chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Multiple small red blisters on her left arm from the shoulder to her elbow. Mom voice that it was warm at touch and itching. No fever present. Parent did not bring her to the clinic to be check they gave her Benadryl for a week orally and topic (cream) the rash last little over a week.
injection site pain; shoulder pain; flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd September 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 2nd September 2022, less than a day after receiving Shingrix, the patient experienced injection site pain, shoulder pain and influenza-like symptoms. On an unknown date, the outcome of the injection site pain, shoulder pain and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the injection site pain, shoulder pain and influenza-like symptoms to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-SEP-2022 Reporter's Comments: The reporter was the patient. The patient received her second dose of Shingrix on 2nd September 2022. That day she experienced pain at the injection site and shoulder. She also had flu-like symptoms. She had nothing else to report. She declined to provide HCP information as she did not see her doctor. The reporter was consented to follow up. Additional Supportive Information: This was 1 of 2 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022131429:Same reporter
Rash and itching at injection site. There was a hard lump area under the skin as well. Patient also said the skin felt warm.
Patient with increased dystonia events -- up to >100/day. Some with laryngospasm and noted desaturation into 70s. Prior to injection, patient was having 2-5 episodes/day. Started noticing increased frequency of dystonia within 30 minutes of getting the vaccine.  Patient with intermittent malaise, fevers.
1 hour after Hep-B was given, pt developed hives on the injection site and then spreading systemically to upper trunk. Treated with Benadryl injection the next day. Pt oriented and no apparent distress.
Patient contracted COVID after being fully vaccinated. Loss of taste, loss of smell, congestion, sore throat, dyspnea, cough, nausea, muscle aches, fatigue
Localized reaction--bright red, swollen, hot to touch, sore--approximately 4"x2.5". Increase in size for 36 hours after injection.
Fatigue; redness on the injection site; itchiness on the injection site; Blisters on her hands; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Blisters on her hands), FATIGUE (Fatigue), VACCINATION SITE ERYTHEMA (redness on the injection site) and VACCINATION SITE PRURITUS (itchiness on the injection site) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced BLISTER (Blisters on her hands) (seriousness criterion disability), VACCINATION SITE ERYTHEMA (redness on the injection site) (seriousness criterion disability) and VACCINATION SITE PRURITUS (itchiness on the injection site) (seriousness criterion disability). On an unknown date, the patient experienced FATIGUE (Fatigue) (seriousness criterion disability). At the time of the report, BLISTER (Blisters on her hands), FATIGUE (Fatigue), VACCINATION SITE ERYTHEMA (redness on the injection site) and VACCINATION SITE PRURITUS (itchiness on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Treatment information was not provided.  Patient received  the 1st dose of the Moderna Covid-19 vaccine at a local pharmacy.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-273456 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Swelling, redness, pain at local site (right deltoid) and regional area (chest and trapezius) area, headache.
fever 100.5; chills; fatigue; headache; nausea; This is a spontaneous report from a contactable Other Health Professional (patient). A 59-year-old female patient (who was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE; Lot Number: EL3246), via an unspecified route of administration, in the arm right on 25Jan2021 at 07:00 (at the age of 59-years-old) as a single dose for COVID-19 immunization, at hospital. Medical history was not reported. Patient received unspecified concomitant medications (within 2 weeks of vaccination). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration in the right arm on 07Jan2021 at unknown time (at the age of 59-years-old) as a single dose for COVID-19 immunization. The patient did not have allergies to medications, food or other products. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Reportedly, patient was not diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination. On 25Jan2021, the patient experienced fever 100.5, chills, fatigue, headache and nausea. The patient did not receive any treatment for the adverse events. The clinical outcome for the reactions fever 100.5, chills, fatigue, headache and nausea was reported as recovered/resolved in 2021.
Sore arm that subsided after 2 days. But after 1 week, suddenly developed a red, swollen lump at the injection site.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 90-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "chronic UTIs" (unspecified if ongoing); "Bladder Disorder" (unspecified if ongoing); "Thyroid Disorder" (unspecified if ongoing); "Osteroporosis" (unspecified if ongoing); "Sleep Apnea" (unspecified if ongoing). The patient has no know allergies.  Patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative and 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.
Presented with currant-jelly stool and lethargy and abdominal pain on 5/29/08- Found to have intussusception, Treated with Barium Enema at clinic.  6/12/2008 MR received for DOS 5/29-30/2008 with DX: Intussusception S/P reduction with Barium Enema.  Infant presented to ER from PCP's office with vomiting, bloody diarrhea and currant jelly stool. Infant fussy. IS reduced with BE. No further problems and D/C next day.
Subject states she had no symptoms until about a week after vaccine.  Symptoms include red, itchy rash on bilateral arms, legs and feet.  Was seen by a practitioner and given steroid cream and Benadryl for treatment.  As of reporting date subject still has rash.
The morning of 09/19/2022, I was in the waiting room of my gastroenterologist when I began to experience acute abdominal pain. I had some diagnostics done that morning where they discovered appendicitis. I was checked into the hospital by 05:00PM and was in surgery by 11:00PM that evening for an appendectomy surgery. It took about 8 weeks for me to recover from surgery.
Received vaccine at 6:30 pm on 12-17-08. Severe vomiting began at 2:30am with fever. Vomiting continued til 9am.
h/a (worsened p/vax);paresthesia of RUE (onset 1hr p/vax);
This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. The patient's medical history and concurrent conidtions were not reported. Concomitant therapies included STERILE DILUENT. On 19-JUN-2017, the patient was vaccinated with VARIVAX lot # K010442 expiration date 22-JUL-2016 for prophylaxis. No adverse event were reported.
Starting the day after the vaccination, severe headaches, overall body aches, coughing, sneezing, fever, chills, lethargy.  This lasted for 4 days and then the coughing and headaches lasted 2 weeks-dry hacking cough that would not stop especially at night.  She had to sleep in the bathrooom with the shower running to increase humidity so she could sleep a little.  After the first week she started azithromycin and prednisone which helped to calm the cough down.  Since those 2 weeks, for the following 2 months and currently at this report time, she has been more tired than usual and complains of being tired all the time.  She has been taking daytime naps which she never had before.  She is slowly improving on the tiredness but is not completlely resolved at this point.
I have rash; its not a rash, its swollen up, its kind of reddish; my arm is swelled up from, its sore, wasn't sore before; its a lot sore then it was before but it bothers me, it felt like I have a fever but it calm down but its still swollen up; my arm is swelled up from, its sore, wasn't sore before; its a lot sore then it was before but it bothers me, it felt like I have a fever but it calm down but its still swollen up; it felt like I have a fever but it calm down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administration date 31Mar2022 (Batch/Lot number: unknown, Expiration Date: 05May2022) at the age of 72 years as dose 4 (booster), single for covid-19 immunisation. Relevant medical history included: "Glaucoma" (unspecified if ongoing), notes: Medical History (disease /surgical procedure / etc.): Glaucoma; "Allergy" (unspecified if ongoing), notes: I do use an allergy pill and the allergy medication which is antihistamine diph, I can't pronounce it. Concomitant medication(s) included: TIMOLOL [TIMOLOL MALEATE] taken for glaucoma; SEROVIT; GABAPENTIN; CYCLOBENZAPRINE; LOVASTATIN; VITAMIN D NOS; VITAMIN D3. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 Immunization. The following information was reported: RASH ERYTHEMATOUS (non-serious), outcome "unknown", described as "I have rash; its not a rash, its swollen up, its kind of reddish"; PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "my arm is swelled up from, its sore, wasn't sore before; its a lot sore then it was before but it bothers me, it felt like I have a fever but it calm down but its still swollen up"; PYREXIA (non-serious), outcome "unknown", described as "it felt like I have a fever but it calm down". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of rash erythematous, peripheral swelling, pain in extremity, pyrexia.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous prospective pregnancy report was received from the patient's husband referring to a female patient of unknown age. No concurrent or historical conditions were reported. On an unknown date, the patient was vaccinated with a dose of VARIVAX (Merck) (lot number and expiration date not provided) dose, route and anatomical location were not reported (vaccine exposure before pregnancy). No concomitant medication was provided. On an unknown date (also reported as not enough one month later), the patient was pregnant. The Last Menstrual Period (LMP) and Estimated Delivery Date (EDD) were unknown. The pregnancy outcome was unknown at the time of the report. Additional information has been requested.
Patient presented to PCP from group home residency on 05/20/2021 complaining of fever up to 100.9, body aches, sore throat, runny nose with known exposure to COVID-19.  Rapid test in office was positive for COVID-19.  Chest Xray findings consistent with COVID pneumonia.  Patient admitted to hospital on 05/20/2021.
FLU-LIKE SYMPTOMS; MUSCLE PAIN; FATIGUE; FEVER; NAUSEA; HEADACHE; INJECTION SITE PAIN; DIZZINESS; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced dizziness. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced injection site pain. On 09-APR-2021 20:00, the subject experienced flu-like symptoms. On 09-APR-2021 20:00, the subject experienced muscle pain. On 09-APR-2021 20:00, the subject experienced fatigue. On 09-APR-2021 20:00, the subject experienced fever. On 09-APR-2021 20:00, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, muscle pain, fever, and nausea on 13-APR-2021, and was recovering from fatigue, dizziness, headache, and injection site pain. This report was non-serious.
After 2nd Anthrax shot, one wk later pt broke out in hives.
RASPY VOICE; FEVER; CHILLS; HEADACHE; HIVES; RASH-SPIDER VEINS; NAUSEA; BODY ACHES; NO ENERGY; DIZZINESS; DIFFICULTY CONCENTRATING; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included allergy to prevnar 13, allergies to shingles shot, osteoarthritis, statin allergy, environmental allergy, shellfish allergy, iodine allergy, beef allergy, and gallidium allergy. The patient was previously treated with pneumococcal vaccine conj 7v (crm197) for prophylactic vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAR-2021, the subject experienced hives. On 10-MAR-2021, the subject experienced rash-spider veins. On 10-MAR-2021, the subject experienced nausea. On 10-MAR-2021, the subject experienced body aches. On 10-MAR-2021, the subject experienced no energy. On 10-MAR-2021, the subject experienced dizziness. On 10-MAR-2021, the subject experienced difficulty concentrating. On 10-MAR-2021, the subject experienced fever. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced raspy voice. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 Unit not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from hives, and rash-spider veins, and had not recovered from headache, fever, chills, nausea, body aches, no energy, dizziness, difficulty concentrating, and raspy voice. This report was non-serious.
Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a health professional. This case involves a 10 months old female patient who was vaccinated with a 0.5 ml dose instead of 0.25 ml dose of vaccine FLUZONE QUADRIVALENT (lot UJ068AB and Exp. Date 30 Jun 2019) via unknown route in the left thigh on 27-Oct-2018. The patients medical history and concomitant medications were not reported. It was an actual medication error due to overdose. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
40-year-old female received the first dose of the Pfizer COVID-19 vaccination on 1/23. Received second dose on 2/13. Patient undergoes COVID-19 testing with only symptom of congestion/runny nose. Nasopharyngeal swab obtained 4/5 at 11:27. Coronavirus PCR test resulted positive later that evening.
2-3 years past due for the second dose; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter asked that the patient was 2 to 3 years past due for the second dose, should they restart the series. Till the time of reporting the patient did not receive 2nd dose, which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available.
Hives on face and arms, mild eyelid swelling. Some itching. BENADRYL given.
About 6 hours after receiving the shot I started experiencing  skin sensitivity (common when I feel ill), chills, aches in my legs and a slight headache. The chills subsided after about 2 hours, but then my resting heart rate went up to 110-120 bpm rather than the normal 75-85 for me. It felt like my heart was beating out of my chest even though I was laying down in bed. That lasted through the night and I felt back to normal around mid-morning.
As per patients family, approx 2 days after receiving Moderna Dose #2 Immunization( was received 5/13/21) patient developed soreness of Rt Arm, body ache, shortness of breath. Was sleeping upright in wheelchair.in order to  breath easier. Family stated due to pt  having polio as a child, he was fearful of hospitals and refused to have family call 911  These symptoms continued until 6/1/2021 when pt was found dead  in wheelchair.by family.
Patient left pharmacy and started to feel really hot at the grocery store. She got home and started to sweat a lot and felt really nauseous and sick feeling. She also had a fever and headache so she laid down for a while. Pt also reports she wasn't able to move her arm much on the 11th due to arm pain (Feeling better on 12th).
Pt seen in ER 12DEC91 & w/an abscess @ the inject site approx 2 months p/receiving TD; pt referred to surgeon & ATB prescirbed to treat rxn; pt returned to ER on 29DEC91 due to discomfort @ the inject site;
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient got flu shot then stood up so brother could get his. She told her mother she felt like she was going to faint. Her eyes rolled back and became dilated and she slowly began going towards the floor. We first got her in a chair, then layed her down. She never lost breathing or heart rate. As she came out of the spell, she said she was warm.  My technician got some wet papertowels and some ice water for her. After sitting for a few minutes and drinking water, she felt better.
After last immunization pt had fever 102- 103 and screaming x 2 hrs increased x 2 days. Parents very concerned. No tx was given by our office.
pt devel a fever of 104-105 & an inj site rxn characterized by erythema, warmth & swelling p/vax;
Seizure like movements (uncontrolled shaking in legs) 3 hours after injection of first dose. Happened twice for about 5 minutes. "Covid Arm"  appeared on injection site about 2 weeks after first dose. Rash on legs and psoriasis flare up a couple days after first dose.
First adverse event on 2/14/21 through 2/15/21 - severe fatigue, headache; second adverse event 2/17 pain in arm at injection site with moderate fatigue and headache .
19 years old  male, indicated no to all questions on vaccination, fainted after few minutes of getting the vaccine, was disoriented for a minute after falling down on his face, was sweating and looked pale , management called paramedics, was evaluated ok after checking all vitals
member complained of dizziness and headache after vaccine administration.  Patient brought to lay down on a gurney.  Headache resolved after patient in supine position.  Vitals stable with noted hypertension:  194/129 that remained elevated for 30 minutes.  Dizziness and headache resolved.  Dr encouraged member ED assessment of continued hypertension.  Member agreed to have wife (at bedside) drive him immediately to the ED.  Per EMR, member went to emergency and was admitted 5/4- 5/6/2021 and placed on antihypertensives and hypothyroid meds.
Covid arm.  1.25 inches red lesion around the injection site.  When I touch it I feel little pain, itching and it is much warmer  than my skin.
Swelling heat at sight of injection & lump developed in breast & under arm on same side of injection. They are currently getting smaller.
Severe attack of Trigeminal Neuralgia requiring being transported to ER via ambulance. Began having attack during the early hours of the morning, 10 days after the 2nd vaccine. She had her first episode of Trigeminal Neuralgia on 1/8/21 and was doing well being treated with Homeopathic remedy Magnesia Phosphorica. Because Bells Palsy has been connected to the vaccine we are concerned that the 2nd vaccine could have exasperated her underlying problem of Trigeminal Neuralgia. Because her attack required treatment to the ER and caused her to require being treated with Carbamazepine we felt it was important to report this incident to you.