chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red rash; Raised rash; Itchy rash; Burning rash; Rash; This case was reported by a consumer via interactive digital media and described the occurrence of red rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis and COVID-19 VACCINE (COVID-19 VACCINE BOOSTER) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine, Flu vaccine and the 4th dose of COVID-19 VACCINE BOOSTER. On an unknown date, unknown after receiving Shingles vaccine and Flu vaccine, the patient experienced red rash, raised rash, itchy rash, burning sensation and rash. On an unknown date, the outcome of the red rash, raised rash, itchy rash, burning sensation and rash were not recovered/not resolved.   It was unknown if the reporter considered the red rash, raised rash, itchy rash, burning sensation and rash to be related to Shingles vaccine and Flu vaccine.     Additional Information:  The patient reported that he/she received Shingles vaccine, flu vaccine and his/her 4th booster dose of Covid vaccine. The patient stated that after received Shingles vaccine, flu vaccine and Covid vaccine the patient experienced red, raised, itchy and burning rash. The patient wanted to know that what could he/she take for this. Additional supportive information: Follow-up would not possible as no contact details were available. It was unknown if the reporter considered the red rash, raised rash, itchy rash and burning sensation to be related to COVID-19 VACCINE.
acute sinus infection; bilateral cerumen impaction; Bilateral otitis media; Had a syncopal episode; Dizzy; This is a spontaneous report from a contactable physician. A 18-years-old female non-pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8730), dose 1 intramuscular, administered in right arm on 24Mar2021 as single dose for covid-19 immunisation. Medical history included dysmenorrhoea, menometrorrhagia, obesity, guillain-barre syndrome. Concomitant medication's included ethinylestradiol, levonorgestrel (LUTERA) taken for an unspecified indication, start and stop date were not reported. The patient previously took fluconazole (known allergies). Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was tested for Covid test post vaccination on 25Mar2021 show the negative result. Patient claimed she became dizzy within 15 minutes of the vaccine and had a syncopal episode. She stated that it occurred twice since the vaccine. This MD conducted physical exam on 30Mar2021 and found bilateral cerumen impaction that was cleared. She reported that this revealed bilateral otitis media and she was diagnosed with acute sinus infection and treated. Although her symptoms can be explained by these findings, this MD was continuing work up for Guillain-Barre. The adverse event result in Emergency room/department or urgent care. Treatment received for the adverse event are supportive care, antibiotic for sinus infection and clearance of impacted cerumen. The outcome of the events were recovered with lasting effects.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: The event syncope  is assessed as possibly related to the suspect vaccine BNT162B2  based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
0922 C/O tingling, blurred vision and nausea. BP 120/70,HR 69,SATs 100%. 1015 HR 68, SATs 100%.Left ambulating reported symptoms improved.
1) Extreme fatigue; 2) Muscle ache; 3) Fever (101.1); 4) Nausea; 5) Headache.
Information has been received from an X-ray technician concerning a 33-year old adult female who was vaccinated with the first and second doses of varicella virus vaccine live. On 05-Apr-2003 a titer was drawn and the patient failed to seroconvert. Unspecified medical attention was sought. No other information was available. Additional information has been requested.
1:17 pm-Patient c/o throat tightness, difficulty swallowing. Denied chest pain, denied shortness of breath. 1:23-C/O dizziness, and lightheadedness. B/P 132/72, HR 86, RR 18, pulse ox 98% on room air. No changes in voice.  Treatment: 25 mg Benadryl given at 1:18pm.       1:43pm- No increase in symptoms. No decrease in symptoms. 1:51pm: 2nd dose (25 mg) Benadryl given. 1:59- B/P 128/69,  HR 88, RR 18, pulse ox 98% on room air.  Patient refused EMS transport. Patient called boyfriend and plan made to meet him at Urgent Care.
There were vaccines drawn from an expired Moderna vial. The vial expired 12/09/21  and the dose was given 12/10.  Patient has not exhibited adverse events post vaccination.  Moderna was called to inquire about further steps and whether or not the patient needs to be contacted to be revaccinated. The case was escalated and the turn around time for a response is 3 days.
Information has been received from a health professional concerning a 17 year old white female student who on 13-JUN-2007 was vaccinated with a first dose GARDASIL. Concomitant therapy included MENACTRA. On 13-JUN-2007 at 9:30 AM the patient experienced syncope. Medical attention was sought. Immediate recovery. Observed for 20 minutes without further adverse events. No product quality complaint was involved. Additional information has been requested.
After  second dose diagnosed with Graves Disease after never having a diagnosis for a hyper thyroid.  Rapid heartbeat,  shaking hands and nervousness.    After booster (3rd dose) experienced sever joint and muscles pain in fingers, hands, arms, ankles and back.
Redness, swelling, firmness, discoloration. Swelling 10 centimeters by 10 centimeters.
experienced a shingles outbreak/ Suspected vaccination failure/ Lack of drug effect; shingles outbreak; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE PFIZER for prophylaxis.   The patient's past medical history included shingles (several shingles outbreaks). Concomitant products included TOZINAMERAN (COVID-19 VACCINE PFIZER).   On an unknown date, the patient received Shingrix and the 2nd dose of COVID-19 VACCINE PFIZER. On an unknown date, less than 2 years after receiving 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.  Additional details were provided as follows: The case was reported by the daughter of the patient The age at vaccination was not reported. The patient's daughter reported the patient had several shingles outbreaks prior to receiving the Shingrix vaccine. The patient has had previous shingles outbreaks in the setting of stress. The patient received Shingrix approximately one and a half years ago from the time of reporting. The patient received the COVID-19 vaccine (dates were not available). One week following the patient's second COVID-19 vaccine, the patient experienced a shingles outbreak. The reporter did not want to share any additional information. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown. The reporter did not consent to follow up.
Intense left sided Neck Pain; Stiffness; This is a spontaneous report from a contactable consumer. A 70-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Pfizer EN6198), via an unspecified route of administration, administered in the left arm  on 03Mar2021 11:30 as a single dose for covid-19 immunization. The patient's medical history included pancreatic cancer and bilateral pulmonary embolism (PE's) from 2015 to an unknown date; and mild chronic obstructive pulmonary disease (COPD) from an unknown date and unknown if ongoing. The patient has no known allergies/no known drug allergies. The patient was not diagnosed with Covid-19 prior to vaccination and has not testes for Covid since the vaccination. Concomitant medication included umeclidinium bromide, vilanterol trifenatate (ANORO ELLIPTA), azelastine hydrochloride (ASTEPRO), and celecoxib (CELEXA) taken for an unspecified indication, start and stop date were not reported. On 03Mar2021 at 04:00 the patient experienced intense left sided neck pain and stiffness. The patient was hospitalized for intense left sided neck pain and stiffness for 2 days.  It was reported that the events required emergency room/department or urgent care. Therapeutic measures were taken as a result of intense left sided neck pain and stiffness (not specified). The outcome of the events was recovering. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Follow-up attempts are needed. Information on lot/batch number was obtained.
Having some difficulties with her arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (Having some difficulties with her arm at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On 08-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOMFORT (Having some difficulties with her arm at the injection site). At the time of the report, VACCINATION SITE DISCOMFORT (Having some difficulties with her arm at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Redness, swelling approximately 8 by 7 cm. on external surface of left upper arm.
few hr p/vax pt felt warm but temp was not taken;woke up several times during noc but not crying;next morning foaming in mouth, back arched, body stiffed & slow movements of hands;saw MD noted clear nasal discharge;observed in office
Light headed; Chest pain; trouble breathing; This is a spontaneous report from a contactable consumer reported for herself. This 16-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 12Jun2021 10:30 (Lot Number: 59267-1000-01) as DOSE 1, SINGLE for COVID-19 immunisation at the age of 16 years old. The patient was not pregnant. Medical history included depression, anxiety, migraines. Known allergies slight elm, almond, cockroach. Did not have COVID prior vaccination. Concomitant medication(s) included fexofenadine (FEXOFENADINE); fluoxetine (FLUOXETINE); quetiapine (QUETIAPINE); topiramate (TOPIRAMATE).  The patient experienced Light headed, Chest pain and trouble breathing on 12Jun2021 11:00 with outcome of recovered with sequelae. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event).  Treatment received for events included Epi pen.  The patient underwent lab tests and procedures which included COVID-19 test (Nasal Swab): negative on 11Jul2021 and 07Sep2021.
Pt received first Pfizer covid vaccine and subsequently developed large rash within 15 minutes of receipt of the vaccine.  Due to prior reactions to vaccines, the patient was taken to the emergency department.  Patient reported tunnel vision, burning feeling on skin with itching, numb lips, tongue and hands.  Patient had rash across neck, chest, arms, and back as well as tongue swelling.  Patient had taken benadryl 50mg prior to immunization and an additional 50mg of benadryl upon feeling reaction.
Soreness and bruising at injection site/pain in knee just as she had when she had the covid virus
This case was reported by a pharmacist and described the occurrence of chest heaviness in a 27-year-old female subject who was vaccinated with influenza virus vaccine (manufacturer unspecified). The subject's medical history, concurrent conditions, and concurrent medications were not reported. The subject had no prior vaccination with influenza virus vaccine. On 20 November 2007 the subject received 1st dose of Influenza virus vaccine (unknown). On 21 November 2007, 1 day after vaccination with Influenza virus vaccine, the subject experienced chest heaviness, panic attack and feeling of esophagus closing (described as pressure felt on the esophagus). At the time of receipt of influenza virus vaccine, the subject was breast feeding a child who was born in June 2007. No other details regarding the neonate were provided. The subject was seen at a physician's office. At the time of reporting the events were worse.  Follow-up information on 17 December 2007 indicated that the events actually occurred on the same day of vaccination, 20 November 2007. Light headedness was reported as an additional event also beginning the same day of vaccination, 20 November 2007. The events were all resolved and indicated as possibly related to influenza virus vaccine.
WHILE PATIENT WAS SITTING IN OUR WAITING ROOM, SHE BEGAN TO FEEL DIZZY. SHE MOVED HERSELF TO THE FLOOR. WHILE LETTING HER REST COMFORTABLY, WE MADE ASKED QUESTIONS TO BE SURE SHE WAS STAYING AWAKE, WE MONITORED HER BLOOD PRESSURE AND PULSE. BLOOD PRESSURE WAS LOW AND PULSE REMAINED WITHIN NORMAL LIMITS. SHE WAITED FOR ABOUT 30 MINUTES, WAS GIVEN WATER AND SHE GRADUALLY MOVED INTO A CHAIR. THEN WHEN SHE FELT BETTER, SHE LEFT. WILL TOUCH BASE WITH HER AGAIN TO BE SURE SHE IS NO LONGER EXPERIENCING SYMPTOMS
After the injections pt states after 10 mins started to have pain at site.  Day of day 2 pain increasing then 3rd day decreasing pain then increasing itching and pain went down over days 4 through 6 but itching increased day 7 extreme itching all redness width of 3 to 3 and 1/2 inches 2/3 of arm circumference but today the redness is going down and swelling.
Redness, Swelling, Fever, Pain to injection site. Achy and diarrhea for 1 week
Post vax, the pt experienced injection site redness, swelling, heat, and discomfort.
diarrhea (from laxative taken today); constipation; sore arm for a few days (left); This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea (from laxative taken today)), CONSTIPATION (constipation) and PAIN IN EXTREMITY (sore arm for a few days (left)) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL, CLOPIDOGREL BISULFATE (PLAVIX), AMLODIPINE, LOSARTAN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and ATORVASTATIN for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm for a few days (left)). On 08-May-2021, the patient experienced CONSTIPATION (constipation). On 10-May-2021, the patient experienced DIARRHOEA (diarrhea (from laxative taken today)). The patient was treated with BISACODYL (LAXATIVE [BISACODYL]) on 10-May-2021 for Constipation, at an unspecified dose and frequency. On 17-Apr-2021, PAIN IN EXTREMITY (sore arm for a few days (left)) had resolved. On 10-May-2021, CONSTIPATION (constipation) had resolved. At the time of the report, DIARRHOEA (diarrhea (from laxative taken today)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  Reporter stated that patient will reschedule the vaccine as soon as possible.
This spontaneous report as received from a nurse refers to a 13 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 31-AUG-2017, the patient was vaccinated with improperly stored GARDASIL 9 (dosing details were not reported) (lot # N007931, expiry date: 17-NOV-2019) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
Severe arm pain and injection site reaction, red/pink puffiness and pain around injection site. Neck, shoulder and back pain on  side of the injection that has not gone away after 2 weeks. Injection site reaction went away after 4 days but then came back 9 days after shot and was pink and itchy, the size of an orange. Lasted 1 day then slightly went away again. Neck, shoulder and upper quadrant left sided pain still occuring, stiffness and tightness. Fatigue also has lasted 2 weeks since injection.
Was informed that patient died 2 days after flu shot, no symptoms were reported by police office department.
HCP confirmed that their practice has not received any reports of a patient involved having any symptoms or medical concerns/ no additional AE/PQC reported; patient inadvertently administered an expired dose of MMR II; This spontaneous report has been received from a healthcare business professional and refers to an 18-month-old patient of unknown gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 27-SEP-2023, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, at a  dose of 0.5 milliliter (ml) (expired product administered) (lot number U029789 has been determined to be valid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), with an expiration date established as 23-SEP-2023), administered for prophylaxis (strength, and route of administration were not provided). The reporter confirmed that their practice had not received any report of the patient having experienced any adverse event.
suspected vaccination failure; shingles; Very painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. The patient stated that, shingles were very painful. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Hives started on my elbows for about 10-14 days, then spread to my knees, and feet, then spread all over my body. Originally thought it was a medication reaction and switched oral contraceptives, but hives persisted. Stopped taking all medications and supplements except for lamotrogine and antihistamines. Contacted my immunologist on March 5, 2021, "I am now weaning off of my lamotrigine so I can clear everything out of my system.  In the last couple weeks I have Taken prednisone 40mg x2 days, 30mg x2days, 20mg x 2days, 10mg x 2days. Then did a medrol dose pack. And have taken hydroxazine, and Zyrtec. The oral steroids just toned it down a little. The day after I finished the medral I woke up the the worst they have ever been. The only place they weren?t was my face.   I?ve been applying hydrocortisone 2.5% 2 weeks on 1 week off and it seems to help it mostly calm down during the day. At night everything flares up and in the morning I wake up to find them back. Some days better than others. I also got blood work done and everything was within normal ranges.  My last allergy shot was in December." Started on 2 zyrtec and famotadine twice daily, along with hydroxazine, benadryl, or doxepin PRN. This helped for about a week, but the hives worsened after that week.   Spoke with immunologist again. Started on Xolair injections. Following the second Xolair injections the hives decreased significantly. Taking the Xolair injections monthly and taking zyrtec in the morning and famotidine before bed keeps the hives mostly at bay with few appearing every few days, but not all over like they were. (I have picture documentation for all.) I have since started back on all supplements and medications with no adverse reactions that were not previously stated. Other adverse reactions are: abnormal menstrual cycles starting in January (I have been extremely regular with the same week since the start of menstruation at age 11, even after pregnancy), severe brain fog and difficulty remembering, new onset gut issues, edema and angioedema with the hives.