chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain right in the middle of the chest; little sharp pain right under breast in the chest; Delayed Reaction; injection site itch; headache; fever; lymph node swelling; fatigue; injection site redness; mild reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (mild reaction), CHEST PAIN (pain right in the middle of the chest), BREAST PAIN (little sharp pain right under breast in the chest), TYPE IV HYPERSENSITIVITY REACTION (Delayed Reaction) and VACCINATION SITE PRURITUS (injection site itch) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION COMPLICATION (mild reaction). On 06-Feb-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (Delayed Reaction), VACCINATION SITE PRURITUS (injection site itch), HEADACHE (headache), PYREXIA (fever), LYMPHADENOPATHY (lymph node swelling), FATIGUE (fatigue) and VACCINATION SITE ERYTHEMA (injection site redness). On 10-Feb-2021, the patient experienced CHEST PAIN (pain right in the middle of the chest) and BREAST PAIN (little sharp pain right under breast in the chest). On 03-Feb-2021, VACCINATION COMPLICATION (mild reaction) had resolved. On 16-Feb-2021, TYPE IV HYPERSENSITIVITY REACTION (Delayed Reaction), VACCINATION SITE PRURITUS (injection site itch), HEADACHE (headache), PYREXIA (fever), LYMPHADENOPATHY (lymph node swelling) and VACCINATION SITE ERYTHEMA (injection site redness) had resolved. On 21-Feb-2021, FATIGUE (fatigue) had resolved. At the time of the report, CHEST PAIN (pain right in the middle of the chest) and BREAST PAIN (little sharp pain right under breast in the chest) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was not provided.
Covid vaccine was >24 hrs from reconstitution and at room temperature when given.  Provider and parents made aware.  Plan to schedule additional dose.  No adverse reaction noted.
Pt. felt flushing of her face, felt things were blurry. Her arms were red. She felt like her heart was racing and had severe pain down her spine. Tx was injection of diphenhydramine, monitoring vitals. Pt. felt better soon & was able to leave.
2 doses by the end of 2021, shingles in summer 2022/suspected vaccination failure; Shingles/ then patient had shingles in summer 2022; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had been having shingles outbreaks every year since 2013).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 23-Jan-2023 Reporter's comment: The patient reported that she received Shingrix vaccine 2 dose series by the end of 2021 and then had shingles in summer 2022. The patient denied to provide any other information or follow up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
This case was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMERIX. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced joint pain and swelling, fatigue, memory loss, tingling in extremities, headaches, visual problems, speech problems, cognitive problems, sleep difficulties, teeth and gum problems, decreased activities of daily life, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all reportedly caused by vaccination with LYMERIX. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Very limited follow-up information was received on 26 October 2006. Follow-up indicated that the subject received LYMERIX twice in early 2000. Polyarthralgias were noted and a history of alcohol abuse. Follow-up information was received on 08 January 2009 via an interview between the subject and attorney(s). The subject received LYMERIX on 04 October 1999 and 28 October 1999. On the same day that he received each dose of LYMERIX, he developed arm soreness which resolved after approximately two weeks. A "couple of months" after the second dose of LYMERIX, he developed joint and muscle pain, fatigue, tingling, and sleep disturbance. In 2000 he developed memory loss and stuttering. In 2000 or 2001 he developed "sweating in bed". In 2001 he developed teeth grinding. In 2005 he developed headaches. In 2006 or 2007, he experienced "writing problems" described as his handwriting becoming progressively worse, and also reported difficulty using tools with his hands. Treatment included ADVIL and other unspecified medications including pain medications. With the exception of arm soreness, the events were unresolved at the time of reporting. The event of difficulty writing was assessed by GSK to be medically significant.
Pt developed left lower lip paresthesia that radiated to L side of face.; Pt developed left lower lip paresthesia that radiated to L side of face.; This is a spontaneous report from a non-contactable pharmacist. A 75-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), intramuscular on 26Jan2021 at 10:00 at a single dose for covid-19 immunisation.  Medical history included transient ischaemic attack (TIA), stroke and chronic kidney disease (CKD) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took gabapentin for facial nerve pain. The patient developed left lower lip paresthesia that radiated to the left (L) side of face on 26Jan2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Vaccine was given by 3:00 pm. By 5:00 pm, soreness was felt in left arm. By the evening, arm was severely sore- painful to lift higher than chest level, extremely tender to the touch as even a shirt brushing up against it was painful. After going to sleep feeling a bit lethargic, I woke up around 2:00 am feeling nauseous with the chills. I woke again a couple of hours later in a full sweat. Through the day, my temperature increased and remained around 101-102 degrees. I took Tylenol. By the evening, the Tylenol didn?t seem to have an effect - I had no energy, a fever of 102.7, and was achy. By the following morning, my fever had broken and I was feeling much better.
10 MINUTES AFTER RECEIVING VACCINES, PT STATES THAT HE IS HAVING DIFFICULTY BREATHING. PTS FACE BECAME VERY RED AND EYES BLOOD SHOT, APPEARS TO BE IN DISTRESS. PTS 02 SATS 90% ON ROOM AIR WITH COARSE BREATH SOUNDS THROUGH OUT. PT STARTED ON OXYGEN WHERE SATS ROSE TO 98%, AMBULANCE CALLED AND PT TRANSFERED BY AMBULANCE TO HOSPITAL.
Extreme brain fog, migraines, memory loss, fatigue, nausea, depression, anxiety, large softball size injection site. Tingling down forearm and into fingers . Sharp stabbing pain in back left side, just off of spine. Irritability, wanting sleep but having trouble sleeping.
Received MMR, VARIVAX, and PREVNAR on 2/24.  That night had episode where child stopped breathing for 15-20 sec., eye rolled back, went limp, and had perioral cyanosis.  Question between breath holding spell or seizure activity.  Possible related to vaccine administration. 4/6/09-records received-office visit 2/24/09-well visit. ED visit 2/25/09-crying after bath held breath while crying, limp. Assessment:possible breath holding spell vs seizure night prior. 3/9/09-rash times 4 weeks. Assessment:eczema.
I had a upper arm pain two days after the vaccination.  I then developed severe arm pain at the injection site when I became ill with cold like symptoms on  8/15/21. The arm pain has intensified at the site and remains sore despite the resolution of illness. There has been no inujury to the arm.
Long event of bruising/ bruises that do not hurt; Big purple spots; This is a spontaneous report from a contactable pharmacist, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration on an unknown date and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3249) via an unspecified route of administration in the left arm on 16Jan2021 as a single dose for COVID-19 immunisation. The patient had no relevant medical history. 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 vaccination. Concomitant medications were not reported. The patient had no known allergies. On an unknown date in 2021, the patient experienced long event of bruising and bruises that did not hurt and caused big purple spots and lasted for days. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were  taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events long event of bruising/ bruises that do not hurt and big purple spots were resolved on an unknown date in 2021.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID-19; COVID-19; This is a literature report for the following literature source(s)  This study involved  individuals aged hospitalized for laboratory-confirmed COVID-19 and a control group of adolescents hospitalized for other causes between June and September 2021. Six vaccinated patients were hospitalized for COVID-19, and none were admitted to the intensive care unit (ICU) or died. It excluded partially vaccinated individuals. A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: vaccination failure (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 2021, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: laboratory-confirmed COVID-19: (2021) positive.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2 vaccine in this patient cannot be completely excluded, Linked Report(s) : US-PFIZER INC-202101695462 Same article/ drug/event and different patient
Severe pain and inflammation in right eye starting on 4/15/2021 @ 3:30am. Condition worsened followed by blurred vision. Went to my eye doctor on 4/26/2021 who diagnosed condition as Panuveitis. My eye doctor prescribed Prednisolone AC 1% Eye Drops (1 drop into right eye four times daily). Treatment with Prednisolone eye drops is current with moderate improvement. I continue to have intermittent pain with blurred vision as of this writing.
new thing is a burning smell that has continued; headache; fever; severe body aches; couldn't open eyes; couldn't move; Very sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): MOD21-157214 (Moderna).  A 59-year-old female patient received bnt162b2 (BNT162B2), administration date 10Apr2021 (Batch/Lot number: unknown) at the age of 59 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 20Mar2021, when the patient was 59 years old, for COVID-19 Vaccination. The following information was reported: HEADACHE (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "headache"; PYREXIA (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "fever"; PAIN (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "severe body aches"; EYE DISORDER (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "couldn't open eyes"; MOVEMENT DISORDER (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "couldn't move"; ILLNESS (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "Very sick"; PAROSMIA (non-serious), outcome "unknown", described as "new thing is a burning smell that has continued".  Additional information: Patient reporting her experiences after receiving the Moderna Covid-19 Booster dose (lot # 076C21A) on 220ct2021. She received Pfizer for both doses of her primary series of the Covid-19 vaccine. Starting 12 hours after her moderna booster dose she became very sick with headache, fever, severe body aches, couldn't open her eyes, or couldn't move. These symptoms lasted about 48 hours. This was all Just like the last time she received a dose of Pfizer on 10Apr2021 but more severe. The new thing Is a burning smell that has continued. She wants to know why that happened & is it normal. Consent granted for follow-up by the Safety Team with her and the vaccination facility. She does not have her doctor's & information currently. Email is the preferred method of contact. Abstract No abstract has been assigned to this case. The patient wants to know why that happened & is it normal. Patient reporting her experiences after receiving the Modema Covid-19 Booster dose. Life Threatening: No, Disabling/lncapacitating: No, Intervention/Medically Important: No, Congenital Anomaly/Birth Defect: No, Death: No, Hospitalization Required: No, Hospitalization Prolonged: No, Other: No, Product Complaint: There is no product complaint associated with this case.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Her pulse was high 178 and her Blood pressure was 168/112, heart palpitations  fever of 101.8 all this maintained for well over a day. she could not sleep from the pain she had in her neck, and whole left arm, she also became very anxious from all this. this all started within 6 hours of receiving the vaccination. I called the online emergency number for the doctors office where they told me that these symptoms could be one of the rare side effects and that I should not be worried but if it continued past 3 days then take her into ER. we was up all night because her heart was beating so fast and fluttering
I received the vaccine and then a week later could not role over in bed.  A visit to the doctor revealed an extreme inflammatory response, diagnosed as PMR.  Unknown as to whether the vaccine was the cause, the Rheumatologist treated accordingly with heavy rounds of prednisone.  My inflammation was brought back to normal by summer.  By September, I was in remission.  I decided to get the second vaccine.  I reacted the same way as I did to the first - confirming that there was a connection between the vaccine and the onset of PMR.    I am afraid to get the booster.  I am slowly working my way to normal inflammation once again.  I have been treated by a rheumatologist and have monthly blood work done to track my progress.
I wasn't feeling good and went to the doctor on the 4th. She gave me Lisinopril 10 mg for High Blood Pressure. I've had other issues in the past with off and on High Blood Pressure. But not as high as this, 150/100. On the 5th, 169/11, blood pressure reading midday. My Blood Pressure it's still high. In the late evenings it's down to closer to where it should be but when I wake up it's high again. I'm feeling better though. I did have a flu shot around 10/1/2021. I had it at the local pharmacy.
VACCINE HIT LIKE A SACK OF BRICKS; MIGRAINE; JOINTS DID NOT SUPPORT HAD TO WAIT 30 MINUTES BEFORE STAND AFTER WOKE UP BECAUSE OF KNEES AND FEET; JOINT PAIN FELT LIKE 40 YEARS OLDER FOR A DAY; EXTREMELY TIRED; FEVER; This spontaneous report received from a patient via a company representative 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, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced vaccine hit like a sack of bricks, migraine, joints did not support had to wait 30 minutes before stand after woke up because of knees and feet, joint pain felt like 40 years older for a day, extremely tired, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine hit like a sack of bricks, fever, migraine, extremely tired, joint pain felt like 40 years older for a day and joints did not support had to wait 30 minutes before stand after woke up because of knees and feet was not reported. This report was non-serious.
1st dose 2 or 3 years ago, 2nd not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose on an unknown date, 2 or 3 years before date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 16-NOV-2022 Reporter's comments:  Pharmacist reported on 16th November 2022 that, female patient received the first dose of Shingrix 2 or 3 years ago (not exact date provided) and the second dose had not been administered yet.  The reporter asked whether they should restart the series. The reporter did not consent to follow-up. The Vaccine Administration Facility was the same as Primary Reporter. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Patient inadvertently given her booster dose at 10 weeks post 2nd shot, instead of 6 months after 2nd dose.  Patient did not experience any reactions to the booster dose given early.  Spoke with patient.   Alerted Medical Director who had no concerns.
Pt had a sudden severe escalation in hepatic and renal function testing within 1wk of receiving vaccine dose #1.
chills; terrible aches and pains; Headache; 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.  An adult female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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: CHILLS (non-serious), outcome "recovered"; PAIN (non-serious), outcome "recovered", described as "terrible aches and pains"; HEADACHE (non-serious), outcome "unknown". Therapeutic measures were taken as a result of chills, pain.  Additional Information: Caller stated that she was pleased to report her side effect that lasted for less than 48 hours. Caller added that the patient had shot on, guess Thursday, and by Saturday was okay actually. Patient never took temperature but had chills, but the patient had terrible aches and pains, but they all vanished. Caller mentioned "Two other people that had very similar side effects just like her, the patient had all the other shots and never had any reaction. That was the first time to have a reaction. The patient never had any reaction and that was the first one to  have a reaction to but that seemed to be common among the elderly. Two friends of mine reported the same thing and they never had the same response like that before. So the patient did not knowthat are they supposed to take Tylenol afterwards, patient did take Tylenol and maybe that helped." Caller said that she had side effects after taking the covid vaccine. Caller did not attempt to take temperature but experienced chills and a headache. Caller would like to know how long  she would be having the side effects and she wanted to know if she could take aspirin. Caller did not attempt to take temperature but experienced chills and a headache.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
What happened was I drew up the wrong vaccine, but didn't realize til I was documenting later. I knew that I had drawn up the 12+ but miscalculated her birth year and realized that she was 11 afterwards. I went straight to patient's PCP and informed her of my mistake, and patient was still in clinic so provider went in and explained what happened to mom. Doctor told me afterwards that there would be no adverse effects on the patient's health, that her elevated BMI would likely be a contributing factor in being able to tolerate the larger dose just fine.
rash on chest and back less than 48 hours after vaccine, same with the second dose prior, rash is worse, chest pain, swollen lymph node on left armpit
Felt pain/achiness in my left ribs, which I thought were normal symptoms post-vaccine. But the pain kept lingering for several days. And 3 days later, on Tuesday April 27th I suddenly felt itching on my back. When I checked in the mirror I had a rash that stretched from my stomach to my spine along my left side. It was faint, but looked like shingles (which I had a very minor case of in college). I immediately contacted my doctor, who told me the symptoms sounded like shingles and prescribed me Valacyclovir. The next day the rash started to blister and continued to get worse. As of today the blisters have scabbed over, and in addition to the itching I'm still feeling the pain in my ribs that I felt immediately after the vaccine.
Burning face and ears initially then face was itchy and woke up on 3/17/21 with swollen face and fingers.