chrisvoncsefalvay/vaers-outcomes huggingface dataset:
TOOK LAST DOSE OF VIVOTIF ONE DAY LATE; This spontaneous case report (PVX2019-2790) was received from a nurse on 12-Nov-2019. It described an 18-year-old female consumer who "took last dose of Vivotif one day late" (PT: Inappropriate schedule of product administration). The consumer was receiving oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took three doses of Vivotif according to schedule but took the fourth dose one day late.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took last dose of Vivotif one day late" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took last dose of Vivotif one day late" was considered as not applicable.
pt devel fever 8/13/99 during the noc t103;lt arm deltoid area red, hot & painful;area approx 3 inch in diameter;MD examined child ENT, chest, abd, clear;instructed to given APAP & apply heat to arm;
Within thirty minutes of administration I started feeling itchy around injection site then all over my entire body.  I stated to have some facial swelling then my throat started to swell/tighten.  I was brought to the ED and an IV was started. They administered IV fluids, Benadryl, Prednisone, and Pepcid. The throat swelling started to interfere with my speaking and vocals. They monitored me for 7 hours then I was discharged home. All symptoms returned within a few hours and persisted for a week following. My PCP took over care and prescribed me the following in replace of the medications the ER prescribed: Albuterol HFA, Dexamethasome, Pepcid, Benadryl, Z-Pak, Vitamin D 100,000iu, and Fish Oil. I missed a week of week then was released to work again on 1/25/21.
received her first dose last Friday and 45 mins after the caller said that her face is swollen and she was having itchiness in her whole; received her first dose last Friday and 45 mins after the caller said that her face is swollen and she was having itchiness in her whole body; pain at the back of her neck; her legs started to hurt on the side; breathing issues; This spontaneous report was received from a Pfizer-sponsored program. A Contactable consumer (patient) reported for herself. A female patient of an unspecified age received first dose of BNT162B2 (COVID-19 Vaccine) via an unspecified route of administration (Batch/lot number: unknown) as a single dose on 26Mar2021 Friday, for COVID-19 immunization. Medical history and concomitant medications were not reported. On the same day, 45 minutes later, she felt that her face was swollen and she was having itchiness in her whole body. On an unspecified date in Mar2021, her legs started to hurt on the side, had pain at the back of her neck and she also experienced breathing issues. She took Benadryl. Action taken with the suspect was not reported. The outcome of the events of face swollen and itchiness in whole body, legs started to hurt on the side, had pain at the back of her neck and breathing issues was not reported.
Flu-like symptoms within 24 hours, post vax. On 3/8/01, examined by PCP and dx'd with serum reaction.
No additional AE reported; Medical assistant reporting that a patient was administered PROQUAD after a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On 01-JUN-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin [rHA]) (PROQUAD) subcutaneous injection, lot # U024508, expiration date 02-FEB-2023 (dose, route of administration, anatomical location were not reported) for prophylaxis (Product storage error).  Administered dose of the vaccine was stored in temperature of 8.3 degrees Fahrenheit for 15 minutes.  There were no previous temperature excursions reported. There was no additional adverse event reported (no adverse event). No further information was available.
I was fully menopausal almost 2 years prior to my second dose and now I am menstruating again. It is light, but it's still there. I would like to add that I am currently menstruating on a monthly, regular cycle.
DIFFICULTY BREATHING, RASH, INCREASED PULSE, TACHYCARDIA, UNCONTROLABLE SHAKING.
Patient scheduled for second dose in Covid-19,mRNA vaccination.  Clinic providing both Pfizer and Moderna vaccination same day/time/location. Patient received Pfizer,Inc Covid-19 mRNA 30mcg/0.3ml dose in Left deltoid at 11:23am. Patient previously received 1st Covid vaccination Moderna on 03/01/2021 . Patient received Pfizer vaccine in error, was scheduled for second dose Moderna vaccine. Patient was unharmed, free from signs or symptoms or injury or adverse reaction. patient monitored for 15 minutes. patient notified by means of translator of vaccine error. patient in agreement and understanding to contact PCP for any signs or symptoms of adverse reaction.  Patient incident documented into chart in addition to site reporting
Upon follow-up information received on 13 February 2015, the case was upgraded from non-serious to serious. Initial unsolicited report received from a healthcare professional on 09 February 2015. A patient, whose age, gender, concomitant medications was not reported and medical history was unknown, had received a dose of FLUZONE (batch number, dose, dose in series, route of administration and site of administration was not reported) on unspecified date. On an unknown date, 90 hours after vaccination, the patient may had experienced neurological symptoms. The patient had required ER/doctor visit. Laboratory investigations and corrective treatments were not reported. At the time of this report the outcome of event was unknown. Follow-up information received for this unsolicited case from a healthcare professional on 13 February 2015: The patient was a female. Lot number for the dose of FLUZONE received was UH745AD. The working diagnosis for the patient was reported to be "global altered sensory disease", which was characterized by loss of taste/smell, altered body temp, decreased sweating, diminished pin prick sensation, prominent loss of vibration sense, and joint position. Apparently onset of symptoms began within 12 hours of vaccination and got progressively worse since. Of note, during the course of her illness, the patient was diagnosed with severe depression (has had suicidal attempts x 4 and Electroconvulsive (ECT) treatments x 15). Case was upgraded to serious. Patient's outcome was not reported. Documents held by sender: none.
60 minutes after oral ROTATEQ vaccine patient returned to clinic with 1 cm oval blisters on upper and lower lips on right of midline. No intra oral lesions. He had not been sucking on anything (like a popsicle) and had no other exposures.
LOT OF BODY PAIN (LEGS, BACK, ARMS, NECK); BLURRY SPOTS IN VISION; NAUSEA; FEVER; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch number. No concomitant medications were reported.  On 31-JUL-2021, the subject experienced lot of body pain (legs, back, arms, neck). On 31-JUL-2021, the subject experienced blurry spots in vision. On 31-JUL-2021, the subject experienced nausea. On 31-JUL-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurry spots in vision, and had not recovered from lot of body pain (legs, back, arms, neck), nausea, and fever. This report was non-serious.
pt had already waited 15 minutes after receiving her vaccine and reported to RN before exiting building that she felt as though her bottom lip was swollen. She also c/o the tip of her tongue being slightly itchy.  As she was describing symptoms to RN, pt stated that her throat was getting scratchy. pt denies difficulty breathing/respiratory distress, headache, nausea. Pt states she "feels ok and does not want to stay".  RN asked to see pt's lip and tongue. Tongue was pink, moist. Bottom lip  without swelling.
Pain at injection site; Redness at injection site; Swelling at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 25th October 2021, the patient received the 1st dose of Shingrix and Boostrix. In October 2021, less than a week after receiving Shingrix and Boostrix, the patient experienced injection site pain, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema and injection site swelling to be related to Shingrix and Boostrix.  Additional information was provided as follows: The case was reported by patient himself. The patient received Shingrix and Boostrix vaccine in his right arm. The patient experienced pain, redness, and swelling at the injection site. The patient inquired how long the side effects would last and the recommendation for the timing of the second dose. The patient was referred to health care professional. The reporter consented to follow up.
Sore right injection site arm after first moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore right injection site arm after first moderna Covid-19 vaccine) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028421A and 045B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore right injection site arm after first moderna Covid-19 vaccine). At the time of the report, VACCINATION SITE PAIN (Sore right injection site arm after first moderna Covid-19 vaccine) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Concomitants and Treatment medications were reported.   This case was linked to MOD-2021-390789 (Patient Link).
Patient presented to the ED on 5/25/2021 for acute cholecystitis. Patient presented to the ED on 5/31/2021 and was subsequently hospitalized for post-op wound abscess. These visits are within 6 weeks of receiving COVID vaccination.
Patient experienced intense pain and swelling in the area 3 days after the injection. She also reported itching.
Temporary moderate strength buzzing in the ears during a few seconds many times a day, occurring on one ear, but alternating to both ears.  Continuous buzzing in the ears noticeable when I?m in a quiet place.  Sensation of blockage on left ear due to pressure change, as if I travelled uphill.
Slight bruising , swelling, and pain on back of hand of vaccinated arm upon waking up.  Patient also reports generalized aches and pains that he did not have prior to vaccination.
Existing lymph node under left arm swelled on both occasions. Pain was quite bothersome and lasted for about 1 1/2 weeks after the first shot. This was repeated the very next day after the 2nd shot. Sleep with arm over head or pillow between arm to alleviate some of the pain. I am not taking any pain reliever such as Advil nor Tylenol. Currently lymph node is swollen and painful.  Also after the 1st shot, I experienced a pain from my left shoulder blade right up the left side of my neck similar to a stiff neck. This lasted for approx. 1 week. Today is my 2nd day after the 2nd shot and I feel a discomfort when I turn my head to the left but so far no pain as I felt after the 1st shot.
Big red spot around injection sites with a dark red ring around the edge. The area is itchy, sore to the touch like a bruise. Came up two weeks after injection.
Day after the vaccine all day long I felt light headed, like an out of body event,I did not like the way I felt. Dizziness and weaker than normal.  Approx. 26 hours later I lost my sense of taste and my eye site was blurred and it is still today Jan. 7, 2021. My taste buds are still not back . My tongue feels rough and I am almost feeling like I have Gerd. A lot of saliva but sour like. Headache , dizzy like and sore arm on day 2all day long.
3/20/09 had GARDASIL #2 at approx. 4:15 pm. Took CLARITIN in AM for allergies. Also takes CONCERTA and ORTHO TRICYCLEN low dose. Used tanning bed and Pomegranate lotion. 3/22/09 had rash behind ears. Used hot tub. 2/23/09 Had rash on chest face and back - "red, bumpy, tiny dots." Went to school nurse at 10 AM and was given BENADRYL and Hydrocortisone cream. Mon. night has rash on inner thighs. 3/24/09 returned to nurse - ears and nose were red and swollen. Nurse called Dr. who wanted her seen at ER. At ER was given steroid shot and Prednisone bid x 4d. Rash was no longer spreading. Was told no to get third GARDASIL. To see regular Dr. 3/27/09.
Five to ten minute seizure, generalized. No meds given for seizure. On ampicillin and Garamycin. Rule out sepsis. Per doc 212025, patient was found to have meningitis unlikely related to vaccines, he originally presented with seizures after vaccines.
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild, Additional Details: Family History: Both parents had sezuires after being immunized in the past and this was their son's first immunization.  Otherwise, the patient was calm and healthy.
4/21/21 ER hpi: 86 y.o. female who presents with unresponsive episode.  Patient is a resident of a nursing home and was apparently talking to members of her family when she collapsed prior to arrival several minutes ago.  Paramedics report patient hypotensive on arrival to scene.  Blood pressure and level of consciousness have improved during transport.  Patient is hypertensive and is on multiple medications.  At this time she has no complaints and states she feels all right.  She does have a history of multiple recurrent urinary tract infections.  Admitted observation to hospital 4/21/21 dx syncope and collapse, positive d-dimer, acute uti
ON 27 JAN 2003, I RECEIVED MY 3RD ANTHRAX INNOCULATION.  BEFORE ANY OF THESE SHOTS, I WAS FINE, A HEALTHY, NORMAL 23 YEAR OLD MALE. NOW, EVER SINCE MY 3RD SHOT OF ANTHRAX, I GET VIRTIGO, RINGING OF THE EARS, AND "BED SWEATS".  I HAVE NOT BEEN TO THE MEDICAL CLINIC YET TO TELL THEM ANYTHING, DUE TO THE FACT THAT OTHERS HAVE BEEN THERE AND THEY HAVE BEEN TOLD "OH, YOUR PROBLEMS ARE NOT RELATED TO THE VACCINE".  SO, THAT'S WHY I'M FILING THIS MYSELF.
1 Day after vaccination had fever, vomiting, decreased appetite and missed 1 day of school because of it. Resolving symptoms by 2 days after vaccine.
Pt & mom report c/o ringing in ears which started later in evening after receiving vaccine - lasting about 1-2 weeks. Noticed mostly at NOL when quiet. Received GARDASIL 8-18-11 & 11-9-11. Ringing in ears with both vaccines.
Fussy infant. No other observed symptoms. Report filed per parents request. (16.21 lbs 11/2/15) 1.25 ml TYLENOL given by parent.
Itching began 6 hrs after dose. 24 hrs after dose swelling & redness began. 48 hrs after dose swelling of entire upper arm w/ redness 300mm x 300mm. Also complains of tingling/numbness in lt hand & neck pain. Symptoms subsided by day 5.
Information has been received from a physician concerning a 32 year old female pt who on 11/4/99 was vaccinated with MMR and on 11/20/99, the pt developed what was described as "big mosquito bites at the injection site." The rash was reported to be red, hot, lumpy and itchy and had spread to the back of her leg and her stomach. Unspecified medical attention was sought. Follow-up information received from a physician indicated that on 11/4/99, the pt was also vaccinated with 1 dose of varecilla virus vaccine and that the pt's reaction 'was because she did not remember that she had the illness when she was a child." No further information is available.
body pain; headache; chills; sweats; fever (high 103.7); sore lower back; This is a spontaneous report from a non-contactable consumer. This consumer (patient) reported that a 46-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6198), dose 2 via an unspecified route of administration, administered in Arm Left on 23Feb2021 (Age at vaccination 45 years) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications. Patient not had allergies to medications, food, or other products. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL9261), via an unknown route of administration at left arm on 02Feb2021 at 08:30 as dose 1, single for covid-19 immunisation. On 18Mar2021 05:45, the patient experienced body pain; headache; chills; sweats; fever (high 103.7) and sore lower back. Patient was not received treatment for events. The patient underwent lab tests and procedures which included body temperature: 103.7 df on 18Mar2021, sars-cov-2 test: negative on 18Mar2021 Negative (12 hrs after symptoms). It was reported that patient commencing on morning of 18Mar2021 thru current (21Mar2021), body pain, chills, sweats, sore lower back, fever (high 103.7), persistent tension/headache. Facility where the most recent COVID-19 vaccine was administered at hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. Patient did not received any other medications the patient received within 2 weeks of vaccination. The clinical outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
Information has been received from a registered nurse concerning a 6 year old Caucasian male who on 03/18/98 was vaccinated with a dose of Varivax, SC in the left arm. There was no concomitant medication. On 12/14/01, the patient had a varicella breakthrough, mild case with less than 50 lesions. There was no prescription drug treatment required for the experience. It was reported  that the patient recovered a week later. Additional information has been requested
left frontal lobe infarction. this happened a second time 13 days after the second shot given on 1/30/2001.
Patient devleloped shortness of breath 9/4 and was vaccinated on 8/28. He then developed acute leg swelling and was then admitted and found to have DVT and bilateral PE
The morning of April 3, staff at the Vaccination Clinic discovered a discrepancy in the preparation of Pfizer vaccine doses. It was discovered that several undiluted vaccine doses were administered. Staff accounted for all unused undiluted vaccine doses. Unfortunately, 10 undiluted vaccine doses had been administered to patients and were not able to be retrieved. This patient received one of the undiluted doses. The medical team contacted the CDC to determine the potential side effects and observation requirements of receiving an undiluted vaccine. The CDC confirmed that the recipients of the undiluted doses may experience stronger side effects and symptoms than someone who received the diluted dose (sore arm, flu-like symptoms, etc.).  The site public health officer spoke with suspected recipients of the undiluted vaccine to explain potential medical side effects. The Vaccination clinic will follow up to monitor their status.
This spontaneous report was received from a registered nurse and refers to a 5 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-AUG-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N013865 with expiry date 31-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
Red, swollen, itchy injection site about 2 inches in diameter exactly 1 week after taking the vaccine.
severe upper abdominal pain after eating; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in left arm on 19Mar2021 16:00 (Lot Number: EN6202) (at age 52 years old) as single dose for covid-19 immunisation in the student health clinic. Medical history included MS and transverse myelitis, and peanuts allergy. The patient was not pregnant. The patient had no covid prior to vaccination and was not tested post vaccination. Concomitant medications included lamotrigine; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); and ocrelizumab (OCREVUS); all taken for an unspecified indication, start and stop date were not reported. The patient previously received the dose 1 BNT162B2 administered in right arm on 01Mar2021 16:00 (Lot Number: EN6202) (at age 52 years old) for covid-19 immunisation. No other vaccine was given in four weeks. The patient stated that she is not sure if this is related to the vaccine, but it's the only thing she has done differently. The day after her vaccine, on 20Mar2021, she had severe upper abdominal pain after eating. Then on day 2 (21Mar2021), she had another bout of unbearably severe pain (10/10) after eating. She went to ER and had a CT scan & ultrasound. The patient was given IV fluids, pain meds, and antacid. Outcome of the event was recovered with lasting effects.
This case was reported by a pharmacist and described the occurrence of injection site redness in a 37-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 29 September 2013 the subject received a dose of FLULAVAL (unknown details). In 2013, less than one month after vaccination with FLULAVAL (described as "right after vaccination"), the subject experienced injection site redness, injection site warmth and influenza. The pharmacist reported that the subject "became sick with the flu right after the vaccination" with FLULAVAL. At the time of reporting the outcome of the events were unspecified. The pharmacist reported other cases with FLULAVAL. See A1047929A and A1047930A for details on the other cases.