant medications were unknown. The patient experienced nose bleed blood clots throughout the week on 25Apr2021. Clots were going down the back of her throat. The patient had to seek medical attention. and currently feels very weak on 25Apr2021, two weeks after vaccination. The outcome of nose bleed blood clots and weak was unknown.   No follow-up attempts are possible. No further information expected.
I started with mild cold symptoms for a couple of days and then I had fever around 101. I had a telehealth visit with my doctor and I was prescribed PAXLOVID. I started the medication on the same day and in 2 days my symptoms improved. I have since recovered to from all symptoms.
arm was itching like crazy; tired; flu-like symptoms; lethargic; achy; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), LETHARGY (lethargic), PAIN (achy), PRURITUS (arm was itching like crazy) and FATIGUE (tired) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concomitant products included DENOSUMAB (PROLIA), DIPHENHYDRAMINE and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.   On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), LETHARGY (lethargic), PAIN (achy) and FATIGUE (tired). On 08-Feb-2021, the patient experienced PRURITUS (arm was itching like crazy). On 07-Feb-2021, INFLUENZA LIKE ILLNESS (flu-like symptoms), LETHARGY (lethargic), PAIN (achy) and FATIGUE (tired) had resolved. On 09-Feb-2021, PRURITUS (arm was itching like crazy) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Additional concomitant drug was mentioned as Allergy shots.  No treatment medication was reported.  Action taken with the mRNA-1273 vaccine in response to the events was not applicable.   This case was linked to MOD21-03671 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up received and contain non significant information. On 21-Jul-2021: Follow up received and patient stated that she was fine, had no problem.; Sender's Comments:  MOD21-03671:1st dose
Patient had a fever of 103 with nausea and fatigue.  He also had heat and pain at the injection site.  He was unable to sleep.  Ibuprofen and acetaminophen brought the temperature down.
inconsolable crying for greater than 3hr the afternoon & evening p/vax;low grade fever;APAP given w/little relief;
Patient received 10 times the amount of covid-19 vaccine for Pfizer bivalent. Received 30 ug rather than 3 ug. Multi-use vial used but it was not diluted and the entire vial was injected into thigh. Contacted family once aware to let them know. Contacted family on 4/22/23 and they were still asymptomatic at that time other than minor nosebleed which resolved quickly. On 4/24/23 patient remained at baseline and asymptomatic.
I tested positive for COVID-19.  Due to me being high risk the symptoms are mild. I'm still going through process of taking medicine.
Significant pain in major muscle groups (quads, upper arms, chest, neck) and joints (knees, wrists, lower back, neck); weakness and spasm in upper legs and lower arms. Pain persistent over one week span; pain lessened by TYLENOL (ex strength).
Pain in chest and down left side. (ER physician said symptoms are not likely related to the flu shot.)
6 month mark missed between doses; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.    Additional Information: GSK Receipt Date: 23-JUN-2022 Reporter's Comments: The patient missed the 6 month mark between dose . This query came in via chat, user abandon chat before any further details were obtained. The reporter did not consent to follow up. Additional Supportive Information: Till the time of reporting, the patient had not receive the 2nd dose of Shingrix, which led to incomplete course  of vaccination.
Child received Dtap, Ipv, MMR, VARIVAX, & Hep, A on 3-8-11. 2 days later he developed itching, erythema, tenderness in L deltoid area. Negative fever, vomiting.
swollen lymp nodes on left side of her breast.  Started 3 days after receiving her first injection , reported it to me 5 days after injection.  3-23-21
Severe pain. Upper arm where injection was swelled a lot. Could not raise right arm because of pain. This is day three and pain and swelling still pronounced
Soon after the patient reports significant bruising and more bleeding than was expected.  Two days later the patient describes a redness and warmth about baseball-sized around the injection site. No fevers, no chills, no streaking and thus unlikely infection-related.  It seems that it was just due to administration and the symptoms sounded like a hematoma. No treatment other than ice and rest was required.  Patient's mother also consulted their physician, who agreed with likely a hematoma and no infectious process.
To be clear - I have had (2) Phizer COVID19 Vaccines.  The above was the 3rd shot, utilizing Moderna as a booster. Adverse effect: very, very loud tinnitus.  Otherwise typical symptoms, fatigue and headache.
Received both flu and Tdap into the Left upper arm at patient request. Next day he felt wrm and nausea. Lasted for two days. Still has soreness and arm feels weak, heavy and achy. No redness or swelling. Has not been to a doctor. Taking Aleve for a few days with ice and heat.
doses were given after expiration date; Vaccine was placed in refrigerator on 25Nov2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was placed in refrigerator on 25Nov2021) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Nov-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine was placed in refrigerator on 25Nov2021). On 08-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was placed in refrigerator on 25Nov2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter stated that the vial did not underwent any temperature excursions, on 25-Nov-2021 the vial was placed in refrigerator and patient did not experienced any adverse event.  No concomitant and treatment drug information was provided.
Spotting as if beginning a menstrual cycle after Pfizer vaccine dose one. I have an IUD so I do not menstruate. No other issues besides noting spotting and increased vaginal discharge the day following vaccination. Symptoms lasted one day.
High pitch ringing in both ears.  Asked my P.A. about my tinnitus symptoms but she said there is not much to be done.  Sometime it is so loud it drives me crazy.  It is worse in the evenings.
Pains/other pain; Chills; Fatigue; Headache; Muscle aches; Had like a little candle in the injection site (spot where she got the vaccine) like a little mosquito bit/ was red; Swelling at injection site; Uncomfortable at injectionsite; A spontaneous report was received from a 43-year-old female patient concerning herself who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pains/other pain, had like a little candle in the injection site (spot where she got the vaccine) like a little mosquito bit/ was red, swelling at injection site, uncomfortable at injection site, chills, fatigue, headache and muscle aches.  The patient medical history was not reported. Concomitant medication was not reported.  On 13-Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 024M20A) via unknown route in right arm for prophylaxis of COVID-19 infection.  On 20-Feb-2021, after the vaccine administration, the patient experienced events like a little candle in the injection site (spot where the patient got the vaccine) like a little mosquito bit, the patient thought is was an allergy reaction, Like covid arm. It really swelling, red and uncomfortable, the patient took diphenhydramine, the patient also experienced fatigue, chills, headache, muscle aches and pains, other pain.  Action taken with mRNA-1273 in response to the events were not provided  The outcome of the events pains/other pain, had like a little candle in the injection site (spot where she got the vaccine) like a little mosquito bit/ was red, swelling at injection site, uncomfortable at injection site, chills, fatigue, headache and muscle aches was considered unknown at the time of this report.; Reporter's Comments: This case concerns a 43-year-old female with a nonserious unexpected event of pain and nonserious expected vaccination site erythema, vaccination site swelling, injection site discomfort, headache, myalgia, chills, fatigue. Event onset 8 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient started having a headache and nausea at 11:30 pm after receiving H1N1 vaccine at 5 PM.  The headache and nausea continued to 6:30 am on 11/3/09.  This has continued to today, 11/4/09.  The headache is in the back of his head.
Patient with Moderna vaccination x2 last dose 03/20/21 admitted with respiratory failure from COVID pneumonia who subsequently died.  Provider discharge summary below:  "Patient with underlying Chronic obstructive pulmonary disease and Chronic systolic heart failure (EF 40% Echo 10/2019)  despite having several vaccinations has developed Acute respiratory failure with hypoxia from Pneumonia due to COVID-19 virus,  Patient was dependent on BiPAP @ FIO2 of 100% with marginal saturations.  Was initially treated with DECADRON, REMDESIVIR but patient continued to deteriorate and patient was not tolerating the BiPAP.  Discussion held with multiple family member outside patient's room on 1/18/22 and we agreed to switch to comfort care.  Patient was started on MORPHINE drip and had been comfortable on the BiPAP./  The family later decided when to remove the life support and he passed peacefully with family at his side. "
Headache, nausea. Myalgia nape and thighs, and arthralgia Tired but insomnia Urinary incontinence dry mouth.
Elevate heart rate both resting and active.  Not above heart association parameters but elevated by personal norms
after receiving Janssen booster, recipient reported "he is about to pass out".  Recipient fell on the floor on his left knee,  pale in color and unconscious for  approximately 45 sec.  Called 911 right away, vital signs was taken, BP 90/60, HR of 56. Applied iced pack on forehead and neck area,  while on the floor with legs elevated. Nurse assessed neurological status, recipient is alert and oriented x 4 remains but remains clammy and sweating.  after approximately 5 minutes on the floor, recipient skin color returned to normal, Vital sign was 140/90, HR 56, reported that he took his prescribed Lisinopril this morning and denies any significant medical history. EMS arrived and report was given. Recipient declined to go to the Emergency Room to be check.
About 8 days after vaccine patient noticed a red patch at vaccine site that is swollen and itchy. He was not concerned enough to seek medical attention.  Ice and topical medication seemed to be helping with the itching. Patient will continue to monitor and let us know of any differences in condition
Patient woke up with pain radiating from left arm and chills. Next morning, pt. noticed 6 welts about the size of a quarter on her arm which were painful to touch. Welts resolved completely in 4 days after taking BENADRYL.
Patient hospitalized on 3/12/21. Patient also presented to the ED and was subsequently hospitalized on 4/6/21.
When I woke up, my smart watch said "Fat burn 88-89 heart rate, I felt a little fluttering of my heart; This spontaneous case was reported by a patient and describes the occurrence of CARDIAC FLUTTER (When I woke up, my smart watch said "Fat burn 88-89 heart rate, I felt a little fluttering of my heart) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014B22A, 002A21A, 03821A and 031H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CARDIAC FLUTTER (When I woke up, my smart watch said "Fat burn 88-89 heart rate, I felt a little fluttering of my heart) (seriousness criterion medically significant). At the time of the report, CARDIAC FLUTTER (When I woke up, my smart watch said "Fat burn 88-89 heart rate, I felt a little fluttering of my heart) had resolved.            No concomitant medication  was reported. The patient took allergy shots and the patient had no complaints after dose 3. The AE did not cause the patient to seek medical care No treatment information was provided.  Company comment- This is a spontaneous case concerning a 53-year-old female patient with no relevant medical history reported who experienced the serious (medically significant) and unexpected AESI cardiac flutter the following day a second booster dose of mRNA-1273 vaccine was administered. When patient woke up, her smart watch said "Fat burn 88-89 heart rate¨. She felt a little fluttering of her heart, but it cleared up pretty quickly. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-630098 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 53-year-old female patient with no relevant medical history reported who experienced the serious (medically significant) and unexpected AESI cardiac flutter the following day a second booster dose of mRNA-1273 vaccine was administered. When patient woke up, her smart watch said "Fat burn 88-89 heart rate¨. She felt a little fluttering of her heart, but it cleared up pretty quickly. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
covid test date: 11Jan2022 / covid test result: Positive; covid test date: 11Jan2022 / covid test result: Positive; sore throat; sinus headache; dry cough; dose number: 3; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Nov2021 19:15 (Lot number: FH8020) at the age of 60 years as dose 3 (booster), single, administered in arm left, administration date 23Feb2021 16:15 (Lot number: EL3247) as dose 2, single and administered in arm left, administration date 04Feb2021 10:30 (Lot number: EL3247) as dose 1, single for covid-19 immunisation at pharmacy or Drug Store. The patient had no relevant medical history. There were no concomitant medications. Known allergies: none. Other vaccine in four weeks: No. Other medications in two weeks: none. Covid prior vaccination: No and covid tested post vaccination: Yes. The following information was reported: IMMUNISATION (medically significant) with onset 09Nov2021 19:15, outcome "unknown", described as "dose number: 3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Jan2022, outcome "unknown" and all described as "covid test date: 11Jan2022 / covid test result: Positive"; OROPHARYNGEAL PAIN (non-serious) with onset 09Jan2022, outcome "recovered" (Jan2022), described as "sore throat"; SINUS HEADACHE (non-serious) with onset 09Jan2022, outcome "recovered" (Jan2022), described as "sinus headache"; COUGH (non-serious) with onset 09Jan2022, outcome "recovered" (Jan2022), described as "dry cough". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Jan2022) positive, notes: Other. Therapeutic measures were not taken as a result of covid-19, oropharyngeal pain, sinus headache, cough.; Reporter's Comments; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events immunization, vaccination failure and covid-19 and BNT162B2.
Induration at injection site, Redness and the provider prescribed diphenhydramine 25mg capsule take q4h as needed.
This is a spontaneous report from a non-contactable nurse (patient herself). This 53-year-old female nurse received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, in Dec2020 at a single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. After the first shot she had moderate pain at injection site for a few days, and fatigue for at least one day. The events were assessed as non-serious. Both events resolved on unknown date. No follow-up attempts are possible. No further information is expected. Information about lot/batch cannot be obtained.
2 inch red, tender, painful to the touch,  itchy spot near injection site of upper left arm, Began in just under 24 hours after 2nd dose of Moderna vaccine administered.  48 hours after injection the redness is still there, although it?s less tender, less itchy and the hardness under the spot has mostly subsided.  I also experienced pain and stiffness in my knees that began about an hour after  the  vaccination. It lasted about  5-6 hours when it totally stopped.
I was notified by the medical assistant at the 15-minute mark after getting the flu vaccine and COVID Bivalent booster the patient needed assistance.  Upon arrival into the room, patient was found laying down on the table, lethargic.  He was arousable to verbal and tactile stimuli.  He was able to move his upper and lower extremities.  Patient able to open up his eyes.  Heart rate regular rate and rhythm.  Lungs clear, no wheezing.  Sensation to light touch intact in the extremities.  There was mild erythema to bilateral cheeks, greater on the left.
Client's mother called health dept to report reaction to vaccines received on 2/10/05. Client's mother reports her daughter's right arm was swollen, had redness and heat at injection sites. She reported that she noted this on 2/11/05. She reports taking her daughter to Dr for evaluation. Dr instructed to monitor site and call back if got worse. She reports arm continued to swell and instructed to go ER on 2/11/05 around 7PM. Client was given Keflex 2mg 4 teaspoon tid. Client's mother reports swelling has decreased.
Initial report received from a patient's parent on  Aug 31 2005. A 17 year old female patient with no significant past medical history had received an injection of Menactra, lot number unknown, administered subcutaneously in error in June 2005. Two months later, during a routine doctor visit, a platelet count was done and was noted to be 20,000. The patient had no other symptoms. At the time of this report the patient had not recovered from this event. (OMIC) Follow-up report states: The platelet count went up to 50,000 after IVIG but then fell to 30,000 again. The patient has had no symptoms. The hematologist elected to treat with IVIG, even though the patient had no bleeding or other problems. The patient is midly anemic (hemoglobin 10), but anemia runs in the family. The patient left for college and is doing fine. She will be followed at the college. When the pediatrician finds out the name of the hematologist, she'll call me with that contact information.
pronounced allergies; This case was reported by a nurse via call center representative and described the occurrence of multiple allergies in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced multiple allergies. On an unknown date, the outcome of the multiple allergies was unknown.   It was unknown if the reporter considered the multiple allergies to be related to Shingrix.  Additional details were provided as follows: The reporter did not have patient's date of birth. The batch number and expiration date was not reported. The nurse called and reported that patient had more pronounced allergies after receiving Shingrix. The reporter consented to follow up.
Fully vaccinated, and boosted 10/27/21.   Asymptomatic COVID infection breakthrough and inpatient hospital stay
Headache; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PAIN (Body aches) 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 (Headache) and PAIN (Body aches). At the time of the report, HEADACHE (Headache) and PAIN (Body aches) outcome was unknown.