chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreame chest pain; Become narcoleptic to the point of not being able to sleep less then 16 hours; I had a vein implode in my leg; This spontaneous case was reported by a consumer and describes the occurrence of NARCOLEPSY (Become narcoleptic to the point of not being able to sleep less then 16 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced NARCOLEPSY (Become narcoleptic to the point of not being able to sleep less then 16 hours) (seriousness criterion medically significant) and VEIN COLLAPSE (I had a vein implode in my leg). On an unknown date, the patient experienced CHEST PAIN (Extreame chest pain). At the time of the report, NARCOLEPSY (Become narcoleptic to the point of not being able to sleep less then 16 hours), VEIN COLLAPSE (I had a vein implode in my leg) and CHEST PAIN (Extreame chest pain) outcome was unknown.            Concomitant medications were not reported. Treatment information was not provided.  Company Comment:  This report concerns a patient who experienced an unexpected serious event of narcolepsy and unexpected non serious events of vein collapse and chest pain unknown duration following vaccination with mRNA-1273. It has been reported that the patient has taken both the doses of the vaccine. Very limited information regarding these events has been provided at this time. However, the benefit-risk relationship of mRNA-1273  is not affected by this report.; Sender's Comments: This report concerns a patient who experienced an unexpected serious event of narcolepsy and unexpected non serious events of vein collapse and chest pain unknown duration following vaccination with mRNA-1273. It has been reported that the patient has taken both the doses of the vaccine. Very limited information regarding these events has been provided at this time. However, the benefit-risk relationship of mRNA-1273  is not affected by this report.
Initial report received from a health care professional on 28 June 2010. A 22-year-old female patient, with no known allergies, no illness at the time of vaccination and medical history not available, received on 25 June 2010 an intramuscular injection to the left deltoid of MENACTRA, lot number U3081AA. On 26 June 2010, one day after vaccination, the patient developed a reddened and swollen left arm from the shoulder area to the elbow. The area was warm to the touch. The patient did not receive any vaccinations within 4 weeks prior to the MENACTRA vaccination. She was not seen by a health care professional (HCP) and received no treatment at this time. The outcome was reported as unknown. Documents held by sender: None.
Patient reports she developed severe headache, chest pain and shortness of breath 3 days after receiving the vaccination.  Her symptoms lasted for 2 days.  She did not need to seek medical care.
Information has been received from a physician who heard from the mother of one of his patients that she was told by a pediatric rheumatologist that a patient with a genetic predisposition for lupus (family members had lupus) was vaccinated with GARDASIL and actually came down with lupus as well. The treating rheumatologist was reported to have thought that the vaccine triggered the onset of the disease. Upon internal review, lupus was determined to be an other important medical event. The existence of an identifiable patient and reporter could not be confirmed. No further information is available.
Patient was given flu shot and felt dizzy for minutes later.  Patient looked pale and always kept talking, never fainted.  Patient drank soda and felt better.
given pfizer vaccine after receiving J&J shot on 03/09/21 at other pharmacy
Lightheadedness (immediately), with hours, racing pulse (136), heart palpations, fatigue,  fever of 101 degree, chills and flu-like symptoms, sore arm.
Nasal Swab: Positive; Nasal Swab: Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 20Aug2021 (Lot number: fc3183) at the age of 62 years as dose 1, single and administered in arm left, administration date 10Sep2021 (Lot number: fe3592) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing). Concomitant medication(s) included: BENAZEPRIL; OMEPRAZOLE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Jan2022, outcome "unknown" and all described as "Nasal Swab: Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Jan2022) positive.
Initial information received on 01-Apr-2019 regarding an unsolicited valid non-serious case received from a health care professional. This case involves a five-years-old female patient who received vaccine DAPTACEL. The patients past medical history, treatments and family history were not provided. Concomitant vaccination included Hepatitis A Vaccine on unknown date. On 01-Apr-2019, the patient received a 0.5ml dose of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine lot C5169AA, expiry date 16-Mar-2019 via unknown route in the right anterior lateral thigh. It was an actual medication error due to expired vaccine used. It was reported that patient received a dose of expired DAPTACEL on 01-Apr-2019 which was expired on 16-Mar-2019. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Entire body locked up like a zombie, could barley walk for 2 months. Pain, everywhere in my body. No appetite, ongoing for 6 months. Lost 25 lbs. Cant sleep more then 2 hours at a time, due to pain.. I've been diagnosed with Psoriatic arthritis in right knee. My markers for inflammation are high and stay high. I've been steroids twice, Only thing that seems to help pain. I'm using walker. My right hand and wrist are in extreme pain, Pain seems to move around, My neck locked up in August.
About 5min after receiving Hep A vaccine, patient passed out. Quickly recovered and was awake and alert within seconds.
My son fainted while still in the hallway of the doctor's office about 5 minutes after receiving the shots. He felt it coming so I was holding on to him trying to get to a chair when he fell to the ground. I was able to lay him down gently. He turned very pale. The nurse said it was a reaction to the HPV vaccine. She gave him a pedialite popsicle and he laid there for about 15 minutes and then he was ok.
I had swollen lymph nodes under both arms and knees for weeks; I had swollen lymph nodes under both arms and knees for weeks; fatigued; falling asleep everywhere; first dose administration date=29May2021/second dose administration date=12Jun2021; I can't get motivated; I feel underwhelmed; I'm basically going through the motions. I still feel happy and sad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Jun2021 10:30 (Batch/Lot number: unknown) at the age of 34 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose number: 1,, administration time=10:30 AM,, vaccine location=Left arm), administration date: 29May2021, when the patient was 34 years old, for COVID-19 immunization.  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 12Jun2021, outcome "unknown", described as "first dose administration date=29May2021/second dose administration date=12Jun2021"; LYMPHADENOPATHY (non-serious), JOINT SWELLING (non-serious) all with onset 02Jul2021, outcome "unknown" and all described as "I had swollen lymph nodes under both arms and knees for weeks"; FATIGUE (non-serious) with onset 02Jul2021, outcome "unknown", described as "fatigued"; SOMNOLENCE (non-serious) with onset 02Jul2021, outcome "unknown", described as "falling asleep everywhere"; APATHY (non-serious) with onset 2021, outcome "unknown", described as "I can't get motivated"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "I feel underwhelmed"; DEPRESSED MOOD (non-serious) with onset 2021, outcome "unknown", described as "I'm basically going through the motions. I still feel happy and sad". Therapeutic measures were not taken as a result of lymphadenopathy, joint swelling, fatigue, somnolence, apathy, feeling abnormal, depressed mood.  Additional information: The patient had swollen lymph nodes under both arms and knees for weeks. I was fatigued and falling asleep everywhere. Now it's a few months later and I feel underwhelmed and have little interest in doing things. I'm basically going through the motions. I still feel happy and sad, but I can't get motivated unless I have to. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination. The patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Mother of child states that the child had a rash on arms the day after receiving vaccines, that itched & some whelps. Some raised areas/rash on legs, as well. Mother applied OTC ointment which has helped.
Severe chills for about 6 hours, rapid heart rate at rest (over 100) for about 12 hours, body aches, headache, fatigue
Dizziness immediately after injection, pt passed out for maybe 2-3 secs and regained consciousness, she stated she had ringing in ears for maybe a minute and pt. vomited soon after; paramedics came and assessed pt. after.
Approximately 12 hours after receiving the vaccine I had a terrible headache, chills, joint pain, and extreme fatigue.  The headache, chills and joint pain have subsided, but the fatigue is still very strong. I?ve been sleeping between 18 and 20 hours a day since I?ve received the vaccine. I still do not feel ?normal.?
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 4-year-old patient of unknown gender. On 05-JUN-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N021720, expiration date 10-AUG-2019 (exact dose and route of administration were not reported) for prophylaxis. This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Patient reported anxiety and light headed. Vitals stable. Laid patient down with legs elevated. cold water offered. patient was fine 15 minutes later.
Hospitalized 10.10.21;  COVID-19 positive (10.10.21);  Fully Vaccinated  Admission Date: 10/10/2021 Discharge Date: 10/13/2021 Admitting Diagnoses:  Pneumonia due to COVID-19 virus PRESENTING PROBLEM:  Hypoxia [R09.02] Fever, unspecified fever cause [R50.9] COVID-19 virus detected [U07.1] Pneumonia due to COVID-19 virus [U07.1, J12.82] HOSPITAL COURSE: 96 y.o. woman who presented to ED with a fever and hypoxia.  Patient is a resident at a facility, where she was noticed to have a fever on 10/10/21.  Patient then was transported via EMS to the emergency room.  Workup evaluation was noted to be COVID positive.  Patient did have a previous COVID test on October 3rd and was negative.  At that time patient was transferred from the emergency department was admitted for severe sepsis septic shock and left lower lobe pneumonia.  She was admitted from 10/04 to 10/8 which she was discharged home on Ceftin 1 orally 2 times a day for 7 days.  Patient did have a large party yesterday with multiple siblings she has a large family 13 and all, and felt fine.  Patient on presentation today has no complaints.  She was found to have a O2 sat of 89% in the ER.  She is not usually on supplemental oxygen. She was treated with decadron and Remdesivir for COVID pneumonia. She had mild infiltrates on CXR. She was weaned off supplemental o2 and noted improvement in her symptoms. She was very weak, PT/OT recommended home health which was set up. She was discharged on 10/13/21.
The day after my second covid vaccine shot, I felt run down and tired, weak appetite, and ached all over. But I also have been getting nose bleeds nearly every morning since, today it was particularly bad, took almost 5 minutes to stop.  Waiting to hear back from doctor about what I should do.
'Flu-like  symptoms: muscle and joint ache, particularly upper arms and back, slight fever, headache and dizziness, fatigue
Information has been received from a registered nurse referring to unspecified multiple patients of unknown age and gender. There was no concurrent condition or medical history reported. The nurse reported that improperly stored ROTATEQ (Lot # L008054, expiration date 30-NOV-2016; lot # K023534, expiration date 22-MAY-2016; lot # K023537, expiration date 22-JUN-2016) (dosage, strength and route not reported) were administered to the unspecified multiple patients on unknown dates. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
the patient experienced scar tissue in colon and pain after took covid 19 booster shot; the patient experienced scar tissue in colon and pain after took covid 19 booster shot; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4308065-00.  A 70 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series immunization completed., Unknown manufacturer., Route : Intramuscular), for COVID-19 Vaccination. The following information was reported: GASTROINTESTINAL SCARRING (medically significant), PAIN (medically significant), outcome "recovered" and all described as "the patient experienced scar tissue in colon and pain after took covid 19 booster shot". The action taken for adalimumab was unknown.The patient had scar tissue removed in his colon in 2021.   The reporter's assessment of the causal relationship of the gastrointestinal scarring and pain with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter's assessment of the causal relationship of gastrointestinal scarring and pain with the suspect product Humira was reported as no reasonable possibility.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events gastrointestinal scarring and pain and the use of suspect product BNT162B2 cannot be fully excluded.
Swelling and redness right upper arm between elbow and injection site.  Slightly warm to touch, but no fever (98.8) Arm sore, but minimal pain.  Began Friday evening February 12, 2021 and still ongoing Saturday morning.  Have used acetaminophen, benedryl, ice and heat compresses.   I have reported to hospital and physician.
Complaining of eye pain. Wont open eyes for 20 minutes at a time. Crying because of eye pain.
Developed severe fatigue & shortness of breath within 48 hrs. of vaccine administration. Subsequently admitted to hospital on 9/12/12 with severe cardiomyopathy & acute M.I. Noted pain & swelling at injection site immediately.
Bells Palsy from 02/20/21 to present. Has improved over time, but still not gone
This case was reported by a consumer via call center representative and described the occurrence of viral infection in a 12-month-old male patient who received FLUARIX TETRA 2018-2019 season (batch number AA73L, expiry date unknown) for prophylaxis. On an unknown date, the patient received FLUARIX TETRA 2018-2019 season (intramuscular). On 15th October 2018, 3 days after receiving FLUARIX TETRA 2018-2019 season, the patient experienced viral infection, cold symptoms, fever and sore throat. On an unknown date, the outcome of the viral infection, cold symptoms, fever and sore throat were unknown. It was unknown if the reporter considered the viral infection, cold symptoms, fever and sore throat to be related to FLUARIX TETRA 2018-2019 season. Additional information was reported as follows: The case was reported by the patient's mother. The age at vaccination was not reported. The patient was vaccinated with a Flu vaccine and became ill 3 to 4 days later. The patient experienced viral infection, fever, sore throat and cold symptoms. The patient was seen at the emergency room and was released. The reported batch number AA731 was not found in the sales database, so it was corrected and replaced with the correct one AA73L.
Information has been received from a mother referring to her daughter of unknown age. No concurrent or historical conditions were reported. On an unknown date the patient was vaccinated with M-M-R II (strength, dose, route, lot# and expiration unknown). On an unknown date, the patient developed a high fever and roseola after receiving M-M-R II. The patient was also reported with autism, but it was not specified if she was diagnosed before or after receiving M-M-R II. The outcome of events was unknown. Additional information has been requested.
Extreme pain in the elbow and inflammation/ pain in the elbows and also inflammation in her wrists; Had broken her arm and it is still hurting but not with that intensity; Extreme pain in the elbow and inflammation/ pain in the elbows and also inflammation in her wrists; This is a spontaneous report from a non-contactable consumer (patient herself). A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 10Feb2021 as dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient called for information about if extreme pain in the elbow and inflammation are common side-effects. She reported that she was administered with the first dose of the vaccine on 10Feb2021 and she reported that she experienced an extreme pain in the elbow that she reported to be like she had broken her arm and it was still hurting but not with that intensity.  She reported that a friend of her also developed pain in the elbows and also inflammation in her wrists. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
anaphylactic reaction; Initial information received on 02-Sep-2020 regarding an unsolicited valid serious case received from a consumer (patient).  This case involves male patient of an unknown age who experienced anaphylactic reaction, while he received INFLUENZA VACCINE.  Medical treatment, vaccination and family history were not provided.  At the time of the event, the patient had ongoing medical history of allergic to eggs (food allergy) and Chronic obstructive pulmonary disease (COPD).  Concomitant medication was not reported.  On an unknown date (reported that 20 years ago), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious anaphylactic reaction (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It was also reported that the consumer also inquired besides injection site tenderness, were there any other side effects. The consumer also reported he has Chronic obstructive pulmonary and wanted to know if FLUBLOK is recommended and if we have any vendor/pharmacy information on where he can get the FLUBLOK vaccine, as he doesn't want to have to worry about the flu and coronavirus disease (COVID 19).  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event anaphylactic reaction was reported as unknown.  Information on the batch number was requested.; Sender's Comments: This case involves a male patient who presented with anaphylactic reaction after vaccination with INFLUENZA VACCINE from unknown manufacturer. The time to onset is unknown. Patient had medical history of being allergic to eggs, and chronic obstructive pulmonary disease at time of vaccination. Additional information on patient's concomitant medication and investigations ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.