chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 60-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject had not experienced adverse events following previous vaccinations. The subject's medical history included allergies and high blood pressure. Concurrent medical conditions included diabetes controlled by diet. There were no concomitant vaccinations. Concurrent medications included SINGULAIR, isoprenaline and multivitamins. On 10 July 2008, 10 October 2008 and 29 January 2009 the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (1 cc, unknown route, alternated between left and right deltoid). On 24 February 2009, 26 days after the vaccination series with ENGERIX B was completed, the subject had a negative titer result (not responding to therapy). The interval between the 1st and 2nd dose of ENGERIX B was longer than the recommended 1 month interval. At the time of reporting the event was unresolved. Follow-up received from reporting healthcare professional on 12 June 2009: The healthcare professional reported that an infectious disease physician recommended the subject be re-vaccinated with series of 3 (vaccine details not provided).
Patient turned pale and passed out after getting the vaccines. We began to apply cool cloths to neck and forehead. Gave the patient a bottle of Gatorade to drink.  His color began to return and he reported feeling fine.  We observed him in our office for approximately 30 minutes.
Extreme dizziness; Nausea; Vomiting; Hot flash; Some congestion; Hoarseness; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 14:30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, diabetes and penicillin allergy. Concomitant medications were not reported. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN), both on unknown dates and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date 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 COVID-19 vaccine. On 01Apr2021 same day after vaccination (also reported as, on evening of second injection - 02Apr2021), the patient experienced extreme dizziness. nausea, vomiting, hot flash, some congestion and hoarseness for the first time. The patient had sudden recurrence daily of dizziness, nausea and sometimes vomiting. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event extreme dizziness. nausea, vomiting, hot flash, some congestion and hoarseness was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL were stored in improper temperature and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had administered dose of GARDASIL on 06-AUG-2013 (lot # H021608, Expiration Date: 13-AUG-2015). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Dizzy, nauseated, abdominal pain.  Lasted about 2 hours.  Pt. monitored in the offfice.  No treatment given.
pt recv vax 11DEC95 & exp a wheal & flare, consisting of raised blotches around the inj site;pt exp itching for 24hr;pt recovered;pt had no adverse exp p/1st dose of vax;
my stomach flip flop; twinge when I move my arm; Pain around injection site.; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (my stomach flip flop), PAIN IN EXTREMITY (twinge when I move my arm) and VACCINATION SITE PAIN (Pain around injection site.) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal, Urinary tract disorder NOS and Macular degeneration. Concomitant products included ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION AREDS) for Macular degeneration, CRANBERRY [VACCINIUM MACROCARPON] for Urinary tract disorder NOS.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (my stomach flip flop), PAIN IN EXTREMITY (twinge when I move my arm) and VACCINATION SITE PAIN (Pain around injection site.). At the time of the report, ABDOMINAL DISCOMFORT (my stomach flip flop), PAIN IN EXTREMITY (twinge when I move my arm) and VACCINATION SITE PAIN (Pain around injection site.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient's concomitant medications included, blood pressure medication.  No corrective treatment was provided.   Reporter did not allow further contact
no adverse event; Patient reporting that facility gave her 1/2 dose of Moderna Bivalent vaccine on 30Sep2022; This spontaneous case was reported by a patient and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient reporting that facility gave her 1/2 dose of Moderna Bivalent vaccine on 30Sep2022) and NO ADVERSE EVENT (no adverse event) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 30-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient reporting that facility gave her 1/2 dose of Moderna Bivalent vaccine on 30Sep2022). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient reporting that facility gave her 1/2 dose of Moderna Bivalent vaccine on 30Sep2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown.            Concomitant medication was not reported. Treatment medication was not reported.   Reporter did not allow further contact
After injection, bleeding, then immediate swelling at injection site. Applied cold compress at injection site for 15 minutes. Patient complained about itching at site and as time went on, complained about itching on face, chest and other arm. Gave 50mg of oral BENADRYL after trial of cold compress without complete resolve. After about 20 minutes after BENADRYL dose, patient swelling decreased and itching decreased but not fully resolved.
Head pressure; Dizziness; Headaches; such imbalance he couldnt stand for an hour; Started losing balance and kept getting worse every day; vertigo; Mini strokes; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (Head pressure), DIZZINESS (Dizziness), HEADACHE (Headaches), TRANSIENT ISCHAEMIC ATTACK (Mini strokes), BALANCE DISORDER (Started losing balance and kept getting worse every day) and DYSSTASIA (such imbalance he couldnt stand for an hour) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 12-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, the patient experienced BALANCE DISORDER (Started losing balance and kept getting worse every day) (seriousness criterion hospitalization). On an unknown date, the patient experienced HEAD DISCOMFORT (Head pressure) (seriousness criterion hospitalization), DIZZINESS (Dizziness) (seriousness criterion hospitalization), HEADACHE (Headaches) (seriousness criterion hospitalization), TRANSIENT ISCHAEMIC ATTACK (Mini strokes) (seriousness criterion medically significant), DYSSTASIA (such imbalance he couldnt stand for an hour) (seriousness criterion hospitalization) and VERTIGO (vertigo). On 26-May-2021, BALANCE DISORDER (Started losing balance and kept getting worse every day) had resolved. At the time of the report, HEAD DISCOMFORT (Head pressure), DIZZINESS (Dizziness), HEADACHE (Headaches), TRANSIENT ISCHAEMIC ATTACK (Mini strokes) and DYSSTASIA (such imbalance he couldnt stand for an hour) outcome was unknown.            Concomitant product use was not provided by the reporter.   No treatment information was provided.  Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding medical history and the events has been provided at this time. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding medical history and the events has been provided at this time. Further information has been requested.
Low grade fever of 100.5; Rolling chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Low grade fever of 100.5"; CHILLS (non-serious), outcome "unknown", described as "Rolling chills". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The report was not related to a study or programme.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
fingers in left arm are hot to the touch; tingling in fingers in left arm; swelling in left arm; Initial information regarding an unsolicited valid non-serious case from a pharmacist via The Agency (Reference number- 00349483) was transmitted to Sanofi on 06-Nov-2020.  This case involved a 35 years old female patient who experienced tingling in fingers in left arm (paraesthesia), swelling in left arm (peripheral swelling) and her fingers in left arm are hot to the touch (Skin warm), while she received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Relevant medical history, medical treatment, vaccination and family history were not provided.  No concomitant medications given.   On 03-Nov-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE prefilled syringe (lot QFAA2056, expiry date: 30-Jun-2021) via an unknown route in left deltoid for prophylactic vaccination.  On an unknown date, the patient developed non-serious tingling in fingers in left arm (paraesthesia), swelling in left arm (peripheral swelling) and her fingers in left arm are hot to the touch (Skin warm), unknown latency following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Relevant laboratory test was not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported events.
Parent went to make f/u apt child not responding to parent when she call child's name, PCR to parent to shake baby's arm and PCR called nurse. Baby appeared sleepy less responsive. Ask parent if baby takes nap, per parent child had nap didn't act this way before. Called ambulance took child's VS doctor seen pt, child sent to ER for eval.   2/23/09 Received hospital consult medical records of 7/7/2008 which are only records available. FINAL DX: altered mental status & possible vaccine reaction Record reveals patient had been seen in PCP office for vaccinations & was healthy at that time.  Within 10-15 min became limp in parent's arms when checking out & appeared cyanotic, difficult to arouse, drowsy but became alert in about 10 min.  Taken to ER where exam WNL.  Admitted overnight for observation & d/c to home in AM.  2/25/09 Received Neuro consult of 7/18/2008. FINAL DX: single paroxymal episode s/p 4 mo immunizations; possible seizure Records reveal patient experienced floppy, unresponsive approx 10 min after vaccines.  Returned to baseline afterward.  Seen in ER where w/u neg.  Neuro exam WNL except for pseudostrabismus vs strabismus.  Referred for head US & to Ophtho.
UNSTABLE ANGINA 3/21/2023 ABNL CERVICAL PAP
knee pain; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Mar2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included knee injury in 2021 (prior to vaccination). The patient's concomitant medications were not reported. The patient had a knee injury last week (in 2021, prior to vaccination). On 09Mar2021, the patient received the 1st shot and experienced knee pain. The patient would like to know if she can take Tylenol for knee pain. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
1/2 hr p/immun pt devel h/a & oral t102, lethargy had redness @ all inject sites; pt given APAP-had h/a & inc temp daily x 1wk; did not see MD
Painful red swelling at the injection site, general itching on my left upper arm. I also experienced about 10 seconds of very mild hives of my left arm approximately 3 hours after receiving the vaccine, but I didn't scratch and they disappeared very quickly. On 3/25 I noticed that my left upper arm was itching, and when I scratched I found that the vaccine site was hard to the touch, like a bump under my skin. As the day progressed, it got more swollen, red, and painful to the touch.
Dizziness, Headache, Myalgia, Arthralgia, Fever, NauseaVomiting,  chills, restlessness, Temp 105.0; pain at injection site Narrative:  Other Relevant History:
as described by phone per pt's mom, rash to lt arm to elbow, up face/neck to lt ear, down lt side & lt leg;denies rash present on this date;
This triggered the diagnosis of severe combined immunodeficiency; two cases of infants who were vaccinated with RotaTeq and subsequently developed strain rotavirus (identified by CDC lab); This spontaneous report was received from a physician referring to a pediatric patient (infant) of unknown age and gender. The patients' concurrent conditions, medical history, concomitant therapies and drug allergies or reactions were not reported. On an unspecified date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose, lot number and expiration date were not reported) route: defaulted to oral for prophylaxis. Subsequently, the patient developed vaccine strain rotavirus (identified by centers for disease control and prevention (CDC) lab). This triggered the diagnosis of severe combined immunodeficiency, and the patient was subsequently treated with stem cell transplants. Post-transplant, the patient continued to have rotavirus (detected by routine lab, presumed to be persistent vaccine strain) and received additional experimental treatment in attempt to clear rotavirus. The outcome of the events was unknown. The causality between severe combined immunodeficiency and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not reported. The reporter considered that rotavirus infection to be related to rotavirus vaccine, live, oral, pentavalent (ROTATEQ).  Upon internal review, severe combined immunodeficiency syndrome was determined to be medically significant.  As of 12-NOV-2019, all telephone attempts to obtain follow-up information have been unsuccessful.  This is one of the two reports received from the same reporter (2 valid linked cases, identified as 2 pediatric patients).; Sender's Comments:  US-009507513-1908USA004390:
t102, fever, legs collapse, unable to walk, jerking-onset 1wk p/vax;
ISSUES WITH PANCREAS; ISSUES WITH LIVER; ISSUES WITH KIDNEY; ITCHING; ELEVATED LIVER ENZYMES; PANCREATIC DEFICIENCY; DIARRHEA (AT ONE POINT WAS NOT ABLE TO LEAVE THE HOUSE BECAUSE OF THE DIARRHEA); This spontaneous report received from a patient via a company representative concerned an 80 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sensitive to all medications, and gout, and other pre-existing medical conditions included: The patient was on medication for gout, but that has been stopped. The patient doctors advised not to take the booster. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced issues with pancreas, issues with liver, issues with kidney, itching, elevated liver enzymes, pancreatic deficiency, and diarrhea ( at one point was not able to leave the house because of the diarrhea). Laboratory data (dates unspecified) included: Allergy test (NR: not provided) Not Reported, Negative, Blood test (NR: not provided) Elevated liver enzymes, Lab test (NR: not provided) No positive results, and Stool culture (NR: not provided) No positive results. Treatment medications (dates unspecified) included: pancreatin, prednisone, and colestipol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated liver enzymes, and pancreatic deficiency, was recovering from diarrhea ( at one point was not able to leave the house because of the diarrhea), and itching, and the outcome of issues with pancreas, issues with liver and issues with kidney was not reported. This report was non-serious.
PT. STATES SHE EXPERIENCED HOT/COLD CHILLS, NAUSEA AND VOMITING, AND DIZZINESS ON 9/28/18, 10/2/18, 10/5/18, AND 10/6/18. SHE STATES THAT THE SYMPTOMS "COME AND GO". SHE DID CALL HER PRIMARY CARE DR. WHO ADVISED HER TO GO TO HOSPITAL; PT. DECLINED TO DO SO.
This spontaneous report has been received from a nurse practitioner via company representative referring to a 13 year old female patient. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were unknown. Approximately in 2006 (reported as 10 years ago), the patient was vaccinated with all the three doses of GARDASIL via intramuscular route, for prophylaxis. The nurse reported that after receiving the third dose, patient began having plantar warts on her feet; 9 on 1 foot, 13 on the other (skin papilloma). The patient required medical attention. The nurse reported that they burned off the plantar warts. The outcome of the event was unknown. The causality between the event and GARDASIL was unknown. Follow up information has been received from the nurse on 02-NOV-2016 concerning the white patient. There was no pre-existing allergies, birth defects or medical conditions. There were no adverse events following prior vaccination. There was no illness at time of vaccination. It was reported that on 11-MAR-2007 the patient started the first dose of GARDASIL (lot# reported as 0188u). On 21-MAY-2007 the patient started the second dose of GARDASIL (lot# reported as 0188u).  On 21-AUG-2013 the patient started the third dose of GARDASIL (lot# reported as 04177BA) (Inappropriate schedule of vaccine administered). There was no relevant diagnostic test and laboratory data. At the time of reporting, the patient was recovered from the event on an unknown date. Lot number 4177BA is an invalid lot number for GARDASIL. Lot number 0657006 (batch 0188U) has been verified to be a valid lot number for GARDASIL. Lot number 0657622 (batch 0388U) has been verified to be a valid lot number for GARDASIL. Additional information is not expected as all the correspondences have been received. Report, Patient, Product, Event and Narrative have been updated.; Sender's Comments: MERCK 1609USA010366:Mfr number.
On day 5 following my first vaccine, I woke up with hives on my neck, scalp, arms, hands, abdomen. I was given a steroid injection and daily steroids, took benadryl, pepcid, and allegra.  On day 7 following the vaccine, I woke up in the middle of the night to joint pain, excruciating pain in both hands - I would describe it like carpal tunnel issues in my wrist and hand.  It hurt to touch of a bedsheet, it hurt to move the hands in anyway.  I went to ER for labs and checkup.  It was unclear but I had some type of inflammation in my joints of the hand and wrist.  That lasted until day 10 and then on day 11, I woke up in middle of night with the same pain in my right foot.  It radiated pain up my heel around my ankle from the touch of the bedspread and any movement I made.  That lasted until day 14-15.  Then I seemed fine.
Heart attack Nov. 27-2015 3 days later pneumococcal pneumonia 8 day ventilator, 10 days ICU, 26 total day in hospital. Discharge Dec 22-2015.
Had. Sinus infection 6wks after vaccine booster. Don?t think the 2 are related
I had a very large, swollen lymph node in the armpit of the same arm I got the shot in. It lasted about a month. I was given Advil for it. It went away about two days before I got my first vaccine.
Moderna for 12+ given to a 5 year old. Parent informed, encouraged to watch for extra side effects and call or have the child be seen if have any concerns. Parent reported child was doing fine at time of call; had been about 2 hours since shot administration.
patient given Hepatitis A injection prior to accepted age range.  This immunization should have been the infant's Hepatitis B vaccination.  Physician identified error.  States no likely harm to child.  Provider contacted patient family.  Hepatitis B vaccine to be given at next routine appt.  Hepatitis A will be repeated at age-appropriate time.
This spontaneous report was received from an adult nurse practitioner concerning a male patient of unknown age with penicillin allergy and with no pertinent medical history. The patient was vaccinated with a dose of M-M-R II (lot numbers, expiry dates, dose and route unspecified) on 12-OCT-1993 and on 07-NOV-1997 by an unspecified pediatrician. There were no concomitant medications. On an unknown date, the patient experienced a negative measles titer. The patient sought medical attention (in office). No treatment was given. The outcome of negative measles titer was reported as not resolved as the patient had the negative measles titer at the time of reporting (reported as currently). The relatedness for negative measles titer was unknown for M-M-R II. Additional information has been requested.