chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3-13-21 1:15PM RASH NOTED ON FACE, NECK AND CHEST, EYES ARE ' ITCHY'.  NO SOB / DYSPNEA,  NO SWELLING OF MOUTH, TONGUE OR THROAT. GIVEN BENADRYL 50MG PO. PT STATES SHE 'FEELS OK TO GO HOME WITH HUSBAND'.  HUSBAND TO DRIVE PT HOME. PT A/O, PINK, W/D, RESP REG WITH EASE. AMBULATORY BRISK/STEADY. NO ACUTE DISTRESS NOTED. 3-15-21 10AM TC: 'STILL HAS VERY SLIGHT RASH, NO OTHER SYMPTOMS'. CHECK WITH PCP R/T DOSE #2.
The night of Monday April 5 I started to feel like I was fighting off a cold. That night I slept almost 11 hours, abnormal for me and woke up with heavy brain fog which has not gone away. I feel cloudy, unclear, slow, it is sometimes hard to finish sentences and complete thoughts.
Raised, red, hot band around left arm. Appeared the day after he received the vaccine.
Mother states child is warm to touch, face and legs are swollen but wanted to go to school today and will contact family MD today or Thursday.
Healthcare worker tested positive by PCR for Covid-19, >14 days post second covid vaccination.   Her husband was positive for covid last week.  Her symptoms are cough, headache, congestion and loss of smell.
Whole body aches and trembling, fever, lightheaded, nauseated, vomiting
One week after vaccination area of injection because swollen, firm, red, hot, and itchy. Two days later a red itchy rash followed on arms and legs. Mild amount of rash on trunk. Rash itches.
pt recv vax & 2hr later c/o having nausea, diarrhea, h/a, numbness in rt eye, hand & rt side of face;BP 110/78, t97.8;no erythema or swelling @ inj site;pt advised to see PMD or go to ER;
I had a cough, phlegm, muscle aches. Fatigue, loss of appetite   The above symptoms persisted for a week during which my temperature was normal and I did not lose my sense of taste or smell
Pt. called 1/6/2021 c/o a hard knot in her arm at the injection site, it was hot to touch, itchy and painful. Pt. stated she has had a prior reaction to the flu vaccine.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 27-MAY-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 5 microgram/0.5 ml (thimerosal free, lot # L033343, expiration date 13-SEP-2017; dose and route were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) were 24, 47 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from the patient's mother refers to a female patient of unknown age. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with the first and the second dose of GARDASIL 9 (dose, route, lot # and expiry date were not reported). Concomitant medications were not reported. On an unknown date (unspecified if after the first or the second dose of vaccine), the patient experienced nail fungal infection on an unspecified toe. The outcome of the event was unknown. The relatedness between the event and GARDASIL 9 was not reported. Additional information has been requested.
I had 2 hours of extreme parenthesis?s. Whole body. Then progressed to just my bilateral arms for another 2 hours.   Fevers. rigors.  Severe fatigue for 2 days.
not received 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 41-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received on 9th January 2012 batch number AHABB207BA).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: not received 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 03-AUG-2023 The pharmacist reported that a patient received one dose of Twinrix, and never received any further dosing but now would like to continue the series.  The dose was administered by a clinic.  At the time of reporting, no additional doses had yet been administered. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Case number PHEH2014US025102 is an initial spontaneous report received from a nurse on 09 Dec 2014. This report refers to a 53 year old male patient. Medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 29 Oct 2014. Nurse reported that patient received FLUVIRIN that was at 49 degree F 12 times over a period of 34 days. The temperature excursions began around 16 Oct 14. 12 separate temperature excursions lasting 30 minutes each in which the temperature was 46-49 degree F during each of those excursions. No adverse event was reported following this maladministration. No further information was provided.
Syncope; This serious case was reported by a consumer via sales rep and described the occurrence of syncope in a 75-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE for prophylaxis.   On 20-OCT-2023, the patient received Arexvy and PNEUMOCOCCAL VACCINE. On 21-OCT-2023, 1 days after receiving Arexvy, the patient experienced syncope (Verbatim: Syncope) (serious criteria GSK medically significant). The outcome of the syncope was not reported.   It was unknown if the reporter considered the syncope to be related to Arexvy.     It was unknown if the company considered the syncope to be related to Arexvy.   Additional Information: GSK Receipt Date: 02-NOV-2023 The reporter stated the patient was given both the Arexvy and pneumococcal vaccine on the same time. The patient experienced syncope. It was unknown if the reporter considered the syncope to be related to pneumococcal vaccine.  The reporter did not consented to follow up.
Fever, chills, headache, progressive nonradiating chest pain spent 7 days in local hospital with discharge diagnosis of pericarditis/myocarditis.
STIFFNESS IN KNEES, HIPS, ANKLES; A LITTLE BIT OF LIGHT HEADEDNESS; KNEES AND HIPS A BIT ACHY LIGHT TO MODERATE; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included mould allergies, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, vaccinated at left deltoid, once a total administered on 28-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 28-MAR-2021, the subject experienced a little bit of light headedness. On 28-MAR-2021, the subject experienced knees and hips a bit achy light to moderate. On 29-MAR-2021, the subject experienced stiffness in knees, hips, ankles. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from a little bit of light headedness, was recovering from knees and hips a bit achy light to moderate, and the outcome of stiffness in knees, hips, ankles was not reported. This report was non-serious.
The patient complained of tongue swelling, hoarse voice and a dry throat.  She did not have difficulty breathing and refused EpiPen administration.  The patient contacted the pharmacy on 5/8/21 to report a rash.
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 07-APR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ lot # L008057 and expiration date 01-DEC-2016, 2 ml administered orally. No adverse effects were reported. The vaccine had one temperature excursion of 48 hours with a lowest recorded temperature of 34 Fahrenheit (F) (1.111111111 Celsius (C)). The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
pt became nauseated & vomited  & fainted in parking lot was dizzy & nauseous for 1hr;waited in parking lot until felt like driving;
ON 5/18/21 CLIENT RECEIVED A THIRD DOSE OF JANSSEN VACCINE.  SECOND DOSE WAS ADMINISTERED ON 4/06/21.  DURING REGISTRATION (PER THE REGISTRANT) CLIENT DENIED RECEIVING ANY PREVIOUS COVID 19 VACCINE OR HAVING ANY VACCINATION CARD.  CLIENT WAS TOLD BY REGISTRANT THAT JANSSEN VACCINE IS A ONE TIME ONLY DOSE, AND CLIENT VERBALIZED UNDERSTANDING.  REGISTRANT PROCEEDED WITH VACCINE SURVEY AND DIRECTED CLIENT TO THE NURSE FOR HIS COVID 19 JANSSEN VACCINATION.  PRIOR TO JANSSEN VACCINATION, NURSE REVIEWED ALL SURVEY QUESTIONS WITH THE CLIENT AND HE DENIED ONCE AGAIN RECEIVING ANY PREVIOUS COVID 19 VACCINATION, SO JANSSEN VACCINE WAS ADMINISTERED.   CLIENT WAS MONITORED AFTER RECEIVING JANSSEN VACCINE.  NO ADVERSE REACTIONS NOTED AND CLIENT REPORTED FEELING FINE AND WAS RELEASED FROM MONITORING AREA.
Gave Pfizer Booster one month early. Contacted Pfizer- stated no additional dose needed.  Contacted Patient 01/27/2022- patient stated, no issues or severe reactions.
Pain in a low back- feels like contractions- few minutes of pain - rest. few hours non stop. After a month still have a pain in a low back
Arm began getting sore within the hour. Soreness spread to aches in muscles all over body during evening, aches became so bad I couldn't sleep. Skin hurt to touch. By midnight I was alternating cold & sweaty. At 5:00 am 10/30 I got up to take some Advil. While walking to the kitchen sweating became worse. I felt like I might pass out. Temperature was 99.3. Vomited about 5 times in a row, then began to feel improvement. Then I had sharp stomach pains for about 20 minutes following the vomiting. Went back to bed. All conditions slowly improved over the next several hours. By 1:00 pm 10/30 I felt good enough to return to daily activities with just minimal muscle aches.
Very bad arm pain night of vaccine and all through the next day.  Fever of 102 the day after the vaccine, very lethargic.  Took Tylenol for pain and to reduce fever.  Fever fell to 101 by following night.  Symptoms are able to be managed with rest and over-the-counter medication.
patient lost taste; throat started to hurt; diarrhea; chills; Soreness all over his body; threw up; This spontaneous case was reported by a nurse and describes the occurrence of AGEUSIA (patient lost taste), OROPHARYNGEAL PAIN (throat started to hurt), DIARRHOEA (diarrhea), CHILLS (chills) and MYALGIA (Soreness all over his body) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Hypercholesterolaemia and Allergy (allergies). Concomitant products included ENALAPRIL for Blood pressure management, ATORVASTATIN for Hypercholesterolaemia.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced AGEUSIA (patient lost taste), OROPHARYNGEAL PAIN (throat started to hurt), DIARRHOEA (diarrhea), CHILLS (chills), MYALGIA (Soreness all over his body) and VOMITING (threw up). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 20-Apr-2021, AGEUSIA (patient lost taste) had resolved. At the time of the report, OROPHARYNGEAL PAIN (throat started to hurt), CHILLS (chills) and VOMITING (threw up) outcome was unknown and DIARRHOEA (diarrhea) and MYALGIA (Soreness all over his body) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Rapid heartbeat; Spotty vision; Shortness of breath; This is a spontaneous report from a contactable consumer, the patient. A 27-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 31Mar2021 at 13:15 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included heart palpitations. The patient was allergic to past drugs acetaminophen (MANUFACTURER UNKNOWN) and montelukast sodium (SINGULAIR). Concomitant medications included propranolol (80mg) (MANUFACTURER UNKNOWN) and lisdexamfetamine mesilate (VYVANSE) (50mg) and an unspecified birth control medication (MANUFACTURER UNKNOWN), all from unknown dates. 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 vaccine. On 31Mar2021 at 14:30, the patient experienced rapid heartbeat, spotty vision, and shortness of breath. It was reported that all symptoms were mild. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcomes of rapid heartbeat, spotty vision and shortness of breath was unknown.  No follow-up attempts are needed; information about lot number cannot be obtained.
Child broke out with erythematous macules to entire body within 24 hours of receiving vaccines. No treatment required. Rash resolved within 48 hours.
5-11 yrs administrated instead of 12 yrs Bivalent booster vaccine  NO adverse reaction/event
Immediate numbness and weakness in RUE. Immediate edema RUE. Diarrhea and fatigue within 8 hours and lasting 48 hours.
Blood Pressure elevated to 160/90, patient self check normal 120/80. Occurred 3 hours after immunization and slowly decrease after 2 hours. Also mild rash on left foot, same time frame. Resolved with Ibuprofen.
Pt. states that after receiving the 1st dose of Influenza High Dose 10/01/2021, started experiencing symptoms 10/02/2021 developing a bruise (2inx2in) at injection site. Currently a greenish/yellowish color *healing. No other symptoms noted, No Primary visit noted (Follow-Up with Primary if continues).
loss of vision; very hard, large lump has surfaced in her left breast/originates from the lymph node in her arm pit and runs to her nipple/Hard lump surfaced on lymph node at base of skull; very hard, large lump has surfaced in her left breast/originates from the lymph node in her arm pit and runs to her nipple/Hard lump surfaced on lymph node at base of skull; 103 fever; constant shaking; uncontrollable vomiting; dry heaving; headaches; extreme aching in back and chest; extreme aching in back and chest; This is a spontaneous report from a contactable consumer (patient) reported for herself.  A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration into left arm on 17May2021 16:00 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation in Pharmacy or Drug Store. Medical history included allergy to bees (known allergies: Bees). The patient's concomitant medications were none (no other medications the patient received within 2 weeks of vaccination), the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. patient previously received first dose of BNT162B2 for COVID-19 Immunization. The patient experienced very hard, large lump has surfaced in her left breast, It is shaped like a straw, over two inches long. it originates from the lymph node in her arm pit and runs to her nipple, Hard lump surfaced on lymph node at base of skull. During 72 hours following second shot: 103 fever, constant shaking, loss of vision, uncontrollable vomiting, dry heaving, headaches, extreme aching in back and chest, all on 18May2021 08:00. the adverse event result in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures in May2021: blood test, mammogram, sonogram test with unknown results. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been has not tested for COVID-19. treatment received for the events included Bloodwork, sonogram and mammogram. Outcome of the events was not recovered. It was reported as non-Seriousness. Seriousness criteria of Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect were all no.  Information on the lot/batch number has been requested.
Swelling from shoulder to elbow, postive erythema, urticaria, flu like symptoms. Reduction of cessation hard. Large local swelling mild erythema and reported urticaria not reported.  Tx iced area
Awoke at 5 AM with extreme nausea and went to bathroom to vomit. Passed out, hitting chin on toilet bowl and chipping front tooth.  After vomiting, laid on floor for 2.5 hours before gaining enough strength to return to bed. Slept for the next 24 hours.  Unusual fatigue still present daily.
Right arm with erythema, warmth and induration 10cm-15cm area, non-tender but itching.
I experienced an immediate affliction of hyperventilation, tachycardia, and lightheadedness that later resulted in going to the ER. They performed diagnostics and ruled out any possible serious complications and gave me the paperwork explaining how to care for my health and worried nature. Later, I experienced chest/injection site pain that has been slowly improving over the past two weeks since administration. Keeping in high Spirits and enjoying life has been the best thing I can do since it happened. for apprehensive individuals, I suggest thoroughly talking with your Dr and using your own best judgement.
Fever, chills and body ache. Flu-like symptoms. Lasted about 2 days. I missed one day of work but felt pretty awful for about two days.
Moderna COVID-19 Vaccine EUA   I started to experience tingling sensation on my left side of my torso towards my back.  It was also painful. I went to the doctor's office on Friday May 21.  I was diagnosed with a muscle pull to my rib area.  Over the weekend, symptoms became worse when a rash showed up on my left side and expanded to my left belly area.  Area remained painful and sensitive to touch like a cactus was on my skin.  I recognized the symptoms as Shingles and saw the doctor on Tuesday.  I was then dx with Shingles and prescribed an Anti viral medicine Valacyclovir for 7 days.
Information has been received from a healthcare worker referring to an unspecified number of children of unknown age and gender. On unknown dates, the children were vaccinated with improperly stored doses of GARDASIL (lot number, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the reporter did not want to be contacted.
Patient inadvertently given Moderna COVID-19 vaccine despite being 17 years old. No allergic reaction noted during waiting period after administration. Scheduled for 2nd Moderna vaccine in 4 weeks per CDC guidelines.
Emp. received H1N1 vaccine. States that approx 10 min later she began to feel hot and her palms became sweaty and she vomited x 2.
Headache; Diarrhea; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 30Mar2021 at 14:45 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, the patient experienced headache, diarrhea and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events headache, diarrhea and fatigue. The clinical outcome of the events headache, diarrhea and fatigue were recovered on an unknown date.   No follow-up attempts are needed. No further information is expected.
Patient called in to our pharmacy for routine refill calls for his specialty medications and reported not feeling like himself after receiving his first shingles vaccine on 3/4/23. Describes having vision changes and feeling "ill." Includes fatigue that is continuing to today, and upon going to his primary care or specialist for imaging, he said he was denied procedure due to possibly elevated Scr (he describes this as "elevated kidney function"). Patient is concerned that the onset of these events stem from almost immediately after receiving his vaccine.
Intense spinning sensation when trying to rise from the floor two days following Moderna booster.  Intense diarrhea came on shortly thereafter.  Went by ambulance to Hospital and remained there under observation for two days.  Some dizziness persisted but never as extreme as the first experience.  Needed to use walker or have help getting to bathroom.  Physical therapists came on day of discharge and performed brief testing.  Concluded that I had BPPV.  Outpatient physical therapy for about two months.
intussusception 11/13/09 DC summary and ER records received for date 10/9/09.  DX: Intussusception, abdominal pain, vomiting. Presented to ER w/ chief c/o vomiting, heart racing, lethargy. Emesis became bilious this day. Assessment: (+)abd pain, vomiting. Air contrast enema performed, successful reduction. Pt admitted for observation.  ICD9 codes: 789.0, 787.03, 560.0.
The following symptoms have gotten worse after dose 5; insomnia, mild depression, panic attacks and anxiety with irritability. Lower back pain and generalized fatigue, body aches and stiffness have gotten worse. I noticed this for certain in December of 2022, but it had been gradual. I contacted the doctor on March 30, 2023 regarding these symptoms and I was prescribed Propranolol and Lithium Carbonate and Strattera.
I was in my first trimester of pregnancy.  I had covid like symptoms for over two weeks after the first shot.  I got tested twice for covid during this time.  Both tests were negative.  I later suffered an abnormal miscarriage.
Patient developed a full body rash from the neck down. Rash included redness, severe whelps, and itching. Patient woke up with rash 2 days after vaccine. He is being treated with diphenhydramine orally and this treatment has been effective so far. But as the medicine wears off the rash and its symptoms return.
Blood clots in left leg, hip, bilateral lungs; treated with blood thinners; was admitted to hospital from 4/1-4/3; discharged to home, stable