chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with one dose of M-M-R II injection (route, lot # and expiry date was not reported) reconstituted with a sterile diluent (MSD) (dose, route, lot # and expiry date was not reported) for prophylaxis while she was nursing (Breast feeding). No adverse effects were reported. Product quality complaint was not involved.
Broke out large red and swollen rash. Took BENADRYL but symptoms got worse. Went to ER and was given antibiotics and prednisone. Swelling better 10/13/14.
On 05/04/2021 numbness and tingling in my extremities, including my head. On 05/07/2021, the symptoms were pretty consistent for a couple of days. I went ER. I was admitted into the hospital because they wanted to do MRIs, and I was diagnosed with MS on 05/10, I was admitted for 3 or 4 days. On 05/24/2021, I was taken to the hospital by ambulance. My condition erupted pretty abruptly. I thought I was having a stroke, facial droop, slurred speech. I was in a wheelchair and couldn't talk for a week and 1/2. I still have numbness on the right side of my body. A lot of neurological symptoms. I am not sure if the MS is related to the second dose. But I had never had any of these symptoms of numbness or tingling prior to the vaccine. I am taking a medication called gabapentin 300 mg od. I am recovered from the AEs which occurred on 05/24/2021, but MS is life long.
I received the HPV Gardasil vaccine on 06/14/2021 around 1pm and started to have severe symptoms on 06/16/2021 around 2am. The symptoms included severe hives all over my body and face swelling. I was worried my throat was going to close so I went to the ER and they gave me steroids.
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # M019706, expiration date 24-OCT-2017 and lot # M025565, expiration date 06-NOV-2017 (dose was not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Respiratory distress, asthma, fatigue, asthma, tiredness, chronic hypertension 145/110.
pt recv vax;devel a vesicular rash;sibling also recv vax&devel vesicular rash;
Left shoulder pain persisting 6+ weeks past vaccination limiting range of motion and causing pain with movement and at rest only at injection site. Physical therapy exercises have been attempted with suspected post-influenza vaccine subdeltoid bursitis.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: She previously has almost fainted to vaccines a couple years ago per patient. Today after the shingrix she only got a little "peaky" or lightheaded she said and felt immediately better after I gave her some water and she drank it. She said she was totally fine then and left after about 20minutes after the appointment.
After first dose, only soreness in arm.  More adverse reaction after 2nd dose which was on Wednesday, February 9, 2021
Right leg, upper thigh is red, swollen, warm to touch in an area of bout 4-6". Hard to the touch over 3-4". Referred to HC for further eval.
Myalgia CHILLS Narrative:  SIDE EFFECTS LASTED 3 DAYS
Rash on face, arms & legs onset approx 2 hrs /p immun, phone call 28Nov91 from mom to report rash which was still present, no significant T elevation, Referred to MD, 29Jan91 P.C.to mom not related to vax was given topical oint for rash.
REPORTED LEGS WERE HURTING AND TINGLING ON PM OF DAY OF VACCINATION.  NEXT MORNING REPORTED HAVING TROUBLE BREATHING, STATES" FELT I COULDN'T GET ENOUGH AIR IN"
Got sick; Fever; Arm was so sore, couldn't even pick up arm; Arm was so sore, couldn't even pick up arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Dec2020 (Lot number: EK5730) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: Other Conditions: No. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 24Dec2020, outcome "recovered", LIMB DISCOMFORT (non-serious) with onset 24Dec2020, outcome "unknown" and all described as "Arm was so sore, couldn't even pick up arm"; ILLNESS (non-serious), outcome "unknown", described as "Got sick"; PYREXIA (non-serious), outcome "unknown", described as "Fever".  Additional information: There were no any vaccines administered on same date with the Pfizer vaccine considered as suspect. There were no requirement to visit emergency Room or physician Office. There were no prior vaccinations within four weeks to the first administration date of the suspect vaccine. No, only other vaccinations caller has ever gotten were when was a young kid for measles, mumps and rubella. There were no any relevant tests done.   No follow-up attempts are possible. No further information is expected.
First began with headache... the following day, still had headache, around 6:00 PM, body was sore to touch, similar to Fibromyalgia.
Got the flu shot on 01/10/2013 and for the first few days I thought the pain at injection site was normal.  Well, here it is 2 weeks later and I am still having really bad pain and stiffness at injection site. It really hurts to take a shirt off & on and hurts to raise arm, lift it and move it around...  WHY after two weeks the injection site of the Flu Vaccine still very, very sore??
Day following booster Pfizer (10222021) I developed large red itchy rash area around injection site (palm sized+). This in addition to chills and fatigue (mild headaches) as in 1st 2 doses. I called pharmacy following Monday (10/25) and told I would need to report and gave me this website. The itching and redness is now fading and feels nearly gone. Appears to be what is referred to as "Covid Arm" online searches.  Did not have rash to this degree previously (achy injection site) and booster in different arm than 1st 2 doses. Am sure you are not getting all the adverse effects because website so cumbersome for patients
Initial unsolicited report received from a patient on 29-Jun-2017. This case involves a female patient, who was vaccinated with Td (batch number, expiry date, dose, route, site of administartion and dose in series not reported) on an unknown date of 1978. Patient's illness at time of vaccination and pre-existing physician diagnosed allergies birth defects, medical conditions were not reported. Concomitant medications were not reported. On an unknown date, following the vaccination, the patient's arm got red, sore, swollen & itchy. Patient required ER/doctor visit. No lab test done. Corrective treatment was not reported. On an unknown date, patient recovered from events'. Documents held by sender: none.
Patient received Pfizer COVID 19 Vaccine (5-11yr) at 11/19/2021 and 12/27/2021. Patient was eligible for a booster starting 5/27/2022. At the time of the event, only Pfizer COVID 19 vaccines are authorized as boosters for patients under 18 years of age. Patient received an unauthorized Moderna (6m-5y) vaccine as a "booster." No adverse outcomes reported.
After 3 weeks on Mar 19th, he was diagnosed with Bell's Palsy.  He is currently being treated with Prednisone (course completed) and Valtrex (course to complete this weekend).  His left eye is unable to close by itself, his left side of the mouth doesn't fully open.
COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Aug2023 at 12:00 as dose 6 (booster), single (Lot number: GM1767) at the age of 69 years, in left arm for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Known allergies: Yes" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Heart disease" (unspecified if ongoing). Concomitant medications included: ATORVASTATIN, start date: 01Jan2023, stop date: 02Oct2023; BABY ASPIRIN, start date: 01Jan2023, stop date: 03Oct2023; FEXOFENADINE HYDROCHLORIDE, start date: 01Jan2023, stop date: 08Oct2023; MULTIVITAMIN [VITAMINS NOS], start date: 01Jan2023, stop date: 08Oct2023; VALSARTAN HCTZ, start date: 01Jan2023, stop date: 08Oct2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 treatment". Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid (lot number: GF6049) from 04Oct2023 to 08Oct2023.
Itchy site of injection; Red site of injection; Skin temperature at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Skin temperature at site of injection), VACCINATION SITE PRURITUS (Itchy site of injection) and VACCINATION SITE ERYTHEMA (Red site of injection) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013LZ0A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Skin temperature at site of injection). On 07-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy site of injection) and VACCINATION SITE ERYTHEMA (Red site of injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ITCH) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Skin temperature at site of injection), VACCINATION SITE PRURITUS (Itchy site of injection) and VACCINATION SITE ERYTHEMA (Red site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported by the reporter.
Really hurt; Painful rash; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a month after receiving Shingles vaccine, the patient experienced pain and painful rash. On an unknown date, the outcome of the pain and painful rash were unknown.   It was unknown if the reporter considered the pain and painful rash to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. In 2021, the patient had just got the vaccine and it really hurt and felt a painful rash after the vaccination. The reporter also stated that one should get vaccinated before they get the shingles.
The patient experienced localized erythema and edema on the vaccinated thigh beginning approximately 24 hrs after vaccination which began to resolve itself approximately 48 hrs after vaccination.
Information has been received from a registered nurse concerning her 17 year old daughter with no relevant medical history reported who on 11-JUN-2007 was vaccinated intramuscularly with a 0.5 ml dose of Gardasil. There was no concomitant medication. On 11-JUN-2007, the patient fainted and "exhibited seizure like behavior" after receiving Gardasil. The patient sought unspecified medical attention. Subsequently, the patient recovered on 11-JUN-2007. Upon internal review, the patient's convulsion was considered an other important medical event. Additional information has been requested.
FEELING HUNGRY; SLEEPY; FELT REALLY TIRED; FELT NOT HUNGRY; This spontaneous report received from a patient concerned a 71 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy (hay fever), and diabetic, and other pre-existing medical conditions included: Patient had not taken insulin and he was taking BP pill, Cholesterol pill. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. Concomitant medications included metformin for diabetes, and acetylsalicylic acid.  On 03-JUL-2021, the patient experienced felt not hungry. On 03-JUL-2021, the patient experienced felt really tired. On 04-JUL-2021, the patient experienced feeling hungry. On 04-JUL-2021, the patient experienced sleepy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt not hungry, feeling hungry, sleepy, and felt really tired on 05-JUL-2021. This report was non-serious.
Patient had the Zostavax vaccination and woke up the following morning with a little rash at the administration site. We called her today 12/27/16 and it has disappeared.
4 mo old given PCV7 and HIB in left leg and Pediarix in Right leg, 10 mins after injection pt developed a blotchy petechial rash from injection site down to knee on left leg. Petechia were about 3-5mm in diameter. Top of leg only. Mom returned at 4:45PM (4 hrs-4 min later) and child had more petechia to mid calf. Top of leg only. No swelling. Eating/drinking/acting normal.
Given influenza vaccine at PCP 's office (specific information on vaccine administered is not available to me). Administered in left upper arm. Developed erythema and edema of left upper arm on day after vaccine administration -- approximately 1/3 of upper arm area inovlved . Associated with smaller area of induration. Treated in ED with Benadryl and admitted to the hospital for observation. No systemic symptoms; no fever, no hives or other diffuse/generalized rash, no vomiting, no wheezing/cough/difficulty breathing. No facial swelling.  Already improving on admission to the inpatient service approximately 2 hours after administration of Benadryl (1mg/kg/dose IV x1).
Twinrix received 3/17/04 in afternoon. A rxn appeared about midnight of same day. She returned 4:30 PM 3/18/04 to report reaction: swollen knuckles (still visible now), swollen eyelids, blisters on hands, difficulty breathing (lung involvement ; not windpipe). Later her BP dropped "30 units." She almost went to ER , but didn't go. Ate chocolates on 3/17/2004.
REDDENED SWOLLEN AREA ON RIGHT ARM AT SITE OF PNEUMO SHOT
Received shots at 10:30 am-ok until 6:30pm- He was dizzy, nauseous, and had joint pains. 8:30 pm vomiting and then dry heaves. Vision was blurry and he was dizzy. 11 pm he had hallucations, seen in office 4-4-07.
PT WAS GIVEN PEDIARIX IN THE RIGHT THIGH BUT WAS THEN GIVEN HEP B VACCINE IN RIGHT THIGH INSTEAD OF HIB. NO ADVERSE REACTIONS OBSERVED WHILE PATIENT WAS IN OFFICE. MOM NOTIFIED OF EXTRA DOSE OF HEP B AND TO CALL BACK IF SYMPTOMS OR SIDE EFFECTS APPEAR.
arm sore; diarrhea; cold and shaking could not warm up; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sore), HEADACHE (headache), DIARRHOEA (diarrhea) and FEELING COLD (cold and shaking could not warm up) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O38K2OA) for COVID-19 vaccination.     Concomitant products included centroid for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm sore), HEADACHE (headache), DIARRHOEA (diarrhea) and FEELING COLD (cold and shaking could not warm up). On 05-Feb-2021, DIARRHOEA (diarrhea) had resolved. At the time of the report, PAIN IN EXTREMITY (arm sore) had not resolved and HEADACHE (headache) and FEELING COLD (cold and shaking could not warm up) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included : ginger ale, rice and soup, salting crackers, tea, banana and Tylenol
Narrative:  89yo male patient died at Hospital on May 9, 2021 per daugher. Agency notified on Oct 18, 2021. Cause of death not stated. Last agency note 4/26/21 when pt was in Hospital rehab with plans for discharge to Home health on 5/1/2021. No info given on circumstances of pt's death. Pt's problem list: h/o prostate ca - followed by urologist hypothyroidism - HTN - meds being adjusted by private md - a - fib - on coumadin - pmd monitors inr monthly allergic rhinitis - low platelets hx microscopic hematuria - aortic stenosis - private card Pt had received covid vaccines on 1/16/21 & 2/13/2021. This death is likely not related to the vaccinations due to comorbidities, age, and length of time from vaccine administration.
Patient found unresponsive at home. Brought to the emergency room by EMS. Found to be in asystole, cyanotic and GCS = 3. Cardiopulmonary resuscitation initiated and central line placed, but patient remained unresponsive. Patent was pronounced dead at 02:41.
Headache, Myalgia, Fever, Soreness on injection site Narrative:
2/4 Right arm pain about 3 hours after receiving PPSV -23 shot in that arm, "feverish" a few hours later; no redness or bruising at site; 2/10 seen in ER with pain in right shoulder and neck, limited movement and weakness in right arm, and history of intermittent fever; Rx diazepam; referred to orthopedist for possible phys. therapy; Pt. reported ER dx was "reaction to vaccine".
My doctor identified this rare reaction.  All my lymph nodes in my neck and head were inflammed to the point that I couldn't find a comfortable way to carry or lay my head down.  He prescribed Aspirin and Advil alternating as well as rub in Voltaren, Aspirin.  It lasted about 4 weeks with great discomfort and then tapered off.
Day1-After receiving the injection, I could  taste  medicine in my mouth and the tissues in my mouth felt sore.  No other pain except for soreness in arm of injection.  Day 2-After 24 hrs sInce injection, I had a a terrible headache with pain around both eyes and back of the head and neck. I rested due to the fatigue and lack of energy to complete the smallest task.  Body aches and pain every where. Ran fever 2nd night  with sweating.  Day3- No appetite  this morning. Vomiting and diarrhea began around 11:00 am.  Continued with clear liquids and chicken broth to settle my stomach. Fever mostly at night with sweats. Headache is still a problem.  Day 4-low grade temp Day 5?low grade rep with fever during the day Today Day 6-  feeling back to normal
Client was diagnosed, by his PCP, with shingles one week post receipt of ZOSTAVAX.  (Client contacted health dept 1/26/08 via email; then unavailable until 2/13/08 for further contact).
Pt stated she thought her throat closing up because she could not see her uvula in the mirror.  Pt was coughing (she already had a lingering cough), but no complaints about struggling to breath.  She stated she was coughing before she got her shot, and she has hx of asthma.  She has no hx of anaphylaxis to medications/food/vaccine, and gets her flu shot yearly with no reaction.      Pt had no other symptoms, other than her visually not seeing her uvula.  Pharmacist gave pt small dose of benadryl and had pt sit down for another 30 minutes.  After thirty minutes, pt said she could see her uvula and went home.  Rph recommended someone drive her home as she took benadryl, but pt refused and left.
had the vaccination and got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In October 2021, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient's wife. The age at vaccination was not reported. In 2018, the patient had the vaccination and still got shingles. He was suffering for 3 weeks so far and was not much better. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.
Pt called in with bruising appearing in right shoulder, pt was counseled on the ADR and response. pt stated no longer growing
consumer answered yes when asked if they experienced any side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (consumer answered yes when asked if they experienced any side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (consumer answered yes when asked if they experienced any side effects). At the time of the report, VACCINATION COMPLICATION (consumer answered yes when asked if they experienced any side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment medication were reported.
This spontaneous report as received from a consumer refers to her 68 or 69 years old grandfather with bronchitis (experienced recently), hypertension, high cholesterol and prophylaxis. The patient's medical history included angioplasty due to blocked artery in heart and back pain. The patient was vaccinated with a dose of PNEUMOVAX 23 (Lot# and route was not reported) in his arm and tetanus vaccine in opposite arm on 25-OCT-2012. No other co-suspects were reported. Concomitant medications included CRESTOR, lisinopril and ibuprofen (It was also stated there was no concomitant medications). On 26-OCT-2012, the patient developed redness, swelling, and heat at the injection site and started using BENADRYL around the clock every six hours. On 27-OCT-2012, the redness, swelling, and heat was worsened and extended past his elbow. The patient had no laboratory tests performed. As of the time of reporting, the events continued and the reporter would advise her grandfather to contact his physician. Additional information has been requested.
severe chills, severe body aches, headache, loss of sleep night following shot used ibuprofen took several days to be back to normal