chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer through the pregnancy registry concerning a 15 year old daughter with pet allergies who on 08-JAN-2007 was vaccinated with the first dose of Gardasil. Concomitant therapy included prenatal medication (therapy unspecified) and erythromycin. On 08-JAN-2007, the patient was vaccinated with Gardasil and the patient was 14 weeks pregnant. The clinic administered the vaccine without confirming if her daughter was pregnant. The consumer stated that her daughter has experienced nausea since she received Gardasil. The physician did not administer the vaccine to the patient as she received the vaccination at a clinic. On 08-JAN-2007 therapy with Gardasil was discontinued. The outcome of the events was not reported. Additional information has been requested.
1 week after receiving injection, injection site is extremely itchy, swollen, hard, red, warm to touch....approximately 3" x 4".  After 2 days, all symptoms began to resolve.
Patient presented w/ 4 inch circular red, warm to the touch rash approx 8 inches on arm. Patient was to follow-up with prescriber.
6 weeks starting getting swollen,extremely chapped and burning lips.Tongue feels like it's on fire and very sensitive to taste.The 3 center fingers in my right hand were very achy.  Now they went into spasm and are swollen.
First dose of Shingrix in 2018 and has not received any further doses; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: Age at vaccination was not applicable for this report. A pharmacy student reported that, the patient had not received any further doses after 1st dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Five days following vaccine #2, pt presented to the emergency department on 3/2/21 with complaint of severe generalized arthralgias and fatigue. Completely different from her chronic osteoarthritis.  Complete work-up including labs were negative. Normal CBC; normal electrolytes; normal inflammatory markers (ESR and CRP); rheumatoid factor was normal; urinalysis was normal; chest x-ray was normal. She was discharged home on no medication.  She was seen by primary care on 3/29/21 and reported her symptoms, although not completely resolved, were markedly improved.  Because of her autoimmune liver disease, she did not take Tylenol or Ibuprofen for her discomfort.
This spontaneous report was received from a consumer refers to a female patient (her sister in law) of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date was unknown). After previously had shingles 3 times. There was no mention of any side effect with this vaccine misuse. Additional information is not expected.
Vax given Tuesday evening. Woke Thursday morning with IM site red, swollen, itching. Lasted until Sunday. Only treatment was cool compress on arm. No fever.
Fatigue, headache, first  menstration cycle after vaccine was much shorter than I've ever had, 22-24 days. Typical cycle is 36-40 days, Several cycles continue to be much closer together 4 months later.
Pt c/o palpitations, denied CP, SOB, LOC, and trauma. Upon assessment by EMT 12 lead EKG shows LBBB.
This case is 1 of a cluster of 3 patients who experienced similar adverse events following vaccination with MENACTRA. Initial report received from a health care professional on 25 May 2010. A 16-year-old female child, with no medical history, received the following injections on 18 May 2010: A right deltoid intramuscular injection of MENACTRA, lot number U3357BA, a left deltoid intramuscular injection of ADACEL, lot number sanofi pasteur Ltd. C3312 and lot number sanofi pasteur Inc. U3051AA, and subcutaneous injection to the right lateral upper arm of VARIVAX (Merck), lot number 1659Y. The patient developed redness, swelling, itchiness at the injection site on the right upper arm which was also warm to the touch on 19 May 2010. The patient was given AUGMENTIN for 10 days and BENADRYL for itching. The patient diagnosis was cellulitis. The outcome for the events was reported as recovered. Follow-up information was received from a health care professional on 19 July 2010 reported that the patient had zero (0) degree of limited mobility to the arm. The patient had no laboratory work ordered or needed. The outcome remained recovered for the events. Documents held by sender: None.
Follow up: Patient received casirivimab instead of intended COVID vaccine. 48-hr follow up didn't identify AEs. Patient  Patient received COVID vaccine on December 31
Information has been received from a medical assistant referring to unspecified amount of patients of unknown age and gender. The patients' medical history, concomitant therapy and drug reactions were not reported. On 26-OCT-2016, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # is reported as M010671 with expiration date 02-JUN-2018, lot # M006112 with expiration date 16-NOV-2017, lot # L046320 with expiration date 29-SEP-2017, lot # M005733 with expiration date 01-OCT-2017, lot # reported as M016919 with expiration date 17-FEB-2018; dose and route were not provided), which were exposed to 49.1 Fahrenheit (F) for 55 minutes. No adverse effects were reported. The data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt recvd 1st dose of Hep B vax & following vax devel flu-like sx, nausea & itching; p/ 4 days pt recovered;
muscle weakness, hospitalized; fatigue, hospitalizaed; fever, hospitalized; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th August 2022, the patient received the 2nd dose of Shingrix. In August 2022, less than a week after receiving Shingrix, the patient experienced fever (serious criteria hospitalization), muscle weakness (serious criteria hospitalization) and fatigue (serious criteria hospitalization). On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the muscle weakness was not recovered/not resolved and the outcome of the fatigue was unknown.   It was unknown if the reporter considered the fever, muscle weakness and fatigue to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-AUG-2022 Reporter's comment: Pharmacist was the daughter of the patient. Who administered vaccines was unknown. Pharmacist reported that the patient received dose of Shingrix vaccine and after receiving the dose (exact time of development of adverse events was not communicated) experienced fever for 3 days, muscle weakness that last until today (day or reporting) and had the patient hospitalized and fatigue. The patient required emergency room visit. Pharmacist did not have lot number nor expiration date of the vaccine. The reporter consented to follow-up. This case has been linked with case US2022119657, reported by the same reporter.; Sender's Comments:  US-GSK-US2022119657:Same reporter
lupus and Sjogren syndrome; lupus and Sjogren syndrome; This is a spontaneous report from a contactable consumer (patient), reported to the Pfizer Clinical Trials Contact Center.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via unspecified route of administration, on an unspecified date in 2021, as dose 1 and dose 2, single (both the doses) for COVID-19 immunisation. Medical history included immunosuppressed system. Concomitant medications included unspecified immuno-suppressant medication. The patient received both Pfizer Covid vaccine shots in 2021. On an unspecified date in 2021, the patient experienced lupus and Sjogren's syndrome. The events were serious (medically significant). The patient underwent lab test which included Antibodies test: unknown results (still do not have any antibodies). The outcome of the events was unknown.   Information on lot/batch number has been requested.
Information has been received from a licensed practical nurse, concerning herself, a female in her 20's, who was vaccinated on an unspecified date, with the first dose of Gardasil. The day following the vaccination, the nurse reported that her period came early, and she felt sick. The nurse recovered after an unknown duration of time. The nurse sought unspecified medical attention. Additional information has been requested.
I had a sore arm and was extremely sleepy. My back hurt so bad. It may have been after my third dose but I am having issues remembering the time frame. I went to the doctor and she prescribed 2 antibiotics for me. I only took one but it did not help. I went to the doctor and they did a culture and admitted me to the hospital. They kept me 24 hours and gave 3 doses of antibiotic drips and they were not helpful either. I tested myself at home and I still had the infection. This was around June 27 but I am unsure of the exact date. At first I was not experiencing any symptoms but now they are back. My back hurts so bad and its worse every day. I had a prolapsed bladder and when I go to the bathroom I am only able to urinate in small amounts. I plan to push up my appointment up.
pt recv vax 21JAN98 & 1hr post vax devel nausea & fatigue which cont for next few days;also devel vomiting & diarrhea;did not take temp but states felt like had a fever;did not seek medical attention & recovered p/several days;
due to the pandemic, many missed their 2nd dose. Some don't remember if they returned to the facility; This case was reported by a pharmacist and described the occurrence of social problem in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 24-Mar-2022 Reporter Comment: The pharmacist reported that due to the pandemic, many patients missed their second dose for a myriad of reasons. Some patients were over 1 year from when they got the first dose and some did not remember if they returned to the facility they got the first one to complete the series. It was enquired that did these patients who got the 1st Shingrix outside the 2-6 months, even 2-12 months range, need to restart the series.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR054447:same reporter
Headache, Fever, Body aches, chills Narrative:  Other Relevant History:
4 year old female presenting to the ER s/p vaccine shot reaction. Patient received her vaccine injection on her left thigh and started noticing a hematoma developing. Patient does have a fever and has been give OTC medication. Patient also has had intermittent diarrhea, no episodes of vomiting.  Hematoma is described as itchy and moderate in pain. No fever.  No vomiting. All other systems reviewed and negative except as otherwise indicated above.
After the vaccine (12/14/2015) and the next day he was sleeping a little more so not alarmed me, during the early hours of 12/16/2015 began with irritability, vomiting and bloody stools for this reason it take to the doctor for this time showed signs of dehydration from vomiting and stomach pain, the doctor decided to hospitalize him, ordering fasting until further instruction to conduct studies to detect these symptoms, a study of blood, ultrasound, x-rays performed contrast media, which was diagnosed intussusception, by this result he remained hospitalized for several days for treatment and observation. As adverse outcome to this result he currently suffering from gastroesophageal reflux disease for which currently still under treatment.
10 days intermittent fever Tm 102; localized vesicular rash at injection site x 10 D; symptoms beginning 8D after injection.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 10Apr2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; Unknown manufacturer), for COVID-19 immunization. The following information was reported: SKIN EXFOLIATION (non-serious) with onset 2022, outcome "unknown", described as "caused severe sloughing on feet and hands"; GLOSSODYNIA (non-serious) with onset 2022, outcome "unknown", described as "residual tongue sensitivity". Additional Information:  Reporter provided verification of contact address on 13Jul2022 I had 2nd Pfizer vac. On 10Apr2022. Patient suffered a reaction that caused severe sloughing on feet and hands. patient also residual tongue sensitivity. patient concerned that patient don't any options for further protection from covid-19. CEP Number: CEP 005570 The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
next morning I had a slight headache; I experienced symptoms within the first 6 hours of getting my second shot. I felt fatigued, body aches, and a low fever (99). The next morning I had a slight headache but took Tylenol and was fine all; felt fatigued, body aches, and a low fever (99); a low fever (99); This is a spontaneous report from a contactable consumer. A 21-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 21Apr2021 at 13:45 (at the age of 21-year-old) as a single dose for COVID-19 immunisation. The medical history included anxiety, depression and ADHD (Attention-deficit hyperactivity disorder). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included escitalopram (MANUFACTURER UNKNOWN) of 10 mg,  XR (unspecified) of 15 mg, folic acid (MANUFACTURER UNKNOWN) and iron (MANUFACTURER UNKNOWN), all from unknown dates and for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 31Mar2021 at 13:45 (at the age of 21-year-old) as a single dose for COVID-19 immunisation. On 21Apr2021 at 19:00, within the first 6 hours of getting second shot, the patient felt fatigue, body aches and a low fever (99). On 22Apr2021, the next morning, the patient had a slight headache but the patient took Tylenol and was fine all day. It was reported that the next day(on 23Apr2021) was the same thing (slight headache and fever/body aches at night). It was been 8 days (at the time of report) since her second shot and had a low fever(always around 99)/body aches almost every night. On 21Apr2021, the patient underwent body temperature test and tested with a temperature of 99 (unspecified unit). The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment for the events body ache, slight headache and fever which included Tylenol. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event body aches, fatigue, low fever and headache was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Muscle cramps on 9/17, multiple seizures lasting a few minutes on 9/19 and 9/20. Wheezing, fever, nausea, soreness, itching all over, muscle weakness, dizziness all throughout.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On an unspecified date, the patient was vaccinated with an improperly stored dose of VAQTA injection (lot# K0053233, expiry date 10-FEB-2017; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. It was reported that the patient sought medical attention in the office, no treatment was given to them and no diagnostic lab studies were performed. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Fatigue; Calf muscle pain; Bad headache; This is a spontaneous report from a non-contactable pharmacist reported for a 14-years-old male patient.    A 14-years-old male patient received second dose of bnt162b2 (BNT162B2, Pfizer covid vaccine), via an unspecified route of administration on 03Jun2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 (BNT162B2, Pfizer covid vaccine), via an unspecified route of administration on an unknown date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. On 04Jun2021, after second dose of vaccine administration, the patient experienced fatigue, calf muscle pain and bad headache. The outcome of the events fatigue, calf muscle pain and bad headache was unknown.  No follow-up attempts are possible and information about lot/batch number cannot be obtained.
Chills, rigors, extreme weakness, severe headache, syncope x 1 episode with brief loss of consciousness, nausea more from the pain
Woke up with discomfort of the left side collar bone . Ran my hand across it to find a painful lump
pt recvd vax 19OCT93 & the following day pt devel a blotchy, itchy rash which progressed to an overall rash w/in 24 hrs;
Patient called and states she received vaccines on 4/6/16 and the pm of 4/8/16 she began to develop a generalized red, raised, pruritic rash to extremities and trunk of body unrelieved by OTC Benadryl; denies any problems at injection sites or trouble breathing; states, "I just didn't feel well the next day. Someone told me I might need some steroids to help the itching."
Dizziness & HYPOtension Narrative:  BP 64/41; pt felt dizzy and sweaty. Taken to ED for observation
Massively sick; Initial information was received on 28-Nov-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case involves an unknown age and gender patient who experienced massively sick (illness) while receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  Past medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious massively sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was reported "Thanks, but you can keep your poison".   It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
0.2 ml given  12 and up pfizer vaccine ...patient received vaccine 2/8/2022 will f/u tomorrow on patients status
no adverse effect; A patient was administered an expired PROQUAD.; This spontaneous report was received from a nurse and refers to a 4 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On 10-JUN-2019, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) lot # N035176, expiration date 09-JUN-2019 for prophylaxis (dose and route of administration were not reported) (expired product administered). No adverse effects. The outcome of expired product administered was not reported.
Pain in chest; Nauseous; Pain under the breast; Back ache; This is a spontaneous report from a non-contactable consumer. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 25Oct2021 18:00 (at 27 years old) as dose 2, single for COVID-19 immunization. Medical history included COVID-19 from an unknown date. Concomitant medications were not reported. Prior to vaccination, the patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously received the first dose o of BNT162B2 on 13Sep2021 (at 27 years old) for COVID-19 immunization. On 25Oct2021, the patient experienced pain in chest, nauseous, pain under the breast, and back ache. The adverse events resulted in a doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse events included Robaxin.   No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.
Watch measures overall Cardio Fitness as 'VO2max'  .  In the month of the this vaccination my VO2max went from above average ' 34 to below average 19.
Sudden all over body rash, intense itching, starting on palms and soles and spreading to whole body, weakness, sudden sweat, difficulty in swallowing. One hour later symptoms subsided except that rash took 48 hours to subside.
Narrative:  The patient received two doses of Pfizer COVID 19 vaccine in Mar 2021. The patient tested positive for COVID 19 on 9 December 2021. The patient was admitted to the hospital on 9 December after syncope episode and severe bout of diarrheal episodes that led to a patient falling. The patient also experienced cough and shortness of breath. The patient was treated with antitussive medication, azithromycin, fluids, and monitored appropriately. The patient was discharged on 13 December 2021 in stable condition.
1/30/02 Rash similar to varicella. Had 20 bumps that lasted from 1/29/02 to 2/05/02.  Itchy, had a blister on most. One as large (red area) pea size came rash with intervals. Afibrile.