chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe nausea, migraine headache, muscle aches, vomiting, low fever, chills, starting 14 hours after injection and lasting for 72 hours.  Following the 72 hours, extreme fatigue and headache lasting for another 72 hours, Following this, continued fatigue and loss of appetite lasting to present day (8 days after vaccine).
This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX vial injection (dose unit, route, lot number and expiry date unknown) single dose. On 15-JAN-2014 the patient developed rash over three areas of arms. The rash was described as larger-size welts, more of a breakout than a typical injection-site reaction than a typical injection-site reaction. No additional adverse event (AE) information was reported. Pharmacist would be interested in the VZV Package. It was also reported that patient haven't improved from the event and sought medical attention. The outcome of rash over three areas of arms was unknown. Additional information has been requested.
Extreme headache, muscle aches, heavy fatigue, joint pain including ankles, back shoulders elbows wrists
Pt fainted after receiving her 1st GARDASIL vaccine.  She recovered without incident after remaining in a recumbent position X several minutes, and drinking some juice.
Myalgia, Fever, FATIGUE AND SORENESS AT INJECTION SITE Narrative: SWABBED FOR COVID 12/29 NEGATIVE
Temp 102 degrees for 48 hours. Papular rash to entire body - confluent, raised. No intra oral lesions. Non blanching.
2hr p/vax c/o face hot, muscle aches all noc, redness @ site, edema from deltoid to elbow, unable to move arm;tx ice to area x 2APAP;
came down with COVID in a week of vaccination; came down with COVID in a week of vaccination; This is spontaneous report from a contactable physician. This physician reported similar events for four patients. This is the 1st of four reports.   A patient of an unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, on an unknown date as a single dose for COVID-19 immunisation. Relevant medical history and concomitant medication were not provided. On an unknown date, the patient came down with COVID in a week of vaccination. The outcome of the event came down with COVID in a week was unknown. The reporting physician stated that he doesn't think that them getting the vaccine and having COVID is related, he thinks it is a coincidence.   Information on batch/lot number has been requested.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given (a week in this case). However, a causal relationship between event "came down with COVID in a week of vaccination" (coded to Drug ineffective / COVID-19) and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) cannot be completely excluded,Linked Report(s) : US-PFIZER INC-2021064978 same reporter/drug/event, different paitent;US-PFIZER INC-2021064979 same reporter/drug/event, different paitent;US-PFIZER INC-2021072675 same reporter/drug/event, different paitent;US-PFIZER INC-2021072675 same reporter/drug/event, different patient.
Pt vaccinated with DTP one of two children who had a "severe" crying spell within 3 hrs of immunization.
A report has been received from a Pharmacist concerning a patient, Female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on an unknown date. Pharmacist knowingly gave FLUMIST QUADRIVALENT to patient with controlled asthma. The outcome of the event of knowingly gave FLUMIST QUADRIVALENT to patient with controlled asthma is unknown. The report was considered to be non-serious.
Patient had a grand mall seizure  at work 28 hours after receiving her first Covid vaccine. She has not had a seizure for several months. She was treated by EMTs  at the scene and released to her parents after confirming she had anti seizure medications.
Dizziness, nausea, abdominal pain, pain and swelling at site of injection, full body muscle aches, headaches, fever, chills, and brain fog.
Patient and family requested Moderna as booster. Nurse did not catch that child 16 years old and Moderna approved only for 18 and over. Child given 0.25ml in left deltoid mistake found later in the day when reviewing paperwork. Child had no issues during 15 minute observation period. Today reports having chills and likely fever not checked last night today no more of that just fatigue, achy and headache. Reports only headache with 2nd dose Pfizer. Discussed with parent today via phone educated as to when to call doctor given my number should he have other questions and notified VAERs report to be completed. Of note 1st dose Pfizer date incorrect should be 5/13/21 according to parent as read from CDC card it is in system as 5/25/21.
Caller states she had her second dose of the Moderna vaccine on yesterday.  Now with tingling in legs and face.  Denies swelling or other discomforts, speaking in clear long sentences and  appears in no distress. Encouraged to increase fluids, and rest and if symptoms worsen or continue to seek care at ED.
While sleeping, rolled over onto left shoulder and felt extreme pain at injection site that radiated through shoulder. Pain continued throughout the morning so she reported to the clinic. No treatment or meds given.
Itchy rash all over-erupted on 3/21/2002. Started in hands, spread to back and legs seen in office on 3/25/o2. rash description scattered pink macules, papules, vesicles, crusts all over. Few look infected. Exposed to chickenpox on 3/11/2002  (goes to daycare)
Patient received the second dose of the Moderna vaccine too early. First dose was administered on 11/21/2021.
dizzy; a fast heart rate; Dose Number:1/ Date of start of drug: 02May2021 / Dose Number:2/ Date of start of drug: 16May2021; This is a spontaneous report from a contactable consumer (patient). A 31-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 16May2021 12:30 (Batch/Lot Number: Ew0171) at age of 31-years-old as single dose for COVID-19 immunisation. Medical history included known allergies: sulfa drug and have allergic reaction to some foods nothing life treating, both from an unknown date and unknown if ongoing. Concomitant medication included omeprazole. Historical Vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 administered in Arm Left on 02May2021 12:30 (Batch/Lot Number: Ew0185) at age of 31-years-old for COVID-19 immunisation. Patient was not pregnant. Facility type vaccine was Clinic/ facility. No other vaccine in four weeks. The patient experienced dizzy and a fast heart rate on 22May2021 22:00 with outcome of not recovered. Clinical course reported as follow: Patient was very dizzy 5 days after and several times she got very dizzy over the last month and now she has been having a fast heart rate for about 3 weeks. She is having tests done now. AE resulted in Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). Patient is being tested now to receive treatment. No COVID prior vaccination. No COVID tested post vaccination.
The pt is a 53 day old male who was transferred here after he began to be ill at 20:00 last night with increased irritability and a high-pitched cry. That evening they also noted some rhythmic lip smacking and twitching of the right side of his face. They brought him to ER and they were sent home with the instructions to observe and return if there is any problems. Throughout the night and morning, the pt continued to have intermittent seizures that increased to the point where he was having them every 5-10 minutes and they lasted less than 1 minute. This afternoon they brought him to ER and there, the physician witnessed twitching of the right eye, eye deviation to the right, twitching to the right side of the mouth which eventually progressed to twitching of the entire body. He was given Ativan IV, continued to have twitching and then was given Versed and then was loaded with fosphenytoin. Labs and LP were done there and then the pt was transferred via helicopter. During transfer the pt had another episode of seizure activity with left facial twitching progressing to include the left arm and leg. When pt was given 2nd dose of fosphenytoin, he remained hemo-dynamically stable and arrives in our PICU. Admit to PICU; fluids, electrolytes and nutrition. We will place on D10 quarter-normal saline with 10meq/liter of K at maintenance. We will allow ad lib Isomil when he is awake. CSF looked good but we will treat with acyclovir because of the history of the father having a cold sore. The parents had also noticed that the pt had a decrease in po intake. On arrival to PICU, the pt was lethargic. Dysconjugate gaze is noted. The seizure activity seems to have resolved and the infant has a high Dilantin level, I would not recommend any additional anticonvulsant meds at this time. If seizures recur, we will treat acutely with Versed or Ativan and load with phenobarbital, monitoring respiratory status closely. In the next exam by another physician at home; he has some weakness of neck flexors with full head lag on pull to sit. Recommended avoiding pertussis vaccine and continue current mediations.
common variable immune disorder; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or about 05-FEB-2008, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On unspecified date, after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered common variable immune disorder. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was determined to be not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The event of common variable immune disorder was determined to be disabling.
This case was reported by a nurse via other manufacturer and described the occurrence of injection site swelling in a adult female patient who received Influenza vaccine. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Influenza vaccine, the patient experienced injection site swelling, injection site erythema and feeling unwell. On an unknown date, the outcome of the injection site swelling, injection site erythema and feeling unwell were unknown. It was unknown if the reporter considered the injection site swelling, injection site erythema and feeling unwell to be related to Influenza vaccine. Additional information received: Nurse who states that she received an unspecified FLU vaccine, date unspecified, which resulted in swelling and approximately 3" of redness surrounding the vaccine site. She also felt sick, so specific qualifiers provided for the term sick, for at least two weeks post vaccination. No other information provided.
Fatigue began around 7pm, went to bed at 8pm the day of vaccination (Tuesday).  Awoke in the night with chills.  Later awoke with heat radiating from body.  Awoke at around 7:30 am Wednesday with extreme headache, pain behind eyes, sensitive to light and sound; extreme body weakness - couldn't roll over on my own, couldn't get out of bed without max assistance, dizzy, nauseous; pulse oxygenation taken multiple times and hovered around 94 or 95; couldn't rest with hands on stomach or chest or felt as if I couldn't breathe.  Severe symptoms lasted until about 5pm, but chills returned with headache around 6:30pm, fell asleep, awoke around 8pm feeling some relief.  Slept until around 8am Thursday am.  Awoke with continued full body weakness, but could get up on my own, although slow, dizzy and shaky.  Slowly  felt somewhat better throughout day, but lack of energy and dizziness kept me seated or in bed most of the day.  Went to bed officially at 10:30pm Thursday and awoke at 8:00 am Friday, still feel dizzy, slow moving, fatigued and weak as I try to move around the house.  My head feels "stuffed."  First vaccine shot.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 17-month-old patient of unknown gender. On 28-MAR-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot number N027002 (expiration date 28-SEP-2019). This is one of multiple reports received from the same reporter.; Sender's Comments: US-009507513-1807USA011661:
Dose administered >12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   13 patients received on the 7th Dec 2021 doses from 2 vials that were first punctured on the 30th Nov 2021 and put on the refrigerator since then  No Concomitant and Treatment medication were reported.   This case was linked to MOD-2021-406677, MOD-2021-406693, MOD-2021-406698, MOD-2021-406702, MOD-2021-406705, MOD-2021-406711, MOD-2021-406712, MOD-2021-406714, MOD-2021-406716, MOD-2021-406721, MOD-2021-406726, MOD-2021-406728 (Patient Link).
she cannot raise her arm more than 45 degrees, it is also painful to touch.; Initial information received on 02-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 69 years old female patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] and reported she cannot raise her arm more than 45 degrees, it is also painful to touch(Pain in extremity).  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On 18-Nov-2019, the patient received 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1951 via intramuscular route in the left arm.  On 02-JAN-2020, the patient cannot raise her arm more than 45 degrees, it is also painful to touch(pain in extremity) 1 month 15 days following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. It was also reported that she received vaccine over a month ago, the next day she could not lift her arm due to pain.  No lab data was reported.  Final diagnosis was pain in extremity.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the patient outcome was Not Recovered from the event.
No additional AE reported; the patient is just starting the ROTATEQ series at 6 months old; This spontaneous report has been received from a medical assistant concerning a 6 months old patient of unknown gender.The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.    On 08-MAR-2021,  at the age of 6 months old , the patient started the series of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), 2 milliliter for prophylaxis (Lot # and expiration date were not reported) (Product administered to patient of inappropriate age). No additional adverse events were reported.
Passed away from colon cancer in June after receiving the primary series from Moderna; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Jan-2022 and was forwarded to Moderna on 21-Jan-2022.    This spontaneous case was reported by a consumer and describes the occurrence of COLON CANCER (Passed away from colon cancer in June after receiving the primary series from Moderna) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Colon cancer (Patient had colon cancer for one year and a half before passing away in June 2021) since July 2020.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced COLON CANCER (Passed away from colon cancer in June after receiving the primary series from Moderna) (seriousness criteria death and medically significant). The patient died in June 2021. The reported cause of death was Colon cancer. It is unknown if an autopsy was performed.            Concomitant medications was not provided by the reporter. Treatment information was not provided. Patient did not had any side effects form the shots,he said it didn't bother him that much. Company comment:This case concerns a male patient of an unknown age with reported concurrent medical condition of Colon cancer since July 2020, who experienced the unexpected Fatal event of colon cancer (seriousness criteria death) which occurred in on unknown date in June 2021 after the second dose of mRNA-1273 vaccine(15-May-2021). The reported cause of death was Colon cancer. It is also unknown if an autopsy was performed. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a male patient of an unknown age with reported concurrent medical condition of Colon cancer since July 2020, who experienced the unexpected Fatal event of colon cancer (seriousness criteria death) which occurred in on unknown date in June 2021 after the second dose of mRNA-1273 vaccine(15-May-2021). The reported cause of death was Colon cancer. It is also unknown if an autopsy was performed. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Colon cancer
No adverse events; patient was administered a GARDASIL 9 vaccine instead of an unspecified PNEUMONIA vaccine; an 83 year old patient was administered a GARDASIL 9 vaccine; This spontaneous report was received from a pharmacist and refers to a 83 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 08-NOV-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (exact dose, route of administration, lot# and expiry date were not reported) for prophylaxis, instead of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as "unspecified pneumonia vaccine"). No adverse events were reported.
MINOR ITCHY ON INJECTION ARM; SORENESS ON INJECTION ARM; This spontaneous report received from a patient concerned a 43 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A,expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced minor itchy on injection arm. On APR-2021, the subject experienced soreness on injection arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the minor itchy on injection arm and soreness on injection arm was not reported. This report was non-serious.
muscle aching & soreness;extreme fatigue, lt arm swollen from shoulder to wrist;saw MD 1wk later tx w/pred;dx serum sickness from Td;
patient claimed that she developed arm pain that radiate to the nick and ear aches after 1 hour from receiving the first dose and pain still occuring 3 days after her first dose. patient denies any allergies. patient is taking synthroid for low thyroid level, lipitor for high cholestrol, and effexor for depression. patient was instructed to take over the counter medication ibuprofen or acetaminophen and to perfom cold compression to help with the pain symptoms,
Vaccine error   Pentacel was administered to the patient  instead of Kinrix.  meaning  that the patient received an extra dose of Hib.