chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning an 8 month old male with congenital adrenal hyperplasia, "AGI", and a history of sepsis victoriana who on 22-AUG-2007 was vaccinated with his third oral dose of Rotateq (Lot# 656379/0505U). Concomitant vaccinations included poliovirus vaccine inactivated (Lot# Z0547) and other multiple medications (specifics unknown). On that same day, the patient developed a high fever and a seizure a few hours after vaccination and was hospitalized. The patient's lab diagnostic studies included bloodwork taken regularly. The patient's recovery status was unknown. There was no product quality complaint. Additional information has been requested.
Pfizer 3/3 and 3/24. Positive on 8/13 admitted on 8/16-current
herpes zoster; post herpetic neuralgia; vision problems; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On or about 07-FEB-2017, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles and zoster-related conditions.  On an unspecified date, subsequent to the patient vaccination, the patient presented herpes zoster, post herpetic neuralgia and vision problems. As a direct and proximate result, the patient had been treated by a medical provided. Additionally, the symptoms had been resulted in physical limitation not present prior vaccination. The patient sustained severe and permanent injuries; the patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's conditions.  As a direct and proximate result, the patient suffered severe and permanent physical injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.   The reporter considered the event of herpes zoster, post herpetic neuralgia and vision problems to be related to zoster vaccine live (ZOSTAVAX).
On 11/4/21 (13 days post moderna booster shot) the following symptoms began and have continued until current date (11/19): Urticaria (hives) occuring over entire body Angioedema (subdermal swelling, pain) on soles of feet and pads of hands Dermatographia over entire body Abdominal pain
This spontaneous report was received from a healthcare worker concerning a male patient of unknown age. No concurrent conditions or medical history were reported. On 14-MAY-2015, the patient was vaccinated with the first dose of VAQTA injection 25/0.5 and on 13-JUL-2015, the patient received the second dose of VAQTA injection 25/0.5 (units not reported) (lot. No., dose, route and anatomical location of administration of both vaccines were not reported). No adverse effects reported. Additional information has been requested.
Doctor provided this 15-year-old patient with the Pfizer vaccine at the Clinic on 04/12/21. Upon processing paperwork on 04/14/21, pharmacy manager, discovered the incident, and WAS NOT able to contact the patient because the phone number was not provided on the consent form **
Extreme fatigue (slept for deeply for three hours). Weakness. Slight dizzyness. Very minor issues with breathing but can get a full, deep breath. Significant aching at injection site. Nothing severe, however, warranting emergency care.
I tested negative for COVID-19. I had Pneumonia like symptoms, coughing, postnasal drip, fever of 101, and shortness of breath. My symptoms lasted for about 2 weeks total. I was prescribed a prednisone and amoxicillin. I am feeling much better now.
DRANK COFFEE 30 TO 40 MINUTES AFTER TAKING VIVOTIF; This spontaneous case (PVX2019-791) was received from pharmacist on 02-Apr-2019. It describes a female consumer who "drank coffee 30 to 40 minutes after taking Vivotif". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.   Case report: The consumer drank coffee 30 to 40 minutes after taking the third dose of Vivotif on 02-Apr-2019.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "drank coffee 30 to 40 minutes after taking Vivotif" was unknown.  Company's Comment: The causality of the event "drank coffee 30 to 40 minutes after taking Vivotif"  was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "drank coffee 30 to 40 minutes after taking Vivotif"  was considered as not applicable.
still very tender; extremely tired; next morning even redder and started spreading; discomfort as if it was shingles; not itching and it hurts; it felt like it was just sitting there in my arm; several hours later, arm started getting sore; felt my arm, it was real hot; felt swollen/5-inch diameter circle; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (it felt like it was just sitting there in my arm), PAIN IN EXTREMITY (several hours later, arm started getting sore), FEELING HOT (felt my arm, it was real hot), PERIPHERAL SWELLING (felt swollen/5-inch diameter circle) and ERYTHEMA (next morning even redder and started spreading) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Appendectomy (2 years ago). Concurrent medical conditions included Cholesterol, Blood pressure and Allergy (cocktail with two allergy).   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced FEELING ABNORMAL (it felt like it was just sitting there in my arm), PAIN IN EXTREMITY (several hours later, arm started getting sore), FEELING HOT (felt my arm, it was real hot) and PERIPHERAL SWELLING (felt swollen/5-inch diameter circle). On 08-Apr-2021, the patient experienced ERYTHEMA (next morning even redder and started spreading), DISCOMFORT (discomfort as if it was shingles) and PAIN (not itching and it hurts). On 09-Apr-2021, the patient experienced TENDERNESS (still very tender) and FATIGUE (extremely tired). At the time of the report, FEELING ABNORMAL (it felt like it was just sitting there in my arm), PAIN IN EXTREMITY (several hours later, arm started getting sore), FEELING HOT (felt my arm, it was real hot), PERIPHERAL SWELLING (felt swollen/5-inch diameter circle), DISCOMFORT (discomfort as if it was shingles), PAIN (not itching and it hurts), TENDERNESS (still very tender) and FATIGUE (extremely tired) outcome was unknown and ERYTHEMA (next morning even redder and started spreading) had not resolved.            Concomitant products included two cholesterol medications and blood pressure medication.Treatment included Tylenol every four hours.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.     On 20-Mar-2021 at 12:06 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 12:06 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 27.72.  Concomitant products were not provided.  On 20-Mar-2021, Excursion time was 10A, temperature was 37, total doses given for the day was 184, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 14 vials were sent to clinic. Vaccine BUD date was 08-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
husband called & stated pt recv vax 14OCT97 & was nauseous, fever, red/hot spot, swollen area;husband thought this was d/t vax since  wife had flu prev;RN suggested cool compresses, APAP for next 24hr;flu vax pre drawn;pneum drawn 1" needle
Patient received the flu vaccine on 11/8/11 at 6:40 pm. She complained of overall "itchiness" around 7:15pm - No swelling, no temp, problems breathing, or chest tightness. No rash noted. Called MD who told her to take BENADRYL - 50 mg by mouth x 1. Pt saw clinic MD - Dr on 11/9/11 and symptoms resolved. He referred pt to an INFLUENZA & allergy clinic.
got up 2PM bawled hard until 4PM & cont crying until 10PM feel asleep & OK p/that; seems to have sore legs; mom used APAP right p/shot;
It's not too too painful it feels like the muscle is been torn apart; Same exact ripping sensation; The first couple of days it was a dull pain and then it was a transition and felt the same exact ripping sensation; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE DISCOMFORT (It's not too too painful it feels like the muscle is been torn apart), LIMB DISCOMFORT (Same exact ripping sensation) and MYALGIA (The first couple of days it was a dull pain and then it was a transition and felt the same exact ripping sensation) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. RA6059) for COVID-19 vaccination.     The patient's past medical history included Surgery (The patient had 7 surgeries from breaking bones (patient played rugby)).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCLE DISCOMFORT (It's not too too painful it feels like the muscle is been torn apart), LIMB DISCOMFORT (Same exact ripping sensation) and MYALGIA (The first couple of days it was a dull pain and then it was a transition and felt the same exact ripping sensation). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MUSCLE DISCOMFORT (It's not too too painful it feels like the muscle is been torn apart), LIMB DISCOMFORT (Same exact ripping sensation) and MYALGIA (The first couple of days it was a dull pain and then it was a transition and felt the same exact ripping sensation) outcome was unknown.            No concomitant medication were reported.  Patient reported that it freaking hurts and it was freaking unusual, like tearing your muscle from two different sites. The patient said that was still feeling it when it stretch arm. The patient said have not been sick in life. Treatment details include BPC 157 and healing peptides.   This case was linked to MOD-2021-255478 (Patient Link).
Patient was 17 years old at time of vaccination. Patient's parent has been alerted that their child would not be eligible to receive a booster of Janssen vaccine as they are not 18 years old.
Initial and follow-up information has been received via a pregnancy registry, from a registered nurse, concerning a 19 year old female patient with a history of abnormal papanicolaou (PAP) smears, who on 23-JUL-2007 was vaccinated IM, with the first dose, 0.5 ml (lot # 0469U) and on 23-OCT-2007 vaccinated IM with the second dose, 0.5 ml, of GARDASIL (lot # invalid). Concomitant therapy included prenatal vitamins (unspecified). On 29-NOV-2007 (currently 7 weeks and 6 days gestation), the patient was pregnant. The patient was seen in the office and the pregnancy was reported as normal (estimated date of delivery, 27-AUG-2008). In follow-up was reported that on 22-FEB-2008, at 14.6 weeks from LMP, the patient had an elective termination. Upon internal review, elective termination of pregnancy was considered to be an other important event. No further information is expected.
BODY ACHES; MUCOUS; CHILLS; HEADACHE; FEELING NOT GOOD; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination at left arm. No concomitant medications were reported. On MAR-2021, the subject experienced feeling not good. On 19-MAR-2021, the subject experienced body aches. On 19-MAR-2021, the subject experienced mucous. On 19-MAR-2021, the subject experienced chills. On 19-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, headache, mucous, body aches, and feeling not good. This report was non-serious.
Arthragia (joint pain) x>3mo.  Reproduced and worsened by shot #2. Member remains on active duty with a permanent exemption to the anthrax vacine. He continues to have joint pain and stiffness especially in the hips that is easily aggravated by exertional exercise. With atmospheric pressure changes, pain in the elbow and shoulder is exaccerbated. Membr reports that he also has been experiencing new symptoms of irritable bowel syndrome since Fall 03.
Patients Mother brought him to vaccination site. Mom reports that the person who administered vaccine, stated that the patient is very small, and she was only going to administer half a dose. Mom reports that she saw some solution remaining in syringe. Pt is a 16 yo male, but only weighs 97lbs. Patient's Mother brought him in for his annual pediatric exam today, and asked myself and the provider if half dose was appropriate, we have not heard of half doses for children.
This spontaneous reported as received from a consumer refers to his male son, of unknown age. Medical history and concurrent conditions were not reported. In approximately 2002 (reported as about 12 years ago), the patient was vaccinated with M-M-R II (dose, strength, route, lot number and expiration date). Secondary and concomitant therapies were not reported. Consumer reported that his son had a violet reaction to M-M-R II in approximately 2002 (reported as about 12 years ago), with high fever. Outcome of the adverse events were not reported. Additional information has been requested.
ARM PAIN; HEADACHE; LOW GRADE FEVER; This spontaneous report received from a patient concerned a female 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced arm pain, headache, and low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm pain, headache and low grade fever was not reported. This report was non-serious.
Pt given KINRIX and PROQUD approx 1:45 on the afternoon of 12/1. By the next day, mo noticed a couple "bumps" on her left thigh that progressed to a swollen area about the size of a fist. Then about 5 pm she developed redness and swelling to the rt side of her face, swelling progressed down neck, chest and behind ear. Tonsils also looked red and swollen. No labored breathing or wheezing. Mom administered oral Benadryl and started to take her to the ER. On their way to ER her sx started to improve and they returned home. Mom gave another dose of Bendaryl on 12/3 and today 12/4 is applying topical hct to swollen area on thigh which is not half the size is was.
I got sick; chills; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I got sick), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (I got sick), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ILLNESS (I got sick), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.            Patient is on Compound hormone therapy in a capsule form and Medication to control bladder leakage.   This case was linked to MOD-2021-404997 (Patient Link).   Reporter did not allow further contact
Patient received a Janseen  vaccine on 4/2/2021 but it was documented in system that he had received Moderna. Patient came in on 8/18/2021 to get a dose of COVID vaccine. We we got into the the System encounter for vaccination, we noted that it was documented that he had received a Janseen vaccine. We reviewed the image of the vaccine Encounter Form that pt had filled out and signed by both patient and the vaccinator--it stated which vaccine was given on the form. It was confirmed that he had received the Janseen vaccine on 4/2. Patient was notified that he does not need any more doses of COVID vaccine, correction was made in System, and he was given a vaccination card stating that he had received Janseen vaccine on 4/2/21.
Immediate symptoms arm pain, dizziness then within an hour bad headache.  Arm pain pretty bad for almost 2 weeks.  Arm pain had just gotten better and I went for a routine nuclear stress test.  The evening after the test I was woken by thump in my back and chest about 5 times.  After waking, I would become extremely dizzy.  I got up went to the bathroom each time.  Every time I tried to go back to sleep I would be woken by thump again.  Byy Wednesday I was in the ER with Tachycardia.  Pain in left side and heart racing continued.  I was in the ER again 4/30 and 5/3. I lost 10 Lbs  My left side pain throughout my ribs, back, should blade and stomach distension still occurring.  The left side of my back and my left breast are swollen.  I have had mammogram, CT scan, ultasound and MRI's plus many visits and calls to many different specialists - heart, GI, Endocrinologist, OBgyn, and primary care doctors over the past 2 months with no answer as to what occurred.  I am taking metropol for the heart racing and it has helped but the left side swelling and pain is persistent.  I am not sure if this relates to the shot but maybe a combination of the 2?  I do not know what happened to my body, but have never experienced anything like this before.  And I had a nuclear stress test at age 40+ with no problems.  My heart was fine but it was completed because of family history, lyme disease and babesia.
Patient had a vasovagal type of reaction. Patient briefly blacked out and then came to a couple seconds later about 3 minutes after the vaccine was administered. After coming to, patient was shaking and profusely sweating until ambulance arrived and checked vitals
This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in a 55-year-old female patient who received SHINGRIX (batch number DK74P, expiry date unknown) and (batch number 75A37 ?, expiry date unknown). Concomitant products included FLUZONE Quadrivalent. On 25th January 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the dose was an unknown dose. In January 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were unknown. It was unknown if the reporter considered the injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient had SHINGRIX (subunit vial lot number DK74P, adjuvant vial lot number 75A37) in the left deltoid. She also simultaneously received Quadrivalent FLUZONE intramuscularly in the right deltoid. The patient presented to the pharmacy on 29 January 2018, after having seen her physician who advised her not to get a second shot, complaining significant pain to the light touch over a 3 by 3 area in the vicinity of where she received the SHINGRIX shot. The pharmacist described the area as red. She did not press on the area but only gave a light touch and the patient complained of significant pain. She did not think the area was indurated. The patient was able to perform normal range of motion. The patient did not have any significant local reaction at the injection site of FLUZONE QIV. There were no other complaints reported. No further information was provided regarding the event. The reported adjuvant batch number (75A37) did not exist in the sales database and was updated to 75A37 ?.
Extreme arm pain that spread down the arm and across the shoulder to neck/shoulder and neck pain, arm was extremely warm. Pt ran fever 100.9 in office while taking ibuprofen. Pt did require steroid dose to counteract reaction. Very limited ROM. Started 1st 24 hrs through 3d. Later could not use arm.