chrisvoncsefalvay/vaers-outcomes huggingface dataset:
head itching on right side; This is a spontaneous report from a non-contactable health care professional. A 65-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on an unspecified date (lot number was not reported) (at the age of 65-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had a mild reaction to the first COVID vaccine which included head itching on right side which resolved without medication. The outcome of the event was recovered on an unknown date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Adverse effects began January 28th, the day after the 2nd dose of Moderna was administered.  Upon awaking that morning , the first symptoms were extreme fatigue, body aches and fever. This persisted throughout the day, afternoon and evening. .  Fever persisted at around  101.  The treatment was, sleeping and resting in bed and drinking fluids.  When waking on January 29th fever was gone and energy level close to normal, body aches were gone.
Patient's date of birth was wrong in his chart and on his consent form. Patient's brother's DOB was listed. Patient received the Pfizer Bivalent booster for 5-11 year olds when he should have received the 12 years and older vaccine.
This spontaneous report as received from a healthcare worker refers to unknown number of patients (sex and age not reported). On an unknown date the patients were vaccinated with a dose of improperly stored GARDASIL (lot# and dose not reported). The GARDASIL was exposed to 30F for 18.5 hours. No adverse effect reported. Additional information has been requested.
This is a spontaneous case, initially received from other health professional on 14-Nov-2018, concerning a 58-year-old, adult, male patient. The patient had no medical history. The patient did not receive any concomitant medications or vaccines. On an unspecified date, the FLUCELVAX QIVc underwent first temperature excursion with maximum temperature (Tmax) 72 Fahrenheit for up to 11 hours. On 14-Nov-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252676 and expiry date: 30-Jun-2019) which underwent temperature excursion. It was reported that, the patient was monitored. At the time of this report, no adverse event was reported. The reporter assessed the case as non-serious.
Approximately 2 weeks after getting the second shot, I began experiencing heart palpitations associated with a racing pulse, which has been verified with my watch. The palpitations and racing pulse continue to this day. I recently had an EKG performed which came back abnormal. I'm still waiting for a consult with a cardiologist.  Less than a year after my second shot, I was diagnosed with shingles and have a severe case on my head and right eye.
I was exposed to COVID from a cruise. About midday on May 24, 2022, I started to feel like I had no energy. I couldn't even walk. Walked 5 feet then was just winded. It just felt like a bad cold from there. No headache, wheezing, chills. Those were the primary symptoms, and I was having trouble cognitively. I was very tired, malaise, absolutely no energy. I couldn't even comprehend the directions to do a self-test for COVID. I went to a clinic and quickly tested me and said I was positive. I then went home and stayed there. The clinic called in a prescription for Paxlovid but I did not take the medication. I was able to research it and I didn't see that there was anything that would help me percentage wise. I just declined to take the prescription also due to medical conditions. I called my GP. She prescribed hydroxychloroquine, prednisone, and azithromycin. By the time I got the prescriptions, I started to feel better. I got COVID previously and was able to get by that on my own, so I decided to do the same thing here. No prescriptions were taken and no interruptions to my regular medication. I'm not 100% but I'm getting close.
Around 5 pm patient got his first dose of the Moderna Covid-19 vaccine,  and after 5 mins,he passed out while he was sitting in the observation area,his wife  was with him, once that incident had been noticed, I ran quickly to him but when I reached him he started to wake up again, I brought the emergency kit , a bottle of water, also I asked pharmacy tech to call  store manager to come over. I asked patient what happened and he stated that suddenly he felt dizzy and that he was anxious about the vaccine from the beginning and excited to get it at the same time, then I measured the blood pressure  it was 125/61 with pulse of 45/min.I offered him and his wife to call 911 but they declined it. I asked him to go back to my consultation area so he could lie down on the floor and raise his legs up so we can bring back the blood pressure up, he did that, and he went with me over there and laid down on the floor and we raised his legs up,later I measured his blood pressure again, and it was 113/71 with pulse 51/minute, I offered again to call 911 but he refused and he said that he was feeling better. I left him about 10 more minutes,then he started to get up and sit by the chair and I re-measured the blood pressure  and it was 121/76 with pulse of 54/minute, he started to drink water. He stated he felt better than he was about 20 minutes ago, then they left once their driver came to pick them up.
Gave rabies # 2 in left deltoid. Minimal bleeding from site after injection. Left arm developed large area of swelling after vaccine (slightly smaller than golf ball) which was hard to palpation. Applied ice.
Perhaps I had enough with ther first injection.; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient stated that she had enough with ther first injection. For tolerance of 2nd dose, refer case US2020AMR045783.
This spontaneous report was received from a Vaccine Coordinator referring to an unspecified number of patients of unknown demographics. On 20-JUL-2017 and 21-JUL-2017, the patients were vaccinated with improperly stored VARIVAX (lot # M044347, expiration date 04-NOV-2018, lot # N000681, expiration date 06-JAN-2019 and lot # reported as N012618, expiration date 21-APR-2019), subcutaneous for prophylaxis. It was also reported that the sterile diluent was properly stored. The temperature/time frame was 15 degrees Fahrenheit to 46 degrees Fahrenheit for 2 hours and 15 minutes with a previous temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 2 hours. (Digital data logger). No adverse events were reported. This is one of two reports received from the same source (Linked report MARRS # 1707USA009932). Sender's Comments: US-009507513-1707USA009932.
no adverse event; a needle was attached to a prefilled VAQTA syringe and placed in a refrigerator. Today, the patient received that VAQTA; This spontaneous report was received from a nurse referring to a patient of unknown age or gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 26-JUL-2021 (reported as yesterday), a needle was attached to a prefilled hepatitis a vaccine, inactivated(VAQTA) syringe and placed in a refrigerator.  On 27-JUL-2021 (reported as today), the patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA) 0.5ml once, lot # T037329, expiration date on 30-APR-2022, for prophylaxis. This adverse event was reported since the nurse wanted to discard that vaccine at the end of the day but instead it was given the next day. No product quality complaint and no further information was available. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T037329; expirationdate: 30-APR-2022; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
pt recvd vax 11AUG93 & on 12AUG93 AM pt had fever of 101; that PM afebrile but exp 2 tonic-clonic sz each lasting less than 30 secs; not seen by MD taken to ER & hospitalized 3 days; EEG nl; treated w/IV ATB; pt recovered;
Headache, Sedation, Myalgia, Arthralgia, Fever, NauseaVomiting, Pain/swelling @ injection site Narrative:
Pt notes sudden and significant increase in bilateral neuropathic pain and increasing restless leg syndrome symptoms.
This spontaneous report as received from a nurse refers to an adult patient (reported as 11 years old on 19-JUN-2009) of unknown gender. On 19-JUN-2009, the patient was vaccinated with a dose of VAQTA for prophylaxis (dose, route and site of administration were not reported). On 10-NOV-2017 and 14-MAY-2018, the patient was given two more pediatric doses of VAQTA (dose, route and site of administration were not reported). No adverse effects were reported.
Patient stated that her arm became very sore, stiff, and swollen the evening of the vaccination, and she lost mobility in her arm.  Also reported pain in back/neck. At time of report, pt stated that the pain was beginning to improve and had decided not to seek medical attention.
Patient resides in a group home.  Group Home Director called to state that it was reported to her that the day after she received her COVID-19 vaccine on 11/17/2022, she was febrile and behaving in a confused manner.  Patient was trying to put on clothing inappropriately and physically having difficulty walking. She had an appointment with her orthopedic that day and the provider became concerned when her SpO2 was very low (number not provided) and the provider directed staff from the group home to take her to the ER for treatment.  Patient was transported to the ER and hospitalized.
Dosing error (2nd dose administered earlier than the recommended interval; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dosing error (2nd dose administered earlier than the recommended interval) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dosing error (2nd dose administered earlier than the recommended interval). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dosing error (2nd dose administered earlier than the recommended interval) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medication information was reported.   Reporter stated that the 2 doses received by the patient were given at the health department who told the patient that she must get a 3rd dose, who was mad at them for the error and so she showed up at their vaccine clinic for her 3rd dose so the reporter called to clarify that they did not give the patient a 3rd dose. Reporter declined for further follow-up.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Updated patient demographics.
Vaccination given at 0919.  Patient reports not feeling well: felt dizzy, "like she might pass out." She was pale and diaphoretic and holding her head in her hands. She said that she was feeling nauseous but that feeling passed once she laid down. She said that she not had a reaction like this to any injection or blood draw in the past.  Patient reports not having eaten yet today. She is currently pregnant and EDD is 5/17/2022. Evaluated by Dr.  who helped her to lay down with her feet elevated.  Vitals taken at 935: BP 97/60 and HR 65 Taken back to a room via wheelchair. Vitals retaken at 940: BP 89/65 and HR  71 Blood sugar taken: 97 Patient continued to lay down on a bed with her feet elevated. She was given apple juice and peanut butter crackers. Vitals retaken at 950: BP 89/58 and HR 70 Patient said that her head was still feeling a little heavy. Reevaluated by Dr.  who encouraged her to continue to rest for a little while longer.  Vitals retaken at 1012: BP 106/73 and HR  83 Patient said that she was feeling better but would call a family member to drive her home.  Patients mom came to the clinic to drive her home.
This issue might/might not have impacted this individual. We identified a possible storage and handling issue of one particular vial of vaccine that might have made the vaccine less potent on June 16, 2022.  Doses from this vial were given to 9 children on the date June 16, 2022. 17 children were vaccinated that day and we have been unable to identify which 9 children received doses from the vial that was impacted.  The vaccine was reconstituted and replaced into the refrigerator for what inadvertently became too many hours before it was used. We did extensive research with Pfizer, the CDC and the local Department of Public Health and have received documentation back from the correct medical unit at the company Pfizer, who researched this vaccine being out of range for possibly 2 additional hours than what they had data for as of June 2022.  Each of the 17 children is being offered an additional dose now, 8 or more weeks after the possibly ?invalid? dose and is encouraged to discuss this with their pediatric primary care provider, who has also been notified by me. We suggested the 8 week delay to potentially reduce the risk of side effects including myocarditis in children after an mRNA if another dose was given sooner. It has now been 8 weeks since that clinic.
Redness swelling and warmth at left deltoid injection site, denies difficulty breathing coughing vomiting or widespread rash has been applying ice no other interventions to date.
Received second COVID shot on December 27th, on December 31st while eating dinner with family experienced a strong scent of a smell that caused a upset stomach. No one else could smell it, it was a very strong chemical smell. Have experienced the smell several times since then, usually around different food items. Was told by the pharmacist to report this.
I received the TDAP vaccine on the morning of Jan. 26. That night, I was unable to sleep, felt very dry, and consumed a large amount of water. The next day, I felt faint, weak and nauseated, and heart fluttering. The following morning, I went by ambulance to the ER because I felt very close to fainting, and my heart was racing, and I felt that I was about to throw up. My heart rate was high, and the doctor noted that I was pale. I had a strong feeling of doom. The ER found nothing peculiar in my bloodwork, and nothing abnormal on a brain scan. They said I was dehydrated, gave me IV fluid, and sent me home. Two days later, despite having consumed large amounts of fluid, I went to an urgent care center for the same symptoms. I collapsed at the center while signing for the co-pay but did not lose consciousness. My blood pressure was not high, but my heart rate was. They said I was orthostatic, gave me IV fluids, and sent me home. The following day, Saturday, I went back to the ER with the same symptoms. They ran blood and urine tests - all normal - said I had a "virus," and provided no treatment. On Monday, one week after the vaccination, I went to see my regular physician, where I had received the vaccine. There I was orthostatic, except my blood pressure was not high; I was sent to urgent care and given IV fluids and sent home. This pattern continued until I had received four different IV fluid infusions. Urgent care referred me to cardiology, which did an echocardiogram (nothing), and which provided me with a 24-hour heart monitor, (also nothing.) With symptoms of racing heart, weakness, nausea and near-fainting continuing, I went to see my endocrinologist, who ran a test for adrenal gland insufficiency (nothing) and who ordered a 24-hour urine sample, to test for various other potential hormonal problems. Not all of these results are in yet, but no results received so far have identified a cause. I have been markedly better since about Feb. 8/9, but still experiencing some symptoms. My doctors have said they do not think this is related to the vaccine because my symptoms continued for several days (more than 48 hours) and because many people receive this vaccine without significant incident. I felt it should be reported anyway, since my symptoms appeared shortly after I received the vaccine, are consistent with potential adverse reaction to the vaccine per the CDC flyer, and the doctors cannot find an alternative cause except for a theoretical virus.
an adverse reaction to the COVID Moderna vaccine; m arm was sore/arm was sore; had a little headache/had a little headache; chill; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (an adverse reaction to the COVID Moderna vaccine), PAIN IN EXTREMITY (m arm was sore/arm was sore), HEADACHE (had a little headache/had a little headache) and CHILLS (chill) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A and 004D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (an adverse reaction to the COVID Moderna vaccine), PAIN IN EXTREMITY (m arm was sore/arm was sore), HEADACHE (had a little headache/had a little headache) and CHILLS (chill). At the time of the report, VACCINATION COMPLICATION (an adverse reaction to the COVID Moderna vaccine), PAIN IN EXTREMITY (m arm was sore/arm was sore), HEADACHE (had a little headache/had a little headache) and CHILLS (chill) outcome was unknown.            Concomitant and treatment medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Added patient identities, vaccine information, event were updated
Three to four hours after vaccine had bruising, major loss of range of motion, severe sharp pain, elevated temp and chills due to reaction of injection site  Treatment given 24 hrs later- strong antibiotics, anti inflammatory, exercise, and three days out of work Due to loss of function of left arm due to inflammation
Patient presented to the hospital because of above given symptoms going on for more than 1 month.  He started experiencing the symptoms after he got his second Covid vaccine in end of September.  He states his wife was sick to where she got better.  He has cough with copious amounts of phlegm.  With cough he has bilateral lower rib cage pain.  He is short of breath.  He also feels hot and cold but he did not check his temperature.  He has whole body aches.  He is also nauseous.  Poor appetite.  No abdominal pain.  He also have diarrhea.  No urinary symptoms. The time of my exam, patient sitting in bed in mild respiratory distress.  He is the source of history. He states he is feeling slightly better.  No headache or dizziness.  No runny nose or sore throat.  No other complaints. Patient here with his wife.  He is independent ADLs.  He used to smoke and quit smoking about 18 days ago because of having shortness of breath.  He states he smoked 1 pack a day for 57 years.  Denies any EtOH or recreational drug use.
PATIENT IS ONLY 16 AND MODERNA IS ONLY APPROVED IN PATIENTS 18 AND OLDER. NURSE GAVE VACCINATION WITHOUT CALCULATING PATIENT'S AGE.
the patient flinched and moved its arm. The patient did not receive a full dose; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: UNDERDOSE (non-serious), outcome "unknown", described as "the patient flinched and moved its arm. The patient did not receive a full dose". The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.  Amendment: This follow-up report is being submitted to amend previous information: deleted the event 'Product administration error'.
This spontaneous report as received from a medical assistant refers to a 12 year 7 months old patient of unknown gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. The patient had completed the (meningococcal protein conjugate) PEDVAXHIB vaccination series in 2005. On 15-JUL-2016, the patient was inadvertently vaccinated with PEDVAXHIB lot # L038501, expiry date: 16-AUG-2018, 0.5 ml once, instead of GARDASIL 9. No adverse effects were reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Extreme Chills, 8 hour fever 102.7, random pains some dull some stabbing all over, severe headache with head pressure.
Initial information received on 22-Oct-2018 regarding an unsolicited valid serious case received from a pharmacist. This case involves a male patient (age was not reported) who was administered with an expired dose of FLUZONE HIGH DOSE (lot number and expiry date not reported) on 20-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is an actual medication error case due to expired vaccine used. It was reported that male patient was administered with an expired dose of vaccine on 20-Oct-2018. It was not reported that the patient had any adverse event. 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 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.
Coryzal sx, cough, fever 3 wks p/flu shot; Does not feel related to vax;
I received my second vaccine on 06-08-2021. I experienced light headedness after my second dose vaccine, the nurse gave me some juice and crackers. I have been having muscle spasms, more worse in my legs since the first dose and they have become more prominent since receiving my second dose. The muscle spasms I am having are more visible. I went to see my PCP and also a neurologist to get some testing done and so far, with my lab work, all has been negative. Next week I am going to have an EMG. I am also supposed to get an EEG but it has not been scheduled yet
Vaccine error Gardasil-9 given on accident. No adverse event(s) as of yet. Unknown of outcomes of adverse events as vaccine error occurred this morning.