chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report was received via a search of the scientific literature on 28 December 2014. A total of 1596 out of 26,229 women experienced chorioamnionitis after receiving ADACEL or another Tdap vaccine during pregnancy. Lot numbers and dates of vaccination were not reported, however all pregnancies ended in live births between 01 January 2010 and 15 November 2012. Women were between the ages of 14 and 49 years of age, and "the majority of Tdap doses administered to pregnant women were ADACEL". Chart reviews were performed on a random sample of 220 of the patients: the median gestational week of vaccination was 28 weeks, 200 were treated with antibiotics, and 209 had an epidural. Outcome was not reported. The following is verbatim from the article: "IMPORTANCE In 2010, due to a pertussis outbreak and neonatal deaths, the Department of Health recommended that the Tdap be administered during pregnancy. Tdap is now recommended by the Advisory Committee on Immunization Practices for all pregnant women, preferably between 27 and 36 weeks' gestation. Limited data exist on Tdap safety during pregnancy. OBJECTIVE To evaluate whether maternal Tdap vaccination during pregnancy is associated with increased risks of adverse obstetric events or adverse birth outcomes. DESIGN AND SETTING Retrospective, observational cohort study using administrative health care databases from 2 Vaccine Safety Datalink sites. PARTICIPANTS AND EXPOSURES of 123,494 women with singleton pregnancies ending in a live birth between January 1, 2010, and November 15, 2012, 26,229 (21%) received Tdap during pregnancy and 97,265 did not. MAIN OUTCOMES AND MEASURES Risks of small-for-gestational-age (SGA) births (<10th percentile), chorioamnionitis, preterm birth (<37 weeks' gestation), and hypertensive disorders of pregnancy were evaluated. Relative risk (RR) estimates were adjusted for site, receipt of another vaccine during pregnancy, and propensity to receive Tdap during pregnancy. Cox regression was used for preterm delivery, and Poisson regression for other outcomes. RESULTS Vaccination was not associated with increased risks of adverse birth outcomes: crude estimates for preterm delivery were 6.3% of vaccinated and 7.8% of unvaccinated women (adjusted RR, 1.03; 95%CI, 0.97-1.09); 8.4% of vaccinated and 8.3% of unvaccinated had an SGA birth (adjusted RR, 1.00; 95%CI, 0.96-1.06). Receipt of Tdap before 20 weeks was not associated with hypertensive disorder of pregnancy (adjusted RR, 1.09; 95% CI, 0.99-1.20); chorioamnionitis was diagnosed in 6.1% of vaccinated and 5.5% of unvaccinated women (adjusted RR, 1.19; 95%CI, 1.13-1.26). CONCLUSIONS AND RELEVANCE In this cohort of women with singleton pregnancies that ended in live birth, receipt of Tdap during pregnancy was not associated with increased risk of hypertensive disorders of pregnancy or preterm or SGA birth, although a small but statistically significant increased risk of chorioamnionitis diagnosis was observed." Documents held by sender: None.
Fever of 99.6, muscle aches, severe headache, chills, nausea
At 4:20pm approx. 13 minutes after receiving first dose Pfizer, patient began to experience itching and rash from right arm to face.  At 4:28 patient took Oral 25mg Benadryl , given by EMT Paramedic. EMT took vitals: BP 158/104, Pulse 68, O2 99%.  Patient declined 911 call/ambulance. 4:46pm Patient left with OK from EMT. She said she felt better.
Symmetrical swelling and pain in hands, wrist, and knees. Severe malaise and fatigue, brain fog
Hives on (R) arm and face 2 days after flu vaccine. Came to clinic 4 days post vaccination with hives remaining on face and arm. Give BENADRYL 25-50 mg Q 4-6 hrs as needed.
No adverse effect; The patietn was administered a dose of improperly stored VARIVAX; This spontaneous report has been received from a nurse, concerning to a patient of unknown age and gender.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies were not reported. Concomitant therapies included sterile diluent.  On 23-JUL-2019, the patient was vaccinated with a dose of improperly stored (product storage error) of varicella virus vaccine live (oka/merck)(VARIVAX) (dose, frequency, and anatomical location were not reported)  (lot # R026715 and expiration date 18-SEP-2020) as prophylaxis.   In addition, temperature: total time in the range -9°C to 8°C (8.2C); time frame: 6 hours 12 minutes, with no previous temperature of excursion. The excursion call was made by a data logger.; Sender's Comments:  US-009507513-1907USA015149: US-009507513-1907USA015150:
This spontaneous report as received from an other health professional refers to a patient of unknown age. On 08-JUL-2017, the patient was vaccinated with ROTATEQ lot # M038208, oral for prophylaxis. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA002122: US-009507513-1708USA004693: US-009507513-1708USA004692: US-009507513-1708USA004691.
tiredness; headache; muscle pain; chills; joint pain; fever; not feeling well; injection site pain; This is a spontaneous report from a contactable consumer. A 58-Years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 31Mar2021 as single dose for Covid-19 immunization. Patients medical history and concomitant medications were not reported. It was reported that patient's sister went in for a chest x-ray and COVID-19 test & the x-ray was clear but she tested positive for COVID-19. Patient had a question, should I wait to go tested or should I just proceed with my second dose. Response received as Spoke from attached document, explained ACIP recommendation, and referred to HCP for further guidance. Patient experienced 8 of the possible side effects as tiredness, headache, muscle pain, chills, joint pain, fever, not feeling well, and injection site pain. Outcome of the event was unknown  No follow-up attempts are needed. No further information is expected.
Onset of a large painful purple blue lump at the injection site within 90 minutes of the vaccine. Progressive pain and swelling at the site for one week with pain traveling down the left arm and up to the left shoulder and upper back. Development of a large raised, itchy red skin lesion at the injection site on day eight followed by a blotchy itchy rash of the left arm, shoulder an upper back. Symptoms progressed until day ten when a Medrol Dosepak was started. The rash and lump on the left arm resolved within twelve hours but intermittent pain of left arm persists.
This worsened the dissociative symptoms of my OSDD/DID.  It's not clear if this was the result of a high fever from the vaccine or something else, but it was like taking my normal dissociative symptoms and magnifying them by 100.  It's a very difficult experience to describe because I wasn't fully aware of everything.  For those that understand DID, we were switching constantly and also not knowing who we were and Littles were out and not understanding what was happening and were mixing currently pain and confusing with past trauma.  I'm not certain how you would investigate this and I don't think this would be a common reaction either, but it could be a common reaction for people with dissociative disorders.  I haven't experienced that intense of a reaction from any other vaccine.
Patient given vaccine on 12/05/2019 - right gluteal (at patient's request-did not want deltoid injection), patient reported to ER on 12/13/19 with cellulitis/right gluteal area - given keflex 500 mg q6 hours to finish 7 day course from emergency room.  Seen in follow up on 12/16/19-SKIN large area of pink/erythema well demaracated over majority of right glute, no TTP. Advised to finished Keflex as prescribed. Seen again on 12/20/19-SKIN no suspicious lesions in exposed areas of skin, warm and dry, the area on the right buttocks where injection was is clean without induration or swelling. There is slight tenderness to deep palpation.
Tested COVID positive on 3/25/2021 after receiving both doses of COVID vaccine on 2/8/21 & 3/8/21
Dull chest pain in sternal area that came and went for 3 hours. Pain escalated to excruciating pain twice during this time period. Would then return to a lesser dull pain after 2-3 minutes.
Violent vomiting; diarrhea; fever; nausea; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8982) via an unspecified route of administration in the left arm on 16Mar2021 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history included celiac disease. Concomitant medications included levothyroxine sodium (SYNTHROID) 100mcg, metoprolol (MANUFACTURER UNKNOWN) 50mg and vitamin d nos (VITAMIN D); all for unspecified indication from unknown date. The patient previously took azithromycin (MANUFACTURER UNKNOWN) for unspecified indication on unknown date and experienced drug allergy. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 23Feb2021 at 11:30 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. 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. On 18Mar2021 at 18:00, the patient experienced violent vomiting, diarrhea, fever and nausea for four days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event.  The clinical outcome of the event violent vomiting, diarrhea, fever and nausea for four days was recovered on 22Mar2021.   No follow-up attempts are needed. No further information is expected.
Non-Stop ringing in my right ear, dizziness, forgetfulness, fogginess   Doctor stated there is no treatment available.  Since there has not been enough research, they believe it is not linked to COVID.
Client's original CDC card was incorrectly written as being Moderna, not Pfizer. Client received Pfizer correct dose today. Card was corrected and client was informed. Client scheduled for 2nd dose of Pfizer at appropriate interval.
Information has been received from a registered nurse concerning a 21 month-old white female who in October 2002, was vaccinate subcutaneously with a dose of varicella virus vaccine live. The mother of the patient reported that on 23-July-2003, the patient developed a "chicken pox lesion on her face, and the next day more lesions appeared". The lesions first appeared "on her face, and then moved to her chest, to her diaper area, then to her legs" and progressed to other parts of her body. It was noted that it "was severe in nature" and as of 07-Aug-2003 the "patient was still developing new lesions". It was also noted the child was "quite sick". The nurse did not treat the patient and did not know who the treated physician was. It was unknown if a prescription drug was required for treatment. It was also noted that the physician may not be contacted. Unspecified medical attention was sought. There was no product quality complaint involved. No additional information was provided. Follow-up information indicated that the nurse spoke with the patient's mother and "the child was misdiagnosed". The child had impetigo, not chicken pox. The child has been treated and is fine." No additional information is expected.
Day after injection I woke up with stiff and achy all over and had redness and swelling from injection site to right above elbow. Then ext day the swelling in redness went below the elbow. I went to my doctor and he prescribed Hydroxy HCL 50 mg. The swelling lasted 4 days.
Parent reports that child felt "woozy" and was unable to eat lunch.  Child was in school and reported to the nurses office and had a temperature of 101 degrees.  Later in the day temperature rose to 102 degrees.  Dad called PHN the next day and reported that the childs temperature went up to as high as 103 degrees overnight. No other symptoms besides lack of appetite and lethargy.
Left arm edema, erythema and pain. Seen in office, tried OTC meds with no relief. Prescribed KEFLEX and MEDROL Pak for Dx: cellulitis.
stated that the vaccine expired on 10/1 and was administered to a child today 10/9 with no reported adverse event; Initial information received on 09-Oct-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 6-months-old male patient who was administered diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV (vero)/ HIB(PRP/T) vaccine [Pentacel (Vero)] today (10/9) that had expired on 10/1 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant: none.  On 09-Oct-2023, the patient received 0.5 mL expired dose 3 of suspect diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV (vero)/ HIB(PRP/T) vaccine, suspension for injection (Strength: standard; Frequency: once) (batch number: UJ807AA; expiry date: 01-Oct-2023) via intramuscular route in the right thigh for Immunization with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  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.
patient became flushed, stated hard to breathe, headache, nausea and back ache
Menstrual cycle changes. MC appeared 9 days early, heavier, and with a clot (very unusual for patient). Otherwise MC the same as normal eg length and pain. No concerns about long term fertility but wanted to share unusual response.
Per the doctor's office, the patient had swelling and redness at the injection site, rashes throughout her body, fever and aches. The Dr. office prescribed a taper of prednisone and told the patient to take over the counter ZYRTEC. Patient has not started therapy yet.
Patient developed painful bumps under skin on legs now turned red. Symptoms started 10-14 days after immunization.
Presented to ER on 9/30/06 with c/o redness and tenderness surrounding his smallpox vaccination site. Received his smallpox vaccination on 9/19/06 and had area checked on 9/28/06 and it looked fine. The redness and tenderness developed on the 30th. He had been involved in training on the 29th and 30th. L upper arm smallpox vaccination site with 6 by 10cm area of warmth, redness and erythema surrounding the area of his previous vaccination. Some break down and maceration of the central area was noted. The area was indurated and warm, consistent with cellulitis. He was given Ancef 2 grams IV piggy-back and was started on Clindamycin 150mg 2 tablets four times a day for 10 day. Warm compresses ordered for four times a day, keep area dressed and clean. SM followed up on 10/2/06. Was to continue on Clyndamycin, RTC to clinic 3 days or prn. Light duty x 3 days.
Received fist Moderna Vaccine 12/30/2020. 01/07/2021 Started with bil leg numbness and weakness. By 1/15/2021 numbness constant both legs. Electric shock sensation at times down spine to feet. Weakness both legs started 1/18/2021. Neurologic injury being worked up for transverse myelith.
Diarrhea; Frequent urination; 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 DIARRHOEA (Diarrhea) and POLLAKIURIA (Frequent urination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 DIARRHOEA (Diarrhea) and POLLAKIURIA (Frequent urination). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient stated she started to feel ill on Tuesday morning 12/18/2018. She had a fever of approximately 102.00 F as well as nausea, shaking, and muscle pain all over. As of Wednesday morning her fever has stopped however she was still experiencing chills and muscle pain all over. She was planning on going home to rest and drink plenty of fluids. If she did not start feeling better by Wednesday evening or if she felt worse she would go to urgent care.
After receiving the vaccine I noticed my gums were bleeding when brushing and flossing, this continues to this day but is resolving, I was very tired the week after the vaccine as well.  I donated whole blood on March 6, 2021 at 8:45am  at the center and when the donation was complete, they were unable to stop my arm from bleeding. After 20 minutes of pressure, they lifted the gauze, and it was still bleeding.  Tight coban was applied and I left the donation facility. Upon returning home (10 minutes later) the gauze and coban was blood soaked.  I purchased coban and re-wrapped my arm. The bleeding did not stop until after 1:30pm, with oozing continuing until 4:00pm. The site was warm and red. Ice was applied. The bruising on my arm is significant, and it is still hard where the hemaotma is. I saw my primary care provider today 3/10/21, blood work was ordered and is pending.
Red swollen leg. Had red speckled rash that turned into big red rash. Just a local reaction. Not having trouble breathing. MOC was advised to give pt Benadryl and call if symptoms worsened.
Difficulty to sleep; Throbbing pain at injection site; Swelling at the injection site like a nut; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Difficulty to sleep), VACCINATION SITE PAIN (Throbbing pain at injection site) and VACCINATION SITE SWELLING (Swelling at the injection site like a nut) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRINE), LOSARTAN, BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE (BISOPROLOL /HCTZ) and ATORVASTATIN for an unknown indication.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced INSOMNIA (Difficulty to sleep), VACCINATION SITE PAIN (Throbbing pain at injection site) and VACCINATION SITE SWELLING (Swelling at the injection site like a nut). The patient was treated with NAPROXEN SODIUM (ALEVE) for Pain, at an unspecified dose and frequency. At the time of the report, INSOMNIA (Difficulty to sleep) and VACCINATION SITE SWELLING (Swelling at the injection site like a nut) outcome was unknown and VACCINATION SITE PAIN (Throbbing pain at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Throbbing pain caused difficulty to sleep.
19Jan98 Pt recv 1dose vax. Approx 2 hr post vax Pt exp bilateral shoulder pain,fever,cough,h/a & general malaise. Health care professional indicated the Pt devel the flu & "this was not an adverse rxn to Varivax.
Chest pain-ER visit X3 (05-08-201)(06-17-2021)(08-09-2021) Nausea, fatigue, weight loss, insomnia Diagnosed with pericarditis on 08-09-2021 Multiple appointments with PCP
Wednesday, March 24th (shot this day @12:40pm) - 6:45pm: Started with slight headache, moved to chills, dizziness, nausea, and fatigue within 6-7 hrs of receiving shot. Elevated temperature (99) Took recommended Tylenol dose right before onset (7pm). Thursday March 25: Woke up next day 8am: felt like hit by a truck. Headache was strong again. Nausea, chills and elevated body temp. - 1pm: took ibuprofen, laid in bed, fell asleep 2hrs and was in sweats. Woke up, droggy, slow, and within 30 mins I felt so much better  Past few days dull headaches  Took Tylenol took edge of body pain...but still felt body pain but not as pulsating.  2pm
I have experienced persistent headaches characterized by dull, throbbing pain in the temporal region. These headaches began approximately and after the vaccination and have been recurring. I have also experienced fatigue in the aftermath of the vaccine suffering from a profound sense of physical and mental tiredness which also began approximately and after the vaccination.
Initial information received on 11-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case was linked to 2018SA285348 (same reporter). This case involves a 25 years old patient of unknown gender who experienced blue or green bruising, hot to the touch, swelling, while he/she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapies taken. On 10-Oct-2018, the patient received a single 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ035AA (expiry date: 30-Jun-2019) via unknown route in the right arm. On an unknown date, The patient experienced bruising, swelling, hot to the touch and blue or green bruising one day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On 11-Oct-2018, patient required visit to doctor. It was a case of actual medication error due to incorrect product storage. It was reported that there being a suspicion that the vaccines might have gotten to cold and perhaps frozen in the refrigerator. Final diagnosis was swelling, hot to the touch and blue or green bruising. Lab tests not reported. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for blue or green bruising, as Unknown for swelling, hot to the touch and blue/green bruising. 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 Directive 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.