chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Which continued throughout my pregnancy and I then had a placental abruption preterm; I received vaccine during my first trimester of 2nd pregnancy. I had awful cramping that started after my 2nd dose.; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 29-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 23Sep2021 as dose 2, single (Lot number: FF2687) at the age of 29 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient was 3 weeks pregnant at the event onset. Concomitant medication(s) included: PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: FC3182, Location of injection: Leg Left), administration date: 26Aug2021, when the patient was 29-year-old, for COVID-19 immunization. The following information was reported: MUSCLE SPASMS (life threatening) with onset 01Oct2021, outcome "recovered with sequelae", described as "I received vaccine during my first trimester of 2nd pregnancy. I had awful cramping that started after my 2nd dose."; PREMATURE SEPARATION OF PLACENTA (medically significant, life threatening) with onset 01Oct2021, outcome "recovered with sequelae", described as "Which continued throughout my pregnancy and I then had a placental abruption preterm". The events "which continued throughout my pregnancy and i then had a placental abruption preterm" and "i received vaccine during my first trimester of 2nd pregnancy. i had awful cramping that started after my 2nd dose." required physician office visit and emergency room visit. Therapeutic measures were taken as a result of premature separation of placenta, muscle spasms.  Clinical course: She had no issues with her pregnancy or delivery for her first child. Emergent C Section did for patient. She received vaccine during my first trimester of 2nd pregnancy. I had awful cramping that started after my 2nd dose. Which continued throughout my pregnancy, and I then had a placental abruption preterm. The AE resulted in other healthcare professional office/clinic visit, Emergency room/department or urgent care, life threatening illness (immediate risk of death from the event).  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information in the case, an association between the reported events MUSCLE SPASMS & PREMATURE SEPARATION OF PLACENTA  and The suspected drug cannot be ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Unknown event/ Brother died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Unknown event/ Brother died) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Heart disorder (Heart problems).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. An autopsy was not performed.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.   Reporters brother died and does not know what happened to him. They did not do an autopsy or anything. Reporter stated her brother had Moderna.   No treatment medication was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This spontaneous case concerns a 79-year-old, male patient with medical history of Heart problems (unspecified), who experienced the unexpected, serious event of death. The event occurred unknown number of days after receiving an unspecified dose of the mRNA-1273 vaccine. Of note, the vaccination date and the event onset date were not provided, hence, the onset latency could not be assessed. The reporter stated that the patient (her brother) died after Mother's Day and the reporter did not know what happened to the patient. No further details were provided. The cause of death was not provided. An autopsy was not performed. The medical history of Heart problems (unspecified) remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 79-year-old, male patient with medical history of Heart problems (unspecified), who experienced the unexpected, serious event of death. The event occurred unknown number of days after receiving an unspecified dose of the mRNA-1273 vaccine. Of note, the vaccination date and the event onset date were not provided, hence, the onset latency could not be assessed. The reporter stated that the patient (her brother) died after Mother's Day and the reporter did not know what happened to the patient. No further details were provided. The cause of death was not provided. An autopsy was not performed. The medical history of Heart problems (unspecified) remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: unknown cause of death
Intern was administering a flu vaccine and removed the needle prior to administering the majority of the vaccine.  Loss was excessive. Dose was repeated and successfully administered
red bumps appeared on all over abdomen about 0.5 hours after administration of fluarix vaccine, no fever, red bumps are painful to touch
Hives; This spontaneous case was reported by a pharmacist and describes the occurrence of URTICARIA (Hives) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) had resolved. Not Provided      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.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Non significant follow up received on 17-MAY-2021, no new information
Pain, redness (about 3 cm in diameter) and swelling at injection site. Muscle pain, soreness in joints (whole body),  muscle pain, tiredness, shivering uncontrollably, fever, and weakness. Took tylenol 1000mg and went to bed at 5pm, I literally could not function. When I woke up the following day, the only remaining syptoms were at the injection site.  Today is day #5 and I'm symptom free.
heart racing, hot inside, hives on neck, offered benadryl , which she declined.
Started vomitting at noon 8/4/09 and again at 8pm. Had fever 99 degress off and on 8/4/09. C/o body aches 8/4-8/5. Tylenol given at 12pm 8/4/09 and 5p 8/4/09. Vomitting subsided today, no fever today c/o body aches.
Later that afternoon swelling, redness and pain noted at injection site.  Area 2.5cm x 5cm (marked with pen), by 12:00 PM next day 2/19/2014 redness and warmth spread to 5cm x 7.5cm.
Male patient reported dryness in the lips, blurry vision, and hot flash in the neck. In that moment head of staff are notified and paramedic attended the situation. Vital was perform; HR 52, BP 100/60, SO2% 95. Patient was sweeting and was reclined in the floor we legs lifted. After works patient was observed by the paramedic and  head nurse. Patient was alert, oriented and responding to questions. Final Vital sing; BP 120/70, SO2% 96, and was transfer to observation area with 30 minutes.
T102, inc pain swelling, redness to lt arm;sterile abscess, gen malaise, h/a;
Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 07-JAN-2019, the patient was vaccinated with improperly stored VAQTA (lot # R013859, expiration date: 14-JUN-2019, strength, dose, frequency and route were unknown) for prophylaxis. No adverse effects were reported. The vaccines were exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. The case was one of the cases received from the same reporter. Sender's Comments: US-009507513-1901USA004786.
Chills intense back pain  Other joint pain wrists fingers ankles Fatigue Injection sir swelling and pain
Fever of 101; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 15-month-old female patient (not pregnant) received BNT162b2 (COMIRNATY), on 28Jun2022 at 14:45 as dose 1, single (Batch/Lot number: unknown) at the age of 15 months intramuscular, in right leg for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 28Jun2022 at 15:30, outcome "recovered", described as "Fever of 101". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia.  Additional information: It was reported that facility type vaccine was Doctor's office/urgent care. No other vaccine in four weeks. No covid tested post vaccination. No Known allergies. It was reported that patient had no other medical history.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Approximately 4 hours after receiving the  the vaccine on 4/7 I experienced flu like symptoms including  inability to regulate my body temperature and muscle aches.  This continued for the following two days.  On 4/10 I began what I thought to be menstrual bleeding, this flow  has been consistent and  persistent  as of today 4/18 with no indication of reducing in volume. On  4/15  I began to notice pin point non-clustered petechiea  throughout my arms legs and chest.  The number present on  my body appears to be increasing in a random distribution.  No other observable abnormalities at this time.
Rash noted by parents about 30 hours after vaccination and during bath time. The rash was on his chest at first at daycare. Today the rash was found to have spread to entire torso and into diaper area. Daycare worker noted her to be very sweaty.
Pt reports one hr post vaccination --> swelling, redness - tenderness in arm below site of vaccine. Applied ice, symptoms decreased, but remain present - effected area covers about a 5cm area near bicep.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On an unknown date, the patient was administered an improperly stored dose of Oka/Merck VARIVAX (lot # N012487, expiry date: 20-APR-2019) for prophylaxis (product storage error). Dosing details were not reported. It was reported that the MERCK STERILE DILUENT (lot # and expiry date unknown) used was properly stored. The temperature excursion occurred on unknown dates between -2.6 degrees Celsius (°C) for a time frame of 28 minutes. No previous temperature excursion occurred. The call was because of a data logger. No adverse effects were reported. Product quality complaint (PQC) was not involved.
After the patient went to bed on the day of the Tdap vaccination, he developed severe abdominal pain without nausea or vomiting.  Went to the ER the next day (03/23/2010).  Was prescribed a medication (he does not know name), and told he has gastroenteritis.  The problem had resolved by 03/24/2010.
Patient reports "the room got really bright" the morning after receiving the vaccine. Lasted briefly (<10 minutes; exact time unknown). No headache or other side effects reported.
I began to experience extreme fatigue shortly after my second dose of Pfizer. The fatigue lasted for a couple months. It was difficult to even get out of bed. It has slowly improved but still not gone. I had an extremely sore arm for a week after 2nd shot. I am experiencing changes in menstruation- which may have nothing to do with the vaccine.
Facial: erythematous maculopapular confluent rash chest, abd, back: Lighter macular erythematous rash. Vaccine (MMR) given: 6-30-16. Date of eruption: 7-10-16. Temp: 99.7. Given DECADRON 4 mg IM, prednisone 10 mg taper, VISTARIL.
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I am extremely concerned about the anthrax vaccine. I am not a vaccine expert, but after having received five anthrax shots myself, and doing extensive reading and research, I feel there is a big problem with the vaccine. If nothing else, there are many questions that need answers. My story should be a familiar one. I was in excellent health and had no family history of autoimmune disorders. While in the military as an enlisted member, I received five anthrax shots. Three cam from lots later identified by the FDA to contain squalene. This is not the adjuvant of the original, licensed vaccine. I had severe site swelling, and by the third shot, the red, hot welt covered 70% of my arm. I had severe fatigue, malaise, joint pain and muscle soreness. I had a miscarriage after the third shot. I have since had to leave the military. Part of the reason is that I would rather quit than be subjected to another anthrax shot. The other part of the reason is that I am now physically disabled (40% so far) with an undiagnosed autoimmune disorder. My blood has been tested and I am positive for anti-squalene antibodies as well. The original vaccine from the 1970's has never proven to be effective. Studies are vague and ambiguous at best. The original product insert states that adverse reaction rate to be 0.2% with minimal side effects. This is well within acceptable industry standards. However, the product insert was changed in 2002 and the adverse reaction rate was raised to 5-35%. This is very high and begs the question, "Why did the rate change so drastically if the vaccine has not been changed?" The updated product insert also lists many autoimmune as side effects and includes fatalities. Why would anyone risk a 35% chance of coming down with an incurable autoimmune disorder or dying from taking a vaccine that has never been proven to be completely effective against all strains and all delivery methods. Finding squalene in the anthrax vaccine is of particular concern since squalene is well documented to cause autoimmune diseases in animals. The military has argued for years that we need a more effective vaccine and has been promoting a second generation vaccine that is not really any different from the original except that squalene is used as the adjuvant. Squalene has never been licensed for use in humans and in my opinion never should. Yet, the FDA found squalene in five lots of anthrax vaccine in amounts equating to a standard dose range study. After finally releasing the information (after sitting on the results for 16 months), the FDA has yet to come up with a plausible reason as to how the squalene got in the vaccine. I would like to know why the FDA hasn't continued to test other lots of anthrax vaccine for this illegal substance. My concern extends beyond just the anthrax vaccine to other new generation vaccines in development that may contain squalene as an adjuvant. (OMIC)
Once i received the 2nd dose-  My arm swollen  for 3 days - continue to be red as thought rash going over the top half of arm around the injected area.  chills , body aches, fever.  stayed in bed the next 3 days.    4 day sweating, and low grade fever , fatigue very weak.
The patient's first dose was Pfizer, Staff member administered the wrong second dose vaccine to patient.
3/18/2023  I had a bladder infection. I had urgency, tingling and burning. I had a telehealth appointment on 3/20/23 and  I was prescribed Bactrim and started taking it that day.  Within a few hours, my symptoms were gone. I took the medication for a week.
This was my first vaccine.  Initial reaction at time of injection was minimal - the standard sore arm, and a little bit tired.  A few days ago (about 10 days after my vaccine) I developed redness on my arm and some swelling around the injection site, followed by a ring of light bruising, and the area is warm to the touch and sometimes itches.  It is not negatively impacting my daily activities, but it is odd to see a reaction like this 10 days after receiving the vaccine.  I've been advised by my doctor to take Advil if needed for soreness and inflammation, and take Benadryl (one 25 mg tablet) as needed for the reaction.
This spontaneous report as received from a healthcare worker refers to an unspecified time amount of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, those patients were vaccinated with doses of LIQUID PEDVAXHIB injection (lot number, dose and route were not reported) that underwent a temperature excursion. The physician reported that the refrigerator temperature had been 57.16 degrees Fahrenheit. The time frame period was from April 2014 to June 2014. Concomitant therapies were not reported. No adverse effect was reported. The physician enquired if patients whom received an improperly stored vaccine, on an unspecified date in 2014, should be re-vaccinated. This is one of several reports from the same reporter. Additional information has been requested.
Freezing cold; Aches; Chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Freezing cold), PAIN (Aches) and CHILLS (Chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING COLD (Freezing cold), PAIN (Aches) and CHILLS (Chills). At the time of the report, FEELING COLD (Freezing cold), PAIN (Aches) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.   Reporter did not allow further contact
Lymph nodes in my left armpit were tender and swollen the day after my Moderna booster shot on 11/20/2021, and I was very fatigued. I had streaking aches radiating from my left armpit through my arm. After varying degrees of lymphatic system inflammation on my left side (including my groin) and the back of my left thigh over a couple of weeks, I started experiencing tender and swollen lymph nodes in my right armpit, too, with the same streaking aches radiating from that right armpit. I continued to experience fatigue. Then the lymph nodes on the right side of my groin became tender and swollen. And the back of my right thing had aching streaks. In mid-December, my throat was hurting and my tonsils were inflamed, and I looked to have tonsillitis. I got a COVID-19 test which turned out to be negative. My kids tests were positive. Over the winter/holiday break while my children isolated in our home with COVID, I had flu-like symptoms (fatigue, headache/head pressure, sore throat, chest tightness, body aches). The inflamed lymphatic system symptoms (aching and tenderness) continued and I noticed were accompanied with neuropathy that started in my left arm and spread to other parts of my body. I don't know if the neuropathy started with the first reactions the day after the booster or not. But I noticed it distinctly in the middle of December. The neuropathy was roving. It started to affect both sides of my body. I felt it in my left chest, left armpit, left leg, mons pubis, right arm, right leg, abdomen, etc. I noticed a soreness and tightness under my left clavicle and in my upper left chest and inside in my trachea area. Since feeling sick, I've taken Vitamin C, D, B and Zinc and a multivitamin. When the symptoms were not resolving, I saw my doctor and took another COVID test at local clinic which was negative. The tests from the doctor were all fine. My blood work was fine. I was negative for strep and mono. EKG was fine. I went to get a chest x-ray. It was fine. The flu-like symptoms and lymphatic system tenderness and soreness started resolving around the week of January 17th. As of today, February 8, 2022, the neuropathy has not resolved but is becoming less intense on most days, Although on some days it is still intense.
Information has been received from a physician concerning a male who was vaccinated with an oral dose of Rotateq. Subsequently the patient experienced a low grade fever and crankiness. It was reported that the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
pt recvd vax 6AUG93 & w/in 12-24 hrs devel a local react consisting of swelling, itching & induration in the lt upper arm; the inject site was red & hot to the touch; also devel diarrhea, nausea, vomiting; devel a raised red rash;