chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt presented @ clinic w/gen urticarial rash on 28MAY96;seen by clinic;DPH prescribed;pt seen 4JUN96 rash resolved;pt had fever 101-102 approx 24AY-31MAY96;
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with the first dose of GARDASIL vaccine (yeast) 0.5ml. Subsequently the patient developed hives. Subsequently, the patient recovered from hives. The patient sought medical attention with a telephone call. Additional information has been requested.
hives in mouth, swollen throat, eyes swollen shut with large amounts of off white mucus coming out, fever (101 degrees) that lasted 2-3 hours (about 5 hours after vaccine given), headache, muscle aches, numbness in face and lips (lasted 48-60 hours after vaccine, shortness of breath
Pt recvd MMR vax on 28APR87 & on 26OCT90 pt was exposed to measles; devel a temp, h/a & was lethargic; was found to be pos for erythema & coryza; pt recovered;
Local erythema 2.5cm x 2.5cm 2 days post injection.
This spontaneous report as received from a nurse refers to a 1 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 30-AUG-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N008823, expiry date: 26-MAY-2018) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054.
swelling on the inner right arm toward the elbow; redness on the inner right arm toward the elbow; Initial information received on 21-Sep-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2023SA291592 (CLUSTER).  This case involves a 71 years old female patient who had swelling on the inner right arm toward the elbow and redness on the inner right arm toward the elbow after receiving influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines administered.  On 19-Sep-2023, the patient received a total dose of 0.7 ml of suspect influenza quadrival A-B high dose HV vaccine prefilled syringe (lot U8130DA, expiry date- 30-JUN-2024) via intramuscular route in the right deltoid for Immunization.  On 21-SEP-2023, (latency- 2 days), the patient developed swelling on the inner right arm toward the elbow (peripheral swelling) and redness on the inner right arm toward the elbow (erythema) following the administration of influenza quadrival A-B high dose HV vaccine.  Reportedly, The reaction is on the same arm that the vaccine was given, but not technically at the injection site, but it is above the elbow on the same arm. Patient has not experienced any fever.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for both the events.
muscle aches; chills; rash on their arm and their chest, with little hives or vesicles that now have started to dry up; sensation of being like in a fog like state, mentally for 24-48 hours; skin would get red as a lobster, like a skin flushing, that came and went for 48 hours; rash on their arm and their chest, with little hives or vesicles that now have started to dry up; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of RASH VESICULAR (rash on their arm and their chest, with little hives or vesicles that now have started to dry up), FEELING ABNORMAL (sensation of being like in a fog like state, mentally for 24-48 hours), ERYTHEMA (skin would get red as a lobster, like a skin flushing, that came and went for 48 hours), VACCINATION SITE RASH (rash on their arm and their chest, with little hives or vesicles that now have started to dry up) and MYALGIA (muscle aches) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) 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 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced RASH VESICULAR (rash on their arm and their chest, with little hives or vesicles that now have started to dry up), FEELING ABNORMAL (sensation of being like in a fog like state, mentally for 24-48 hours), ERYTHEMA (skin would get red as a lobster, like a skin flushing, that came and went for 48 hours) and VACCINATION SITE RASH (rash on their arm and their chest, with little hives or vesicles that now have started to dry up). On an unknown date, the patient experienced MYALGIA (muscle aches) and CHILLS (chills). At the time of the report, RASH VESICULAR (rash on their arm and their chest, with little hives or vesicles that now have started to dry up), FEELING ABNORMAL (sensation of being like in a fog like state, mentally for 24-48 hours), ERYTHEMA (skin would get red as a lobster, like a skin flushing, that came and went for 48 hours), VACCINATION SITE RASH (rash on their arm and their chest, with little hives or vesicles that now have started to dry up), MYALGIA (muscle aches) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Pt had syncope within 3 min, fell to floor, hit head.  Unresponsive for several minutes.  VS were stable.  Went to ER for eval.  Recovered, sent home.
Pain in left arm (the arm which received the shot) for five days, heavy but I was not immobilized. Fatigue for 60 hours (2.5 days, where my work was compromised).  I napped throughout the day and slept long hours at night.   Onset of chills at 4 p.m. (about 7 hours after shot) lasting until about 4 a.m. (12 hours) This was not a pleasant experience, especially the fatigue and the chills, and the ongoing pain -- all of it.  Two weeks later I still have a sore bump at the injection site.  I have in my years never experienced an adverse reaction to shots or medication, and I have lived abroad and traveled many regions of the world.
About 4cm hard, painful swelling to right deltoid several days after Tdap (5 days) vaccine. Pain with arm movement. Treated w/ KEFLEX, Dx cellulitis. T = 99.2.
Diffuse chest pain onset approx. after 24 hours. It started diffuse across bilat anterior chest and spread to his right arm.
Redness and pain at injection site  Narrative: Patient received Moderna COVID-19 vaccine on 12/23/20,  administered to left deltoid without complications. Veteran was monitored for 15  minutes after administration and no adverse effects were noted at that time. RN  note on 12/25/2020 reported that veteran had redness to left deltoid where COVID  vaccine was administered that was reportedly the size of a half dollar. RN note  states patient verbalized soreness at his left deltoid but denied other symptoms.  RN note on 1/3/21 reported patient had a rectangular patch of redness (1 in x 3 in)  from injection site on left deltoid that was reportedly traveling from injection site  towards dorsal deltoid. RN reported swelling at injection site. Skin reported to be  intact, no reported discharge or pain on 1/3/20.
pain in arm; Lightheadedness; pain in arm; temperature was 94 then 93.8; Tiredness; unsteady; Flu- like symptoms; left side of his face feels slightly num; freezing; vivid dreams; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of PAIN IN EXTREMITY (pain in arm), DIZZINESS (Lightheadedness), GAIT DISTURBANCE (unsteady), INFLUENZA LIKE ILLNESS (Flu- like symptoms) and HYPOAESTHESIA (left side of his face feels slightly num) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (doxycycline series antibiotics) and Drug allergy (Morphine). Concomitant products included OMEPRAZOLE, CEFADROXIL and FENTANYL for an unknown indication.    On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced GAIT DISTURBANCE (unsteady), INFLUENZA LIKE ILLNESS (Flu- like symptoms), HYPOAESTHESIA (left side of his face feels slightly num), FREEZING PHENOMENON (freezing), ABNORMAL DREAMS (vivid dreams) and FATIGUE (Tiredness). On an unknown date, the patient experienced the first episode of PAIN IN EXTREMITY (pain in arm), DIZZINESS (Lightheadedness), BODY TEMPERATURE DECREASED (temperature was 94 then 93.8) and the second episode of PAIN IN EXTREMITY (pain in arm). At the time of the report, DIZZINESS (Lightheadedness), GAIT DISTURBANCE (unsteady), INFLUENZA LIKE ILLNESS (Flu- like symptoms), HYPOAESTHESIA (left side of his face feels slightly num), ABNORMAL DREAMS (vivid dreams), the last episode of PAIN IN EXTREMITY (pain in arm) and FATIGUE (Tiredness) outcome was unknown and FREEZING PHENOMENON (freezing) and BODY TEMPERATURE DECREASED (temperature was 94 then 93.8) had not resolved.            No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-163697 (Patient Link).   Reporter did not allow further contact
Within a few days of getting the vaccine, I developed Irritable Bowel Syndrome, which I had never had before.  It was controllable only by Imodium.  After about two months of constant IBS, it  has become a sometimes occurence.  Although I have mostly recovered, the recovery is not complete.
Fever 101, chills, Arthralgia, red,hard sore painful left deltoid. Treated with Tylenol, Doxycycline started on 1/15
Diarrhea, nausea, vomiting, dry heaves and weight loss. Three months after the initial symptoms, I still suffer from many of these. Additionally, as a side to this, I have lost a good deal of my strength.
BREATHING IS HARSH; SICK; VOMITING; DIARRHEA; CHEST FEELS TIGHT SOMETIMES; FEEL BAD; SEVERE CHILLS; FEELING RUN DOWN; NAUSEA; This spontaneous report received from a patient concerned a 56 year old male. 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: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021, in the left arm, for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced breathing is harsh. On 16-MAR-2021, the subject experienced sick. On 16-MAR-2021, the subject experienced vomiting. On 16-MAR-2021, the subject experienced diarrhea. On 16-MAR-2021, the subject experienced chest feels tight sometimes. On 16-MAR-2021, the subject experienced feel bad. On 16-MAR-2021, the subject experienced severe chills. On 16-MAR-2021, the subject experienced feeling run down. On 16-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe chills on 17-MAR-2021, was recovering from chest feels tight sometimes, had not recovered from feeling run down, sick, vomiting, diarrhea, breathing is harsh, and nausea, and the outcome of feel bad was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Approximately 36 hours after the first Covid-19 injection, I experienced intense chills at night that lasted about 4 hours, which was also accompanied by a fever.  In the morning the chills and fever were mostly gone.
Post vax, the pt had swollen red area 2 x 2 cm on right thigh. Able to move extremities. Low grade fever at home.
Fever 103 x 24 hours, then 101 x 24 hours, afebrile by 4/14/2000. Vomiting x 12 hours. Fist sized knot with redness on left arm. As of 4/14/2000, recovering.
11APR91 p/HIBtiter/DTP/OPV, mom called, pts thighs were swollen & had fever; @ office visit-no fever, normal legs; next day, mom c/o pt had bulging fontanelle & fever; taken to ER, fever 101, & sl bulging; WBC showed viral infect; 17APR-af;
Monovalent Moderna administered instead of bivalent Moderna. Wrong bottle of vaccine pulled from the refrigerator.
Information has been received from a consumer, for HPV vaccine, a Pregnancy Registry product, concerning her daughter, a 16 year old patient with acne and intermittent headaches and a history of major back surgery spinal fusion when 14 years old (in approximately 2009) and no drug reactions/allergies stated by the caller who on 10-AUG-2011 was vaccinated with the first dose of HPV vaccine (lot # not provided) in her right arm. Concomitant therapy included MENACTRA minocycline and ADVIL. A urine pregnancy test taken at home on 19-SEP-2011 was positive. The patient was seen by an obstetrician-gynecologist (OB/GYN) on 03-OCT-2011. Sonogram, and blood work labs were performed, and all are normal. It was reported that the patient was not experiencing any problems, no adverse effects. The LMP was 08-AUG-2011. Est Delivery Date was 14-MAY-2012. Follow-up information has been received from the consumer concerning her daughter with kyphosis resulting in spinal fusion and no previous pregnancy history who on 10-AUG-2011 was vaccinated with HPV vaccine (Lot number 06647 is an invalid lot number for HPV vaccine. On 03-OCT-2011, the patient had ultrasound which was normal. Additional information has been received from a certified medical assistant who concerning the single student with no known drug allergies who had menarche at 11 year old, menses monthly, frequency was 28-30 days. She had a history of murmur and irregular rhythm. On 20-SEP-2011 (previously reported as 19-SEP-2011), the patient had beta-human chorionic gonadotropin (HCG) test. On 12-OCT-2011, at about 6 weeks of gestation, an ultrasound was performed which showed EDD would be 06-JUN-2012 (previously reported as 14-MAY-2012). On 13-OCT-2011, hematocrit was performed which showed 38.5% and hemoglobin showed 132. At the time of reporting, the outcomes of murmur and irregular rhythm were unknown. Follow up information has been received from the certified medical assistant who reported that on 21-MAY-2012 the patient delivered a baby girl by spontaneous vaginal delivery. The baby was vigorous and apgar scores were 9 and 9. The baby weighed 5lb 13oz and was in excellent condition. She was a normal healthy infant. Additional information is not expected.
Vaccine given 02/10/05. Child brought back in to the office on 02/17/05 for knot on right thigh at the injection site. No treatment given.
Case number PHHY2012US107065 is an initial literature report received on 21 Nov 2012. The authors presented a self-controlled analysis on the risk of Guillain-Barre syndrome associated with H1N1 and seasonal influenza vaccines. This report refers to an unspecified age and gender patient. The patient was vaccinated with two-doses of H1N1 vaccine (manufacture and batch number: unknown, conservatively considered as pandemic influenza vaccine INN) on an unspecified date. After vaccination, on an unspecified date, the patient experienced Guillain-Barre syndrome. The outcome, seriousness and causality of the event was not reported. The authors concluded that, these attributable risks are similar to those of some previous formulations of seasonal influenza vaccine (about one to two cases per million doses administered), suggesting a low risk of GBS following the H1N1 vaccine that was not clearly higher than that of seasonal influenza vaccines.
Headache, dizziness, chills, fever, eye movement, nausea, chest pain, muscle weakness and pain, falls.
Narrative: COVID fully vaccinated admitted with fevers and confusion found to be COVID positive (given remdesivir and dexamethasone)
PATIENT STATES PNEUMOVAX 23 VACCINE CAUSED HER INJECTION SITE TO SWELL UP. PAIN WAS HARD TO BARE. THE SWELLING TRAVELED TO HER PALMS THE FOLLOWING DAY. SWELLING HAS ALSO REACHED HER BODY.
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 04-APR-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.
Fever 105 within 24 hours,  Tremors in arm, Tylenol
After the vaccine the patient started feeling ill to the stomach and couldn't keep her eyes open.  The patient then fainted momentarily, moved to the floor on her own accord gently and began to vomit.  After vomiting the patient said she felt much better and all symptoms resolved.  The mother claimed the patient had had similar reactions when getting blood drawn likely due to low blood sugar and/or nerves.
I was 7 months pregnant at the time that I was taking my second dose of the Covid-19 Vaccine. My due date was April 20th. On Thursday, February 18th I got my 2nd dose. That morning, I had been checked by my doctor and had  a 32 sonogram and everything was deemed healthy. On Friday, I felt achy and had slight fever- I attributed it to the vaccine and took it easy that day, resting. On Saturday, I was still achy. I also started having Braxton hicks contractions (or so I thought) around 12 pm. I was achy and not feeling well all day and again attributed that to the vaccine. Early Sunday morning (2/21) around 12:30 am, I realized that my braxton hicks contractions were increasing and getting worse. By the time I realized I was in labor it was 2 am.  We rushed to the hospital and I had my son at 32 weeks. The adverse event is that I gave birth 8 weeks early and that my son had to spend 2 weeks in the NICU just days after receiving my second dose. (In my previous two pregnancies, my body had never gone into labor itself. I had to be induced.)
Mom noted skin colored papules day after vaccines along both thighs. On 09/19 scabbing near some papules along right thigh. Rash worse this time than previously seen/reported with last vaccine administrations. No evidence of allergic reaction. No evidence of other systemic reactions at this time.
This spontaneous report as received from a physician refers to a 18 months old patient. The patient was vaccinated with VARIVAX (Merck). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced shingles. No treatment information was reported. The outcome of shingles is unknown. The relatedness for shingles is unknown for VARIVAX (Merck). The physician reports a then 12 month old infant, gender unknown was given the VARIVAX, on and unknown date about 6 months age for vaccination. The patient's relevant medical history, concomitant medications and past drug history is unknown. On an unknown date the infant was 18 months old, they broke out in shingles. It is unknown if there is any relevant laboratory data. As of 29Oct2012 it is unknown if this infant will received another VARIVAX injection and at 18 months they broke out with the shingles, it is unknown if they have recovered. Additional information has been requested.
Lasted 24 hours, fever,headache,body aches, fatigue and weaknesses.
This spontaneous report was received from a registered pharmacist refers to a patient of unknown age and gender. On 05-JUN-2013 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # 672608/1715AA, expiration date 02-FEB-2013 and route not reported). The pharmacist stated that the patient administered an expired ZOSTAVAX to himself/herself. No adverse effect reported. Additional information is not expected.
I hot, raised itchy at the vaccine site lasting 6 days. I went to see PCP was told I has normal reactions.
A reaction to PEG; A reaction to PEG; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (A reaction to PEG) and ALLERGY TO VACCINE (A reaction to PEG) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (A reaction to PEG) and ALLERGY TO VACCINE (A reaction to PEG). At the time of the report, VACCINATION COMPLICATION (A reaction to PEG) and ALLERGY TO VACCINE (A reaction to PEG) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported. Patient was prescribed Cetirizine and Benadryl.   Reporter did not allow further contact
April 24, 2000 the child developed an injection site reaction characterized by a 3 inch area of redness, swelling, and pain at the site. The patient recovered. This is 1 of 3 patients from this facility who developed reaction.
This spontaneous report as received from a registered nurse refers to a 13 years old patient of unknown gender. On 22-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) lot # K003422, expiration date 06-MAR-2015 (dose, dose number, route and frequency were not reported) that was exposed to 19.5 F for 9 hours (supported). No adverse effects were reported. No product quality complaint (PQC) involved. This is one of the several reports from the same source. Additional information has been requested.