chrisvoncsefalvay/vaers-outcomes huggingface dataset:
03/05/21  2:00pm - Temperature rises. Feels as if fever is coming.  03/05/21 7:00pm - Fever continues. Chills.  Injection site is red.  03/05/21 11:30pm - Fever continues. Headache begins.  03/06/21 7:00am - Fever is gone. Headache continues. Rash has developed at injection site.  03/07/21 - All side effects have disappeared aside from injection site rash. Large red rash is present.  03/09/21 - Redness/rash has decreased. Arm begins to itch at injection site.  03/10/21 - Injection site is increasingly itchy.
pt recvd vax;had rash x 3 days at inject site;at 4 mo, recvd tetramune/opv , devel rash, irritability;felt hot to touch; t not taken;MD visit,had bruise,induration at inject site;maculopapular rash; no rx;
Towards the end of November 2003 the subject noticed a decrease in his physical fitness abilities. He began to notice he was tired and was SOB. In January 2004, he noticed that when he climbed stairs, he was SOB. Around that time he noticed chest pain. He went to the doctor for his shortness of breath and chest pain. He was put on a 10 day course of Vioxx for the chest pain and a 10 day course of antibiotics for suspected pneumonia. His symptoms did not resolve so he returned to the doctor. A stress test and chest CT scan were performed on 4/9/04. The stress test was normal and the doctor said his heart is healthy. The CT scan showed that his lymph nodes were swollen in his upper chest area near his airway. A lymph node biopsy was performed on 5/17/04 and he was diagnosed with stage 2A Hodgkins lymphoma that was only present on his left side. He underwent chemotherapy from 6/04 through 11/04. In June 2004, he was hospitalized for an internal bleeding hemorrhoid. A colonoscopy was to be performed but was cancelled due to a low WBC count and a fever of 104 F. The subject was initially on a 4 drug combination for his chemotherapy. It was determined that the Bleomycin was causing lung tissue damage and it was discontinued. Due to this lung damage shortness of breath remains and he is not able to do physical fitness at the same level as he had prior. Radiation began in January 2004 and continued through 2/25/05. 5 days later the subject noticed swelling in his underarm and chest area near his clavicle. A follow up PET scan was performed and he was told that the area that was originally affected was clean. A second round of radiation was done in April-May 2005. A follow up PET scan is scheduled for June 20, 2005 and the results will be given to the subject on 6/27/05 at his doctors office. He believes that an outpatient summary will be performed to remove the underarm mass and scar tissue and that this will leave him in remission. A follow-up report was submitted by BioPort Corp. on July 20, 2005. BioPort has no further information at this time.
developed a rash on her face/Arm/chest; This case was reported by a consumer via call center representative and described the occurrence of rash in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix and an unknown time after starting prednisone, the patient experienced rash. The patient was treated with prednisone and famotidine (Pepcid). On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The reporter reports that the patient received the shingrix and developed a rash on her face,arms and chest.  The reporter put patient on Pepcid and prednisone but was not able to diagnose what kind of rash patient had developed. The follow up consent was not granted.
This case was reported by a physician (also the mother of the patient) and described the occurrence of abdominal cramp in a 15-year-old female subject who was vaccinated with HAVRIX, GlaxoSmithKline.  Concurrent medications included over the counter sinus medication.  On 8 June 2007 the subject received unspecified dose of HAVRIX at 0.5 ml.  At an unspecified time after vaccination with HAVRIX, the subject experienced abdominal cramping, fever less than 101 F, nausea and vomiting (once only).  At the time of reporting the events were improved.  The physician/mother reported that the events were not related to menstrual cramps and they were possibly related to treatment with HAVRIX.  Follow-up information was received from the physician on 21 June 2007.  Concurrent medications included Pepcid AC.  The events started on 08 June 2007, the same day as vaccination with HAVRIX.  The events resolved on 09 June 2007.  The physician considered the events were related to vaccination with HAVRIX.  The physician indicated that the immunization series with HAVRIX was not discontinued or delayed.
I woke up at 3 am on the 9th day since I had received my first vaccination and discovered I had a 2 inch rash below the injection site of my left arm.  It is very itchy and somewhat red. Sent photos to Dr. today (2/22) and had a virtual visit with her ,  She directed me to this site so that I may report the adverse reaction.
No adverse outcomes reported at time of filing report. Reporting d/t administration error. Administered 3 days past expiration date.
product=COVID 19 Treatment, brand=Paxlovad/vaccine brand=Pfizer / BioNTech; product=COVID 19 Treatment, brand=Paxlovad/vaccine brand=Pfizer / BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Oct2021 as dose 3 (booster), single (Lot number: Ff2593) at the age of 45 years, on 23Mar2021 as dose 2, single (Lot number: Er8727) and (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Ibuprofen, reaction(s): "known allergies Ibuprofen". The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "recovering" and all described as "product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06May2022) Negative; (13May2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Additional information: Anti-viral details product=COVID 19 treatment (brand=Paxlovid). treatment start date=30Apr2022 and stop date=04May2022, indication is use for treatment of COVID-19. adverse event 11May2022 she started coughing and sneezing, then headache and heartburn. Muscle pain specifically in hips started 12May. 13May rapid test showed a strong positive result while rapid test was already negative by 06May. if patient is Recovering. The patent was not received treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Began developing a fuzzy eye sight in right eye; progressively worse, unable to focus. On Wednesday 2/3/2021 I noticed a large amount of long and moving floaters in the ight eye, swirling, growing and then fading - like someone poured a stream of ink in water. By Friday 2/4/2021 unable to focus from right eye and went to Ophthalmologist for eye exam; He made arrangements to send me to a clinic in and I will see them on Wednesday 2/10/2021. I don't know whether or not this is related to the COVID vaccine but it is the only unusual event that has occurred in the last 45 days.
whole body rash,+itching ,pt. was given Diphenhydramine 25 mg's 2 tabs, zantac 159mgs.  3 hours later received IM demethasone 10mg and Depomedrol 80mg. cont to take dphenhydramine over night. 10/22/2009 receied depomedrol 80mg and demethasone 10 mg. rash better but cont on 10/32/2009
headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 HEADACHE (headache) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Extreme dizziness, unable to stand, Low blood pressure, Headaches, Blurry vision in left eye, Unsettled stomach, Hard to concentrate, Rapid heart rate.
neck was stiff; legs and arms were very stiff; tired; I couldn't go to bathroom and walk back to the bed/I couldn't move my arms and legs; I still don't feel wonderful; headache; exhausted; I woke up and I couldn't move; I actually couldn't move so, I have been in bed for quite a while now; I was too weak to really get up and go to bathroom; This is a spontaneous report received from a contactable other hcp. A 70-years-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Batch/Lot Number: EX0181), at the age of 70 years old, via an unspecified route of administration, administered in Arm Left on an unspecified date as Dose 1, Single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced her neck was stiff , legs and arms were very stiff, tired, she couldn't go to bathroom and walk back to the bed/i couldn't move my arms and legs,she still don't feel wonderful , headache, exhausted, patient woke up and she couldn't move, she had been in bed for quite a while now; patient was too weak to really get up and go to bathroom on an unspecified date.The outcome of the events was unknown.The Caller wanted to know if she can get the second dose of the vaccine.The Caller mentioned that she spoke to the department which took down her medical and physician information.Consumer was informed about the role of Pfizer Drug Safety Department.The response received was The line got disconnected automatically. Outbound call was attempted # 1 12Aug2021 8:00 pm. Outbound disclaimer was provided as follows:As noted in the Fact Sheet for Recipients you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine.The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection.Your healthcare provider knows your health situation and has access to information that can better help inform this decision.Pfizer cannot provide treatment recommendations. However,the CDC has established a project comprised of a team of vaccine safety experts who can be consulted on complex COVID-19 vaccine safety questions.More information is available on their website, which is www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/cisa/index.html. The patient had not received any treatment for the event,she just drank lot of water. Follow-up(12Aug2021): This followup information stated about the patient calling to Pfizer medical information regarding the stiffness,headache fatigue event after patient had received the covid vaccine.Reporter seriousness for My neck was really stiff and my legs were heavy was Unspecified.NDC and expiry date of vaccine was unknown.patient height and weight was reported to be approximately 112 and 5 (feet) and 4.5 (inches).The patient didn't mention her email id,ethinicity No lab test data was available.
She got her vaccine, had no reaction at first was fine all day.  They walked around in a store and had dinner and everything was fine up until 10:00 PM.  She had no reaction or any topical reaction.  During the night she started throwing up, she said that she was very sick.  Then in the morning her daughter noticed that she started throwing up about 6:30 - 7:00 and her temp was 99.2.  Her daughter states that she threw up again later within 45-an hour and gave her some Mylanta and she threw up that too.  She called the pharmacy around 9-10 and the aide tried to give her a sip of water which she threw up again.  She was given something for nausea about an hour (emetrol).  She gave her 15 cc's and seems to be holding that down now and will give her another 15 cc's in about an hour, which the pharmacy suggested.  She is not giving her anything for a while and is not going to take her to the ER unless she gets worse.  Daughter is a nurse.    She was fine with her flu shot last year, and was surprised that she had a reaction with this and she has never had a one like this before.
Started with severe chills, body aches and feverish. The. Slight leg pain which worsened with time , swelling on the right leg calf, warm to touch and difficulty breathing. Got hospitalized on 1/16 21 with multiple clots in my right leg and clot in the lung. Still in the hospital now.
Bruise 2cm by 4cm. Redness 12cm by 21cm. Warm and painfull.
Pt c/o painful, swollen and red at site, reaction increasing in size and pain daily, pain into rt shoulder and neck and reports elevated temp at home.
2/20 received first shop and within 6 days awakened with vertigo. After speaking to doctor went to PT. Was relieved of symptoms for 8 days.  Then on 3/19 received 2nd dose and shortly after began feeling dizzy and experienced severe head aches. Trying for 2 weeks to work through symptoms but was admitted to the hospital with extreme dizziness and unable to walk.  While in I was diagnosed with Guillain-Barre' Syndrome. It has completely debilitated me causing extreme unsteady and uncoordinated body functions that could possibly last for the remainder of my life.  Since I am an active gym athlete, this is devastating.
I woke up around 1 am so sick that I could not sleep. My head was throbbing with every single heart beat. I had a fever of 102 and was constantly switching between chills and sweating through my sheets. The room felt like it was spinning and I felt like I was going to puke. Lastly I started to get chest pain which was by far the most concerning part to me. I still have a headache and chills but the fever is gone, and I am recovering
9-23-09 Morning after immunization one seizure at daycare (twitching movements & eye rolling back) taken to ER. Three more episoded in ER, Tx of fosphenytoin & ATIVAN. IV fluids Distributed at .45 cc/hour oxygen. ROCEPHIN 700 mg IV every 12 hours. Discharged 9-24-09 pt on KEPPRA 150 mg two times daily prior to admit increased 240 following admit.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I had a sore throat, and my glands were swollen. My nose was congested so I went to clinic, and I was diagnosed with sinus infection. One week later, I was diagnosed with ear infection, and I was in pain.
Patient was inadvertently given DTap instead of Tdap. Patient contacted today and has had no adverse events.
when he had his first COVID vaccine that his arm was sore but it was not black and blue with a bruise like hers was; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "when he had his first COVID vaccine that his arm was sore but it was not black and blue with a bruise like hers was".  Additional information: Reporter stated that patient said that when he had his first COVID vaccine that his arm was sore but it was not black and blue with a bruise like hers was. Reporter declined to complete a safety report for the patient.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
mom recv vax 13JUN97 & 19AUG97;  Breast feeding infant exp   upset stomach (throwing up);it was noted that infant only became sick to stomach p/nursed;
Patient's wife called this morning stating that her husband has passed away last night. After receiving first dose of Pfizer COVID-19 vaccine at around 0830, patient remained in the Immunizations Department for the 15-minute monitoring period. Per wife, patient's only complaint was pain at the injection site. At 1300, wife states that patient complaint of dizziness which "dissipated after a few minutes" followed by a headache which "dissipated after a few minutes" as well. Then patient complained of nausea, no vomiting and "couldn't relax." Per wife, from around 1400/1500, patient stayed on his recliner while still having a conversation with her--"he didn't get up to eat." Last conversation they had was around 2000/2100. Per wife, at around 2100/2200, patient was quiet and when she checked on him, "he wasn't responding anymore." Wife then called 911, "but they couldn't revive him."
Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided y the reporter.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) had not resolved.
Chills, vomiting, diarrhea, sweats, tremors, dizzy, headache, unsteady gait, fever 101. Symptoms lasted for 24 hours and then I was feeling bad and in bed for 3 days. I took Tylenol for symptoms. I called my doctor and was advised to take Tylenol.
Vomiting, 101.8 Fever, shortness of breath,  neck pain, headache, sore bicep, sore forearm, chills, dizziness.
Came into the ER on 2/1 with elevated INR. INR 24.7.  Vit K 5mg PO given. Held Coumadin Covid test positive. No S:S of covid. Chest Xray neg. No bleeding. Vit K 2.5 ordered TID. INR on 2/2 9.6. INR on 2/3 1.0, on 2/3 2.0, on 2/5 1.0. Initially was going to change pt from Coumadin to Xarelto after discharge, but patient requested to stay on Coumadin due to having a stroke while on Xarelto. Discharged home on 2/5/2022 on Coumadin home dose and follow up with clinic
after 6 min of vaccine pt started sweating and convulsion was noted for about 1 min. then pt had sob.
My arm became very sore, puffed up, very red, hot to the touch and then very itchy.  It has gone down a lot but it is now 10 days after and it is still hot to the touch, a little sore and itchy. Should I take the second shot in the same arm?  Can I take Tylenol before getting the second shot?
Disgust towards food; there was like a ball in my arm; Fever; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of EATING DISORDER (Disgust towards food), VACCINATION SITE MASS (there was like a ball in my arm), PYREXIA (Fever) and VACCINATION SITE PAIN (Vaccination site pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     Concomitant products included VITAMIN C [ASCORBIC ACID] and VALERIAN [VALERIANA OFFICINALIS] for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced EATING DISORDER (Disgust towards food), VACCINATION SITE MASS (there was like a ball in my arm), PYREXIA (Fever) and VACCINATION SITE PAIN (Vaccination site pain). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 25-Apr-2021, EATING DISORDER (Disgust towards food), VACCINATION SITE MASS (there was like a ball in my arm), PYREXIA (Fever) and VACCINATION SITE PAIN (Vaccination site pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient took concomitant medication salmon pills.
Terrible pain from injection site extending to breast, chills, fever, exhaustion, difficulty breathing, all for about 5 days. Difficulty breathing persisted for over 2 weeks. Skipped menstrual period for 3 months, resuming in August 2021. Lingering pain left chest as of September.
3/20/2018 - Sore arm at 7PM. 3/21/2018 - Nausea, fatigue, headache upon awakening in the morning. 3/21/2018 - Headache better in the evening. 3/24/2018 - Noticed herpes rash on back of left leg.
Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 months old male patient who was vaccinated with second dose of DTAP-IPV and 0.5 ml second dose of ACT-HIB (Batch number: UIN07AA, expiry date: 26-Oct-2019)via intramuscular route in right thigh instead of PENTACEL (batch number: C5530AA and expiry date: 04-Oct-2019) via intramuscular route in the left thigh and ACT-HIB on 18-Oct-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) and ROTAVIRUS VACCINE LIVE ORAL 1V. It was a case of actual medication error due to wrong vaccine administered and extra dose administered because two vaccines were give in same visit. It was reported as patient was supposed to receive DTaP/IPV vaccine and ACTHIB but was given PENTACEL and ACTHIB at same visit. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.