chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, injection site swelling and injection site cellulitis. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site swelling and injection site cellulitis were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site pain, injection site swelling and injection site cellulitis to be related to SHINGRIX.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. After vaccination, the patient experienced injection site reactions consistent with cellulitis, such as pain, redness and swelling. The reporter was not certain that this case confirmed with cellulitis, but the events were resolved spontaneously. The pharmacist reported the all events to VAERs. The call center representative advised to reporter, called to GlaxoSmithKline if had any future events. This is one of the 13 cases reported by same reporter.
Patient reported to pharmacy that injection site is red, warm, and itchy. "Seems to be getting better." Advised patient to take Benadryl and inform primary physician to see if follow-up is needed.
He was fine with the first dose of the vaccine. With the second dose he had high fevers that didn?t respond to Tylenol. The vaccine brought on PFAPA symptoms starting from 01/07 to 01/13. I took him to the doctor on 1/11 because symptoms were not improving. Fevers were as high as 103.7 and only got better with an ice pack that we consistently had to apply. Lymph nodes were extremely swollen, he complained of neck pain, tonsils were more inflamed than they usually get with a PFAPA episode. Very tired, nausea, and hardly ate. At the doctor they told us to give him Motrin and that helped but it didn?t complete get rid of the fevers until 01/14 he did wake up sweating and no more fevers. After this his PFAPA episodes have lasted longer than they used to. It takes him longer to recover and doesn?t look well. He doesn?t seem the same.
Pt was given tetanus instead of TB for a TB shot. Area measured induration on 6/19/03. Vaccine ? Td. (+) skin rxn to SQ ? of Td. Area of erythema/induration (-) abscess.
On the day after the second dose of the Covid-19 Moderna vaccine, I experienced chest pressure and pain and as a result went to the emergency room. At the hospital, I was diagnosed with myocarditis and pericarditis which the cardiologist established as being caused by the vaccine.  I stayed in the hospital for two days and then returned home, although I was extremely fatigued for several weeks following the event. For about half a year I stayed on medication intended to aid recovery, specifically colchicine, carvedilol and lisinopril, and this was also roughly the timeframe during which I still had reoccurring symptoms (chest pain, pressure and discomfort). After this time period I have been mostly recovered with only occasional flareups.  In addition to the medical outcomes, I have also experienced financial difficulties as a result of the event - more specifically, the hospital charges ended up at somewhat over $18,000 and neither the hospital nor the insurance company has been willing to bill this as a Covid-19-related issue since it was caused by the Covid-19 vaccine and not Covid-19 itself, making it impossible for me to have the expense covered by the systems in place to aid in Covid-19-related expenses.
Broke out in rash all over trunk 12 days after patient received HIB, PCV, MMR, Varicella. Instructed to give toddler Benadryl-appropriate dose.
7 days after receiving 1st covid vaccination (Moderna) start of rash on left arm about 2 inches below injection site.  Rash spread to most  of upper arm.  Went to Urgent Care and was diagnosed with COVID-Arm - (cutaneous hypersensitivity) -they provided an intravenous antibiotic drip with a light steroid. Rash has continued but is slightly lighter....no pain or itching.  Reporting this on 10th day of having rash.
patient received her first GARDASIL9 on an unspecified date in February 2020/the patient is at the pharrnacy today, 06/10/2020, to receive her second dose of GARDASIL9; This spontaneous report as received from a pharmacist refers to a 22-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date in February 2020, the patient was vaccinated with the firs dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 10-JUN-2020, the patient was at a pharmacy to get her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. It was unknown if the patient received her second dose of the vaccine.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 31-year-old male patient received BNT162b2 (BNT162B2), on 22Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 31 years for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, Covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Bone Aches; weakness\ want's to stand and don't have the strength to do it; feels like drugged/laying in bed; Chills; Body aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bone Aches), ASTHENIA (weakness\ want's to stand and don't have the strength to do it), FEELING ABNORMAL (feels like drugged/laying in bed), CHILLS (Chills) and MYALGIA (Body aches) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history was reported.).   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced BONE PAIN (Bone Aches), ASTHENIA (weakness\ want's to stand and don't have the strength to do it), FEELING ABNORMAL (feels like drugged/laying in bed), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Headache). At the time of the report, BONE PAIN (Bone Aches), ASTHENIA (weakness\ want's to stand and don't have the strength to do it), FEELING ABNORMAL (feels like drugged/laying in bed), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Headache) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Significant: Outcome of event provided
Bruising Swelling at injection site Swelling on same arm Fatigue Muscle aches Fever
01/17/2022 morning my Covid symptoms started. I had clear mucous, a cough, and it felt like the sinusitis I always get. I had no fever or body aches. I went to fairgrounds that day and tested thinking it would be negative but it came back positive. It is very mild.
pt recvd vax & 2 wks later pt began to exp discomfort @ inj site; There was no redness, induration, or swelling noted; The discomfort lasted for approx 2 wks, then began to abate;
Patient was called to schedule 2nd dose of Moderna.  Patient reports "about 6 days after my COVID shot, I had about a 4" in diameter selling, reddness and hives to the outside of my arm.  This is the arm I got my shot in".  Reports did not show any health care provider, did not seek medical attention, did not require use of OTC or Rx meds.  Complete resolution of symptoms 4 days later.
Since receiving all of those vaccines 2.7.23  at once and never having one prior patient has been experiencing phantom pains where she will scream that her arm,leg,stomach is hurting her . This lasts for about a minute and then she stops screaming.  2.17.23 - present patient is covered in a bumpy itchy red rash from her head to her toes.
Injection was given into Left lower shoulder above deltoid. Shoulder joint became extremely painful. Shoulder is painful to touch. I have limited range of motion in the left arm related to weakness and pain. Pain is constant with a burning sensation and sharp with movement of arm. I am unable to lift anything with the left arm.
Information has been received from a medical assistant referring to a 6 month old male patient. No relevant medical history or concurrent conditions were reported. On 18-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Breathing became labored, hard to catch breath, pressure lasted for about 3 hours  This is the same symptoms I had before I found out I was allergic to gluten
Got shot on 10/3/16. By 10/5/16 PM started having fever, sore throat chills, cough, body aches. Was unable to sleep all night due to cough. On  10/6 morning, sore throat worse, laryngitis, loss of voice, low grade fever and body ache had worsened. Fever gone by 10/8/16 but still symptoms of cough, hoarseness in voice, headache and body ache continue. Reporting on 10/13. Has taken flu shots every year with no reaction.
PATIENT REPORTED SEVERE NAUSEA, VOMITTING, DIARRHEA, AND FEVER BEGINNING 2 DAYS AFTER RECEIVING VACCINE.
The second the shot was administered there was intense pain at the injection site on the left shoulder but no redness or swelling. Immediately after completion the pain traveled down my arm, quickly spreading up my neck to part of the my face and down my left leg. The pain stayed localized to left side, the side of the injection. It was a gnawing, near-tingling-but-not-quite sensation. Within a 2 minutes I was feeling woozy. Within 5 I began to grey out while sitting, quickly plunging my head below my heart. A nurse provided a soda. It kept the passing out at bay. I then sat for close to an hour slowly, barely resolving to a point where upon they could draw blood. About an hour after the injection I was slightly improved from a fainting spell, but hardly. My vein blew when they were going to draw blood (I was already in a lying position). They decided against the blood draw. I laid there possibly for 15 minutes, was move to a sitting position. 2 hours + after injection I was still light headed, slightly weak, and still experiencing left side pain, fatigue, slight numbness. 3 hours after I ate a meal comprised of eggs and toast, immediately feeling lethargic and increasingly fatigued. I ended up napping on and off for 2 hours before forcing myself to get up and call a medical professional. At 7 pm, an hour after waking, my legs were heavy and shaky, I remain lightheaded, weak as ever. Left side heaviness had increased. Drove to ER. Was administered Benadryl and steroids nearly 10 hours after initial injection. Shook furiously from the Benadryl. Saw no real change in symptoms, although leg heaviness slightly slightly decreased. Was sent home after a clear CT scan and was in a weakened state for nearly 6 days, unable to work. It is now the 7th day from injection and still not 100% and only some minor improvements. Now beginning to experience joint pain in both sides of body-arms, legs, back, neck. Still have lighthead spells and an overall 'humming to my body almost like one has when experiencing a fever. No recorded fever as of yet. Left side weakness has severely decreased but am still experiencing random points of intermittent tingling and bouts of nerve burning sensations.
heart stopped/collapsed; slipped and fell with fractured hips; very weak; slipped and fell with fractured hips; This spontaneous case was reported by a patient and describes the occurrence of CIRCULATORY COLLAPSE (heart stopped/collapsed), HIP FRACTURE (slipped and fell with fractured hips), ASTHENIA (very weak) and FALL (slipped and fell with fractured hips) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included Kidney transplant, Dialysis since an unknown date and Pacemaker insertion (cardiac). Concurrent medical conditions included Fistula (Patient had fistula in arm for dialysis).    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced CIRCULATORY COLLAPSE (heart stopped/collapsed) (seriousness criteria hospitalization and medically significant), HIP FRACTURE (slipped and fell with fractured hips) (seriousness criteria hospitalization and medically significant), ASTHENIA (very weak) (seriousness criterion hospitalization) and FALL (slipped and fell with fractured hips) (seriousness criterion hospitalization). The patient was hospitalized on 30-Jan-2021 due to ASTHENIA, CIRCULATORY COLLAPSE, FALL and HIP FRACTURE. The patient was treated with Surgery (Pacemaker) for Circulatory collapse. At the time of the report, CIRCULATORY COLLAPSE (heart stopped/collapsed), HIP FRACTURE (slipped and fell with fractured hips), ASTHENIA (very weak) and FALL (slipped and fell with fractured hips) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2021, Heart rate: abnormal (abnormal) abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information not provided. Company Comment: Based on the current available information and temporal association between the use of the product mRNA-1273 and the start date of the serious unexpected event of Circulatory collapse, a causal relationship cannot be excluded. The remaining serious unexpected events of Hip fracture, Fall and Asthenia were more consistent with the possible complications secondary to circulatory collapse complicated by advanced age.; Sender's Comments: Based on the current available information and temporal association between the use of the product mRNA-1273 and the start date of the serious unexpected event of Circulatory collapse, a causal relationship cannot be excluded. The remaining serious unexpected events of Hip fracture, Fall and Asthenia were more consistent with the possible complications secondary to circulatory collapse complicated by advanced age.
On March 27, 2021 at 11:30pm started to not feel well, went to sleep woke up on and off through the night with chills, on march 28th felt nauseous on and off throughout the day, also had a slight fever of 101°F took tylenol and it helped
60 yo woman who 3-5 minutes post vaccination developed facial itching and erythema, initially in her eyes and nose. Administered 50 mg diphenhydramine PO. In the minutes thereafter, the pruritis  spread to the upper lip, then face and scalp, and became more generalized (but mild) on limbs.  She also reported a "dry throat" sensation, but denies throat tightness or itching and did not have any respiratory compromise for the hour that she remained under observation. Symptoms subsided and patient left the facility. Followed up with her later by phone to inform her that her immediate allergic reaction was a contraindication to her receiving the second Pfizer COVID-19 vaccine and that she should not return for a second appointment. Advised that she seek allergist consultation given her history of multiple allergies, and to determine whether there was a common substrate for any of them. Said that she could possibly consider the Johnson&Johnson vaccine thereafter, if she did not have any known allergies to components of it.
10/3/14 - noon - rec shot. 10/4/14 - pt woke up with severe flu like sx (HA and increased fever) and inj site swelling/hot/tender size about 1/2 dollar. 10/5/14 Flu sx a little better - arm had halo around site and was getting bigger. 10/6/14 - flu sx gone - saw Dr - Dx cellulitis - Rx KEFLEX - area on arm getting larger. 10/9/14 saw Dr - Didn't think it was cellulitis but advised pt to finish KEFLEX. Felt it was a very bad rxn to the vaccine and would take "a while" to go away. 10/11/14 - lightened up in color and has not shrinking in size - now like a bulls eye and still tender. Is in process of recovering.
The immunizations were given at approximately 12:23 pm. The patient states he started having weakness, shaking, difficulty breathing, and fever later that night. As of the next morning 09/16/2023 the patient had not yet seeked medical treatment.
Pt seen in EC approximately 24 hours after onset of symptoms complaining of itchy rash spreading to arms, face, chest, and knees.  Assessed by provider and given rx's for Medrol dosepack and Atarax and instructed to be seen in primary care clinic the next day for follow up.  Primary care clinic saw pt and noted that the pt complained that the itching had increased and there was swelling of the ears and elbows.  A same day consult with dermatology clinic was obtained since there was concern that the pt was due to transfer in a few days abroad.  Dermatologist stated that pt had a diffuse, erythematous, maculopapular, morbilliform rash of face, ears, neck, chest, back and all 4 extremities.  She also assessed the smallpox inoculation site and stated the reaction was normal.  Patient had a biopsy performed in office and was then admitted to hospital with isolation and respiratory cautions for continued observation of rash.  Biopsy results are consistent with non-specific drug reaction.  Pt was discharged from hospital.
Client received the 2nd dose of Moderna COVID vaccine lot #026C21A and expiration date 7/11/21 at approximately 3:57PM.  Client arrives to the vaccine observation room and reports feeling dizziness to EMT. Client is provided with a water bottle and drinks some.  Client reports having eaten an hour ago. EMT takes vitals: blood pressure 140/98, heart rate 76 and oxygen: 97%. PHN arrives to assess client.  Client is upright in chair alert and oriented x 4.  Client denies chest pain, blurred vision, headache or difficulty breathing. Client reports having a history of high blood pressure and takes aspirin, metropolol and two other anti-hypertensive medications but she cannot remember their names. Client reports no history of allergies.  At 4:03pm client reports feeling sweaty, no sweat is visible and that dizziness has resolved.  At 4:07pm vitals: blood pressure:140/92, pulse:73, and oxygen:96%.  PHN notes rash on chest and offers client Benadryl. Client declines Benadryl. PHN calls another PHN over to discuss Benadryl with client. Upon arrival PHN notes rash on right side of neck and chest. Client denies itchiness, shortness of breath or feeling throat closing. Client explains she needs to drive her children and does not want to be drowsy and will be unable to get home.  Client reports no shortness of breath and only feels sweaty. At 4:10pm client is still feeling sweaty but no sweat is visible.   At 4:12pm client reports no dizziness, no chest pain and no other symptoms except for mild sweating, not visible.  At 4:15pm client reports sweatiness is resolving and PHN check rash and does not observe any spread.  Client reports it is not itchy and is not having any difficult swallowing or breathing.  At 4:18pm vitals: blood pressure:140/90, pulse:78, and oxygen:97%.  Client reports no chest pain, no shortness of breath, no dizziness, no difficulty breathing, no blurred vision,  and no headache. Client is alert and oriented x 4.  At 4:21pm client reports sweating has completely resolved. At 4:23pm vitals: blood pressure:140/90, pulse:83, and oxygen:98%.  Client reports no symptoms. At 4:30pm vitals: blood pressure 138/92, pulse:83, and oxygen:97%. Client reports no chest pain, no headache, no trouble breathing, no other symptoms. At 4:35pm, vitals: blood pressure:148/98 and pulse:80 and oxygen: 98%. No symptoms reported, assessed for hypertensive crisis.  At 4:42pm,reassess blood pressure:150/90 and client reports no shortness of breath, no chest pain. PHN provided ER precautions and advised client see PCP about rash. Client completed 30 minute observation and rash still noted on chest and neck. Client reports no difficulty breathing and that she "feels fine to drive."  Client left facility at 4:46pm walking out with a steady gait, unassisted.
Medication error-  MMRV inadvertently given instead of MMR, resulting in 2 doses of varicella being given on same day.
Admit for COVID and respiratory failure after exposure to daughter, and concern for bacterial infection. Fully vaccinated. Placed on HFNC, steroids, tocilizumab, vanc, azithro, cefepime, rocephin, flagyl, zinc. Eventual progression to vent support. Extubated 1/22 then reintubated 2/6 after sudden deterioration. Profound shock. Expired on ventilator. Patient remained intubated and sedated, stayed on 2 pressors at low doses, palliative care involved and patient was made DNR. On 2/9 in the afternoon, patient went into Vtach and passed away
Received 1st Moderna Vaccine on 1/6/21.  On 1/21, started experiencing symptoms of UTI, received meds from GYN.  Symptoms subsided until 1/22 when began experiencing significant abdominal pain, which later subsided.  On 1/25 pain returned and she went to the ED and was diagnosed with a large kidney stone blocked in the ureter.  Ablation was performed on 1./26.  Discovered that kidney stones are rare complication of vaccine.  no prior of family history of kidney stones.
felt some pain higher up in the shoulder area; This is a spontaneous report from a contactable other health care professional received via sponsored program Support. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, on 22Jul2021 as dose 2, single for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number unknown, via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunization. On 22Jul2021, the patient believed that vaccine was administered too high and into the shoulder joint instead of the deltoid muscle because she felt some pain higher up in the shoulder area. It was reported that pharmacy intern would be calling to see how to proceed and if the second dose needs to be repeated or not. The outcome of the events was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.