chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Starting in June, I noticed a swath of density on my right breast from the 11 o'clock area to the 1 o'clock area, upper right breast area. I went to see my PCP who stated that it was most likely a cyst. She ordered an ultrasound and when I went to get that done, they also did a mammogram for screening. Between the two tests, it was noted that I had an abnormality and had a needle core biopsy done which showed cancer. The type of cancer was lobular and invasive. After the pathology came back on the needle core biopsy, I had surgery scheduled for a double mastectomy and had that done. I have to start chemo next week. Unsure if this is even in relation to the vaccine.
She got her vaccine, had arm soreness, and a headache.  Then the next day she had pain, and felt very tired.  That Wednesday she got her  period and it lasted until today, 6/29/22, longer period than usual.  On Sunday, 6/26/22 she had a blood clot in her period.  Today, she had four bouts of diarrhea in a row with chills and sweating.  She did not notify her doctor her symptoms.  She did call the gynecologist who said to make an appointment to go on birth control pills to help the periods.  She did take Advil PM and a tired release Tylenol that she took.    Had a history of long periods last year, which her periods were heavier after the vaccine, and in November she had excessive bleeding and went to the ER for that.   She went to the gynecologist and was put on BCP for 2 months.
Client receiving 6 vaccines today. Client appeared well, but tearful following first 3 injections in right arm. Immediately following the last injection in the left arm, client lost consciousness and began to seize. Seizure lasted approximately 30 seconds. Oxygen brought to client, however, not used due to seizure complete when oxygen arrived. Client immediately regained consciousness upon completion of seizure and was A/O x 3. When asked if still felt dizzy, client reported "just a little bit". Denied nauseousness. Client given juice and damp towels. Client remained in clinic for 20 minutes following episode for observation, and reported feeling "fine and normal" prior to leaving.
patient fell due to his body giving out.; pain in the joints; This spontaneous case was reported by a consumer and describes the occurrence of FALL (patient fell due to his body giving out.) and ARTHRALGIA (pain in the joints) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 032M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FALL (patient fell due to his body giving out.) and ARTHRALGIA (pain in the joints). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FALL (patient fell due to his body giving out.) and ARTHRALGIA (pain in the joints) outcome was unknown.            No concomitant medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.
She said she received her First Covid vaccine on 12/22/2020.  She said on 1/4/2021 she worked that evening and started having severe pain in calf of her left leg no redness ,no heat, just hurt to work  1/8/2021 She had surgery on her left leg.  2nd Covid Vaccine  received on 1/12/2021 She said she had PT on her right leg with severe pain in her left calf  She said she did not have any therapy on her left leg. Two ? three hours later she developed chills, temp 100.1  took temp again later is was 99. She had ultrasound that showed a large blood clot She said the PA told her the blood clot could be from receiving the Covid vaccine
Positive COVID Case; Positive COVID Case; BOOSTER; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Dec2021 (Lot number: FJ8757) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. Vaccination history included: Bnt162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer, Prev dose brand unknown=False, Prev dose lot number=EP6955, Prev dose lot unknown=False, Prev dose administrator route=Intramuscular, Prev dose administration date=12Apr2021, Prev dose dose number=2, Prev dose vaccine location=Left arm), administration date: 12Apr2021, when the patient was 39 years old, for Covid-19 immunization; Bnt162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer, Prev dose brand unknown=False, Prev dose lot number =EP6955,, prev_dose_lot_unknown=False,, Prev dose administrator route=Intramuscular, Prev dose administration date =23Mar2021, Prev dose dose number=1, Prev dose vaccine location=Left arm), administration date: 23Mar2021, when the patient was 39 years old, for Covid-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. No known drug allergies.  The following information was reported: IMMUNISATION (medically significant) with onset 17Dec2021, outcome "unknown", described as "BOOSTER"; COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 27Dec2021, outcome "recovered with sequelae" and all described as "Positive COVID Case". The event "positive covid case" and "positive covid case" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Dec2021) positive. Therapeutic measures were not taken as a result of covid-19, vaccination failure.  No follow-up attempts are needed. No further information is expected
Information has been received from a female patient with hypothyroidism who on 23-FEB-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported) at a local pharmacy (unspecified). Concomitant therapy included SYNTHROID, fenofibrate and QUESTRAN. The reporter stated that about a weeks after being vaccinated ("on 02-MAR-2010") she developed a 2 inch diameter, red, solid (not patchy), itchy, rash just below the "needle entry site". The reporter stated no fever and said there was no treatment was given for the rash and it resolved on its own in "about a week". The patient went to pharmacy to show pharmacist. Additional information is not expected.
received shingles shot and died; received shingles shot and it triggered GBS; had cancer, received shingles shot, cancer free; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included cancer.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant), guillain barre syndrome (serious criteria GSK medically significant) and unexpected therapeutic effect. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the guillain barre syndrome and unexpected therapeutic effect were unknown. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death and unexpected therapeutic effect to be related to Shingles vaccine. The reporter considered the guillain barre syndrome to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 04-SEP-2022 Reporter's comment: The patient's relative reported this case via interactive digital media. The reporter reported that the patient received Shingles shot and it triggered GBS (Guillain Barre syndrome) and he died cancer free. Additional supportive information: The follow-up would not possible as no contact details were available.; Reported Cause(s) of Death: Unknown cause of death
Numbness, tingling from waist down. Firing of nerves constant pins and needles feeling. After four weeks, numbness and tingling moved up to breast line and through middle of the back.
PT HAD RASH EMERGE ALL OVER BODY, PT WENT TO DR AND GOT BLOOD WORK DONE. NO ABNORMALITIY IN BLLOD WORK FOUND. PT RECEIVED LORATADINE 10 MG QD
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 3:42 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 16-Nov-2021 at 3:42 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  It was reported that the vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported. The patient received vaccine which was stored in an ultra-cold freezer at minus 82 degrees Fahrenheit.  It was unknown if the patient had allergies to medications, food and other products.  No treatment information was provided.   This case was linked to MOD-2021-402935 (Patient Link).
Breakthrough case admission after 3 vaccines Moderna 5/25/21 Lot# 033C21A;  Moderna 6/2/21 Lot# 043B21A;  Moderna 11/8/21 Lot# 034F21A
Onset of vesicular rash consistent with varicella, against which he was immunized 3 weeks before.
Pt exp convul 27MAY92 lasted 30 sec according to parents report; mom states that pt had night sweats; was taken to ER & checked by MD;
Dizziness, increased heart rate, numbness and tingling in spine, neck, cheeks, jaw, crotch, feet, and hands. Stiffness of back, shoulders, and neck. Numbness is not complete; it's like when you get really cold and then start to get warm again, and you can feel but not completely. Only medication was 200mg ibuprofen.
Constant dizzyness unless lying down (could not drive at times) Falling sensations when moving Headaches Earaches Toothaches Constant pressure in head, ears, sinuses, felt like balloon in my head! Extreme tension pain in neck, jaw, could barely chew at times Tinnitus much worse Tingling in arms and legs Bloody noses Heart racing/tickling in chest/pain (called 911) Shortness of breath Deep depression due to symptoms Joint pain Muscle cramps in legs during sleep   Symptoms last for many months, tapered off, then returned after booster in Jan 2022.
Headache, Myalgia, Fever, BRAIN FOG/CHILLS/RIGORS/GENERAL MALAISE Narrative:
09/09/21 The patient presents with COVID-19 related sx. Pt tested positive for COVID on 8/19. Pt is experiencing weakness. Pt has had chest pain with deep breaths.  Pt has no chest pain or SOB presently. Pt usually wears oxygen at home for CHF. Pt denies any other sx.  The onset was 08/19/2021 . Risk factors consist of hypertension and CHF.  Prior episodes: none.  Therapy today: EMS.  Associated symptoms: denies chest pain, denies abdominal pain, denies nausea, denies vomiting, denies shortness of breath, denies fever, denies chills, denies headache, denies dizziness and denies back pain.
An erythematous rash started on trunk area and gradually spread to face and extremities over a period of three days.  The rash included marked erythema with red, raised target lesions of various sizes. There was no parities.  The episode lasted for approximately 4-5 days before improvement was noted with decreasing intensity of the rash.  Fever of 101 - 102 was present for the first 2 days.  The patient was never in any distress.  There was no clinical response to antihistamines or corticosteriods.
8 days after the 2nd Pfizer shot sudden vomiting including blood and then collapse and died.   No other symptoms of sickness leading up to this.
Temp: 105.0 F, Vomiting x 3/24 hrs, body aches for 24 hrs. Low grade fever (100.0 F)x 3 days.  Treatment: Tylnol 500mg, Po, Q4H
feel chest pain, sitting heat rate 140, fever around 10:00am and urgent care found  that EKG show symptoms. Went to ER at the same day.
Varicella given 6/5/13 and varicella-like rash, with low grade fever appeared approx 6/11 - 12/13.
This spontaneous report as received from a pharmcist via a representative refers to a 65 to 70 years old female patient. On unknown date, the patient was vaccinated with ZOSTAVAX. The pharmacist reported that the female patient (anonymous) who reported injection site redness and swelling within a 24 hour period. The patient had sought medical attention since he returned to pharmacy for consultation. The relatedness for all the events was not reported. This is one of several reports received from the same source. Additional information has been requested.
Soreness at injection site Arm weakness Dizziness  Feeling of being violated Stress due to mandatory vaccine against my will
vaccine exposed to the negative 7.8 degree Celsius over a period of 40 minutes and given to two patients after the excursion with no reported adverse event; Initial information was regarding an unsolicited valid non serious case was received from a nurse via Agency (Reference number- 00887754) and transmitted to Sanofi on 07-Dec-2021.  This case is linked to case 2021SA412334 (CLUSTER).  This case involves a 14-years-old male patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] exposed to the negative 7.8 degree Celsius over a period of 40 minutes and given to two patients after the excursion (product storage error).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 03-Dec-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (Frequency: once, lot UT7378KA, expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination. It was an actual medication error due to product storage error (latency: same day).  At time of reporting, no adverse event reported.  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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Rapid HR 92, in 4-6 hours after injection. That nite or the next nite, dizziness with turning side to,  Head fells fuzzy, Worse after yoga (last nite-not better today.
I administered vaccine 3 days after best if used by date, actual expiration date on vial was 12/21
Breakthrough case COVID-19 after fully vaccinated with 3 doses of Pfizer.
Patient felt light headed and was close to passing out (clammy and pale skin).  Placed patient in trendelenburg position and felt better in a few minutes.
Per program and FDA proclamation of moratorium on use of mRNA monovalent vaccines and as booster doses after 31 AUG 2022, and DHA instruction to enter doses administered as such into VAERS; this report was entered for documentation purposes.
After 3 minutes post injection, pt experienced vasovagal, no LOC, no head trauma, clammy Pale, EMS at site, Legs elevated to 45 degrees, no further episode. vs 101/67, Hr 67, o2 Sat 99 . R 18. in no respiratory distress, no chest pain. Pt observed and hydrated. Dr and EMS personnel with patient.  Second VS Stable BP 117/75, HR 68 RR 20 SaO2 98 RA.
Rash and broken blood vessels across shoulders  High fever (103.5) Seizures Difficulty breathing  Headache  Fatigue Dizziness
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age (gender unspecified). On 04-NOV-2011 the patient was vaccinated with the first dose of GARDASIL. Lot# and administration route was unspecified. On 15-MAY-2013, the patient was in the office to receive the second dose. No adverse event reported. Additional information is not expected.
Information has been received from a registered nurse and a physician referring to a 12 months old patient of unknown gender. Concurrent conditions and medical history were not reported. On 02-MAR-2015, the patient was vaccinated with a dose of improperly stored (Merck) VARIVAX (lot# J013728, expire date 30-OCT-2015, dose, route, anatomical location were not reported) (incorrect product storage). No adverse effects were reported and no product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected since all the follow up has been done.
Fever 102+, chills, aches, headache, nausea, heart rate 135 at rest.  Symptoms began 8 hours after injection and lasted for 48 hours.
Raised, painful red bump at injection site. Counseled pt on pain relief options and advised to go to clinic for follow up.
Shortness of breath,chills,hot sweating. Later that night legs aching like a toothache all night sharp shooting pain in left shoulder couldn't sleep. Next day chills nausea aching legs migraine. Couldn't eat. Still having problems with legs.
Potential AE due to doses administered from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  Moderna vaccine was ordered on 03-Jan-2022.  The beyond use date of the vaccine was reported as 02-Feb-2022.  The reporter reported that they had a group of 13 pharmacies that had administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware that in some of the freezers there was a temperature excursion that their data logs showed.  They wanted to reach out to see if the vaccines had been compromised. The vaccines had never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had paper logs to monitor those temperatures.  The reporter asked whether they need to take any action in relation to the doses administered since the vaccines were stored in an unapproved freezer without a digital data logger. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log.  No treatment information was provided.
Moderate pain at injection site for over 48 hours Vomiting, chills, shakes, sweats the whole night after the vaccine.   Moderate Inguinal pain began on 2nd day after vaccine.  Full body aches began a few hours after the vaccine and continue on.  Moderate chest pain and tightness ongoing since the day of the vaccine.  Severe decreased appetite ongoing since vaccine.  Severe fatigue since vaccine and continues.
5-30-08 at 230 lower L VL 32 mm x 40 mm area red, swollen, & hot to touch.
body itchy; black and blue at injection site; injection site itchy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (body itchy), VACCINATION SITE DISCOLOURATION (black and blue at injection site) and VACCINATION SITE PRURITUS (injection site itchy) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031620A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Pain.    On 04-Feb-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 (body itchy), VACCINATION SITE DISCOLOURATION (black and blue at injection site) and VACCINATION SITE PRURITUS (injection site itchy). At the time of the report, PRURITUS (body itchy), VACCINATION SITE DISCOLOURATION (black and blue at injection site) and VACCINATION SITE PRURITUS (injection site itchy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications reported were asthma medicine, pain medicine. Treatment details was not reported by the reporter.
In addition to common side effects including fatigue and headache, my arms became covered in rashes, particularly my elbows. The rashes persisted for about 10 days and are starting to vanish.