chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It put him to sleep for 14 hours, woke up for an hour and went back to sleep for 5 more hours,  just want to sleep; Very lethargic; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SOMNOLENCE (It put him to sleep for 14 hours, woke up for an hour and went back to sleep for 5 more hours,  just want to sleep) and LETHARGY (Very lethargic) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 043B21A) for COVID-19 vaccination.     Concurrent medical conditions included Memory disturbance (Patient is taking memory pill). Concomitant products included APOAEQUORIN (PREVAGEN [APOAEQUORIN]) for Memory disturbance, SERTRALINE, LOSARTAN, ATORVASTATIN, VITAMIN D NOS, FAMOTIDINE, FISH OIL, TOPIRAMATE, ACETYLSALICYLIC ACID (BABY ASPIRIN) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced SOMNOLENCE (It put him to sleep for 14 hours, woke up for an hour and went back to sleep for 5 more hours,  just want to sleep) and LETHARGY (Very lethargic). The patient was treated with IRON for Iron supplementation, at an unspecified dose and frequency and ASCORBIC ACID (VIT C) for Vitamin C supplementation, at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (It put him to sleep for 14 hours, woke up for an hour and went back to sleep for 5 more hours,  just want to sleep) and LETHARGY (Very lethargic) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable.  The patient consulted his Doctor who did a CT scan of his brain as well as checked his B12 and Iron levels.
BREAKTHROUGH COVID: FULLY VACCINATED WITH PFISER, COVID test positive. 87-year-old male with history of NSTEMI, decompensated heart failure, presenting with shortness of breath x 1 week and diarrhea, with   Continues to have bothersome diarrhea on scheduled Immodium. GRANDSON WAS NOTED TO HAVE COVID 2 WEEKS AGO, COUGHING WAS NOTED AT ADMISSION. PT INIALLY REFUSED COVID TESTING. PT WAS TREATED FOR KNOWN SXS.
constant back pain that started on April 11 presented to ER on April 19 for back pain and abdominal pain, afraid that she has a clot a few days ago, started having shortness of breath and left leg pain that radiates to the left groin
3 cm red, raised, lesion with very small blisters (3), on left thigh - from varicella vaccine, started 8/28/11. F/u appt 9-14-11. Greater than 50% of this 30 minute visit was spent in counseling and coordination of care as summarized here: REk of varicella reaction and discussion of behavior issues. He had some mild varicella lesions that spread to his buttocks but these are resolving. Mom reports he has started some oppositional defiant behaviors, sometimes lying, some stealing. School performance has declined. We discussed options for getting him some more male interaction as well as getting some one on one time with mom. Consider eval for attention deficit but this seems unlikely. Consider family counseling but resources for this are limited.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of influenza like illness (1st dose, refer case US2018145428). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient's friend reported this case. The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The patient experienced flu like symptoms that lasted a day or two. This reporter had not yet received the vaccine. The reporter denied permission to contact their physician. The reporter declined to provide any additional information and said she would tell her friends to call the global response center (GRC). The reporter declined follow up contact. This case has been linked to US2018GSK150389 and US2018GSK150390, reported by the same reporter.
Broke out in hives all over morning after imms given. Possible from imms or other environmental source. Hives continued to come & go for 3 days after. No hives this morning. Instructed to call for appt hives return. Given BENADRYL q6hrs.
Patient received vaccine at 12:30pm, at 12:35 pm, patient felt dizzy and felt like he had a lump in his throat that made it hard to swallow.  Upon assessment, patient had constricted pupils, skin was cold and clammy.  Patient respirations were rapid but unlabored.  Nurse administered 25mg of benadryl and had patient drink Pepsi while waiting for an ambulance.   Ambulance arrived at 12:52 and assessed patient.  At 13:09, patient refused vital signs by squad and refused to be evaluated at hospital, stating he was feeling much better and thinks he just had an anxiety attack due to witnessing another patient have a reaction.  Patient stayed onsite with nurse until 14:00, when he called someone to come drive him home.  Patient texted nurse at 15:40 stating he arrived home safely and felt fine.
Slight swelling of left lymph node within 20 minutes of injection, resolved overnight. Swelling and pain and redness at injection site with diameter of 1.5 inches for redness, and 3 inches for swelling  continued for 4 days ?through 11/17.  Redness has subsided on 5th day (11/18)  swelling still present 1 inch around injection site.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 84-year-old female patient who received SHINGRIX for prophylaxis. On 8th March 2018, the patient received the 1st dose of SHINGRIX. On 21st March 2018, 13 days after receiving SHINGRIX, the patient experienced shingles. The patient was treated with VALTREX. On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported that the patient reported Shingles outbreak that began within 3 weeks after receiving SHINGRIX. The event resolved with VALTREX. On 28th August 2018, the 2nd dose was given with no reaction. The healthcare professional did not have lot number or expiry date. The reporter did not consent to follow up.
Pfizer-BioNTech COVID-19 Vaccine EUA  - started feeling somewhat unwell app. 8 h after vaccine - started having a fever app 10-12 h after vaccine. Fever was highest app. 24 h after vaccine (38.9C). Fever disappeared app. 38 h after vaccine. Somewhat raised temperature (0.5 - 1 C more than normal for another 12h. - lots of vomiting (5x?), temporarily unable to retain fluids, unable to eat, app. 20 h - 36 h after vaccine  - headache 12 h - 50 h after vaccine, despite hydrating whenever possible. - sweats, weakness, dizziness when not resting 40 h - 48 h after vaccine
2.5-3 inch rectangle Black and blue circle with redness showing up next morning under and behind the bruised area. It was swollen and sore to touch.
This spontaneous report was received from a registered nurse refers to a patient of unknown age (gender unspecified). On 20-FEB-2013, the patient was inadvertently vaccinated with a dose of live ZOSTAVAX, (lot number, expiry date and route was reported) as opposed to live (Merck) VARIVAX. Concomitant medications were not reported. No adverse effect was reported. This is one of the three reports received from the same reporter. Additional information has been requested.
feeling a little tingling; bad headache from eyebrows into her teeth, both upper and lower teeth are aching, and into the back of her neck; could not stand the pain; This is a spontaneous report from a contactable consumer (patient). A 83-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6201; Expiration Date: Jun2021) via an unspecified route of administration, administered in right arm on 23Feb2021 13:30 (at the age of 83-year-old) as dose 1, single for COVID-19 immunisation. Medical history included arthritis from an unknown date and unknown if ongoing, normally has headaches, like sinus headaches, sinus conditions and pain from an unknown date and unknown if ongoing. Concomitant medication included Tylenol taken for arthritis and pain. On 23Feb2021, the patient experienced bad headache from eyebrows into her teeth, both upper and lower teeth are aching, and into the back of her neck. Patient normally takes Tylenol for Arthritis and the person who gave the patient the COVID vaccine, told her to try not to take the Tylenol, but patient could not stand the pain, so at 18:30 or 19:00 last night (on 23Feb2021), the patient took some Tylenol. Patient was wondering if she was doing okay by taking the Tylenol to help alleviate the pain. She has headaches, like sinus headaches, daily. She takes a couple Tylenol and on a CPAP machine to help with her headaches, but her typical headache was not to the degree that she had yesterday. she did get a notice for her next appointment for the second dose, for 16MAR2021.Patient stated that the headache reoccurred at 6:00 this morning (on 24Feb2021) and she took Tylenol and now she was feeling a little tingling. Patient had no other vaccines on the same day as her COVID vaccine. Outcome of the event bad headache from eyebrows into her teeth, both upper and lower teeth are aching, and into the back of her neck was recovering, outcome of pain and feeling a little tingling was unknown at the time of reporting  No follow-up attempts are possible. No further information is expected.
Patient fainted about 2 minutes after receiving vaccine. She experience nausea, dizziness , and a moment of confusion.  Patient stated at pharmacy for 1 hour after episode. She was given water and crackers but refused other medical attention.  Patient denied shortness of breath: difficulty breathing. Checked patients blood pressure. It was 144/74. Patient left pharmacy after 1 hour. She called when she make it home. She said she was still a little dizzy and nauseous. She had vomited. I asked patient if she was alone or if someone was there with her. She stated her sister is a nurse and was with her.  Will follow up with patient on 3/10/21
Erythema and swelling of face, trunk and extremities - woke with symptoms day after vaccine.
Initial report was received 07 October 2009 from a consumer, who is the patient's parent. A three-year-old male patient with no concurrent illness and a history of hay fever, had received an Influenza vaccine (intramuscular, lot number, route and site not reported) on 28 September 2009, and eight days later, he developed a fever (temperature not reported). The patient had no other symptoms. The patient was evaluated by their pediatrician who performed an unspecified "flu test" which was positive for Influenza A. According to the reporter, the physician diagnosed her son with the flu and told her that it was "probably H1N1 since he had seasonal vaccine". The patient received TAMIFLU as corrective treatment. Recovery status was not reported. Documents held by sender: None.
Continuous mild headache; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 49-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 26Feb2021 at 16:30 (at the age of 49-years-old), as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the right arm on 05Feb2021 at 16:30 (at the age of 49-years-old), as a single dose for COVID-19 immunisation. On 28Feb2021 at 12:00, after the second COVID vaccination, the patient experienced continuous mild headache. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event continuous mild headache was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
fatigue, fever, muscle ache, fully body chills, headache, pain at injection site
Fever of 100.7, moderate to severe headache, body aches everywhere, malaise
Information has been received from a registered nurse concerning a 6 year old white female who on 21-JUN-2000 was vaccinated with a dose of Varivax (lot # 634844/1869J). Subsequently, the patient experienced varicella vaccine failure. No further information was provided. Additional information has been requested.
Information has been received from a 27 year old female who on 28-JUN-2007 was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL. The consumer reported that she became pregnant after receiving a dose of GARDASIL. The consumer also reported that "she started cramping", but it is "getting better." She reported that "she does not think that this is related to GARDASIL. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/8/2008. Information has been received from a 17 year old female through the Merck pregnancy registry for GARDASIL who on 28-JUN-2007 was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL. The consumer reported that she became pregnant after receiving a dose of GARDASIL (LMP 26-JUL-2007). The consumer also reported that "she started cramping", but it is "getting better." She reported that "she does not think that this is related to GARDASIL. In follow up from the patient's physician's office it was reported that the patient vaginally delivered full term, healthy, normal infant weighing 6 pounds, 6 ounces. It was reported that the patient was treated (unspecified) for preterm labor during the pregnancy, however delivered full-term. The patient was also treated for preterm labor during her first pregnancy. No further information is expected.
Heart is fluttering; Erratic heartbeat; Feeling a distress in the chest; Feeling like a "bu-bump, bu-bump"; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Heart is fluttering) and ARRHYTHMIA (Erratic heartbeat) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CARDIAC FLUTTER (Heart is fluttering) (seriousness criterion medically significant), ARRHYTHMIA (Erratic heartbeat) (seriousness criterion medically significant), CHEST DISCOMFORT (Feeling a distress in the chest) and FEELING ABNORMAL (Feeling like a "bu-bump, bu-bump"). At the time of the report, CARDIAC FLUTTER (Heart is fluttering), ARRHYTHMIA (Erratic heartbeat), CHEST DISCOMFORT (Feeling a distress in the chest) and FEELING ABNORMAL (Feeling like a "bu-bump, bu-bump") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. The patient reported that he was experiencing heart fluttering (2 or 3 times a day); at least twice a day, usually in the morning, he was feeling a distress in the chest, like a "bu-bump, bu-bump" for the last week and a half, along with erratic heartbeat, but not shortness of breath. The patient stated that he never felt this before. Treatment information was unknown.  Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded.
Information has been received from a pharmacist concerning his daughter (age unknown), who, on an unspecified date, was vaccinated with a dose of Gardasil. Subsequently, the patient experienced nausea for two days. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Within  a couple of hours had high temperature (102.7 F fever)then had chills. Diarrhea, couldn't fall asleep because of the horrible chills for days. Headache that only lasted for the first day on and off. Didn't leave the house because he was feeling too weak. Runny nose for the first three days after the vaccine. Nausea but no vomiting for about three days after the the shot. Lost about 10 pounds couldn't eat anything. Forced himself to eat.
After vaccine administration, pt experienced severe diarrhea with incontinence.; After vaccine administration, pt experienced severe diarrhea with incontinence.; This is a spontaneous report from a non-contactable pharmacist. A 78-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EK5730, intramuscular from 16Dec2020 to 16Dec2020 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. After vaccine administration on 16Dec2020, The patient experienced severe diarrhea with incontinence. The outcome of the events was unknown.  No follow up attempts are possible. No further information is expected.
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was  refrigerated packaging tote to maintain a temperature of 36 F - 46 F. However, that is not approved for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Left upper arm with 4 in x 3 in area of slight erythema and warmth, no tenderness. Likely large weal inflammatory reading.
The patient experienced swelling at the injection site.  The swelling occurred at the upper arm.  The patients arm was hot as well.
This spontaneous report was received from a health professional refers to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported.  Nurse reported that on 22-AUG-2017 the expired PROQUAD lot # M007963 and expiry date 15-AUG-2017(Dose,frequency,route unknown) was given to a patient for prophylaxis. o adverse effects.
patient received an expired dose, with no reported adverse event; Initial information was received on 29-Oct-2021 regarding an unsolicited valid non-serious case from an other health professional via consumer via phone call (under  Medical Information Inquiry Number: 00834434) in a specific country.  This case involves a 48 years old female patient who received an expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] with no reported adverse event (expired product administered).  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.   On 29-Oct-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (prefilled) (lot number: UT7108KA and expiry date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency: same day).  It was reported "How do we handle it; health care professional (HCP) reporting a patient who received an expired dose of FLUZONE QUADRIVALENT (prefilled); caller would like counselling on revaccination process and adverse effects to look out for."  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Hands turned bright red and swollen, resolved the next day.  Continued sick feeling weeks afterwards.
Rigors, fever, cold sweat began 12 hours after injection.  Subsided the next morning. Body Aches and head ache until 24 hours post vaccination, then all symptoms resolved.
Vaccine was given to the pt, asked if he was ok. He stated he felt good. Mom headed to check out with patient & while at check out patient went down, hit his head off the wall. Patient was brought back with smelling salts, (PA) reevaluated the patient.
On June 26th (11 days after 2nd COVID shot) my left arm became cold & numb from the elbow down.  Went to ER.