chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Syncope. Arrived to pt side at 1419. Pt sitting in chairs next to lab. Staff assisting. Pt's mother states pt had a seizure, and lost consciousness mother in chair next to her witnessed, first to arrive at chairside MA. Mother states pt c/o dizziness/lighthheadness and "her eyes rolled back in her head", states body position was with neck extended to left rigidly, gasped for air a few times with arms bent at elbow does not recall if hands were opened or closed and extension of the legs with toes pointed. Pt did not have bowel or bladder incontinence. Eyes: 3mm/3mm PERRL Skin: pale, cool and clammy. When asked her name and dob answered appropriately, conversing with staff and mother denies pain, HA, nausea, SOB, HR 54 RA O2sat: 100% pt tearful states is embarassed. Pt had just received four vaccines and was awaiting labwork. Mother and pt state that pt has an "intense" needle phobia. Pt also states has only eaten a couple pretzels today and nothing else. Juice given. Dr at chairside 1425 examining pt. 1455: HR 59 BP: 108/62. States a little dizzy but improving. 1510: HR 60 BP: 96/60. States feeling "back to normal" with mild dizziness.
My son had a 12-15 min. convulsive episode (seizure) 6.5 days after his shots. He was non-responsive / staring, limp for about 5 min. When I picked him up he could not use his legs and collapsed, his neck lolled to the side, his eyes crossed, tongue came out, he made a choking gasp, then turned red and convulsed. I called 911. He foamed at the mouth and I tried to clear his airway. He was not breathing for several minutes and I was told by operator how to perform CPR. Rolled him on his side, I attempted CPR, he started breathing and fell asleep. Convulsions and lack of oxygen lasted between 7-10 minutes and ended 2-3 minutes before paramedics arrived. Paramedics checked oxygen level / temp. (both normal). He was taken to the ER where they ran blood work for meningitis, high white blood cell count, infection, and/or a vitamin deficiency. All blood work came back normal. He had no fever. No EEG was given. We were told that sometimes seizures in young children "just happen" and to watch him closely for the next 48 hours. He has not had another seizure since his immunizations. Note: There is a family history of adverse reaction to the DTP shot. My sister had a febrile seizure with her DTP shot. Was told that it wouldn't be a problem with my son because this was Dtap with the acellular pertussis. Clearly that is NOT the case and the Dtap can still lead to seizures.
I was very sick. High fever, headache, chills, heavy breathing for a short period of time and a lump under my left armpit. I still have the lump.
this is the first time she got COVID; this is the first time she got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "this is the first time she got COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Caller explained that she had the Pfizer COVID vaccine and booster. She mentioned that this was the first time she got COVID and she decided to take Paxlovid as she was not sure if her body could take it as she just gotten over a pretty bad cold. She said that she was "progressing well and it's been mild". Caller agreed to be transferred but disconnected while on hold. Was able to provide contact information to the caller. First attempt to connect to Safety agent was unsuccessful as they could not hear the agent. Second attempt was successful.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
From telephone contact with reporter, it was stated that a 4 year old patient ( 2 of 3) received a Tripedia vaccination (date not specified). Sometime after vaccination, the patient developed swelling at the injection site. Further information is requested.
Sore arm/Still slightly sore; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm/Still slightly sore) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Heart disease, unspecified.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced MYALGIA (Sore arm/Still slightly sore). At the time of the report, MYALGIA (Sore arm/Still slightly sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatment information was reported.   Reporter did not allow further contact
Patient came in for a Pfizer COVID Bivalent booster vaccination. Regular Pfizer (Not Bivalent) was administered in error.
CHILLS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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,) dose, start therapy date were not reported for prophylactic vaccination.  The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on APR-2021. This report was non-serious. This case, from the same reporter is linked to.
Fever of 101.2 noticed at 7pm. Pt was given Tylenol which brought fever down. Fever (102.1) at 10am the following day (11/13) and Tylenol given. Fever didn't return until the night time on the 13th which again Tylenol was given. Arm soreness and redness lasted for about 5 days after vaccine shot. Day 2 and 3 it was also itchy.
The day after sx developed; severe chills, some nausea, some body aches, headache. Rested all day and by the next day (day 2 after injection) I felt 95%. Took 2 Tylenol at bedtime on the day with the sx. No other OTC drugs. Did not contact my physician or felt the need to; really not bad sx.
High heart rate -140 Blood pressure- 199/99 fever of 104 , chills, headache, back pain, body aches Dizzy - felt like passing out
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 01Feb2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic renal disease" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical courses: No other medication in 2 weeks. Anti viral details: COVID 19 Treatment from 05Jul2022 to 10Jul2022. Rebound COVID (on 15Jul2022 09:00 AM) 5 days after completing Paxlovid. No treatment received. No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on possible temporal association and lack of effect the causal association  of suspect  cannot be excluded for reported events.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Patient came to the pharmacy to get his first Pfizer vaccine dose. He stated that he tends to pass out with immunizations.  I administered the vaccine.  He passed out within about a minute after administration.  He lost consciousness 3 times.  During the second time he started to shake/seize.  His friend and I stayed with him the whole time and held him steady so that he didn't bump his head.  After the third episode he regained full consciousness.  We laid him in the floor on a pillow with his feet propped up to help blood flow to his head and got him some cold water.  We did not administer any medications.  Patient waited in the pharmacy area for 30-40 minutes after administration and left on his own free will.  He was able to walk to the car unassisted.
Client had mild out break of disease on 08/17/2005 with 40-50 pox.
Heart arrhythmia. Chest pain. Shortness of breath. Lightheaded.
Pneumovax booster triggered generalized swelling and intense itching, Prednisone PO and clinic exam only.
Fever 102+, projectile vomiting,  tremors,  muscle weakness,  fatigue  lasting 30 hours
No additional AE reported.; expired dose of VAQTA was administered to a patient; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 06-AUG-2021, the patient was vaccinated with an expired dose of hepatitis A vaccine, inactivated (VAQTA) lot # T018670, expiration date 11-JUL-2021 (dose, route of administration and anatomical location were not reported) for prophylaxis. No additional adverse event was reported.
approx 2mins w/p vax pt devel a welt & redness in lt upper arm;welt approx 2" circumference w/redness to notified Md instructions: warm soaks 20mins x 3, observed for further rxn;
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication was reported. On 10-SEP-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # L007720 Expiration date: 08-JUL-2016, 0.5 ml (route and anatomical location of administration were not reported). The vaccine had two temperature excursions one of 328 hours with a lowest recorded temperature of 29 Fahrenheit (F) (-1.666666667 Celsius (C)) and other one of 264 hours with a lowest recorded temperature of 33 F (0.555555556 C). The storage criteria and the storage type were reported as "Refrigerator (R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Received vaccine in the morning, mom reports "knot and redness" starting that afternoon that worsened and starting itching over the next 48 hours. Improving today.
Mild Varicella Like Syndrome. Characteristic rash, fewer than 100 lesions, mild pruritis, no fever or associated symptoms.
Had shot around 9AM fussy during day; Woke up around 1PM screaming bloody murder-unconsolable; pt taken to MD observed 1 hr  felt allergic rxn to pertussis; Gave advil which calmed him down nl fussy p/this; sore leg episode x 1 1/2 hr;
pt devel abd pain & passed bloody stool; A BE was done & intussusception reduced; pt went home & did well;
body pain in the left arm; sore throat; body pain; headache; fever of 100; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (body pain in the left arm), OROPHARYNGEAL PAIN (sore throat), MYALGIA (body pain), HEADACHE (headache) and PYREXIA (fever of 100 ) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 023M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced PAIN IN EXTREMITY (body pain in the left arm), OROPHARYNGEAL PAIN (sore throat), MYALGIA (body pain), HEADACHE (headache), PYREXIA (fever of 100 ) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (body pain in the left arm), OROPHARYNGEAL PAIN (sore throat), MYALGIA (body pain), HEADACHE (headache), PYREXIA (fever of 100 ) and CHILLS (chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Body temperature: 100 (High) 100.         No concomitant medications were reported.
Information has been received from a health professional concerning a 13 year old female with no allergies or history who in June 1998, was vaccinated with a dose of varicella virus vaccine live. On 2/2/2005 the patient experienced 75 to 100 diffuse pox. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information indicated that on 4/1/2005 the patient had about 75-100 pox that were very small with few vesicles. The patient recovered on 4/6/2005. No additional records are available. Additional information is not expected.
MY TONGUE AND INSIDE CHEEKS OF MY MOUTH BEGAN TO BURN.  IT FELT LIKE 1000 OPEN BOILS WERE ON MY TONGUE AND INSIDE EACH CHEEK AND UPPER LIP. I WENT TO THE EMERGENCY ROOM AT 7AM THE NEXT MORNING WHERE I RECEIVED AN IV OF STEROIDS TO REDUCE THE SWELLING OF MY TONGUE, CHEEKS AND LIPS.  MY ENTIRE HEAD FELT LIKE IT WAS SWELLING.  THE NURSE SAID MY ENTIRE HEAD HAD BECOME "FLUSH" RED.  I WAS GIVEN A RX OF PREDNISONE AND 1000mg VALTREX WHICH I TOOK FOR 7 DAYS.  IN LESS THAN ONE WEEK AFTER COMPLETING THE MEDICATION, THE CONDITION RETURNED AND EXTREME PAIN AND BURNING BEGAN AGAIN.  I IMMEDIATELY CALLED DR WHO GAVE ME ANOTHER RX OF VALTREX.  I THEN HAD AN ADDITIONAL OUTBREAK ON THE BACK OF MY NECK AND MY LEFT WRIST.  AS OF THIS DATE, 12/21/2009, MY TONGUE IS STILL INFLAMED AND BURNING.  MY 2ND RX OF VALTREX IS ALMOST EXHAUSTED.  HOW LONG CAN I KEEP TAKING VALTREX WITHOUT LIVER DAMAGE?
developed bells palsy.; in their late 40s received shingrix; This case was reported by a physician via sales rep and described the occurrence of bell's palsy in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant) and inappropriate age at vaccine administration. On an unknown date, the outcome of the bell's palsy and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the bell's palsy to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported but selected as an adult as per vaccine indication. The reporter stated that, the patient in 40's received dose of Shingrix, which led to inappropriate age at vaccine administration. The reporter stated hat, about 1 year ago the patient received Shingrix and had bell's palsy.
On 1/24/2021 I noticed that the site of the injection looked bruised and had some red rash around it.  The site was warm.  By the morning of 1/25/2021, the rash around the site has increased considerably and the site remains warm to touch.  I feel slightly clammy but have no fever.
Severe itchiness that started in legs and spread to whole body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Severe itchiness that started in legs and spread to whole body) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, MONTELUKAST SODIUM (SINGULAIR), AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3), MULTIVITAMINS & MINERALS PLUS LUTEIN and ESTROGENS CONJUGATED (ESTROL) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PRURITUS (Severe itchiness that started in legs and spread to whole body). At the time of the report, PRURITUS (Severe itchiness that started in legs and spread to whole body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient did not take anything to treat but did drink water till cooling down.
We received a prescription for an antibiotic for the above patient on 11/10/17. As the pharmacist was counseling the patient regarding the prescription she picked up on 11/10/17, the patient informed the pharmacist that the reason she was picking up the antibiotic was because of the reaction she had to the immunizations she had received on 11/8/17. The patient stated that the evening of the day she received the above immunizations, she started to experience a burning sensation, rash, and swelling in the same arm in which she received the immunizations. She told the pharmacist the doctor said that her condition was a reaction to the immunizations she had received from this pharmacy on 11/08/2017.
This is a spontaneous report from a contactable pharmacist through a Pfizer sales representative. A female patient of an unspecified age received PREVNAR 13 on an unknown date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient felt like she was drunk. Clinical outcome was unknown at time of this report. The information on the lot number has been requested.
Extreme fatigue; Headache; Loss of appetite; Feeling hot (no fever); This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 03Mar2021 at 18:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety disorder. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medication included prescribed anxiety medication (unspecified); for anxiety from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Feb2021 at 09:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. On 04Mar2021 at 11:00, the patient experienced extreme fatigue and headache for 3 days following vaccine, loss of appetite and feeling hot (no fever). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events extreme fatigue and headache was recovered on 07Mar2021 however the events loss of appetite and feeling hot (no fever) was recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Pt came 6/18/07 for 2nd dose of Rabies vaccination. When questioned about current health status or adverse reactions from 1st dose, pt. stated that she developed a "shooting" and "tingling" pain down left arm the Saturday after being vaccinated. Pt. discussed pain as being painful to light touch. We contacted the CDC and vaccine manufacturer re reaction and decided to withhold the 2nd dose until symptoms had fully resolved and reevaluated
Redness, Swelling, Pain, and Itching surrounding injection site, approximately 5 inches in diameter when reported approx 24 hours post-injection.
Systemic: Dizziness/Lightheadedness-Severe. Systemic: Bradycardia-Medium. Systemic: Vomiting-Mild.
The severity of headache increased following the vaccinations, mild nausea (unable to eat dinner evening of vaccinations) also stated fever was present. Client may have received OTC pain reliever medicine on 5/21/14, unknown. Family memebers instructed client to rest. Upon awakening the morning of 5/22/2014, client felt warm to the touch (no thermometer to measure temp) and unable to eat, still c/o of severe headache; clt received 200 mg ibuprofen client stayed home from school on 5/22/2014. On 5/23/2014, client still complaining of headache but of lesser intensity; fever has subsided related to use of fever reducing medication; client missed a second day of school. No report on whether appetite returned; on Right arm 4 inch diameter swelling that is red and blotchy in appearance; that area is warm to the touch. Left arm only has mild discomfort if touched. Client has not sought other medical attention at this point.
Information has been received from a registered nurse concerning a 6 year old white male student with no medical history and no allergies who on 4/25/97 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live (lot # 620614/1106D). On 4/25/97 the patient was also vaccinated SC in the left arm with a first dose of MMR (lot # 619133/1250D) and IM in the right arm with a fourth dose of Haemophilus B conjugate vaccine (lot M035PE). There was no concomitant medication. There was no illness at the time of vaccination. In the fall of 2002, the patient developed chicken pox with many vesicles. The patient was never seen in the office. Subsequently, the patient recovered. It was also noted that the patient's 10 year old sister was vaccinated with a first dose of varicella virus vaccine and developed varicella, a cough, and pneumonia. No further information is expected.
VACCINE EUA 18 I  Lost the ability to get drunk . Liquor or wine taking  not taking  affect .   I am serious this is not a JOKE i am for real . I enjoy liquor   but cannot get drunk any more after the vaccine  Any idea what has happen to my DNA
I developed a sore throat within 2 hours of receiving the vaccine. I was sick the next day with a sore throat and cold symptoms (sneezing, fatigue, runny nose, sore throat). Advil didn't help with my sore throat. I'm still sick the second day with the same symptoms.