chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via sales rep and described the occurrence of low blood pressure in a 16-year-old male patient who received BEXSERO for prophylaxis. Co-suspect products included Hepatitis A vaccine for prophylaxis and MENACTRA for prophylaxis. On 24th August 2018, the patient received BEXSERO, Hepatitis A vaccine and MENACTRA. On 24th August 2018, less than a day after receiving BEXSERO and Hepatitis A vaccine, the patient experienced low blood pressure, disorientation, fainting and rigidity. On 24th August 2018, the outcome of the low blood pressure, disorientation, fainting and rigidity were recovered/resolved. It was unknown if the reporter considered the low blood pressure, disorientation, fainting and rigidity to be related to BEXSERO and Hepatitis A vaccine. Additional details were provided as follows: This case was reported by a medical assistant. The patient received BEXSERO, MENACTRA and Hepatitis A vaccine on the same day on an empty stomach. The patient almost fainted and had to lie down but recovered completely within 15 minutes. No call back or follow up had been initiated by the patient since then. It was unknown if the reporter considered the low blood pressure, disorientation, fainting and rigidity to be related to MENACTRA as well. This case was linked with case US2018155237, reported by the same reporter.
ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/18/2022 ATRIAL FIBRILLATION, PAROXYSMAL  HYPOXIA 12/1/2022 ATRIAL FIBRILLATION, PAROXYSMAL  ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/18/2022 ANEMIA  HYPOXIA 12/1/2022 ANEMIA  ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/18/2022 ATRIAL FIBRILLATION, PAROXYSMAL  HYPOXIA 12/1/2022 ATRIAL FIBRILLATION, PAROXYSMAL
CNS Demyelinating disease, probable Multiple sclerosis symptoms 13 days following AVA and Smallpox vaccine.
pt recv vax;inconsolable crying 3 1/2-4 hr;high pitched cry; T 101;seemed to be in pain per mom;some swelling at inject site;apap given;30jun95 mom stated pt doing fine;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EM9808), in left arm, on 23Mar2021 as dose 2, single (Lot number: EN6207), in left arm, on 12Oct2021 as dose 3 (booster), single (Lot number: FF2589), in left arm and on 12Apr2022 at 08:00 as dose 4 (booster), single (Lot number: 3303680), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Keflex series of antibiotics" (unspecified if ongoing), notes: Known allergies: Keflex series of antibiotics. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Other medication in 2weeks were reported as, yes. Anti-viral details was Brand name Paxlovid, Treatment start date was 13Jun2022, Lot number: FW4118, Indicated for treatment of COVID-19. Other medication in 2 weeks products with start date 12Jun2022 was Lipitor, Chorthalidone, Hygroton, Gabapentin, Multi-Vitamin and Vitamin C. Metallic Taste in mount (continuous), Diarreha (2 days), Severe night sweats (enough to soak the sheets and my pajamas on nights 2 and 3 of the medication. No treatment.  No follow-up attempts are possible. No further information is expected.
Localized swelling, redness, within 24 hrs after receiving Dtap 5 and IPV 4.  Given Ibuprofen with prescription to take med for pain; also recommended compresses to area (arm) and elevation. Monitor for progression; RTC prn
Rigors and fever several hours, post vax. Presented to walk-in clinic after 48 hours with right arm redness, swelling and pain. IV Nafcillin and 7 days of Keflex po.
This is a spontaneous report from a contactable nurse. An elderly patient of unspecified age (over 65 years old), gender and race/ethnicity received PREVNAR 13 on an unspecified date, at single dose, for immunization. Medical history and concomitant medications were not reported. On an unspecified date, 24 hours after vaccination, the patient had a stroke. Event outcome was unknown. No follow-up attempts possible. No further information expected.; Sender's Comments: There is no plausible mechanism to implicate the suspect vaccine to the occurrence of the serious event .  Considering the patient's old age (over 65 years), the event more likely related to the underlying clinical conditions of the patient and unrelated to the vaccination with PREVENAR 13. 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.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On 13-APR-2013, the patient was vaccinated with GARDASIL dose 1 (route and lot number were not reported). On 11-JUL-2013, the patient was vaccinated with GARDASIL dose 2 (route and lot number were not reported). On 11-SEP-2013, the patient was vaccinated with GARDASIL dose 3 (route and lot number were not reported). The nurse reported that the patient was in the office to receive dose 3 of GARDASIL which would be late. No symptoms reported. Additional information has been requested.
This spontaneous prospective pregnancy report was received from a nurse via a company representative referring to a female patient approximately 32 years old. The patient's relevant medical history, concurrent conditions and concomitant therapy were not reported. On 07-FEB-2018 the patient was vaccinated with second dose of M-M-R II (strength, dose, frequency, route, lot # and expiry date were not reported) for prophylaxis. The patient had received first dose of M-M-R II (strength, dose, frequency, route, lot# and expiry date were not reported) on an unspecified date. It was reported that, the patient and her husband have been trying to get pregnant, and the patient was unsure if she was pregnant. The patient sought medical attention, she visited the Physician office on 07-FEB-2018 to receive second dose of M-M-R II. No product quality complaint was not involved. At the time of reporting, the outcome of exposure during pregnancy was unknown. The relationship between exposure during pregnancy and M-M-R II was not provided.
Plenty of blood clots; 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 THROMBOSIS (Plenty of blood clots) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Plenty of blood clots) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Plenty of blood clots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. No Treatment information was provided.  Very limited information regarding this event has been provided at this time.  Further information has been requested; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested
Four days after getting the vaccine I developed a hive-like rash in the form of elevated, itchy, red spots all over my left arm. Took Benadryl but did not do much and woke up the next day worse and with more spots.  Went to critical care and was given prednisone which has helped alleviate it but is not completely gone yet (1/5/2021).
Blotches all over his body arms, legs and crotch/ blotches again appeared; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Blotches all over his body arms, legs and crotch/ blotches again appeared) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH MACULAR (Blotches all over his body arms, legs and crotch/ blotches again appeared). In 2021, RASH MACULAR (Blotches all over his body arms, legs and crotch/ blotches again appeared) had resolved.            No concomitant medications were provided.  The patient had taken both his doses through their local county health department.  The patient went to the emergency room and was given steroid injectable form but he was advised to take it orally. The blotches did not resolve so he went to his doctor who prescribed him with an oral steroid over a 2 week period. He stated that it took 2-4 weeks before the blotches went away.   This case was linked to MOD-2021-290082 (Patient Link).
Information has been received from a physician concerning an 84 year old male patient with iodine and NEOSPORIN allergy, osteoporosis and osteoarthritis who on 26-JAN-2009 was vaccinated with his second dose of PNEUMOVAX 23 (lot # 663012/1163X) IM. On 28-JAN-2009 the patient developed erythema and slight tenderness at the injection site. The patient was instructed to apply heat to the area. The patient had visited office for medical attention. At the time of reporting, the patient's erythema and slight tenderness at the injection site persisted. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports from the same source. Additional information has been requested.
Fine the same day and monitored and on the 28th she complained of shortness of breath and chest pain. She also had a 4lb weight gain. She was sent to the ER on the 28th and keep her over night and sent her back the next day. She passed the on 31st of Oct.
Patient presented to our ER with erythema and pain at site of injection of pneumonia shot (which was received at their pharmacy). Patient received DECADRON, PEPCID, BENADRYL and PERCOCET as discharge prescriptions.
Immediately noticed small, red itchy bumps, a few days after it was all over her body. Loose stool lasted for about 3-4 hours then went away. Presently, she has itchiness all over and her upper part of her legs are small red bumps.  She has a Dr appt on 04/16 and Dr told her to get saline and did not prescribe her anything.  RN recommends bathing in ivory soap or soap void of any dye or harsh perfumes, same with lotion... benedryl and cortizone or the itchiness.  was agreeable. She has an appt with the dermatologist Friday 04/23.
Patient presented to the ED reporting that he was feeling "real weak". In the ED, he was found to be hypoxic, tachycardic, and hypothermic with a temperature of 93.2. Pt has history of COPD (on chronic oxygen), HTN, CAD, atrial fibrillation, spinal stenosis, bilateral pleural effusions requiring thoracentesis. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.
heard of 4 or 5 people with heart attacks after the COVID-19 Vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, 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: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heard of 4 or 5 people with heart attacks after the COVID-19 Vaccine".  Clinical course: Caller wanted to know if this had been reported since he didn't find any information on the internet. Caller then mentioned about how he heard of 4 or 5 people with heart attacks after the COVID-19 Vaccine. He added that he's obviously not going to take another booster. When caller was referred to his HCP, he mentioned that in one of the visits, he was told the booster reacts with immunological system and that his doctor said things that didn't made sense, and that he was actually medical misdiagnosed, which is common to happen to him. Knows people who have heart attacks from the shot. Has heard several people with recent immunization, who got the shot, had heart attacks.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I developed a sore arm a few hours after administration. The soreness was at its worst the following morning when I woke up; I was barely able to lift my arm above my shoulder. It took about 2-3 days for the soreness to completely go away.
Arm was red, swollen, warm to touch Md gave patient KEFLEX 500 mg one twice a day for 5 days. Md told patient it could be infected.
Onset of symptoms of myasthenia gravis started after receiving 1st GARDASIL vaccine on 4-12-10. Patient being treated at hospital where they suspect symptoms are related to GARDASIL (ocular myasthenia gravis).
Flu like symptoms Joint pain Sinuous and ear pressure Mild fever All started at about 9am the 27th of May  Extra strength Excedrin taken to every 6 hours as needed  All symptoms still present as of 1pm May 28th just much more mild and manageable without pain medication
This case was reported by a consumer and described the occurrence of mitochondrial dysfunction in a male subject of unspecified age who was vaccinated with PEDIARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included jaundice. There was no concurrent medications. On 24 May 2006 the subject received unspecified dose of PEDIARIX (unknown). At an unspecified time after vaccination with PEDIARIX, the subject experienced mitochondrial dysfunction, immunological reaction, "eye contact", "speech problems", diarrhea, "skin issues" and "greater than 100 titer levels of hepatitis B". It was found upon testing, that the subject had greater than 100 titer levels of hepatitis B. The subject had a severe immune reaction and mitochondrial dysfunction. The mother of the subject inquired how to treat the enormous titer levels. The subject currently is 4-years old. This case was assessed as medically serious by GSK. The subject was treated with TYLENOL. At the time of reporting the mitochondrial dysfunction and immunological reaction were unresolved; eye disorder, speaking problem, diarrhea and skin problem were unspecified.
w/in 1hr of vax pt developed single hive on the hand then face & then diffuse blotchy urticarial rxn;edema hands, fever intermittent urticaria;lt thigh inc erythema;
Patient c/o left cheek feeling "sore/numb" that he "can't control it" and occasional twitching 5d after receiving vaccination. Denies other neurologic symptoms. Referred to ER for evaluation.
My daughter received her first covid vaccine on 11/30/2021.  Two days following her first dose, she had a runny nose and congestion for approximately 3 days.  She just received her 2nd dose yesterday.  She has the typical symptoms of a low grade fever and fatigue, but again has nasal congestion and a runny nose.  I don't see that nasal congestion/runny nose is a typical response.
severe headache, sneezing, coughing, chills, fever, diarrhea, vomit (1 episode), nausea, dizziness, body ache  I was prescribed  Dicyclomine, Metronidazole, Ondansetron and Methylprednisolone
Since I received the shot I have not felt ok. I almost feel like I have been poisoned. Horrible pain in my left arm shoulder and neck. High fever, sweating and tightness in my throat and neck when I woke up. Every joint in my body feels swollen and a head ache like I have never had before.  I absolutely did not want to get it and clearly I should have listened to my gut telling me not to.  I am pretty positive I had covid before the stay at home order but no one was saying anything yet.  I can?t even get out of bed snd cannot stop dry heaving. This is absolutely crazy snd I
still feels very odd; off balance like feeling kind of drunk.; allergic reaction to antibiotic.; dizziness; lost of balance; headache; was very tired the whole day; nausea; little bit of headache; acial flushing; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (acial flushing), DIZZINESS (dizziness), BALANCE DISORDER (lost of balance), FEELING ABNORMAL (still feels very odd) and FEELING DRUNK (off balance like feeling kind of drunk.) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for an unknown indication.    Concurrent medical conditions included Allergy to antibiotic (no medication history reported). Concomitant products included TAMOXIFEN for Breast cancer, MAGNESIUM, CALCIUM and MINOCYCLINE for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose. On 24-Feb-2021, the patient experienced FLUSHING (acial flushing) and HEADACHE (little bit of headache). On 25-Feb-2021, the patient experienced FATIGUE (was very tired the whole day) and NAUSEA (nausea). On 26-Feb-2021, the patient experienced DIZZINESS (dizziness), BALANCE DISORDER (lost of balance) and HEADACHE (headache). On 27-Feb-2021, the patient experienced FEELING ABNORMAL (still feels very odd), FEELING DRUNK (off balance like feeling kind of drunk.) and DRUG HYPERSENSITIVITY (allergic reaction to antibiotic.). At the time of the report, FLUSHING (acial flushing), DIZZINESS (dizziness), BALANCE DISORDER (lost of balance), FEELING ABNORMAL (still feels very odd), FEELING DRUNK (off balance like feeling kind of drunk.), DRUG HYPERSENSITIVITY (allergic reaction to antibiotic.), FATIGUE (was very tired the whole day), NAUSEA (nausea), HEADACHE (headache) and HEADACHE (little bit of headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Tylenol tablet was taken as treatment. received the first dose of the Moderna vaccine on Wednesday, 24Feb2021 on her RIGHT deltoid. She had facial flushing and a little bit of headache. On Thursday, she was very tired the whole day. Then yesterday, was fine but had a sudden wave of nausea, dizziness, headache and lost of balance that continued until today. She said that she still feels very odd, her head feels foggy and off balance like feeling kind of drunk. She has allergic reaction to antibiotic.
Spoke with Pt on 1/21/20 to remind her to complete her Twinrix series.  It sounds like she is experiencing SIRVA.  Her arm is still hurting down to her elbow.
Vomiting; This is a spontaneous report from a contactable consumer (patient). This 72-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in right arm on 11Feb2021 15:00 (batch/lot number: EL9262; expiration date: 31May2021) as a single dose for covid-19 immunization. The patients medical history and concomitant medications were not reported. The patient previously had BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in right arm on 21Jan2021 15:00 (batch/lot number: EL9261; expiration date: Apr2021) as a single dose for covid-19 immunization. On 14Feb2021, at 03:00, the patient experienced vomiting, after the second Dose on 11Feb2021 at 3PM, the reaction vomiting happened on the 3rd day being sunday morning. She woke up at 3AM vomiting and continued to vomit. She could not keep anything down for 24 hours. She didn't know if it had to do with the vaccine, when it passed she actually saw it online. She never had vomiting like that in her life. She could not even hold down ice cubes or water. She has learned that was better to have something in the stomach to throw up, then nothing and so she would eat a cracker. Caller clarified that the vomiting started at 3AM on 14Feb2021 going into the early hours of 15Feb2021. She was able to eat breakfast on the 15Feb2021 Monday. She initially provided her weight at 130, but then stated to put 135, she knows she was not that heavy but would rather be on the heavy side. On 15Feb2021 Monday, she was iffy and only had toast, tea, anything that stayed up and would keep it from upsetting the stomach. She had no other vaccines on the same day or 4 weeks prior. She did not have any ER visit. She did not visit her doctors office but only called them. She has no relevant family medical history that she would like to provide. Caller also complained about the Pfizer reporting website online, she tried on Monday because there were 36 people ahead of her, the online forms ask so many questions, they need to simplify it, it was asking for information like addresses and thing that she did not have, and it would not let her skip it or move on without plugging in the information. Caller again stated that the online report does not allow to skip questions. She even tried to auto fill information, but it did not work. Caller has no reference number from the online reporting. She did not complete it. The outcome of the event vomiting was recovered on 15Feb2021.