chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blurred vision; dizziness; Swollen lymph node in left underarm; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0177) via an unspecified route of administration in the left arm on 08Jun2021 at 16:15 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included depression, anxiety and penicillin allergy. The patient received other medications within two weeks of vaccination, names were unspecified. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0183) via an unspecified route of administration in the left arm on 18May2021 at 16:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not 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 09Jun2021 at 14:15, the patient experienced blurred vision, dizziness, swollen lymph node in left underarm. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events blurred vision, dizziness, swollen lymph node in left underarm was recovered on an unspecified in Jun2021.  No follow-up attempts are possible. No further information is expected.
Information has been received from a company representative concerning a 6 year old female with no known drug allergies who on  09/06/1996 was vaccinated with a dose of Varivax . On approximately 02/01/02, the patient presented to a physician's office with chicken pox. Additional information has been requested.
No additional AE reported; Office manager reports ROTATEQ was administered after a temperature excursion to 23 patients.; This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.    On 06-JUL-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) once, (lot number W011279 has been verified to be a valid lot number, expiry date 02-NOV-2023) as prophylaxis (strength, dose, route of administration, and anatomical location, date were not provided) (product storage error).  The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored at a temperature of 9 degree Celcius (C) for the time frame of 1 hour and 32 minutes. There was no previous temperature excursion.  No additional adverse events reported.  This is one of several reports received from the same reporter.
Pt called with redness from elbow to armpit, but no fever and no other symptoms. I recommended her to see a physician. Physician determined it was probably an allergy and for patient to continue on benadryl. Pt reported that redness has gone down and is much better 2 days later on 12.17.2018
Chills; bad migraine; This is a spontaneous report from a contactable other HCP (patient) via Pfizer Sales Representative. A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2, Solution for injection, batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 on an unspecified date for covid-19 immunisation. Patient reported having adverse events after receiving the second dose of the Covid-19 vaccine. She was totally fine with the first dose within 12 hours after receiving the second dose she developed chills and a bad migraine on an unspecified date. The outcome of the events was resolved on an unspecified date.  information on the Lot/Batch number has been requested.
Generalized rash and itching. Saw physician and received 2 shots (doesn't know what they were) and oral prednisone that she took for several days.
The pt complained of the leg where injection was given, very swollen and red. Entire thigh inner to outer, groin to knee, red, swollen, warm. No difficulty with ambulation.
Information has been received from a physician for GARDASIL, a Pregnancy Registry product, concerning a baby. The baby's 19 year old mother with no pertinent medical history or drug reactions/ allergies who on 22-JAN-2009 was vaccinated IM with the first 0.5ml dose of GARDASIL (lot number reported as "0615X"). There was no concomitant medication. On 12-FEB-2009, the mother had her intrauterine device removed. Then the mother discovered that she was pregnant. On 03-MAR-2009, urine pregnancy test was performed at the office with positive result. The mother's last menstrual period was 18-JAN-2009, the estimated delivery date was 25-OCT-2009. On 26-MAR-2009, the mother was vaccinated IM with the second 0.5 ml dose of GARDASIL (661952/1129X). No adverse effect reported. The mother sought medical attention by phone visit. Follow-up information was received from the physician concerning the 19 year old mother with once previous pregnancy and full term delivery and no birth defect in previous pregnancy. Other medication in the pregnancy included prenatal vitamins. Follow-up information has been received from the physician concerning the 19 year mother who on an unspecified date was delivered the "normal infant" baby. The physician also stated that the infant experienced congenital anomaly of small ventricular septum defect and patent ductus arteriosus. The mother's experience has been captured in WAES 0904USA01160. Additional information has been requested.
was given a dose of Shingrix adjuvant only; was given a dose of Shingrix adjuvant only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number K7T79, expiry date 14th April 2023) for prophylaxis.   On 4th November 2021, the patient received the 1st dose of Shingrix. On 4th November 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The practice manager reported that, the patient was given a dose of Shingrix adjuvant only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
1.  Runny nose & sore throat 2.  Entire aches & pains with chills 3.  Fever developed in evening - Normal temp is 98.2 F  Slowly raised to 98.8 F Next day 1.  Dry Eyes 2.  Mild ear ache in both ears 3.  Fever developed in afternoon to 100.5. 4.  Who body aching all day with shooting pain from right leg and shooting pain from right knee. 5.   Pin point headache above eye - right frontal lobe Long Term - Shoulders, hips and knee joints inflammed.  Hard to walk.
Localized redness, pain, and itching occurred 8-12 hours after immunization was administered, (area upper thigh, other immun lower thigh).
Arm began quite swollen and bright red from arm pit to elbow and extending almost all around upper arm. Saw MD the afternoon of 10/25/00. Received 2 injections and cephalexin X 9 days and Levaquin X 1 dose given.
felt "bed sick"; Pain at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling unwell and injection site pain. On an unknown date, the outcome of the feeling unwell and injection site pain were recovered/resolved.   It was unknown if the reporter considered the feeling unwell and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Several patients received Shingrix and experienced pain at the injection site and felt bed sick. The reporter did not consent to follow up. For tolerances of 2nd dose, refer case US2020091016, reported by same reporter for the several patients.
This spontaneous report as received from a Medical Assistant refers to 6 months old infant, gender not reported. On 19-NOV-2014, the patient was vaccinated with ROTATEQ, Lot # K009181, orally. It was reported that the administered vaccine was subjected to temperature excursion during storage. No adverse event was reported. This is one of the several reports from the same reporter. Additional information has been requested.
6/4 I had mild headache, fever, sleepiness, 6/5 woke up to swollen lymph node in left armpit, 6/6 woke up to pain in injection site with red circle.  "COVID arm lasted only 2 days, but Swollen lymph node about 2+ weeks.  On 6/7 started feeling random intermittent numbness and tingling in arms, legs, face and heat sensations in back chest and abdomen. Mind feels foggy, some vertigo feelings. Got more intense by 6/9 and got scared to went to ER.  Urine and blood results didnt show anything bad so Dr. diagnosed as paresthesia.  Symptoms have bot gone away and started feeling heat and head pressures top/back of head that comes and goes. Went to Dr. he thinks I have anxiety which is likely true, but I cannot get the head pressures to subside. I still feel foggy and like my body is trying to fight off an infection of some sort
pt c/o nausea, h/a, fever; pt tx'd w/Motrin;
Flu like symptoms; foggy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 01Apr2021 (Batch/Lot number: unknown) as single dose for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Product: COVID-19,, Lot unknown: False,, Dose number-1), for covid-19 immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu like symptoms"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "foggy". It was unknown if therapeutic measures were taken as a result of influenza like illness, feeling abnormal. No follow-up attempts are possible. No further information is expected.
Myalgia, Fever & Diarrhea  Narrative:  diarrhea, weakness and temperature of 100.9.
burning sensation in back of my throat; all I taste is saline; This is a spontaneous report from a contactable consumer (patient). This 31-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0171) via an unspecified route of administration on 22May2021 (at the age of 31-years-old) as a single dose in the left deltoid for COVID-19 immunization. Medial history included polycystic ovary syndrome (PCOS). Concomitant medications included ethinyl estradiol, ferrous bisglycinate, levonorgestrel (BALCOLTRA) from an unknown date for birth control. The patient previously received dose 1 of BNT162B2 on 01May2021 for COVID-19 immunization and experienced sore arm for a week and tired. On 22May2021, the patient experienced a burning sensation in the back of her throat and all she tasted was saline. She wanted to know if she had any allergic reaction. The patient did not receive any treatment for the events. The outcomes of burning sensation and tasted saline were unknown.   No follow-up attempts are needed. No further information is expected.
Acute respiratory Failure, Covid 19, COPD exacerbation, HTN, Sepsis, DN2, Atrial Fibrillation. Patient Died.
Case was vaccinated for Covid in May 2021, then was hospitalized for Covid in January 2022. Hospitalized at: Medical Center.  Admitted to hospital with diarrhea, dehydration,  and hypoxia. Symptoms treated to fairly stable condition but was very deconditioned.  Self-discharged AMA.
Malaise, swelling, throbbing to 3 inches below the right elbow, radiating to inner right arm, painful to touch. 10-13-05 started Benadryl and Aleve every 4-6 hours. 10-17-05 swelling and inflammation gone but aching remains. Will continue Aleve. 10-19-05 tenderness only at injection site.
Increasing heart palpitations for 1 month following vaccination, palpitations slowly decreased to normal after 1 further month. Increased clotting factors, liver problems similar to what alcoholics report.
strong pulsating heartbeat; severe arm pain; fever with temperature of 102 [units unspecified]; abdominal pain; general weakness; unquenchable thirst; very bad headache; tiredness; This is a spontaneous report from a contactable healthcare professional (patient). A 28-year-old male patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration on 10Jan2021 10:00 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he did not experience any symptoms yesterday (unspecified date) and a few hours ago, he started to experience severe arm pain, fever with of 102 [units unspecified], abdominal pain, general weakness, unquenchable thirst, very bad headache, tiredness and strong pulsating heartbeat. The outcome of the events was unknown.  Information about lot/batch has been requested.
patient received MMR dose 2 weeks early.  Patient report dizziness and nausea and felt more thirsty than normal.  Patient evaluated in the emergency room on 5/10/2021.  Treated for UTI.  Does not appear from the MMR vaccine be given  too early.  Patient reports she felt fine prior to receiving the vaccine
Chest and neck tightness/pain, shortness of breath, dizziness, ears ringing, vision spotty followed by sweating and weakness.
skin sensation / it burn; red bumps between waist to knees; itchy; Scratch; extremely tired; arm was terrible sore; had fever; aches /I scratched were very painful!; napped throughout the day; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles few years ago).   On 14th February 2020, the patient received the 2nd dose of Shingrix. On 15th February 2020, 1 days after receiving Shingrix, the patient experienced fatigue, pain in arm, fever, general body pain and bedridden. On 29th February 2020, the patient experienced burning sensation, red rash, pruritus and scratch. On an unknown date, the outcome of the fatigue, pain in arm, general body pain, bedridden, burning sensation, red rash, pruritus and scratch were recovering/resolving and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fatigue, pain in arm, fever, general body pain, bedridden, burning sensation, red rash, pruritus and scratch to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported but selected as an adult as per vaccine indication. After vaccination, the next day had terrible sore arm, fever, aches and was extremely tired, napped throught day and was better on sunday. Just over 2 weeks after vaccination,on the evening of Saturday before the date of reporting, the patient felt skin sensation, scratched a bit, did it burn and very painful. The patient reported that, when changing for bed I found small red bumps between waist to knees and itchy. The last evening before the date of reporting,  found couple more and in the morning of day of reporting experienced 2 more. At the time of reporting, did not have fever and aches. The patient reported that, had shingles few years ago and could not get the shots due to out of stock at pharmacy being administering it to older seniors.
No adverse events occurred  No signs or symptoms reported.  Administration error- vaccine was expired within past 24 hours on 12/16/2020. IIV4 was given following month on Jan. 21,2021.
This study case was received from the investigator on 27 August 2012. A 19-year-old male subject with a medical history of frequent or severe headaches (concomitant medication FIORICET) had received ACAM2000 (lot number, route, site and date of administration not reported) and an unspecified amount of time later was found to have on 20 May 2011 (also with a reported date of 21 May 2011) an elevated central laboratory Troponin level of 0.12 ng/ml and on 26 May 2011 a central laboratory Troponin level of <0.10 ng/ml. The date of recovery was reported as 26 May 2011. The subject had a rapid Troponin I level on 20 May 2011 that was within normal limits (negative). On 26 May 2011, the subject had a normal ECG reading. There was no other reported visit. No further information was available at the time of the report. The subject's outcome was recovered. According to the investigator, the event of elevated central lab Troponin was considered an important event and possibly related. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. List of docs held by sender: medical records.
Janssen COVID-19 Vaccine Fever (100.8F), headache, nausea, soreness
Patient was erroneously given additional dose of the HIB vaccination.  CMT gave patient the Vaxelis which includes Hib with an additional Hib vaccination.  CMT charted in the chart that the Pediarix which includes DTaP, hep B, IPV was given when in fact the Vaxelis was given.  Immunization was verified with another CMT. Patient will be seen today in clinic due to fever and vomiting.
Pt had complaints of hip aching and right bicep pain with elbow flexing. Pt also experienced hip stiffness in the AM. Symptoms began in 12/99. Exam essentially normal. Also has occasional sharp epigastric pain relieved by bowel movement. Pt reported complaints 3/28/00.
Swollen and sore throat, skin in throat coming out of mouth, bleeding tongue, body aches and pains.
This case was reported by a consumer and described the occurrence of fatigue in a 30-year-old male subject who was vaccinated with TWINRIX, GlaxoSmithKline, HEPATITIS B vaccine.  A physician or other health care professional has not verified this report.  Concurrent medications included Acyclovir.  On 13 September 2007 at 15:00 the subject received the first dose of TWINRIX (unknown, left arm), which was administered prior to traveling to a foreign country.  Upon his arrival in a foreign country, the subject believed that he may have been exposed to hepatitis B, and presented to a medical facility.  On 23 September 2007, the subject received a dose of Hepatitis B vaccine (which the subject believed to be a GlaxoSmithKline product although this was not confirmed).  The subject considered this vaccination to be a "possible duplicate first-in-series" dose of hepatitis B vaccine.  On the same date, 23 September 2007, the subject received a dose of hepatitis B immunoglobulin at what he considered to be a possible subtherapeutic dose.  On 24 September 2007, eleven days after vaccination with TWINRIX and one day after receiving hepatitis B vaccine and hepatitis B immunoglobulin, the subject developed fatigue.  At the time of reporting, the fatigue was unresolved.
Pain in the right arm; affected the rotator cuff; taste and smell were affected; my taste and smell were affected; This is a spontaneous report from a non-contactable other healthcare professional (patient).  A 54-year-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Batch/Lot number was not reported) administered in Arm Right in Feb2021 as 2nd single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 in Jan2021 (at the age of 54years) for Covid-19 immunization. Medical history included lupus, fatty liver disease (genetic, not caused by any other issues), asthma, heart disorder, rheumatoid arthritis, various food allergy, latex allergy, and allergic to Sulfa drugs; all from an unknown date and unknown if ongoing. The patient's concomitant medications included fexofenadine hydrochloride (ALLEGRA) for an unspecified indication and salbutamol (ALBUTEROL) for asthma; start and stop date of both were not reported. The patient previously took Phenergan and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. In Feb2021, the patient experienced pain in the right arm following the 2nd dose that never went away, and instead got a lot worse. It has affected her rotator cuff and required a cortisone injection. In 6 weeks, if that has not worked, further testing will be done beyond the X-ray on an unspecified date. Also, following the 2nd dose, her taste and smell were affected, and she has not been able to handle the taste of coffee. She added that she has Lupus and genetic fatty liver disease. The hepatologist had her drinking coffee for that reason. The only thing off on her blood work related to not being able to drink the coffee (as reported). The patient also mentioned that she was having difficulty working at this point in time, because she works at a computer and it's affecting the arm she uses for the mouse. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The events were treated with cortisone injection and X-ray. She also has tested negative to Covid 19, and negative to the antibodies in Mar2021. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Assuming a plausible drug-event temporal association, the company cannot completely exclude a causal relationship between BNT162b2 administration and the onset of the reported, serious events. The event 'pain in extremity' is also expected in the safety profile of the suspect product.  The impacts of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Injection site pain initially (11/11/21). Followed by generalized body aches starting approximately 12 hours later. Significant lymphadenopathy in the left axilla (same arm as injection site), with tenderness, generalized aching, and obvious swelling and fullness to palpation of the left axilla. Body aches were treated with Tylenol and resolved in 24 hours. Lymphadenopathy in the left axilla persisted until 11/17/21, with improvements in severity of ache and size of swelling noted on 11/16/21.
Patient states he experienced vision changes and muscle spasms in his hand the day following his vaccination. States it would come and go, was not sure if it was due to the vaccine so he ignored it. After he got his 2nd dose on 3/2/21, patient states symptoms returned, and would come and go, lasted about 6 months. He did not seek treatment for his symptoms and hasn't reported it.