chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a round (approximately 2.5 inches in diameter) area of inflammation / at the injection site; redness at the injection site; skin was warm to touch; also experienced a headache; first dose of Shingrix April 5, 2021 / on May 3, 2021 / received the second vaccine; This case was reported by a consumer via call center representative and described the occurrence of injection site inflammation in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number F5XN2, expiry date 8th October 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 3rd May 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 3rd May 2021, immediately after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced injection site inflammation, injection site erythema, skin warm, headache and drug dose administration interval too short. On 7th May 2021, the outcome of the injection site inflammation was recovering/resolving. On an unknown date, the outcome of the injection site erythema and skin warm were recovering/resolving and the outcome of the headache was not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the injection site inflammation, injection site erythema, skin warm and headache to be related to Shingrix.  Additional information was provided as follows:  On 5th April 2021, the patient received 1st dose of Shingrix. The patient was instructed to return to receive 2nd dose of shingrix and the patient received 2nd dose of Shingrix, less than the recommended interval, which led to shortening of vaccination schedule. Immediately after receiving 2nd dose, the patient noticed a round (approximately 2.5 inches in diameter) area of inflammation and redness at the injection site. The skin was warm to touch. Those symptoms had improved. On the same day, she also experienced a headache and continued till the reporting date. The reporter consented to follow up via email as well as with her HCP (health care professional).
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 25-APR-2014 the patient was vaccinated with MMR II (strength, dosage and route were not reported) lot number: J009706, expiration date: 15-AUG-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the MMR II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was an any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Body aches, headaches. Followed by bronchitis. No fever and oxygen levels @95. Terrible non-stop coughing. Lungs very ?junky?, wheezing, whistling, heaviness, trouble breathing. After one week, went to  Urgent Care   At the time I got the vaccine, a family member had been sick for 2 weeks with bronchitis. I believe I caught his ?bug? due to lowered immunity after getting the vaccine.
Narrative: Pt received Moderna Covid #1 on 3/11/21 and #2 on 4/8/21. He was followed by his healthcare provider and was noted to have wounds on his legs. On 4/20/21, family contacted healthcare provider to report he was feeling bad x 5 days with constant tremors, no appetite, productive cough and inability to stand. On 4/21/21, he was seen by his healthcare provider and during that visit, he had mild hallucinations (seeing a spider and a person that were not there). On 5/13/21, he was admitted to a facility and treated for septic shock, acute renal failure and hyperkalemia. He received ceftriaxone, calcium gluconate, fluconazole, Novolin R, sodium bicarbonate, kayelexate, vancomycin and Lopressor. Notes indicate that he was a DNR. He passed away on 5/14/21. No autopsy report available. Time from second vaccine to date of death was 36 days.
Patient developed a raised red rash that covered an area approximately the size of two hands on the left hip/buttock region. It developed around 24 hours after the administration of the shot.
Patient received Moderna COVID vaccine on 3/11/21 and when came back to the clinic for second dose, Pfizer COVID vaccine was administered.  No adverse events reported at time of immunization or after immunization.
STroke April 6 at hospital I am PCP, not admitting doctor I wanted to be sure you were aware of thromboembolic event
Severe pain and swelling in L shoulder going across neck and up into jaw. Still there after 4 days. Can't lift L arm.
about 3 hours after vaccine was administered i noticed lower back pain, over the course of about 3 days the pain became so severe that i had to go to the ER. I have had back pain in this location before but never so severe nor has it lasted as long as this did. i also noticed a very sharp pain in my abdomen. after consulting with my PCM he said he did not know why, but to come back in 2 weeks.
Muscle weakness; Severe Fatigue; pretty bad headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Muscle weakness), FATIGUE (Severe Fatigue) and HEADACHE (pretty bad headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-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) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced MUSCULAR WEAKNESS (Muscle weakness), FATIGUE (Severe Fatigue) and HEADACHE (pretty bad headache). At the time of the report, MUSCULAR WEAKNESS (Muscle weakness), FATIGUE (Severe Fatigue) and HEADACHE (pretty bad headache) had resolved.            Concomitant product use was not provided by the reporter.  Treatment information was not provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up received on 25-jun-2021 included outcome of the events.
Postural Orthostatic Tachycardia Syndrome.  Symptoms have been present from 8 weeks and are not going away. Symptoms include: Lightheaded, weak, feeling faint, short of breath, sweating, leg trembles, heart racing, blood pressure is high when standing, heart rate is high when standing.  Exercise intolerant.  Has missed 8 weeks of school as a result of this.
Symptom onset approximately 4 hours after immunization. Unable to lift arm past should height without pain. Vomiting and chills lasting 24 hours. Vomited approximately 6 times. Lower back pain, tightness, and muscle weakness.
Swelling; Pain; Redness; This is a spontaneous report from a contactable consumer. This consumer reported for female patient (reporter's wife). A 48 years old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL1283, Expiration Date: Apr2021), via an unspecified route of administration in right arm on 07Jan2021 (at the age of 48-year-old) as dose 2, single for COVID-19 immunization (hospital employee and required require). Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EK5730, Expiration Date: did not put on vaccination card), via an unspecified route of administration in right arm on 17Dec2020 (at the age of 47-year-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. Caller mentioned that, his wife had swelling, pain and redness after getting the vaccine on 08Jan2021. He confirmed his wife informed him details of this event. She works in a hospital as an Ultrasound technician. The swelling, redness, pain, started the second day which was on 08Jan2021. It lasted 2-3 weeks. The patient was fine now. The outcome of the events was recovered on an unspecified date in 2021.
Low grade fever 100.3F, sore throat, chills, headache, and itching.
Sunday March 7th started to get itching on face and lips Monday March 8th got progressively worse, took Benadryl and didn?t help. Felt as though my throat was closing, got to urgent care where it got worse while I was waiting to be seen, was rushed back and given a shot of epi pen and predisone, and Tagament had to have an iv with 2 bags of fluid.   Went home, continued to have  Face swelling, itching, pain .  Took regimen of drugs I was told to take, got worse. Went back to urgent care and was given another epi pen. Face itching turned into burning pain which continued until March 13th afternoon and slowly went away. Face was back to normal March 15th. Horrible excruciating burning, red, hot pain all over my face.
Pt was given ID injection of Jynneos Vaccine. Upon administration in left arm, plunger of syringe collapsed, needle of vanish point retracted, and no wheel was visibly present. Pt went to observation area with no reactions and left. I was uncertain if pt was either under-dosed, or had a broken syringe and a failed injection, so we called pt to see if they could return to our clinic. Once he returned I assessed his injection site, and decided to administer a second dose to make sure they in fact received a successful ID injection. Administered dose ID route on Right arm, with a wheel present. Pt left after Injection.
just started feeling naeous my blood pressure jumped up, i was right down the road from the hospital so i went there, i took baby aspirin to try and get it to go down i had to take another med to get my pressure down, ct scan, 2 mri, mra, blood work
Sore arm felt shot was given too high on arm pain lasting re check 11/9/15 arm still sore and pain in elbow and arm feels tight no redness swelling or drainage.
Second dose was not applied in the recommended interval (40 days since first dose); This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose was not applied in the recommended interval (40 days since first dose)) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-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 PRODUCT DOSE OMISSION ISSUE (Second dose was not applied in the recommended interval (40 days since first dose)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose was not applied in the recommended interval (40 days since first dose)) outcome was unknown. Not Provided      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.   patient that has an upcoming hip replacement surgery soon patient's doctor didn't want for the patient to get the second dose before the surgery.
pt recvd & 5-6hrs p/vax exp lumps on both arms & itching between fingers & palms;sx cont;
PT WAS GIVEN VACCINE ON 2/27/2021 AND BEGAN HAVING SYMPTOMS ON 3/5/2021. PT ARM BEGAN HURTING AGAIN , ARM WAS RED WITH A KNOT AND WAS WARM TO TOUCH. ALSO HAVING PAIN THAT GOES DOWN ARM.  SYMPTOMS ARE SOMEWHAT BETTER TODAY.
On 11/20/18, Patient stated that at about 0900 pm he had the chills, took his temp because he was feeling warm and it was 102.0. Patient stated it went up to 103. He did not take any medication for the fever, he applied a cold towel to his head and covered himself with a blanket and the fever broke. This morning his temperature was 98.1 but has started with a cough and feels pressure in his head. He stated he has had the flu shot for 10 years and has never had side effects like he is having this time. Same day, patient stated that his fever is waxing and waning and goes from 99 to 102. Patient is concerned that he continues to have a fever. Appointment made for tomorrow morning. Patient was encouraged to go to ER if he became worse overnight. Patient is unsure if he will go to ER. Patient stated he took 2 TYLENOL for fever and will continue to monitor his symptoms and is staying hydrated. 11/21/18, Patient saw physician and diagnosed with post-injection cellulitis and arthus reaction. Patient given cephalexin 1000 mg PO TID.
erythema, color & tenderness @ inject site 15 cm diameter; vesicular eruption on lips & nares, fever to 103 orally;
Information has been received from a physician concerning a 30 year old female with an allergy to cefuroxime axonil and azithromycin, who on 9/3/99 was vaccinated IM in the deltoid with the first dose of Hep b vaccine. Subsequently, 3-6 hours post vax, the pt experienced a reddened rash on her face and under her arms. The pt was treated with Benadryl. On 9/3/99, the pt recovered. Additionally, the reporting physician noted "do not continue with series." No further information is available.
Chills for about an hour followed by uncontrolled shivering severe enough couldn't walk without hanging on to something.  Went to bed with extra clothing and slept 12 hours.  Never had this type of reaction to any previous vaccine.  Normal health next morning.
Eyes rolled in head...thought child might not have been breathing for a min...coughing and wheezing came after.
He reports he is still having ?burning, constant ache to his Lt deltoid area and still hurts when he raises his arm. Not used to it lasting this long. Patient experiencing these symptoms from 11/16-12/13
A few hours after the first shot of the pfizer Covid-19 shot I broke out in hives while working out. I had never had hives and was currently training for a boxing match. Since having this shot, I have been unable to exercise without getting hives. I also developed POTS.
@1110 Placed pt on the gurney as a precaution because pt had a late reaction during observation period and pt reported having a rash when they got home. Pt was doing well during the whole observation period.  @1140 During ambulation trial, pt became nauseated. Alcohol swab to smell to relieve nausea, and emesis bag provided. Symptoms eventually went away. VS137/61 (89) 70 98% 16RR. Pt and daughter confident in going home. ED precautions discussed with pt and daughter. Instructed to follow up with PMD and to take Benadryl as directed by MD if rash develops. DOD, aware of pt's situation and disposition.
Pt received 2 doses of the Pfizer 5-11 Covid Bivalent. One dose was given on 11/11/22 at a Pharmacy location and because of incorrect information  sent over from the monitoring system a second Pfizer5-11 Covid Bivalent dose was given here in the office on 1/30/23.
pediatric dose (0.5ml) to a 21 years; pediatric dose in error to a 21 year old; This case was reported by a physician via sales rep and described the occurrence of underdose in a 21-year-old patient who received HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric .5 ml. On an unknown date, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional details provided were as follows: The physician reported that a pediatric dose was administered in error to a 21 year old which led to underdose and adult use of a child product. The reporter denied to follow-up.
PATIENT STATED AFTER RECEIVING HER SECOND DOSE THAT SHE WAS UNABLE TO RAISE HER ARMS & HAD SWELLING. SHE WENT TO SEE HER DOCOTOR, RECEIVED A STEROID SHOT & WAS TOLD SHE WAS OKAY TO GET HER BOOSTER.
Patient called today and reported a rash on her left arm.  She said it was not at the injection site, but further down her arm.
skin on her face feels burnt and sore to touch; skin on her face feels burnt and sore to touch; Bad headache; medical history:  lupus anticoagulant positive; medical history:  lupus anticoagulant positive; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248), via intramuscular route of administration on 19Jan2021 at 12:00 at a single dose in the arm left for COVID-19 immunization. The patient's medical history included high blood pressure, hypothyroidism, depression, lupus anticoagulant positive, and anemia. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), verapamil, apixaban (ELIQUIS), montelukast sodium (SINGULAIR), levothyroxine sodium (SYNTHROID) , ergocalciferol (VIT D), cetirizine hydrochloride (ZYRTEC), hydrocodone bitartrate, paracetamol (NORCO). The patient previously took sulfamethoxazole, trimethoprim (BACTRIM) and acetylsalicylic acid (ASPIRIN) and experienced allergies. The patient also previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140 ) on 29Dec2020 at 08:00 pm, via intramuscular route in the left arm for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. On 19Jan2021 at 19:00, the patient stated that her skin on her face feels burnt and sore to touch without any redness or signs of injury and had a bad headache. The patient did not receive any treatment for the reported events skin on her face feels burnt and sore to touch and bad headache. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient has not recovered from the events.
pt states that she had a normal sore arm and fatigue after the injection but on 2/13/21 she noticed she had developed a 2x 2 1/2" itchy, raised, red area around the injection site.  She said she self diagnosed it as covid arm.  She took pictures of it and sent them to her PCP and also contacted her Asthma doctor.  She was told to put ice pack on the infected area, take Benadryl and use cortisone cream.  Pt states it is improving.
This spontaneous report as received from a nurse refers to a 14 year old patient of unknown gender. On 10-AUG-2017, the patient was vaccinated with PROQUAD injection, lot # N013270 with expiration date of 25-OCT-2018 (dose and route of administration). The vaccine was reconstituted with sterile diluent (manufacturer unknown). No adverse effects were reported. Additional information has been requested.
CLIENT SIGNED CONSENT FOR BOOSTER AND RECEIVED PEDIATRIC LOT# FK5127 AND DOSE 0.2ML INSTEAD.
1/12/2021- 1/13/2021- Fever of 100-102, came and went 1/14/2021- 1/16/2021- nothing, felt normal 1/17/2021- stuffed up nose and congestion 1/18/2021-Current- coughing, pressure in chest, runny nose/ congestions, Fatigue, headache
Major muscle aches the next morning and throughout that first day.   Days 3 -10 Swollen Face, yellowing of eyes, blurred vision, watery/goopy eyes in the morning, metallic taste for most of these days, and really bad, smelly gas for over 2 weeks!   To this day, I still have yellowing in my left eye and it is watery/sticky and goopy every day when I wake.
Immunocompromised patient administered with a booster dose instead of a full 3rd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient administered with a booster dose instead of a full 3rd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Transplant. Concurrent medical conditions included Immunocompromised (due to a transplant).   In September 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised patient administered with a booster dose instead of a full 3rd dose). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised patient administered with a booster dose instead of a full 3rd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. HCP did not have any details on transplant. No treatment medication reported by reporter.
Redness, swelling, and warmth, worsened over days, treated for cellulits by urgent care with oral cephalexin with improvment.
fatigue; high blood sugar; high heart rate; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 10Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, for Covid-19 Immunisation. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "fatigue"; BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "high blood sugar"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "high heart rate". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
10/1/2020 MOC noticed a slight red rash on chest and arms of child. No fever, did not seem bothered by it.  Saw a PNP and was told that it might be a reaction to his MMRV vaccination given on 9/21/2020. 10/2/2020 Child woke up completely covered in a rash, described as small red blisters and some welts, itchy, "even behind his ears", "over every inch of his body". No fever, but child irritable and scratching at rash.  Saw Dr. and was told that it was most likely chicken pox.  Instructed to give Benedryl for the itching, and to use calamine lotion, after a warm bath with oatmeal. MOC currently doing all the recommended treatment, but verbalized frustration with this happening.
Two weeks after my booster, I began experiencing a daily rash. I?ve had no new exposure to pets or animals and no new exposure to foods or other chemicals. The rash improves with zyrtec, but reappears globally after 24 hours unless I use zyrtec again. The rash is spontaneous and travels. I can?t predict where it will reappear, except that it seems to begin on my head/scalp first sometimes. I am still experiencing the rash.