chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHHY2012US051973 is an initial literature report received on 12 Jun 2012. Authors searched VAERS for reports for adverse events (AEs) in pregnant women who received trivalent inactivated influenza vaccine from 01 Jul 1999 through 30 Jun 2009. This case refers to a pregnant female patient (age not specified). She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) at an unknown gestational age, on an unspecified date between 01 Jul 1999 through 30 Jun 2009. On an unspecified date after vaccination she was diagnosed with autoimmune hemolytic anemia. The outcome of pregnancy was not reported. The causality was not reported. Authors stated that the VAERS system does not allow for active follow-up of adverse events among pregnant women; thus, pregnancy outcome data are not available for women who had an adverse pregnancy event. Authors concluded that no unusual patterns of pregnancy complications or fetal outcomes were observed in the VAERS reports of pregnant women after the administration of trivalent inactivated influenza vaccine.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient stated she received the 1st dose of SHINGRIX vaccine in April of 2018. She experienced pain at the injection site that lasted for about 3 hours with dose one. She experienced pain at the injection site with dose number two and that lasted for about one hour and it was less severe than the dose one. The reporter gave consent to follow up. No further details were provided. For tolerance after 2nd dose of SHINGRIX, refer case US2019052631.
no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 22-MAY-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, lot # R034700, expiry date 16-JUN-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 Fahrenheit degrees for 4 hours and 54 minutes. Digital data logger was involved. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000926: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000927: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000928: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000929: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000862: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000882: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925:
After vaccination, we were notified of temperature monitoring issue prior to arrival at our clinic.  Patient called and informed of recommendations to revaccinate.  Patient was revacicnnated n 10/14/2022.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient is a 73YO M with COPD, tobacco use, Crohn's disease, DM (Type II), GERD, CKD stage 3, Malignant tumor of lung, Obesity, Hyperuricemia, Iron deficiency anemia. Discharge notes from 2.5.21 says recent diagnosis with a cavitary RUL lung lesion who was admitted to the hospital for further evaluation for mycobacterial infection. He was recently hospitalized, where the lung lesion was incidentally noted during preop evaluation prior to patient undergoing repair of an incarcerated umbilical hernia. For NSCLC patient was getting treatment Chemo treatment. Per 2/17 notes patient requested to go to hospice. Patient was deceased on 5.6.2021.
Flublok was given to a 14 year old/no AE; Initial information received on 10-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 14 years old patient who was given vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot number not reported via unknown route.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to Inappropriate age at vaccine administration.  It was unknown if any adverse event occurred.  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 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  Information on the batch number was requested  List of documents held by sender: none
minor itching starting day following inoculation. The last couple of days, the itching has increasing noticeably.. There is a red circle of about three quarters of an inch diameter around the place of inoculation.
3 years ago received PNEUMOVAX 23 with no problems. 1 year ago received PREVNAR 13 with no problems. Vaccination felt like flooded shoulder. Discomfort in shoulder started that night, lasted for 2 days and gradually subsided. 12 days later still there is discomfort in muscle. After vaccination area got swollen and hard. Next morning irregular heart beat started to this day still has palpitations. Reported to doctor via call on 3/20 and today to pharmacist.
Patient with history of syncope. After after administering HPv4#1 and MCV#2 patient felt faint and passed out with muscle tightening x 2 within 15 min of each event.
I received the 1st moderna shot on 12/23/20. A couple hours later I experienced extreme fatigue. My memory became cloudy and I was so tired that I had difficulty walking. This fatigue lasted the rest of the day. I awoke the next morning with less fatigue but feeling hungover. I also had blurry vision that morning. The blurry vision abated within 5 hours. The fatigue was much improved within 36 hours. My allergy symptoms were triggered the day after the shot and my dermatitis flared within a couple days of that- super annoying because I have significant allergies and dermatitis that took specialists a couple years to control. All was "in remission" until the covid vaccine. Hoping that everything better by tomorrow- fingers crossed.
Woke up feeling very itchy with welts and hives all over the red marks.  This has persisted and happens whenever something comes in contact with my skin.   Rash, welts, and hives appear if I scratch my skin.  They usually go away after 30 minutes.  Symptoms subside with Benedryl or Zyrtec.  Symptoms come back after medicine wears off.
Patient described a local reaction on her right arm that was warm to the touch, painful, and swollen that started approximately the day after the vaccine was given and lasted about 5 days. She said also, about 1-2 days after vaccination she started seeing a rash on her right arm, mostly forearm, that has since spread to her other arm and stomach; now it is on her hands somewhat. She has been taking Benadryl, which has helped the itching.  When asked to describe the way the rash looks, she denies any fluid filled looking bumps, but says yes to red raised bumps.
Numbness tingling internal vibrations in legs feet hands. Neuropathy symptoms in hands and feet started after second dose and continues now after 2 1/2 months.  Tried course of prednisone minimal improvement
[Moderna] use for COVID-19 under Emergency Use Authorization (EUA): Patient received two doses of vaccines and had breakthrough infection, hospitalization.
Initial report received from a HCP on 23 Dec 2009. The patient was vaccinated with S-OIV FLUVIRIN (batch no 960374P) 0.5 ml, intramuscular, on 17 Dec 2009. The patient experienced with flu-like symptoms, including fever, chills, and muscle pain on the same day, 17 Dec 2009. The outcome of the events were reported as condition unchanged.
Shingles; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0182), via an unspecified route of administration in left arm on 12May2021 (at the age of 56 years old) as single for covid-19 immunisation. Medical history included chronic atrophic gastritis, prediabetes, gluten sensitivities. The patient had known allergies to shellfish, Bentyl, sulfa meds. There were no concomitant medications. The patient did not receive other medications in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0171), via an unspecified route of administration in left arm on 21Apr2021 (at the age of 56 years old) for covid-19 immunisation. On 15Jun2021 patient experienced shingles. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 25Jul2021. The event resulted in [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. Therapeutic measures were taken as a result of shingles with gabapentin and Tylenol with codeine. The outcome of event was recovered with sequelae on an unspecified date in 2021.
muscle pain; tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021766644 (Pfizer).  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Jun2021 (Lot number: EW0164) at the age of 40 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, LOT: ER8703, NDC: Unknown, Expiry Date: Unknown, injection, left arm, unknown dosage, time: in the morning), administration date: 11May2021, when the patient was 40 years old, for COVID-19 immunization. The following information was reported: MYALGIA (non-serious) with onset 02Jun2021, outcome "not recovered", described as "muscle pain"; FATIGUE (non-serious) with onset 02Jun2021, outcome "not recovered", described as "tiredness".  Additional information: Caller stated that she was not sure about her height, maybe 5 ft 2 in. Caller stated that she just wanted to know how long this would be going on, she was not sure. Caller stated that it started after she took the last vaccine. Second dose on 01Jun2021, LOT: EW0164, NDC: Unknown, Expiry Date: Unknown, Injection, left arm, unknown dosage, time the vaccination was given in the afternoon. Caller stated that she felt it 2 days after. Stated that she did not want her kids to get the vaccine if they were going to feel the way that she felt. No emergency room or physician office required for AE. No prior vaccinations (within 4 weeks) or other vaccinations was given within four weeks prior to the first. Relevant tests were none.  No follow-up attempts are possible. No further information is expected.
Planter facialitis like symptoms  Julianne barre like pin and needle pain on feet Knee pain
Both twins were sick throwing up, sisters fever got to 105, but she is fine. They would throw up though everyday for about a week, her more than him. He has some spells where when he is playing he will stop and his eye will go up to the left and he will blink a lot, then stop blinking but his eyes will still be there, then he will stop and go back to playing. The doctors are thinking it is a seizure we are going to be going to a neuro the end of the month at hospital, because it hasn't stopped he is doing it more. It started around the time he got the shot.
Itching, hives all over body.  Started on arms and within 24 hours covered 1/2 of his body in patches of hives.
On 4/27/21, client was brought to vaccine site by case manager, who stated that he is homeless and currently at an inpatient psychiatric facility awaiting placement and needed a COVID vaccine in order to get housing. Case manager assisted client fill out Vaccination Screening Form with client signing it. After reviewing answers to questions with client (client denied having been vaccinated previously), Moderna vaccine was administered at 14:45. Client was monitored for the required 15 minute observation, with no adverse effects and stated "I feel fine." Two hours later, after the close of the vaccine clinic, documentation of the vaccine discovered that a previous COVID vaccine dose had been documented on 2/03/21. Th
Following the last 2 doses of Prevnar, a few days later the pt experienced wheezing and respiratory distress.
Patient reports adverse event as therapist told her to do so.  She reports a severe headache on the evening of 12/03/2004 and by 12/04/2004 she went to the ER. By this time was experiencing pain and swelling in left arm that required to be ice packed for 1.5 days. She is currently in therapy for her left arm. Reports no more headaches and improving left arm.
Shingrix sprayed out when reconstituted; Product Complaint; This case was reported by a other health professional via call center representative and described the occurrence of intercepted product preparation error in a female patient who received Herpes zoster (Shingrix) (batch number ya29d, expiry date 6th October 2023) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted product preparation error and pharmaceutical product complaint. Shingrix was interrupted. On an unknown date, the outcome of the intercepted product preparation error and pharmaceutical product complaint were unknown.   Additional Information: GSK receipt date: 23-Nov-2022 Reporter's comment: An administrator from a medical clinic stating that they had a dose of Shingrix that sprayed out when the nurse went to withdraw the reconstituted vaccine, not enough of the vaccine was able to be withdrawn to make a full dose and they did not have another dose on hand to give the patient.  The patient was not able to get the vaccine at that time. The nurse reconstituting the vaccine was an experienced user.  None of the vaccine in question was given. Asked the questions as per content. The reporter answered the questioned as 0.25 ml vaccine was left in the affected vial, the nurse stopped trying to withdraw the vaccine after it started to spray out, the stopper pierced was in the circular area dedicated to perforation, no air was injected into the vial, the nurse could not told exactly where the leak was coming from, no the vial rubber stopper/metallic skirt detach or become loose during handling or without any manipulation, only the plastic flip top was removed before handling the vial and there was no evidence of leakage in package or carton (example wet PIL or faded label) Related product quality complaint report was completed.  The reporter will send pictures and request to please send a single dose replacement to the clinic and also send a return shipping label for them to mail back the defective vials. Did not consent to follow-up. Additional supportive information: A dose of Shingrix that sprayed out when the nurse went to withdraw the reconstituted vaccine, not enough of the vaccine was able to be withdrawn to make a full dose, which led to intercepted product preparation error. In worst approach case was processed with intercepted product preparation error as the vaccine was leaked while handling during reconstitution and even the patient was not involved. Product complaint event was coded in worst approach as product complaint reference number was reported.
Vaccine error: 5/24/23 I had asked Dr. what immunizations pt was due for. I sent her a list asking if he was due for Hib, PCV, dtap, polio and hep 3. Per doctor he was due for all 5. I confirmed with her again the list of immunizations and she stated yes those are the ones he is due for. At the time the patient was in office for his well child appt we had to call emergency services for pts mother due to her severe SOB. At that time I had stayed with the child and his father while EMS was taking care of pts mother. Pt, myself and pts father switched over to another room to give EMS some space to get pts mother on a stretcher to take her to the ER during this time CMA was helping gather the immunizations the pt needed while I was with pt and pts father in room 1. I confirmed the list with CMA the immunizations doctor had requested while I stayed in room 1 while she went to grab them.  Upon reconcile with RMA, office manager she noticed some immunizations missing upon reviewing pts immunizations given that day it appears pt was given all the correct vaccines except one. After RMA, myself and CMA reviewing vaccines looks like pt was given a meningococcal instead of PCV which meningococcal is not recommended until age 12. I did call and check on pt and his mother the next day which both was doing fine. I also reached out again the next week both still doing well.
exacerbation of her thyroid autoimmune condition; exacerbation of her thyroid autoimmune condition; fatigue; aches; weakness; Initial information received on 11-Aug-2021 regarding an unsolicited valid serious case from a consumer.  This case is linked to case 2021SA266989.  This case involves a 47-year-old female patient who experienced exacerbation of her thyroid autoimmune condition (autoimmune thyroid disorder and condition aggravated), fatigue, aches (pain) and weakness (asthenia), after receiving INFLUENZA VACCINE.  Medical treatment, vaccination, concomitant medication and family history were not provided.  At the time of the event, the patient had ongoing Autoimmune thyroid disorder.  On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number: unknown and expiration date: unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious fatigue, aches (pain), weakness (asthenia) and exacerbation of her thyroid autoimmune condition (autoimmune thyroid disorder and condition aggravated), (unknown latency) following the administration of INFLUENZA VACCINE. These events were assessed as medically significant.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of events were reported as unknown.  Information on the batch number was requested.; Sender's Comments: This case involves a 47-year-old female patient with autoimmune thyroid disorder who had her condition aggravated with fatigue, pain and asthenia, after receiving INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. Additional information regarding patient's other medical history, condition at the time of the events, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Immediately after receiving the vaccine, patient began complaining of a metallic taste in her mouth; burning of her tongue and lips; swelling of lips; burning of hands and feet; and tinnitus.
Severe inflammation in the left eye; This is a spontaneous report from a contactable consumer (patient himself) via COVID-19 Vaccine Adverse Event Self-Reporting Solution (COVAES) portal. A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 26Apr2021 at the age of 46 years old (Batch/Lot Number: EW0171, Expiration date: unknown) as dose 1, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at the public health clinic/veterans administration facility. The patient had no medical history. There were no concomitant medications. The patient had not received any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On an unspecified date in 2021, the patient experienced severe inflammation in the left eye, which started about a week, week and a half after the first dose and had been present since at different levels of severity. The reporter assessed the event as non-serious. The adverse event did result in a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of severe inflammation in the left eye, which included antiviral medications (meds), antibiotics, and steroids. Since the vaccination, the patient had been tested for COVID-19; the patient underwent COVID-19 test via nasal swab: negative post vaccination on 27Aug2021. The patient was not recovered from severe inflammation in the left eye at the time of the report.