chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Three months since first dose (in April); 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 PRODUCT DOSE OMISSION ISSUE (Three months since first dose (in April)) 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. In April 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Three months since first dose (in April)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Three months since first dose (in April)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Rash on face and torso. Redness in eyes. Gradual onset. Eyes clearing overnight. Rash reduced overnight. No pain. No fever.
Information has been received from a 23 years old female for the Pregnancy Registry for GARDASIL who on 16-MAY-2008 was vaccinated intramuscularly with her first dose GARDASIL and found out three days later that she was pregnant. The patient's estimated LMP was 20-APR-2008 and she had a positive pregnancy test. Subsequently the patient experienced no adverse event symptoms and sought unspecified medical attention on an unspecified date by calling the office. Follow up information has been received from the patient who stated that she did get the GARDASIL last year but at 10 weeks in her pregnancy she had a miscarriage. At the time of her receiving the first dose of GARDASIL, she had a negative pregnancy test at the office. After one to two weeks, she performed a home pregnancy test which was positive. She called the physician's office to report it as she was concerned. On her initial prenatal visit, her physical exam was completely normal, and an ultrasound was not routinely done. When she sent to have an ultrasound at the office at 10 weeks, it was found there was no fetal heartbeat. She was asymptomatic. She stated the doctor told her it looked like the fetus had stopped developing about a week or two before that. After the ultrasound, she had some abdominal cramping type pain, but did not spontaneously pass the pregnancy. She "ended up needing a D&C". That went OK, she said, and at her 2 week checkup "everything was fine". Upon internal review, the intra-uterine death and abortion induced were considered as Other Important Medical Events. Additional information has been requested.
dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 007B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Hiatal hernia in July 2018. Concurrent medical conditions included Sinus infection. Concomitant products included CEFTRIAXONE SODIUM (ROCEPHIN) and AMOXICILLIN SODIUM (AMOXICILLIN [AMOXICILLIN SODIUM]) for Sinus infection.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced DIZZINESS (dizziness). The patient was treated with MECLIZINE [MECLOZINE] ongoing since an unknown date for Adverse event, at a dose of 1 dosage form and MECLIZINE [MECLOZINE] for Adverse event, at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness) had not resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient has reported concomitant medications including unspecified blood pressure medication, unspecified cholesterol medication, unspecified allergy medication and unspecified acid reflux medication.   The patient reported experiencing dizziness within 20-30 minutes of receiving the first vaccine dose, which went away within 48 hours. The patient reported experiencing dizziness within 20-30 minutes of receiving the second vaccine dose, which has persisted. The patient reports that dizziness increases with reaching and bending, and that the prescribed Meclizine has been mildly effective.   This case was linked to MOD-2021-232615, MOD-2021-232615 (Patient Link).
Pt into clinic with complaint of reaction to MMR given on 8/7/01. She states it is "very painful"; has not used any comfort measures or taken anti-inflammatories as yet. On 8/8/01, she states that site was itching and she scratched the area. It became red and painful to touch during the day with worsening overnight, last night. She awoke this AM and noticed increased swelling and redness with increased pain. It was noted that the size of the reaction was approx. less that the size of a quarter initially with swelling and redness around site approx. 1/2" to 1" surround area. It was noted that there was a 22mm reaction noted at site with 1/2" to 1" of redness surrounding site. Instructed pt to immediately begin taking ibuprofen or Tylenol every 4-6 hours until pain resolved and apply warm compress to area. Instructed client to report to ER or PMD if symptoms worsen. Assessment and consultation performed by LPN and RN.
patient states his left arm and right leg feel funny, tingly. patient told to stay for observation. Patient brought crackers and water, states he ate a full meal prior to vaccine. A few minutes later patient states he still feels funny, patient gets up and sits in corner, places head on wall. States he feels really tired.
At around 10pmdate of administration, patient  reported starting of symptoms ( body aches,  no  fever, joint pain, injection site pain)
This health authority case was initially received on 26-OCT-2015. The case report was received from a Health Professional and concerns a 58 year old female patient. Concurrent medical condition(s), medical and drug history: The patient has a medical history of Asthma, Hypertension and Depression. The patient had no current illness at the time of vaccination. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 14-SEP-2015 - unknown stop date, Batch no: U56406, Route of administration: Intramuscular, Dose; 0.5 ml. Additional suspect drug(s): PNEUMOVAX, Indication, not provided. Reaction(s)/event(s) and outcome: On 14-SEP-2015, shortly after starting / treatment with AFLURIA the patient experienced Back pain (non serious, outcome: Recovered / Resolved), Spasms / Muscle spasms (non serious, outcome: Unknown). Patient recovered while waiting and stated that she felt unrelated to immunization but thought to be back spasm. She also stated that she was extremely anxious about receiving shots and could also be anxiety related. Patient insisted she was fine and that event was possibly related to how she twisted when she sat on the bench. Reporter's assessment: non serious.
Patient felt lightheaded and was unable to stand without assistance.  Was hypotensive.  IV established and fluid administered IV.  Transported to medical center via ambulance.
Headache, Fever, altered senses/behavior changes, chills, fatigue Narrative:  Pt reported Altered sensorium/behavior change, feverish/chills, headache, fatigue. Pt treated with Tylenol & ibuprofen. Occurred on same day pt received dose #2 of vaccine.  Other Relevant History:
CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and chills was not reported. This report was non-serious.
Discomfort; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of discomfort in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced discomfort (Verbatim: Discomfort). The outcome of the discomfort was not reported.   It was unknown if the reporter considered the discomfort to be related to RSV vaccine.     It was unknown if the company considered the discomfort to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 27-SEP-2023 The patient reported after the shot effects of shot were almost as bad as the shingles shot. Th effects were not pleasant, but patient rather put up with some discomfort and then ended up in hospital. The follow-up could not be possible as no contact details were available.
Very swollen Rt eye and also later left eye. Red spots on forehead and rash - then scabs. ON chest, back and lips. Rx 3-28-08 Erythromycin ophthalmic ointment. Rx 3-29-08 Famcyclovir 500 mg TID.
SORENESS AT INJECTION SITE; SINUS PRESSURE AND DRAINAGE, BODY ACHE;FATIGUE; LUMP UNDER ARM Narrative: STATES SHE NOTICED A LUMP UNDER HER ARM (ARM VACCINATED)
Severe vertigo, body aches, fever. The vertigo was so severe that I could not move without feeling like I would fall down.  Also nauseous from said vertigo
Left arm with redness, swelling, warm to touch.  Apply ice, and take Tylenol.
patient received half of dose from vaccine due to making movement; A spontaneous report was received from a physician concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced incorrect dose administered.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 24 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011j20a)intramuscularly for prophylaxis of COVID-19 infection.   On 24 Dec 2020, during vaccine administration, the patient experienced incorrect dose administered. The physician reported the patient moved while being given the vaccine and about half of the dose was injected and the other half was not. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not reported.  The event, incorrect dose administered, was considered resolved on 24 Dec 2020.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot 011j20A), reporting Incorrect dosage administered without any associated adverse events.
Information has been received from a registered nurse (R.N.) concerning an 18 year old female patient with a known seizure disorder that was well-controlled who on an unknown date, was vaccinated with a first dose of GARDASIL (dose, route and lot number not reported). Concomitant therapy included "several seizure meds" and oral contraceptives started at the same time as vaccinations with GARDASIL. It was reported that the patient developed tiny seizures, minor seizure-like episodes randomly in the weeks after vaccination and did not appeared to be syncopal in nature, however, however, the episodes were not full blown seizures. The reporter stated that she was aware that the birth control prescribed was known to decrease the efficacy of one of the "several seizure meds" the patient had been taking concomitantly. It was unknown if the patient sought medical attention. At the time of the report, the patient's outcome was unknown. Upon internal review, tiny seizures, minor seizure-like episodes were determined to be other important medical events. Additional information has been requested.
Development of a tender nodule at site of administration.  Nodule became pea sized and persisted for 3-4 weeks.  Patient's stools became "mucousy".
diagnosed with cancer; This is a spontaneous report received from a contactable reporter(s) (Physician), Program ID: (159558).  A male patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "diagnosed with cancer".  Clinical information: Patient diagnosed with cancer and was fully vaccinated and want to knew the necessary dosing for booster so patient would be fully immunized. Caller relays the patient had 2 doses of Pfizer last year and when he went for the booster he got the Moderna booster which he believe a half dose like 50 and the patient was waiting around until he got the 2nd booster. Patient was over 50 at a time of reporting. While waiting for his 2nd booster he was diagnosed with cancer. The patient falls into a category, what first came to his mind was like the pediatric population, by the time they come for their 2nd shot they might be in different age bracket. That was the best he could thought to describe it. Caller had no idea the process to report or if the patient needs to be involved. Caller stated patient was not able to report at this time, he had a patient walking in any minute.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of malignant neoplasm. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Approximately 5-10 minutes after vaccine was administered patient reported feeling like she could fly, her arms later felt heavy. She was dizzy and disoriented. She was taken to her private physician. Admitted for altered mental status.
Body aches, fever, headache and insomnia starting on the evening of event (Wednesday) and continuing the following day.  Took Tylenol Extra Strength on Thursday afternoon, all side effects went away. No other symptoms until Friday night when headache returned out of the blue, persisting today (Saturday).
Severe pain in shoulder/upper arm limiting movement and disrupting activities.  Followed up with doctor on 2/18 when pain didn't subside and was diagnosed with tendonitis from the shot being administered in the wrong location on my shoulder.  It has now been nine days and I am still in intense pain.
Vaccine recipient developed Shingles 11/17/2021 around the left knee.  He was also diagnosed with a 4cm pancreatic mass on 11/10/2021.   Biopsy is to be scheduled.
She is still experiencing the excruciating headache; fever; nausea; diarrhea; dizziness; confusion; This is a spontaneous report from a contactable consumer (Self) or other non-healthcare professional.  A 43-years-old female patient received the second dose of BNT162B2 (BNT162B2, PFIZER-BioNTech COVID-19 VACCINE, solution for injection, lot number: ER8729), via an unspecified route of administration on 10Apr2021 (Age at vaccination 43 years) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. The patient concomitant medications were not reported. She has previously received the first dose of BNT162B2 (BNT162B2, PFIZER-BioNTech COVID-19 VACCINE, solution for injection, lot number: ER8727) via an unspecified route of administration on 20Mar2021 as dose 1, single for COVID-19 immunisation, and had excruciating headaches. On an unspecified date, she was still experiencing excruciating headaches, fever, nausea, diarrhea, dizziness, and confusion. The clinical course was she had the second dose of the COVID-19 Vaccine on 10Apr2021. She had bad side effects. She was still experiencing the excruciating headache. States that her doctor gave her some medication for it, but it was only enough for 5 days. Reports her age as 43 years and 4 months. The caller stated she had the second dose of the Pfizer COVID-19 vaccine on 10Apr2021. The caller stated the first two days she had very bad side effects. The caller stated the worst was an excruciating headache plus fever, nausea, and diarrhea. The caller stated all the symptoms went away on day three. The caller stated the headache has not gone away on day 11. The caller stated it was not bad but still there. The caller stated she was also experiencing dizziness and confusion since the second dose. The caller stated she saw her doctor last Thursday and the neurology exam was normal. The caller stated the doctor gave her migraine medicine for short-term use and it helped some but now the medicine is gone. The case was classified as non-serious. On an unspecified date, the patient underwent lab tests and procedures which included neurological examination: normal. The outcome of the event headache was not resolved, events fever, nausea, and diarrhea was resolved on an unspecified date and the remaining events confusion and dizziness was unknown.  Follow-up (21Apr2021): This is a follow-up spontaneous report from a contactable consumer.  No follow-up attempts are possible. No further information is expected.
Developed an urticarial/erythema multiforme type (target lesions) rash on 10/04 with erythema and swelling of knees and elbows and some involvement of wrists. Treated with Atarax, Resolved completely within 3 days.
pt was vaxed w/MMR & devel rash; No further details were provided;
Tested positive for the COVID-19; Tested positive for the COVID-19; Headache; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect via a contactable consumer (patient) reported for herself. A female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient got her first dose of this Vaccine date is 29Dec2020 and now she had tested positive for the COVID-19, so she wants to know if what to do if she should take the second dose which is scheduled 19Jan2021. Physician confirmed it was COVID-19 Vaccine of Pfizer. She had got a headache. Events outcome was unknown.  Information about lot/batch number has been requested.
I have sever lower back problems from time to time and  the first vaccine, in March, triggered severe spasms and fatigue which I reported. The second shot triggered a reaction similar to being stung by a wasp, I am allergic to wasps and carry an epipin; however, I broke out in a red rash all over my body and remained very red Saturday and Sunday and now months later, I have unexplained rashes which  pop up on my arms from time to time. Thankfully, they go away within a day or so,  but the rashes are annoying, especially bc they seem to be spontaneous.  Also, when I got the second shot, it felt like someone was grabbing my heart from time to time on the morning of my shot. Sorry for only reporting this now.
Healthy 55-year old who was into health and fitness since childhood. Worked out at least 5 times a week. Work out included running, lifting weights, bicycling, yoga, etc. Part of the fitness regimen and healthy eating was due to history of heart disease in family, which I was determined to avoid. Got regular heart checkups to make sure that did not get heart disease. Very low cholesterol levels, no high blood pressure, excellent BMI, and did excellent on the treadmill stress tests. I was unable to sleep at night because of the constant and irregular pounding of the heart. The sound was loud in my ears. This was accompanied with shortness of breath as though I had just run a marathon. These symptoms got progressively worse over the weeks. Initially we never made the connection between my symptoms and the vaccine because I thought my thyroid levels were off, which may be causing the irregular heartbeats, even though I had not experienced anything like this before. The irregular heartbeats got so bad that I stopped all my workouts and tried just walking instead. Even gentle walking trigger arrhythmia and rapid heartbeat. So I stopped walking as well. By mid-September, roughly 3 weeks after taking the first vaccine, my heartbeats were so irregular that I was massaging my heart constantly in an attempt to alleviate the symptoms. Not only was it skipping beats but also it felt like a burning sensation with mild moderate pain. I could not shake off the sensation that you get when you are in an airplane and it descends suddenly. After I got my second dose in October, I had fever for about 2-3 days. The irregular heartbeats and shortness of breath became even more acute. Just standing in one place triggered irregular heartbeats. Almost a year later, I have not been able to work out at all or perform any physical activity that elevates my heart rate. My life has completely changed. It is not an exaggeration to say that I am completely disabled. Unsurprisingly, this has had an adverse effect on my mental well-being.
This spontaneous report was received from a physician refers to a patient of unknown age with prophylaxis. The medical history, concurrent conditions and concomitant medications are not reported. On 17-AUG-2017, the patient was vaccinated with a dose of VARIVAX (N014371 09-MAY-2019) reconstituted with sterile diluent (manufacturer unknown) M042852 30-May-2019 for prophylaxis. No adverse effects were reported. Temperature was reported as 6 degree Fahrenheit to 14 degree Fahrenheit and time frame of 10 minutes. There was no previous temperature excursion. There was data logger. Additional information has been requested.
Diffuse red flat rash on head, arms, and trunk. Slight redness right thigh at injection site. No signs of infection. Was well appearing and happy. Was seen by FNP. Rash lasted for 3 days and there was some skin peeling as per mom.
Headache from 2 days post vaccine through 4 days. Most severe day 4. 12/31/19. Day 5 resolved.
bloody stools; This case was reported by a physician via call center representative and described the occurrence of blood in stool in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   On 11th July 2019, the patient received the 1st dose of Rotarix lyophilized formulation (oral) 1 ml. On 11th July 2019, immediately after receiving Rotarix lyophilized formulation, the patient experienced blood in stool (serious criteria GSK medically significant). On an unknown date, the outcome of the blood in stool was recovered/resolved.   It was unknown if the reporter considered the blood in stool to be related to Rotarix lyophilized formulation.  Additional details were provided as follows: The patient experienced blood stools shortly after receiving Rotarix vaccine. The patient had a few episodes of bloody stools before the issue resolved.