chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered IMOVAX subcutaneously in the wound, instead of intramuscularly with no AE; Initial information regarding an unsolicited valid non-serious case was received from pharmacist Global Medical Information (Reference number- 00710123) and transmitted to Sanofi on 04-Aug-2021.  This case involves a 58 year old male patient who experienced administered imovax subcutaneously in the wound, instead of intramuscularly [incorrect route of product administration] while receiving RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 04-Aug-2021, the patient received a 1 mL dose of suspect RABIES (HDC) VACCINE [lot T1C662M and expiry: 17-Jun-2022] via a subcutaneous route in unknown administration site (hand (reporter unsure if it was left or right hand) for prophylactic vaccination.  It was a case of actual medication error due to incorrect route of product administration [Latency: on the same day].  It was reported that, "Caller reports that a patient came in with animal bites and a nurse administered IMOVAX subcutaneously in the wound, instead of intramuscularly".  No laboratory test was reported.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event administered imovax subcutaneously in the wound, instead of intramuscularly.   At the time of report no adverse event was reported.  The reporter assessed the causal relationship with suspect vaccines as: related for the 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 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.
Diagnosed with Pericarditis; Stabbing pain upon breathing, ER visit; Heart palpitations, ER visit; Shortness of breath, ER visit; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERICARDITIS (Diagnosed with Pericarditis) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Contrast media allergy. Concomitant products included FLUOXETINE for Anxiety.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced PAINFUL RESPIRATION (Stabbing pain upon breathing, ER visit), PALPITATIONS (Heart palpitations, ER visit) and DYSPNOEA (Shortness of breath, ER visit). On 02-Jun-2021, the patient experienced PERICARDITIS (Diagnosed with Pericarditis) (seriousness criterion medically significant). The patient was treated with METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) on 18-May-2021 at a dose of 1 dosage form, Prescribed twice. At the time of the report, PERICARDITIS (Diagnosed with Pericarditis), PAINFUL RESPIRATION (Stabbing pain upon breathing, ER visit), PALPITATIONS (Heart palpitations, ER visit) and DYSPNOEA (Shortness of breath, ER visit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2021, Electrocardiogram: normal (normal) Nothing found on test. On 14-May-2021, X-ray: normal (normal) Nothing found on test. On 02-Jun-2021, Echocardiogram: abnormal (abnormal) Revealed Pericarditis..     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Other treatment products include Narcotics, Non-Steroidal Anti-Inflammatory and Stomach Protectant medications.  Other lab test include on 14-May-2021, R/O for blood clots was done and nothing was found.  Very limited information regarding the events has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-101590 (Patient Link).; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
I awakened 3 times that night after my injection to get up and  urinate in the toilet. (Normally, I only awaken  once or twice a week and then it's only once per night). The third time I felt a little 'foggy', but I went back to sleep. I woke up ~8:30 am and got up to take my shower. While brushing my teeth, I felt like I was going to faint. I made it back to my bed (~10 feet away) just in time, threw myself on the bed and stayed there ~ 4 more hours. I drank water often during that time (that my husband brought the water to me.  At ~1:00 pm  I felt strong enough to go downstairs. I was okay the rest of the day, just tired. The next morning I felt 100%.
After eating lunch approx. 24 hours after receiving the 1st dose of the vaccine, I began to cough suddenly. I then got itchy eyes, had some wheezing, and sneezed/got a runny nose. About a half hour after getting these symptoms, I took 10mg of children?s Benadryl (Diphenhydramine). I then found two hives/itchy bumps. One on my right arm near my elbow and one on the left side of my abdomen. About 20 minutes after taking the Benadryl, the symptoms mostly went away and I felt very tired. I still have some wheezing.
Moderna COVID-19 Vaccine EUA After receiving shot 1 at 8:56 AM I started running a fever of 101 by 6:00 PM on 1/2/21.  By 7:30 PM it was 102.8.  I alternated Tylenol and Ibuprofen which took over an hour to have any impact on the fever.  I have used ice packs to also control my body temperature throughout the night.  I woke up with fever and have run fever all day 1/3/21.  It is 4:49 PM and it is currently 101.4 which is 20 minutes after my Tylenol has worn off.  I am also experiencing intestinal issues and started having diarrhea at 3:30 PM on 1/3/21.  I am very concerned about taking dose 2!
fever 104 & ?sore throat, runny nose starting 7 hrs p/vax; MD prescribed ATB 2DEC92;
Information was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 11-JUL-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L041206 (dose, route and expiration date not reported). Concomitant therapy was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Persistent rash, itching on different parts of the body - back of the knees, back of the right thumb, upper chest.
Tested pos. for COVID 19 on 9/12/2022. Symptoms; chest congestion; coughing and fatigue for about one week. I was prescribed a course of PAXLOVID and have no new symptoms to report.
Infant developed fussiness, low grade fever to 100, liquid watery stools as many as 10 per day beginning 9-14-21 evening. Infant seen in clinic 9-18-21 to assess fussiness, hydration. Hemoccult was negative. No blood seen in stool.
patient developed symptoms of COVID including shortness of breath, myalgia, fever and mild nonproductive cough and tested positive on 10/28/21
I noticed small red broken capillaries under the skin on both forearms, where I had not bruised the  location.  They just sprung up out of nowhere.  The first ones were about the size of a pencil eraser, then in August one broke out on my  left forearm that was the size of a silver dollar.  I had done nothing to injure my arm(s).  Thrombocytopenia?
Pink, itching area 3X4 inches  around injection site.  Just noticed  today - one week after injection.  Slight increase in soreness at the site.
1:00 PM 0.5mL flu vaccine given IM. 1:30 PM BP 130/80, P 72, Resp 20. 1:33 PM complaints of dizziness and nausea, skin warm, dry, resp 20. 2:00 PM complaints of headache and decreased dizziness. 2:45 PM no headache or dizziness, slight nausea and fatigue. Discharged home to rest, no respiratory distress, instructed to call 911 with any shortness of breath.
3rd dose of Engerix-B devel lump & swelling @ inject site; shortly p/sx of diarhea, fatigue, muscle ache; discovered rise in liver enzymes; had Hep B unrelated to vax;
Information has been received from a physician concerning a less than 12 month old female with a history of diarrhoea (patient recovered one day prior to first vaccination of Rotateq from a previous case of diarrhea) who on unspecified dates was vaccinated with the first and second doses of Rotateq. Concomitant medication was not reported. Subsequently on an unknown date, the patient received the first dose of Rotateq and experienced fever, diarrhea, vomiting and fever (unspecified time course and resolution). On an unspecified date, the patient received the second dose of Rotateq and experienced fever, diarrhea, vomiting starting the same day (resolution unspecified). The patient sought unspecified medical attention. The physician decided not to administer the third dose of Rotateq. Subsequently on an unspecified dates, the patient recovered from both incidents of fever, diarrhea and vomiting. Additional information has been requested.
Red skin around injection site- patient said it was warm to touch.  Patient came to pharmacy approximately 48 hours after injection to show pharmacist the reaction
Expired Dose was Given to a Patient; Initial Report Received on 04-APR-2023.  A pharmacist reported that a patient (age, gender, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that was expired.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient received a dose of HEPLISAV-B (Lot #937233, expiration date 11-MAR-2023 and NDC #43528-003-05) from a pharmacist (route and injection site not provided).  On an unspecified date, the patient was vaccinated with HEPLISAV-B which was noted to have been an expired dose.  No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
muscle aches low back and leg pain, shooting towards the foot sometimes and spasms, come and goes  problem walking,  fatigue
After receiving her 3rd dose of the Hepatitis B vaccine in her right deltoid, at 08:52 the patient notified me that she had pain, tingling and a burning sensation throughout her right arm with most of the pain located in her forearm.  I assessed the patient for any other signs and symptoms of a reverse reaction and no other symptoms were present.  Consulted with designated Provider. Applied ice to injection site, encouraged water intake and movement. Continued to monitor for 30 minutes with no change to symptoms.  Followed up with the patient later that evening and she stated that her symptoms have resolved.
Appy 8 hrs after receiving vaccination felt very tired eyes tearing and swollen. Developed terrible headache, fever, chills and body aches. Took Ibuprofen 400 mg Q 6 h. Also c/o both hands stiff and "dry heaves".
Parent describes patient having blue lips x30 min - did not seek medical evaluation then had enuresis x 5-6 x a day for 6 days and diarrhea x 2 days. No cyanosis. Enuresis resolved.
contracted COVID-19 from his wife/confirmed on the 5th by rapid test; contracted COVID-19 from his wife/confirmed on the 5th by rapid test; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in arm right, administration date 02Nov2021 09:00 (Batch/Lot number: unknown) at the age of 49 years as dose 3 (booster), single, intramuscular, administered in arm right, administration date 01Mar2021 13:00 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administered in arm right, administration date 09Feb2021 13:00 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not diagnosed with COVID-19 prior to vaccination. Concomitant medication(s) included: ATORVASTATIN; OZEMPIC; TRISIBAM; LISINOPRIL; SYNJARDY XR; LEVOTHYROXINE; VITAMIN E [TOCOPHERYL ACETATE]; ASPIRIN [ACETYLSALICYLIC ACID], and an unspecified multivitamin. Past drug history included: Hydromorphine, reaction(s): "known allergies: Hydromorphine". The following information was reported: IMMUNISATION (medically significant) with onset 02Nov2021 09:00, described as "booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Jan2022 17:00, outcome "recovered" (Jan2022) and all described as "contracted COVID-19 from his wife/confirmed on the 5th by rapid test". The patient contracted COVID-19 from his wife on 05Jan2022. His wife was confirmed by PCR on 04Jan2022, while he was confirmed on 05Jan2022 by rapid test (positive). The events were reported as serious; however, it did not result in death, were not life-threatening, did not cause/prolonged hospitalization, were not disabling/incapacitating, nor resulted in congenital anomaly/birth defect. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
1week after shot I got a Rash down my arm ,swollen and hot to touch. My arm and neck on the left  side is sore when I move them and I have been getting headaches.
red dots on neck hands and arms; developed random red bumps not at the injection site but on neck. They went away and got some on arms and hands; Initial information received on 31-Aug-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 19 years old female patient who experienced red dots on neck hands and arms and developed random red bumps not at the injection site but on neck. they went away and got some on arms and hands, after receiving vaccine YELLOW FEVER VACCINE -  [YF-VAX].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Aug-2022, the patient received a dose number 2 of suspect YELLOW FEVER VACCINE -   injection(lot UJ602AA and expiration date: 13-Jul-2023)at a dose of 0.5ml total via subcutaneous route in the left arm  for immunization.  In AUG-2022 (latency: approximately a week) , it has been over a week since the patient her yellow fever vaccine and she developed random red bumps not at the injection site but on her neck (rash papular).They went away and she got some on her arms and her hands (rash erythematous). The bumps do not hurt or itch they are just there and she wanted to know if it is associated with the vaccine. It was also reported the first injection the patient received the syringe was a faulty syringe and started leaking as soon as the syringe was injected  Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the events .   Outcome: unknown for both events
dysuria, generalized myalgia, arthralgias, fever, chills & nausea;
Patient received 3rd Pfizer vaccine on 9/2521 but no lot number in System; event occurred after third vaccine; breakthrough case admisson
Hepatitis B and Hib combination vaccine and the Varicella vaccine given 3/20/02 at 1 yr well child physical. 3/22 Awoke very hot. Tylenol given. Jerking X 4-5 mins., arched, crying and upset. Seen at ER
burning up; achy; Initial information was received on 15-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via social media under (reference US-SA-SAC20211019001210).  This case involves a patient of (unknown demographics) who experienced burning up and achy (pyrexia, pain) when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot 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 non-serious burning up and achy (pyrexia , pain) (1 day) following the administration of INFLUENZA VACCINE.  It was reported "Yeah, I just got my flu shot yesterday and today I am burning up and achy. Thanks. I would have been the same with the flu (if I got it)".  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the events.  At the time of reporting, the outcome was unknown for the events (burning sensation, pain).  There will be no information available on the batch number for this case.
Information has been received from a physician concerning a patient who on 31-MAY-2007 was vaccinated subcutaneously in the right deltoid with 0.5 mL (appropriate dose is 0.65 mL) instead of zoster vaccine live (Oka/Merck) (Lot # 652455/1018R) instead of zoster vaccine live (Oka/Merck). Physician reported that there were 2 boxes behind one another and the physician didn't see the zoster vaccine live (Oka/Merck) box. This is not product confusion. Patient sought unspecified medical attention. No further information was available. Follow-up information received from the physician's office stated that the patient did not experience an adverse event as a result of the product confusion. The physician simply grabbed the wrong vial out of the freezer as the varicella virus vaccine live (Oka/Merck) and zoster vaccine live (Oka/Merck) were next to one another. The patient was not on chemotherapy, corticosteroids and did not have a history of HIV/AIDS, cancer or any other immune deficiencies. Additional information is not expected.
Muscle spasms (sometimes in both arms), vomiting, jitters, concentration issues, forgetting of words and speech impediment.
30 minutes post vax, the pt had a fever of 102, nausea, headache, and felt like she was going to pass out-but didn't. Yesterday morning she started throwing up and light hurt her eyes. Mom carried pt to physician this am, he didn't know if it was the TD or not. He prescribed Phenergan.
This non-serious initial spontaneous case was received from other health professional (pharmacist) on 05-Nov-2017, concerning a 57-year-old adult male patient. The patient had no any medical history and concomitant medications. On 05-Nov-2017, the patient was administered with FLUAD (TIV) (dose; 0.5 ml, route of administration: intramuscular, anatomical location: deltoid). The patient received the vaccine under 65 years of age (explicitly coded as inappropriate age at vaccine administration). It was reported that, the patient had not experienced any adverse events or reactions after the vaccination.
A couple that we know had the same experience but one was Moderna and one Phizer  In my case the reaction was later about 6pm and I had my shot at about 11am WED the same day. They had me sit in the holding area as they do for 15 minutes but they are more concerned about breathing issues. At 6pm I was a bit dizzy but it got worse. I was trying to look at my laptop and my eyes were dancing around the screen like a pin ball machine. I quickly gave up and figured I would watch TV HA HA jokes on me!  Same issue with the TV, so I closed my eyes and just listened for about an hour or so occasionally checking the TV but not acceptable for a couple hours before I could sit up. My arm Continually became more sore my the the minute and tender. I had absolutely no reaction early in the day aside from some minor pain as the day went on and expected.  I then tried to stand up about 7pm and WHOA I like to fall over I was so dizzy. I then had chills that faded in a hour or so. As it was getting close to bed time I knew there was no way I could make it to our 1st floor bedroom even if a friend assist me.  I asked her to go upstairs and get my old faithful walker from my 2016 escapades. I had balance issues back then from the sepsis and staph infection and everything else that was nothing like this. I was holding on to the walker for dear life and it was like someone was trying to throw me out of the walker, I'm wondering if it was a severe inner ear issue I suspect.  Off to sleep with no problem and later the next day I stared feeling better. I do have vertigo from time to time and took a pill but it was nothing like that. My greatest fear is what IF I were out in the car running an errand when all this took place. I checked this online but found nothing. There is a site you can post concerns over any abnormal symptom and I will report this on the CDC site as we should. They need to capture things like this with such short trials. Mine was the Moderna vaccine.
Janssen COVID-19 Vaccine EUA Immediately after getting the vaccine, I experienced severe nausea for 10-20 minutes. I experienced no symptoms for 3-4 hours afterward, but then began to develop a low-grade fever,  muscle aches, a headache, and became nauseous again.  Around 12 hours after getting the vaccine, I developed a fever of 102 F, I began to experience severe muscle aches and cramps in my calves and abdomen. I also began to develop a much worse headache and lost partial vision in my right eye for a few hours. This is when I became violently nauseous, but I was unable to throw up, or defecate.  I was unable to sleep during this time, and at 2 am, my nausea peaked, and I threw up incredibly violently and incredibly suddenly. It was so violent, it caused me to pop a blood vessel in my eye, and gave me a sore throat. However, after throwing up, most of nausea subsided.  At this point, the vision began to return to my eye. 20-40 minutes after throwing up, I began to experience chills that lasted for up to an hour. Eventually, I slept at 4 am, but slept fitfully, and woke every 40 minutes to 2 hours.  At 7 am on the 9th, the nausea was completely gone the day after my vaccination, but the muscle aches and headaches were back. My fever was down to 101, and I took some Tylenol and slept fitfully until 2 pm when I woke up feeling significantly better.
This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 80-year-old female patient who received SHINGRIX. In March 2018, the patient received the 1st dose of SHINGRIX. In March 2018, 2 days after receiving SHINGRIX, the patient experienced upset stomach, weakness, chills, influenza-like symptoms and feeling cold. In March 2018, the outcome of the upset stomach, weakness, chills, influenza-like symptoms and feeling cold were recovered/resolved. The reporter considered the upset stomach, weakness, chills, influenza-like symptoms and feeling cold to be related to SHINGRIX. Additional information was received as follows: The side effects the patient experienced were almost like to flu. The patient reported chills, caused the patient to feel very cold. The patient was shivering, layering clothes and using blankets to stay warm. All the events were resolved in the next day. The patient could not remember the exact date she had the injection. The patient has denied permission to contact their physician.