chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a practice manager concerning a 20 year old female who on approximately 07-JUL-2008 (reported as "last week") was vaccinated intramuscularly with first 0.5 ml dose of GARDASIL vaccine (yeast) (lot# unspecified). It was reported that the patient has been experiencing nausea and vomiting and that the symptoms lasted through the weekend and up to and including today, 14-Jul-2008. Unspecified medical attention was sought. It was reported that the physician will be prescribing a suppository (unspecified brand) for her symptoms. No other details. At the time of this report the patient's nausea and vomiting persisted. No other details available. 10/08/08 This is in follow-up to report(s) previously submitted on 8/14/2008. Follow-up information was received on 14-AUG-2008 from the practice manager. On 10-JUL-2008, at 8:30 a.m., the 20 year old female student with allergies to penicillin and codeine was vaccinated in the left arm with a first dose of GARDASIL (Lot #0152X). On 10-JUL-2008, following vaccination with GARDASIL, the patient experienced nausea and vomiting which lasted 4 days. "On day 4" (13-JUL-2008), the patient was treated with phenergan suppositories and recovered from the events. Additional information is not expected.
Headache starting 3hrs after vaccine and lasting about 28 hrs, chills starting about 11 hrs later and lasting a few hrs, fatigue the day after, and swollen lymph node left lower cervical  lymph node.
Headache, fatigue, painful arm at injection site.  2 inch red circle, warm and hard to the touch. It itches terribly.
I havent been able to go out for a couple of days; Whole Body is Aching; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I havent been able to go out for a couple of days) and MYALGIA (Whole Body is Aching) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Pfizer and Pfizer. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I havent been able to go out for a couple of days) and MYALGIA (Whole Body is Aching). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I havent been able to go out for a couple of days) and MYALGIA (Whole Body is Aching) outcome was unknown.            No relevant concomitant medications were reported. No treatment medication reported.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Headache, chills, fever ~ 100 degrees from 10AM through 4:30PM (now).
Area around injection site warm to touch, edematous, 4 cm area of erythema. Rx Doxycycline Hydrate PRN.
Information has been received from a physician concerning a 1 year old female who on 17NOV2003 was vaccinated with varicella virus vaccine live. On 27NOV2003 the patient developed "full blown case of chicken pox." The patient sought unspecified medical attention. It was also reported that another patient developed chickenpox after being vaccinated with varicella virus vaccine live. Additional information has been requested.
Redness, "bump" swelling and itching the size of the bandaid at injection site. Stated 10/19/14 verbally. Vaccinated 10/17/14 two days prior. Not getting worse and will allow to heal on its own.
Pain, erythema and severe swelling at the injection site. Joint pain, numbness and tingling in left arm. Headache, severe fatigue, fever, severe sweating/chills, heart palpitations and racing heart. Irregular and later missed menstrual periods.
After administration varicella, MMR and Hep A, pt had possible body stiffening with arms flexed up and eyes rolled up for 5 seconds. In setting of charge and breath holding. Pt returned to neurologic borderline immediately.
Persistent L deltoid, triceps pain, 2 weeks after vaccine, discomfort with lifting arm
Ever since I got my shot I have been having a lot of acid reflux. Constant burping. My wife really loves it?. Not! My blood pressure has also been higher
Case number PHEH2012US006927 is an initial spontaneous report received from a consumer (parent) on 09 Mar 2012. This case refers to an 18-year-old female patient. She was vaccinated with MENVEO (batch number: unknown) on an unspecified date. The reporter stated that a mistake was done by the healthcare professional who administered the vaccine; the patient was given only the liquid component without reconstituting it with the powder component of MENVEO. The powder was afterwards resolved in salt water and injected. No other information was available at the time of this report.
20JAN97 staring, not blinking-pt limp, shallow resp, rapid lasting 5-10min;woke up & vomited several times;taken to ER pulse 125, resp 36, t101.1;02 started 97%;EEG WNL;
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with a first dose of GARDASIL (lot number not provided) 0.5 ml intramuscular on an unknown date in 2008. No other co-suspects were reported. No concomitant medications were reported. The patient vaccinated with a second dose of GARDASIL (lot number not provided) on an unknown date in 2010 and came to the office on 02-AUG-2012 "today" for the third dose. It was unspecified if the patient had sought medical attention. No adverse effects reported. Additional information has been requested.
Dose 1: I went out to eat after and on the drive home, I started to feel weird. Almost like I shouldn?t be driving. Foggy, tired, eye lids were heavy, almost felt drunk or withdrawing from drugs. (Similar to when I was prescribed Cymbalta and forgot to take one, years ago. But much worse.) I went home and laid down. My heart was racing. I felt nauseous. I didn?t feel like I had control over my thoughts, if that makes sense. My chest hurt. My mouth was watering. It was scary. I slept for 11.5 hours, on and off. I had a hard time staying asleep. I woke up in the morning feeling much better, but my arm hurt pretty bad and I was still exhausted and nauseous. I stayed home from work. The next day, I felt more myself, but my arm still hurt.  Dose 2: I expected to feel the same or even worse after this dose, so I planned to go straight home and lay down and took the following day off from work in advance. I went straight home and waited, but I felt fine. I went to bed at my normal time. Slept fine. Woke up fine. I thought I got lucky. I called and told work that I?d be in. I had a calm morning, but then we did a fire drill at 9:45am or so. After the fire drill, I started to feel weird again. All of the same symptoms. By 10:30, I told my boss I needed to leave. I felt paranoid. I had a couple hallucinations. I was falling asleep. I was scared to be working. I felt guilty for putting my boss in this predicament. I wasn?t able to get coverage until about 1pm. By then, I was terrified of driving home, but forced myself to. I live 2 minutes away. I told my kids that I didn?t feel well and went to sleep. My heart was racing. All of the same symptoms plus these, but all heightened. I kept telling myself that they would go away. I just needed to sleep. So, I did. Again on and off, it was hard to stay asleep. My Fitbit showed that my heart rate was elevated once the symptoms started and the entire time I was sleeping. I woke up feeling exhausted again. Nauseous. This time, my arm felt like I was shot with a gun. I took the day off from work. My arm actually still doesn?t feel the same today.
locked jaw; Musculoskeletal-Myalgia; arthralgia; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced locked jaw, musculoskeletal-myalgia and arthralgia. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
achiness; headache; sore arm; chills; fever; fast heart beat; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Apr-2021 and was forwarded to Moderna on 12-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PAIN IN EXTREMITY (sore arm), CHILLS (chills), PYREXIA (fever) and HEART RATE INCREASED (fast heart beat) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced HEADACHE (headache), PAIN IN EXTREMITY (sore arm), CHILLS (chills), PYREXIA (fever) and HEART RATE INCREASED (fast heart beat). On an unknown date, the patient experienced PAIN (achiness). On 08-Apr-2021, HEART RATE INCREASED (fast heart beat) had resolved. On 09-Apr-2021, HEADACHE (headache), PAIN IN EXTREMITY (sore arm), CHILLS (chills) and PYREXIA (fever) had resolved. At the time of the report, PAIN (achiness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Acetaminophen and Water   This case was linked to US-MODERNATX, INC.-MOD-2021-074900 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-074900:1st Dose
Burry vision, itchy eyes and itchy hives on face above the eyes.  Vision is normal now, but itchy does not go away..  Doctor gave mimyx cream and others and pill, but not very effective.  Doctor
This case was reported by a physician via a sales representative and described the occurrence of fever in a subject of unspecified age and gender who was vaccinated with Pediarix for prophylaxis. On an unspecified date, the subject received an unspecified dose of Pediarix (lot number not specified). On an unspecified date after vaccination with Pediarix, the subject developed a fever. At the time of reporting, the outcome of the fever was unspecified.
Two days after receiving vaccine, I had arrived at work and felt the need to take a deep breath. After that, my chest became tight followed by shortness of breath. That evening began having severe reflux with pain at the lower sternum. In the following days chest tightness continued along with shortness of breath and calves became extremely sore. Reported to ED 4 days after symptoms began, cardiology workup and blood work was normal. Lost appetite with dry mouth two days after ER visit and experiencing weakness in arms and legs. Scheduled appointment with PCP. Diagnosed with reflux brought on by the shot. Sent home with meds. That evening extreme chest pain and shortness of breath with fatigue. Went to ED by Ambulance. Blood work, cardiology workup and CT scan were all normal. Sent home with additional medicine. All symptoms persisted until the following week. Saw PCP again to be evaluated for Guillain Barre syndrome; was negative. Sent back home and told to "ride it out". Three weeks post vaccine, still pain in calves, weakness in limbs, random heart burn, tightness in chest and sometimes shortness of breath. Had EGD which was negative and waiting to do a gallbladder ultrasound. Currently also on multiple supplements and OTC meds. Now suspected that I may also have Costochondritis.
My daughter went twice to the operation room because the doctor decided to laser the Condylomas and the genital warts that beginning in the external vaginal area all thru the vaginal canal to the Uterus, after that in January 2017 he freeze another ones that was located in the vaginal area and he took a biopsy that tested positive to HPV16-DNA. On May 23, 2017 she went again to the operation room in order to remove another condylomas. We need to go every two weeks to the doctor.
After first dose on 3/25/21, I experienced an intense headache within a few hours and sore arm at injection site, both subsided. I started my menstrual cycle two days later. Then 10 days later, I started spotting (very unusual for me) and had another menstrual cycle a few days after that. This resulted in two cycles within 21 days, which is also very unusual for me. After the second vaccination on 4/15/21, I experienced body aches and a fever within 12-36 hours from injection. I also experienced soreness in my right breast and lymph node above the breast (now 13 days post-vaccination and this has not subsided). I also had an episode of vertigo lasting 12 hours on the 10th day after the second vaccination.
Patient felt dizzy and lightheaded after injection and felt she was going to faint. Pt wanted to lay flat on the floor and we assisted her to the floor. Blood pressure was normal while lying flat. Provided with snacks and drinks. Blood pressure remained normal and symptoms resolved.
Starting around midnight, my joints were extremely achy. I went to bed, but tossed and turned, even though I was very tired, but so sore. I got chills and fever, but didn't take my temperature. The next morning, took my temperature and it was 101. Ate a piece of coffee cake with some tea. Was very tired, so went back to  bed. Was also a bit queasy, and not hungry for lunch, and had a mild headache. Slept most of the day, had chills and fever off and on, and joints very sore. I did eat dinner. The next day I was much better, but still had some soreness in my joints, one or two episodes of mild chills, was somewhat tired and lethargic. The next day I was more or less back to normal. I did take Tylenol at some point, but I can't remember if it was the afternoon of the first day of fever, or not until the next afternoon. I know I did take it again the next morning.  All in all, it felt like a full-blown case of the flu, but was of short duration.
Patient admitted from ED after presenting with suicidal thoughts with intent to complete. Started Lamictal and add Seroquel 50 mg at bedtime to help with sleep and anxiety and mood management. Patient responded well to the start of medications.  ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Tinnitus that has progressively worsened. Initially it was mild and intermittent. Now it is constant, never goes away and is getting louder in volume and higher pitch.
As per mother fever the night of 8/29/07.  Temp 100.5 F.  Stomach pains on 8/30/07.  On 8/31/07 no problems noted.  Child is feeling well.
Initial report was received 30 September 2010 from a health care professional. A 52-year-old female patient had received an intramuscular left deltoid injection of H1N1, lot number UP006AA on 22 October 2009 and an unknown amount of time after vaccination, the patient developed pain, swelling and tenderness at the site lasting six months. The patient had concurrent illness of diarrhea at the time of vaccination. She had known allergies to codeine, penicillin, tetracycline and NAPROSYN. The event did not require a doctor's visit. According to the reporter, the patient recovered. Follow-up information was received from the health care professional on 10 November 2010. The reporter clarified that the patient did not have diarrhea at the time of vaccination, but developed it following vaccination. The patient had no illness at the time of vaccination, and did not receive any other vaccines within 4 weeks pandemic influenza vaccine. Concomitant medications included ALLEGRA D, NORVASC, DIOVAN, and hydrochlorothiazide. According to the reporter, the patient subsequently received influenza vaccine in 2010 without incident. No additional information was available. Documents held by sender: None.
I had vaginal bleeding but I just had my periods like a week and a half ago; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (Pfizer COVID-19 Vaccine, Solution for injection) via an unspecified route of administration on an unspecified date (NDC/UPC number: Unknown, Expiry date: Unknown) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, the patient had vaginal bleeding, but she just had periods like a week and a half ago. Consumer stated, "she had first Covid vaccine shot today and after she got home several hours later, noticed that she had vaginal bleeding but had periods like a week and a half ago. So, she was just wondering, what she should do about that". Consumer was informed about the role of Pfizer Drug Safety and also informed about Pfizer Medical Information department and provided with the number. In response to probing for safety report, consumer stated, "No, not right now". Further probing could not be initiated as consumer was unwilling to further answer the questions. Hence, product details (LOT number, expiration date, NDC number, UPC number), purchase details and other details were unknown and limited information was available over the call. Outcome of the event was unknown.  Information regarding the Lot/Batch number has been requested.
Flu shot administered in shoulder hurt going in. Pain has worsened as the weeks have progressed, with no relief. Motrin seems to have no effect on easing pain.
high risk patient who is under age 65 was administered Fluzone HD with no adverse event; Initial information regarding an unsolicited valid non-serious case from consumer /non-health professional via Information (Reference number- 00578828).  This case involves a 55-year old female patient who was in high risk patient and who was under age 65 was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age) (lot number: unknown and expiration date: unknown] at an 0.7 ml total dose via unknown route in unknown administration site for prophylactic vaccination.  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination was not reported.  It was an actual medication error due to inappropriate age at vaccine administration (latency: unknown).  At the time of report, no adverse event was reported.  It was not reported if the patient received a corrective treatment.  Disclaimer: 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. 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.  There will be no information available regarding batch number in this case.
Administered the flu shot 1 week prior. Started to experience ringing in both ears within 24 hours after. Feels like ears are 'stuffed up'. Pt complains of slight blurred vision.  Cataract surgery about a month prior to flu shot. After surgery, still experienced the blurry vision. Lasted 'longer then it should'.  Patient is very healthy male, only takes the flu shot.
1) Pain in right upper leg, started in hip joint area, radiates down thigh.  Some pain while walking, more intense pain at night when trying to sleep. 2) Fatigue - worsened over months following the vaccine, more on days following any physical activity (walking dog), sometimes interfering with ability to work a full day.
Patient stated she noticed redness and soreness around area of the shot. She states she had a sore arm over the last day. The the area appears to be slightly swollen with redness and tender to the touch. the diameter appears to be roughly 3-4 inches. Patient instructed to keep monitoring the area for the next 24 hours for changing in pain/swelling/size. Instructed patient to seek additional medical attention if condition worsens.
within an hour after vaccine, both arms and face began tingling and went numb.. mouth/gums front teeth numb...felt dizzy and double vision with a headache the entire day..  by evening the numbness went away but headache and dizzy/double vision continued through the night.  Noticed eyeballs hurt when touching eyelids and felt like I was looking through a double lense that kept jumping around, couldn't focus or see properly.  Through the night had strange pains ping on different areas of body, keeping me from sleeping.  The 2nd day still had brain fog, double vision, headache and fatigue but numbness went away.  Joints (elbow/shoulder/hips) had extreme pain.  3rd day headache better, but still having vision problems and eyeball pain and joint pain.   Day 4 (today) still struggling with vision issues and sore eye sockets and major joint pain.
Swelling and rash at injection site,  pain Chills and body aches, headache
This case was reported by a consumer via call center representative and described the occurrence of loss of consciousness in a 70-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included drug allergy (had an anaphylactic reaction to Prilocaine previously). On 11th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, less than a week after receiving SHINGRIX, the patient experienced loss of consciousness (serious criteria GSK medically significant), sleepiness and rash. On an unknown date, the patient experienced pain in arm and pruritus. The patient was treated with ibuprofen and BENADRYL. In May 2018, the outcome of the sleepiness was recovered/resolved. On an unknown date, the outcome of the loss of consciousness, pain in arm, pruritus and rash were recovered/resolved. It was unknown if the reporter considered the loss of consciousness, pain in arm, pruritus, sleepiness and rash to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccine in the left deltoid. The patient stated that the vaccine knocked her out and she slept for 2 days. She developed a rash within a week after that shot on her palms, the bottoms of her feet, under her arms, legs, under her breasts and down her stomach. The patient took BENADRYL and the rash resolved but it came back and resolved after a week and a half. The patient was instructed to take Ibuprofen for her sore arm.
mild joint pain, headache, fatigue, unable to sleep. No treatment - told to wait it out Went away about a week later