chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash on her legs and ankles; This is a spontaneous report from a contactable other healthcare professional (patient). A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 18Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced rash on her legs and ankles on 19Apr2021. The patient wants to know if it is ok to get the second dose after having this side effect. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Blisters on inside of mouth. White blisters on inner lining of lips and jaws. No course of treatment was taken. Blisters were of varying sizes. Lasted around 72 hours before beginning to go away. Went away completely and with no lingering problems.
Patient reported red, slightly raised rash on Left arm. Hot to the touch and slight itching.
Hour or so after the vaccine experienced rapid heart rate and onset of headache and fatigue, injection site pain.  8-10 hours after vaccine symptoms increased to include headache, body aches, fever, chills, muscle and joint pain as well as continued injection site pain. Inability to sleep first night frequent urge to urinate. Symptoms lasted 48 hours.
Fever, (temperature not taken mother was asleep at 2 am)  Chills, Headache, Chest Pain, Insomnia, Feeling of weightlessness,  onset at 2 am bedridden  Tylenol given at 6 pm  6/16/21
Patient returned to clinic on 10/9/19 complaining of having local injection site reaction with swelling, redness and warmth the evening of 8/27/19 after receiving MMR vaccine. Redness & swelling subsided after a few days but a "knot" mass has not resolved. Patient wants to know if it is related to the vaccination.
After vax on 5/5/99 at Health Dept & 11/3/99 at Health Dept, infants neck became swollen, red & whelps appeard 45 mins after shots.  No other symptoms noted. No med treatment. Spoke with MD on phone.
Extreme burning pain at injection site, traveling to elbow, back, shoulder, neck and into scalp. Went to Outpatient care then to Emergency Room and then to Primary Doctor for follow-up.
Information has been received from a nurse concerning a one of the twins (gender and age unknown). On unknown date, the twins were vaccinated with VARIVAX (lot number not provided). No other co-suspects were reported. No concomitant medications were reported. It was reported that their county was experienced an out break of chickenpox. Also, the patient developed chickenpox. The nurse stated that this county had a very high rate of parents who opt-out of vaccines. At the time of the report, the outcome of chickenpox was unknown. The relatedness for chickenpox was unknown for VARIVAX (Merck). Additional information has been requested. This is one of the several reports of the same source. The experience of the other one of the twins was captured in MARRS# 1211USA005227. The experience of the other one of the twins was captured in MARRS# 1211USA005227.
Approximately 7 days after vaccine individual developed skin eruptions that resembled drug-induce urticaria and/or wheals on the hands, arms, legs, and in the buccal area, which was associated with significant itching, and prompted medical attention (PCP) to be seen.  Prior to development of skin reaction, individual reported headache, nausea and dizziness.
My lower right eyelid became itchy and irritated.  Two days later it became swollen and bumpy.  I made an appointment at my eye doctor.  Initially he thought it might be a stye but it did not react to treatment like a stye.  He referred me to two eyelid specialists.
Patient developed CP a week later with mildly elevated troponins, initially worked up for ACS. Care team felt inflammatory response to vaccine.
EYEBALL HURTING; CHILLS; HEADACHES; FEVER; BODY MOVEMENT ALL THE TIME; SWEATING; PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was fine for 2 hours after taking the vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 18-OCT-2021 16:00 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On OCT-2021, the patient experienced body movement all the time. On OCT-2021, the patient experienced sweating. On OCT-2021, the patient experienced pain. On 18-OCT-2021, the patient experienced eyeball hurting. On 18-OCT-2021, the patient experienced chills. On 18-OCT-2021, the patient experienced headaches. On 18-OCT-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain, and the outcome of fever, chills, headaches, eyeball hurting, body movement all the time and sweating was not reported. This report was non-serious.
Itchy hands & swelling - several hours. Pt took OTC allergy meds w/ resolve.
Patient received his vaccine around 5 pm on 12/7/21. He woke up and was normal this morning, but once he was at school around 10 am on 12/8/21 he started to break out in hives with a fever. He reports that he feels fine, no difficulty breathing. His mom provided liquid benadryl and called us. We recommended that she touch base with the pediatrician and monitor for signs of difficulty breathing.
Patient reported that this would be their second shot and had a card showing it would be their second shot. When records were reviewed after patient left, it was shown that it was patient's third vaccination. Patient was contacted and admitted that it was their third shot. Pt said that time between 1st and 2nd shot was longer than 21 days, so they spoke to their provider, who "authorized" them to get a third shot.
Pfizer vaccine given on 8/27/2021 at pharmacy resulted in immense itching on Saturday that is continuing to date. I listed my allergies on the document i filled out at pharmacy. Nothing was discussed about the vaccine ingredients I have a 2nd Pfizer vaccine scheduled and need to take it because if I don't I will lose my job.
I had gotten my flu shot and on the 6th woke up with a sore throat. I had a runny nose and a decrease in smell. I developed congestion and was feeling tired and still really couldn't smell. I tested positive that day for COVID-19. I had really those symptoms for the duration.
33y/o male reports itching on the bottom of both feet at ~17min post-Pfizer vaccination into the left arm on 3/17/21. He states that he has h/o allergic reactions that typically present this way. He reports pain at injection site that he rates as a 3/10. He has associated itching/tingling sensation that he rates as a 2/10. He also feels flushed/heat in his face. He denies throat discomfort/swelling, difficulty breathing, shortness of breath, chest pain, palpitations, blurry vision, dizziness, lip/tongue swelling, or nasal congestion. Patient reports resolved sensations at 35min post-injection.  He reports h/o allergic reactions to river water, Chantix, Zyrtec and seasonal allergies. He states that he has never needed epinephrine and his past symptoms resolved without intervention and he was monitored.  Physical Exam: BP; 155/110 Cardiac: regular heart rate and rhythm. Radial Pulse 2+ Lungs: Clear to auscultation bilaterally Skin: no rash, erythema, or injection site redness/swelling  Plan: Patient reported symptoms resolved at 35min after injection and left clinic. He was advised to call 911 if he develops any allergic reactions or respiratory issues including hives, difficulty breathing, chest pain, or throat/lip/tongue swelling.   He was also informed that his blood pressure was high and that he would need to follow up with his PCP. Patient reports that it typically rises when he speaks to providers.
Nurse stated the 20 patient received the Moderna vaccine from the temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Nurse stated the 20 patient received the Moderna vaccine from the temperature excursion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048c21a) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Nurse stated the 20 patient received the Moderna vaccine from the temperature excursion). At the time of the report, PRODUCT STORAGE ERROR (Nurse stated the 20 patient received the Moderna vaccine from the temperature excursion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided No Treatment information provided
patient did a mammogram because developed and irregular looking thing in the breast.; This spontaneous case was reported by a consumer and describes the occurrence of BREAST MASS (patient did a mammogram because developed and irregular looking thing in the breast.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041M20A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced BREAST MASS (patient did a mammogram because developed and irregular looking thing in the breast.). At the time of the report, BREAST MASS (patient did a mammogram because developed and irregular looking thing in the breast.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did a mammogram and will have the results on Thursday, when a biopsy will be made.Lymph nodes are looking okay Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.
Patient received vaccine then stood up to walk to the other side of the counseling room. After around 1 minute the patient fell onto his brother who was sitting in a chair next to where the patient was standing. The patient appeared to have passed out, so with the help of his mother we lowered him to a sitting position on the ground and attempted to wake him. The patient was out for around 1-2 minutes during which his mother and I tried to arouse him and I asked the nurse at the store's clinic to assist with caring for the patient. After the patient woke back up he was agitated and screamed and fought away the hands of his mother. Patient appeared pale at this point. Following the patient waking up the nurse from the clinic advised he be placed on his back with his feet up, after which the patient slowly came back. Patient slowly became more alert and oriented to time, place and person. Color was seen coming back to face and body. Gave patient fluids, ice, and gatorade and as patient became more comfortable let him sit in a chair. As he was becoming more comfortable patient did dry heave/ vomit with little production. Patient continued to feel nauseous but felt well enough to walk out of the counseling room and have a seat in the lobby.
patient immediately vomited after vaccine, was monitored for additional 15 min and followed up with mom 1 hour later patient was fine
left arm started hurting at the injection site/just soreness at site my second vaccination; felt the pain has gone from front to top to back over her scapula/has hurt cents then moves around the joint area; where the first vaccination was given started to hurt; feels like she has lost mobility and range of motion in the arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101067388 (Pfizer).  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Mar2021 (Lot number: EN6207) at the age of 68 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 01, Anatomical Location: Left arm, lot number:EN6198), administration date: 19Feb2021, when the patient was 68 years old, for Covid-19 Immunization, reaction(s): "She had just a little soreness for one day". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 12Mar2021, outcome "unknown", described as "left arm started hurting at the injection site/just soreness at site my second vaccination"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset 2021, outcome "unknown", described as "feels like she has lost mobility and range of motion in the arm"; ARTHRALGIA (non-serious) with onset 12Mar2021, outcome "unknown", described as "felt the pain has gone from front to top to back over her scapula/has hurt cents then moves around the joint area"; PAIN IN EXTREMITY (non-serious) with onset 12Mar2021, outcome "unknown", described as "where the first vaccination was given started to hurt".  Additional information: There was no prior vaccinations within 4 weeks.There was no other relevant medical history including but not limited to these conditions, diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity.   No follow-up attempts are possible. No further information is expected.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unknown) dose was not reported, administered on 04-OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 04-OCT-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Pt recvd 2nd dose of Hep B on 10JAN91 & 11JAN91 pt exp neck pain & stiffness on the side of inject as well as arm pain;
Extreme Headache (whole head), fever, Diarrhea   Treatment was advil after 6 hours of symptoms persisting.  symptoms did not completely disappear until  12-9
12JAN99 pt c/o itching & pain gave APAP, called 13JAN99 let mom know bring in immed rash was 6 1/4-5 cm;
Information has been received from a healthcare worker concerning a 14 year old male patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 18-DEC-2000, the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX (lot #, expiration date, dose and route not reported). On 29-AUG-2013, following that administration of vaccine, an unspecified type of blood test was performed for serological testing to confirm the patient's varicella immunity. The results of the blood test determined the patient to be seronegative for varicella titers. It was confirmed by the reporter that the second dose of (Oka/Merck) VARIVAX was not administered. The outcome of seronegative for varicella titers was unknown.  Additional information has been requested.
Child was given a Tdap injection instead of a Pediarix injection. No adverse affects to patient have been noted
Was nauseated for a while in bed.  Went to bathroom to look for Phenergan.  Started to pass out.  Lying on floor with dry heaves.  Took Phenergan and went to sleep.  Next day at 2 PM still dizzy.  Pulse 64 sitting.  110 standing.  B/P 84/40 standing.
Swollen, red, and feverish circle around vaccination site on my arm, about 2.5 inches in diameter.  I did not have any arm reaction like this from the first dose of the vaccine, only the second. The skin is starting to look more rash-like.
Covid arm. Approximately a week after the shot, I got a red spot around the injection site. Over the next few days the ring grew in diameter on my arm. It is tender, itchy, and has a firm spot under the skin.
This case was reported by a physician (subject's father) and described the occurrence of injection site cellulitis in a child female subject who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date, the subject received an unspecified dose of KINRIX (unknown route, unknown arm). Less than one month after vaccination with KINRIX, the subject experienced a small wheal an inch below the injection site. 2 weeks later, the subject experienced a hot, crusty 5 cm patch of cellulitis at injection site. It was nearly extending in size to her elbow. This case was associated to a product complaint since the reporter stated that he wondered if the adverse event was due to a 'bad batch' of KINRIX. This case was assessed as medically serious by GSK. The subject was treated with antibiotics. At the time of reporting, the outcomes of the events were unspecified.
Patient received pfizer vaccine on 5/5/21, 5/26/21 and 12/8/21. Presented to ER on 6/16/22 and found to be COVID positive. Patient is a 64-year-old male with past medical significant for chronic diastolic CHF, paroxysmal atrial fibrillation on Xarelto admitted on June 16th with generalized weakness x 3 days.  CT angio chest was done which showed no evidence of PE, but showed cardiomegaly with evidence of right heart failure and pulmonary edema.  Ground-glass opacities typical for COVID-19 pneumonia, large layering right pleural effusion and small left pleural effusion was also seen.  Patient underwent thoracentesis and 1850 mL fluid was removed.  Patient oxygen was gradually tapered down and now is doing well on room air.   Has finished course of IV Rocephin, doxycycline  for COVID pneumonia. Discharged on room air on 6/29/22
Extreme pain in arm and left side of chest for 2 days (Saturday and Sunday; July 31st and August 1st). Patient drank water and took Tylenol and symptoms/event has since resolved. Advised patient that she can consult her physician prior to receiving second dose.
Noticed a pea-sized lump under skin, above mid-clavical, left size on April 2, 2021.  It has not changed in size.
Headache, Myalgia, Fever, Headache, sore muscles, fever and sore throat Narrative:
Red rash; Rash around the injection site on her left arm in the shape of a square; The site as been itchy all along; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash), VACCINATION SITE PRURITUS (The site as been itchy all along) and VACCINATION SITE RASH (Rash around the injection site on her left arm in the shape of a square) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Adhesive tape allergy (Allergy to adhesive).    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (The site as been itchy all along). On 14-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Red rash) and VACCINATION SITE RASH (Rash around the injection site on her left arm in the shape of a square). At the time of the report, RASH ERYTHEMATOUS (Red rash), VACCINATION SITE PRURITUS (The site as been itchy all along) and VACCINATION SITE RASH (Rash around the injection site on her left arm in the shape of a square) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. The patient did not take any treatment medication.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up received on 05-Aug-2021 and included No new information.
Severe muscle soreness (paralyzing); Severe muscle soreness (paralyzing); soreness in tissue and bones; soreness in tissue and bones; unable to walk straight; numbness in hands, arms, and feet.; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 15Apr2021 11:00 (Batch/Lot Number: EW0162) at the age of 49 years, as 0.3 ml single for covid-19 immunisation.  Previously the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot: EN6207, on 25Mar2021 at 11:00 AM at 0.3 ml single in left arm. Medical history included calcium deposits and mitral valve prolapse, from an unknown date and unknown if ongoing.  The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported.  On 15Apr2021 at 18:00 the patient experienced severe muscle soreness (paralyzing), soreness in tissue and bones, unable to walk straight, numbness in hands, arms, and feet (severe symptoms as such for 4 days). The outcome of the events was resolving.
major pulsating headache, malaise, fatigue, fever like symptoms (increase in temperature) - 1 day injection site soreness - ongoing (2 days)
Didn't help me a bit; sick; Initial information received on 16-Dec-2022 regarding an unsolicited valid serious case received from a patient (consumer) via social media.  This case involves a patient of unknown age and gender who reported it didn't help me a bit and got sick after receiving influenza vaccine.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, lot number and expiry date - not reported) via unknown route in unknown administration site for flu (Influenza).  On an unknown date the patient reported didn't help me a bit (vaccination failure) and got sick (malaise) (unknown latency) following the administration of influenza vaccine.    It was unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (sick)  At time of reporting, the outcome was Unknown for both the events.  Seriousness criteria: Medically significant for the event didn't help me a bit (vaccination failure).; Sender's Comments: Sanofi company comment dated 23-Dec-2022: This case involves a patient of unknown age and gender who reported it didn't help me a bit and got sick after receiving influenza vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.