chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 27-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypercholesterolemia since 2017. Concomitant products included CLINDAMYCIN and BENZOYL PEROXIDE for Acne, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in November 2020 and the estimated date of delivery was date. On 10-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 10-Feb-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Dec-2020, Pregnancy test: positive (Positive) Positive. On 02-Dec-2020, Ultrasound antenatal screen:. On 17-Feb-2021, Ultrasound antenatal screen: normal (normal) Normal.         The patient's estimated date of conception is 24 Nov 2020. Treatment information was not provided.
Severe headache that did not stopped and lasts 9 months. Right side of the head. Diagnosis: hemicrania continua. Neurological treatment. A persistant incapacity of the ability to conduct normal life functions.
I STARTED GETTING HEADACHES DIZZY THEN JOINT PAIN SO BAD EVEN PAIN PILLS DIDNT HELP, THEN THE PAINS SHIFTED INTO NEW JOINTS, BACK PAIN, SHOULDERS, LEGS I WAS PARALIZED IN PAIN FOR THREE OR FOUR DAYS AT A TIME COUDNT WALK, THEN IT MOVED TO THE JOINTS IN MY HANDS AND LEGS AND NECK  THEN I STARTED HAVING MORE TORUBLES BREATHEING .I WENT TO HOSPITAL THEY SENT ME TO JOINT SPECIALIST SHE PUT ME ON PREDIZONE AND I FELT GREAT FOR ALMOST A WEEK NO PAIN THEN IT ALL STARTD UP AGAIN  EACH TIME THE PAIN STRTS IT AWLAYS PAINNIN THE PLACE I GOT THE SHOT
Days after receiving flu shot in (R) deltoid developed severe soreness in (R) armpit area rec'd vaccine 9-13-16.
3 patients were given doses that expired on Saturday; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 patients were given doses that expired on Saturday) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) 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 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 patients were given doses that expired on Saturday). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (3 patients were given doses that expired on Saturday) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment medications provided.
This spontaneous report was received from an allied health and refers to a multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown dates, multiple unspecified patients were vaccinated with improperly stored dose of VAQTA (lot number M033611, expiration date 02-MAR-2018). No adverse effects were reported. Temperature and time frame of excursion was unknown by the reporter. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact reporter. Sender's Comments: US-009507513-1704USA006550: US-009507513-1704USA006551: US-009507513-1704USA006552: US-009507513-1704USA006552: US-009507513-1704USA006553.
102 degree fever; sweats; chills; body aches; fatigue; lack of appetite; sever gastrointestinal issues; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6206) via an unspecified route of administration  on 14Mar2021 at 13:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. Concomitant medications included apremilast (OTEZLA) 30 mg for an unknown indication from an unknown date.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not had any known allergies to medications, food, or other products. The patient underwent lab test and procedure which included body temperature on 15Mar2021 and the result was shown as 102. On 15Mar2021 at 01:00, the patient experienced 102 degree fever, sweats, chills, body aches, fatigue, lack of appetite, and severe gastrointestinal issues, which lasted about 36 hours and was once every 1-2 hours occurrence. The patient did not receive any treatment for the reported events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events of  fever, sweaty, chills, general body pain, fatigue, appetite lost and gastrointestinal discomfort was recovered on an unknown date in Mar2021. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER3784) via an unspecified route of administration in the left arm on 14Apr2021 at 13:30 (at the age of 39-year-old) as a single dose for COVID-19 immunisation and experienced no events.  No follow-up attempts are needed. No further information is expected.
Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 13Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious) with onset Mar2021, outcome "unknown", described as "Diarrhea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Red welt on the arm, size of two quarts in width, appeared 2 days after injection. Hot to the touch and itchy. Pain through the shoulder and armpit. Over the next few days, red welt grew outward, stretching toward armpit, and pain began radiating down toward the wrist and fingers. Middle of the welt began to look more bruised (gray vs red), while surrounding areas were slightly less red.
I observed patient fanning herself with a piece of paper. Patient reports feeling lightheaded, hot and nauseous. Wheeled patient to private area. Vital signs at 1612 were BP 113/62, P 81, R 20, O2 99% on RA. Patient removed mask and drank water. After 15 minutes patient reported feeling back to baseline and daughter wheeled patient to the car.
This spontaneous report was received from a pharmacy technician referring to a 66 year old female patient. The patient's pertinent medical history was not provided. Concurrently, she had a drug reaction/allergy to penicillin. Concomitant therapies included an unspecified statin, fluticasone propionate (FLONASE) and progesterone (manufacturer unknown). On 23-MAR-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly, lot # N013521, expiration date on 23-JAN-2019, as routine vaccination (strength was not reported). On 24-MAR-2018, reported as "the next day", the patient started to experience discomfort and pain at the injection site (injection site discomfort and injection site pain). Additionally, there was swelling in the muscle that was the size of a baseball (muscle swelling). After the injection, on an unspecified date in 2018, the pain and discomfort became very severe. The patient went to an unspecified emergency clinic and it was unknown if she was hospitalized. She received an unspecified medication as treatment but it was unknown if any laboratory study was performed. At the reporting time, the outcome of muscle swelling, injection site discomfort and injection site pain was unknown. The causality assessment between the aforementioned adverse events and PNEUMOVAX 23 was not provided. The pharmacy technician requested a lot check on PNEUMOVAX 23 lot number provided.
Fever of 100.6 F on 08/06/2015, fever of 101.2 on 08/07/2015, left upper arm very red, swollen and painful - approx. 6 x 5 in. Fatigue, aching knee joints, light-headedness, flu- like symptoms, chills.
Pityriasis rosea; This spontaneous case was received on 28-Oct-2020 with additional information (being processed together) received on 29-Oct-2020 from physician via Med Communications (reference number: SEQW20-04410) and concerned a 63-year-old female patient.  The patient's concurrent conditions included low vitamin D and rash. The patient's historical vaccines included Afluria Quadrivalent (influenza vaccine) in 2019, after which the patient was diagnosed with pityriasis. The patient was not taking any concomitant medications.  On 15-Oct-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, anatomical location: right deltoid, route of administration: not reported) for influenza prophylaxis. The batch number reported was P100251770, expiration date: 30-Jun-2021.  On the same day, the patient was vaccinated with non-company co-suspect Shingrix vaccine (varicella zoster vaccine rge (cho); dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.  On 19-Oct-2020, four days after vaccination, the patient developed rash. The patient did not receive any treatment.  On an unknown date in 2020, the patient went to her dermatologist and after biopsy, she was diagnosed with pityriasis rosea.  At the time of initial reporting on 28-Oct-2020, the patient had not recovered from the event.  The reporter did not provide a causality assessment.  This case is linked to the cases 202005898 and 202005897 (the same patient).   Additional information received on 03-Dec-2020 from physician, with additional information (being processed together) on 07-Dec-2020: Historical vaccine from 2018 removed, as it was confirmed that the rash was a month before receiving the flu vaccine. Rash was added as historical condition, Lab data updated with biopsy. Event of rash recoded to pityriasis rosea, since diagnose from dermatologist was provided. Narrative was amended accordingly.  Company comment: A 63-year-old female patient experienced pityriasis rosea 4 days after administration of Afluria Quadrivalent and a non-company co-suspect Shingrix vaccine. The event was confirmed after biopsy and consultation with dermatologist. The patient's concurrent conditions included low vitamin D and rash, while historical vaccines included Afluria Quadrivalent (influenza vaccine) in 2019, after which the patient was diagnosed with pityriasis. The patient was not taking any concomitant medications. Causality is assessed as possibly related having in mind presented information.; Sender's Comments: A 63-year-old female patient experienced pityriasis rosea 4 days after administration of Afluria Quadrivalent and a non-company co-suspect Shingrix vaccine. The event was confirmed after biopsy and consultation with dermatologist. The patient's concurrent conditions included low vitamin D and rash, while historical vaccines included Afluria Quadrivalent (influenza vaccine) in 2019, after which the patient was diagnosed with pityriasis. The patient was not taking any concomitant medications. Causality is assessed as possibly related having in mind presented information.
Driving home right arm started shaking uncontrollably, then my left arm and then my right leg.   I pulled into a store parking lot where there happened to be a cop.  My insides were shaky.  They called ambulance.  They gave me iv and Benadryl.  Did a lot of blood work and tests.  Shaking lasted 3 hours.  While laying at rest heart rate spiked as high as 142 and then a few times in mid 120s.    Need to know if I should get 2nd dose
face feels like she came from the dentist office; annoying numbness; not severe but feels like Novocain is wearing off; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL DISCOMFORT (face feels like she came from the dentist office), HYPOAESTHESIA (annoying numbness) and FEELING ABNORMAL (not severe but feels like Novocain is wearing off) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]) for Headache.    On 01-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced FACIAL DISCOMFORT (face feels like she came from the dentist office), HYPOAESTHESIA (annoying numbness) and FEELING ABNORMAL (not severe but feels like Novocain is wearing off). At the time of the report, FACIAL DISCOMFORT (face feels like she came from the dentist office), HYPOAESTHESIA (annoying numbness) and FEELING ABNORMAL (not severe but feels like Novocain is wearing off) was resolving.        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.   Other concomitant medications included blood pressure medications. Patient reported of not taking anything for numbness. Treatment medications not reported.
Herpes Zoster- Information has been received from a physican concerning a patient who was vaccinated with the first and second dose of varicella virus live at ages 1 and 5 respectively.  Subsequently the patient developed zoster.  The reporting physician noted that the patient still had some post herpetic neuropathy and mild skin hypersensitivity.  The patient was treated with acyclovir.  Additional information has been requested.
Adverse event reported on 6/19/2012.  Stated had bilateral hip joint stiffness and muscle aches/weakness to bilateral legs.  On 6/19/2012 stated had been riding horses after vaccine, so not sure if symptoms were related to vaccine.  On 6/19/2012, stated symptoms getting better.
The day after immunization, she woke up with swollen legs and rashes on both arms. She went to the doctor and was given steroids.
This spontaneous report as received from a physician refers to his 15 month old daughter. The patient had no relevant medical history. The patient had no history of reactions to vaccines. On 11-SEP-2014 the patient was vaccinated with VARIVAX (Merck) in the thigh (dose, frequency, route and lot # unknown). Concomitant therapies included M-M-R (manufacturer unknown) and PCV (unspecified) on 11-SEP-2014 in the thigh.On 19-SEP-2014 the patient developed subcutaneous induration about the size of a walnut, about 7.5 cm, and a tiny vesicle around the site of administration. Topical cortisone cream was applied to the induration. On 20-SEP-2014, the patient experienced erythema. The physician wasn't sure if it was an insect bite, hematoma, or a reaction to the VARIVAX (Merck), since the onset of events were 8 days after the vaccine. The physician read in the prescribing information that if erythema developed after VARIVAX (Merck), it would be within 2 days. The patient had been acting normally. There was no relevant lab data. As of 20-SEP-2014, it was unknown if his daughter would receive VARIVAX (Merck) again and the size of induration had decreased, erythema persisted, and the outcome of tiny vesicle was unknown. The physician did not have the lot number or expiration date when asked. The relationship between events and VARIVAX (Merck) was unknown). Additional information has been requested.
There was just normal arm soreness immediately following the injection. I remember feeling a little warm that night when I slept. Then about 11-12 days later I noticed a rash appear at the injection site. The rash was about 6" large. It didn't hurt or itch, but it did feel slightly warm to the touch.  That same day I started to feel some fatigue. I'm not sure if it was true fatigue from the vaccine kicking in or if it was due to other circumstances (or possibly even a placebo type effect taking place?). The rash has slowly started to fade. I can still see it today, but it's smaller and not as dark/noticeable.
Large local inflammatory rxn (painful red edema & induration for 3 days), followed by discrete urticaria from knee to hip for 2-3 days.
20 year old male immunized with SPV and typhoid vaccines develops chest pain on the evening of 12/25. Chest pain continues into 12/26 causing patient to go to the hospital. Patient is hospitalized with myocarditis. Symptom: Chest Pain, sub-sternal, Start: 12/25/05 End: 12/26/05. Comment: Described as a sitting on my chest substernal chest pain without dyspnea. Symptom: Nausea without vomiting Start: 12/25/05 End: 12/26/05. Comment: occurred in association with the chest pain. Follow-up Information: 20 y/o male presents for followup of hospitalization for myocarditis. Patient reports he was hospitalized from December 26 through December 29, 2005 in Knoxville, Tennessee. The patient was on leave at his grandmother's house when he developed substernal chest pain starting on Christmas night. He reported the pain was similar to chest pain he had when diagnosed with "myocarditis" at age 17. He denied any SOB or vomiting with the pain. He managed to sleep some from the pain but the pain persisted into the next day. The chest pain was worse by the am of December 26, 2005. He noticed the radiation of pain into both arms and nausea. No vomiting reported, no dyspnea, no shortness of breath on the am of December 26. The patient decided to go to the hospital ER. The patient was seen in the local ER. When the ER doctor noticed the abnormal cardiac chemistries, the patient was transoprted via ambulance to a hospital for further care. The patient was admitted to the hospital on 12/26/05. Patient reports he was hospitalized at age 17 for "myocarditis". He does not remember or know what the etiology was. Review of systems was positive for Chest Pain. The patient also complained of achy joints for one week prior to his chest pain.
Case number PHEH2014US021408 is an initial spontaneous report received from a nurse on 23 Oct 2014. This report refers to a 93 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly at a dose of 0.5 ml on 30 Sep 2014. It was reported that on an unknown date after vaccination, she experienced fever, chills, muscle ache and fatigue. The events outcome was reported as complete recovery. The seriousness and causality were not reported.
MINOCA-MYOCARDIAL INFARTC NON-OBSTRUCTIVE CORONARY ARTERIES HOSPITALIZATION FOR 3 DAYS. CATHETERISM HAD TO BE DONE
Twelve hours after I received the injection (starting at 12:45 AM on Friday), I experienced chills and body aches. The chills lasted approximately 2 hours. The body aches increased in intensity over time for the next 24 hours and I developed stiffness in my joints, too. Starting at 9:00 AM on Friday, I took acetaminophen or ibuprofen every 6-8 hours, which made the aches less severe.  I also felt fatigued for approximately 72 hours afterwards (but this could have been due to the loss of sleep the night after I received the injection.)   I also experienced a red, hard, hot, and tender-to-the-touch rash on my arm (diameter: 3" x 4") about 2" below the injection site on my left arm on Sunday afternoon (approximately 72 hours after I received my injection). I noticed this immediately after taking a hot shower. During the afternoon, the redness and hardness became less noticeable. It is almost 24 hours after noticing the rash; the area on my arm is still warm and slightly pink, but it is no longer tender or hard.
She got hives after 30minutes of vaccination randomly. She got hives from face to feet at 10pm. I gave her BENADRYL 25mg every 4 hours and she was fine next morning.
After receiving  Pfizer booster, pt was initially fine, but 5 minutes later, he experienced dizziness and fainted, falling to the floor.  He came to within a minute but experienced lingering nausea, dizziness, weakness and after 10 minutes also threw up from the nausea.  911/paramedics were alerted as patient was not recovering completely.  Vitals were taken and all reported to be good and patient felt better after paramedics were there and was able to stand and leave (returning home with wife instead of going to hospital).
One of the above 3 patients received an incorrectly prepared ActHib vaccine. ActHib was prepared with MMR diluent instead of Diluent packaged with ActHib Vaccine. Pts re-immunized.
Information has been received from a physician concerning a male patient (age not reported) who on unspecified date was vaccinated with a second dose of Rotateq (Lot # not reported). On 26-MAR-2007 the patient experienced hematochezia. The patient sought unspecified medical attention. Subsequently, the patient recovered from hematochezia. There was no product quality complaint involved. No further information is available.
Information has been received from a physician via a company representative referring to a 2 month old female patient. The patient's concurrent conditions, concomitant medication and medical history were not provided. On an unspecified date of 2016 (reported as "sometime last week"), the patient received a dose of ROTATEQ (oral, lot#, dose and dose number were unspecified) to prevent rotavirus. On an unspecified date after this, the "patient's whole family, and possibly also the patient, developed diarrhea". No lab diagnostics study was performed. The present status of the patient and the patient's family was unspecified. It was unspecified how many people were included in the patient's "family". Additional information is not expected because there was no consent to contact the physician.
Every time I have taken the COVID-19 vaccine, with the exception of my 3rd dose, my ALT levels have risen. The rising numbers were unknown to me until I contracted COVID-19. I was participating in a trail at the time, and they performed X-rays on my chest. I was feeling pain in my right breast, and it was swollen. The rising levels were discovered after I had to go to the hospital on multiple occasions within a 30-day period. While seeing my gynecologist, she informed me that I had blood in my urine. I was told that I had long haul COVID-19. They tested me for all sorts of issues like breast cancer bladder cancer. Ultimately, I was taken off all of my mental health medication to help with the elevated ALT levels. I have been able to get the ALT levels down each time. After receiving this fourth dose of Pfizer, I almost immediately didn't feel well. I could tell that my liver was inflamed again, and I was feeling some pain and swelling in my breast. A few days later I was feeling worse, and I tested myself for COVID-19, but it was negative. Within the next 5 days, I became more uncomfortable and had been feeling flu like symptoms. I went to the doctor for another COVID-19 test. I also did a urinalysis and blood culture, along with a liver function test. The doctor was afraid to give me any antibiotics because of the issues I've had with my liver. I am now being treated for pneumonia. I'm still having pain in my abdomen and am scheduled for an ultrasound this coming week.