chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reports feeling pain at injection site starting on 7/31/17 around dinner time. Then patient experienced redness as big as their fist, swelling, and warmness that has persisted up until 8/1/17 when they reported the reaction. Patient self medicated with TYLENOL on 7/31/17 at dinner and again at bedtime.
No adverse event, treatment or outcome at this time. Submitting report due to incorrect dose administered.
rashes; This is a spontaneous report received. A contactable consumer (patient) reported a 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unknown route of administration, administered on left arm on 18Feb2021 17:00 (Batch/Lot number: EN6201) as 1st dose, single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. The patient has not had COVID before vaccination nor tested after vaccination. On 20Feb2021, the patient experienced rashes at various parts of his body. He claimed that the rashes tend to become darker and start out very rough like medium sandpaper. The patient reported that he had not known of any allergies and it was his first reaction in over 30 years. The patient did not receive treatment for the reported event. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Patient waited in pharmacy for 25 minutes. Upon return home patient felt tingling and numbness in the lips. Patient reported swelling in lips. Patient was advised to take Benadryl and seek medical attention at nearest ER or urgent care. Patient spoke to nurse on phone and advised to take Benadryl at home after complete consultation of symptoms over the phone.  Patient symptoms resolved with Benadryl and did not seek further medical attention.  Upon follow-up call in AM of 4/20/21 patient reported symptoms had resolved and was doing good.
This spontaneous report was received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. Between 28-APR-2016 and 17-AUG-2015, the patients were vaccinated with the improperly stored doses of (Oka/Merck) VARIVAX lot # L03777 with expiration date 04-FEB-2017 and lot # L011082 with expiration date 01-APR-2017; dose and route of administration were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information was received from a nurse concerning a fifth grade student who on 16 JUL 1999 was vaccinated with a dose of Varicella.  On 16 DEC 2004 the student developed chickenpox.  According to the school nurse there were 58 other elementary school students and 34 of them had previously been vaccinated with a dose of Varicella.  Unspecified medical attention was sought.  There was no information regarding the present status of the student.  No product quality complaint was involved.  Additional information was requested.
VASOVAGAL EPISODE POST VACCINATION, PT WAS IN A CAR, FOOT DEPRESSED THE ACCELERATOR AND RAN INTO A TENT, CAUSING THE COLLAPSE OF THE MONITORING TENT, PORT-A-POTTY AREA. CODE GREEN CALLED, PARAMEDIC CAME, TRANSPORTED PT TO HOSPITAL
go to the bathroom, remember wiping and them my husband standing over me on the floor; Sweating profusel; Product use for unapproved combination; This is a spontaneous report from a contactable consumer (patient). This 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3249) via an unspecified route of administration in the right arm on 19Jan2021 at 09:15 at single dose for COVID-19 immunisation. The patient was not pregnant. She received another vaccine (unspecified) in the left forearm on the same date of BNT162B2. Relevant medical history included allergies to tape and potential basal cell cancer. Concomitant medications included melatonin and multi vitamins. The patient previously received varicella zoster vaccine rge (cho) (SHINGRIX) on 21Dec2020, second dose in the left arm. The patient reported that she felt great after the shot at 9:30 am on 19Jan2021 and, at 13:30, she had a potential basil cell cancer removed, and she felt great. On 20Jan2021, at 1:55 am, she got up to go to the bathroom, she remembered wiping and then her husband standing over her on the floor. On 20Jan2021 at 01:45 am, she was sweating profusely; after a minute, she got herself off the floor, back in bed, and she had no feelings of any illness. The patient did not receive corrective treatments for the reported events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19. The patient recovered from the events on an unspecified date.
Patient's arm hurts upon raising. He said it began hurting about 2 days after receiving the shot.
RASH; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not 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 17-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the subject experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash. This report was non-serious.
This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies. The reporter stated that, since 09-MAR-2017, the patients received an improperly stored dose of PROQUAD recombinant human albumin (rHA) lot number M038227, expiration date: 06-MAR-2018; lot number: M033209, expiration date: 09-JAN-2018; and lot number: M019232, expiration date: 17-OCT-2017 (strength, dose, frequency, route of administration, and anatomical location were not provided) for prophylaxis. The licensed practical nurse did not have access to the lot numbers and expiration dates for the diluent that was used. The vaccine was exposed to a temperature between 15 and 46 Fahrenheit (F) for 15 hours. The call was not because of a data logger, and there was no previous temperature excursion. No adverse effects had been reported. There was no product quality complaint involved. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA007551.
light headache; back pains; This is a spontaneous report from a Pfizer-sponsored program. A contactable Consumer reported similar events for 2 patients. This is 2nd of 2 reports. A male patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 05Feb2021 as a single dose for covid-19 immunization.  Medical history and concomitant medications were not reported. On an unspecified date, she experienced light headache and back pains and would like to know if she can take Tylenol. The clinical outcome of the events headache and back pain was unknown.  Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021144697 same reporter, case for Wife
Pharmacist described "covid shoulder" and I got an intensely itchy, swollen red shoulder at and below the injection site starting about a week after the injection.  It measures 2 inches wide by 4 inches long and is also firm.  I have put OTC steroids on it multiple times without any improvement.  Now on day 2 1/2 of symptoms.
Patient received Flu vaccine at pharmacy in Nov 2015. Reported to our office during appointment: (R) deltoid pain since receiving vaccination.
The day I got the vaccine I didn't have any pain or swelling. The next day (Saturday) I had a little soreness. As the day progressed the pain got worse. By Saturday night it was swollen, warm and the pain had increased. The pain was in my shoulder and I had a burning pain down the back of my arm. On Sunday I was in a lot of pain. The pain was impacting my ability to perform my regular duties. I went to Urgent Care and they said it was infected and they gave me an antibiotic. On Monday it was still warm, swollen, and I had zero change in the pain. Tuesday the warmth was gone and some of the swelling. The pain was still the same. I went to my physician and she said it was just a reaction to the vaccine. She gave me a steroid dose pack and Benadryl. Four hours after taking the steroids and Benadryl the burning down the back of my arm was gone. On Wednesday the swelling was gone and there is only a little pain in my shoulder. By Thursday my arm was normal.
Phone call on 8/3/01 from mother to report increased fever. Woke up at 01:30 today with a fever of 106F (R). Called ER and was advised to give Motrin. She did and the fever went down within 20 minutes. Pt slept the rest of the night and at 07:30 on 8/3/01 pt had a fever of 101F (R). He was given Motrin again. No other symptoms. He did have Tylenol 1/2 hour prior to vaccines and at 13:30 the day of vaccines as he was fussy and crying. As of 8/3/01 phone call, temperature is "still up slightly".
Chills and fever; Chills and Fever/Fever has gotten better went from 103to99; Broke out in rash; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown), dose 2 via an unspecified route of administration, administered in right arm on 18May2021 at 08:30 as single dose for covid-19 immunization. Medical history included breast cancer from 19Jun2019. She had surgery in Jul2019, a lumpectomy and they did radiation on her left breast in Sep2019 and Oct2019 then she went into remission. The patient's concomitant medications were not reported. No prior Vaccinations (within 4 weeks). No AE(s) following prior vaccinations. The patient previously received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number: unknown) in right arm on 27Apr2021 at 08:30 (at the of 60-year-old) as single dose for covid-19 immunization. She got the shot on Tuesday. When she got her shot she did not start having a reaction until Thursday night. Then Thursday 20May2021 until 22May2021 not having chills anymore, running low grade fever. She had chills and fever on 20May2021 around 5:00 to 6 in the evening. She clarified that it has not went away she is still having a reaction. Her fever has gotten better went from 103 to 99. She took Tylenol and packed herself in ice. Around midnight she broke out in rash on left breast, abdomen and side. It started Thursday (20May2021). It has continued and is persisting. She has taken Benadryl every six hours and ice packs. She is a breast cancer survivor. She is going try to go to the doctor today because her rash is not going away. A visit to emergency room or physician office was not required. The outcome of the events chills was recovered on 20May2021, fever was recovering; rash was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
After both the booster shot and a subsequent mild case of Covid (onset: December 26, 2021) I experienced a reoccurrence of herpes simplex. The first time my entire upper palate was affected; I saw my periodontist. The second time (after the illness) the problem was milder lasting four days and then healed. I first had herpes simplex in 1962; since then, have had very few outbreaks until Covid vaccine and then the actual Covid illness.
High fever, chills, nausea, fast heart beat started about 14 hours after the injection and lasted about 8 hours. Very achy and fatigued for an additional 6 hours after the most severe symptoms passed.
Rotarix after receiving Rotatech; This case was reported by a nurse via call center representative and described the occurrence of interchange of vaccine products in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis and ROTAVIRUS VACCINE (ROTATEQ) for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation, Rotarix Oral Applicator Device and ROTATEQ. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comment: The reporter reported that, the patient received a dose of Rotarix after receiving an initial dose of Rotateq. The reporter did not provide lot number, expiration date, patient demographics, or full mailing address. Additional Supportive Information: The patient received a dose of Rotarix after receiving an initial dose of Rotateq, which led to interchange of vaccine products.
Patient received DTap,HIB,PCV, and IPV.  She began to cry, then her right and left feet, ankle, up to mid tibia turned bright red, hot , and slightly swollen.  I administered benadryl and within 30 minutes symptoms began to subside Follow up 02/21/05: Patient had redness at injection site.
Fever 103 degrees, angioedema, allergic asthma, abdominal pain, systemic anaphylaxis, severe psychiatric manifestation, depression, hallucinations, no sleep, dehydration, weakness malaise.
headache,nausea, chills, body aches, fatigue  Acute for 18 hrs then lessening . Mild symptoms for another 24 hrs.
Severe arm soreness then the next day she noted increased redness, swelling that extended lower in the upper arm and around the back.
1st dose approximately 11 hours after receiving, I began to have chills, fever.  Fever climbed to 104.5.  Chills, sweating, rapid heart beat.  Body aches and pains. Lasted for 72 hours. 2nd dose approximately 8 hours after receiving chills began.  Fever climbed to 103.  Chills, body aches and pains.  Fever last 48 hours, I am still experiencing the body, joint aches and pains.
Patient called on 10/20/21 around 4pm stating that in the AM she experienced pain in the arm, redness and swelling at the injection site. The pain was traveling through her left arm. I suggested she contacted her primary care doctor Dr. Her reaction is part of the side effect of the vaccination. I notified Dr. medical assistant, she stated she would notify the DR and contact the patient.
The day after the vaccine, in addition to soreness of the arm, i felt muscle and joints soreness and fatique. The next day, the pain gets worse and feeling severe fatigue. Pain and fatique continue ti get worse and with chills included. On Thursday, June 2, while driving, i had very bad cramps on my right toes that lasted for about 45 min. That evening, I had cramps on my right and left toes,  very bad crams that lasted for more than an hour. I went to bed feeling really bad. The bext day, I woke up with so much pain from waist down, was not aboe to walk and my left leg Is huge and different color. My husband called 911.
4 months after 2nd injection developed AFIB; This is a spontaneous report from a contactable consumer (patient).  A 64-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 intramuscular, administered in Arm Right on 07Apr2021 (Batch/Lot Number: ER8729) as age at vaccination of 64-years-old, as single dose, for covid-19 immunisation. Medical history included chronic fatigue syndrome from 2004 and ongoing, migraine from an unknown date and unknown if ongoing. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular, administered in upper left shoulder on 17Mar2021 (Batch/Lot Number: EP7534), age at vaccination of 64-years-old, as single dose, for covid-19 immunisation and experienced acute diarrhea. Concomitant medication included sumatriptan (SUMATRIPTAN) taken for migraine from 2016 and ongoing. The patient did not receive any other vaccines. The patient experienced Afib (atrial fibrillation) in Aug2021 (4 months after 2nd injection).  The patient underwent lab tests and procedures which included blood test with normal results on 25Mar2021. Outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
Information has been received from a nurse concerning an 11-12 year old female who was vaccinated with VARIVAX (Merck) (lot no., route and site of administration were not reported) 6-8 months ago. At the same time the patient was vaccinated with HPV (lot no., route and site of administration were not reported. The vaccinations were given in the same arm. The day after the patient received the vaccinations, the patient developed redness, swelling and welt 3 inches diameter at the injection site. It was reported that these events had an onset date of 6-8 months ago (approximately October 2007). All symptoms resolved in a few days. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information is not expected.
Hives/were all over his body; Diarrhea; Fever; Vomiting; Lack of appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 6 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19Dec2021 09:30 (Batch/Lot number: unknown) at the age of 5 years as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: URTICARIA (non-serious) with onset 22Dec2021 14:00, outcome "recovered" (26Dec2021), described as "Hives/were all over his body"; DIARRHOEA (non-serious) with onset 22Dec2021 14:00, outcome "recovered" (26Dec2021), described as "Diarrhea"; PYREXIA (non-serious) with onset 22Dec2021 14:00, outcome "recovering", described as "Fever"; VOMITING (non-serious) with onset 22Dec2021 14:00, outcome "recovering", described as "Vomiting"; DECREASED APPETITE (non-serious) with onset 22Dec2021 14:00, outcome "recovered" (26Dec2021), described as "Lack of appetite". The events "hives/were all over his body", "diarrhea", "fever", "vomiting" and "lack of appetite" were evaluated at the physician office visit. Therapeutic measures were taken as a result of urticaria, diarrhoea, pyrexia, vomiting, decreased appetite.  Additional information: Hives were managed with Benadryl but continued until 26Dec2021 and were all over his body including his face. The patient did not have Covid prior vaccination. The patient does not tested for Covid post vaccination. The patient given privacy policy consent. Device timestamp: 28Dec2021.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Within 15 minutes of the vaccine I developed blurry vision. Within 3 hours of receiving the vaccine I developed dizziness which lasted for 6.5 months. The dizziness was frequent and unpredictable. It occurred daily for 4 months and then was slightly less frequent. It happened while walking, sitting, working, etc. I also developed extra sensitivity to lights and sounds which has not stopped to date. I had an MRI and was seen by a neurologist who indicated I had migraine activity in my brain, which was a new development with my health history. After 6.5 months the dizziness lessened to occurring only randomly.
Continued vomiting until administered phenergen.  High fever, diarrhea and sever body shaking from the feeling of being very cold.  My wife took me to Hospital Emergency Room.  Was adminstered Toradol, phenergen, Motrin, Tylenol, mylanta and multiple IVs.
pharmacist asked what to do with a patient who passed the 42 day mark to get the second dose of the Moderna vaccine, should the patient repeat the dose or not; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (pharmacist asked what to do with a patient who passed the 42 day mark to get the second dose of the Moderna vaccine, should the patient repeat the dose or not) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (pharmacist asked what to do with a patient who passed the 42 day mark to get the second dose of the Moderna vaccine, should the patient repeat the dose or not). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (pharmacist asked what to do with a patient who passed the 42 day mark to get the second dose of the Moderna vaccine, should the patient repeat the dose or not) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Per pt arms started to hurt around 1030am while at school and she called dad. By then her legs and back also started to  hurt. Dad called office and was advised to take her to the ER.
Left arm swelling,  painful, Erythema. 8/1/19 diagnosed with cellulitis of LUE.  Keflex 500mg presribed. ICE, motrin, mark swelling, RTC as needed.
3/21 had case of COVID-19 but reporting numbness that occurred after COVID-19. 4/2 began having numbness in my fingertips. Left side I went into my forearm, calves, and upper thigh. Right side starting at my collar bone and going all the way down. I experience the numbness on both sides but it is more pronounced on right side. Called PCP and they stated there was nothing that could be done.
About 30 minutes after receipt of the first dose of the Pfizer COVID vaccine, my upper lip was slightly swollen on the same side as where I received the vaccine (left), and I had redness in my face for about 1.5 to 2 hours. I also had a slight lump in my throat 15-30 minutes after receipt. I never felt like I was in danger or needed immediate medical attention, and the symptoms subsided without medication.
This report described cellulitis in the injection area in a four year old male who received DTaP. On 06/11/01, the vaccinee received a 0.5 cc IM dose of DTaP; it was not known how many previous doses of DTaP the vaccinee had received. Subsequently, the left arm injection site was red and hot to touch with indurations from the injection site down to elbow. There was "some" swelling but no pus. The vaccinee wad found to have cellulitis. He was treated with amoxicillin trihydrate/clavulanic acid 400 mg/5 ml 1 1/2 teaspoons twice daily for seven days. As of 10/04/01, the outcome of the events was unknown
Severe body aches, chills, fever, shaking, lethargy all staring about 12 hours after 2nd dose; symptoms lasted about 18 hours. Mild arm soreness occurred with both doses.