chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 02-MAY-2016, the patient was inadvertently vaccinated with expired PROQUAD lot # K020756, expiry date 30-APR-2016 (route and site of administration were not reported). No adverse effects were reported. Additional information has been requested.
Started feeling really tired with a slight sore throat after being around people who had COVID-19. Took a home COVID-19 test and was positive. My doctor prescribed me Paxlovid.
Guillain Barre; Myelitis; could not walk without assistance; had severe leg pain; lower back pain; numbness in his lower extremities; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of BACK PAIN (lower back pain), GAIT DISTURBANCE (could not walk without assistance), HYPOAESTHESIA (numbness in his lower extremities), PAIN IN EXTREMITY (had severe leg pain), GUILLAIN-BARRE SYNDROME (Guillain Barre) and MYELITIS (Myelitis) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Myelitis (admitted in the hospital with Gillian barre or myelitis) since 10-Apr-2021.    On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced BACK PAIN (lower back pain) (seriousness criterion hospitalization) and HYPOAESTHESIA (numbness in his lower extremities) (seriousness criterion hospitalization). On 10-Apr-2021, the patient experienced GAIT DISTURBANCE (could not walk without assistance) (seriousness criterion hospitalization) and PAIN IN EXTREMITY (had severe leg pain) (seriousness criterion hospitalization). On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain Barre) (seriousness criteria hospitalization and medically significant) and MYELITIS (Myelitis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 10-Apr-2021 due to BACK PAIN, GUILLAIN-BARRE SYNDROME and MYELITIS. At the time of the report, BACK PAIN (lower back pain), GAIT DISTURBANCE (could not walk without assistance), HYPOAESTHESIA (numbness in his lower extremities), PAIN IN EXTREMITY (had severe leg pain), GUILLAIN-BARRE SYNDROME (Guillain Barre) and MYELITIS (Myelitis) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 10apr2021, he could not walk without assistance and had severe leg pain then went to the emergency department. Treatment: IV steroids, and IV immunoglobulin.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid Treatment start date: 09Nov2023. Known allergies: No.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300366010 same reporter/patient, different drug/event;
fever/Fever for 36 hours after getting the vaccine; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, assuming lot was EK9231), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunisation.  Medical history was none. The patient's concomitant medications were not reported. Patient experienced fever for 36 hours after getting the vaccine. Patient was just wondering if she should be concerned about lasting dizziness. It's been about 56 hours since she had the injection. Therapeutic measures were taken as a result of the events included paracetamol (TYLENOL), 500 mg. Patient reported the due date for the second dose would be 29Jan2021. Outcome of the events was unknown.  Information on lot/batch number has been requested.
CVA symptoms on 7/16, confirmed CVA on 7/18, post CVA workup with no other finding as reason for CVA included TEE, multiple blood tests
On Tuesday, Jan 5 pm swelling four by  six inches on upper  right arm very red  hot area .  Area still  the same at 7:30 pm on January 6.
This spontaneous report was received from a consumer concerning his 4 week old daughter with no known pertinent medical history or drug reactions/allergies. On 13-AUG-2013, the patient was inadvertently given a dose of ROTATEQ (lot # and dose not provided) oral. The patient was also given concomitantly two unspecified "non-live" vaccines. On 13-AUG-2013, since the administration of ROTATEQ, the consumer's daughter has been lethargic. No laboratory tests were performed. There was not given any treatment for the event. At the time of the report, the outcome of lethargy was unknown. Additional information has been requested.
This spontaneous report as received from a other health professional refers to a 21 year old female patient. On 21-JUN-2017 the patient was vaccinated with an expired dose of GARDASIL 9 lot # M014929, expiration date 27-MAY-2017, dose 2 for prophylaxis. No adverse event or product quality complaint was reported.
Local redness/swelling and pain on Day #1 then central clearing but surrounding redness on day 2 (+) tender.
Patient experienced a tender, red swallen area around the injection site and also noticed her neck hurt several days after the vaccine and she felt weak.
This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 32-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). The subject's medical history included four full-term previous pregnancies; history of the births was not known. On 10 October 2012 the subject received unspecified dose of FLUARIX (unknown). Her last menstrual period was on an unspecified date and estimated date of delivery in February 2013. The subject was exposed to FLUARIX during unknown trimester. On 10 October 2012, at the time of vaccination with FLUARIX, the subject experienced vaccine exposure during pregnancy. The outcome of the pregnancy was unknown. Follow up information was received on 26 November 2012 via healthcare professional. The subject's last menstrual period was on 27 July 2012 and estimated date of delivery was 16 April 2013. The pregnancy was by normal conception and consisted of one fetus. The subject was exposed to FLUARIX at 10 weeks gestation during the first trimester. The reporting healthcare professional considered the event of vaccine exposure during pregnancy to be serious [clinically significant] due to the potential risk of congenital anomaly. At the time of the report, the congenital anomaly was not confirmed by diagnostic/ prenatal testing or relevant medical history; no details were provided. The outcome of the pregnancy was ongoing.
Mild wheezing and hoarse without sore throat on 12/21 Developed cough and wheezing, malaise, low grade temp, myalgia, arthralgia on 12/22 Tested positive for Covid on 12/23/20 at a drive through site. No other medical treatment was needed.  I suspect I was infected but asymptomatic at the time I was vaccinated.  I was told by the Health Department on the telephone to complete this form anyway.
Systemic: Allergic: Itch (specify: facial area, extremities)-Mild, Additional Details: ITCHY THROAT. 25 BENADRYL GIVEN - MONITORED FOR 30 MINUTES.
''I'' had a very violent episode of vertigo; Continued on and off dizziness since then but not as bad as the first day; This is a spontaneous report from a non-contactable consumer, the patient. A 68-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration on 08Feb2021 as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included bimatoprost (LUMIGAN), for an unknown indication from an unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8982) via an unspecified route of administration in the right arm on 18Jan2021 as a single dose for COVID-19 immunisation. On 14Feb2021, about 6 days after vaccination, the patient had a very violent episode of vertigo. Continued on and off dizziness since then but not as bad as the first day (day 1 on 09Feb2021). She still had dizziness on and off throughout the day. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events very violent episode of vertigo and continued on and off dizziness were recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Patient came back to pharmacy about 24 hours after ZOSTAVAX administered with some swelling around the injection site, approximately 2" x 4" in upper arm. No other allergy symptoms, recommended BENADRYL and to keep an eye on it.
sudden onset whole body chills, aching, tired,  took Motrin, with relief except tiredness. needed to take mortin over the next 36 hours
Fever; Chills; Body aches; Extreme fatigue; Terrible headache for 24 hours; This is a spontaneous report from a contactable Nurse (patient). A 30-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9265) via an unspecified route of administration, administered in left arm on 03Feb2021 at 14:00 (at the age of 30-years-old) as a SINGLE DOSE for covid-19 immunization. Not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. Allergies to medications, food, or other products: Penicillin. Patient previously received first dose of BNT162B2 lot number: EL3249, at left arm on13Jan2021 at 01:00 PM for covid-19 immunization. The most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. Since the vaccination, the patient has not tested for COVID-19. On 03Feb2021 at 06:00pm, 4hrs after the administration of vaccine the patient experienced Fever, chills, body aches, extreme fatigue and terrible headache for 24 hours. On 03Feb2021 Lab test included Body temperature: Fever. No treatment received for the adverse event. The seriousness criteria reported as non-serious. The outcome of event was recovered.  Follow-up attempts are completed. No further information is expected.
Large knot and soreness in armpit, soreness in neck and upper spine. Knot at injection site, very warm.
No AE/PQC reported; adult dose of VAQTA was accidentally administered to 18-month-old patient; This spontaneous report was received from a nurse referring to an 18-month-old patient of unknown gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 12-APR-2023, the patient was vaccinated with an adult dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, administered once daily for prophylaxis (lot number: W023489, which was verified to be valid with expiration date: 27-DEC-2023; strength, anatomical site injection, and route of administration were not provided) (incorrect dose administered).  It was reported that the patient did not experienced an adverse event (AE).
This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced RHINORRHOEA (Runny  nose). At the time of the report, RHINORRHOEA (Runny  nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided Treatment information was not provided
Information has been received from a physician concerning a 68 year old female who in February 2007, was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included FAMVIR.  Subsequently the patient developed a case of shingles.  Unspecified medical attention was sought.  No additional information was provided.  There was no product quality complaint involved.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/24/2007.  Initial and follow up information has been received from a physician concerning a 68 year old retired female who on 28-FEB-2007 was vaccinated in the right deltoid with a dose of ZOSTAVAX (Oka/Merck) (Lot # 656606/0033U).  Subsequently in July 2007 the patient developed a case of shingles in her right buttock area.  The patient was seen by a dermatologist and was prescribed FAMVIR 500mg three times a day for ten days.  The patient did not have a rash at the injection site or elsewhere within 42 days of the vaccination.  The patient had a history of chickenpox as a child, but there was no recent exposure to chickenpox or herpes zoster.  There was no direct fluorescent antibody done, nor was a specimen collected for PCR.  No additional information was provided.  At the time of this report the patient had recovered.  There was no product quality complaint involved.  Additional information is not expected.
Woke up unable to move neck due to pain. It was on the opposite side as injected. Now have shoulder pain and feeling of weakness in legs that comes and goes.
In drawing up the Pentacel DTap/IPV/Hib I did not reconstitute he Hib portion into the the DTap/IPV so the Hib was not administered.
Site of injection, signs of cellulitis. Treated: dicloxacillin; Motrin; Atarax
Patient reported diaphoresis, tachycardia, and tingling bilaterally in arms about 5 minutes after vaccine administration.  We monitored B.P. and within 30 minutes the patient stabilized and felt fine.
Chills, diarrhea, aches, headache, flu like symptoms started  20 hours after injection. Also got a pneumonia shot two days prior
My diastolic blood pressure reading has been steadily increasing since my first and second dose. I didn't relate the reading to the vaccine until my husband suggested a possible connection.  My diastolic readings were ranging from high 60's to high 70's.  I am now getting readings in the 80's and 90's.  The number is consistently increasing.  I'm reaching out to my dr. However, I wanted to alert you and hope there is some explanation and remedy for what I am experiencing.
Doctor ordered PEDIARIX, HIB, PREVNAR, & oral Rotavirus. However, Hepatitis B was given instead of the HIB vaccine.
pt recv vax 9JAN97 rt arm was swollen, temp 102, hives, itching, h/a, pain from shoulder to neck & diarrhea;
This case was reported by a consumer via call center representative and described the occurrence of contusion in a 66-year-old male patient who received Influenza vaccine. Co-suspect products included VOTRIENT tablet for lung disorder. Concurrent medical conditions included sleeve gastrectomy, diabetes mellitus, blood pressure high, artificial cardiac pacemaker user and renal cancer. Concomitant products included ACTOS, lisinopril and NORVASC. In October 2014, the patient received Influenza vaccine. In May 2014, the patient started VOTRIENT (oral) 800 mg once daily. In October 2014, less than a month after receiving Influenza vaccine and several months after starting VOTRIENT, the patient experienced contusion and skin disorder. On an unknown date, the outcome of the contusion and skin disorder were not recovered/not resolved. The reporter considered the contusion to be almost certainly related to Influenza vaccine and VOTRIENT. The reporter considered the skin disorder to be probably related to Influenza vaccine and VOTRIENT. Additional information: The patient reported that he had a flu shot (unknown manufacturer) in October 2014 and experienced bruising on his arms and hands. The patient also reported that he experienced bruising on his arms and hands after taking VOTRIENT. The patient planned to continue follow-up with his physician on an unknown date.
Information has been received from a medical assistant referring to a 7 months old male patient. No relevant medical history or concurrent conditions were reported. On 15-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Chills and flu like symptoms and later around 12:00PM started with swelling and such while driving home. Texted co-worker who contacted my PCP. After about 1hr and 30min talked to my PCP and found it may be anaphylactic shock. Advised to go to ER or get Benadryl to help. After taking Benadryl 20ml the swelling receded in about 3 hours but was feeling bad for 3 days. Later, the 3rd day I started to recover and by the 4th day I was able to function.
18 y/o male recruit with c/o posterior L arm redness and soreness X 3 days with suspected MOI of adverse reaction to SUB-Q immunizations which were given 4 days ago. Reports day following immunizations he woke up with pain in arm and this is when he first observed redness. Pain is currently 3/10 and is localized specifically to site of immunization. Was last seem by medical yesterday and given Rx BENADRYL and TYLENOL which have significantly improved s/sx and pain (5/10 yesterday). Reported numbness and tingling yesterday however these s/sx have improved. Denies fevers, chills, night sweats, NVD, constipation, dyspnea/SOB, cold s/sx, chest pain, dyspnea, or neck pain/stiffness. Member is otherwise asymptomatic and has no further medical complaints or concerns at this time. Exam Findings: Golf ball sized tender area of induration localized to L tricep with erythema directly over but no warmth to touch. Otherwise no significant findings on exam. Contact clinic and confirmed that pt was given SUBQ Varicella in L arm. Suspect adverse reaction to this immunization. Skin rash. Diphenhydramine 50 mg QID, Acetaminophen 1000 mg QID.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, headache, stiff neck, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site pain, headache, stiff neck, injection site swelling and injection site warmth were recovered/resolved. It was unknown if the reporter considered the injection site pain, headache, stiff neck, injection site swelling and injection site warmth to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported, but it could be 74 or 75 years old. The patient received the SHINGRIX vaccine on left arm. The patient stated the area of injection site was hot. She also experienced stiff neck on the left side. She stated all her symptoms lasted for total of 3 days and then she recovered. The patient had denied permission to contact their physician. No further details were provided.
The next day patient was dizzy; arm swollen, red and infected spot on left arm. Patient called primary care MD (on a Sunday) and was told to go the ER. Meclizine, Cephalexin and Bactrim DS prescribed.
Severe stomach cramps; Severe diarrhea; He felt like he was running a fever; Chills; Sweats; Shakes; This is a spontaneous report from a contactable consumer (Patient) from a Pfizer-sponsored program. A 54-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL8982), intramuscular on 02Feb2021 at around 10:00 (at the age of 54-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was not reported. The patient had a family history of dementia. Concomitant medications were not reported. The patient did not receive other vaccines within 4 weeks prior to vaccination. About 36 hours after getting the vaccination (unknown date Feb2021), the patient experienced severe stomach cramps, severe diarrhea, felt like he was running a fever, chills, sweats, and shakes. The clinical outcome of the stomach cramps, diarrhea, fever, chills, sweats and shakes was recovered on an unknown date in Feb2021 (symptoms lasted about 18-24 hours).
Information has been received from a physician concerning a 12 year old female who on 26-NOV-2007 was vaccinated with a first dose of Gardasil vaccine injection. Concomitant therapy on the same day included varicella virus vaccine live (unspecified) and Menactra. On 27-NOV-2007, the patient came back into the office with a fever, no appetite and a headache. Medical attention was sought. Subsequently, on an unspecified date the patient recovered from the events with therapy unspecified. There was no further AE information. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/14/2007. Information has been received from a physician and an other health professional concerning a 12 year old white female who on 26-NOV-2007 at 5:00PM, was vaccinated intramuscularly into the left arm with a second dose of GARDASIL (Lot# 659055/1522U). Concomitant therapy also given on 26-NOV-2007 included intramuscular vaccinations with second doses of VARIVAX (Lot# 656279/1503F: right arm), MENACTRA (Lot# U2390BA: right arm) and BOOSTRIX (Lot# AC528018AB: left arm). There was no illness at the time of vaccination. The physician reported that on 27-NOV-2007 the patient came back into the office with a fever, no apppetite and a headache. Additional information reported by a health professional indicated that on the morning of 27-NOV-2007, the patient had developed fatigue and fever. The physician reported that on an unspecified date the patient recovered. Additional informationm is not expected.