chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information regarding PREVNAR (unspec) was received from a healthcare professional regarding a male patient who experienced otitis media. The patient completed his primary series, having received a fourth dose on 29-Oct-2003. The patient has a past history of otitis media (Nov-2004 and Apr-2005 (recovered) See related cases HQWYE105409MAY07 and HQWYE105509MAY07). Product was administered on 29-Oct-2003. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. On 29-Oct-2003, the patient received a fourth dose of PREVNAR completing his primary series. In Nov-2005, the patient experienced otitis media. On an unspecified date, the patient recovered. See related case(s): HQWYE062008MAY07 (adverse event, expedited); HQWYE105409MAY07 (adverse event, non-expedited); HQWYE105509MAY07 (adverse event, expedited); HQWYE105709MAY07 (adverse event, expedited); and HQWYE105809MAY07 (adverse event, expedited). No additional information was available at the time of this report.
Started feeling tingling/itching sensation at injection site immediately. Moments later arm felt heavy with pain down to elbow. Started feeling tired and shortness of breath about 3 minutes later for about 15 minutes at 3:23 in PA's office felt pain down to wrist. At night still arm throbs (per patient 10/11/13) not much pain during day. PA gave benadryl and Zyrtec and advised not to get flu shot again.
Patient complained of itching and hives occurring a couple of days after vaccination over entire body. A rash had developed near neck on the shoulder. Her left arm was in pain immediately after receiving vaccination. It is difficult to move the left arm in any direction. The patient took Tylenol for 3 days after the injection and was still experiencing pain in her arm. The patient started taking Benadryl a week after itching and hives. She takes Benadryl once a day. It helps but the itching and hives comes back the next day. This is a daily occurrence for the patient and has not received any relief. The patient said there were no issues with the first two vaccinations. Patient has no known allergies
This spontaneous report as received from a register nurse refers to a 1 month infant, of unknown gender. Medical history and concurrent conditions were not reported. On 27-FEB-2014, the patient was vaccinated with first dose of ROTATEQ, lot #J007283; expiration date: 27-SEP-2014 (dose and strength were not reported. Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reported. Additional information has been requested.
Patient received DTaP vaccine on 10/07/2005 complained of arm aching, awoke 10/08/2005 with grossly swollen, red arm, complained of aches, chills, temperature 100 maximum. Complained several body aches, soreness.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756500A, A0756502A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The reporter indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Sore throat on 1/9/00-1/14/00. Flu-like symptoms 1/14/00-1/15/00. Dull headache 1/15/00-1/22/00.
Excessive bruising noticed post vaccine. Upon routine visit to doctor CBC was ordered that showed LOW PLATELETS @ 25.
3rd dose given at 0.25ml to an immunocompromised patient; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (3rd dose given at 0.25ml to an immunocompromised patient) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and Cancer (been on chemotherapy for cancer prior to getting the 1st dose of   the Moderna Covid-19 vaccine).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (3rd dose given at 0.25ml to an immunocompromised patient). At the time of the report, ACCIDENTAL UNDERDOSE (3rd dose given at 0.25ml to an immunocompromised patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 07-NOV-2012 13:02, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not provided. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0395AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
numbness in legs, unable to support weight, feeling weak, eyes burning, red, itching, SOB, h/a, pain-pt to ER 30JUL 0531; 30JUL 2240 c/o nausea, feeling faint, weak when standing, arms itching, SOB, eye bloodshot, h/a, skin sensitive to tou
Pt given vaccination on 7/28/11. Mom reports pt woke up w/right upper arm very red & swollen on 7/29/11. Right arm - 1cm area of ecchymosis around injection site. Has about 8.5-9.0 cm by 5.5-6.0 cm of induration below injection site. (+) swelling, (+) erythema, (+) warm, (-) painful to palpation. Pt treated w/KEFLEX BID x 10 days.
side effect with moderna; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (side effect with moderna) in a 57-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (side effect with moderna). At the time of the report, IMMUNISATION REACTION (side effect with moderna) outcome was unknown.            No concomitant medications were provided by the reporter.  Treatment information was not provided.
Patient had received flu shot on 9/20/13 and still ended up getting serious flu enough to be hospitalized 3 months after shot. Flu shot did not protect and gave any immunity against flu.
Patient reported immediate pain after injection and suspects SIRVA (shoulder injury after recent vaccine administration). The vaccine was administered high in the deltoid (almost to the divot just under the shoulder). Patient has been experiencing shoulder pain and limited range of motion on the left shoulder from time of vaccination to present (currently 18 days). For example, even small motions such as reaching for the turn signal can cause a jolt of pain.
Upper left arm and joint sollen to about twice the normal size. A red rash/welt about 5" inches in length and 31/2" in width. Hot to the touch. He favors the arm when playing even though it is normally his dominate hand. Below normal temp 98.3.  This the first day after the injection and symptom are growing worse as the day progress. Rash was the size of my child's fist at 6:30 AM (The rash had a redder ring around it). At 12 PM  it was the size of my fist (red ring fadding). At about 3 pm is was the size of my husbands fist (no red ring). 9:00 pm rash is still spreading and swelling is increasing. No response to the Diphenhydramine apparent after two doses.
This spontaneous report has been received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was inadvertently administered a dose of VARIVAX lot # M037643, expiration date 01-SEP-2018 (dose and route of administration were not reported) instead of a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). The vaccine was reconstituted with sterile diluent (DILUENT MRK) lot # M016885, expiration date 07-DEC-2018 (dose and route of administration were not reported). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Patients granddaughter reported the patient was breaking out and felt his lips were swelling. Patient went to ER and got a prescription for prednisone and a possible steroid shot at the ER.
Client developed mild cough, some "wheezing", swollen, watery, itchy eyes, large thick wheals (hives) over body. No fever. Mom took client to Urgert Care Facility. No tests performed, no meds prescribed.  Mom gave Chlorpheniramine 8 mg. x1 8/11/2010 then gave client Zyrtec x2 days.
left arm swelling with pain for more than two weeks. Pt had pain preventing ADL's, including sleep. Pt could not make a fist for a few days.
This spontaneous report as received from a physician refers to a 19 years old female patient. The patient had no pertinent medical history and no drug reaction. The patient was vaccinated with the first dose of 0.5 ml GARDASIL (lot number not provided) intramuscularly on 24-OCT-2012. No other co-suspects were reported. There were no concomitant medications. On 25-OCT-2012 the patient experienced substernal, sharp, stabbing chest pain which was worse with inspiration. No treatment was given for adverse event. No laboratory studies were performed. The outcome of adverse event was reported as not recovered. The patient had sought medical attention via office visit. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: I gave patient orange juice and crackers after reported.   Took blood pressure, slightly elevated. after 1/2 hour patient feeling better but still tingling, offered to call 911, but mother, who was in attendance, said was going home.  She also told me she had the same response when she received same vaccine.  Mother is contacting doctor to determine is pt should take 2nd dose.  Offered benadryl, but mother refused.
Pt's husband reports she experienced bone pain, fatigue, lack of appetite for months (2-3 months).
Child given Tylenol post shots then developed fever and seizured.  Taken to hospital per ambulance and stayed 2-3 days.  Given Tylenol & Motrin to bring down temperature.  No further seizures.  Not on any medications. Records received 5/15/07-05/15/07-records received for ER visits 12/12 and 10/13/06-Chief complaint Fever 103.3. No vomiting. Parents felt he appeared jittery. No loss of consciousness. First ER visit generalized febrile seizure with eyes rolling and generalized trembling motion of arms and legs. No color change. PE: pharynx reddened with 3+ reddened tonsils, swollen tonsils. Fever probably secondary to pharyngitis.
This spontaneous report as received from a pharmacist refers to a 75 year old female patient with no pertinent medical history and concurrent conditions. On 30-JUN-2014 the patient was vaccinated with ZOSTAVAX. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The pharmacist reported that the patient had an injection site reaction which began on an unspecified date in 2014. Pharmacist reported that the patient would be coming into the pharmacy later on 03-JUL-2014 for the pharmacist to assess. The outcome of injection site reaction was unknown. The patient sought medical attention. No treatment was given for adverse event. No lab diagnostics studies were performed. This is one of two reports from the same source (other case # 1407USA002415). Additional information has been requested.
Numbness  and weird feeling in left arm  (injected in left arm) started like 8pm got worse. Also still felt awful comes and goes cold and feverish again. Felt good a day and a half. Then bad again but was at work. Woke up 2am with pain in chest and  arm felt numbness and very strange and pain in chest - which did subside but almost called 911. Will go to urgent cate today to get checked out. Took BP at home and it was normal/ took an aspirin at 2am as well/
Local reaction at site of injection--redness and tenderness, muscle ache in same arm and left side of neck  Gave 3 days of NSAID and instructed to apply ice pack
Sweaty, hot and ?felt like his vision was closing in on? him.  DENIES SOB
Pt. presented to clinic on 8/11/09 with history of blisters X 2 d.  Fever 100 - 101 AX.  Exam revealed approx. 80 - 100 vesicles primarily on the torso.  Dx: Cpox Rx AVEENO, BENADRYL.  No ASA.  Isolate.
Patient felt faint about 5 minutes after getting vaccinated. Patient sat down and we observed her for 30 minutes. Patient states she felt better. Patient did not want to lay down on cot. After patient left and went outside. She felt faint again and sat down on a chair. Called code green and paramedics arrived. Vital signs stable.
Rash at injection arm and trunk on that side of body, congestion and fatigue, chills and headaches
Consumer said that after receiving the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine, she developed a swollen lymph node under her armpits from where she received the vaccine; She also said that her shoulder blades hurt.; This is a spontaneous report from a non-contactable consumer via medical information team. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date consumer said that after receiving the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine, she developed a swollen lymph node under her armpits from where she received the vaccine. She also said that her shoulder blades hurt. Consumer wants to know how long these side effects would last. The outcome for the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
PATIENT WAS ADMINISTERED SECOND DOSE OF THE SERIES 2 DAYS POST VACCINE MANUFACTURER ON 4/3/2023. VACCINE MANUFACTURER EXPIRATION IS 4/1/2023
Vaccination site started itching; Big red spot the size of tennis ball around the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Vaccination site started itching) and VACCINATION SITE ERYTHEMA (Big red spot the size of tennis ball around the vaccination site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Vaccination site started itching) and VACCINATION SITE ERYTHEMA (Big red spot the size of tennis ball around the vaccination site). At the time of the report, VACCINATION SITE PRURITUS (Vaccination site started itching) and VACCINATION SITE ERYTHEMA (Big red spot the size of tennis ball around the vaccination site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: outcome of event changed from unknown to recovered .Reporter Email address was updated.
This is a spontaneous report from a non-contactable consumer who reported for his son. A male patient of unknown age and ethnicity received TRUMENBA, single dose on unknown date. After vaccination the arm was got all red which was about 10 inches long and painful. The outcome of the events was unknown. No follow up attempts possible. No further information expected.
pt recv vax & devel diarrhea, was taken to ER & hosp;MD reported that child was still hosp but had no diarrhea, or any other apparent adverse events;
Initial information received on 29-Jun-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves Child patient who received PENTACEL inadequately divided, did not receive the IPV and DTaP, while he/she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect PENTACEL lot C5464AA via unknown route. It was a case of actual medication error due to inappropriate schedule of vaccine administered. (Other relevant tests included No lab data.) Final diagnosis was PENTACEL inadequately divided, did not receive the IPV and DTaP. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Applicable for PENTACEL inadequately divided, did not receive the IPV and DTap. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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.
9 yr old pt was immunized with HBV # 1 in right deltoid on 4/18/2000. Was seen on 4/20/2000 with redness and swelling of right deltoid.
Heart Arrhythmia; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Heart Arrhythmia) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (Heart Arrhythmia) (seriousness criterion medically significant). At the time of the report, ARRHYTHMIA (Heart Arrhythmia) outcome was unknown.            Concomitant medications were not provided. Patient was under medical treatment.  Company comment: This case concerns a 44-year-old, male patient with no relevant medical history, who experienced the unexpected serious event of Arrhythmia. The event occurred at an unknown interval after a booster dose of mRNA-1273 (Moderna covid-19 vaccine). Patient reportedly was medical treatment. The rechallenge was not applicable as event occurred after the booster dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a 44-year-old, male patient with no relevant medical history, who experienced the unexpected serious event of Arrhythmia. The event occurred at an unknown interval after a booster dose of mRNA-1273 (Moderna covid-19 vaccine). Patient reportedly was medical treatment. The rechallenge was not applicable as event occurred after the booster dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.
I had a heavy head and later had a nose bleeding. I thought nothing much of it until I had my arm and hand seize up and couldn't move it. Saw my primary care physician and did MRI and nothing but and enlarged lymph node was found. No treatment given for the enlarged lymph. No diagnosis given even though the test was reviewed by multiple doctors. Blood work and allergy test given. Even though I have Hashimoto's disease, the doctor said it was not related to it.