chrisvoncsefalvay/vaers-outcomes huggingface dataset:
when took bandage off of left arm saw big spot of blood approximately the size of a nickel where she received the Bexsero vaccination; she was told to get the Menveo, Bexsero, Prevnar 13 and Haemophilus influenzae type B (HIB) vaccine after her surgery; This case was reported by a consumer via call center representative and described the occurrence of injection site bleeding spot in a 70-year-old female patient who received Men B NVS (Bexsero) (batch number ABX797AB, expiry date 30th September 2020) for prophylaxis.   The patient's past medical history included spleen operation. Previously administered products included Bexsero with an associated reaction of contusion (1st dose received on 22nd June 2020, refer case US2020186261), Menveo with an associated reaction of contusion (2nd dose received on 22nd June 2020, refer case US2020186261), Haemophilus influenzae type B vaccine with an associated reaction of contusion (received Haemophilus influenzae type B vaccine on an unknown date) and Prevenar 13 with an associated reaction of contusion (received Prevenar 13 vaccine on an unknown date). Concurrent medical conditions included appendix cancer and platelet count high. Concomitant products included acetylsalicylic acid (Baby Aspirin).   On 15th September 2020, the patient received the 2nd dose of Bexsero. On 15th September 2020, less than a day after receiving Bexsero, the patient experienced injection site bleeding spot and off label use. On an unknown date, the outcome of the injection site bleeding spot and off label use were unknown.   It was unknown if the reporter considered the injection site bleeding spot to be related to Bexsero.  Additional details were provided as follows: The patient reported for herself. The patient mentioned that she is on a daily baby aspirin because her platelets were high from the spleen surgery. The patient received Menveo and Bexsero vaccinations on 22nd June 2020 and was supposed to get the second dose 60 days later.  The patient received her second dose of Bexsero on 15th September 2020 however, she never received her second dose of Menveo.  On 15th September 2020, when patient took her bandage off of her left arm, she saw a big spot of blood approximately the size of a nickel on her arm where she had received the Bexsero vaccination.  The patient could not recall which two vaccines she had received in her left arm in June 2020.  The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020186261:same reporter
Headache, muscle ache in evening for few hours. Nausea And vomiting in the morning. Vomited 3-4 times in morning, then  sore stomach rest of day( persistent after 14 hrs.). Able to eat light meals throughout day.
21MAY92 pt recvd vax & held breath very briefly; pale; HR >100; remained in ofc X 15 mins;
Information has been received from a health professional concerning an 11 year old white female who on 27-MAR-2008 at 14:00 was vaccinated intramuscularly into the left deltoid with the third dose of GARDASIL (Lot # 660387/1967U). Concomitant therapy included a second dose given intramuscularly into the left deltoid of HAVRIX (Lot # AHAVB256AA). On 27-MAR-2008 at 14:00 the patient experienced nausea. On 27-MAR-2008 the patient recovered. No further information is available.
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: tingling of hands
LEG PAIN X 1 WEEK STARTING S/22, BIG LEFT TOE PAIN X 2 WEEKS STARTING 1/22 Narrative:
reaction to the vaccine and almost lost his life. #GBS; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a male 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 guillain barre syndrome (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingles vaccine.  Additional details were provided as follows: The patient was the reporter's brother. The age at vaccination was not reported. The patient had a reaction to the shingles vaccine and almost lost his life. The reporter hash tagged Guillain Barre syndrome (GBS).
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 29Dec2020 at 10:00 as dose 1, single (Lot number: EH9899), in left arm, as dose 2, single (Lot number: EL1283), in left arm and on 09Oct2021 at 14:15 as dose 3 (booster), single (Lot number: FF2589) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidaemia" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR, start date: Jan2020, stop date: 25May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Conclusion of Previously Completed Investigation: The complaint for 'Lack of Effect' of the PFIZER BIONTECH COVID-19 VACCINE lot FF2589, EL1283 and EH9899 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot FF2589, fill lot FF2558, and the bulk formulated drug product lot FE5318. The final scope included the reported finished goods lot EL1283, fill lot EL1281, and the formulated drug product lot EL1279. The final scope included the reported finished goods lot EH9899, the formulated drug product lot EH9782. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Batch and lot tested and found within specifications checked in product tab.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
Information has been received from a physician concerning a 6 year old patient who was vaccinated, when younger, with a 0.5ml subcutaneous dose of varicella virus vaccine live.  It was reported that the child came to the physician's office with chickenpox.  The patient may have had greater than 50 lesions.  Unspecified medical attention was sought.  No product quality complaint was involved.  Additional information has been requested.
Joint pain, hair loss, night sweats, fatigue. These are some symptoms I have started to have over the past 6 years since receiving the 3 shots. Have pain everyday, feel like I'm 80 years old and I'm only 32. Don't have money to run to doctor for pains just have been dealing with it hoping it would get better over time.
The Pfizer vaccine for age 5-11 years old was sent to use on 08/26/2022. We put it in the fridge with the CDC label that stated to put a 10 week expiration date. We put a use by date of 11/4/2022. The manufacturer date on the vial was 10/2021 so the expiration date on the vial would have been 09/30/2022.
Child's right thigh bright red at site of injection with knot on edge of swollen red area. Painful to touch, child taken to be assessed and site was drained.
Appendicitis, presenting as periumbilical tenderness  at onset (26 hrs after vaccine admin) migrating to RLQ approx 20hrs later (46hrs after vaccine admin) accompanied by fever, chills, sweats, and nausea. Presented to ER  that evening and CT confirmed appendicitis (52hrs after vaccine admin). Surgery following day laparoscopic appendectomy (69hrs after vaccine admin). Recovery and clinical improvement over next 8hrs (77hrs after vaccine admin). Discharged following day (96hrs after vaccine admin)
5 days, post vax, on 5/14/00, pt developed fever of 103F X 2 days, vomited X 1, pale. Fever resolved and macular-papular rash appeared on 5/19/01. Probable viral illness. Mother wished to report.
Itching on the right knee and both legs below the knees.  Swollen spot below right knee that itches.  Right eye is swollen.  I took allergy eye medicine , a 24 hour tablet of Allegra, and put Cortizone 10 on my legs below the knees.  As of 1/26/2021 - the medicine has stopped the itching, but eye is still slightly swollen.
On the second and third date after the first shot I fell minor chest pains but on the second week after the first shot I fell strong chest pain for about 5 minutes.
Limited movement of Left Arm. Difficulty with swallowing. Joint and muscle pain. Shortness of breath. Unusual tiredness and weakness. Dark colored urine. Difficulty with moving. Hair loss and Thinning of hair. Muscle cramps and spasms. Trouble sleeping. Inflammatory arthritis. Fatigue.
Received flu shot 16 Sep 15. Next day I could hardly move my left arm. (Meloxicam) Reaction. Physical therapy. No help. 4 Jan 2016 xray of left shoulder. Osteoarthritis. Injection of MEDROL. Oct 2015 had cortisone shot. Also on 4 Jan 16 had a cortisone shot. Please see attached.
On 7-9-2022, the day after the vaccine, I started having a scratchy throat and a slight cough. On 7-10, these symptoms continued so I took a home Covid19 test with positive results. I did not call the doctor. I did not take any OTC medications. There were no other symptoms and I am feeling fine since 7-13. I have still remained isolated. I have taken the home Covid19 tests daily since 7-9 and all have remained positive.
severe muscle tension; Extreme pain; numbness in site arm; inability to grip; migraine; moderate nausea; This is a spontaneous report from a contactable other HCP (patient). A 37-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on 16Feb2021 at 12:30 (at the age of 37-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive any other vaccine in 4 weeks. The patient had an allergy of gantricin and milk/soy intolerant. The patient's medical history included chronic bronchitis/pneumonia, asthma, sprained or torn left rotator cuff. Concomitant medication was not reported. On 17Feb2021 at 12:15 the patient experienced severe muscle tension through neck and down to elbow and numbness in site arm, inability to grip objects, migraine, moderate nausea, extreme pain. On an unspecified date, the patient underwent lab tests and procedures which included Extreme pain: 8-9/10. No covid not had prior vaccination, covid test not done post vaccination. The patient was received treatment as Tylenol, ultram, and tizanidine do not help at all and had an Rx for prednisone for a sprained rotator cuff, but have not started and not sure when I can start due to no one knowing an answer with vaccine when I can have it. The outcome of events was not recovered.    Follow-up attempts completed. No further information expected.
Skin rash and hard knot, swelling and redness at injection site, pain that radiates up arm to shoulder, itchy rash on right forearm. Methylprednisolone 80 mg once, Methylprednisolone 4 mg other, Diphenhydramine 25 mg QID.
STUTTER WHEN HE TALKS; SENSITIVE TO NOISE; RUNNY NOSE; SOMETHING WRONG IN BODY; NOISE IN THE EARS LIKE BLOWING OUT LIKE RAINING INSIDE; PAIN IN THE HEAD LIKE BLOWING OUT; PAIN IN SHOULDER; LITTLE PAIN IN THE ARM; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 22-NOV-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 23-NOV-2021, the patient experienced little pain in the arm. On 24-NOV-2021, the patient experienced pain in shoulder. On 25-NOV-2021, the patient experienced pain in the head like blowing out. On an unspecified date, the patient experienced stutter when he talks, sensitive to noise, runny nose, something wrong in body, and noise in the ears like blowing out like raining inside. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the little pain in the arm, pain in shoulder, pain in the head like blowing out, noise in the ears like blowing out like raining inside, runny nose, sensitive to noise, stutter when he talks and something wrong in body was not reported. This report was non-serious.
Inappropriate schedule of product administration; swelling up; inflammation in the left arm pit; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling up), INJECTION SITE INFLAMMATION (inflammation in the left arm pit) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0039B21A and 022C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced SWELLING (swelling up) and INJECTION SITE INFLAMMATION (inflammation in the left arm pit). On 23-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration). On 23-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration) had resolved. At the time of the report, SWELLING (swelling up) and INJECTION SITE INFLAMMATION (inflammation in the left arm pit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) The doctor did not see any lymphatic inflammation, abnormal, or anything out of the ordinary. On an unknown date, Ultrasound scan normal: normal (normal) The doctor did not see any lymphatic inflammation, abnormal, or anything out of the ordinary.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided. No treatment medications were provided   This case was linked to MOD-2021-331802 (Patient Link).; Sender's Comments: This case concerns a 40-year-old, male patient with no relevant medical history, who experienced the non-serious event of Swelling and expected non-serious event of Injection site inflammation. The events occurred after the first dose of mRNA-1273 (COVID-19 Vaccine Moderna). An additional event of Inappropriate schedule of product administration is added as dose 1 and dose 2 were administered at a time interval of 38 days. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 (COVID-19 Vaccine Moderna) is not affected by this report.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: WI9266), in left arm, on 06Mar2021 as dose 2, single (Lot number: EN6202), in left arm, on 26Sep2021 as dose 3 (booster), single (Lot number: FF2587), in left arm and on 23Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic obstructive pulmonary disease" (unspecified if ongoing); "Penicillin: Allergy" (unspecified if ongoing); "Sulfa: Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which includes Paxlovid from 31Oct2022 to 04Nov2022.
First wheal was not created. Had to repeat ID injection. Pt left in NO Distress
Red knot and rash at immunization site. The follow up states Dr indicated in chart he believed varicella caused reaction.
3 days post vaccination patient experienced diarrhea, 10 days post vaccination patient experience fatigue, loss of taste and smell and was "bedridden"
Warmth, redness and swelling in right arm 2"x2". Bruised area at injection site.
The client was given undiluted Pfizer COVID-19 5-11 vaccine. The orange cap was removed and 0.2cc drawn up and given to client. The mother was notified on 12-30-21 at noon. No issues noted at that time.  1-3-22 interview with mother completed. She reported that the child had a fever 100.1 the night of 12-30-21 with a sore arm. By 12-31-21 am, the child's symptoms were resolved without medication.
Pt had a 17cmx21cm erythematous urticarial type eruption surrounding injection site.
There is a red, warm and raised red area about 2-3 in from where I received the shot.
pt recv vax & exp a 3cm x 2cm induration, the area was warm to touch & a flare @ the inj site;
Severely red eyes, eyes watering, lips swollen, slight fever and chills, slight problem breathing, a bit of a cough, runny nose, congestion in sinuses, achy joints in certain limbs.
COVID infection per rapid test; COVID infection per rapid test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EL3247), in left arm, on 31Mar2021 as dose 2, single (Lot number: EL3247), in left arm and on 11Dec2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 40 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Jun2022 at 10:00, outcome "recovering" and all described as "COVID infection per rapid test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Jun2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Additional information: No covid prior vaccination. No treatment AE  Follow-up attempts are completed. No further information is expected.
Extreme soreness, swelling and heat at injection site, then muscle aches, headache, fatigue, and fever which persisted off and on (used some NSAIDs for pain relief) but mostly on for the next 2-3 days. It's still 10/26/15, so we don't know how this will resolve.
SOB, cough, chest congestion, pneumonia- antibiotics,  decadron,
Gradual onset of tremor, then aching of proximal muscles.  After office visit and multiple phone calls, aldolase, CK checked -- these were mildly elevated.  Now have returned to normal.  Still getting work up.  ANA negative.  Has rheumatology visit pending.
FLUARIX given at 3:45 PM 10/7/16 after about 15 min, patient had syncope.
Following her first Pfizer Covid shot her period came early, and was extremely heavy with severe cramping/Same experience w two subsequent periods; Following her first Pfizer Covid shot her period came early, and was extremely heavy with severe cramping/Same experience w two subsequent periods; Following her first Pfizer Covid shot her period came early, and was extremely heavy with severe cramping/Same experience w two subsequent periods; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16May2021 13:00 (Lot number: EWO179) at the age of 12 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: POLYMENORRHOEA (non-serious), DYSMENORRHOEA (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious) all with onset 18May2021, outcome "not recovered" and all described as "Following her first Pfizer Covid shot her period came early, and was extremely heavy with severe cramping/Same experience w two subsequent periods". Therapeutic measures were taken as a result of polymenorrhoea, dysmenorrhoea, heavy menstrual bleeding.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior vaccination. Patient has not been tested for COVID-19 since vaccination. Patient did not receive any other medication within two weeks. The patient had no known allergies. The patient's medical history was none. It was reported that usually, the patient menstruation was mild flow without cramps. Following her first Pfizer Covid shot her period came early and was extremely heavy with severe cramping. Same experience with two subsequent periods. The patient had taken Ibuprofen as a treatment.  No follow-up attempts are possible. No further information is expected.