chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itchy; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy) and SWELLING (Swollen) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D43L20A) for COVID-19 vaccination.     No medical history information was reported.     On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced PRURITUS (Itchy) and SWELLING (Swollen). At the time of the report, PRURITUS (Itchy) and SWELLING (Swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 12-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy) and SWELLING (Swollen) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D43L20A) for COVID-19 vaccination.     No medical history information was reported.     On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced PRURITUS (Itchy) and SWELLING (Swollen). At the time of the report, PRURITUS (Itchy) and SWELLING (Swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. In 2018, the patient received a dose of SHINGRIX. No further details were provided. This case has been linked with case US2018GSK186075 (vaccinated with same lot number), reported by the same reporter.
Patient reports to pharmacy 2 days after vaccination with a local site reaction: redness, swelling, rash at the site of injection. Patient was not in distress. Recommended applying over the counter neosporin to prevent infection. Informed patient to contact the primary care prescriber if not resolved in the next few days.
Mother called clinic on 12/4/06 reported that night before 12/3/06 child displayed red rash like bumps to entire body, face, neck, back. Reports pruritis but trying not to scratch. Denies difficulty breathing, hoarseness, wheezing, no signs of anaphylaxis. Additional information: 12/27/06 talked to mother-mother states child taken to emergency room 12/3/06 and told "rash" was due to immunization. Mother states "hives" lasted for one week. No further or previous problems.
swollen, tender, colored toe/COVID toe, the color was like a purple color; swollen, tender, colored toe/COVID toe; swollen, tender, colored toe/COVID toe; This is a spontaneous report from a contactable consumer, the patient.   A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EN9581), via an unspecified route of administration, administered in arm left on 13Feb2021 10:00 as dose 1, single (at the age of 62-years-old) for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 15Feb2021, the patient experienced swollen, tender, colored toe/covid toe, the color was like a purple color. The patient used anti-inflammatory cream and she sticks to medical advice for the events. Patient underwent laboratory test included x ray resulted x-ray to rule out arthritis and confirmed it was also the so called COVID toe.The patient visited the physician office for the events. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
No additional AE or PQC reported; MMR II was administered after a temperature excursion.; This spontaneous report was received from a healthcare professional and refers to a patient of unknown age and gender. The patient's medical history, and concurrent conditions were not reported. Concomitant therapies were not reported.  On 08-MAR-2022, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, at a dose of 0.5 milliliters (lot #T016198, expiration date: 11-MAY-2022) administered for prophylaxis (strength, and route of administration were not provided) after a temperature excursion of 46.4 Fahrenheit (°F) for 1 hour, another one of 48.4F for 2 hours 25 minutes and 49.3F for 2 hours 50 minutes  No additional AE or PQC reported.  No previous temperature excursions were reported.
pt recv vax;devel flu like sx;n,stiff neck;f/u:md reported pt exp n,HA,lt neck soreness,v for 1 day & tender at infect site;tx w/ meds;pt still exp sx at time of rpt;
Throbbing pain R. Clavicle, shaking hands, Flushing, increased B/P
Information was received on 04-APR-2017 from a medical assistant regarding 7 patients of unknown ages and gender. The patients' concurrent conditions, medical histories and concomitant medications were not reported. The medical assistant reported that on unknown dates, 7 unspecified patients may have been vaccinated with PEDVAXHIB, (lot number N000236, expiration 24-OCT-2019), intramuscular for prophylaxis during or after a temperature excursion occurred. No adverse events were reported. The vaccines were stored at 52 degrees Fahrenheit for 2 hours. There was no previous temperature excursion. The call was made due to a data logger. No additional information was provided. Additional information has been requested. Lot number N000236 has been verified to be a valid lot number for Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate.)
Per Dr, three immunizations were given to patient on 06/02/2016 at 10:45am, Tdap and TRUMENBA given in Left deltoid IM given one inch apart. Hep A was given in Right deltoid IM. After injection of Hep A patient, who was in a sitting position, stated that she would like to lay down. As I was still at her side I assisted her to a prone position on the exam table. Patient immediately has jerking motion of arms and legs which consisted of 10-15 jerking motions. Patient closed eyes for 2-3 seconds. Patient was not left alone at bedside and a call for doctor assist was given. Patient stopped jerking motions and was orientated to person and place and stated she thought she had fallen asleep. 10-15 seconds time elapsed from start to end of jerking motions. Time elapsed from start of injections to end of jerking episode was 3 minutes. Upon end of episode of jerking motions Dr arrived for evaluation of patient. Please note, patient has previously had MENACTRA vaccination on 08/03/2015 with no adverse event. Today, on 06/02/16 patient was given TRUMENBA vaccination to complete series.
I developed COVID 19 on 2/9/22 with symptoms of intense sneezing, post nasal drip, congestion, coughing, overwhelming fatigue, chest tightness, excruciating headache on Friday and Saturday with body aches. The cough has resolved, but post nasal drip, and chest tightness have lingered.
due to a reaction; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (due to a reaction) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (due to a reaction). At the time of the report, IMMUNISATION REACTION (due to a reaction) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported. The dosage text was reported as unknown. No treatment medication was reported.
Burning sensation similar to shingles. Pain to the touch, this also happened shortly after my covid vaccine.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient was administered the three doses in the GARDASIL series on 28-AUG-2015, 30-OCT-2015 and 01-DEC-2015 respectively. The timing between the second and third doses was outside the labeled recommendations in the GARDASIL prescribing information. No adverse effect was reported. Additional information has been requested.
Diarrhea; Dehydrated; Upset with her stomach; Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Diarrhea), DEHYDRATION (Dehydrated), ABDOMINAL DISCOMFORT (Upset with her stomach) and VACCINATION SITE PAIN (Sore arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On 15-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), DEHYDRATION (Dehydrated) and ABDOMINAL DISCOMFORT (Upset with her stomach). On 19-Mar-2021, VACCINATION SITE PAIN (Sore arm) had resolved. At the time of the report, DIARRHOEA (Diarrhea), DEHYDRATION (Dehydrated) and ABDOMINAL DISCOMFORT (Upset with her stomach) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided.  No relevant concomitant medications were reported. The patient did not receive any treatment
Patient received the flu immunization in the left thigh on 10/08/14 in the AM. In the PM there was a small bump. Today his leg is red, swollen, hard and warm to the touch. No breathing difficulties.
3 cm x 3 1/2 cm induration red, minimally tender, warm. Tx: Ibuprofen/cool compress/observe. Recheck in 2 day if not better.
Site: Bruising at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Severe, Additional Details: vasovagel reaction pt layed down on floor with legs elevated for 30 min felt better and coloring came back to skin and he was released, tried to call at 5 pm after clinic to follow up to see how feeling no answer on above phone number
Cellulitis following administration PNEUMOVAX (R) deltoid 9/14/10 with erythema and warmth around injection site and swelling (R) upper arm and shoulder with decreased ROM. Given 2 shots ROCEPHIN IM 9/15/10 and 9/16/10 and prescriptions for BACTRIM DS 1 BID and CEPHALEXIN 500mg 1 TID along with LORTAB 7.5mg prn severe pain.
Started with dizziness around 5 PM.  The next morning when I awoke at 7 AM I experienced extreme vertigo.  Dizziness & fatigue continued throughout the day into the night, for a total of 40 hours.  After that I was fine.
This spontaneous report was received from a male patient of unknown age, who was reporting on himself. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On approximately 2003 (reported as about 15 years ago), the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). Other suspect therapies included (crm197) PREVNAR given about "two years ago", approximately in 2016. On an unspecified date (reported as a few months ago), the patient developed a case of pneumonia. The patient wanted to know if he should get re-vaccinated with the PNEUMOVAX 23 because he was concerned the pneumonia prevention vaccination he had already received previously was losing its effectiveness. The outcome of pneumonia and drug effect decreased was unknown as well as the causal relationship between the events and vaccination with PNEUMOVAX 23. Upon internal review the event pneumonia was considered to be medically significant.
she has not had her period yet since 07Mar2021 or 56 days; This is a spontaneous report received from a contactable female consumer reported for herself. A 24-year-old non-pregnant female patient received second dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Batch/Lot number: Unknown, Expiration date: Unknown), via an unspecified route on 23Apr2021 (age at vaccination: 24-year-old) as a single dose for covid-19 immunization. The patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Batch/Lot number: Unknown, Expiration date: Unknown), via an unspecified route on 24Mar2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, patient reported that she has not had her period yet since 07Mar2021 or 56 days. The patient underwent lab test and procedure which included blood drawn for HCG and had been negative for being pregnant. The patient was asking if this is normal or has anyone reported the same side effect. The clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.
This is a spontaneous report obtained from a non contactable consumer through a Pfizer sales representative. A male patient received PREVNAR 13 on an unknown date. Vaccine was administered in the arm. Relevant medical history and concomitant medications were unknown. Vaccines given on the same day and taken within the last four weeks were unknown. On an unknown date, the patient experienced soreness in his arm at the site of injection. Relevant laboratory data was unknown. At time of this report, the clinical outcome of the event was unknown.
Mild headache after approx. 24 hours. Lasted for approx. 3-4 hours.
30 minutes after getting the vaccine, my eyes started burning. The next day my eye was still burning. All of a sudden I started having uncontrollable tremors in my left hand. I went to see a doctor the next day for my eyes and he gave me prescription eye drops. They haven't helped. A couple days later I started having pressure on my chest as if someone was sitting on my chest and my heart was racing. I went to another doctor the day after that and my blood pressure was high when I arrived. The doctor told me to monitor my blood pressure for a week. He prescribed medication for anxiety because of my tremors. I stopped taking that medication because it didn't help. When I monitored my blood pressure it was high each time. My blood pressure was 177 over 102. The doctor monitored me until my blood pressure was lower. The doctor didn't let me leave until he prescribed me some blood pressure medication. I also told my doctor that I had been experiencing severe back pain. I had a back injury 17 years ago that haven't bothered me until now causing extreme pain. The doctor recommended I go to a spine doctor. So I went there and had injections twice but they haven't worked. The other option is to have my nerve endings burnt, but I can't do it now because of the heart surgery I had done. The doctor said I had a left bundle branch block heart condition that was found. He recommended to see a cardiologist as soon as possible. I went to a cardiologist and they seen that I had some problems and recommend to have a nuclear stress test did. They also did an examination with my heart. The results of those test came back and the doctor said I needed to go have a heart catheter done. I was having open heart surgery the next day. I had five bypasses done on August 27th. I still have the tremors, back pain, and my eyes are still burning. My doctor recommended not to have the 2nd shot. He said that the shot caused my heart to have the issues a lot quicker, but I would've had the issues come up at a later time anyway.
contact claims covid vaccine booster caused her cancer to come back; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An adult female patient (unknown if pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (ongoing), notes: contact claims covid vaccine booster caused her cancer to come back. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1 (not bivalent)), for Covid-19 immunization. The following information was reported: RECURRENT CANCER (medically significant), outcome "unknown", described as "contact claims covid vaccine booster caused her cancer to come back". It was unknown if therapeutic measures were taken as a result of recurrent cancer. Additional information: Most recent dose 2 of COVID 19 was not bivalent. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event: "Recurrent cancer" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Patient developed arrhythmias; Myocarditis; This spontaneous case was reported by a physician and describes the occurrence of ARRHYTHMIA (Patient developed arrhythmias) and MYOCARDITIS (Myocarditis) in a 30-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (Patient developed arrhythmias) (seriousness criteria hospitalization and medically significant) and MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, ARRHYTHMIA (Patient developed arrhythmias) and MYOCARDITIS (Myocarditis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided. No treatment information was provided.  Company's comment: This case concerns a 30-year-old, male patient with no previous relevant medical history reported, who experienced the unexpected events of arrhythmia and myocarditis. The events occurred on an unknown number of days after an unknown number of doses of mRNA-1273. The rechallenge was unknown since no information regarding the number of the doses was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.; Sender's Comments: This case concerns a 30-year-old, male patient with no previous relevant medical history reported, who experienced the unexpected events of arrhythmia and myocarditis. The events occurred on an unknown number of days after an unknown number of doses of mRNA-1273. The rechallenge was unknown since no information regarding the number of the doses was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.
Prenatal patient (G3P2) with EDD 11/3/18 given Tdap at 28 5/7 weeks gestation on 8/16/18. The patient returned to urgent care on 8/27/18, reporting not feeling fetal movement in over 48hrs. In urgent care, unable to find fetal heart tones with a doppler & no heartbeat seen on bedside ultrasound. Patient was transferred to the hospital (Medical Center) for probable fetal demise, confirmation and induction.
low grade "fever 100.5"; "feeling tired"; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade "fever 100.5") and FATIGUE ("feeling tired") in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE BESILATE (NORVAS), LEVOTHYROXINE SODIUM (SYNTHROID) and FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PYREXIA (low grade "fever 100.5") and FATIGUE ("feeling tired"). On 12-Mar-2021, PYREXIA (low grade "fever 100.5") and FATIGUE ("feeling tired") had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Body temperature;;100.5;The patient had a low-grade fever
Information has been received from a health professional concerning an 18 year old female with a history of Lyme disease who in approximately August 2007, was vaccinated with her first dose of GARDASIL vaccine (yeast). The patient had a Thin Prep PAP HPV DNA test which detected she was high risk for types 16, 18, 31, 35, 39, etc. The patient also had a STD screening performed which was negative for epithelial malignancy. The patient has never had intercourse, has never been sexually active. The health professional questioned whether GARDASIL vaccine (yeast) can cause patients to test positive for HPV DNA. The health professional did confirm the results with the lab. The patient's outcome was not reported. Additional information has been requested.
Flu-like symptoms within 24 hours lasting 4 days and numbness starting 48 hours post immunization last 8 days.
nodule appeared approx 8hr p/vax;redness & swelling @ the site @ same time;h/a subsided w/APAP;redness starting to enlarge over a 24hr period;
Patient reported fever, night sweats, chills 1 day after receiving two vaccines on the right deltoid with presence of erythematous warm macule on right arm at area of injection.