chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient's mother was not notified that wrong dose was given.  Mother states daughter had no adverse reactions, and felt fine afterwards while at home and went to school as normal.
Lightheaded after injection. Got worse later in evening after 6 glasses of wine. Was told to only have one glass if it all. Also told that alcohol does not interact with vaccine but it did with me. I also had severe fatigue next day & was non-functional. Couldn?t eat & had fitful sleep for 18 hrs . Vaccine plus alcohol does NOT work & folks who drink regularly like myself need to know this!!! I was so worried about the reactions to 2nd dose that needed to ?self-medicate? afterwards in preparation.
Eyes, itchy, watery, red. Nose, runny, clear secretion. Up for the past five weeks. Started on Astelin 137 mcg spray. Patanol 0.1% solution started 11/23/09.
Day after vaccine: fatigue, aches, headache, and mild chills. These symptoms cleared up by the next day (3/10). Had bruising at injection site that disappeared after a few days.   7 days post-vaccine (3/15) I noticed that I had developed a raised, red, inflamed blotch of skin around the injection site. It was slightly tender. The red mark expanded over the next 2 days, though the redness and inflammation decreased. It was gone after approximately 5 days.  Beginning 3/15, I experienced pain and inflammation in my armpit on the arm in which I received the vaccine. Pain became moderate-severe over the next few days, to the point where I considered visiting an urgent care clinic. Pain was exacerbated by arm movement and use of muscles surrounding armpit, but was mostly cared for by taking ibuprofen. Pain slowly faded over the course of 8 days, and was gone by 3/25.
Kinrix given at age 1 year and 3 months.  There were know adverse effects from this.
11.22.19 PM, malaise. Gone by morning. 11.23.19 AM, runny nose, nasal congestion, sneezing. Decongestant OTC med, symptoms at 25% previous level in 24 hours. 11. 24. 19, 2 AM, GI signs, intestinal cramps with diarrhea.  Duration 4 hours.
He came down with covid; This is a spontaneous report from a contactable Consumer (patient)  A male patient received frist dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 20Jan2021 at SINGLE DOSE for covid-19 immunization .  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient stated he came down with covid on 01Feb2021. Lab data included sars-cov-2 antibody test (01Feb2021): came down with covid (postitive) .The reporter added he received antibodies and was told not to take the second shot for 90 days. Outcome of the event was unknown. Information on the lot/ batch number has been requested.
Developed acute diarrhea about 3 to 5 days post-vaccine. It has not stopped since. Had diagnostic upper and lower endoscopy on 3/2/21 with gastroenterology. The biopsies showed lymphocytic colitis which can be either induced by NSAID use (I take ibuprofen 1-3 times a month) or can be autoimmune in nature. Biopsies for celiac were negative. Stool studies were negative for O and P, giardia, crypto, and c.diff. Labs for autoimmunity are pending. Lymphocytic colitis is generally chronic but manageable and I have not yet had remission of symptoms but am managing with loperimide.
Pt inadvertently given inadequate dose of Moderna vaccine, no signs or symptoms of adverse reaction
I am not feeling great/Discomfort/Not feeling very good; achy; chills; Fever; Discomfort; This is a spontaneous report from a contactable consumer (patient).    A female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine), via an unspecified route of administration on 03May2021 (Batch/Lot number, Expiry Date and NDC number were not reported) as dose 2, single for covid-19 immunisation. Medical history included body ache. Concomitant medications included naproxen sodium (ALEVE) taken for pain. On 04May2021 the patient experienced event reported as: I am not feeling great/discomfort/not feeling very good, achy, chills, fever and discomfort. The patient reported that "I got my second Pfizer Covid 19 vaccine dose yesterday (03May2021) and today on 04May2021 I am not feeling great. I am more achy and I have chills this time. The first dose was like nothing. Is it ok to take Aleve or Alka-Seltzer Plus Cold?" She said she just experienced something minor and has a question.  She said she had the first one done and felt nothing after it. She had her second vaccination yesterday and she was not expecting to feel like she does today. She said it was not terrible, she had a little discomfort. She said they told her she could take something, she did not remember what they said to take, but she did not take that. She said she usually takes Aleve for any kind of body ache. She asked them if she could take Aleve and they said sure. She said she was not feeling very good today and she was out of Aleve. She said she has Alka-Seltzer Plus Cold Medicine which basically covers all the same symptoms, like fever and that. She asked can she take Alka-Seltzer Plus Cold Medicine instead of Aleve. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
gave a dose of an expired vaccine which had been expired for about a month with no reported adverse event; Initial information was received on 02-Jun-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional (Inquiry number: 00624801).  It was reported a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Suspension For Injection) which was expired a month ago was administered to a patient (age and gender not specified) on an unknown date via an unknown route for prophylactic vaccination (expired product administered).  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event reported.  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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.  There will be no information available on batch number for this case.
couldn't sleep, chills, aches, joint pain, headache; in morning, nausea, profuse sweating, loss of appetite, bad headache which lasted all day; didn't feel better until 2 days after shot
One week after injection I developed a small hive at Injection site. the next day it was a 1 inch ciruclar red mark that was swollen and hot and painful and slightly itchy. Then the next day, 9 days after injection it was about the size of a baseball. The redness started going down and wasn't completely gone until about day 12. One day 14 after shot, I developed lesion/pimple like spot at injection site that opened up and left a sore about the size of a pencil eraser. I spoke to my doctor and also the hotline from the vaccination site about it and was advised that it is ok to get second shot.
This spontaneous case reported by a consumer, describes the occurrence of vaccination site warmth (warm to the touch at the injection site with itching), vaccination site rash (rash in the injection site) and vaccination site pruritus (warm to the touch at the injection site with itching) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jan 12, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 21, 2021, patient experienced vaccination site warmth (warm to the touch at the injection site with itching), vaccination site rash (rash in the injection site) and vaccination site pruritus (warm to the touch at the injection site with itching). At the time of the report, vaccination site warmth (warm to the touch at the injection site with itching), vaccination site rash (rash in the injection site) and vaccination site pruritus (warm to the touch at the injection site with itching) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications or treatment information provided. This case linked to MOD-2021-048030 (patient link).
Influenza vax, site became red, itchy, swollen, warm.  Became flushed, c/o nausea, dizziness, headache.
Patient was administered Meningococcal vaccine. About 15 minutes later, when exit the store, the patient lost consciousness. Patient regained consciousness quickly was able to answer question, but felt sleepy. Pulse 60 beat per minute. EMS arrived at store and look patient.
PT RECEIVED VACCINE ON 04/05/2021 IN THE EVENING. THEN, IN THE EVENING ON 04/08/2021, PT EXPERIENCED "SPONTANEOUS ITCHING AND HIVES" WHILE AT HOME. PT THEN TOOK OTC BENADRYL AND CORTISONE CREAM WHICH "HELPED." HOWEVER, IN THE MORNING ON 04/09/2021, PT WOKE WITH THE SAME SPONTANEOUS ITCHING AND HIVES AGAIN. THE PT NEVER EXPERIENCED ANY TROUBLE BREATHING AT ANY POINT. PT AND HER HUSBAND DO NOT FEEL IT IS SOMETHING THEY NEED TO BE SEEN AT A HOSPITAL FOR, BUT WANTED TO REPORT THIS REACTION AS THEY DO NOT BELIEVE IT IS CAUSED BY ANYTHING, OTHER THAN THE VACCINE.
No additional AEs; ROTATEQ administered after temperature excursion; Information has been received from a medical assistant referring to a patient of unknown ages and gender. Information about concurrent condition, concomitant medication and medical history was not provided.     On 20-JUN-2022, the patient were vaccinated with temperature excursion Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (2ml, lot # U006165, expiration date on 18-OCT-2022) orally for prophylaxis. No additional adverse events was reported. The vaccines had a temperature excursion of 49.8 Fahrenheit (F) for 2 hours. It was also confirmed that no previous temperature excursions occurred.
He got his vaccine, he felt like he was going to pass out, dizzy and woozy.  He got his neighbor to drive him to the Hospital to the ER.  He ended up sleeping in he ER.  He had numerous tests, put on  monitors, CT scans.  They let him go home, and tried to him it was his heart and wanting to do some sort of surgery.  He told him to FU with a cardiologist, and he told them it was a shot.  They wanted to do an ablation of his heart, which he refused to have done.  They said he had an irregular heart beat.  He repeated what they told him in the ER.  He was in the hospital for 3 days, which did not show anything after that from the monitor, just the one episode.  He did FU with his cardiologist who did not feel that he needed surgery.  He was not put on any new medicine.    He did not have any more episodes since that initial one, and dealing with radiation issues with his prostate cancer.  He had a colonoscopy in 2022 which was OK.   He has been having some problems with his legs and has been diagnosed with venous insufficiency, and says that they are not telling him anything.    He was diagnosed with a blood clot on 1/21/22 of his calf after it was warm to the touch, red and swollen.  They did an US in his leg and gave him an aspirin and told him to go to the vascular doctor.  His legs look lumpy since then, but they look different.
Lg. area of redness & swelling on left upper arm hot to touch & hard ball in the center of reddness - getting progressively worse. Prescribed by physician Amoxicillin. Recovering.
Itchy Rash all over back, head, arms, neck, and stomach; Looks like hives covering entire body; Shaky; Weak; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0151) via an unspecified route of administration in the arm left on 13Apr2021 at 11:00 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 23Mar2021 at 11:00 (at the age of 24-year-old)as a single dose for COVID-19 immunisation. The patient had no known allergies. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 12:00, the patient experienced itchy rash all over back, head, arms, neck and stomach (looked like hives covering entire body), shaky and weak. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events itchy rash all over back, head, arms, neck and stomach, looked like hives, shaking and weakness was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Left arm is sore, bad headache which did get better after took Tylenol, left arm still sore 1/19
"mom reported apparent afeb sz w/confusion, rigidity & flickering of eyes taken to ER/mom;"
Hospital employee was fully vaccinated with Pfizer vaccine but came down Covid + on 09/18/21 First dose: 01/08/21 lot#EJ1686 2nd dose: 02/08/21 lot#EL8289
a GARDASIL 9 alternate dosing interval; This spontaneous report was received from a pharmacist referring to a 18 years old male patient. The patient's concomitant mediation, pertinent medical history and drug allergies or reactions were not reported.  On an unknown date in November 2019, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot # and expiration date were unknown) for prophylaxis. According to the prescribing information, instead of receiving the second dose 2 months later in January 2020, the patient missed the January 2020 dose and received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot # and expiration date were unknown) for prophylaxis on an unknown date in November 2020 (inappropriate schedule of product administration).
T78.40XA ALLERGIC REACTION, INIT 3/29/2023 UPPER GI HEMORRHAGE
The day after the vaccine I had injection site pain, some redness in the area of the injection and it was hot to the touch. This lasted one day, then the arm was sore for 1 more day following the injection. Then on Tuesday, March 23 (a week after the vaccination) my right arm (injection site) started to itch terribly. The redness returned, along with heat, swelling, and pain at the injection site. The symptoms have carried on to Wednesday, March 24 and now include nausea, exhaustion, diarrhea.
On 02/26/18, I took my daughter for her 2nd series of Hep A vaccine. Not sure what brand or type. On 02/27/18, early AM hours, my mother noticed my daughter broke out in hives all over her body except her head. I called the pediatrician later on in the day. They suggested I take some pictures and give her about 1/2 teaspoon for the itching and to make it go away and bring her in for a sick visit the next day. On 2/28 I took her to the pediatrician they suggested that maybe it's from a virus and not the vaccine. No test was done but because my daughter developed a cold on Tuesday 2/27 that was the assumption. They gave her some benadryl and sent her home. The symptoms lasted about 4 days and then it went away. I did nothing new with my daughter (ie: no new clothes, detergent, food etc.....).
Since the morning after receiving a flu vaccine in my left upper arm near my shoulder, that shoulder is extremely sore and feels weak. Range of motion is impaired. Can't engage in many daily activities that involve shoulder muscles. The pain keeps me awake at night and is especially bad in the mornings.
Information has been received from an RN concerning an 30 year old female employee who on 23OCT2003 was vaccinated SC with a dose of pneumococcal 23v polysaccharide vaccine. On 23OCT2003, 4 hours after vaccination, the pt called and asked if soreness, pain and a knot at site of injection was normal. The lot number was not known. Unspecified medical attention was sought, but no treatment was required for the event. No product quality complaint was involved. Additional information has been requested.
This happened with both doses (first in early May, second in late July): Swelling, redness and pain at site of injection. Fever, chills, muscle aches, lethargy which lasted about 36 hours.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On 17-OCT-2014 the patient was vaccinated with an expired dose of GARDASIL, first injection in the series. Lot # reported as 1745AA, expiration date: 13-SEP-2014 (dose and route of administration were unknown). No adverse effects were reported. Additional information has been requested.
Raised, red rash over trunk, arms, scalp; This is a spontaneous report from a contactable other hcp.   A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EK923), at single dose into the left arm on 30Dec2020 at 03:45 PM for COVID-19 immunization. The patient medical history was not reported.  Concomitant medication included diphenhydramine hydrochloride (BENADRYL) 25g and gabapentin 300mg. On 31Dec2020 at 06:00 PM the patient experienced raised, red rash over trunk, arms, scalp.  The outcome of the event was recovered.  It was reported that the patient received the second dose of BNT162B2 on 20Jan2021 at 07:45 AM in the Left arm.
Immediately after standing up experienced ringing in the ears and faintness. Was helped back to nurse who laid me for 15 minutes for observation. When I laid down I became very flush and sweaty.  Then at 12am experienced fever of 101, body aches, and sharp stabbing chest pain which has lasted 18 hours so far.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (strength, dose, route, anatomical location, lot number and expiration date were not provided), for prophylaxis. It was also reported that the administered doses experienced an unknown temperature excursion during unspecified time frame on unknown dates. No previous temperature excursion and no adverse effects were reported. A data logger issue was not involved. Sender's Comments: US-009507513-1707USA007523.
Headache, Fever, fatigue, chills,body aches,joint aches Narrative:
70x70mm 3x3 inches No specific knots, warm, red, slighting raised. No limited ROM no pain. Self limited. Treated systematically. Denied any systemic reaction.
This is a literature report for the following literature source(s): "Covid-19 Pfizer- BioNTech vaccine induced VTA.", Journal of Investigative Medicine, 2022; Vol:70(2), pgs:563-564, 10.1136/jim-2022-SRMC.227. A 73 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing), notes: on 2 L home oxygen. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 IMMUNIZATION, reaction(s): "acute hypoxic respiratory failure". The following information was reported: DEEP VEIN THROMBOSIS (hospitalization, medically significant), outcome "unknown", described as "Vaccine induced DVT". The patient underwent the following laboratory tests and procedures: echocardiogram: revealed a round mass in the left atrial appendage, notes: which was likely a thrombus, she was discharged on warfarin; imaging procedure: revealed right interlobar pulmonary embolism and, notes: right superficial femoral vein thrombosis without any provoking factors. Therapeutic measures were taken as a result of deep vein thrombosis. The treatment received as warfarin. Sender's Comments: As there is limited information in the case provided, the causal association between the event Deep Vein Thrombosis and the suspect drug cannot be excluded. The case will be reassessed once new information is available. Linked Report(s): US-PFIZER INC-202200333581 Same article/drug/patient and different dose/event.
tested positive after being fully vaccinated; tested positive after being fully vaccinated; This is a spontaneous report from contactable consumer (Patient wife). A 44-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration in Arm Right on 27Apr2021 (Batch/Lot Number: EW0167, NDC number and Expiry Date: Unknown) as dose 1, single (Age at Time of Vaccination: 44-years-old) and dose 2 via an unspecified route of administration in Arm Right on 18May2021 (late morning) (Batch/Lot Number: EW0178, NDC number and Expiry Date: Unknown) as dose 2, single (Age at Time of Vaccination: 44-years-old) both taken for COVID-19 immunisation. Medical history included crohn's disease (Diagnosed Spring 2018) from 2018 and ongoing. Concomitant medications included infliximab dyyb (INFLECTRA [INFLIXIMAB DYYB]) taken for crohn's disease from an unspecified start date and ongoing; azathioprine taken for crohns disease from an unspecified start date and ongoing. The patient previously took remicade on an unknown date. The patient underwent lab test and procedure which included tested positive (SARS-CoV-2 test): Positive on 18Aug2021. There was no history of all previous immunization with the Pfizer vaccine considered as suspect, there were no additional vaccines administered on same date of the Pfizer suspect, there were no prior vaccinations (within 4 weeks) the patient took. The vaccine was administered at Military facility. The patient did not have adverse event following prior vaccinations. The reporter stated that her husband was fully vaccinated, He had the second dose on 18May2021 and since tested positive for the virus (18Aug2021). They have 4 other friends who are fully vaccinated who tested positive. The reporter would give them the number to call and added that the phone tree was horrific to try to get through on. The patient did not go to Emergency Room and Physician Office. The events were considered as serious (Medically Significant). The outcome for events was unknown.  Follow-up attempts are completed. No further information was expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101095815 same reporter/drug/AE, different patients.;US-PFIZER INC-202101095813 same reporter/drug/AE, different patients.;US-PFIZER INC-202101095814 same reporter/drug/AE, different patients.;US-PFIZER INC-202101095816 same reporter/drug/AE, different patients.
Hives. Spontaneous.  Onset approximately 10 days after 3rd dose.  No skin symptoms after 1st dose (3/2/2021, LouVax, Lot # 001A21A) nor 2nd dose (3/30/2021, LouVax, Lot # 003A21A).  Has continued on a daily basis since onset and still occurring today.  Only occurred in the evenings at first, then progressively, symptoms started occurring earlier in the day (worse in the evenings) and ultimately/currently symptoms occur throughout the day.  Dermatographia-like.  Worse in areas under pressure or with rubbing.  Also, itching (without rash) on palms of the hands and soles of the feet.  Skin symptoms respond to antihistamines but returns as medications wear off.  Have used diphenhydramine 25mg-50mg at bedtime, fexofenadine 180mg daily, famotidine 20mg BID, hydrocortisone topical cream.