chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 12 year old female who on an unspecified date was vaccinated with a booster dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient experienced a "neurological event." Unspecified medical attention was sought. No other information was provided. There was no product quality complaint involved. Additional information has been requested.
pt recv vax & devel a rash, hives, bronchial problems following vax w/Hep B vax; pt had eaten anchovies @ time of vax; No further details were provided;
COVID-19; First dose taken on 12-Apr-2021 and second dose on 18-May-2021; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose taken on 12-Apr-2021 and second dose on 18-May-2021) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0220ZIA and 037BZIA) for COVID-19 vaccination.  Patient had no allergies to medications, food, and other products. Patient had no acute illnesses at the time of vaccination and up to one month before. Patient had no chronic or long-standing health conditions Patient did not took prescriptions, over-the-counter medications, dietary supplements, or herbal remedies at time of vaccination.  On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose taken on 12-Apr-2021 and second dose on 18-May-2021). On 15-Oct-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose taken on 12-Apr-2021 and second dose on 18-May-2021) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Oct-2021, SARS-CoV-2 test: positive (Positive) Positive.  Both doses of mRNA-1273 (Moderna COVID-19 Vaccine) was received on arm. It was unknown if there were any other potential causes. No treatment medications were reported.  Company Comment: This is a Spontaneous case concerning a 56-year-old male patient, with no medical history reported, who experienced the unexpected, non-serious, and AESI of COVID-19. The event occurred approximately 5 months after the second dose of mRNA-1273 vaccine. Inappropriate schedule of product administration was noted, as doses were given 36 days apart. SARS-CoV-2 test was performed, with positive result. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-117988 (Patient Link).; Sender's Comments: This is a Spontaneous case concerning a 56-year-old male patient, with no medical history reported, who experienced the unexpected, non-serious, and AESI of COVID-19. The event occurred approximately 5 months after the second dose of mRNA-1273 vaccine. Inappropriate schedule of product administration was noted, as doses were given 36 days apart. SARS-CoV-2 test was performed, with positive result. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
fever (101.0) chills body Aches and joint pain when walking.  headache and loss of appetite
After1st vaccine severe flatus, after 2nd vaccine chronic diarrhea; loose watery stools q 2hrs with onset 02/15/2021  . No other s/s. No improvement with OTC medicine and diet.   Telemedicine appt. pending today with primary care physician.
Beginning Jan/24/06 pt woke in middle of night with dizziness, continued each day with increasing dizziness. Eye could not focus, felt like they were drawing to center. This lasted approximately 3 weeks - went to 2 - eye, ear, nose and throat Drs as well as ophthalmologist - was put on acyclovir, still taking. Unable to concentrate - stressful. Was put on acylcoivr 21 day. Still taking. Pt still has dizziness at night -sometimes day- Prescribed 2nd prescription was diagnosed with viral inner ear infection on 3/14/06 for 6 wks. Unable to concentrate-stressful. Took acyclovir 21 day. Prescribed 2nd prescription was diagnosed with viral inner ear infection. On 5/14/06 for 6 wks.
Participant was vaccinated with influenza/ Novartis injection while stating she is pregnant. No Adverse reaction occurred.
Dose given more than 6 hours after first vial puncture; This spontaneous case was reported by a health care professional and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Dose given more than 6 hours after first vial puncture) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Dose given more than 6 hours after first vial puncture). On 13-Mar-2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Dose given more than 6 hours after first vial puncture) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and Treatment medications were not provided by reporter.
Case number PHEH2014US019006 is an initial spontaneous report received from a consumer on 19 Sep 2014. This report refers to a 74 year old female patient. Her past medical history and concomitant medications were not reported. On 03 Sep 2014, she was vaccinated with FLUCELVAX (batch number: not reported) intramuscularly into her arm. On the same ay, after the vaccination, she developed hotness and itching on her arm at the site of injection. She completely recovered from the vents on 10 Sep 2014. The seriousness and causality of the events were not reported.
I became itchy all over and had a hives near the injection sight.  Breathing was slightly labored.  I took Benadryl and felt better.
Since the vaccination, has the patient been tested for COVID-19?:Yes; Since the vaccination, has the patient been tested for COVID-19?:Yes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2022 as dose 1, single (Batch/Lot number: unknown), in left arm and on 15Apr2022 at 11:00 as dose 2, single (Batch/Lot number: unknown) at the age of 24 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. 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 "Since the vaccination, has the patient been tested for COVID-19?:Yes". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (23Dec2021) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No known allergies. The patient did not receive any other vaccine in four weeks. The patient received other medications in two weeks was Nikki Birth Control. Patient received treatment of carvedilol and amlodipine Patient did not have covid prior vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Child with difficulty breathing, swelling to lip and tongue, shaking, red skin, and tight jaw - mother's report. Mother gave Benadryl and took to ER (5 min) and no respiratory distress noted by ER, but given prednisolone and another dose of Benadryl. Tachycardia noted and erythema to skin.
Enormous Swelling at injection site, fever of 101F, headache, body aches and pains. - Chicken Pox first appeared on Sunday, May 28, 2011.
Upper arm became extremely painful and within a couple hours I could not lift the arm. Am still putting ice on it per my doctor.
More breathing problems than normal/gasping; Oxygen level down to 80 after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (More breathing problems than normal/gasping) and OXYGEN SATURATION DECREASED (Oxygen level down to 80 after 1st dose) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2021 and Liver transplant. Concurrent medical conditions included COPD and Emphysema.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced DYSPNOEA (More breathing problems than normal/gasping) (seriousness criterion hospitalization) and OXYGEN SATURATION DECREASED (Oxygen level down to 80 after 1st dose) (seriousness criterion hospitalization). At the time of the report, DYSPNOEA (More breathing problems than normal/gasping) and OXYGEN SATURATION DECREASED (Oxygen level down to 80 after 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment included oxygen.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The patient's medical history of COPD and COVID-19 infection are confounders; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The patient's medical history of COPD and COVID-19 infection are confounders
Rash at injection site. Red swollen and itches. It is about 6 inches in length and about 4-5 inches in width
patient got the flu and it turned into double pneumonia; patient got the flu and it turned into double pneumonia; Initial information received on 01-Dec-2020 regarding an unsolicited valid serious case from a consumer (patient) via social media.  This case involves a patient (unknown demography) who got the flu (influenza) and it turned into double pneumonia (pneumonia), after receiving INFLUENZA VACCINE.  The patient's past vaccinations included flu shot for about 6 years and ended up sick.  Medical history, medical treatment(s), concomitant medication(s) and family history were not provided.   On an unknown date in 2001, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date in 2001, the patient developed flu (influenza) and it turned into double pneumonia (pneumonia) (serious), (unknown latency) following the administration of INFLUENZA VACCINE. The event pneumonia was assessed as medically significant.  Patient had not taken flu shot since then. This year patient was contracted with COVID-19 (coronavirus disease) and still not taking a flu shot.  No laboratory data reported.    It was not reported if the patient received a corrective treatment.  At the time of reports, the outcome was unknown for influenza and pneumonia.  Information on the batch number to be requested for this case.; Sender's Comments: This case involves patient of unknown demographics who presented with influenza and pneumonia, after vaccination with INFLUENZA VACCINE. The patient's past vaccinations included flu shot for about 6 years and always ended up sick. The time to onset is unknown in current scenario. Moreover, patient's medical condition at the time of vaccination and lab tests were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Patient signed up for  "Pfizer 2nd dose" appt, arrived at appt and indicated with limited english that 1st dose was received elsewhere; after receiving dose of Pfizer, patient provided previous record card which indicated that the 1st dose was Moderna. Mixed-series error was explained to patient. Patient had no adverse effects during 15 minute observation, and indicated understanding that he did not need to repeat either series.
Extreme Headache,  chills, extreme  body aches, felt like fever, body sweats.
Felt very hot and fainted shortly after waking in the night, lost consciousness for several minutes, and struggled to get back up without help for about 20 minutes after regaining consciousness.  Was able to stand again after resting, cooling, and consuming water. Voluntarily visited an urgent care facility for evaluation as no other walk-in clinic was open. Nearly fainted again while sitting in waiting area and needed to lie down. Vitals and other test results were normal. Diagnosed as vasovagal syncope potentially relating to stress and discomfort from more typical vaccine side effects and instructed to hydrate and rest. Left clinic and suffered no further events after 8-9am.
3 people that were fully vaccinated with the Pfizer covid 19 vaccine and have contracted covid.; 3 people that were fully vaccinated with the Pfizer covid 19 vaccine and have contracted covid.; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: en5318), via an unspecified route of administration on an unspecified date and second dose of bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: el8982), via an unspecified route of administration on an unspecified date as SINGLE DOSE, for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, on unspecified date, the reporter had 3 people that were fully vaccinated with the Pfizer covid 19 vaccine and had contracted covid. He asked if there were any issues with specific lot numbers: el8982, en5318. He did not have any information to provide for the people. The seriousness of the events reported as non-serious by reporter. The outcome of the events was reported as unknown.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and the suspect vaccine,Linked Report(s) : US-PFIZER INC-2021669273 same reporter/drug/event, different patient;US-PFIZER INC-2021665561 same reporter/drug/event, different patient
Information has been received from a registered nurse concerning a 5 year old male pt who was vaccinated with his first dose of MMR II. Subsequently, the pt developed mumps-like symptoms, including regional lymphadenopathy. No further info was available. Unspecified medical attention was sought. Additional info has been requested.
Shortly after vaccination patient reporting nausea, chills, and headache and later developed arm and shoulder pain. Nausea, chills, and headache sooner resolved but arm pain persisted. Two days after vaccination primary care provider prescribed naproxen and tramadol and instructed patient to take acetaminophen. Two weeks after initial primary care provider visit patient returned with continued shoulder pain. Diagnosed with subacromial bursitis and provider recommended corticosteroid injections.
Weakness; Joint pain; Dizziness; Tiredness; Headache; Swollen lymph nodes; Feeling unwell; Muscle pain; A bad rash; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The consumer reported the side effects included dizziness and weakness, a bad rash on the patient's "right leg where it was given in his/her right arm" (not clarified further), tiredness, headache, muscle pain, joint pain, feeling unwell and swollen lymph nodes. The outcome of the events was unknown.  Information on lot/batch number has been requested.
At 11:51 AM, RN administered 0.1cc dose of Jynneos vaccine Lot # FDP000014 exp date 11/17/2023 via intradermal route to right arm to patient, age 58 and a wheal was not produced. RN notified clinic lead nurse, PHN regarding incident and per clinical guidance was instructed to give a 2nd dose. Patient requested to get 2nd dose on left arm. Educated patient that because no wheal was produced, a repeat dose must be placed to the other arm or 2 inches away from the 1st dose. Patient verbalized understanding. RN re-administered another dose of 0.1cc of Jynneos Lot #  FDP000014 exp date 11/17/2023 left arm and a wheal was produced. Patient was educated to observe for adverse reactions.
I started feeling nauseous, diarrhea, headache and some symptoms from Covid. It was continuous it didn't just come and go for a few days. I called my Dr. and she had me follow the Covid protocol. Dr. had the same symptoms I did and had COVID but I tested negative both times. After 2nd test I went back to work and by that time I didn't have any symptoms. The only thing I wasn't experiencing was the fever.
Dr asked me to give 4 immunizations: Dtap, HIB, PCV-7 and MMR. We both checked the electronic medical record prior to determining the need for vaccination. After all vaccines were administered I noted in the patient's personal blue book/personal record that the 4th PCV-7 had been given on 1/20/06. So today's dose was unnecessary. Once the error was recognized Dr. was notified as well as the family. The director of Clinical Services was also informed. A call was placed to the manufacturer of Prevnar (PCV-7). The family was informed of all possible side effects of receiving a 5th dose of PCV-7. We will also follow-up with the family within one weeks time. In the interim, the family will call the health center with any questions or concerns. No adverse events occured. Patient received an extra dose of PCV 7
Patient developed extreme tachycardia after COVID infection which resolved after a few months. After receiving both Pfizer COVID vaccines tachycardia returned and patient has had difficult time controlling.
Patient broke out in hives on the legs, arms, and neck. Patient was given Benadryl, she is getting better now. Was taken to Urgent care on 10/4/21
From initial information received on 1/4/05 from a health care professional regarding an adverse event occurring in the USA, it was reported that a male patient in his 50's received a dose of FLUZONE administered on an unspecified date. The lot number, route and site of administration were not reported. Four hours later, the patient experienced a severe hypoglycemic attack. Per the reporter, he refused to be transferred to the hospital. Twelve hours later, the patient had a cardiac arrest and was found dead. Reportedly, the patient had Type I Diabetes, but was non-compliant. Discharge Summary received on 1/20/2005 states past ischemic injury and myocardial fibrosis.
Information has been received from a licensed practical nurse concerning a female patient who in approximately 2202 was vaccinated with a second dose of varicella virus vaccine live.  The nurse reported vaccine failure and indicated that a person off the street came in to ask for a vaccination of varicella virus vaccine live.  The patient explained that she had the vaccine twice before, and as recently as two years prior, but still had a negative titer.  Unspecified medical attention was sought and no treatment was required.  A product quality complaint was not involved.  Additional information has been requested.
On the 7th day a red rash also appeared on legs; Tenderness, redness and swelling on both breasts; Tenderness, redness and swelling on both breasts; Tenderness, redness and swelling on both breasts; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 26Apr2021 at 14:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included ductal carcinoma in situ (DCIS) in 2011 and recent urinary tract infection (UTI); both were unknown if ongoing and it was reported that she had implants due to breast reconstruction in 2011 following a bi-lateral mastectomy. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included unspecified antibiotics for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 04Apr2021 at 12:45 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. On 01May2021 at 15:00, 5 days after the second dose, the patient experienced tenderness, redness and swelling on both breasts. On 03May2021, 7 day after the vaccination, the patient had red rash appeared on her legs. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with unspecified antibiotics where her doctor feared for possible infection. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tenderness, redness and swelling on both breasts and red rash appeared on her legs was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
pt recv vax AUG96 & pt became itchy;No further details were provided;
This spontaneous report as received from a registered nurse refers to a 13 months old male patient with no pertinent medical history. The patient was vaccinated with a dose of VARIVAX (merck) on 05-JUN-2012 (Lot# reported as 0262AE, dose and route not reported). Other suspect therapies included M-M-R II and VAQTA. Concomitant medications included: PREVNAR 13. On 11-JUL-2012 the patient developed less than 50 vesicular rashes on legs, trunk and arms. The patient had no fever. The patient saw a physician for medical attention. No lab diagnostics studies were performed. No treatment was given. At the time of this report the patient was recovering. Additional information has been requested.
HEART RACING; SLIGHTLY DIZZY/LIGHTHEADED; ANXIETY; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced heart racing. On 09-APR-2021, the subject experienced slightly dizzy/lightheaded. On 09-APR-2021, the subject experienced anxiety. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart racing, slightly dizzy/lightheaded, and anxiety. This report was non-serious.