chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a patient (age and sex not reported) who was "recently" (approximately March 2007) vaccinated subcutaneously with a second dose (0.5 ml) of Varivax. Concomitant therapy included Vaqta. Medical history was reported as unspecified. In approximately March 2007 (date unspecified), the patient experienced erythematous area of about 12 cm diameter, with induration, at injection site. No other symptoms were noted. Subsequently, the patient recovered from erythematous area of about 12 cm diameter, with induration, at injection site. The patient sought unspecified medical attention. The events involved intervention to prevent serious criteria (other important medical event). There was no product quality complaint involved. Additional information has been requested.
Pt was doing fine after receiving the vaccine.  That following day, she reported having flu-like symptoms.  She had covid-19 about 9 months prior and knew that she may have more severe symptoms.  Later that day, she reported having shortness of breath and could not talk without taking breaks in-between.  She also had a difficult time walking.  Pt was seen and treated in the emergency department.  I feel this was more patient issues since she has had a history rather than direct effect of the vaccine.
On April 18, 2023, the FDA amended the emergency use of COVID-19 Vaccine authorizing bivalent vaccine to be used for all doses administered to individuals 6 months of age and older. The monovalent Pfizer COVID-19 Vaccine is no longer authorized for use. I was advised to wait until CDC approved FDA recommendations, which I verified on 04/20/2023. Patient was given a 2nd dose of Moderna Monovalent Lot# AS1417B on 04/20/2023 days after the 18th which was no longer authorized.
Headache, stiff neck with myalgias - treated with Motrin.  No Kernigs/Brudinski.
Decedent was on the mend and the upswing. Spouse stated he was fine post booster for the days following, no physical or verbal complaints nor sickness from boosters. They prepared for bed after a busy day and slept in separate bedrooms, and after their typical evening routine and kiss goodnight, he retired a little weary from a busy day of celebrations. Spouse awoke when she received a phone call from a the pacemaker nurse to "speak to patient." and when she went to his room that is when she released he had died. Post-autopsy, GI inflammation was found. Vaccination information is based on what we have received, but does not correlate with vaccination records appropriately.
Area where shot administered as well as entire upper arm region swollen and very sore. The following day, June 3rd, as soon as I woke up felt stinging pain in armpit region. This area has become extremely swollen and large, and very sore.
Pfizer COVID vaccine was given 4 days past "use by" date. Called manufacturer + was advised "off label" use can be 14 days past recommended 31 days in refrigerator, so do not need to repeat vaccine.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 38 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958566, 20210959351, 20210958518, 20210959620, 20210958321, 20210958806, 20210958425, 20210959581, 20210958371 and 20210958525.
- got sick immediately after for a few days, the same as the first 2 doses (nausea, vomiting, fatigue, heavy limbs)  - the side effect I am most concerned about began Friday December 10th.  - I have started my period almost a week early. Usually my periods are painful, but it is especially painful with cramping, nausea that is affecting my appetite (can't eat much at all), swollen and sore breasts, and it is extremely heavy.
Headache, progressing in intensity to severe with light sensitivity Chills Nausea Vomiting Fatigue Moderate to significant arm soreness These symptoms persisted for 18 hours "Brain fog" Occasional lightheaded-ness These symptoms persisted for 3 to 4 days
Patient had an allergic reaction.  Onsite EMS was called vitals HR 110 BP 144/78  100% O2. Patient refused evaluation or care. Released against medical advise.
After one day of the vaccination, the patient began feeling the left arm with inflammation, soreness, redness, itching. Also below her left eye was presented inflammation, like a bump with liquid with a lot of itching and inflammation. Pt took ZYRTEC and then BENADRYL and triple antibiotic to the arm. Tinnitus in left ear was also reported.
Mouth ulcer, heart pounding and night sweat after vaccination. 4/30 Saw a Rheumatologist. 5/3 Blood test results confirm Lupus Flare.  Started Hydroxychloroquine treatment.
My taste and smell are inconsistent; My taste and smell are inconsistent; This is a spontaneous report from a contactable healthcare professional (patient). This 53-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EM9809) intramuscularly on 06Feb2021 at 13:15 (at the age of 53-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 08Feb2021 the patient experienced taste and smell were inconsistent. He could not taste certain foods. It was mostly more noticeable at night. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcome of taste and smell were inconsistent was unknown. It was also reported that since the vaccine, the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
The patient accidentally took all 4 oral capsules in one dose on 8/22/23 rather than taking one capsule by mouth every other day as instructed. He reported only mild upset stomach.
I've had headaches around my upper right temple and eye since the 3rd dose. I didn't get any treatment until after the most recent 5th vaccine. They gave me antibiotics and thought that maybe I had a sinus infection. They did a CT scan and MRI and they didn't find anything. After the 5th dose, they sent me to an ear nose and throat specialist, and he gave me allergy medication. That didn't help either. My arm has also been really painful and sore along with the headaches since that 5th shot.
Low grade Fever 99.9 F (After Second Shot); Body Aches (After Second Shot); Pounding Headache (After Second Shot); This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade Fever 99.9 F (After Second Shot)), MYALGIA (Body Aches (After Second Shot)) and HEADACHE (Pounding Headache (After Second Shot)) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02K21A and 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced PYREXIA (Low grade Fever 99.9 F (After Second Shot)), MYALGIA (Body Aches (After Second Shot)) and HEADACHE (Pounding Headache (After Second Shot)). At the time of the report, PYREXIA (Low grade Fever 99.9 F (After Second Shot)), MYALGIA (Body Aches (After Second Shot)) and HEADACHE (Pounding Headache (After Second Shot)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2021, Blood pressure measurement: 127/93 mmHg. On 13-May-2021, Heart rate: 110 BPM. On 13-May-2021, Pyrexia: 99.9 F.         Treatment medications were not reported. Concomitant medications were not reported.   This case was linked to MOD-2021-128082 (Patient Link).
terrible chills, T 100, every joint in her body hurt, terrible headache, skin hurt all over like when you have the "flu", nauseous, stiff neck. fatigue over the course of a few days
Fluvirin administered via Bioject injection device on 10/24/06.  Ct. returned to clinic on 10/25/06 to present with contusion 105 mm (w) by 70 mm (l).  Ct. state L upper arm was sore from the time she recieved the vaccination. In the evening she noticed the bruising and swelling when she undressed.  Rates pain 3 on 1 - 10 scale.  Also states she "bruises easy".
8/4/21: presented to the ED for evaluation of generalized weakness and bright red rectal bleeding for 1 day. patient is usually able to ambulate and stand however after waking up yesterday morning patient had significant generalized weakness and was unable to get up from her bed. Tested positive for covid-19 on 8/5/21.  Note: patient previously vaccinated with Pfizer COVID-19 vaccine: First Dose: 04/17/21 Lot Number EP7534; Second Dose: 05/08/21 Lot Number EW0171 Treated for generalized weakness. Was not treated for any Covid related diagnoses.  8/5/21: Discharged
Approx. 2 minutes after receiving the Moderna Booster (0.25ml) in left arm,  she complained of nausea. Given emesis bag and bottle of water. Denied shortness of breath, denied feeling the her throat was closing, no itching, no hives. I examined injection site, warm to touch, no swelling or redness. She states she hasn't eaten today--given small bag of peanuts.  She was still feeling nauseous 8 minutes later. Still sitting in office being observed by nurse. Inquired if she wanted to be checked out in emergency room--she refused. After being observed for another 10 minutes she stated she was feeling  less nauseous but says she now has a headache from dry heaving. She decided to return back to her worksite--denied feeling lightheaded or dizzy. Advised to go to Emergency Room if she continues to feel bad.
Information has been received from a nurse practitioner concerning a 25 year old female who on an unspecified date was vaccinated with first 0.5 mL dose of GARDASIL (route and lot number mot reported). The nurse practitioner reported that the patient experienced joint pain in her hands. The nurse also reported that the patient did finish the series of GARDASIL. however she was complaining about pain in her hands. The patient sought unspecified medical attention. Additional information has been requested.
Unconsolable crying for 3 and 1/2 hours.  Very high pitched scream type cry in an infant that normally does not scream when crying.
After contracting COVID, I had noticed I was having something in my coughing and phlegm.
Arm swelling swelling and redness of a 2 -3 inch circle area adjacent to the injection site; Arm swelling swelling and redness of a 2 -3 inch circle area adjacent to the injection site; Burning; Itching; This is a spontaneous report from a contactable consumer (patient).  A 73-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm, on 24Feb2021 at 09:45 AM (Batch/Lot Number: 9267), at the age of 73 years old, as second single dose, for COVID-19 immunisation. Medical history included coronary artery disease. The patient was not pregnant at the time of vaccination. The patient received unspecified concomitant drugs within 2 weeks of vaccination. The patient had received the 1st single dose of BNT162b2 on 03Feb2021 at 09:45 AM (lot number: 8982), always in the left arm. The patient had not received any other vaccines within 4 weeks prior to BNT162b2 vaccination. Prior to vaccination, the patient was never diagnosed with COVID-19, and since the vaccination, has the patient have not been tested for COVID-19. On 26Feb2021 at 08:00 AM, the patient experienced arm swelling and redness of a 2 -3 inch circle area adjacent to the injection site, with burning and itching. No treatment was needed for the events which were described as non-serious by the reporter (patient). The patient was recovering from the events.   Follow-up attempts completed. No further information expected.
No adverse event; 4 year old received the pediatric Moderna vaccine instead of the toddler Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (4 year old received the pediatric Moderna vaccine instead of the toddler Moderna vaccine) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (4 year old received the pediatric Moderna vaccine instead of the toddler Moderna vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (4 year old received the pediatric Moderna vaccine instead of the toddler Moderna vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (4 year old received the pediatric Moderna vaccine instead of the toddler Moderna vaccine).    Concomitant medications details were not reported by the reporter. It was reported that patient height and weight were unknown. Treatment details was not reported by the reporter.
Started with itch on left inner thigh that turned in several raised bumps that resembled hives. After about an hour, it went away. Several hours later, I started having the same reaction on the sides of my torso, under my arms to my waist line. I had a virtual doctor visit that evening where the doctor prescribed Prednisone 20mg for 5 days and Benadryl. Saturday, April 3rd, took second dose of Prednisone and continued Benadryl every 4 hours. Symptoms were better in the late morning and early afternoon then started getting worse. Started getting the hives on my arms, legs, and started spreading to my neck, back of my scalp, and onto my face. It got worse at the night progressed and I went to a 24 hours urgent care at 2am on Sunday, April 4th. The doctor checked me out and noting the severe case, increased my prescription to 60mg Prednisone, decreasing 10mg every day, and Famotidine 20mg daily, Clairitin in the morning, and Benadryl at night. Taking the 60mg of Prednisone on April 4th has drastically reduced the symptoms. I will continue the regime to determine if the issue goes away completely.
erythema multiforme is reported in a pt receiving 1 dos of fluogen on 24OCT93 pt exp mild erythema multiforme on trunk, thighs & legs; pt is being treated w/atarax & Diprolene ointment; pt persisted until 1 wk course of methyl prednisone;
This retrospective pregnancy case was reported in a literature article and described the occurrence of spontaneous abortion in an adult female subject who was vaccinated with H1N1 (manufacturer unspecified). On an unspecified date, the subject received an unspecified dose of H1N1 (unknown route and injection site, batch number not provided). The subject's last menstrual period was on unspecified date and estimated date of delivery was not provided. The subject was exposed to the vaccine during the first trimester. On unspecified date, at an unspecified time after vaccination with H1N1  and at unspecified weeks gestation, the subject experienced a spontaneous abortion. This case was assessed as medically serious  by GSK. At the time of reporting, the outcome of the event was unspecified. The authors reported 33 other cases. Summary of the article: The potential serious consequences of maternal influenza infection in pregnancy have long been recognized; pregnant women are at increased risk for influenza-associated morbidity and mortality. As reviewed recently, there are limited data on the safety of influenza vaccine in pregnancy; however, to date, there has been no indication that seasonal influenza vaccines containing inactivated virus pose a risk to the mother or the foetus. This has led to the current recommendation that all pregnant women be vaccinated with the seasonal influenza vaccine regardless of trimester. Despite these recommendations, vaccination rates remain less than optimal. Surveys have demonstrated that mother's concerns about safety contribute to poor compliance with vaccine recommendations. This situation was escalated during the 2009-10 H1N1 season, when lack of safety data about the H1N1 was coupled with intensive public health messaging that emphasized the need for all pregnant women to be vaccinated. Additional safety information on H1N1-containing vaccines when used in pregnancy was therefore needed. The purpose of this study was to evaluate the foetal risk and relative safety of the H1N1. To assess risks and relative safety of the H1N1-containing vaccines, the author conducted a prospective cohort study of H1N1-vaccine-exposed and unexposed comparison women who were recruited during pregnancy and followed to outcome between October 2009 and August 2012. There were 1032 subjects available for analysis; 841 women were exposed to a H1N1-containing vaccine in pregnancy, and 191 women were unexposed to any influenza vaccine in pregnancy. Nine of 328 (2.7%) first-trimester-exposed pregnancies resulted in an infant with a major birth defect compared to 6/188 (3.2%) in the unexposed. The hazard ratio (HR) for spontaneous abortion was not elevated. Adjusted HRs for preterm delivery were elevated for exposure anytime in pregnancy, specifically with exposure in the 1st or 2nd trimester. However, the mean decrease in gestational age in the exposed pregnancies was approximately three days. In conclusions, no meaningful evidence of increased relative risk or HR for major birth defects, spontaneous abortion, or small for gestational age infants was demonstrated.
Yesterday at 10:30am I got my third dose (booster) of Pfizer COVID vaccine. I was fine most of the day. Around 9pm started feeling sluggish but not concerning as it was close to bedtime. At 2:37am I woke up having difficulty breathing and feeling my heart racing and my head felt hot and hurt. I had to call my parents using the cellphone to come into my bedroom because my crisis wouldn?t subside. My dad gave me an ibuprofen with a bit of water and my mom took my BP/Pulse 148/111 - 101, oxygen at 97 (I sleep connected to concentrator). They had to add blankets because I was cold/shaking. I was able to fall back to sleep. I woke up at 5:25am but feel discomfort in my chest area and some congestion.
PATIENT STATES THAT SHE HAD PAIN AND BRUISING FROM THE SHOT THAT HAS NOT GOTTEN BETTER (WED TO SUNDAY).
Patient was in a seated position approximately 5 minutes after receiving the Janssen COVID vaccine. He briefly lost consciousness for about 30 seconds. His head was back and feet were outstretched. He never stopped breathing. His change in condition was noticed by one of the pharmacy employees who is a Registered Nurse. He had regained consciousness by the time I responded. He stated that he felt lightheaded and was sweating. He was given some water and crackers and observed for approximately 20 more minutes.
36 hours of fever (101 degrees) and chills, plus severe pain in right arm (the arm that was injected)
24 hours after vaccine administration patient was seen in urgent care w/Dx of arm pain, and referred to or the further evaluation. Patient complained of pain, limited range of motion to Left arm.
This spontaneous report was received from the physician assistant and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On an unknown date, the patient was vaccinated with PROQUAD via intramuscular route instead of subcutaneous route for prophylaxis (lot number and expiration date were not reported). The vaccine was reconstituted with sterile diluent. There was no adverse effect reported.
Swollen, red, area covered from patient's left arm from his elbow to his shoulder.
little drowsy; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 via an unspecified route of administration on an unspecified date at a single dose as Covid-19 vaccine. Medical history and concomitant medications were not reported. The patient slept really good. It was reported that he got a little drowsy after being vaccinated on an unspecified date. The outcome of the event was unknown.  Information on the lot/ batch number has been requested.
local exaggerated reaction at site of injection. Red, swelling, temp. 99.9, painful